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Full text of "Global Biosecurity
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1 NATIONAL LAW SCHOOL |
OF INDIA UNIVERSITY |
BENGALURU
oe
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_ Pe
pine Anee eee
GLOBAL
BIOSECURITY
GLOBAL
BIOSECURITY
Towards a New
Governance Paradigm
By
Nayef R.F. Al-Rodhan
Lyubov Nazaruk - Marc Finaud - Jenifer Mackby
Editions Slatkine
GENEVE
2008
urchased:
Approval:
Gratis: U2569
Acc No:
Price:
ONara,
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National 1
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Cover page:
Earth: NASA, Earth Science, Apollo 17.
© 2008. Editions Slatkine, Genéve.
www.slatkine.com
Reproduction et traduction, méme partielles, interdites.
Tous droits réservés pour tous les pays.
ISBN 978-2-05-102054-1
CONTENTS
Part 1
Acknowledgements .
Situating Global Biosecurity
|. Biosecurity as a Significant Global Security Issue
2. Overview of the Book
Past, Present, and Future Challenges
Introduction to Biosecurity
1. Multiple Discourses of Biosecurity and Biosafety
2. Biological Risk Management
3. Understanding Biosecurity from the Historical Perspective
Foci of Biosecurity
1. Biological Threats
2. Bioterrorism
3. Intentional or Unintentional Misuse of Life Sciences
and Technology (the ‘Dual-use Dilemma’); Genetic
Manipulation
4. Biological Threat Agents
New Technologies and Their Implications for Biosecurity
1. Life Sciences
2. Biotechnology: Promises and Perils
3. Nanotechnology and Genomics
4. Information Technology
5. Microbial Genome Databases
6. Ethical Implications of New Technologies
13
16
Part 2
Containing Biological Risk:
Biosecurity-related National and International Norms
1. Deliberate Hostile Use of Biological Agents: Biological
Weapons
2. Deliberate Hostile Use of Biological Agents: Biological
Terrorism
3. Protection Against the Natural or Accidental Spread of
Infectious Diseases
4. Redefining the Role of Scientists from the Military-
industrial Complex
Opportunities and Solutions
The Human Dimension of Biosecurity
1. Challenges of Poverty, Exclusion, and Development
2. ‘DNA for Peace: Reconciling Biodevelopment and
Biosecurity’
3. Importance of Education, Training, and Communication
4. Raising Awareness
5. Aiming at Transparency and Open Dialogue Between
Major Actors
6. Fostering a Culture of Shared Responsibility
Governance of Research in the Life Sciences
1. Knowledge and Transparency: A Call for a Global
Approach to Ensuring that Science Is Not Misused
2. Biosecurity and Secrecy
3. Proposing a New Code of Conduct for Scientists
4. The International Council for the Life Sciences
Harmonisation of Existing Biosecurity Standards and
Regulations
1. General Overview
2. Harmonising National Legislation
3. Life Sciences/Biotechnology-related Legislation
4. Biosecurity-related Legislation in International Law
5. Strengthening the Biological and Toxin Weapons
Convention
81
8]
9]
106
120
137
137
139
141
143
145
147
153
153
156
158
162
169
169
170
175
177
179
10
6. Attempts to Unify Global Biosecurity Measures and
Responses
Global Biosecurity Governance:
Search for a New Paradigm
1. Defining the Theoretical Foundations of a Global
Biosecurity Paradigm
2. Proposing a New Paradigm
3. Towards a Global Biosecurity Network
4. Redefining the Roles and Responsibilities of Actors
Involved
5. Defining a Global Biosecurity Strategy
6. Designing a Global Legal and Regulatory Framework
Conclusions
1. Mapping Future Biosecurity Threats
2. Future Policy Directions
3. Policy Recommendations
Index
183
191
19]
199
201
207
208
212
223
223
224
228
235
ACKNOWLEDGEMENTS
The authors would like to express their sincere gratitude to the
following people for their generous support in the publication of this
book.
We thank Ambassador Dr. Fred Tanner, Director of the
Geneva Centre for Security Policy (Geneva, Switzerland); Dr. Jean
Pascal Zanders, Director of the BioWeapons Prevention Project
(Geneva, Switzerland); and Mr. Terence Taylor, President and
Director of the International Council for the Life Sciences
(Washington, DC, United States), for their constructive and insightful
comments on the manuscript.
We are grateful to Bethany Reichenmiller for her invaluable
role in coordinating the production of this manuscript.
Finally, the authors would also like to express their special
thanks to the faculty and staff of the Geneva Centre for Security
Policy for their continued support.
The views expressed in this book are entirely those of the authors and
do not necessarily reflect those of the Geneva Centre for Security
Policy (GCSP).
CHAPTER |
SITUATING GLOBAL BIOSECURITY
1. Biosecurity as a Significant Global Security Issue
In the 21" century, the nature of global threats to peace and security is
becoming ever more complex. New challenges related to the risk of
the proliferation of biological weapons (BW) and the possible threat
of bioterrorism, combined with rapid progress in the life sciences and
biotechnology, have led the global public policy community to
consider biological safety and security as a major global security
concern and a significant problem requiring transnational cooperation:
“There is no issue that illustrates more vividly the need for and the
potential of global cooperation.”
We live in an era of rapid connectivity, interdependence, and
shared vulnerabilities of globalisation. In this context, biosecurity is a
truly global problem, as it does not respect any geopolitical borders. It
is a challenging, multidisciplinary field of ever growing interest to the
global community, governments, private industry _ scientists,
laboratories, as well as individuals. As underlined by the United
Nations (UN) High-level Panel on Threats, Challenges and Change, in
the near future, biosecurity and biological threats will position
themselves among the key global security concerns.’ This is why the
global policy-making community needs to find innovative and
integrative solutions in order to face these concerns constructively.
The two concepts of biosafety and biosecurity will be
analysed in a shared analytical and policy-making framework.
““Biosafety’ is a term whose meaning shifts with diplomatic and
scientific context, its two major usages relating to laboratory
containment and to biotechnology hazards. ‘Biosecurity’ is a closely
related term increasingly heard in arms control and in health and
agriculture; but which also lacks a consistent usage.” The broad
notion of biosecurity implies the safety of living organisms or the
freedom from concern for sickness and disease. It also refers to
14. GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
institutional and personal security measures aimed at preventing the
theft or misuse of pathogens and toxins. Some authors believe that
biosecurity ensures that systems maintaining either people or other
living organisms are preserved (which includes natural habitats and
productive enterprises such as agriculture), as well as “deals with
threats such as biological warfare or epidemics”.* In the last decade,
the term biosecurity has also been used to define security concerns
related to the misapplication of new technologies associated with the
life sciences. In the next chapter, we will provide a more detailed
discussion on what various actors mean by biosafety and biosecurity,
as well as offer our own definition of biosecurity.
The main driving forces of biosecurity include globalisation,
rapid technological advancements, and numerous emerging diseases.
As a result, major foci of biosecurity stem from: 1) the natural world;
and 2) the understanding, exploitation, manipulation, and use of
knowledge and materials derived from the natural world.”
Furthermore, “the risks (and uncertainties) of significant impacts from
harmful organisms ... [have been] increasing as a result of the
globalization of trade and travel, and transport; climate and land use
change; political instability; and crime (bioterrorism itself and other
crimes, such as smuggling, that involve living, potentially harmful
organisms)”.° Thus, the key components of biosecurity embrace such
aspects of security as physical, personal, information, transfer, and
material control.
One of the foremost challenges related to global biosecurity is
the proliferation of biological weapons. Such weapons may consist of
“pathogens (bacteria, viruses, or fungi which cause disease) or toxins
(chemical substances obtained from living organisms including
microbes and plants)”.’ It has to be noted that “[t]housands of
pathogens and toxins occur naturally; about 30 have been considered
potentially useful in biological weapons”.* This type of weapon offers
a relatively inexpensive method of inflicting mass causalities,’ which
means that improving defences against a potential biological attack
has become a major security issue.
Another major challenge to biosecurity is the rapid
technological advancement and the associated possibility of misuse
(as reflected in the potentially benevolent and malevolent uses of
technology). The benefits of the rapid advances in the life sciences are
impressive, but they can also pose risks when misused.'° Recent
progress in the life sciences and biotechnology has made possible
SITUATING GLOBAL BIOSECURITY 15
many kinds of manipulations that provide the potential, amongst other
things, to turn non-pathogenic agents into dangerous pathogens."
According to the International Committee of the Red Cross (ICRC), a
list of existing and emerging capabilities that might be misused
includes:
e “Deliberate spread of existing diseases such as typhoid,
anthrax and smallpox to cause death, disease and fear in a
population.
e “Alteration of existing disease agents rendering them more
virulent, as already occurred unintentionally in research on the
“mousepox’ virus.
e “Creation of viruses from synthetic materials, as occurred this
year using a recipe from the Internet and gene sequences from
a mail order supplier.
e “Possible future development of ethnically or racially specific
biological agents.
e “Creation of novel biological warfare agents for use in
conjunction with corresponding vaccines for one’s own troops
or population. ...
e “New methods to covertly spread naturally occurring
biological agents to alter physiological or psychological
processes of target populations. ...
e “Production of biological agents that could attack agricultural
or industrial infrastructure. ...
e “Creation of biological agents that could affect the makeup of
human genes, pursuing people through generations and
adversely affecting human evolution itself.”'”
There are a number of legal norms and instruments that aim to
address the main challenges to global biosecurity. One of the key
international agreements dealing with the issue of biological threats is
the 1972 Convention on the Prohibition of the Development,
Production and Stockpiling of Bacteriological (Biological) and Toxin
Weapons, also known as the Biological and Toxin Weapons
Convention (BWTC or BWC). It makes formal prohibitions against
the production and stockpiling of biological weapons,” which
embodies the law that was established in the 1925 Geneva Protocol
and promoted by various UN General Assembly Resolutions. This
16 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Convention creates the necessary foundation for the multifaceted
range of efforts that is required to effectively tackle the biological-
weapons problem. Nevertheless, “a major shortcoming of the BWC
was that, despite its comprehensive ban on biological weapons, it
lacked mechanisms for ensuring confidence in compliance”.
Some of the key BWC-related challenges that ought to be
resolved in the very near future include: a stronger support institution;
national implementation; enhancing transparency in the context of
information exchange and confidence-building measures; resolving
tensions in the relationship between non-proliferation and peaceful
cooperation; addressing advances in science and technology; and
achieving universality.'” In addition to the BWC, there are other legal
instruments in place. Unfortunately, as will be discussed in this book,
global biosecurity-related legislation is rather fragmented and
inconsistent, which implies that “a lack of understanding of the
differing priorities can hinder international cooperation in enhancing
biological safety and security”.'®
The challenges posed to preventing the proliferation of
biological weapons — “the dual-use character of materials and
equipment, the small amounts of agents initially needed and their
availability from natural outbreaks, and the dynamic nature of
biotechnology”’’ — require an effective approach to addressing the
issue of global governance of biological security. At present, there is
no globally designed and agreed-upon comprehensive strategy for
global biosecurity that would address the wide range of challenges
posed by biological threats. Taking into account the fact that there are
“many conflicting and vested interests”,'* it might be a difficult task to
develop such a strategy. Most importantly, any successful global
biosecurity governance model should be defined by all actors involved
in the process of governance of global biosecurity in order to provide
a meaningful framework for tackling major biosecurity-related issues.
2. Overview of the Book
The main purpose of this book is twofold: 1) to inform policymakers
and the general public on the key developments and trends in the
emerging field of biosecurity; and 2) to offer a roadmap for addressing
the issue of global biosecurity, by proposing a new comprehensive
paradigm of governance of global biosecurity.
SITUATING GLOBAL BIOSECURITY 17
The book is structured in the following way. The first chapter
situates biosecurity as a significant global security issue. The second
chapter provides a general introduction to biosecurity. It offers a
detailed analysis of the existing discourses of biosafety and
biosecurity, as well as presents an analytical framework for analysing
them. This chapter also looks at biosecurity from the historical
perspective. The third chapter discusses the major foci of biosecurity,
ranging from the existing and potential biological threats and
bioterrorism to various forms of misuse of the life sciences and
biotechnology. Chapter 4 analyses the main trends in the fields of the
life sciences, biotechnology, nanotechnology, genomics, and
information technology. It discusses the sensitive issue of the ethical
implications of newly emerging technologies. In addition, this chapter
examines the matter of microbial genome databases and _ their
repercussions for global biosecurity.
The fifth chapter offers a detailed analysis of existing
biosecurity-related national and international norms. It introduces the
major legal instruments covering the problems of deliberate hostile
use of biological weapons (the Brussels Declaration, the Hague
Conventions, the Geneva Protocol, and the Biological and Toxin
Weapons Convention). This chapter also discusses export control
regimes, the G8 Global Partnership, and the role of the International
Committee of the Red Cross in dealing with the problem of biological
weapons. Furthermore, it presents the legal instruments covering
issues of biological terrorism. It highlights some of the responses to
the challenge of biological terrorism that have been made by the
United Nations, the International Criminal Police Organization
(Interpol), the World Health Organization (WHO), the European
Union (EU), the Organisation for Economic Co-operation and
Development (OECD), the Organization for Security and Co-
operation in Europe (OSCE), the North Atlantic Treaty Organization
(NATO), the G8, the Global Health Security Initiative (GHSI), the
Program for Monitoring Emerging Diseases (ProMED-mail) of the
Federation of American Scientists (FAS), the Organization of
American States (OAS), the Association of Southeast Asian Nations
(ASEAN), and the Economic Community of West African States
(ECOWAS).
Chapter 5 also focuses on the national responses to
bioterrorism of such selected states as the United States (US), France,
and Japan. This chapter proceeds with an examination of the legal
18 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
instruments related to protection against the natural or accidental
spread of infectious diseases. In the spirit of analysing major
biosecurity-related projects and institutions across the world, their
contexts and achievements, the fifth chapter looks at the International
Science and Technology Center (ISTC) and the Science and
Technology Center in Ukraine (STCU). It concludes with a discussion
of the problem of redefining the role of scientists from the military-
industrial complex.
Chapter 6 focuses on the human dimension of global
biosecurity. It addresses the challenges to biosecurity stemming from
poverty and exclusion. This chapter also concentrates on the issues of
reconciling biodevelopment and biosecurity. It explains the role of
education, training, and communication in facing global biosecurity
concerns. This chapter also discusses the importance of nurturing
transparency, raising awareness, and fostering a culture of shared
responsibility and open dialogue between the major actors involved in
dealing with global biosecurity.
The seventh chapter focuses on the importance of governance
of research in the life sciences. It discusses knowledge and
transparency, policies of secrecy, as well as the great need for
designing and advancing codes of conduct for scientists. This chapter
also introduces the International Council for the Life Sciences (ICLS)
as a leading non-governmental institution dealing with the governance
of the life sciences. The eighth chapter addresses the problem of
harmonisation of the current biosecurity standards and regulations. It
discusses existing national legislation, life-sciences- and biosecurity-
related legislation in international law, and it analyses some recent
attempts to unify global biosecurity measures and responses.
The ninth chapter presents a new paradigm for addressing the
issue of global biosecurity governance. It starts by defining the
theoretical foundations of a proposed global biosecurity paradigm. It
then presents a new biosecurity governance model, its main actors
(governments, private industry, scientific community, academia, non-
profit organisations), structure (network-based, horizontal, flexible,
open, integrative), strategy (global, cross-cultural, transparent,
multidisciplinary, and reconciliatory) and legal framework (aimed at
being globally harmonised, legitimate, coherent, and built upon
commonly agreed concepts and definitions). This is a key chapter, as
it offers the policy-making community an innovative model for
tackling the challenge of global biosecurity. Finally, the last chapter
SITUATING GLOBAL BIOSECURITY 19
concludes with a reflection on future biosecurity threats. Most
importantly, it strives to map possible future biosecurity policy
directions and offers relevant up-to-date policy recommendations.
We hope that our study will make a meaningful contribution
to a better understanding of the current biosecurity concerns. We also
hope that the proposed global biosecurity paradigm will offer a good
roadmap for approaching the issue of global biological security from a
more integrative and inclusive perspective, one that encourages
greater mutual understanding.
REFERENCES
' B. Jones, “Bio-Security, Nonstate Actors, and the Need for Global Cooperation”,
Ethics & International Affairs, Vol. 20, No. 2, Summer 2006, http://www.cceia.org/re
sources/journal/20_2/roundtable/5395.html.
? United Nations, A more secure world: Our shared responsibility, Report of the
High-level Panel on Threats, Challenges and Change, UN documents A/59/565, 4
December 2004 and A/59/565/Corr.1, 6 December 2006, http://www.un.org/ga/59/do
cumentation/list5.html.
> The Sunshine Project, “Biosafety, Biosecurity, and Biological Weapons: A
Background Paper on three Agreements on Biotechnology, Health, and the
Environment, and Their Potential Contribution to Biological Weapons Control”,
October 2003, p. 2.
* See the draft National Biosecurity Strategy of the Commonwealth of the Bahamas,
p- 5, http://www.unep.ch/biosafety/development/Countryreports/BSNBFrep.pdf.
R. Murch, D. Franz, and P. Singer, “Global Biosecurity: The Vital Role of
Academic Leadership”, Occasional Paper No. 1, Virginia Tech’s National Capital
Region, Fall 2005, http://www.biosecuritycodes.org/docs/VTBioSecurity.pdf.
° L.A. Meyerson and J.K. Reaser, “Biosecurity: Moving Toward a Comprehensive
Approach”, BioScience, Vol. 52, No. 7, July 2002, p. 595, http://www.nrs.uri.edu/filea
dmin/files/LauraFiles/PdfReprints/Meyerson&Rearson2002_ BioSciences. pdf.
’ See the section “Biological Weapons” on the website of Australia’s Department of
Foreign Affairs and Trade, http://www.dfat.gov.au/security/biological_weapons.html.
Ibid.
” Office of Technology Assessment, Proliferation of Weapons of Mass Destruction:
Assessing the Risks (Washington, DC: Government Printing Office, 1993), OTA-ISC-
559, p. 53.
'° See Appendix 14A, “Enhancing bio-security: the need for a global strategy”, in R.
Roffey and F. Kuhlau, S/PRI Yearbook 2006, Armaments, Disarmament and
International Security (Oxford: Oxford University Press on behalf of Stockholm
International Peace Research Institute, June 2006), p. 738.
20 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
'! PB. Lista, “Genetic Databases of Bio-threat Agents”, OECD/Russian Federation
Workshop on “Biosecurity of Microbial Biological Resources — Complementing
Innovation”, Ministry of Education and Science, Moscow, 20-21 September 2006, p.
18, http://www.fp6-food.ru/meeting/2006/oecd/W orkshopbooklet.pdf.
!2 International Committee of the Red Cross, “Appeal on Biotechnology, Weapons
and Humanity”, 25 September 2002, http://www.icrc.org/Web/eng/siteeng0.nsf/htmlal
VSEAMTT.
'3 See the website of the Biological and Toxin Weapons Convention, http://www.opb
w.org/.
'4 J Borrie, “The Limits of Modest Progress: The Rise, Fall, and Return of Efforts to
Strengthen the Biological Weapons Convention”, Arms Control Association, October
2006, http://www.armscontrol.org/act/2006_10/BWC.asp?print.
'S See the section “Key Issues” on the BWC Observer website, http://www.bwc06.org
/key-issues.
'© T. Taylor, “Safeguarding Advances in the Life Sciences”, EMBO reports, Vol. 7,
No. S1, 2006, p. S64, http://www. iclscharter.org/images/Safeguarding advanceces_in
the life _sciences.pdf.
'7 C.F. Chyba, “Toward Biological Security”, Foreign Affairs, Vol. 81, No. 3,
May/June 2002, p. 127.
'§ World Health Organization, “Scientific Working Group on Life Science Research
and Global Health Security, Report of the First Meeting”, WHO/CDS/EPR/2007.4,
Geneva, 16-18 October 2006, p. 12, http:/Awww.who.int/csr/resources/publications/del
iberate-WHO CDS EPR _2007_4n.pdf.
PART 1
PAST, PRESENT, AND FUTURE CHALLENGES
CHAPTER 2
INTRODUCTION TO BIOSECURITY
1. Multiple Discourses of Biosecurity and Biosafety
For the purpose of intellectual and policy-making clarity, we believe it
is important to understand what various actors involved in the
governance of biological security mean by “biosafety” and
“biosecurity”. Although biosafety and biosecurity relate to rather
different aspects of biological risk (intended versus unintended), they
share a common goal of ensuring management of biological security.
Consequently, biosecurity and biosafety must be regarded as
coordinated, complementary systems. In the scientific and policy-
making communities, the terms “biosecurity” and “biosafety” are
often used to underline aspects of biological risk management that,
although interlinked, are still rather nuanced: “Whereas biosecurity
measures are intended to prevent deliberate diversion of deadly
pathogens for malicious purposes, biosafety measures are intended to
prevent accidental infections of researchers or releases of pathogens
from a research facility that could endanger public health or the
environment.”' According to the World Health Organization,
biosafety “describes containment principles, technologies and
practices that are implemented to prevent unintentional exposure to
pathogens and toxins, or their accidental release”, while “biosecurity
describes the protection, control and accountability for valuable
biological materials ... in order to prevent their unauthorized access,
loss, theft, misuse, diversion or intentional release.”
Biosafety usually refers to the prevention of loss of biological
integrity. Biosafety can be defined as “a set of measures aimed at
regulating and ensuring the safe use of genetic engineering and
transnational movements of genetically modified organisms”, or
“activities aimed at enhancing safety when working with pathogens”.
It falls within the scope of the Cartagena Biosafety Protocol under the
Convention on Biological Diversity.
24 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
The main “objective of biosafety is to reduce or eliminate
exposure of laboratory workers or other persons and the outside
environment to potentially hazardous agents involved in
microbiological or biomedical facility research. Achieving biosafety
requires the implementation of various degrees of laboratory
‘containment,’ or safe methods of managing infectious materials in a
laboratory setting. There are three elements of containment: laboratory
practice and technique, safety equipment (primary barriers), and
facility design and construction.” A “holistic approach to biosafety
encompasses scientific, ecological, health, social, economic, cultural
and ethical dimensions. It also requires a long-term perspective in
assessing technology and its products”.® In addition, “{a]
comprehensive biosafety policy needs to be accompanied by, and
integrated with, policies in other related fields such as agriculture,
science and technology, industrial development, health, biodiversity
and environmental protection”. ’
As discussed before, biosecurity is a broad concept that
includes strategies to prevent the intentional “introduction of
pathogens into a community or ecosystem and includes efforts to
prevent malicious use of biological agents, skills, tools, and
knowledge”.® Biosecurity can be understood as an attempt to improve
security at various facilities “in order to preclude unauthorised access
to agents, materials and knowledge”.’ Biosecurity covers several
thematic areas, namely: invasive alien species; consumer protection:
access to genetic resources and benefit-sharing; and conservation and
sustainable use of biodiversity (diversity of and in nature). The
following, however, are among the main priorities in biosecurity:
human and animal health; plant protection; border control; capacity-
building; risk analysis, monitoring/surveillance, and management with
respect to genetically modified research; and enforcement.
The definition of biosecurity changes within different national
languages and contexts. For example, in the United States, the term
“biosecurity” has been applied to encompass efforts to prevent harm
to human health and infrastructure, as well as to the environment.
from various introductions of organisms. ° Thus, the United States
National Association of State Departments of Agriculture (NASDA)
defines biosecurity as “the sum of risk management practices in
defence against biological threats”.'' Fidelis N. Hegngi from the
National Animal Health Policy and Programs of the United States
Department of Agriculture (USDA) believes _ that biosecurity
INTRODUCTION TO BIOSECURITY 25
“embodies all the cumulative measures that can or should be taken to
keep disease (viruses, bacteria, fungi, protozoa, parasites)” from being
transmitted to agricultural facilities or people.'? The United States
Department of Energy (USDE) advocates that “the objective of
biosecurity is to protect against the theft or diversion of high-
consequence microbial agents, which could be used by someone who
maliciously intends to conduct bioterrorism or pursue biological
weapons proliferation”.'> The Carnegie Corporation of New York
suggests that biosecurity “implies the prevention of the deliberate
misuse of pathogens and toxins”."*
According to the European Union, the definition of
biosecurity “focuses primarily on the prevention of access to sensitive
materials by theft, diversion or intentional release”.'” In the view of
the European Association for Bioindustries (EuropaBio), the term
biosecurity refers to “policies and procedures designed to prevent the
deliberate theft or diversion of deadly pathogens and toxins for
criminal purposes”.'° Importantly, the European BioSafety
Association (EBSA) links the concepts of biosecurity and biosafety.
According to EBSA, biosafety refers to “the management of actual or
potential risks to human health and/or the environment resulting from
all types of activities involving natural or recombinant biological
agents and toxins, including the prevention and management of
accidental spills and releases as well as their potential misuse
(‘biosecurity’)”."”
Interestingly, in Arabic and Mandarin, the terms biosecurity
and biosafety combine into only one word in translation.'* The
translation of biosecurity in “Romance languages is the same word as
that used for biosafety” (e.g., biosécurité in French, bioseguridad in
Spanish).'” Slavic languages are prone to associate the concept of
biosecurity with biosafety because no linguistic differentiation is made
between the two (e.g., 6uono2zuuecKaa be3z0nacHocmb in Russian,
bionoziuna be3nexa in Ukrainian). In Russia, biosecurity is usually
“referred to as deficiencies in the protection against bioterrorism, in a
similar manner to the USA”.”° However, until recently, biosecurity
“enjoyed relatively little attention from the Russian government”.”|
To add another level of complexity to the linguistic diversity,
biosecurity has shifting meanings in different areas of specialisation. It
reflects the multiple discourses and positions of various international
institutions dealing with various aspects of biosecurity. The United
Nations Food and Agriculture Organization (FAO) defines biosecurity
26 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
as “a strategic and integrated approach that encompasses the policy
and regulatory frameworks (including instruments and activities) that
analyse and manage risks in the sectors of food safety, animal life and
health, and plant life and health, including associated environmental
risk. Biosecurity covers the introduction of plant pests, animal pests
and diseases, and zoonoses, the introduction and release of genetically
modified organisms (GMOs) and their products, and the introduction
and management of invasive alien species and genotypes. Biosecurity
is a holistic concept of direct relevance to the sustainability of
agriculture, food safety, and the protection of the environment,
including biodiversity [italics in original].”” Importantly, “the FAO’s
definition of biosecurity does not include steps to protect high-
consequence microbial agents and toxins against theft or diversion
from biomedical laboratories and transportation systems”.”°
The World Health Organization focuses mostly on laboratory
biosecurity, which involves “the protection, control and accountability
for valuable biological materials ... within laboratories in order to
prevent their unauthorised access, loss, theft, misuse, diversion, or
intentional release”.** Certain policy communities, for example,
agriculture and environmental protection, understand biosecurity “to
mean mechanisms that detect and respond to invasive species”.”°
While agricultural biosecurity implies food safety, animal safety
(zoonoses), plant safety (pest insects and plant diseases),
environmental biosecurity focuses on invasive species and GMOs.
According to the Organisation for Economic Co-operation and
Development, biosecurity is defined as “institutional and personal
security measures and procedures designed to prevent the loss, theft,
misuse, diversion or intentional release of pathogens or parts of them,
and toxin-producing organisms, as well as such toxins that are held,
transferred and/or supplied by BRCs [biological resource centres]”.”°
Biosecurity involves “measures to protect against the malicious use of
pathogens, parts of them, or their toxins in direct or indirect acts
against humans, livestock or crops”.’’ The Stockholm International
Peace Research Institute (SIPRI) believes that biosecurity involves
“taking active measures to enhance and raise awareness of the risks of
proliferation and to protect know-how and dangerous pathogens and
toxins against theft or malicious diversion from facilities”.”*
Importantly, the scientific/academic community broadens our
understanding of biosecurity discourse. The Statement for the Future
Engagement of Academia for Biosecurity underlines that biosecurity
INTRODUCTION TO BIOSECURITY 27
should be recognised as a new interdisciplinary field of study that is
intended to prevent or reduce the threat, use, and impacts of new and
emerging diseases to humans, animals, and plants through natural,
accidental, and intentional means; it aims “to prevent, reduce or
eliminate the threats, applications and effects of intentional and
unintentional misuse of life sciences and technology, while promoting
and pursuing beneficial pursuits and uses”.”’ In the view of the United
States National Academy of Sciences (USNAS), the term biosecurity
is used to refer to “security against the inadvertent, inappropriate, or
intentional malicious or malevolent use of potentially dangerous
biological agents or biotechnology, including the development,
production, stockpiling, or use of biological weapons as well as
natural outbreaks of newly emergent and epidemic diseases”.*’ The
United States National Science Advisory Board for Biosecurity
(NSABB) defines biosecurity in the framework of any concerns
relevant to the misapplication of information or technologies resulting
from research, not the conduct of research itself.*'
The difference between the two concepts is reflected in the
following matters. As discussed, “both are based on the inherent risks
of certain micro-organisms and toxins. While a biosafety risk
classification system is based on the inherent capability of micro-
organisms to cause disease, of lesser or greater severity, in humans,
animals, and plants, a biosecurity risk classification system is founded
on the potential of a micro-organism or toxin to be used as a
weapon”.** In addition, “while the majority of measures under both
concepts are more or less the same, the biosecurity concept focuses
primarily on the prevention of access to sensitive materials by theft,
diversion or intentional release”.*> As we have seen, the two notions
have many overlapping areas. Consequently, a comprehensive,
integrative framework is required for dealing with both biosafety and
biosecurity.
As we can see, the meaning of biosecurity shifts with a
national and/or institutional context. For an agricultural specialist,
biosecurity encompasses measures to reduce transmission of disease
among animals or plants; for scientists, biosecurity refers to the
challenge of dual-use technology or research. “In the corporate world,
biosecurity can mean prevention of intellectual-property theft.”
Security specialists define it broadly to refer to any measures taken to
prevent the malicious use of pathogens against humans, animals, and
plants, or to pathogen security, or to “attempts to keep dangerous
28 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
pathogens out of terrorist hands”.”’ Therefore, we can speak of
multiple definitions of biosecurity at national and global levels. For
the purposes of this research, we will use the term biosecurity within a
wide conceptual framework that integrates various aspects of both
biosafety and biosecurity, and that thus reflects diverse sides of the
biological security problem, ranging from the safety of all living
organisms, protection from biological harm (diseases, pests, or
bioterrorism), and risk management practices in defence against any
biological threat, to preventing or eliminating the effects of intentional
or unintentional misuse of the life sciences and technology.
2. Biological Risk Management
Both concepts of biosafety and biosecurity can be dealt with within
the framework of biological risk management. The concept of
biological risk management often refers to “the process of weighing
policy alternatives, considering risk assessment and other factors
relevant to biosecurity, and selecting appropriate prevention and
control actions”° or “the analysis of ways and development of
strategies to minimize the likelihood of the occurrence of biorisks”.”’
Biological risk management applies to biological materials at all
times, including the receipt, storage, use, transfer, and disposal of
materials. The spectrum of biological risk ranges from naturally
occurring disease, re-emerging infectious disease, unintended
consequences of research, and various laboratory accidents, to lack of
awareness, negligence, and deliberate misuse.** For example, two
well-established organisations, the American Biological Safety
Association (ABSA) and the European Biological Safety Association,
are striving to address the issues of biosafety and biosecurity along the
full spectrum of biological risks.
In general, “there may be differences between means to
prevent an unintended release into the environment (sometimes
referred to as ‘biosafety’) and means to prevent abuse or theft
(sometimes referred to as ‘biosecurity’). But conceptually, legally, and
in terms of organization and implementation, there are broad
overlapping areas. A wide shared conceptual framework that
integrates sectoral notions of ‘biosafety’ and ‘biosecurity’ is required
in order for each sector (agriculture, human and animal health,
disarmament, environment) that address them to be efficient and
effective.”
INTRODUCTION TO BIOSECURITY 29
As will be discussed in more detail later in this book, the main
components of a global harmonised approach to biological risk
management should be awareness-raising, risk assessment, and
oversight." Strengthening/integration of biological risk management
requires increased awareness to change current culture and clarify
terminology, development of targeted training strategies, and securing
commitment from key stakeholders. Successful risk management
requires cooperation among all stakeholders. It “involves a constant
balance between action and reaction, between preventing a risk from
occurring and dealing with its consequences when it does, between
acting rashly and acting too late”.*!
According to the World Economic Forum (WEF), the five
pathways to constructive risk management involve: “Improving
insight: [by] moving risks from the unknown to the known through
research. ... Enhancing information flow ... Refocusing incentives ...
[P]roviding the investment necessary to mitigate risk. ... [I]mproving
(or creating) the framework needed to mitigate risks for which an
institutional response is required”.** What is truly essential to
successful risk management “is to foster an environment that
emphasizes a habit of practice, a work setting, and a culture of
responsibility in which the ethical uses of the life sciences is the
paramount ethos and the norm against misuse remains strong”.”°
Therefore, common standards can help in defining mutual objectives
and shaping shared expectations.”
3. Understanding Biosecurity from the Historical Perspective
The history of medicine and warfare abounds with examples of
attempts to use disease as a weapon. The existing information on
historical cases is rather incomplete. “Without a realistic threat
assessment based on solid empirical data, government policymakers
lack the knowledge they need to design prudent and cost-effective
programs for preventing or mitigating future incidents.” Various
cases related to biological threat agents can be traced well back in
ancient history (see Table 1). For example, Hindu and Greek literature
include accounts of plague or anthrax in animals and humans. Greek
mythology speaks of Pandora, who, unable to overcome her curiosity,
opened a box given to her by Zeus, and, as a result, released plague
upon the world.
30 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Moreover, the list of historic pandemics is rather impressive.
The first recorded pandemic, known as the Plague of Justinian, dates
back to the sixth century. Its causative agent was the bacterium
Yersinia pestis, and it arguably resulted in approximately 100 million
deaths.“° The Black Death pandemic, caused by the same bacterium,
resulted in 25 million deaths.*’ The China Plague, or the Third
Pandemic, of 1896-1930 touched 30 million lives and resulted in 12
million deaths.** Finally, the so-called Spanish Flu (the influenza A
virus) of 1918-1919 resulted in approximately 50-100 million
deaths.” The most recent major global pandemic, the Severe Acute
Respiratory Syndrome (SARS), occurred between November 2002
and July 2003 and took the lives of 774 people (among 8,096 known
cases).°’ This discussion of biosecurity from the historical perspective
is important, as it provides detailed background on the use of
biological weapons throughout the centuries and thus helps us to
better understand the overall context of the problem of global
biosecurity.
Table 1: A Summary of Some Recorded Historical Incidents
|Date ————si|: Type off Incident
6" century BC During the siege of Krissa, Solon of
Athens poisoned the water supply in the
212 BC
city with the noxious roots of the
Helleborus plant, a primitive but effective
biological toxin of plant origin.’
The defenders of Syracuse drew the
besiegers into an area that was known to
them to be disease-ridden, thus weakening
them for two consecutive summers. The
ruses used would fall under the prohibition
of perfidy (disloyalty). There was an
outbreak of plague in the Carthaginian and
Roman armies during the siege of
Syracuse.”
INTRODUCTION TO BIOSECURITY 31
Although no firsthand account of the
events as described exists, it is believed
that invading Tatars intent on controlling
the Silk Road trade attacked the Black Sea
port of Caffa (at that time occupied by
Genoese; now Feodosiya in Crimea,
Ukraine). “The Tatar army, already
exposed to the Black Death, hurled
plague-infested cadavers over the walls of
Caffa to infect the enemy population. It is
usually reported that the fleeing Genoese
brought the Black Death with them — via
plague-infested rodents, along shipping
routes to Sicily, Sardinia, Corsica, and
Genoa — and from there it spread overland
throughout Italy and Europe. Over a four-
year period, the plague eventually caused
25 million deaths — one-third of Europe’s
population at the time.”°° There are
alternative explanations as to how the
plague got into Caffa, such as rats using
tunnels under the walls.
“At the battle of Carolstein, bodies of
plague-stricken soldiers ... were hurled
into the ranks of enemy troo
French and British soldiers and civilians
infected North American Indian
populations with European diseases.
During the French and Indian Wars, Sir
Jeffery Amherst, commander-in-chief of
the British forces, urged the spread of
smallpox among the disaffected tribes. In
June 1763, Captain Ecuyer of the Royal
Americans met with two Indian chiefs
under a pretence of friendship and gave
them blankets infected with smallpox.
Many Indians eventually died of the
disease.”
1422
17° -18" centuries
32 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
During the war between Russia and
Sweden, Russian troops caused a plague
epidemic among their enemy.”
Napoleon tried “to force the surrender of
Mantua by infecting the citizens with
fever” (malaria).”’
Under the supervision of Shiro Ishii of
Japan, an actual biowarfare unit (Unit 731)
was formed in Manchuria. It was officially
known as the Army Anti-Epidemic
Prevention and Water Supply Unit. It
studied, cultured, and developed a large
number of biological agents, including
anthrax, which were used on prisoners of
war. Over 9,000 people eventually died
there. Ishii tested biological warfare on the
Chinese, soldiers, and civilians. Many died
as a result of plague, anthrax, etc.®
On 4 October, the Japanese released
plague bacteria at Chuhsien that killed 21
people. On 29 October, plague was
dropped by Japanese at Ninpo, causing 99
deaths. On 28 November, Japanese planes
dropped biological bombs at Chinhua. No
casualties were registered.”
The US launched its own studies
surrounding the use of, and defence from,
biological agents. Field-testing was
established in Mississippi.”
The US conducted a test of its
vulnerability to a covert biological-
weapons attack by releasing a harmless
biological stimulant into the New York
City subway system.°’
1940
1941-1943
1966
INTRODUCTION TO BIOSECURITY 33
Members of the right-wing group Order of
the Rising Sun were arrested in Chicago.
They possessed 30-40 kg of typhoid
cultures that were to be used to poison the
water supply in Chicago, St. Louis, and
some other US cities.”
On 7 September, Bulgarian exile Georgi
Markov was injected with a steel ball
filled with ricin via a specially constructed
umbrella. The assassination was carried
out in London by the communist
Bulgarian government with technology
supplied by the Soviet Union.”
On 2 April, there was an outbreak of
pulmonary anthrax in Sverdlovsk, Soviet
Union. There were many fatalities. In
1992, Russian President Boris Yeltsin
acknowledged that the outbreak was
caused by an accidental release of anthrax
spores from a Soviet military
microbiological facility.
In September, with the aim of influencing
the outcome of local elections that would
give it control of the country’s
government, the Rajneeshes cult (which
was formed in India in the 1960s by guru
Bhagwan Shree Rajneesh) contaminated
salad bars in several cities in Oregon, in
the United States, with Salmonella
typhimurium.®° 751 people were
poisoned.
In April, the members of the Japanese
Aum Shinrikyo cult used a car “to disperse
botulinum toxin through an exhaust
system; the group then drove the car
around the Japanese parliament
building”.”’
34 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
On several occasions, “Aum Shinrikyo
attempted to disperse anthrax, botulinum
toxin, Q fever, and Ebola virus against the
mass population and authority figures in
Japan”. It should be noted that Aum
Shinrikyo failed to produce a viable
biolo ent.
A series of anthrax attacks, also known as
Amerithrax, took place in the United
States. Letters containing anthrax spores
were mailed to US Senators Tom Daschle
and Patrick Leahy, as well as to several
news offices, namely ABC News, CBS
News, NBC News, and the New York
Post. The attacks killed five people and
infected 17 others.”
September-December
2001
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' J.B. Tucker, “Biosecurity: Limiting Terrorist Access to Deadly Pathogens”,
Peaceworks, No. 52, 2003, p. 12, http://www.usip.org/pubs/peaceworks/pwks52.pdf.
World Health Organization, “Biorisk Management: Laboratory Biosecurity
Guidance”, WHO/CDS/EPR/2006.6, September 2006, pp. iii-iv, http://www.who.int/
cst/resources/publications/biosafety/WHO CDS_EPR_2006_6.pdf.
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” Ibid.
INTRODUCTION TO BIOSECURITY 35
* J.E. Fischer, “Speaking Data to Power: Science, Technology, and Health Expertise
in the National Biological Security Policy Process”, The Henry L. Stimson Center,
Washington, DC, October 2004, p. 25, http://www.stimson.org/cbw/pdf/SpeakingData
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Roffey and Kuhlau, op. cif., note 4, p. 732.
° L.A. Meyerson and J.K. Reaser, “Biosecurity: Moving Toward a Comprehensive
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' National Association of State Departments of Agriculture, The Animal Health
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? FN. Hegngi, “Overview of Biosecurity and Avian Influenza”, CDC/NIOSH/OSHA
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'3 Salerno and Koelm, op. cit., note 5, p. 7.
'$ MJ. Zuckerman, “Biosecurity: A 21" Century pool nee Carnegie
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'© See the section “European Taskforce on BioTerrorism” on the website of the
European Association of Bioindustries, http://www.ecuropabio.org/eu_biosecurity.htm.
'7 European BioSafety Association, “Biosafety and Biosecurity within the Context of
the European Regulatory Framework”, http://www.ebsaweb.eu/ebsa_media/Downloa
ds/EBSAActivities/EBSA_BiosecurityinEurope-view_image- led_by-eb :
18 M.L. Ostfield, “Global Progress on Biosecurity: U.S. Vision and International
Efforts”, United States Department of State, 9 March 2007, http://www.state.gov/g/oe
s/ris/rm/2007/8161 1. htm.
'? The Sunshine Project, “Biosafety, Biosecurity, and Biological Weapons: A
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2° R. Roffey, “From bio threat reduction to cooperation in biological proliferation
prevention”, Stockholm International Peace Research Institute, Background Paper 4,
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Disarmament: How Can Community Instruments Contribute?”, Brussels, 7-8
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2 See the section “Biosecurity for Agriculture and Food Production” on the website
of the Food and Agriculture Organization of the United Nations, http://www.fao.org/b
iosecurity/.
23 Salerno and Koelm, op. cit., note 5, p. 5.
4 World Health Organization, op. cit., note 2, p. iv.
36 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
*> Organisation for Economic Co-operation and Development, Workshop on
“Biosecurity of Microbial Biological Resources — Complementing Innovation”,
Chairman’s Summary, Moscow, 20-21 September 2006, p. 5, http://www.oecd.org/dat
aoecd/24/14/37819508. pdf.
© Organisation for Economic Co-operation and Development, Biotechnology
Division, “Implementing Biosecurity as a Complement to Innovation in the
Biosciences, Partnership for Global Security”, Washington, DC, 6 March 2007,
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*7 See the section “Glossary of Terms” on the website of the OECD’s International
Futures Program, http://www.biosecuritycodes.org/gloss.htm.
*® Roffey, op. cit., note 20, p. 1.
2°? 'R. Murch, D. Franz, and P. Singer, “Global Biosecurity: The Vital Role of
Academic Leadership”, Occasional Paper No. 1, Virginia Tech’s National Capital
Region, Fall 2005, http://www.biosecuritycodes.org/ddocs/V TBioSecurity pdf.
° Committee on Advances in Technology and the Prevention of Their Application to
Next Generation Biowarfare Threats, Development, Security, and Cooperation Policy
and Global Affairs Division, Board on Global Health, Institute of Medicine, Institute
of Medicine and National Research Council of the National Academies,
Globalization, Biosecurity, and the Future of the Life Sciences (Washington, DC: The
National Academies Press, 2006), p. 32.
*! United States National Science Advisory Board for Biosecurity, “Charter, National
Science Advisory Board for Biosecurity”, http://www.biosecurityboard.gov/revised%
20NSABB%20charter%20signed%2003 1606.pdf.
*? European Union, op. cit., note 15, p. 3.
°? Ibid.
** Ostfield, op. cit., note 18.
» bid.
°° Organisation for Economic Co-operation and Development, OECD Best Practice
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ataoecd/6/27/3 8778261 .pdf.
*” World Health Organization, op. cit., note 2, p. iii.
* T. Taylor, “Safeguarding Advances in the Life Sciences”, EMBO reports, Vol. :
No. S1, 2006, p. S61, http://www.iclscharter.org/images/Safeguarding advances _ in
he_life_sciences.pdf.
*° The Sunshine Project, op. cit., note 19, p. 2.
* World Health Organization, “Scientific Working Group on Life Science Research
and Global Health Security, Report of the First Meeting”, WHO/CDS/EPR/2007.4,
Geneva, 16-18 October 2006, p. 8, http://www. who.int/csr/resources/publications/deli
berate/WHO_CDS_EPR_2007_4n.pdf.
*' World Economic Forum in Collaboration with Citigroup, Marsh and McLennan
Companies, Swiss Re, Wharton School Risk Center, Global Risks 2007: A Global
Risk Network Report (Geneva, World Economic Forum, 2007), p. 21, http://www.wef
orum.org/pdf/CSI/Global_Risks_2007.pdf.
* Tbid., p. 23.
** M. Moodie, “Biological Threats to Security: Harmonizing International Standards
for Biosecurity”, p. 1, http://www.un-globalsecurity.org/pdf/moodie.pdf.
Ibid.
INTRODUCTION TO BIOSECURITY 37
*° J.B. Tucker, “Historical Trends Related to Bioterrorism: An Empirical Analysis”,
Emerging Infectious Diseases, Special Issue, Vol. 5, No. 4, July-August 1999, p. 498,
http://www.cde.gov/ncidod/eid/volS5no4/pdf/tucker.pdf.
*© Committee on Advances in Technology and the Prevention of Their Application to
Next Generation Biowarfare Threats ef al., op. cit., note 30, p. 36.
*” Ibid.
*8 Ibid.
*° M.T. Osterholm, “Preparing for the Next Pandemic”, Foreign Affairs, Vol. 84, No.
4, July/August 2005, http://www.foreignaffairs.org/2005070 1 faessay 84402/michael-t-
osterholm/preparing-for-the-next-pandemic.html?mode=print.
°° World Health Organization, “Summary of probable SARS cases with onset of
illness from 1 November 2002 to 31 July 2003”, http://www.who.int/csr/sars/country/
table2004 04 21/en/index.html.
>! Ibid.
*2 C. Enemark, “Infectious Diseases and International Security: The Biological
Weapons Convention and Beyond”, Nonproliferation Review, Vol. 12, No. 1, March
2005, p. 108, http://biosecurity.anu.edu.au/pdf/Enemark-NPR-0305.pdf.
*3 National Research Council of the National Academies, Biotechnology Research in
an Age of Terrorism (Washington, DC: The National Academies Press, 2003), p. 34,
http://books.nap.edu/openbook.php?record_id=10827&page=34.
*# A.H. Cordesman, The Challenge of Biological Terrorism (Washington, DC: Center
for Strategic and International Studies, The CSIS Press, 2005), p. 12.
*° National Research Council of the National Academies, op. cit., note 53, p. 34.
*© Biological Terrorism Response Manual, “History of Bioterrorism: A chronological
History of Bioterrorism and Biowarfare Throughout the Ages”, http://www.bioterry.c
om/HistoryBioTerr.html.
*” Ibid.
8 Ibid.
»° Ibid.
Ibid.
°' Cordesman, op. cit., note 54, p. 13.
*? Biological Terrorism Response Manual, op. cit., note 56.
® W.S. Carus, “Bioterrorism and Biocrimes: The Illicit Use of Biological Agents
Since 1900”, Center for Counterproliferation Research, National Defence University,
Working Paper, August 1998 (February 2001 Revision), p. 59, http://www.fas.org/irp/
threat/cbw/carus.pdf.
°* Cordesman, op. cit., note 54, p. 14.
® Ibid., p. 15.
°° Carus, op. cit., note 63, p. 50.
*? Cordesman, op. cit., note 54, p. 15.
°8 Ibid.
® Tbid., pp. 17-22.
CHAPTER 3
FOCI OF BIOSECURITY
1. Biological Threats
Advances in genomic sequencing, new production methods,
antibodies, and pharmaceutical products are becoming more
widespread and offer enormous potential for advancing the health,
environmental, and economic security of the world’s population. The
human race has benefited greatly from health technology, including
the development of vaccines that have practically eliminated diseases
such as smallpox, polio, diphtheria, tetanus, and whooping cough.
At the same time, rapidly advancing new technologies can
also be employed to harm humans, either intentionally or
unintentionally. For example, in 2004, researchers in Madison,
Wisconsin, in the United States reconstructed the virulent 1918
influenza by employing reverse genetic engineering. Experts surmise
that the techniques used to reconstruct deadly viruses may become
relatively easy to use in the future; thus, in the odd event that no new
emerging epidemics occur naturally, humans may be able to copy
what has occurred in the past. The same reverse engineering that can
be employed to develop new vaccines against viruses could also be
used to modify viruses in order to make them far more virulent. Thus,
the new tools for analysing and changing an organism’s genetic
material that have created a revolution in biotechnology could also
assist in the unfortunate development of bioweapons. Today, most
“countries have the technological potential to produce large amounts
of pathogenic micro-organisms safely”.' According to experts, only
several countries are suspected of having biological-weapons
capabilities.”
40 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
2. Bioterrorism
There is no officially agreed definition of bioterrorism. The United
States Federal Bureau of Investigation (FBI) identifies it as the
“unlawful use of viruses, bacteria, fungi, toxins or other pathogenic
material against a government, the civilian population, livestock,
crops or any segment thereof, in furtherance of political, social and/or
economic objectives”.’ According to an unofficial Russian definition,
“Bioterrorism is the use of dangerous biological agents for inflicting
damage to the life and health of people in order to reach goals of a
political and materialistic nature.” The bioterrorists’ vector can
include water, food, land, air, animals, and people. As for the human
population, considerable literature exists on possible scenarios of
pathogens being released in subways, sports arenas, railway stations,
or other places where crowds gather.
Following the events of 11 September 2001, some in the
media coined the term “weapons of mass effect” to refer to truck
bombs or hijacked airliners, for example, that could cause deaths and
cause pandemonium and psychological anguish among the population
and/or economic damage. These could include chemical, biological,
nuclear, and radiological or explosive weapons.”
In addition, plant and animal security is paramount to the food
supply and to the public and economic health of a country. It is not
difficult to produce plant pathogens that cause smut, mould, scab,
crop-killing fungi, or rust. Since the majority of farms and agricultural
fields are not protected or guarded in any viable way, they are
vulnerable to bioterrorism. Detection and identification methods are
needed to allow for the possibility of applying effective
countermeasures. New fungicides and insecticides, as well as
pathogen-resistant plants and even methods to survey and police
agricultural areas have been suggested as ways to cope with this
potential threat.°
The World Health Organization has expressed concern about
the lack of physical security of biological agents in a number of
facilities.’ The movement of these dangerous agents is not easily
detected, and thus illicit trafficking of drugs, arms, and materials for
weapons of mass destruction across borders is a possibility in regions
where terrorists travel. A number of bilateral and multilateral efforts
have concentrated on securing and consolidating weapons of mass
destruction (WMD). In particular, the United States, through the
FOCI OF BIOSECURITY 41
Nunn-Lugar Act of 1991, has provided considerable cooperative
threat reduction, and the G8 countries agreed in 2002 to form the
Global Partnership Against the Spread of Weapons and Materials of
Mass Destruction.* It should be noted that some experts believe the
threat of bioterrorism has been exaggerated and that resources should
be devoted instead to valuable medical research.’ Others believe that
just because there have been only a few incidents of bioterrorism, that
does not mean there is an absence of danger.'”
3. Intentional or Unintentional Misuse of Life Sciences and
Technology (the ‘Dual-use Dilemma’); Genetic Manipulation
In the context of the life sciences and biotechnology, dual-use risk
refers to applications that can be used for both positive and malicious
purposes. Dual-use biological research is defined by the US National
Science Advisory Board for Biosecurity as “biological research with
legitimate scientific purpose that may be misused to pose a biologic
threat to public health and/or national security”.'' Some base the
concept of dual use on research involving specific pathogens on the
select agent list (i.e., agents that pose a certain threat to public health
and security). Others concentrate on whether the research might have
weapons implications rather than on specific pathogens.'” Finally, the
US National Academies of Science refer to dual use as the capacity or
potential for biological agents, information, materials and supplies, or
technologies to be used for either harmful or peaceful purposes."
As has been the case with other scientific revolutions, the
advances in biotechnology could have negative consequences as well
as positive ones. “Every new major technology has been used for
hostile purposes, and many experts believe it naive to think that the
extraordinary growth in the life sciences and its associated
technologies might not be similarly exploited for nefarious
purposes.”"* In addition, experts believe that the traditional category
of select agents is important, but that it represents only one part of the
evolving panorama of threats, because technology is developing so
rapidly. Some experts posit that small biologically active organic
compounds called bioregulators — which are not included in the list of
select agents — and other potentially toxic compounds are a dual-use
hazard.'° Coupled with enhancements in methods of dissemination,
these bioregulators can produce severe damage to the neurological,
endocrine, and immune systems in particular.’
42 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Advances in biotechnology, and its potential for misuse, along
with the ease of transporting biological agents across borders, pose
severe threats that have not been adequately addressed. Although
United Nations Security Council (UNSC) Resolution 1540 calls for
increased export controls on biological materials and technology
(which will be discussed in more detail in Chapter 5), it is rather
difficult to enforce. Genetic engineering has already entered uncharted
territory, as scientists are conducting research into combining the
genes of different species, altering their genetic codes, and creating
new organisms. This obviously raises many social and ethical
concerns, as well as questions about the effects on human and animal
health, the environment, and agricultural practices. Some argue that
genetically altered products can propagate, mutate, and migrate, and
once they are released it will be impossible to recall them.’”
The scientific community has begun to respond to the
potential to exploit scientific discoveries for malicious purposes.'* It
has also considered how to preserve national security, as well as the
openness of scientific information. Nevertheless, as biodefence
research expands and evolves around the globe, concerns increase
about the possibility of accidental release of genetically modified
pathogens. Without available countermeasures, such a release could
pose a threat to endemic species and possibly to humans. Some of the
most deadly organisms have been sequenced: Yersinia pestis
(causative agent for plague), variola major (smallpox), bacillus
anthracis (anthrax); and an increasing number of other bacterial
genomes are being completely sequenced.'”
Given the fact that poliovirus has been synthesised and the
sequence of the agent is available online”, concerns may be justified
that artificial synthesis of other agents (e.g., ebola) might also be
developed. The example of the recent re-creation of the 1918 Spanish
Flu, although useful to understand the possible mutations of bird flu,
raises many questions about whether such material should be made
publicly available, what kinds of research should be carried out in
various levels of secure laboratories, and what measures should be
taken to ensure the security of the agents.*' Bacteria can be genetically
altered to invade cells, and although this is applied in very positive
ways for pharmaceutical products, it can also be used for negative
purposes.”
A number of additional dual-use examples that illustrate the
scale of the problem have been widely written about. For example, the
FOCI OF BIOSECURITY 43
DNA (deoxyribonucleic acid) sequences of human pathogens are
available in databases and could assist in showing the possibility for
resisting antibiotics, as well as in the development and production of
biological-weapons agents.’ Already in 1998 reporters were writing
about another genetically engineered strain of bacillus anthracis that
could resist the anthrax vaccine that currently exists.** Overall, new
advances and future applications in the life sciences will greatly
influence human health, agriculture, the environment, and nutrition in
the years to come. The rapid pace of discovery in biotechnology could
also have a substantial influence on the gamut of threats, threats that
may change with the globalisation of technology and the growing
numbers of actors with access to it.
When dealing with the biological research and development
(R & D) of states, “the distinction between defensive and offensive
biological R & D is largely a matter of intent”. This is a very
difficult concept to define. States are more likely to gear their
activities to the capabilities of potential adversaries rather than to their
stated intentions. Thus, if a country pursues defensive threat
assessment activities, other countries may perceive them to be
offensive activities. This will be especially true if the activities
involve genetic modification of pathogens.
While the life sciences need to continue to contribute to the
improvement of human, animal, and plant health, governments and
scientists must be vigilant and able to respond to the potential threat of
the misuse of biological technology and materials. This challenge will
require the attention and cooperation of the world community in order
to provide oversight of research and the dissemination of “sensitive”
information, and to educate the scientific community on potential
threats, as well as on biosafety and biosecurity.
4. Biological Threat Agents
The group of agents that have received the most attention are
pathogens and toxins. Pathogens are “natural or genetically
engineered biological agents that may cause epidemics or
pandemics”.”° Toxins are “poisonous substances produced by living
cells or organisms”.”’ Pathogens and toxins are potentially capable of
having a mild to severe impact on public health. A number of these
agents are found naturally in endemic foci around the world. In
addition, global progress in the fields of the life sciences and
44 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
biotechnology has increased the potential for the development of
genetically engineered biological threat agents.”
Table 2: A List of Biological Threat Agents
The most dangerous agents that include
organisms that pose a risk to national
security because they “can be easily
disseminated or transmitted from person
to person; result in high mortality rates
and have the potential for major public
health impact; might cause public panic
and social disruption; and require special
action for public health preparedness”.”’
Anthrax is a disease caused by Bacillus
anthracis, a bacterium (a very small
organism made up of one cell) that
forms spores (cells that are dormant but
may come to life under the right
conditions). There are three major types
of anthrax: skin (cutaneous), lungs
(inhalation), and digestive
(gastrointestinal).°
Botulism is “a muscle-paralysing disease
caused by a toxin made by the bacterium
Clostridium botulinum. There are three
main kinds of botulism: Foodborne
botulism occurs when a person ingests
pre-formed toxin that leads to illness
within a few hours to days. ... Infant
botulism occurs in a small number of
susceptible infants each year who
harbour C. botulinum in their intestinal
tract. Wound botulism occurs when
wounds are infected with C. botulinum
that secretes the toxin”.”’
Plague is “caused by Yersinia pestis (Y.
pestis), a bacterium found in rodents in
many areas around the world”.*”
CATEGORY A
e.g., 1. Anthrax
(Bacillus anthracis)
2. Botulism
(Clostridium
botulinum toxin)
3. Plague (Yersinia
pestis)
FOCI OF BIOSECURITY 45
4. Smallpox (Variola
major)
Smallpox is an acute, “contagious, and
sometimes fatal infectious disease”
caused by the variola virus (an
orthopoxvirus), and marked by fever and
a distinctive progressive skin rash.”
Tularemia is “caused by the bacterium
Francisella tularensis found in animals
(especially rodents, rabbits, and
hares)”.**
Viral hemorrhagic fevers are included in
“a group of illnesses that are caused by
several distinct families of viruses”.”°
The term “viral hemorrhagic fever”
describes a severe multi-system
syndrome when multiple organ systems
in the body are affected. Usually, the
overall vascular system is damaged, and
the body’s ability to regulate itself is
impaired. These symptoms are often
accompanied by haemorrhage
(bleeding).*° “While some types of
hemorrhagic fever viruses can cause
relatively mild illnesses, many of these
viruses cause severe, life-threatening
disease.””’
5. Tularemia
(Francisella
tularensis)
6. Viral hemorrhagic
fevers (filoviruses
such as ebola,
marburg, and
arenaviruses such as
Lassa, Machupo)
46 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Second highest priority agents, which
“include those that are moderately easy
to disseminate; result in moderate
morbidity rates and low mortality rates;
and require specific enhancements of
CDC’s diagnostic capacity and enhanced
disease surveillance”.*®
Brucellosis is an infectious disease that
is “caused by the bacteria of the genus
Brucella. These bacteria are primarily
passed among animals, and they cause
disease in many different vertebrates”.*”
“In humans, brucellosis can cause a
range of symptoms that are similar to the
flu and may include fever, sweats,
headaches, back pains, and physical
weakness. Severe infections of the
central nervous system or lining of the
heart may occur. Brucellosis can also
cause long-lasting or chronic symptoms
that include recurrent fevers, joint pain,
and fatigue.’*°
The epsilon toxin “is one of 12 protein
toxins produced by Clostridium
perfringens... There are five strains of
C. perfringens, designated A through E.
Each strain produces a unique spectrum
of toxins. The epsilon toxin is made by
pes B and D.””*!
Salmonellosis is an infection caused by
the bacteria Salmonella.” Escherichia
coli O157:H7 is “one of hundreds of
strains of the bacterium Escherichia colli.
This strain produces a toxin that can
cause severe illness.”*’ Shigellosis is “an
infectious disease caused by a group of
bacteria called Shigella... The Shigella
germ is a family of bacteria that can
cause diarrhoea in humans”.
CATEGORY B
e.g., 1. Brucellosis
(Brucella species)
2. Epsilon toxin of
Clostridium
perfringens
3. Food safety threats
(e.g., Salmonella
species, Escherichia
coli O157:H7,
Shigella)
FOCI OF BIOSECURITY 47
4. Glanders
(Burkholderia mallei)
Glanders is an infectious disease that is
caused by the bacterium Burkholderia
mallei (“an organism that is associated
with infections in laboratory workers
because so very few organisms are
uired to cause this disease”).*”
Melioidosis, “also called Whitmore’s
disease, is an infectious disease caused
by the bacterium Burkholderia
pseudomallei”.*°
Psittacosis refers to “any infection or
disease caused by Chlamydia psittaci,
one of several micro-organisms in the
genus Chlamydia. This disease can be
transmitted from infected birds to
humans. Parrot disease, ornithosis, and
chlamydiosis are other names for
psittacosis”.*”
Q fever is “a zoonotic disease caused by
Coxiella burnetii, a species of bacteria
that is distributed globally”.
Ricin “is a poison that can be made from
the waste left over from processing
castor beans”. It “can be in the form of a
powder, a mist, or a pellet, or it can be
dissolved in water or weak acid”.””
“Staphylococcal enterotoxin B (SEB) is
an exotoxin produced by Staphylococcus
aureus. It is one of the toxins
responsible for staphylococcal food
poisoning in humans and has been
produced by some countries as a
biological weapon. SEB is a
superantigen; it acts by stimulating
cytokine release and inflammation.
5. Melioidosis
(Burkholderia
pseudomallei)
6. Psittacosis
(Chlamydia psittaci)
7. Q fever (Coxiella
burnetii)
8. Ricin toxin (from
Ricinus communis,
castor beans)
9. Staphylococcal
enterotoxin B
3950
48 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Epidemic typhus “results from infection
by Rickettsia prowazekii, an obligate
intracellular bacterium. At least two
strains can be distinguished by genetic
analysis. One strain is found only in
humans; the other also occurs in flying
squirrels in the United States.””!
“Acute viral encephalitis (enkephalos + -
itis, meaning brain inflammation) is
often an unusual manifestation of
common viral infections... Some viral
diseases, such as measles and rubella,
can also progress to involve
inflammation of the brain. Other micro-
organisms, such as bacteria, fungi, and
parasites, are capable of triggering
encephalitis, but viruses — particularly
the group known as enteroviruses — are
the leading cause. Once inside the blood,
the viruses migrate to the brain where
they start to multiply. The body notices
the invasion and mounts an immune
system response. This causes the brain
to swell. The combination of infection
and immune response creates the typical
symptoms of viral encephalitis. The
major risk is permanent brain
damage.”””
Vibrios are highly motile, comma-
shaped rods. Of the vibrios that are
clinically significant to humans, Vibrio
cholerae O group 1, the agent of
cholera, is the most important.
Cryptosporidium parvum is
characterised by “profuse, watery
diarrhoea, cramping, abdominal pains,
weight loss, anorexia, flatulence and
malaise; nausea, vomiting, and in some
5
cases, fever”.
10. Typhus fever
(Rickettsia
prowazekii)
11. Viral encephalitis
(alphaviruses, e.g.,
Venezuelan equine
encephalitis, eastern
equine encephalitis,
western equine
encephalitis)
12. Water safety
threats (such as
Vibrio cholerae,
Cryptosporidium
parvum)
FOCI OF BIOSECURITY 49
CATEGORY C Includes “emerging pathogens that could
be engineered for mass dissemination in
the future because of availability”, “ease
of production and dissemination”, and
“potential for high morbidity and
Many times, emerging infectious
diseases exist in nature as zoonoses and
emerge as human pathogens only when
humans come into contact with a
formerly isolated animal population.
“Examples of emerging and reemerging
zootonic disease agents include equine
e.g., 1. Emerging
infectious diseases
(such as Nipah virus,
equine morbillivirus,
Japanese encephalitis,
Australian bat
lyssavirus, equine
encephalitis, morbillivirus, Japanese encephalitis, and
enterohemorrhagic Australian bat lyssavirus in Australia,
Escherichia coli,
dengue virus)
equine encephalitis virus in Colombia
and Venezuela, enterohemorrhagic
Escherichia coli in Japan, the bovine
spongiform encephalopathy agent in the
United Kingdom, and dengue virus in
South America.”*> Drug-resistant
organisms could also be included as the
cause of emerging infections since they
exist because of human influence. Some
recent examples of agents responsible
for emerging infections include human
immunodeficiency virus, Nipah virus, or
Mycobacterium tuberculosis. Nipah
virus is “a newly recognised zoonotic
virus that was ‘discovered’ in 1999. The
virus is named after the location where it
was first detected in Malaysia. Nipah is
closely related to another newly
recognised zoonotic virus (1994), called
Hendra virus, named after the town
where it first appeared in Australia. Both
Nipah and Hendra are members of the
, ; ce 56
virus family Paramyxoviridae”.
50 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
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' J. van Aken and E. Hammond, “Genetic engineering and biological weapons”,
EMBO reports, Vol. 4, Supplement 1, June 2003, www.pubmedcentral.nih. gov/article
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* See S. Squassoni, “Nuclear, biological and chemical weapons and missiles: Status
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> R.J. Frerichs, R.M. Salerno, K.M. Vogel, N.B. Barnett, J. Gaudioso, L.T. Hickok, D.
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* J. Mackby, “Strategic Study on Bioterrorism”, Swedish Institute of International
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> “Preventing the Entry of Weapons of Mass Effect Into the United States”, Homeland
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° Mackby, op. cit., note 4, p. 16.
7 World Health Organization, “Biorisk Management: Laboratory Biosecurity
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sources/publications/biosafety/WHO CDS _EPR_2006_6.pdf.
* The Global Partnership is a G8 initiative committed to preventing terrorists from
acquiring or developing nuclear, chemical, radiological, or biological weapons,
missiles, or related equipment and technology. The G8 countries announced at the
June 2002 Summit in Kananaskis, Canada, that they would pledge $20 billion over the
next 10 years to fund projects, initially in Russia, to achieve this goal. See www.sgppr
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* M. Leitenber, “Assessing the Biological Weapons and Bioterrorism Threat”, paper
for “Meeting the Challenges of Bioterrorism: Assessing the Threat and Designing
Biodefence Strategies”, Furigen, Switzerland, 22-23 April 2005.
'° A.H. Cordesman, The Challenge of Biological Terrorism (Washington, DC: Center
for Strategic and International Studies, The CSIS Press, 2005), p. ix.
'' Department of Health and Human Services, National Science Advisory Board for
Biosecurity Charter, 4 March 2004. The NSABB was created within the Department
of Health and Human Services to provide guidance for review and oversight of
experiments of concern.
'2 D.A. Shea, “Oversight of Dual-Use Biological Research: The National Science
Advisory Board for Biosecurity”, CRS Report for Congress, 10 July 2006.
'’ Committee on Advances in Technology and the Prevention of Their Application to
Next Generation Biowarfare Threats, Development, Security, and Cooperation Policy
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of Medicine and National Research Council of the National Academies,
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National Academies Press, 2006), p. 28.
EG at
. 3 ; < u > _
a i a8 % F ae re yy
LPC WA a , ae
MATAN Ra ©) p.»--Focior BIOSECURITY 51
A). “T3 a oe Wi rE a P . “
'* Committee on Advances in Technology and the Prevention of Their Application to
Next Generation Biowarfare Threats, Development, Security, and Cooperation Policy
and Global Affairs Division, Board on Global Health, Institute of Medicine, Institute
of Medicine and National Research Council of the National Academies, An
International Perspective on Advancing Technologies and Strategies for Managing
Dual-Use Risks: Report of a Workshop (2005) (Washington, DC: The National
Academies Press, 2005), p. 1, http://books.nap.edu/openbook.php?record_id=11301&
page=5.
> J.B. Tucker, “Dual Use Dangers: Biotechnology and Global Security Are
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07/10/dual-use-dangers/.
'© K. Nixdorff, “Assault on the Immune System”, in United Nations Institute for
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rR Cummins, “Problems with Genetic Engineering”, Synthesis/Regeneration, No.
18, Winter 1999, http://www.greens.org/s-r/18/18-02. html.
'® Committee on Advances in Technology and the Prevention of Their Application to
Next Generation Biowarfare Threats ef al., op. cit., note 13.
'? M. Dando, “The Impact of Scientific and Technological Change”, in A. Wenger
and R. Wollenmann (eds.), Bioterrorism, Confronting a Complex Threat (Boulder,
Colorado: Lynne Rienner Publishers, 2007), pp. 82-83.
2° Ibid., p. 83.
71 TM. Tumpey, C.F. Basler, P. Aguilar, H. Zeng, A. Solérzano, D.E. Swayne, N.J.
Cox, J.M. Katz, J.J. Taubenberger, P. Palese, and A. Garcia-Sastre, “Characterization
of the Reconstructed 1918 Spanish Influenza Virus”, Science, Vol. 310, 7 October
2005, pp. 77-80. An editorial published in the same issue of Science by P.A. Sharp,
“1918 Flu and Responsible Science”, examined the potential implications of the
research vis-a-vis biosecurity.
2 Dando, op. cit., note 19, p. 82.
? C.M. Fraser and M. Dando, “Genomics and future biological weapons: The need
for preventive action by the biomedical community”, Nature Genetics, Vol. 3, No. 29,
2001, pp. 253-256.
4 WJ. Broad, “Gene-engineered anthrax: Is it a weapon?”, The New York Times, 14
February 1998, p. A4.
AR. Tucker, “Biological Threat Assessment: Is the Cure Worse Than the Disease?”,
Arms Control Association, October 2004, http://www.armscontrol.org/act/2004_10/Tu
cker.asp/.
7° World Health Organization, “Biorisk management: Laboratory biosecurity
Guidance”, WHO/CDS/EPR/2006.6, September 2006, p. 16, http://www.who.int/csr/r
esources/publications/biosafety/WHO CDS EPR _ 2006 _6.pdf.
77 Ibid.
8 Ibid.
° See the section “Bioterrorism Agents/Diseases” on the website of the Centers for
Disease Control and Prevention, Department of Health and Human Services, http://w
ww.bt.cdc.gov/agent/agentlist-category.asp.
30 «Anthrax: What Do You Need to Know”, ibid., http://www.bt.cdc.gov/agent/anthra
129603
52 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
x/needtoknow.asp.
31 “Pacts About Botulism”, ibid., http://www.bt.cdc.gov/agent/botulism/factsheet.asp.
32 “Prequently Asked Questions (FAQ) About Plague”, ibid., http://www.bt.cde.gov/a
gent/plague/fag.asp.
33 «Smallpox Disease Overview”, ibid., http://www.bt.cdc.gov/agent/smallpox/overvie
w/disease-facts.asp.
" “Key Facts About Tularemia”, ibid., http://www.bt.cdc.gov/agent/tularemia/facts.a
sp.
3 ceViral Hemorrhagis Fevers”, ibid., http://www.cdc.gov/ncidod/dvrd/spb/mnpages/d
°° Tid.
37 M.G. Kortepeter and G.W. Parker, “Potential Biological Weapons Threats”,
Emerging Infectious Diseases, Vol. 5, No. 4, July-August 2000, p. 526, http://www.cd
c.gov/ncidod/EID/vol5no4/pdf/kortepeter.pdf.
38 “Bioterrorism Agents/Diseases”, op. cit., note 29.
39 See the section “Brucellosis” on the website of the Centers for Disease Control and
Prevention, Department of Health and Human Services, http://www.cdc.gov/ncidod/d
bmd/diseaseinfo/brucellosis_g.htm#whatis.
*° Ibid.
*! See the section “Epsilon Toxin of Clostridium Perfringens” on the website of the
Institute for International Cooperation in Animal Biologics, The Center for Food
Security and Public Health, Iowa State University, January 2004, p. 1, http://www.cfs
ph.iastate.edw/Factsheets/pdts/epsilon toxin_clostridium.pdf.
* See the section “Salmonellosis” on the website of the Centers for Disease Control
and Prevention, Department of Health and Human Services, http://www.cdc.gov/ncid
od/dbmd/diseaseinfo/salmonellosis_g.htm#What%20is%20salmonellosis.
*° “Escherichia Coli O157:H7’, ibid., http://www.cdc.gov/ncidod/dbmd/diseaseinfo/e
scherichiacoli_g.htm# What%20is%20Escherichia%20coli%200 157:H7.
“ “Shigellosis”, ibid., http://www.cdc.gov/ncidod/dbmd/diseaseinfo/shigellosis_g.htm
#What%20is%20shigellosis.
7 “Glanders”, ibid., http://www.cdc.gov/ncidod/dbmd/diseaseinfo/glanders_g.htm#w
hatis.
© “Melioidosis”, ibid., http://www.cdc.gov/ncidod/dbmd/diseaseinfo/melioidosis g.h
tm.
‘7 See the section “What Is Psittacosis” on the website of the Canadian Centre for
Occupational Health and Safety, http://www.ccohs.ca/oshanswers/diseases/psittacosis.
html.
“8 See the section “Q Fever” on the website of the Centers for Disease Control and
Prevention, Department of Health and Human Services, http://www.cdc.gov/ncidod/d
vrd/gfever/index.htm.
” The National Terror Alert Response Center, “Frequently Asked Questions (FAQ)
About Ricin”, http://www.nationalterroralert.com/ricin/.
*° Center for Food Security and Public Health, Iowa State University, “Staphylococcal
Enterotoxin B”, http://www.cfsph. iastate.edu/Factsheets/pdfs/staphylococcal_enteroto
*! “Typhus Fever — Rickettsia Prowazekii”, ibid., http ://www.cfsph. iastate.edu/Factsh
eets/pdfs/typhus_fever.pdf.
FOCI OF BIOSECURITY 53
52 “Viral Encephalitis”, http://www.emedicine.com/neuro/topic393.htm.
*S See “Material Safety Data Sheet — Infectious Substances” on the website of the
Public Health Agency of Canada, http://www.phac-aspc.gc.ca/msds-ftss/msds48e.htm
|
4 “Bioterrorism Agents/Diseases”, op. cit., note 29.
°° Institute of Medicine, Emerging Infectious Diseases from the Global to the Local
Perspective: Workshop Summary (Washington, DC: The National Academies Press,
2001), p. 10, http://books.nap.edu/execsumm_pdf/10084.pdf.
*© See the section “Nipah virus” on the website of the World Health Organization,
http://www.who.int/mediacentre/factsheets/fs262/en/.
CHAPTER 4
NEW TECHNOLOGIES AND THEIR IMPLICATIONS FOR
BIOSECURITY
1. Life Sciences
The life sciences are considered to be “the next wave of the
knowledge-based economy”,' where the expansion of the knowledge
base is happening at an unprecedented rate, “opening up new
applications in healthcare, agriculture and food production, and
environmental protection, as well as new scientific discoveries. ...
The common knowledge base relating to living organisms and
ecosystems is producing new scientific disciplines such as genomics
and bioinformatics, as well as new applications, such as gene testing
and regeneration of human organs and tissues.”” Such new discoveries
will have a profound impact on our societies. The time between new
discoveries and their application has grown ever shorter, which raises
particular challenges not only for policymakers but also for society as
a whole.
The biological sciences have experienced impressive growth
in recent decades: “In these early years of the 21“ century, scientific
discovery and understanding are playing an important and growing
role in meeting the challenges — environmental, human _ health,
economic — facing societies elsewhere. At the forefront are advances
in biology. Indeed, it is reasonable to say we are entering the Age of
Biology, paralleling in many ways the Age of Physics in the first half
of the 20" century.” The growth of biological sciences was “fueled
by a stream of discoveries, such as the principles of genetics, the
structure of recombinant deoxyribonucleic acid (DNA), and the
discovery of gene-splicing technologies”.* Fundamentally, such
innovations “have opened new fields of inquiry and provided the basis
for myriad applications in industry, agriculture, and medicine”.
Today, the life sciences are in the midst of a technological
revolution that has already yielded great benefits to society. The
56 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
discovery of the structure of DNA in 1953, followed by the invention
of DNA recombinant technology — which refers to “a set of techniques
that make it possible to combine genes (DNA sequences) from two or
more different species’”® — two decades later “paved the way for the
powerful potential to manipulate genes directly and in such a way that
the ‘nature’ of an organism can be altered with precision in a single
generation. In 2001, scientists finished the initial draft of the human
genome sequence, representing a shift in the way biology is studied
and opening a portal to vast post-genomic possibilities — from RNA
[ribonucleic acid] interference therapeutics to DNA nanotechnology.”
Among the technological breakthroughs, genetic engineering plays a
particularly significant role.
The life sciences are defined “to include any field of science
that is leading to, or has the potential to lead to, an enhanced
understanding of living organisms, especially human life”.*
Technological growth arising from advances in the life sciences has
several important characteristics. First of all, progress in biology has
been marked continually by “successive serendipitous discoveries and
applications that over time have led to the widespread adoption of new
technologies with independent’ scientific and economic impacts”.”
Second, it is very difficult to predict what kind of technological or
scientific breakthrough will be next.'® Third, “the number of known
biologically active molecules, and potential genetically engineered
organisms, that could cause harm to humans through inadvertent use,
inappropriate use, or as a result of purely malevolent intent such as the
development of a weaponizable biological or chemical agent, is
increasing rapidly”."!
Significantly, the life sciences are expanding general
understanding of the genetic make-up of all living organisms,
including humans, which paves the way to: new molecular diagnostics
and targeted medicine (including use of the understanding of the
biology of the human body, such as in cell and gene therapy and the
treatment of rare diseases); development of plants as bioproduction
systems for new high-quality materials; development of industrial
biotech applications such as bioplastics, production of biofuels and
many other applications of enzymes in various types of industry.'* The
life sciences offer the possibility “to protect and improve the
environment ... including bioremediation of polluted air, soil, water
and waste as well as development of cleaner industrial products and
processes, for example based on use of enzymes (biocatalysis)”.°
NEW TECHNOLOGIES AND THEIR IMPLICATIONS FOR BIOSECURITY 57
The life sciences and _ biotechnology offer multiple
opportunities to address many of the global needs relating to health,
ageing, nutrition, the environment, and to sustainable development.
Some of the most obvious benefits of the life sciences and
biotechnology include: 1) feeding a growing population; 2) benefits
for the environment; 3) the quality of nutrition; 4) advances in
medicines and health care; or 5) industrial applications (for example,
the ones that help to reduce the world’s dependence on oil and natural
gas).'* The life sciences and biotechnology are very well positioned to
address world hunger as a complex challenge. They could increase
crop productivity in the developing world by up to 25 percent, as well
as substantially reduce post-harvest losses. '°
In addition, these sciences constantly create more effective
medicines that benefit numerous people worldwide who suffer from
such diseases as cancer, diabetes, Alzheimer’s, or acquired immune
deficiency syndrome (AIDS). Such research activities have “resulted
in numerous new biopharmaceutical products ... [namely] human
recombinant insulin for the treatment of diabetes, a vaccine against
hepatitis B...”.'° They “enable cheaper, safer and more ethical
production of a growing number of traditional as well as new drugs
and medical services”.'’ Knowledge of “living organisms and
ecosystems is producing new scientific disciplines such as genomics
and bioinformatics and novel applications such as gene testing and
regeneration of human organs or tissues”.'* This, in turn, could have
profound impacts throughout our societies. “In response to the
opportunities presented by these developments, the resources devoted
to the life sciences have increased dramatically, making further
discoveries possible”.'”
2. Biotechnology: Promises and Perils
Biotechnology is considered one of the key enabling technologies of
the 21° century. Biotechnology refers to “any technological
application that uses biological systems, living organisms, or
derivatives thereof, to make or modify products or processes for
specific use”.”° In a broad sense, biotechnology could be defined as
the “use of biology in various new technologies that benefit human
beings”.’' Human medicine and health care are the most prominent
fields of application of modern biotechnology, as it “is behind the
paradigm shift in disease management towards both personalised and
58 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
preventive medicine based on genetic predisposition, targeted
screening, diagnosis, and innovative drug treatments”.””
According to Karl Herkley, biotechnology refers “to methods
and techniques that permit products to be produced from the raw
materials with the aid of living organisms, without defining how and
what could be the products of technology”. With science progressing
at an ever-increasing speed, biotechnology is becoming a much
broader concept. In the Convention on Biological Diversity,
biotechnology has been defined as “any technological application that
uses biological systems, living organisms or derivatives thereof, to
make or modify products and processes for specific use”.~*
Biotechnology is a technology based on biology. The main
application areas of biotechnology “can be classified into three
groups: healthcare and pharmaceutical applications; industrial
processes and manufacturing; and agriculture, livestock, veterinary
products and aquaculture”.” The distinctive features of biotechnology
are leading-edge scientific research and a strong link between
innovation and competitiveness. For example, biotechnology “has
helped replace chemical processes, allowing an improvement in
process efficiency, a decrease in energy and water consumption, and a
reduction of waste molecules”.*° Moreover, “[m]Jodern biotechnology
refers to the application of: [i]n vitro nucleic acid techniques,
including recombinant deoxyribonucleic acid (DNA) and direct
injection of nucleic acid into cells or organelles; or [f]usion of cells
beyond the taxonomic family”.”’ In order to produce their goods and
services, biotechnology companies use a variety of tools and
technologies, ranging from recombinant DNA, molecular biology, and
genomics to live organisms, cells, and biological agents.”®
Biotechnology allows a more efficient production of “new
drugs and medical services (e.g. human growth hormone without risk
of Creutzfeldt-Jakob disease, human insulin, and vaccines against
hepatitis B and rabies)”.”’ “Pharmacogenomics, which applies
information about the human genome to drug design, discovery and
development, will further support this radical change. Stem-cell
research and xenotransplantation [from another species] offer the
prospect of replacement tissues and organs to treat degenerative
diseases and injury resulting from strokes, Alzheimer’s and
Parkinson’s diseases, burns and spinal-cord injuries.””°
Numerous “recombinant techniques have spawned a vibrant
biotechnology industry focused largely on the development of new
NEW TECHNOLOGIES AND THEIR IMPLICATIONS FOR BIOSECURITY 59
pharmaceuticals to fight disease. By 2000 the annual investment in the
biotechnology industry peaked at nearly $29 billion”.°' According to
Ernst & Young’s Beyond Borders: Global Biotechnology Report
2007, in 2006, global biotechnology made “historic advances” when
the revenues of the world’s publicly traded biotech companies grew
14 percent, reaching $73.4 billion; the global biotech industry raised
$27.9 billion in 2006, compared to $19.7 billion in 2005, and research
and development expenditures increased 31 percent to $5.2 billion.*”
“After years of downturn and painful restructuring, the European
biotech industry is firmly back on the right path, and is sustaining
newfound progress and momentum.”*° The leader of the European
biotech industry is the United Kingdom (UK): “The UK biotech sector
continues to lead the European revival.”**
In terms of revenue generation, the United States is the world
leader of the global biotech industry. It is closely followed by the
European Union and Canada.*° Growth in the biotechnology sector in
other parts of the world is equally noteworthy. For example, the Japan
Bioindustry Association has about 300 corporate members, 100 public
organisation members, and about 1,300 individual members from
universities.°° The Australia’s Biotechnology Industry Organisation
(AusBiotech) currently has 2,550 members that cover the human
health, agricultural, medical device, bioinformatics, environmental,
and industrial sectors in biotechnology..’ The number of biotech
companies in Brazil grew from 76 in 1993 to 354 in 2001, and in
Israel from about 30 in 1990 to about 160 in 2000.**
The biotechnology industry is dominated by small to medium-
size companies. Interestingly, “[d]uring the 1980s, biotechnology in
Europe developed primarily within large companies”.”” Recently
though, there has been a fast expansion of the small-company sector in
Europe. In 2002, there were more dedicated biotechnology companies
in Europe (1,570) than in the United States (1,273).*° EuropaBio, the
European Association for Bioindustries, whose mission “is to promote
an innovative and dynamic biotechnology-based industry in Europe”,
currently represents 1,800 small and medium-sized businesses
“involved in research, development, testing, manufacturing, and
commercialisation of biotechnology products”."'
The life sciences and biotechnology research has become a
truly global enterprise. Interestingly, “over 10,000 journals in the life
sciences are published worldwide. Biological Abstracts, an
international database on biology, clinical and experimental medicine,
60 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
biochemistry, and biotechnology, provides coverage of over 6,000
active international journals and 14,000 archival titles from over 100
countries.”** Rapid advances in the life sciences and anticipated
developments in biotechnology, nanotechnology, and _ genetic
engineering not only have the potential to produce new drugs to treat
multiple diseases, but they also could pose serious security risks by
exploiting the technology in causing biologically related damage. “On
the one end of the debate are those who believe that biotechnology
will benefit humanity by unlocking the scientific, health, food, and
commercial potential contained within biological diversity — more
specifically, within genetic resources. On the other end are a range of
social, scientific, and community actors who decry the dangers
inherent in the manipulation of genetic diversity and the release of
genetically modified organisms into the environment.”””
Biotechnology “represents a dual-use dilemma in which the
same technologies can be used legitimately for human betterment and
misused for bioterrorism”.“* The recent growth of the global
biotechnology industry has resulted in the rapid expansion of dual-use
technologies. “The ease of transfer of small quantities of agents and
immense diversity of potential agents has increased concerns that
would-be proliferators could be trying to obtain biological agents for
hostile purposes. These concerns have arisen from the potential of
biological weapons for inflicting mass panic with relatively limited
resources, and that signatures for misuse, or intended misuse, can be
hidden easily under the guise of legitimate biotechnological
activities.”
A report from the US National Academy of Sciences called
Biotechnology Research in an Age of Terrorism resulted from a
meeting held in January 2003 chaired by Gerald Fink, Professor of
Genetics at the Whitehead Institute for Biomedical Research at the
Massachusetts Institute of Technology (MIT). The report’s main
objective was to “safeguard the integrity of science”.*° Namely, the
Fink Report has recommended:
1) “Educating the Scientific Community We recommend that
national and international professional societies and related
organizations and institutions create programs to educate
scientists about the nature of the dual use dilemma in
biotechnology and their responsibilities to mitigate its risks.
2)
3)
4)
5)
6)
NEW TECHNOLOGIES AND THEIR IMPLICATIONS FOR BIOSECURITY 61
“Review of Plans for Experiments We recommend that the
Department of Health and Human Services (DHHS) augment
the already established system for review of experiments
involving recombinant DNA conducted by the National
Institutes of Health to create a review system for seven classes
of experiments (the Experiments of Concern) involving
microbial agents that raise concerns about their potential for
misuse. ... Experiments of Concern would be those that:
e “Would demonstrate how to render a_ vaccine
ineffective.
e “Would confer resistance to therapeutically useful
antibiotics or antiviral agents.
e “Would enhance the virulence of a pathogen or render
a nonpathogen virulent.
e “Would increase transmissibility of a pathogen.
e “Would alter the host range of a pathogen.
e “Would enable the evasion of diagnostic/detection
modalities.
e “Would enable the weaponization of a biological
agent or toxin.
“Review at the Publication Stage We recommend relying on
self-governance by scientists and scientific journals to review
publications for their potential national security risks.
“Creation of a National Science Advisory Board for
Biodefense We recommended that the Department of Health
and Human Services create a National Science Advisory
Board for Biodefense (NSABB) to provide advice, guidance,
and leadership for the system of review and oversight ... .
“Additional Elements for Protection Against Misuse We
recommend that the federal government rely on _ the
implementation of current legislation and regulation, with
periodic review by the NSABB, to provide protection on
biological materials and supervision of personnel working
with these materials.
“A Role of the Life Sciences in Efforts to Prevent
Bioterrorism and Biowarfare We recommend that the
national security and law enforcement communities develop
new channels of sustained communication with the life
62 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
sciences community about how to mitigate the risks of
bioterrorism.
7) “Harmonized International Oversight We recommend that
the international policymaking and scientific communities
create the International Forum on Biosecurity to develop and
promote harmonized national, regional, and international
measures that will provide a counterpart to the system we
recommend for the United States [bold in original].”*’
In order to find a solid solution to the dual-use dilemma posed
by advances in biotechnology-related research, the United Nations
University (UNU) launched a Biodiplomacy initiative. “Biodiplomacy
may be seen as the international negotiation process leading to the
development of new legal and policy frameworks to respond to these
challenges — guided by principles of equity and the need to ensure
global sustainable development. These frameworks are necessary to
regulate scientific and commercial exploitation of genetic diversity in
accordance with emerging precepts on ethics, rights, obligations, and
responsibilities which are potential harbingers of a new social contract
between the commercial and scientific communities, industrialized
countries and developing countries, and scientific, industrial, and local
community stakeholders.””®
3. Nanotechnology and Genomics
Some of the most prominent examples of biotechnology include
nanotechnology, genetically engineered food, and genetic engineering.
The term nanotechnology has evolved over the years. Now it usually
refers to “the science and engineering that focuses on the
manufacturing of useful objects with scales less than 1 micrometer. It
is also an inquiry into the new science and engineering embodied in
complex systems with components less than 1 micrometer. Chemical
engineers, material scientists, and contemporary biotechnologists have
for many years dealt with molecule assemblages and polymers of 10
to 20 nanometers, but with the successes of microfabrication
technologies, an international interest in smaller and smaller devices
has led to major efforts in submillimeter device development.””’ One
nanometer is one-billionth of a meter.” Nanotechnology “operates on
the scale upon which biological systems build their structural
components, like microtubules, microfilaments, and chromatin. In
NEW TECHNOLOGIES AND THEIR IMPLICATIONS FOR BIOSECURITY 63
other words biochemistry, genomics, and cell biology are nanoscale
phenomena”.”!
Nanotechnology is one of the fastest-growing industries in the
world and is expected to become a $750-billion market by 2015.” It is
also a multidisciplinary field, and therefore, nanotechnology
encompasses diverse lines of inquiry. It is widely believed to be the
next industrial revolution.» Nanotechnology “represents the state of
the art in advances in biology, chemistry, physics, engineering,
computer science, and mathematics. The major research objectives ...
are the design, modeling, and fabrication of molecular machines and
molecular devices”.** The most recent creation in nanotechnology is
“DNA nanotechnology, or nanobiotechnology, as well as the closely
related field of DNA-based computation by algorithmic self-
assembly”.*°
Another example of biotechnology, genomics, “has already
reshaped biological inquiry in fundamental ways, and as genomics and
proteomics meld further with developmental/cell biology and the
agricultural sciences, our world will be transformed”.°° Genomics is
the study of genomes (“[t]he complete array of genetic material that
resides in the nucleus of each cell of an organism” and “consists of
two sets of chromosomes, one from each parent”).°’ Advances in
genomic research will establish cures or therapies for numerous
diseases that were considered to be incurable. Advances in technology
have dramatically increased the speed at which it is possible to
identify, characterise, and manipulate genes. “If a gene is a working
sub-unit of DNA which encodes a specific product, such as a protein,
then the genome is the entire collection of genes within an
organism.”’* Due to the significant amounts of genetic information
being generated, scientists have started discussing genomes as
opposed to individual genes. Genetic engineering refers to “a
technique that permits the artificial modification and transfer of
genetic material from one organism to another and from one species to
another. This technology is used throughout the world to alter the
protein produced by a gene and to design organisms with desirable
traits for applications ranging from basic research and development
activities to pharmaceutical and industrial uses.”””
Such advanced techniques as DNA _ sequencing, DNA
synthesis, DNA silencing, and DNA shuffling represent enormous
progress in genomics. DNA sequencing refers to “the identification to
the order of the nucleotides which make up genetic information”.”” It
64 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
is not a new technology. Since 1997, entire genomes have been
sequenced: “the first eukaryotic [from cells of animals, plants, or
fungi] genome (a yeast) in 1997; the first animal genome in 1998; the
human genome in 2001”.°' One of the most prominent examples of
the evolution of DNA sequencing technology is the Human Genome
Project (HGP). It began formally in 1990 and aimed to accomplish its
task in about 15 years, by using a relatively large number of highly
specialised facilities and staff.°° As technology improved, automation
and miniaturisation allowed post-doctoral researchers to be replaced
by master’s students; master’s students to be replaced by
undergraduates; and technicians, with only minimal higher learning, to
replace the undergraduates. The adoption of sequencing advances
allowed a commercial rival to publish a draft of the human genome at
the same time as the international coalition, despite the latter having
started on the project almost ten years later.®
The Human Genome Project involved the sequencing of the
entire human genome.” It aimed “to gain insight into the organisation
and function of genetic material and to provide a solid, molecular base
for physiology and medicine”.” It was a massive international effort
to understand how genes work, how genes code for proteins that build
cells, and most importantly, how genomic knowledge can be used to
prevent, diagnose, and treat human disease. However, certain aspects
of the Human Genome Project generated several controversial issues,
some of which included:
e Embryo research, especially in relation to embryonic stem
cells;
e Cloning issues;
e DNA databases, particularly in relation to issues of “open” vs.
“specific” consent; privacy of personal data; sharing of tissue
samples and genetic data;
e Genetic testing;
¢ Gene therapy issues. ”
The most recent developments in genomics, “such as capillary
sequencing machines and DNA chips, are enabling studies of
sequence variation within species by sequencing large numbers of
strains, including pathogens, in parallel”.°’ Existing work also
concentrates on creating machines capable of reading a single copy of
a sequence, which will reduce the number of errors incorporated into a
NEW TECHNOLOGIES AND THEIR IMPLICATIONS FOR BIOSECURITY 65
sequence, “allowing the genome of an individual cell to be read more
accurately and enable advances in functional genomics and
proteomics [the large-scale study of proteins, their structures and
functions — italics in original]”.”*
The reverse process to DNA sequencing is DNA synthesis,
which involves turning the sequence data back into physical
material.°’ Although the process itself is not new, there have been
significant improvements in the efficiency and automation of the
process. “Experiments in 2002 and 2003 demonstrated that it was
possible to assemble the entire genomes of viruses from scratch and
that these viruses could then function as well as their natural
counterparts”.”° The older versions of simultaneous DNA synthesis
machines started to appear for sale on Internet auction sites for
between $5,000 and $10,000.” “Simple DNA sequencers can be built
from scratch from commonly available components using instructions
available on the Internet for around $10,000... Currently, the cost of
DNA fragments is around $0.10 per base pair. For context, if the
entire structure of the smallpox virus were to be produced (in
numerous segments) it would cost in the region of $18,000.” This
progress has been helped by the commercialisation of the technology,
as well as by the fact that gene-sequencing companies are rapidly
increasing in number throughout the world.
DNA silencing can be understood in the following way.
Humans, animals, plants, and fungi share a certain form of defence
against some types of viruses. “The presence of certain viral genetic
information (known as dsRNA) in a cell starts a mechanism (known
as RNA interference or RNAi) to stop the dsRNA replicating, by
interfering with the process by which genetic material is read and
converted into a product.””? This process was described in 2001. It
became possible to selectively switch off the operation of a given
sequence. Now scientists have launched a project aimed at using this
technology to determine the function of every gene in the human
genome.” A very interesting point here is that the technique of RNA
interference was “discovered” by a group who wanted to produce
petunias with a colour that does not occur naturally or through
hybridisation. This demonstrates the difficulties in predicting where a
breakthrough will occur, as well as the challenges of oversight.
DNA shuffling “takes a library of related versions of the same
sequence (such as genes from related species), breaks them apart and
then recombines them into new versions of the basic sequence”.”” In
66 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
2002, DNA shuffling, which allows for the simultaneous mating of
numerous species, was used to combine sequences “with 270 to 540
times greater activity than the best parental sequence”.”° It is now
possible to shuffle entire genomes (experiments have already been
completed using related bacteria). ”’
All of the above-discussed advanced techniques can have both
positive and negative implications for global security. There have
been multiple attempts to characterise experiments of concern. Some
of them have already been conducted, while others are considered to
be theoretically possible. As we have seen, the United States National
Academy of Sciences included in its report Biotechnology Research in
an Age of Terrorism a list of seven experiments of concern. ”*
It is widely accepted that “(t]he life sciences revolution was
born in, and is fed and nurtured by, research. ... The success of any
knowledge-based economy rests upon the generation, diffusion, and
application of new knowledge.”” Public research laboratories and
universities are at the core of science-based interaction.*’ An
extremely rapid pace of technological growth in life sciences research
“reflects a revolutionary change in the way people interact with
biological systems and a growing capacity to manipulate such
systems”.*' Life science knowledge and technologies are advancing at
an incredibly high speed, making it possible to identify and
manipulate features of living organisms in ways never before possible.
In addition, “other fields not traditionally viewed as biotechnologies —
such as_ materials science, information technology, and
nanotechnology — are converging with biotechnology in unforeseen
ways and thereby enabling the development of previously
unimaginable technological applications”.*”
4. Information Technology
The new generation of biological sciences is strongly linked to
progress in information technology: “in order to exploit the enormous
scientific data value of biological data for understanding living
systems, the information must be integrated, analyzed, graphically
displayed, and modelled computationally in a timely fashion”.*’ The
development of such computational models is essential for progress in
the life sciences and biotechnology. Some of the challenges in the
development of computational environments that integrate large
amounts of biological information could be the following: 1)
NEW TECHNOLOGIES AND THEIR IMPLICATIONS FOR BIOSECURITY 67
exponential growth of the biological data in databases; 2) complexity
of new biological data; and 3) algorithm development.”
As stated, computing and the biological sciences are becoming
more and more intertwined, opening numerous new possibilities. In its
report Mapping the Global Future, the US National Intelligence
Council (NIC) suggested that “future technology trends will be
marked not only by accelerating advancements in_ individual
technologies but also by a force-multiplying convergence of the
technologies — information, biological, materials, and
nanotechnologies — that have the potential to revolutionize all
dimensions of life”.*° With the introduction of Web 2.0 and related
technologies, information and communication technologies can
empower various communities, “with profound impact on business,
politics, and society”.®° The impact on society, especially on models
of innovation, promises to be profound, with “a far-reaching impact
on personal and collective identity”.*’ These new technologies raise
important policy and societal concerns that must be addressed with a
high degree of sensitivity. It is important to have a shared vision and
common objectives in order to address the combined challenges and
opportunities of the life sciences, biotechnology, and information
technologies.
5. Microbial Genome Databases
The development of biotechnology and the life sciences is dependent
on the storage and analysis of increasingly large amounts of genetic
data (which could be defined as “all data, of whatever type,
concerning the hereditary characteristics of an individual or
concerning the pattern of inheritance of such characteristics within a
related group of individuals’”**). Genetic research involving the use of
databases containing human genetic and genomic information has
become increasingly important. Many of these emerging databases
focus on and include information and biological samples from various
populations. These databases, also referred to as microbial genome
databases, may contribute significantly to our understanding of the
complex basis of diseases and consequently lead to improvements in
their detection, prevention, diagnosis, treatment, and cure. At the same
time, such databases raise a number of issues and concerns.
Despite such concerns, “there is limited international guidance
on the establishment, governance and management” of such
68 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
databases. “The governance of databases involves numerous
operational, technical and legal issues, including consideration of
applicable legislation and regulation, the role of ethics and oversight
committees”, as well as the security features of such databases.”
Some of the examples of microbial genome databases include
CARTaGENE,”: the United Kingdom Biobank,” GenomEUtwin,” the
International HapMap Project,” COGENE,” the Public Population
Project in Genomics (P3G),”° the Nucleotide Sequence Database from
the European Molecular Biology Laboratory (EMBL) that has been
operational at the European Bioinformatics Institute (EBI) since
1980,”’ and Swiss-Prot, which was established in 1986.”® Today, there
are over a thousand different life sciences databases with contents
ranging from “gene-property data for different organisms to brain
image data for patients with neurological disorders”.””
Taking into account the complexity of the issue of microbial
genome databases, it is important to address the issue of the role,
nature, and function of oversight committees, and ensure that such
databases comply with the mechanisms for enforcement of decisions
as well as ethical guidelines, which in turn will ensure that privacy
and security policies are respected. Given the potential for misuse of
data and samples collected in microbial genome databases, their
security (in both legal and technical dimensions) is essential.
However, taking into account that the fundamental purpose of
microbial genome databases is to foster research, access to these
databases raises key questions for consideration, namely the question
of “who would have access to the database”.'”° As of today, there are
open genetic databases with open access.
According to the OECD, “Biological resource centres [BRCs]
are an essential part of the infrastructure underpinning biotechnology.
They consist of service providers and repositories of living cells,
genomes of organism, and information relating to heredity and the
functions of biological systems. BRCs contain collections of
culturable organisms (e.g. micro-organisms, plant, animal and human
cells), replicable parts of these (e.g. genomes, plasmids, viruses,
[complementary DNAs] (cDNAs), viable but not yet culturable cells
and tissues, as well as databases containing molecular, physiological
and structural information relevant to these collections and related
bioinformatics. BRCs must meet the high standards of quality and
expertise demanded by the international community of scientists and
industry for the delivery of biological information and materials. They
NEW TECHNOLOGIES AND THEIR IMPLICATIONS FOR BIOSECURITY 69
must provide access to biological resources on which R & D in the life
sciences and the advancement of biotechnology depends”.
In this context, according to the Organisation for Economic
»> 101
Co-operation and Development, it is essential that BRCs “assess
potential for malicious misuse based on the following key factors:
“Availability: the number of facilities that stock the biological
material and their geographical distribution.
“Amplification: the ease with which the biological material
can be replicated ... .
“Skills and knowledge: the ubiquity or rarity of the skills and
knowledge necessary to amplify and/or genetically modify the
biological material.
“Dispersal: the ease and effectiveness with which the
biological material can be dispersed ... .
“Environmental viability: the hardiness of the biological
material across a range of temperatures, humidity levels, light
exposures.
“Countermeasures: the existence of, and ease of access to,
prophylaxis, post-exposure treatment and detection and
decontamination measures.
“Economic consequences: the extent to which the biological
material may be used to bring about harmful economic
consequences ffor humans, _ crops, livestock, or
infrastructure.”!””
Moreover, “BRCs should assess virulence based on the
following key factors:
“Infective dose: the smallest quantity of the biological
material necessary to cause infection.
“Pathogenicity: the disease-causing ability of the biological
material.
“Lethality: the ability of the biological material to cause death
to the host.
“Transmissibility: the ease with which the biological material
can spread... .”!
70 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
More importantly, “facilities that handle materials and
information that could potentially be of ‘dual use’ have the added
oq oye . ° ss 104
responsibility to make special efforts to secure against loss or theft”.
In addition, the “prospect of bioterrorism gives rise to the need to
protect facilities that work with, store or transfer dangerous biological
materials from being intentionally misused”.'° That is why it is
essential that BRCs focus not only on promoting scientific openness,
but also on global security. According to the OECD, it is important
that BRCs implement biosecurity best-practice guidelines “in a
manner that does not conflict with obligations under national, local
and/or international law and regulations”.'°° BRCs should ensure that
a detailed inventory of the different biological materials they hold is
available. In addition, “BRCs should conduct a risk assessment of
biological materials in their inventories for the purpose of assigning
such materials to biosecurity risk levels, which may be assigned as
high, moderate, low or negligible. The level of biosecurity in the use
of biological material should be determined according to the best
available information on its potential for malicious misuse (including
economic consequences) as well as its virulence. Risk assessment
should address the potential of biological materials, should they be
obtained and misused by unauthorised persons, to cause harm to the
health of humans, crops, livestock or infrastructure.”””’
6. Ethical Implications of New Technologies
Some people may argue that “[m]oral imagination is more important
than scientific imagination.” '°* When we think of ethics or morals, the
first thing that comes to mind is distinguishing between right and
wrong, such as the Golden Rule (humans should not be treated as
means to an end but as ends unto themselves), or a code of
professional conduct, such as the Hippocratic Oath. The most
common definition of ethics pictures it as moral philosophy, as the
study of values and customs of a person or a group. Ethics could also
be defined as “a method, procedure, or perspective for deciding how
to act and for analyzing complex problems and issues”.'”’ Some of the
key ethical principles include respect for life, doing good
(beneficence), doing no harm (non-maleficence), justice, and freedom
of moral decision-making. Most importantly, ethics is by its nature
crosscutting and multidimensional.
NEW TECHNOLOGIES AND THEIR IMPLICATIONS FOR BIOSECURITY 71
Scientific and technological progress gives rise to new ethical
or societal implications. The emerging life-science technologies
associated with germline engineering, gene therapy, cloning, and
methods of human enhancement, as well as other new technologies
such as synthetic biology (which refers to “the use of advanced DNA
synthesis techniques to design and fabricate biological components
and systems that do not exist in the natural world, or to redesign and
fabricate existing biological systems, in pursuit of practical
applications”''’), computer-brain interfacing, brain imaging, and space
exploration, carry with them some known, as well as unknown,
risks.''' These issues should be addressed timely, taking into account
the moral obligations towards present and future generations, as well
as the responsibility of the strong towards the weak.
Today, there is no moral consensus about the ways in which
the new technologies may contribute to the development and
production of biological weapons. The 1972 Biological and Toxin
Weapons Convention was one of the most prominent international
treaties that legally banned biological weapons (see Chapter 5). The
main prohibition in Article | of the Convention is based on a principle
that bans all work on biological agents for non-peaceful intents and
purposes: “Each State Party to this Convention undertakes never in
any circumstances to develop, produce, stockpile or otherwise acquire
or retain: ... Microbial or other biological agents, or toxins whatever
their origin or method of production, of types and in quantities that
have no justification for prophylactic, protective or other peaceful
purposes.”''* This duality creates serious ethical dilemmas and
uncertainties for scientists involved in the field of biotechnology.
In the last decade, the number of authors contributing to
scientific biological research has been rapidly increasing.
Consequently, “the act of putting together a written work has grown
more complex, and the issue of authorship itself has come under
increasing scrutiny”.''’ It is important that authors take responsibility
for the accuracy of scientific articles. Although the peer review
process is very rigorous, some unforeseen misuse of information may
occur. The importance of this was underscored with the retraction in
2005 of a well-known paper on DNA repair, after it was proven that
falsified data had been supplied by one of the authors without the
knowledge of the lead author. “Prior to publication, it appears that
none of the other authors of the paper had validated, verified or
reviewed the data, even though the data were critical to the
72 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
conclusions they reported. Their conclusions may eventually prove to
be correct, but the incident has had a negative effect on the careers of
all the authors and may result in sanctions by the agency that granted
support to the study.”’”
As we can see, the ethics of research is becoming ever more
important. “Scientific misconduct encompasses acts of data
falsification, fabrication, and plagiarism, as well as dishonest
representations in scientific writings and engineering documents.
Misconduct may also consist of inappropriate claims by authors,
biased evaluations of scientific grants and manuscripts by reviewers,
and conflicts of interest in the activities of scientists, professors, and
even institutions. The intentional stealing of ideas of others without
proper attribution is perhaps the most serious example of scientific
misconduct.”''? Given the importance of ethics for the conduct of
research, many government agencies and professional scientific
associations have adopted specific codes, rules, and policies relating
to research ethics. Influential research ethics policies include the
Nuremberg Code, the Declaration of Helsinki (World Medical
Association), and the Council for International Organizations of
Medical Sciences (CIOMS) International Ethical Guidelines for
Biomedical Research Involving Human Subjects.''® As suggested by
David B. Resnik and Adil E. Shamoo, most existing codes address the
following ethical principles:
e “Honesty Strive for honesty in all scientific communications.
Honestly report data, results, methods and procedures, and
publication status. Do not fabricate, falsify, or misrepresent
data. Do not deceive colleagues, granting agencies, or the
public.
e “Objectivity Strive to avoid bias in experimental design, data
analysis, data interpretation, peer review, personnel decisions,
grant writing, expert testimony, and other aspects of research
where objectivity is expected or required. Avoid or minimize
bias or self-deception. Disclose personal or financial interests
that may affect research.
e “Integrity Keep your promises and agreements; act with
sincerity; strive for consistency of thought and action.
e “Carefulness Avoid careless errors and negligence; carefully
and critically examine your own work and the work of your
peers. Keep good records of research activities, such as data
NEW TECHNOLOGIES AND THEIR IMPLICATIONS FOR BIOSECURITY 73
collection, research design, and correspondence with agencies
or journals.
“Openness Share data, results, ideas, tools, resources. Be
open to criticism and new ideas.
“Respect for intellectual property Honor patents,
copyrights, and other forms of intellectual property. Do not
use unpublished data, methods, or results without permission.
Give credit where credit is due. Give proper
acknowledgement or credit for all contributions to research.
“Confidentiality Protect confidential communications, such
as papers or grants submitted for publication, personnel
records, trade or military secrets, and patient records.
“Responsible publication Publish in order to advance
research and scholarship, not to advance just your own career.
Avoid wasteful and duplicative publication.
“Responsible mentoring Help to educate, mentor, and advise
students. Promote their welfare and allow them to make their
own decisions.
“Respect for colleagues Respect your colleagues and treat
them fairly.
“Social responsibility Strive to promote social good and
prevent or mitigate social harms through research, public
education, and advocacy.
“Non-discrimination Avoid discrimination against
colleagues or students on the basis of sex, race, ethnicity, or
other factors that are not related to their scientific competence
and integrity.
“Competence Maintain and improve your own professional
competence and expertise through lifelong education and
learning; take steps to promote competence in science as a
whole.
“Legality Know and obey relevant laws and institutional and
governmental policies.
“Animal care Show proper respect and care for animals when
using them in research. Do not conduct unnecessary or poorly
designed animal experiments.
“Protection of human subjects When conducting research on
human subjects, minimize harms and risks and maximize
benefits; respect human dignity, privacy, and autonomy; take
74 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
special precautions with vulnerable populations; and strive to
distribute the benefits and burdens of research fairly [bold in
original].”""’
One of the key elements in enhancing global biosecurity is
“the promotion of best standards and practices in the conduct of
research and development activities and in the operations of life-
science facilities and laboratories”.''* In the search for a plausible
solution, it is important to ensure a dialogue among experts,
decisionmakers, and the public (bearing in mind that the role of the
expert becomes more important the more advanced the technology).'””
For example, the European Commission’s (EC) European Group on
Ethics in Science and New Technologies’”’ plays the role of political
broker. It aims to contribute to the debate about the relationship
between new scientific breakthroughs and the evolution of the
attitudes that this process brings. It plays an important role in
networking with and between European national ethics bodies.’”'
Another set of ethical issue includes ethics of prevention (one
of the most tempting steps to take in the face of biological-warfare
risks is to protect citizens through massive vaccination campaigns,
which implies various ethical concerns, as vaccines carry their own
risks); and ethics of the allocation of treatments. Ethical questions that
arise include: “Who should profit from treatments, vaccines, and cures
for biological warfare agents? Should the government compel drug
companies to make therapeutic drugs and vaccines? Who should
control the pricing of these drugs? How will the uninsured be treated?
What principles should govern liability for side effects, injury or the
failure of drugs or vaccines to protect or cure?”’~”
Overall, the explicit dual-use nature of biotechnology requires
applying ethical decision-making rules to research. In this respect,
transparency, accountability, and participatory approaches should be
reinforced, and comprehensive codes of conduct should be
encouraged throughout the scientific and decision-making
communities, with the aim of successfully addressing the issue of
ethical implications of new technologies.
NEW TECHNOLOGIES AND THEIR IMPLICATIONS FOR BIOSECURITY 75
REFERENCES
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Ibid.
* J. Cracraft, “Editorial: A New AIBS for the Age of Biology”, BioScience, November
2004, http://www.aibs.org/bioscience-editorials/editorial 2004 11.html.
* National Research Council of the National Academies, Biotechnology Research in
an Age of Terrorism (Washington, DC: The National Academies Press, 2003), p. 16,
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5 :
Ibid.
® A.J. Grotto and J.B. Tucker, “Biosecurity: A Comprehensive Action Plan”, Center
for American Progress, June 2006, p. 50, http://www. icanprogress.o iosecu
rity_a_ comprehensive action _plan.pdf.
’ Committee on Advances in Technology and the Prevention of Their Application to
Next Generation Biowarfare Threats, Development, Security, and Cooperation Policy
and Global Affairs Division, Board on Global Health, Institute of Medicine, Institute
of Medicine and National Research Council of the National Academies,
Globalization, Biosecurity, and the Future of the Life Sciences (Washington, DC: The
National Academies Press, 2006), p. 15.
* Ibid., p. 27.
® Ibid., p. 24.
'° Ibid., p. 25.
'' Ibid., p. 26.
'? European Commission, “New Perspectives on the Knowledge-Based Bio-Economy,
Transforming Life Sciences Knowledge into New, Sustainable, Eco-efficient and
Competitive Products”, Conference Report, Brussels, 15-16 September 2005, http://ec
.curopa.eu/research/conferences/2005/kbb/pdf/kbbe_conferencereport.pdf.
- European Commission, op. cit., note 1.
'* Confederation of Indian Industry and the Department of Biotechnology of the
Ministry of Science and Technology of the Government of India, “Facts about
Biotechnology”, http://www.ciionline.org/Common/282/Images/bro-bi.pdf.
Ibid.
'© National Research Council of the National Academies, op. cit., note 4, p. 17.
European Commission, op. cit., note 1, p. 10.
'8 Thid., pp. 7-8.
'? National Research Council of the National Academies, op. cit., note 4, p. 17.
2° See the draft National Security Strategy of the Commonwealth of The Bahamas, p.
6, http://www.unep.ch/biosafety/development/Countryreports/BSNBFrep.
71 TF. Budinger and M.D. Budinger, Ethics of Emerging Technologies, Scientific
Facts and Moral Challenges (New Jersey: John Willey & Sons, 2006), p. 467.
22 European Commission, op. cit., note 1, p. 10.
> M. Bhardwaj, “Global Institutionalization of Governance of Biotechnology and
Universality of Ethical Principles”, Eubios Journal of Asian and International
Bioethics, Vol. 14, 2004, p. 208, http://www.eubios.info/EJ146/e)146g.htm.
76 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
a
24 See the website of the Convention on Biological Diversity, http://www.cbd.int/conyv
ention/convention.shtml].
2° See the section “Competitiveness in biotechnology: Introduction” on the website of
the European Commission, http://ec.europa.eu/enterprise/phabiocom/comp_biotech_i
ntro.htm
© Ibid.
77 The Commonwealth of The Bahamas, op. cit., note 20, p. 6.
8 Committee on Advances in Technology and the Prevention of Their Application to
Next Generation Biowarfare Threats et al., op. cit., note 7, pp. 85-86.
2 European Commission, op. cit., note 1.
°° Ibid.
3! National Research Council of the National Academies, op. cit., note 4, p. 17.
32 “European biotech industry shows double digit revenue growth”, Emst & Young,
press release, 16 April 2007, http://www.ey.com/global/content.nsf/UK/Media_-
07_04_16 DC - European biotech industry shows double digit revenue growth.
se
Ibid.
** Ibid.
*° Committee on Advances in Technology and the Prevention of Their Application to
Next Generation Biowarfare Threats et al., op. cit., note 7, p. 86.
** Japan Bioindustry Association, http://www. jba.or.jp/english/about/index.htm|.
37 AusBiotech, Australia’s Biotechnology Organisation, http://www.ausbiotech.org/co
ntent.asp?pageid=3.
*8 Committee on Advances in Technology and the Prevention of Their Application to
Next Generation Biowarfare Threats et al., op. cit., note 7, p. 86.
*’ European Commission, op. cit., note 1, p. 14.
*° Ibid.
*! See the EuropaBio website, http://www.europabio.be/eu_index. htm.
*? National Research Council of the National Academies, op. cit., note 4, p. 18.
* AH. Zakiri, S. Johnston, and B. Tobin, “The Biodiplomacy Initiative: Informing
Equitable and Ethical Decision-Making for Present and Future Generations”, Work in
Progress, Vol. 17, No. 2, Summer 2005, p. 3, http://www.unu.edu/hq/ginfo/wip/wip1
7-2-summer2005.pdf.
“4 National Research Council of the National Academies, op. cit., note 4, p. 1.
*© United Nations Office in Geneva, “Message of Director-General of UNOG to
Roundtable Debate on Developing a Comprehensive Global Biosecurity Regime”, 15
November 2006, http://www.unog.ch/80256EDD006B9C2E/(httpNewsBy Year_en)/8
ADDD3268093 1A33C1257227003A3C42?OpenDocument.
*° National Research Council of the National Academies, op. cit., note 4, p. 1.
"7 Thid., pp. 111-126.
7 Zakiri et al., op. cit., note 43, p. 3.
; Budinger and Budinger, op. cit., note 21, p. 467.
Committee on Advances in Technology and the Prevention of Their Application to
Next Generation Biowarfare Threats et al., op. cit., note 7, p. 87.
! [bid.
» Ibid.
* C. Cookson, “Nanotech experts launch big push”, Financial Times, 25 June 2007.
NEW TECHNOLOGIES AND THEIR IMPLICATIONS FOR BIOSECURITY 77
4 See the section “Nanotechnology Introduction” on the Nanotechnology Now
website, http://www.nanotech-now.com/introduction.htm.
Committee on Advances in Technology and the Prevention of Their Application to
Next Generation Biowarfare Threats ef al., op. cit., note 7, p. 87.
™ oy Craeralt, op. cit., note 3.
.” Budinger and Budinger, op. cit., note 21, p. 471.
*8 Sixth Review Conference of the States Parties to the Convention on the Prohibition
of the Development, Production and Stockpiling of Bacteriological (Biological) and
Toxin Weapons and on Their Destruction, Secretariat, “Background Information
Document on New Scientific and Technological Developments Relevant to the
Convention”, BWC/CONF.VI/INF.4, Geneva, 28 September 2006, p. 4, http://www.b
wpp.org/6RevCon/documents/B WCCONF. VIINF.4.pdf.
°° National Research Council of the National Academies, op. cit., note 4, p. 16.
*° Sixth Review Conference, op. cit., note 58, p. 4.
*! Ibid.
*? About the Human Genome Project, http://www.ornl.gov/sci/techresources/Human
Genome/project/about.shtml.
® Sixth Review Conference, op. cit., note 58, p. 4.
* About the Human Genome Project, op. cit., note 62.
°° K. Nixdorff and W. Bender, “Biotechnology, Ethics of Research and Potential
Military Spin-off’, International Network of Engineers and Scientists Against
Proliferation, /nformation Bulletin, No. 19, March 2002, http://www.inesap.org/bulleti
n19/bull 9art05.htm.
B. Salter and N. Perez-Solorzano, “Civil society and the governance of human
genetics: Report to the King Baudouin Foundation regarding its project ‘Citizen
participation in the European public debate on the issue of human genetics”, April
J
2003.pdf.
°? Sixth Review Conference, op. cit., note 58, p. 4.
** Ibid.
” Ibid.
”8 National Research Council of the National Academies, op. cit., note 4, pp. 111-126.
its European Commission, op. cit., note 1, p. 13.
*° Ibid.
5! Committee on Advances in Technology and the Prevention of Their Application to
Next Generation Biowarfare Threats et al., op. cit., note 7, p. 15.
*? Thid., p. 16.
83 N. Maltsev, “Computing and the ‘Age of Biology’”, CTWatch Quarterly, August
2006, http://www.ctwatch.org/quarterly/print.php?p=40.
78 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
*4 Ibid.
8 National Intelligence Council, Mapping the Global Future: Report of the National
Intelligence Council’s 2020 Project Based on Consultations With Nongovernmental
Experts Around the World (Pittsburgh, PA: Government Printing Office, 2004), p. 34,
http://www. foia.cia.gov/2020/2020.pdf.
8° K. Schwab, “Preface”, in S. Dutta and I. Mia, Global Information Technology
Report: Connecting to the Networked Economy (Basingstoke: Palgrave Macmillan,
2007), p. v, http://www.weforum.org/pdf/gitr/preface2007.pdf.
87 World Economic Forum Annual Meeting 2007, “Shaping the Global Agendas: The
Shifting Power Equation”, Newsletter, January 2007, http://www.weforum.org/pdf/Ne
wsletter/NLenJan07.pdf.
8 See “Executive Summary” in Organisation for Economic Co-operation and
Development, Creation and Governance of Human Genetic Research Databases
(Paris: OECD, 2006), p. 10, http://www.oecd.org/dataoecd/61/29/37647338.pdf.
8° Tbid., p. 9.
°° Ibid., p. 14.
°! CARTaGENE, http://www.cartagene.qc.ca/.
*° The United Kingdom Biobank, http://www.ukbiobank.ac.uk/.
3 GenomEUtwin, http://www.genomeutwin.org/.
** The International HapMap Project, http://www.hapmap.org/index.html.en.
*° COGENE, http://hg.wustl.edu/COGENE/index.html.
°° Public Population Project in Genomics (P3G), http://www.p3gconsortium.org/.
*? The European Molecular Biology Laboratory, http://www.embl.org/aboutus/genera
linfo/index.html.
*8 Swiss-Prot Group, Swiss Institute of Bioinformatics, http://www.isb-sib.ch/group/S
wiss-Prot.htm.
” A. Gupta, “Life Science Research and Data Management — what can they give each
other?”, Association for Computing Machinery, http://acm.org/sigmod/record/issues/0
406/01.Amanathintro.pdf.
'© Organisation for Economic Co-operation and Development, op. cit., note 88, pp.
15-16.
'°! Organisation for Economic Co-operation and Development, Biological Resource
Centres: Underpinning the Future of Life Sciences and Biotechnology (Paris: OECD,
2001), p. 7, http://www.oecd.org/dataoecd/26/19/3 1685725.pdf.
' Organisation for Economic Co-operation and Development, OECD Best Practice
Guidelines on Biosecurity for BRCs (Paris: OECD, 2007), p. 9, http://www.oecd.org/d
ataoecd/6/27/38778261 pdf.
103 hid.
18 G.J. Annas, “Governing Biotechnology”, Institute on Biotechnology & the Human
Future, http://www.thehumanfuture.org/commentaries/general/general commentary a
nnasO1.html.
' D.B. Resnik, “What is Ethics in Research and Why is It Important?”, National
Institute of Environmental Health Science, http://www.niehs.nih.gov/research/resourc
NEW TECHNOLOGIES AND THEIR IMPLICATIONS FOR BIOSECURITY 79
es/bioethics/whatis.cfm.
'!° Grotto and Tucker, op. cit., note 6, p. 50.
''' Budinger and Budinger, op. cit., note 21, p. 460.
'!2 See the website of the Biological and Toxin Weapons Convention, Convention on
the Prohibition of the Development, .Production and Stockpiling of Bacteriological
(Biological) and Toxin Weapons and on Their Destruction, http://www.opbw.org/.
''? Budinger and Budinger, op. cit., note 21, p. 55.
''4 Ibid.
''S Ibid., p. 70.
'!© World Health Organization, “Operational Guidelines for Ethics Committees That
Review Biomedical Research”, TDR/PRD/ETHICS/2000.1, Geneva, 2000, http://ww
w.who. int/tdr/publications/publications/pdf/ethics. pdf.
'!? Resnik, op. cit., note 109; D.B. Resnik and A.E. Shamoo, Responsible Conduct of
Research (New York: Oxford University Press, 2004).
mak Taylor, “Safeguarding Advances in the Life Sciences”, EMBO reports, Vol. 7,
No. S1, 2006, p. S63, http://www.iclscharter.org/i Safe ing advanceces in
the life sciences.pdf.
'!? Budinger and Budinger, op. cit., note 21, pp. 460-461.
120 European Commission, European Group on Ethics in Science and New
Technologies, http://ec.europa.eu/european_ group ethics/index_en.htm.
'2) Tid.
122 A. Fiester, “Bioethics & Bioterrorism”, Penn Bioethics, Vol. 9, No. 4, 1 March
2002, pp. 6-7.
CHAPTER 5
CONTAINING BIOLOGICAL RISK:
BIOSECURITY-RELATED NATIONAL AND
INTERNATIONAL NORMS
1. Deliberate Hostile Use of Biological Agents: Biological Weapons
From time immemorial to the most recent advances of science,
humankind has been confronted with a whole range of risks and
threats associated with microscopic living organisms. Experts have
enumerated the components of this spectrum of risks, ranging from
the most natural/involuntary to the most artificial/voluntary ones:
e Naturally occurring diseases;
e Re-emerging infectious diseases thought to have been
eradicated;
e Unintended consequences of scientific research;
Laboratory accidents leading to contamination and spread of
diseases;
e Lack of awareness of the dangers of biological agents among
the public;
e Negligence in handling, storing, or transferring pathogens;
e Deliberate misuse of biological agents in warfare or by
terrorists.’
Governments, international organisations, academic
institutions, and industry have been facing the challenge of assessing,
managing, and countering those risks, both from a normative and a
practical viewpoint, in order to prevent or treat their negative,
sometimes deadly, natural or man-made consequences. Considering
that pathogens know no national boundaries, cooperation between
states and between non-governmental organisations (NGOs) is
required to deal with them. This chapter will examine the main efforts
82 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
made in recent decades by the international community and states to
contain biological risks, be it at the global, regional, or national level.
It will address the above-mentioned risks starting with the deliberate
misuse of biological agents and finishing with the most naturally
occurring phenomena.
(a) The Brussels Declaration and the Hague Conventions
In view of the dangers it entailed not only for soldiers but above all for
civilian populations, it was in the 19" century that the major powers
began to attempt to control the deliberate spread of infectious
diseases. On the initiative of Russian Tsar Alexander II, 15 European
states adopted on 27 July 1874 the Brussels Declaration concerning
the laws and customs of war, banning, among others, the use of
“poison or poisoned weapons” (implying both biological and chemical
poison).” This treaty was never ratified, but it served as a basis for
further international agreements, the Hague Conventions of 1899° and
1907,’ which reiterated this prohibition.
The Brussels Declaration and the Hague Conventions were
attempts to codify customary law. The Brussels Declaration was a first
attempt, and it became the blueprint for the 1899 Hague Convention.
The 1907 Hague Convention is still in force, since the 3“ Hague Peace
Conference never took place. In addition, at the Nuremberg Trials, the
Hague Convention was declared to be universally applicable (which
included the poison clause). Thus, the Hague Convention is
conventional law; its provisions were subsequently taken over in the
Geneva Conventions.
(b) The 1925 Geneva Protocol
The large-scale use of chemical weapons in World War I led to a
major international effort to curb the use of biological weapons. The
Conference for the Supervision of the International Trade in Arms and
Ammunition, held in Geneva under the auspices of the League of
Nations from 4 May to 17 June 1925, agreed upon a Convention for
the Supervision of the International Trade in Arms, Munitions and
Implements of War. It has never entered into force because several
arms-producing states have not ratified it. As a separate document, the
League agreed to a Protocol for the Prohibition of the Use in War of
Asphyxiating, Poisonous or Other Gases, and of Bacteriological
Methods of Warfare, known as the Geneva Protocol.’ It extended the
original notion of poison to chemical and microbial agents and
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reinforced the existing laws on the use of these weapons. In particular,
it extended the prohibition of the use in war of chemical weapons to
include biological weapons. At that time, only bacteria (like anthrax)
were known by science, but when the destructive power of other
living organisms such as viruses (like smallpox), rickettsiae (like Q
fever), chlamydia, or fungi were later discovered, it was considered
that they were also covered by the prohibition.
The Geneva Protocol, which entered into force on 8 February
1928 and now has 134 parties,° only prohibits the use in war of such
agents, that is to say not their use in internal conflicts or if belligerents
do not consider themselves at war. It is important to bear in mind that
the Geneva Protocol belongs to the laws of war and is not an arms-
control or disarmament treaty. It does not ban the threat of such use or
the possession, stockpiling, transfer, or development of the weapons;
it contains no verification mechanism. When they signed the treaty or
acceded to it, some 40 states parties formulated a reservation by
stating that they were not bound by the prohibition in the event that
another state, with which they were engaged in armed conflict, did not
observe the ban. These states reserved the right to retaliate in kind.
Since then, 15 of those parties have lifted their reservations.’
In spite of its shortcomings, the Geneva Protocol of 1925
reflected a widely held moral pressure against biological warfare. For
its time, it was a powerful and remarkable legal instrument. Since the
entry into force of the Protocol, the only documented large-scale use
of biological weapons occurred in World War II, when Japan, which
had signed but not ratified the Protocol, used these weapons in attacks
on 11 Chinese cities. It is estimated that as many as 200,000 people
died.* Overall, the Geneva Protocol was intended as a strong statement
pending the start of the comprehensive disarmament negotiations
within the context of the League of Nations. Later, as those
negotiations failed in the 1930s, the Protocol took on far greater
significance than was originally intended. After World War II, several
countries, including the US, the UK, and the Soviet Union, conducted
research and development programmes on biological warfare and
manufactured both biological and toxin weapons.’ It should be noted
that the scope of the Geneva Protocol has expanded to cover armed
conflict in parallel with the understanding of humanitarian law.
84 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
(c) The 1972 Biological and Toxin Weapons Convention and Its
Review Process
On 25 November 1969, convinced by defence experts of the strategic
inefficiency of such weapons in a military conflict, President Richard
Nixon announced unilaterally that the US would destroy all stockpiles
of biological weapons, irrespective of any international agreement,
and asked the US Senate to ratify the Geneva Protocol.'° One year
later, Nixon also declared the destruction of US toxin weapons.
Western countries, supported by a 1969 report of the UN Secretary-
General on chemical and bacteriological weapons,'’ proposed to the
Eighteen-Nation Disarmament Committee (ENDC) in Geneva a draft
treaty banning biological weapons, deliberately excluding chemical
weapons because the prohibition of the latter would be more difficult
to verify. As a result, the Convention on the Prohibition of the
Development, Production and Stockpiling of Bacteriological
(Biological) and Toxin Weapons was signed on 10 April 1972 and
entered into force on 26 March 1975." As of August 2007, the
Convention had 159 states parties.’°
The Convention formally prohibits the development,
production, and stockpiling of biological weapons at the state level. It
embodies a norm that already existed (via early bans on poison and
the 1925 Geneva Protocol and many UN General Assembly
resolutions). However, in comparison with the Geneva Protocol, the
states parties to the BWC undertook “never under any circumstances
to develop, produce, stockpile or otherwise acquire or retain:
e “Microbial or other biological agents, or toxins whatever their
origin or method of production, of types and in quantities that
have no justification for prophylactic, protective or other
peaceful purposes;
e “Weapons, equipment or means of delivery designed to use
such agents or toxins for hostile purposes or in armed
conflict.”"
Although the Convention contains no definition of biological
weapons, it implies that biological agents depend for their effect on
their multiplication within the target organism, while toxins are
poisonous products of organisms incapable of reproducing
themselves.'° It also prohibits the transfer of such agents or weapons
to any recipient, whether a state or a non-state actor. It provides for
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the destruction of all stockpiles or their diversion to peaceful uses. In
fact, it is the first multilateral instrument in history to prohibit a whole
category of weapons. After its entry into force, the US announced that
it had destroyed its stockpiles; the UK declared that it had none
(actually they had been disposed of before the Convention was
negotiated); the Union of Soviet Socialist Republics (USSR) did the
same, but in 1992 President Yeltsin admitted that the Soviet Union
had retained clandestine stockpiles and programmes that Russia would
terminate.’°
At the time of the negotiation of the Biological Weapons
Convention, “effective verification measures or complaint resolution
procedures were not incorporated into the Convention. This was due
partly to political difficulties in negotiating such measures at the
time”.'’ This constitutes the main flaw of the Convention. The
initiators of the treaty expected that it would be fairly easy to track the
origin of any attack using biological weapons. However, they did not
suspect that some states parties would start or continue clandestine
research and production of agents to be weaponised, often under the
disguise of peaceful scientific activities. After some suspicions were
raised by the US on Soviet compliance, the Second Review
Conference of the states parties decided in 1986 to introduce voluntary
transparency and confidence-building measures. Since this did not
appear sufficient to alleviate concerns, the following Review
Conference of the states parties established in 1991 the Ad Hoc Group
of Governmental Experts on Verification (VEREX), with the aim of
examining potential verification measures from a scientific point of
view.
In 1994, the states parties agreed to create an Ad Hoc Group
“in order to negotiate and develop a legally binding verification
regime for the Convention. To this end, the Ad Hoc Group was
mandated to consider four specific areas, namely: definitions of terms
and objective criteria; incorporation of existing and further enhanced
confidence-building and transparency measures, as appropriate, into
the regime; a system of measures to promote compliance with the
Convention; and specific measures designed to ensure the effective
and full implementation of Article X on international cooperation and
exchange in the field of peaceful bacteriological (biological)
activities”.'* Although there are major differences between chemical
and biological weapons, states parties were encouraged by the
progress made in designing a strong verification mechanism for the
86 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
prohibition of chemical weapons, which was eventually included in
the Convention banning chemical weapons, concluded in 1992 and
opened for signature in 1993 (entry into force was in 1997).
The Ad Hoc Group on biological weapons reported a draft
protocol to the Fourth (1996) and Fifth (2001) Review Conferences.
But at the latter, the US delegation rejected the draft verification
protocol agreed by the Ad Hoc Group,’” arguing that it would not
ensure sufficiently tight verification. According to US Ambassador
John Bolton, “giving proliferators the BWC stamp of approval, the
Protocol would have provided them with a ‘safe harbor’ while lulling
us into a false sense of security”.“’ Other considerations explaining the
American position also include US fears of possible breaches of
commercial confidentiality and possible access of foreign intelligence
to US biodefence programmes.”! An independent expert study
conducted by the Washington Center for Strategic and International
Studies (CSIS) with representatives of the biotechnology industry
suggested in 2004 that it was feasible to inspect this industry while
protecting confidential commercial information.”
The 2001 Review Conference agreed that the states parties
would hold annual meetings of their representatives and experts in the
following three years leading up to the next Review Conference in
November 2006. Those meetings allowed an in-depth discussion of
the national measures needed to strengthen implementation of the
Convention (criminal legislation, export controls, biosecurity,
biosafety, codes of conduct for scientists, etc.).7* The outcome of the
Conference will be discussed in depth in Chapter 8. In general, of
particular value is the growing synergy established throughout the
intersessional meetings between representatives of governments,
academia, industry, and non-governmental organisations. Among
these, one can point to the work achieved in particular by the
University of Bradford and its Project on Strengthening the Biological
and Toxin Weapons Convention, as well as the BioWeapons
Prevention Project (BWPP), a consortium of various institutions and
NGOs active in this field.”
(d) Export Control Regimes
As with other weapons of mass destruction, the Biological and Toxin
Weapons Convention could not operate effectively if suppliers of
dual-use materials or technology could export them freely to any state,
irrespective of the efforts made by such states to prevent the misuse of
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biological science. This is why treaties relating to weapons of mass
destruction always contain a non-transfer clause. In the case of
biological and toxin weapons, it is Article III, according to which:
“Each State Party to this Convention undertakes not to transfer to any
recipient whatsoever, directly or indirectly, and not in any way to
assist, encourage, or induce any state, group of states or international
organizations to manufacture or otherwise acquire any of the agents,
toxins, weapons, equipment or means of delivery specified in article |
of this Convention.”
In the biological area, a number of suppliers decided to
coordinate their export control regimes for biological agents and
equipment within the framework of the Australia Group, created in
1985 in response to evidence that Western countries had supplied Iraq
with dual-use chemicals that were diverted to its chemical-weapons
programme. In 1990, the Group expanded its scrutiny to biological
materials, as information revealed that Iraq had also been pursuing a
biological-weapons programme. In 1991, it drew up a warning list
covering 54 materials (including pathogens and toxins or dual-use
equipment) that was shared with industry and the scientific
community. The Group promotes information-sharing on suspicious
activities among participants. As of March 2007, its membership
included 40 states and the European Commission.”°
Developing nations often accuse the industrialised countries
that harmonise their policies within export control regimes such as the
Australia Group of denying them access to the materials or technology
necessary for their economic development.”’ Exporting countries
consider that “coordination of national export control measures assists
[them] to fulfill their obligations under the Chemical Weapons
Convention and the Biological Weapons Convention to the maximum
extent possible. Indeed, in the absence of a verification body for the
Biological Weapons Convention, the Australia Group’s development
of control lists covering biological materials and technologies is the
only form of internationally harmonized control over such items.”*
Indeed, the 2006 Review Conference, on the one hand, called
“for appropriate measures, including effective national export
controls, by all States Parties to implement [the non-transfer
obligation], in order to ensure that direct and indirect transfers
relevant to the Convention, to any recipient whatsoever, are
authorized only when the intended use is for purposes not prohibited
under the Convention”. On the other hand, it reiterated that “States
88 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Parties should not use the provisions of [the non-transfer clause] to
impose restrictions and/or limitations on transfers [made] for purposes
consistent with the objectives and provisions of the Convention of
scientific knowledge, technology, equipment and materials under [the
article relating to international cooperation]”.~’ Industrialised
countries, in particular multinational companies, would certainly
prefer to be able to make profits from exports of their dual-use goods
and technology without restrictions to any solvent customer. But it is
in the interest of the whole international community that demand be
satisfied only where there are sufficient guarantees that the final uses
of such goods and technology will be peaceful and that they cannot be
diverted to hostile uses.
Another reason for strengthening export controls is the
potential unpredictable evolution in the life sciences, in particular
genetic manipulation or engineering, which may lead to, or facilitate,
the diversion of biological agents from peaceful to non-peaceful uses,
as we saw in Chapters 3 and 4. Indeed, the 2006 Review Conference
recognised that, “while recent scientific and technological
developments in the field of biotechnology would increase the
potential for co-operation among States Parties and thereby strengthen
the Convention, they could also increase the potential for the misuse
of both science and technology”. In this regard, the Conference
decided that, when the states parties meet in 2011 to review the
operation of the Convention, they will take into account the “new
scientific and technological developments relevant to the
Convention”.*' In other words, states parties have a duty to monitor
those evolutions in the biological area that could affect the prohibition
of use of biological agents for hostile purposes.
(e) Investigations by the UN Secretary-General of Alleged Use of
Chemical and Biological Weapons
During the Iraq-Iran war (1980-1988), several allegations of use of
chemical weapons by the belligerents were made. The UN General
Assembly (UNGA) considered in 1982 that the UN Charter gave the
Secretary-General fact-finding authority to investigate alleged use not
only of chemical, but also of biological and toxin weapons as
violations of the Geneva Protocol. The General Assembly invited him
to compile and maintain lists of qualified experts and analytical
laboratories to assist him in his investigations, and these experts were
tasked with developing procedures for such investigations (Resolution
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BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS 89
37/98D, 13 December 1982).** In 1987 and 1989, a new group of
experts updated and revised the previous guidelines, which were
endorsed by the UN General Assembly (Resolution 42/37C, 30
November 1987° and Report A/44/561 of 4 October 1989).* The
authority of the Secretary-General to conduct investigations of
allegations of the use of biological (and chemical) weapons was also
strengthened by the UN Security Council in its Resolution 620 of 26
August 1988.°°
(f) The G8 Global Partnership
As we have seen, states parties to the BWC are committed to
destroying all biological weapons, to discontinuing any biological-
weapons programmes, or diverting such weapons or programmes to
peaceful uses. Since Russia admitted in 1992 that the Soviet Union
(although one of the three depositaries of the treaty with the US and
the UK) had violated its obligations under the Convention, the
Russian Federation undertook to complete the process of full transfer
of any weaponised agent or research and development programme to
peaceful uses. This is not an easy task and can require time, effort, and
resources. The Global Partnership Against the Spread of Weapons and
Materials of Mass Destruction, established by the G8 countries at the
Kananaskis Summit in 2002, decided to assist Russia and other former
Soviet states in the destruction of their weapons of mass destruction.
Russia decided that the main priority of the Global Partnership
was the destruction or re-conversion of its nuclear warheads or
submarines, as well as the destruction of its chemical weapons in
accordance with the 1993 Chemical Weapons Convention. As a result,
biological weapons have not been considered a priority, in spite of the
potential risks of diversion by individuals or terrorist groups. Barely
1.5 percent of the $20 billion pledged by participating states has until
now been devoted to biological-related programmes.*° Only Canada,
Finland, France, Sweden, and the US, which have a significant
biotechnology industry, have contributed somewhat, in bilateral
programmes or within the Global Partnership, to raising awareness on
the need to improve the security and safety of laboratories and
facilities handling dangerous pathogens, as well as funding site
security enhancements.’ The US Center for Strategic and
International Studies, which monitors the implementation of the
Global Partnership programme, considers that “there is a dangerous
90 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
gap between the progress being made and the scope and urgency of
the threat”.°®
(g) The Role of the International Committee of the Red Cross
(ICRC)
As the guardian of international humanitarian law, including the laws
of war and rules on the use of certain weapons, the ICRC plays a
major role as the moral and legal conscience of the international
community. When the time came, in 1974, to complement the 1949
Geneva Conventions with an additional protocol, the issue of
regulating the use of weapons of mass destruction, especially nuclear
weapons, was discussed. Because nuclear powers insisted that their
strategy of deterrence contributed to preventing conflict, weapons of
mass destruction could not be included in the Additional Protocol,
eventually signed in 1977. But the ICRC considers that its role
includes inviting and helping states in implementing the provisions of
the treaties that have been concluded to prohibit weapons of mass
destruction, such as the Nuclear Non-proliferation Treaty (NPT), the
Biological Weapons Convention, and the Chemical Weapons
Convention.*’
With regard to the biological threat, the ICRC launched in
September 2002 an “Appeal on Biotechnology, Weapons and
Humanity”, which called on states, the scientific community, the
biotechnology industry, and civil society in general to “ensure that
potentially dangerous biological knowledge and agents” are subjected
to effective control.“° At the 2006 Review Conference of the BWC,
the ICRC called “on states to reaffirm the ultimate objective of the
Convention — to exclude completely the possibility of bacteriological
agents and toxins being used as weapons” — and to take supplementary
measures to ensure that this objective is met. The ICRC urged “states
to engage in dialogue with all those concerned and to foster a co-
operative approach to preventing the hostile use of biological agents
and toxins”, involving “not only members of the public health sector,
law-enforcement agencies, and other government officials, but also
life scientists and those in the defense and security community and in
industry”.“' The ICRC called for “building an effective ‘web of
prevention’ that can help protect humanity from poisoning and the
deliberate spread of disease in the future”.“”
Finally, the ICRC has established some “Principles of
Practice” that aim to “build a bridge from pertinent ethics and laws
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which should prevent poisoning and deliberate spread of infectious
disease to best practice within the life science community”.””
2. Deliberate Hostile Use of Biological Agents: Biological
Terrorism
States do not have a monopoly on the spread of infectious diseases for
hostile purposes. This has been resorted to as a weapon also by non-
state actors, mainly terrorist groups or individuals. Although
awareness of the risk implied by such a potential use has grown in
recent years, most experts consider that the responses of nations and
the international community to combat such a phenomenon are still
not commensurate with the danger that the world is facing.
(a) Cases of Bioterrorism
The difficulty in assessing the bioterrorist risk derives from three
factors:
4 The relative ease with which the preparation of a bioterrorist
attack could be concealed and would escape the vigilance of
law enforcement or intelligence services. Such an
apocalyptic scenario is well described in the science-fiction
thriller Executive Orders by Tom Clancy.“
. The uncertainties related to future progress in
biotechnology. As two leading experts have put it, “the
revolution in biotechnology will ... almost inevitably place
greater destructive power in the hands of smaller groups of
the technically competent: those with the skills sufficient to
make use of the advances of the international scientific
community”.”
a The fact that there have been few attempted attacks,
(although a great thing) does not help in providing useful
lessons for countering similar attacks. According to the Pan
American Health Organization (PAHO), there have been
only 222 bioterrorism-related incidents in a 100-year period,
and in only 24 cases have there been confirmed attacks, an
average of one every four years worldwide. According to
the US National Defense University, which researched 142
cases of bioterrorism or biocrime in the past 100 years
across the globe, 115 of those occurred in the 1990s.“°
92 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
“Fourteen of the 24 confirmed cases of bioterrorism or
biocrimes were food- or agriculture-related; of those cases,
11 involved food poisoning, and only 3 targeted commercial
animals or plants. Of the 222 documented incidents, only 6
appear to be clearly linked to attacks on commercial plants
and animals.”*’
(b) Responses to Bioterrorism at the Global Level
Considering the growing perception by governments and international
organisations of the potential threat resulting from the deliberate
spread of diseases, a number of initiatives have been taken at various
levels to counter such a threat.
(i) The UN Security Council (UNSC)
The UNSC has adopted Resolution 1373 on 28 September 2001,
shortly after the 9/11 attacks.“* Using for the first time its
comprehensive enforcement powers under Chapter VII of the UN
Charter, the Security Council decided that all member states had the
legal obligation to prevent and fight terrorism, its financing, any
support to it, the movement of terrorists, etc., and that they needed to
cooperate to that end. In particular, it noted “with concern the close
connection between international terrorism and_ transnational
organized crime, illicit drugs, money-laundering, illegal arms-
trafficking, and illegal movement of nuclear, chemical, biological and
other potentially deadly materials, and in this regard [emphasized] the
need to enhance coordination of efforts on national, subregional,
regional and international levels in order to strengthen a global
response to this serious challenge and threat to international
security”.”? In order to monitor the implementation of the Resolution,
it established a Counter-Terrorism Committee, to which all member
states had to report on the measures they had taken to fulfil their
obligations. This Committee was later assisted in its tasks by experts
meeting in a Counter-Terrorism Committee Executive Directorate
(CTED), established by UNSC Resolution 1535 of 26 March 2004.°°
The second time that the UNSC decided to use its Chapter VII
powers for a general anti-terrorist initiative was when it adopted
Resolution 1540 on 28 April 2004.°' According to this landmark
Resolution, all member states have the legal obligation to “refrain
from providing any form of support to non-state actors that attempt to
develop, acquire, manufacture, possess, transport, transfer or use
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nuclear, chemical or biological weapons and their means of
delivery”? Moreover, such activities must be criminalised by all
states: they must “adopt and enforce appropriate effective laws which
prohibit any non-state actor to conduct such activities”.”> According to
the Resolution, states must ensure domestic control over weapons of
mass destruction and related materials, and in particular:
e “Account for and secure such items in production, use, storage
or transport”;
Apply “appropriate effective physical protection measures”;
Apply “appropriate effective border controls and law
enforcement efforts to detect, deter, prevent and combat ...
the illicit trafficking and brokering in such items”;
e Apply “appropriate effective national export and _ trans-
shipment controls over such items, including appropriate laws
and regulations to control export, transit, trans-shipment and
re-export and controls on providing funds and services related
to such export and trans-shipment such as financing, and
transporting that would contribute to proliferation, as well as
establishing end-user controls; and establishing and enforcing
appropriate criminal or civil penalties for violations of such
export control laws and regulations”.
In particular, the requirement of strict measures to secure
facilities handling weapons-related materials, such as dangerous
pathogens, as well as strong export controls, are obligations deriving
from the Biological Weapons Convention, which are now extended to
all states, even if they are not party to the Convention. The Resolution
also established a special Committee (the 1540 Committee), assisted
by experts, tasked with collecting and analysing the reports that
member states must send to the Security Council to describe the
measures that they have taken to implement the resolution. Initially,
the mandate of the 1540 Committee was for two years. It was renewed
by Resolution 1673 adopted on 27 April 2006.
(ii) The United Nations Global Counter-Terrorism Strategy
On 6 September 2006, on the basis of the report of the Secretary-
General “Uniting against terrorism”, the UN General Assembly
adopted the UN Global Counter-Terrorism Strategy.°° Kofi Annan had
underlined in his report that: “Preventing bioterrorism requires
94 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
innovative solutions specific to the nature of the threat. ... Soon, tens
of thousands of laboratories worldwide will be operating in a multi-
billion-dollar industry. Even students working in small laboratories
will be able to carry out gene manipulation. The approach to fighting
the abuse of biotechnology for terrorist purposes will have more in
common with measures against cybercrime than with the work to
control nuclear proliferation.”’’ Thus, in their unprecedented Strategy,
the member states, in particular, invited the UN to develop a single
comprehensive database on biological incidents, and “the Secretary-
General to update the roster of experts and laboratories, as well as the
technical guidelines and procedures, available to him for the timely
and efficient investigation of alleged use”.”®
In addition, the UN General Assembly noted “the importance
of the proposal of the Secretary-General to bring together, within the
framework of the United Nations, the major biotechnology
stakeholders, including industry, the scientific community, civil
society and governments, into a common programme aimed at
ensuring that biotechnology advances are not used for terrorist or
other criminal purposes but for the public good, with due respect for
the basic international norms on intellectual property rights”.
Moreover, the UN General Assembly recalled the obligations derived
in particular from UNSC Resolution 1540 to prevent the illegal
trafficking of biological weapons and related materials; it called on the
UN to improve its inter-agency cooperation in planning the response
to a possible biological attack.
Finally, it “encourage[d] the World Health Organization to
step up its technical assistance to help states improve their public
health systems to prevent and prepare for biological attacks by
terrorists”.°” This comprehensive strategy will serve as a major
reference for governments and international organisations to elaborate
and implement measures of prevention against terrorist attacks using
biological agents, and mitigate possible consequences of such an
occurrence. Indeed, a strong defence against such aggressive acts — in
so far as it is feasible — would act as a deterrent against terrorist
groups seeking maximum casualties and disruption.
(iii) The International Criminal Police Organization (Interpol)
Interpol has done pioneering work in analysing the bioterrorist risk
and elaborating guidelines for national law-enforcement and
intelligence services in their counterterrorist activities. In 2004, it
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created a dedicated Bioterrorism Prevention Unit in its secretariat; it
launched a police training programme; it organised a Global
Conference on Bioterrorism in 2005 to raise awareness of the issue; it
elaborated fact sheets, reference training manuals, and investigative
guides for law-enforcement agencies (such as the “Bioterrorism
Incident Pre-Planning and Response Guide”).°!
Interpol also encourages states to introduce new legislation or
adapt their legislation in order to allow investigations prior to any
bioterrorist incident; indeed, as Secretary-General Ronald K. Noble
said in 2006, “While many member countries have recognized the
need for specific laws to combat this threat, only a few so far have
drafted or implemented the necessary legislation.’ Interpol also
helps under-equipped developing countries to build their capacities,
and, for that purpose, has been convening regional seminars in former
Soviet countries, Latin America, Africa, and Asia. Finally, it seeks to
enhance cooperation between various national stakeholders (public
health officials, customs, and law enforcement), as well as between
international organisations.
(iv) The World Health Organization (WHO)
In May 2002, the WHO Secretariat submitted a report entitled
“Deliberate use of biological and chemical agents to cause harm”®? to
the World Health Assembly. It recalled that the “WHO focuses on the
possible public health consequences of (a biological) incident,
regardless of whether it is characterized as a deliberate act or a
naturally occurring event’, but the WHO offered assistance to many
member states in response to their request focusing on deliberate use.
Thus, the World Health Assembly passed Resolution WHAS5S5S.16 on
18 May 2002, “Global public health response to natural occurrence,
accidental release or deliberate use of biological and chemical agents
or radionuclear material that affect health”,” calling on the WHO to
develop a strategy in this area.
The WHO’s response to this resolution is based on the
following four main areas:
e International preparedness: the WHO _ runs _ technical-
assistance and training programmes on national preparedness
and response; it updated in 2004 its 1970 guidelines Health
Aspects of Biological and Chemical Weapons; it has
established a Chemical and Biological Weapons (CBW)
96 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Scientific Advisory Group as a permanent resource for the
WHO Secretariat and its member states;
e Global alert and response: the WHO’s activities and
operational framework in this field would be vital for effective
international containment efforts in responding to potential
deliberate use of biological agents;
e National preparedness: the WHO is developing guidelines for
the assessment of national CBW health preparedness and
response plans; jointly with the UN Disaster Management and
Training Programme (DMTP). “The objective is to respond to
the increased number of requests by Member States for
technical assistance on national CBW preparedness and
response programmes and training”, by preparing “a training
module on the management of preparedness and response to
chemical, biological and radionuclear incidents”; reinforcing
“laboratory and epidemiology country capacities”, and
“strengthening surveillance and early-warning systems for
epidemic-prone diseases, including those associated with
deliberate use”;
e Preparedness for selected diseases/intoxication: the WHO
establishes global networks of experts and laboratories, and
develops standards and procedures; it has conducted a risk
assessment analysis that has identified 11 biological agents®’
likely to be used deliberately.
The WHO has also focused on malicious contamination of
food by terrorists, and has, among others, published guidelines to
improve nations’ response capacity, such as its publication Terrorist
Threats to Food: Guidelines for Establishing and Strengthening
Prevention and Response Systems.**
(c) Responses at the Regional Level or among Like-minded States
(i) The European Union (EU)
Shortly after the 9/11 attacks and the anthrax scare in the US, the EU
adopted, on 17 December 2001, a Programme of Cooperation on
Preparcaniess and Response to Biological and Chemical Agent
Attacks.” Essentially, this programme was assigned four main goals:
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e To improve internal coordination within the EU; to that end,
the EU, among others, established a Health Security
Committee to coordinate all responses in terms of public
health related to attacks in which biological agents might be
used;
e To ensure rapid detection and identification of agents and
cases involved in such attacks;
e To elaborate an inventory of medicines and services useful in
case of a bioterrorism incident;
e To develop and adapt relevant internal legislation and
regulations (such as restrictions on the movement of people
and goods), in cooperation with international organisations
like the WHO.”
Most of this programme was put in place by 2003.”' In
February 2004, the European Commission also organised an
international conference on “Ethical Implications of Scientific
Research on Bioweapons and Prevention of Bioterrorism”.’’ The
European Commission issued a Green Paper on Bio-preparedness in
July 2007.” This document is intended to stimulate a debate on how
to reduce biological risks and enhance preparedness and response
capabilities.
(ii) The Organisation for Economic Co-operation and Development
(OECD)
In January 2004, the 30 Ministers of Science of OECD member states
addressed the issue of “the role of responsible stewardship in helping
to achieve a balance between scientific freedom and _ security
concerns”. In September 2004, the International Futures Programme
(IFP) of the organisation brought together 55 selected participants
from industry, academia, public research, scientific societies,
publishers, and government to discuss how to avoid the potential
abuse of research and resources. Consequently, the OECD has
developed a follow-up Programme on Biosecurity,’ which includes
the following prospects for action:
e “{T]o provide a framework for developing the appropriate
oversight responses to biosecurity concerns — including codes
of conduct — among the academic, government and industry
scientific communities;
98 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
e “{T]o devise criteria and subsequent processes to
operationalize such actions at the national and international
75
levels’’.
In addition, it was suggested to establish an inventory of
policy and legal approaches to biosecurity with a view to harmonising
them or making them mutually compatible. In this context, the OECD
has been organising regular workshops and seminars not only to raise
awareness of biosecurity risks, but also to promote capacity-building
in emerging or developing countries. ”°
(iii) The Organization for Security and Co-operation in Europe
(OSCE)
The major documents adopted by the OSCE on terrorism until
recently (the 2001 Bucharest Plan of Action for Combating
Terrorism,’’ the 2001 Bishkek Program of Action,’® the 2002 OSCE
Charter on Preventing and Combating Terrorism,” and the 2002 Porto
Ministerial Council Decision No. 1)*° hardly mentioned the risk of
terrorist use of weapons or materials of mass destruction, let alone
biological ones. However, more recently, the OSCE has decided to
increase awareness of the bioterrorist risk among its member states:
for instance, it organized a workshop on this topic in September 2004,
and supported a joint US-Swiss International Coordination Exercise in
2006 (Black ICE).*
(iv) The North Atlantic Treaty Organization (NATO)
NATO initially focused on defence against a chemical, biological,
radiological, or nuclear (CBRN) attack against the military (through a
deployable analytical laboratory, an event response team, a virtual
centre of excellence for CBRN defence, a defence stockpile, a disease
surveillance system, and a multinational CBRN defence battalion).
But NATO and its partners of the Euro-Atlantic Partnership Council
(EAPC) also adopted a Civil Emergency Action Plan for the
Improvement of Civil Preparedness against Possible Attacks against
the Civilian Population with Chemical, Biological, or Radiological
Agents as part of the Partnership Action Plan against Terrorism,”
adopted at the Prague Summit on 22 November 2002. It is designed to
improve civil preparedness against, and manage the consequences of,
in particular, possible bioterrorist attacks.
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Among others, NATO established a Civil Emergency
Planning (CEP) inventory, listing national civil and _ military
capabilities that could be made available to assist stricken nations. The
EAPC decided, notably, to support national authorities in improving
detection and warning of the population in case of bioterrorist threats,
as well as to promote medical protocols that would improve
coordinated response capability.
(v) The G&
As early as 1986, the group of the most industrialised countries
established an Expert Group on Terrorism. In 2003, at the Evian
Summit, G8 countries decided to transform it into a Counter-terrorism
Action Group open to non-G8 donors, and offered capacity-building
assistance to developing countries in the areas identified by the UN
Counter-Terrorism Committee, which include export controls. But it
was only in 2004, at the Sea Island Summit, that they agreed that
“Bioterrorism poses unique, grave threats to the security of all nations,
and could endanger public health and disrupt economies”.
Consequently, an Action Plan on Nonproliferation was
adopted, containing, among others, commitments “to concrete national
and international steps: (to) expand or, where necessary, initiate new
biosurveillance capabilities to detect bioterror attacks against humans,
animals, and crops; improve our prevention and response capabilities;
increase protection of the global food supply; and respond to,
investigate, and mitigate the effects of alleged uses of biological
weapons or suspicious outbreaks of disease”.*’ The G8 stressed that:
“The BWC is a critical foundation against biological weapons’
proliferation, including to terrorists. Its prohibitions should be fully
implemented, including enactment of penal legislation.”
(vi) The Global Health Security Initiative (GHSI)®
The GHSI is an informal international partnership of like-minded
countries aimed at strengthening health preparedness and global
response to threats of chemical, biological, radiological, or nuclear
(CBRN) terrorism and pandemic influenza. The GHSI was launched
in November 2001 by Canada, the European Commission, France,
Germany, Italy, Japan, Mexico, the United Kingdom, and the United
States. The WHO is a technical advisor to the GHSI. It is not intended
to replace, overlap, or duplicate existing forums or networks, but to
promote better cooperation and coordination among the various
100 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
stakeholders at national and international levels. At its seventh
ministerial meeting’’ in Japan in November 2006, the GHSI reviewed
the actions of the members with respect to improving communications
in cases of outbreaks, capacity-building, risk assessment, health
security research, simulation exercises, infected patient transfers or
isolation techniques, implementation of International Health
Regulations (IHR), etc.
(vii) The Program for Monitoring Emerging Diseases (ProMED-
mail)*’
ProMED-mail is a programme of the International Society for
Infectious Diseases of the Federation of American Scientists. It is a
non-governmental network reporting on disease outbreaks and often is
the first one to detect an emerging disease (as in the case of Severe
Acute Respiratory Syndrome (SARS) in China).** The Program for
Monitoring Emerging Diseases is one of the largest emerging disease
and outbreak reporting systems in the world. As the SARS epidemic
demonstrated, the emergence and spread of infectious diseases in the
era of globalisation must be recognised anywhere in the world in order
to respond appropriately. Originally founded in 1994, ProMED-mail
has more than 40,000 participants in over 165 countries.
(viii) The Organization of American States (OAS)
In 1998, the OAS established an Inter-American Committee against
Terrorism (CICTE).” In its 2006 San Carlos Declaration, it expressed
its commitment to “identifying and fighting emerging terrorist threats,
regardless of their origin, such as ... bioterrorism, ... and the
possibility of access to, and possession, transportation, and use of
weapons of mass destruction and related materials and their vectors in
the hands of terrorists”,”’ as well as “to developing and adopting co-
operative programs”.”' The OAS has also supported regional seminars
and training programmes initiated by Interpol.
(ix) The Association of Southeast Asian Nations (ASEAN)
At their 8th meeting on 21 June 2006 in Yangon, the Health Ministers
of the ASEAN countries pledged to “lead every effort necessary in
making sure that [their] communities understand and are prepared for
potential public health emergencies such as natural disasters.
bioterrorism or outbreaks of communicable diseases”.”* They
committed themselves to “strengthen existing capabilities in each of
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[their] countries to prepare for these emergencies by allocating
necessary resources for early warning and rapid response to disease
outbreak”.”*
(x) An International Group of Experts from Europe and Russia,
Supported by the Swedish Government and the US Center for
Strategic and International Studies (CSIS)
The group issued in 2006 a report entitled “Strategic Study on
Bioterrorism” to raise awareness on the bioterrorist risk and assist
states in assessing it, preventing its occurrence, and managing the
possible consequences of a bioterrorist attack. It contains several
practical recommendations to governments and scientific institutions,
such as: comparing and harmonising regulations on biosecurity and
biosafety, licensing, first responders, protection of the population, etc.;
promoting cooperative projects on medical countermeasures based on
biotechnology (like storing strains and mastering the technology of
hybridomas and monoclonal antibody production); developing
syndromic surveillance methods to detect changes in the patterns of
reported symptoms indicating an outbreak; developing exchange
programmes between European and Russian scientists on key areas
(improving drugs and other prophylactics, new methods of diagnostics
and detection, aerosol vaccines and antitoxins, standard methods of
disinfection, medical emergency action); sharing methods of
inspection and sanitary control of food and water supply;
standardising detection and diagnostics; developing common research
on epidemic modelling systems, pathogen emergence scenarios, and
epidemic forecasting experiences; analysing the psychological, social,
and economic consequences of bioattack/threat scenarios to develop
the resilience of societies against bioterror. This study will serve as a
guide to further activities designed to implement those
recommendations.
(xi) The Economic Community of West African States (ECOWAS)
A regional meeting in support of the universalisation of the BWC was
held in Dakar, Senegal, on 17-18 April 2007.” It targeted the states
not party to the Biological Weapons Convention in West and Central
Africa. The issues of the proliferation of biological weapons and
bioterrorism were discussed.
102 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
(d) National Responses
Under the influence or with the assistance of international or regional
organisations, or because they realised the potential dangers posed by
the intentional spread of diseases, some governments have already
enacted or strengthened legislation and regulations about the
prevention of bioterrorism. Only a few examples will be mentioned
here.
(i) The United States (US)
As early as 1999, the US Congress charged the Department of Health
and Human Services (DHHS) and the Centers for Disease Control and
Prevention (CDC) with the establishment of the National
Pharmaceutical Stockpile (NPS), renamed in 2003 the Strategic
National Stockpile (SNS), a nationwide system of storage facilities
with medicine, equipment, and supplies (‘“antibiotics, chemical
antidotes, antitoxins, life-support medications, ... airway maintenance
supplies, and medical/surgical items”’°) to address an emergency like
bioterrorist attack. It is now managed jointly with the Department of
Homeland Security.”’ This programme includes preparedness training
and education for state and local health-care providers, first
responders, and government officials. However, critics argue that
delivery plans are still inadequate and local agencies underfunded and
understaffed.”®
On 12 June 2002, President George W. Bush signed the Public
Health Security and Bioterrorism Response Act, also known as the
Bioterrorism Act (BTA),” stating that it would “enhance [US] ability
to prevent and detect bioterrorist attacks ...; strengthen the ability of
[the US] health care system to expedite treatments across [the] country
...; help [the US] develop better medicines for the future”.'°° This
comprehensive piece of legislation addresses a whole range of topics,
from national preparedness to controls on dangerous biological agents
and toxins, as well as safety and security of food and drug supply and
of drinking water. Its implementation is shared by several agencies
(Department of Homeland Security, Food and Drug Administration,
Department of Agriculture, and US Customs and Border Protection).
In particular, the bill requires all domestic and foreign food facilities
that manufacture/process, pack, or hold food for human or animal
consumption in the United States, and prior notice must be submitted
for any shipment of human or animal food imported or offered for
import into US territory.
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The consequences of the introduction of this legislation have
been sweeping in terms of adaptation of domestic penal and
commercial law, changes in record-keeping regulations, trade
practices, etc. It has led the US government to ensure, through a major
public relations effort, that the new requirements are well known in all
countries exporting food to the United States, in particular by using
professional associations and regional organisations as relays. The
“FDA estimates that the total number of food facilities that must
register with FDA is approximately 420,000, approximately half of
which are domestic. As of July 3, 2007, FDA had received 322,744
registrations, of which 188,946 are foreign facilities and 133,798 are
domestic facilities”.'°' With regard to defence against a possible
bioterrorist attack, the US government also introduced in 2003 the
BioWatch Program, a network of environmental sensors “to detect the
release of pathogens into the air, providing warning to the government
and public health community of a potential bioterror event”'”’ and, in
2004, the BioShield Project,’ to speed the development and
acquisition of new medical countermeasures against bioterrorism.
In May 2002, the New York City Office of Emergency
Management conducted a six-hour simulation exercise to verify the
capacity of the city’s services to distribute antibiotics to the population
in case of a biological attack; this exercise revealed a capacity to treat
1,500 people per hour.'™ With respect to international cooperation,
some independent US institutions, namely the Center for Biosecurity
of the University of Pittsburgh Medical Center, the Center for
Transatlantic Relations of the Johns Hopkins University, and the
Transatlantic Biosecurity Network, initiated in March 2005 a trans-
Atlantic exercise with world leaders, called Atlantic Storm, which
simulated a coordinated bioterrorist attack in the United States and
some European countries.'” The lessons learned from that exercise
showed that: preparedness was still insufficient; homeland security
needs an international and holistic approach; the authority and
capabilities of the WHO must be strengthened; effective
communication between nations and with the public should be
improved; adequate medical countermeasures have to be developed;
and biosecurity is one of the greatest security challenges. ‘°°
(ii) France
After the September 2001 attacks in the US, France strengthened its
preventive and defensive policy by introducing the Biotox National
104. GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Plan'”’ against bioterrorism. The Plan, coordinated by the Prime
Minister’s Secretariat of National Defence, provided for: stricter rules
on containment of dangerous biological agents, including by the
pharmaceutical industry; improved protection of water delivery
networks; specialised anti-poison units in hospitals on permanent
alert; training programmes for the medical and paramedical
professions; the installation of dedicated equipment in each regional
hospital and of toxin detectors in water analysis laboratories; the
definition of new emergency plans for hospitals in case of mass
casualties; the development of security stockpiles of medicines
(antibiotics, antidotes); the elaboration of an immunisation strategy in
case of smallpox aggression. In close collaboration with the Ministry
of Health, the Institute of Health Surveillance (InVS) is involved in
the implementation of the Plan and “would participate in:
e “strengthening surveillance activities in the area of infectious,
chemical, and toxic risks;
“improving the sensitivity of case ascertainment;
“investigating potential threats that may be related to
bioterrorism;
e “conducting epidemiological investigations in the event of
deliberate release of a bioterrorism agent”. '™
In addition, “[a] group has been created at the InVS to
coordinate all activities related to bioterrorism. Guidelines for the
investigation of threats have been produced and disseminated at
regional and district levels. ... Anthrax has been added to the list of
statutory notifiable diseases, and, in addition, it is now recommended
that health-care professionals notify district health offices of any
unusual health occurrence that may represent a threat to public health
or might be related to bioterrorism. Furthermore, the InVS has
conducted an epidemiological analysis of the need for smallpox
immunisation at the request of the Ministry of Health. ... This analysis
has been used by the Advisory Committee on Immunisation of the
Ministry of Health to consider recommendations for a smallpox
vaccine strategy”. °”
Moreover, a September 2001 Ministerial Order bans the
fraudulent use or acquisition of dangerous pathogens by requiring
government authorisation for any acquisition, distribution, and
transport of certain agents that generate infectious diseases.
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pathogenic micro-organisms, and toxins. A second Ministerial Order
classifies those agents to be covered. Yearly reports of pathogen
stocks are required by the French Agency for Sanitary Safety and
Health Products.''? After a parliamentary report showing an
insufficient state of preparedness of French emergency services, the
Biotox Plan was updated and strengthened in 2003.''! In particular, a
specific plan was adopted to react to a possible deliberate spread of
smallpox.''” Obviously, France, being a member of the WHO, the EU,
NATO, the OECD, and the OSCE, coordinated its policy in this area
with that of those organisations.
(iti) Japan
After the 1995 Aum Shinrikyo incident, the National Police Agency
(NPA) established in 2000 the post of Special Advisor on Terrorism,
tasked with coordinating response capability for all terrorist events,
including bioterrorism. Special counter-terrorist units were created in
the police forces of the two largest cities. Manuals for first responders
and consequence management were published or updated. But it was
only after the 2001 anthrax scare in the US that a new security plan
was introduced: the NPA strengthened its terrorism investigation
units; the Japan Defence Agency (JDA) increased the production of
antibiotics and supported the development of the emergency medical
system; the National Fire Department organised its own Nuclear
Biological and Chemical (NBC) terrorism units; the Ministry of
Education and the Maritime Safety Agency distributed protective suits
and materials to hospitals; and “the Ministry of Health began to create
a vaccine stockpile and prepared for decontamination units to be
deployed to Emergency Relief Centres”.''”
“On 16 December 2001, the BTWC Implementation Law was
amended when the International Convention for the Suppression of
Terrorist Bombing entered into force for Japan. This act prohibits not
only the use of biological weapons ... but also the dissemination of
biological agents and toxins that do not take the form of biological
weapons. ... And the penalty has become much more severe”.''* In
parallel, the Japanese authorities have been testing new methods of
detection, including using small fish as indicators of water
contamination.'"”
In 2004, the Japanese parliament adopted the Act on National
Defence and Citizen Protection from Attack by Force, which defines
the responsibility of central and local government (e.g., the Ministers
106 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
of Health and Labour in the event of an infectious-disease attack) and
mandates cooperation of citizens and evacuation of residents in order
to protect citizens from the attack and minimise the effect of the attack
on Japanese society and its economy. It also stipulates that, in the
event of an armed attack, the government may order facilities
containing biological materials to move, restrict access to, or destroy
those materials.''°
3. Protection Against the Natural or Accidental Spread of
Infectious Diseases
As could have been expected, the systems put into place for protecting
populations against the intentional hostile use of biological agents in
warfare or by terrorists would inevitably be useful in cases of
unintentional spread of infectious diseases due to natural or
involuntary man-made causes. This was one of the lessons learned
from the 2005 Atlantic Storm exercise.''’ The main difference
between two such sets of occurrences is obviously that, if the cause
appeared intentional, national-security and law-enforcement services
would investigate and search for the possible perpetrators to prosecute
or neutralise them, while health and emergency services would
attempt to mitigate the consequences for the populations.
With the emergence of “new” diseases, such as HIV/AIDS in
the 1980s or SARS in 2003, and severe outbreaks of “old” diseases
such as ebola in Africa or hantavirus in the US, the international
community has become gradually aware of the acute need for
domestic and global systems of detection and monitoring of, and
response to, infectious diseases during the last two decades. As for
protection against the hostile spread of pathogens, the resulting set of
measures adopted in the world for the natural or accidental spread of
contagious diseases was designed simultaneously at the global,
regional, and national levels.
(a) Responses at the Global Level
The responses of the international community to health risks are not
new, but they have become increasingly more complex with
globalisation, since they have to encompass various interrelated
aspects dealing not only with public health, but also trade, economic
development, transport, tourism, and the protection of the
environment and in particular biodiversity. This is why they require
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close international cooperation among states and _ international
organisations, both governmental and non-governmental, as well as
industry, academia, and the scientific community.
(i) The World Health Organization (WHO)
When addressing biosecurity, the focus is on communicable or
infectious diseases, although the work of the WHO extends much
further beyond this scope and also embraces non-communicable
diseases that threaten public health. In order to develop global disease
surveillance, the WHO has introduced several instruments in recent
years:
° The Public Health Mapping Programme and Geographic
Information Systems, which has been, since 1993, created to
“provide ideal platforms for the convergence of disease-
specific information and their analyses in relation to
population settlements, surrounding social and _ health
services, and the natural environment. They are highly
suitable for analysing epidemiological data, revealing trends
and interrelationships”.''*
* The Epidemic and Pandemic Alert and Response, which is
based on the revised International Health Regulations of
2005 provides a global framework to address the need for
rapidly identifying and _ containing public health
emergencies and reducing disruption of trade, travel, and
society. It does this “through a collective approach to the
prevention, detection, and timely response to any public
health emergency of international concern. This programme
has six core functions: [s}upport Member States for the
implementation of national capacities for epidemic
preparedness and response... including laboratory
capacities and early warning alert and response systems;
[s]upport national and international training programmes for
epidemic preparedness and response; [c]oordinate and
support Member States for pandemic and seasonal influenza
preparedness and_ response; [d]evelop standardized
approaches for readiness and response to major epidemic-
prone diseases (e.g., meningitis, yellow fever, plague);
[s]trengthen biosafety, biosecurity, and readiness for
outbreaks of dangerous and emerging pathogens outbreaks
108
GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
(e.g., SARS, viral haemorrhagic fevers); [mJaintain and
further develop a global operational platform to support
outbreak response and support regional offices in
implementation at the regional level.”'”
The Global Outbreak Alert and Response Network
(GOARN), which is a technical collaboration of existing
institutions in member states and international organisations
(such as United Nations Children’s Fund (UNICEF), the
ICRC, the Office of the UN High Commissioner for
Refugees (UNHCR), and NGOs) that “pool human and
technical resources ffor the rapid identification,
confirmation, and response to outbreaks of international
importance. The Network [established in 2000] provides an
operational framework to link this expertise to keep. the
international community constantly alert to the threat of
outbreaks and ready to respond. ... [It] has been bringing
agreed standards ... [for] epidemiological, laboratory,
clinical management, research, communications, logistics
support, security, evacuation and communications systems”,
as well as coordination of international assistance.'*’ The
first successful test of the Network was its capacity to
contain the outbreak of SARS in 2003.'*!
The WHO _ Biosafety and Laboratory Biosecurity
Programme, which, as we have seen, was designed to
reduce the spread of disease caused by inappropriate
handling or usage of pathogenic micro-organisms, can also
be crucial to preventing and responding to accidentally or
naturally spread diseases. Indeed, it promotes safe practices
in the handling of pathogenic micro-organisms based on
best practices and international rules and regulations in
health care or manufacturing facilities, research
laboratories, and transport; it strengthens, coordinates, and
evaluates efforts for the establishment of national, regional,
and global plans of action for the safe handling of infectious
substances; it promotes safety standards in laboratory
facility construction and post-construction evaluation. With
a number of partners (namely, the United Nations
Committee of Experts on Transport of Dangerous Goods,
the United Nations Industrial Development Organization
(UNIDO)/the United Nations Environment Programme
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(UNEP)/WHO/FAO Working Group on Biosafety, the
Universal Postal Union, the International Civil Aviation
Organization (ICAO), the International Air Transport
Association (IATA), the American Biological Safety
Association, the European BioSafety Association, the
European Federation of Biotechnology (EFB), the Basel
Convention on the Control of Transboundary Movements of
Hazardous Wastes and their Disposal, and the UNEP
Convention on Biological Diversity), it develops norms,
standards, and UN Model Regulations, publications,
guidelines, training manuals, and _ information for
stakeholders; it provides technical assistance to member
states, including on harmonising their regulations with
international standards; it conducts advocacy programmes
and promotes research in the biosafety area.'~”
(ii) The World Commission on the Ethics of Scientific Knowledge and
Technology (COMEST)
Composed of 18 independent experts, COMEST was established in
1998 to advise the United Nations Educational, Scientific and Cultural
Organization (UNESCO) on its programme concerning the ethics of
scientific knowledge and technology. In 2006, the Commission issued
an interim report on its survey of the existing codes of conduct and
codes of ethics in the world.'”
(iii) The Food and Agriculture Organization (FAO)
For the FAO, biosecurity has been a constant concern for many years.
It considers that biosecurity “encompasses the policy and regulatory
frameworks (including instruments and activities) that analyse and
manage risks in the sectors of food safety, animal life and health, and
plant life and health, including associated environmental risk.
Biosecurity covers the introduction of plant pests, animal pests and
diseases, and zoonoses; the introduction and release of genetically
modified organisms and their products; and the introduction and
management of invasive alien species and genotypes. Biosecurity is a
holistic concept of direct relevance to the sustainability of agriculture,
food safety, and the protection of the environment, including
biodiversity.” !~* In 2003, at the end of a consultation process, the FAO
adopted Recommendations on biosecurity in food and agriculture.
110 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Among others, this document recommended that: states
determine the potential for synergies and harmonisation within their
national and sub-national regulatory frameworks that would result
from a holistic and coordinated approach to biosecurity; risk analysis
and management frameworks improve collaboration among diverse
interests and institutions (particularly agriculture, public health,
environment, trade, and their associated stakeholders) to avoid
duplication and possible inconsistencies; tools be developed to extend
the Phytosanitary Capacity Evaluation to other sectors, to assist
countries in analysing their capacity-building needs to take account of
the full scope of biosecurity, including the communicational, legal,
institutional, scientific, and technical aspects; a publicly accessible,
Internet-based Biosecurity Portal mechanism be established for
exchange of official information on food safety, and animal and plant
health and the environment, to improve communication among
countries in these sectors; all stakeholders, including members of the
public, be involved in addressing biosecurity to enable them to
contribute in meaningful ways to the design and implementation of
biosecurity risk management frameworks.'*° The Biosecurity Internet
Portal was thus developed and is actively spreading useful
information.'~°
In addition, the FAO established a Working Group on
Biosafety to coordinate its priority areas for interdisciplinary action on
the one hand on biosecurity for agriculture and food production, and
on the other hand on biotechnology applications in agriculture,
fisheries and forestry, in: providing advice on approaches to biosafety
in the FAO’s Program of Work; preparing discussion papers,
information notes, and other materials on biosafety in food and
agriculture, including fisheries and forestry, for both internal and
external users; organising technical or scientific expert meetings on
biosafety in food and agriculture, including fisheries and forestry;
providing reports on the status of biosafety as relevant to FAO
programmes; circulating proposals for biosafety-related programmes,
technical cooperation activities, and capacity-building activities;
liaising with peer agencies working in the field of biosafety to ensure
coordination of efforts. '7’
In parallel, the FAO has provided, jointly with the WHO, the
scientific basis for the work of the Ad Hoc Intergovernmental Task
Force on Foods Derived from Biotechnology through a series of
scientific expert consultations on the safety and nutritional aspects of
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genetically modified foods. In 2003, this Task Force developed
standards, guidelines, and recommendations for foods derived from
biotechnology or traits introduced into foods by biotechnology.'~*
Although there is a specialised agency for animal health, the
FAO is also active in promoting biosecurity in this field. In 1994, it
established the Emergency Prevention System for Transboundary
Animal and Plant Pests and Diseases, within which the Livestock
Program plays a major role in the fight against persisting and/or
spreading transboundary animal diseases at the global level, with
emphasis on developing countries. It is thanks to this programme that
the disease due to the Rinderpest has been eradicated from most of
Asia and Africa.'””
With regard to plant health, the FAO hosts the Secretariat of
the International Plant Protection Convention (IPPC), an international
treaty dating back to 1951 that aims to prevent the spread and
introduction of pests of plants and plant products, and that promotes
measures for their control.'*° It is governed by the Commission on
Phytosanitary Measures, which adopts International Standards for
Phytosanitary Measures. The Secretariat of the IPPC maintains an
Internet portal for national reporting and the exchange of more general
information among the phytosanitary community."”'
The International Code of Conduct on the Distribution and
Use of Pesticides adopted by FAO in 1985 “is designed to provide
standards of conduct and to serve as a point of reference in relation to
sound pesticide management practices, in particular for government
authorities and the pesticide industry”.'’* Finally, regarding forestry,
the FAO has developed biosecurity activities on the basis of a 2003
study entitled “Biosecurity and Forests: An Introduction — with
particular emphasis on forest pests”, showing that: there was an urgent
need for surveys and identification of the pests and diseases associated
with many important tropical timber trees, in both natural and
plantation situations; an increasing number of accidental introductions
of alien invasive species could be expected as a result of the growing
internationalisation of trade, the increased movement of people and
the resultant overstretching of quarantine services; the development of
genetic modification had created new challenges in risk assessment;
and raising awareness, training, and capacity-building should be
important components of any biosecurity programme.»
112 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
(iv) The World Organisation for Animal Health (OIE)
The main tasks of the Paris-based organisation are:
e To “{e]nsure transparency in the global animal disease
situation” through the dissemination of national reports for
possible preventive action by member states;
e To “{clollect, analyse, and disseminate veterinary scientific
information” on animal disease control;
e To provide expertise and “encourage international solidarity
in the control of animal diseases”, in particular through
assistance “to the poorest countries to help them control
animal diseases that cause livestock losses, present a risk to
public health, and threaten other Member States”.'** One
channel of this assistance is the World Animal Health and
Welfare Fund established in 2004;'°°
e To “safeguard world trade by publishing health standards for
international trade in animals and animal products” under the
World Trade Organization (WTO) Sanitary and Phytosanitary
Agreement’”* in order “to protect ... [countries] from the
introduction of diseases and pathogens without setting up
unjustified sanitary barriers. The main normative works
produced by the OIE are: the Terrestrial Animal Health Code,
the Manual of Diagnostic Tests and Vaccines for Terrestrial
Animals, the Aquatic Animal Health Code, and the Manual of
Diagnostic Tests for Aquatic Animals”;'”’
e To “[{i]Jmprove the legal framework and resources of national
Veterinary Services” in emerging countries while reducing the
threat for other countries that are free of diseases;
e “[(T]o provide a better guarantee of food of animal origin and
to promote animal welfare through a science-based approach”
in collaboration with the Codex Alimentarius Commission'™
(part of the Joint FAO/WHO Food Standards Programme);
e To support the objectives of the Biological and Toxin
Weapons Convention.”
Among the organisation’s recent priorities is the fight against
the spread of highly pathogenic avian influenza, inter alia, by
disseminating all relevant information on a dedicated Internet
portal.'“” The OIE’s Terrestrial Animal Health Code is designed “to
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assure the sanitary safety of international trade in terrestrial animals
and their products. This is achieved through the detailing of health
measures to be used by the veterinary authorities of importing and
exporting countries to avoid the transfer of agents pathogenic for
animals or humans, while avoiding unjustified sanitary barriers”. '*!
(v) The Cartagena Biosafety Protocol
In 1992 at the Rio Earth Summit, 150 government leaders signed the
Convention on Biological Diversity’ to promote sustainable
development. The Convention recognises that biological diversity is
not only about plants, animals, and micro-organisms and _ their
ecosystems but also about people and their need for food security,
medicines, fresh air and water, shelter, and a clean and healthy
environment. The Secretariat of the Convention is hosted by the
United Nations Environment Programme.'*’ Under the Convention,
the Conference of the Parties “established an Open-ended Ad Hoc
Working Group on Biosafety to develop a draft protocol on biosafety,
specifically focusing on transboundary movement of any living
modified organism resulting from modern biotechnology that may
have adverse effect on the conservation and sustainable use of
biological diversity”.'“* The Working Group met between 1996 and
1999. The Conference of the Parties met in 1999 in Cartagena,
Colombia, and later in Montreal in 2000. On 29 January 2000, it
adopted the Cartagena Protocol on Biosafety'*? and established an
open-ended ad hoc Intergovernmental Committee for the Cartagena
Protocol on Biosafety with a mandate to prepare for the meetings of
the states parties.
The Protocol seeks to protect biological diversity from the
potential risks posed by LMOs resulting from modern biotechnology.
It establishes an advance informed agreement procedure for ensuring
that countries can make informed decisions before agreeing to the
import of such organisms into their territory. The Protocol contains
reference to a precautionary approach and reaffirms the precautionary
language in Principle 15 of the Rio Declaration on Environment and
Development.'”° The Protocol also establishes a Biosafety Clearing-
House to facilitate the exchange of information on LMOs and to assist
member states in their implementation of the Protocol. As of April
2007, the Protocol, which entered into force on 11 September 2003,
had 140 states parties.
114 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
The primary steps in the implementation of the Protocol are
the translation of the instrument’s requirements into appropriate
domestic laws and other practical measures. In particular, member
states need to introduce national biosafety frameworks into their
legislation where appropriate. The Conference of the Parties serving
as the Meeting of the Parties to the Protocol (COP-MOP) meets
regularly and reviews in particular the implementation of the Action
Plan on Capacity-Building, designed to assist developing countries in
the discharge of their obligations under the Protocol.'*” Most of this
assistance to developing countries is delivered through the Global
Environment Facility (GEF) established as early as 1991 as the
financial institution of the international environmental conventions.’
The GEF financed projects before and after the entry into force of the
Protocol for some $74 million in more than 140 countries.”
(vi) The United Nations Industrial Development Organization
(UNIDO)
UNIDO has adopted a Voluntary Code of Conduct for the Release of
Organisms Into the Environment, which is aimed at helping
“industries, organizations, and scientists seeking to facilitate, develop,
and apply biotechnology for social and economic improvement to be
aware that their judgements and actions involving GMOs, if taken
with adequate review and notification, will ensure public health and
environmental safety and thereby promote, and not jeopardize, the
long-term development of the technology”.'”°
(b) Responses at the Regional Level or Among Like-minded States
(i) The European Union (EU)
The EU began in the 1990s to elaborate a public health policy where
responsibilities of member states and EU institutions are increasingly
complementary. The EU Public Health Programme (as part of the
Action Programme in the Field of Civil Protection agreed on by the
member states in 1997) supports the European Health Strategy (from
2000) and Public Health Programme (2003-2008),'°' based on the
European Commission Communication on the Health Strategy of the
European Community, adopted on 16 May 2000.'* One of the aims of
the Public Health Programme is to provide information to EU citizens,
thus supporting a rapid-reaction mechanism between the EU and its
member states to health threats, and tackling health determinants, as
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well as dealing with policy and legislation practice. The European
Commission cooperates with the member states via two institutions:
e The High Level Committee on Health, an informal advisory
board to Commission services consisting of Health Ministries’
senior Officials tasked with providing strategic advice for the
development of a health strategy, and a forum for information
exchange on health-related developments in the member
states.
e The High Level Group on Health Services and Medical Care,
which brings together health experts from the member states
and reports on a yearly basis to the Employment, Social
Policy, Health and Consumer Affairs Council. The Group
“works in seven main areas: cross border healthcare
purchasing and provision; health professionals; centres of
reference; health technology assessment, information, and e-
health; health impact assessment and health systems; and
patient safety”.'»°
In 2004, in order to enhance its capacity to protect human
health through the prevention and control of human disease, the EU
established the European Centre for Disease Prevention and Control
(ECDC), headquartered in Sweden. Modelled on the US Centers for
Disease Control and Prevention, this institution received as its main
tasks “to identify, assess and communicate current and emerging
threats to human health from communicable diseases. In the case of
other outbreaks of illness of unknown origin which may spread within
or to the [European] Community, the Centre shall act on its own
initiative until the source of the outbreak is known. In the case of an
outbreak which clearly is not caused by a communicable disease, the
Centre shall act only in cooperation with the competent authority upon
request from that authority. In pursuing its mission the Centre shall
take full account of the responsibilities of the Member States, the
Commission and other Community agencies, and of the
responsibilities of international organisations active within the field of
public health,”'* such as the WHO. Its core activities are in the areas
of: disease surveillance; scientific advice; identification of emerging
health threats (epidemic intelligence); training; communications; and
providing technical assistance (country support).'”? Hopefully, now
that the ECDC is fully operational, it will no longer be possible for
116 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
experts to assert that “the EU is not institutionally prepared for
transnational, rapidly moving diseases that could cause grave
; ’ 156
consequences in Europe and other regions”.
(ii) The International Centre for Genetic Engineering and
Biotechnology (IC GEB)'”’
The ICGEB was established in 1983, first as a UNIDO programme,
and from 1994 as an independent institution, now with 54 member
states. “Located in Trieste, Italy, and New Delhi, [it] has been
conducting biosafety training courses and workshops since 1991, with
the overall participation of about 900 scientists from more than 80
countries. The Centre has since extended its work in this area with the
establishment of a biosafety unit and a biosafety outstation”, which
provide institutional services related to the biosafety of GMOs and
their release into the environment, and conduct research on the
biosafety of such organisms.’ The ICGEB has developed various
information tools such as the following: “(a) a database containing
more than 5,000 biosafety studies; and (b) the Risk Assessment
Searching Mechanism, which provides access to official documents
on risk assessment related to genetically modified crops. ... The
Centre [also] publishes the ‘Collection of biosafety reviews’, a
compilation of scientific studies in areas of major interest to biosafety
and risk assessment by internationally recognized scientists ... [as
well as] Environmental Biosafety Research, the official journal of the
International Society for Biosafety Research [italics in original]”.’””
The ICGEB “has been actively participating in the
establishment of codes of conduct for scientists in relation to the safe
and ethical use of biological sciences, ... [and it] has launched a
programme for training and research in risk assessment and
management of the release of genetically modified organisms to the
environment, focusing on the safe use of agricultural products derived
from biotechnology”.'”” Like most other institutions dealing with
biosecurity and biosafety, its activities contribute to improving global
protection against both the intentional and unintentional spread of
diseases, with a strong emphasis on the possible consequences of gene
manipulation and biotechnology. The ICGEB, on the basis of a
consultation with national academies of science, proposed in 2004
possible elements of a common draft Code of Conduct for Scientists
in Relation to the Safe and Ethical Use of Biological Sciences.’*'
Among such elements is “the moral duty of scientists, in particular
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those who work with pathogenic microorganisms or with dangerous
toxins, to adopt the use of best practices to ensure high standards of
professionalism, safety and security, so as to minimize the risk of
intentional or unintentional damage”.'™
(iii) Codes of Conduct for Biological Safety and Security
Taking account of the involvement of scientists in all areas of
biosecurity and biosafety, whether they belong to governmental or
academic institutions or the corporate sector, many such institutions,
individually or collectively, have attempted to develop norms
applicable to scientists on a voluntary basis. Covering the ethical and
safety aspects of scientific work in the life sciences, these codes are
intended to ensure that scientists not only abstain from, and contribute
to preventing, illicit activities such as the transfer of bioweapons
agents or bioterrorist activities, but also exercise their work in a
responsible way, abiding by biosecurity and biosafety regulations.
Here, too, the result of the implementation of these codes is to protect
populations against the deliberate spread of diseases, as well as the
consequences of negligence, accidental release, or naturally occurring
events.
By definition, codes of conduct are adhered to voluntarily, but
once this is done, they impose strong moral obligations, possibly
leading to exclusion of non-compliant scientists from their institution
or company, but also to criminal prosecution or civil liability. Two
compilations of existing codes of conduct, one including references to
biological weapons or bioterrorism,'® the other not mentioning such
issues,’ were elaborated by the UN Secretariat on the occasion of the
2005 intersessional Meeting of Experts of the states parties to the
BWC. Apart from the initiatives already mentioned above at the
universal level, and in addition to national codes of conduct, the main
international initiatives described in this document are:
e The 2002 Washington Declaration'’® adopted by the General
Assembly of the World Medical Association states in
particular that “medical associations and all who are
concerned with health care bear a special responsibility to lead
in educating the public and policy makers about the
implications of biological weapons and to mobilize universal
support for condemning research, development, or use of such
weapons as morally and ethically unacceptable”. Moreover,
118 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
this declaration stressed that, “[i]t is especially important that
physicians be alert to the occurrence of cases or clusters of
unusual infectious diseases, to seek help from infectious
disease specialists in diagnosis, and to report cases promptly
to public health authorities.”
e The study was conducted in 2002 by the International Council
for Science (ICSU), the global umbrella organisation for
national and international academies of science, on the
commonality of 115 different ethical codes.'° It gave some
useful insights into the development of ethical guidelines in
the international arena. It provided a reference point for
further enquiries and discussion within the scientific
community.
e The Code of Pharmaceutical Marketing Practices'®’ of the
International Federation of Pharmaceutical Manufacturers and
Associations is concerned with the ethical conduct of
marketing and promotional activities, rather than with
scientific ones.
(iv) The Kampala Compact: The Global Bargain for Biosecurity and
Bioscience
In October 2005, a conference in Kampala, Uganda, was held by the
International Law Institute of Uganda of the African Center of Legal
Excellence, and the International Consortium on Law and Strategic
Security with the support of the ICSU. It elaborated the Kampala
Compact: The Global Bargain for Biosecurity and Bioscience'™ as an
initiative to give Africa a greater role in promoting global biosecurity.
This document affirms agreed-upon principles and endorses a bargain:
health is Africa’s priority and since prevention of bioproliferation is
intricately linked to health, Africa must support all efforts to prevent
bioproliferation. However, the document recalls that “Africans are
grappling with enormous health crises in the form of HIV/AIDS,
tuberculosis, malaria, emerging infectious diseases, poor health
infrastructure, and food security. It is illegitimate to address threats of
biological weapons without addressing these other health crises.”'”
Professor Barry Kellman, Director of the International Weapons
Control Center at the DePaul University College of Law in Chicago,
who had initiated the Kampala conference, subsequently launched
projects in sub-Saharan Africa, Eurasia, and Latin America to study
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BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS_ 119
national legislation pertaining to biosecurity and prevention of
biothreats.'”°
(v) The Global Health Security Initiative (GHSI)
This initiative aims not only at preventing bioterrorism and mitigating
its possible consequences, but also at strengthening the global system
of biosecurity. '”' When it was launched in 2001, its members decided
to develop activities in the following fields:
? “To explore joint cooperation in procuring vaccines and
antibiotics.
> “To engage in a constructive dialogue regarding the
development of rapid testing, research in variations of
vaccines, and our respective regulatory frameworks for the
development of vaccines, and in particular smallpox
vaccines.
‘ “To further support the World Health Organization’s
disease surveillance network and WHO’s efforts to develop
a coordinated strategy for disease outbreak containment.
. “To share emergency preparedness and response plans,
including contact lists, and consider joint training and
planning.
: “To agree on a process for international collaboration on
risk assessment and management and a common language
for risk communication.
+ “To improve linkages among laboratories, including level
four laboratories, in those countries which have them.
° “To undertake close cooperation on preparedness and
response to radio-nuclear and chemical events.
° “To share surveillance data from national public health
laboratories and information on real or _ threatened
contamination of food and water supplies along with
information on risk mitigation strategies to ensure safe food
supplies.”
A Global Health Security Action Group of senior officials was
established by ministers to develop and implement actions to improve
global health security. It also serves as a network of rapid
communication/reaction in the event of a crisis. Current GHSI
120 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
working groups/networks are focusing on: risk management and
communications; pandemic influenza; chemical events preparedness;
and the global health security laboratory network.'”
As we have seen, there exist numerous biosecurity-related
norms at national and global levels. However, in many instances, they
overlap and often lack consistency. The need for further
harmonisation of existing biosecurity standards and regulations will be
discussed in Chapter 8 of this book.
4. Redefining the Role of Scientists from the Military-industrial
Complex
(a) Defining the Issue
The scope of the bioweapons programme of the former Soviet Union
has been the subject of inquiry among researchers, as the details of the
numbers of scientists and kinds of installations have been difficult to
discern. Experts believe that there were more than 40 facilities in the
region.'”* Because of this, the United States undertook its Co-
operative Threat Reduction efforts under the Nunn-Lugar legislation
of 1991, the G8 adopted its Global Partnership against the spread of
weapons of mass destruction in 2002, and, in recent years, the United
States, the European Union, Canada, France, Sweden, and Finland
have been involved in securing the former Soviet Union’s biological
weapons and agents. Several national government programmes fund
the employment of scientists through the Moscow-based International
Science and Technology Center (ISTC) and the Science and
Technology Center in Ukraine (STCU).
(b) The International Science and Technology Center
The ISTC was established in November 1992 to provide weapons
scientists from Russia and the Commonwealth of Independent States
(CIS) countries new opportunities in the civilian, as opposed to the
military, arena. Founded by the European Union, Japan, Russia, and
the United States, the ISTC is a multilateral organisation of 37
nations. Under the terms of the agreement, the ISTC’s “principal
activity is to develop, approve, finance, and monitor science and
technology projects for peaceful purposes, which are to be carried out
primarily at institutions and facilities located in the Russian
175
Federation’’.
CONTAINING BIOLOGICAL RISK:
BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS 121
The ISTC coordinates the efforts of governments,
international organisations, and private-sector industries by linking
international markets to the many expert-level scientists in former
Soviet countries. Since 1994, Armenia, Belarus, Finland, Georgia,
Kazakhstan, Kyrgyzstan, Norway, South Korea, and Sweden have
joined the ISTC. Other countries such as Switzerland have also
participated. According to the ISTC website, 67,684 participants from
922 institutes in Russia and the CIS have received ISTC funding.'”
The ISTC makes tax-free payments directly to the scientists and
researchers who participate in the projects. The ISTC does not have a
method of tracking the scientists after they complete their contracts,
and thus it is difficult to assess the overall success of the redirection
efforts on a long-term basis. To date, an estimated 20,000 bioscientists
have been engaged by the ISTC.'”’
The ISTC is involved in basic and applied research,
innovation, and commercialisation. The US Department of
Agriculture has funded a project that introduced an H/V antigen into
tomatoes. The goal of the project is to develop edible vaccines against
Hepatitis B and H/V using transgenic tomatoes, cucumbers, and other
vegetables consumed without preliminary heat treatment.'’* Hundreds
of other ISTC projects deal with everything from controlling sheep
pox to disinfecting anthrax and avian flu. [STC projects are
implemented in Russia, Belarus, Georgia, Armenia, Kazakhstan,
Kyrgyzstan, and Tajikistan. The ISTC Science Project Program
solicits scientific proposals from institutes throughout the CIS and
provides funding and logistic support to project teams. Through the
ISTC Partner Program, ISTC partners (private companies, government
agencies, and non-governmental organisations) can fund or co-fund
research and development projects undertaken by Russian and CIS
scientists and institutions.
The ISTC also supports non-proliferation activities such as the
disposal of weapons-grade plutonium, the destruction of chemical
weapons, nuclear material control and accounting, and support to the
Comprehensive Nuclear-Test-Ban Treaty (CNTBT). Since _ its
inception, the ISTC has devoted 21 percent of its total project funding
to biotechnology and the life sciences. This is its single largest area of
project funding, amounting to roughly $198 million for approximately
660 projects.'””
The ISTC has sent delegations of Russian and CIS experts to
meetings in Germany and the United Kingdom to exchange ideas and
122 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
presentations on biotechnology. Exchanges have also been carried out
with Japan to partner in workshops, as well as in commercial and
technology projects. Frequent exchange visits of US and CIS scientists
have been successful in establishing confidence among the scientists,
as well as producing results in their work. The goal is to create
medium- to. long-term sustainable business and R & D partnerships
between international companies and organisations and former
Russian/CIS weapons scientists. '*°
(c) The Science and Technology Center in Ukraine
The Science and Technology Center in Ukraine (STCU), established
in 1993, is similar to the ISTC.'*’ It is funded by Canada, the US, and
the EU, and the recipient states include Azerbaijan, Georgia,
Moldova, Ukraine, and Uzbekistan. The STCU supports research and
development activities for peaceful purposes of scientists and
engineers in the recipient countries who previously worked on WMD.
The STCU is independent from the ISTC, though their objectives are
the same and they collaborate with each other.
Following the collapse of the Soviet Union, Ukraine
became responsible for the security of former biological-weapons
research laboratories, and the STCU was the first intergovernmental
organisation based in Ukraine. Under the STCU, more than 1,000
projects have been supported for a total of $150 million'®’ since 1993
by some 120 private companies and government agencies from the
European Union, the United States, and Canada. The STCU assists in
the planning of projects and preparing agreements between donor and
recipient countries. Like the ISTC, the STCU provides oversight of
project implementation and expenditures, as well as tax-free grant
payments directly to the researchers and assistance in clearing
customs.
In 1995, “the United States and Ukraine have signed an
agreement to counter the threat of bioterrorism and to prevent the
proliferation of biological weapons, technology, materials and
expertise”.'*> The agreement included assistance to: “{ujpgrade the
security for pathogens stored at various health laboratories throughout
Ukraine; [s]ignificantly reduce the time required to accurately
diagnose disease outbreaks in Ukraine and assess whether they are
natural or the result of a terrorist act”.'™
STCU projects cover a gamut of issues in the fields of
biological materials, medical analysis, and diagnosis to
CONTAINING BIOLOGICAL RISK:
BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS ~ 123
nanotechnology and plasma physics. Included in many of the projects
are workshops, seminars, and conferences that involve scientific
exchanges with scientists from other countries. “Since the
establishment of the Partnership Program in 1997, STCU Partners
have contributed over US $34 million and received a total R&D return
valued at approximately 10 times their initial investments.”'™
(d) Other Support: Contributions of Individual Countries
As we have seen, within the context of the G8 Global Partnership
Against the Spread of Weapons and Materials of Mass Destruction,
only 1.5 percent of the $20 billion that the G8 agreed to spend over 10
years has been devoted to bio-related programmes. The United States
spends about $90 million annually on biological threat reduction, and
European countries have contributed collectively $500,000 to bio-
related projects and $25-30 million to science centres in Russia and
Ukraine.'*° Canada has also contributed to projects related to reducing
the biological threat through a programme of workshops in Russia and
the CIS to engage and promote biosafety through training and sharing
knowledge. It has also organised forums in Canada for representatives
from the business and academic sectors in biotech and the life
sciences.
The Cooperative Threat Reduction (CTR) Program of the
United States emanated in 1991 from legislation sponsored by
Senators Nunn and Lugar to provide for the consolidation, securing,
and destruction of WMD, delivery systems, and _ associated
infrastructure in former Soviet countries. The objective was to prevent
the proliferation of WMD and related materials and expertise from
former Soviet states. A number of agencies in the United States
Government are involved in the threat-reduction efforts: Departments
of Defense, State, Energy, Health and Human Services, Agriculture,
and the Environmental Protection Agency.
For the fiscal year 2007, the United States is spending over
$90 million on biological threat reduction worldwide. The Department
of State (DOS) manages three programmes that engage former Soviet
biological scientists with weapons expertise in peaceful civilian work
that is considered sustainable. These are the Science Centers Program,
Bio-Chem Redirect Program (BCR), and BiolIndustry Initiative (BII).
In addition, the DOS engages biological scientists through its Iraqi
Scientist Redirection Program and through its new global Biosecurity
Engagement Program.
124. GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
The Science Centers Program provides funding (over $220
million allocated since 1994) for the ISTC and the STCU and engages
nuclear, chemical, biological, and missile scientists; the other DOS
programmes are more narrowly focused. The BCR has allocated more
than $80 million to engage former biological-weapons scientists since
1997. The Biolndustry Initiative is the only US programme aimed at
reconfiguring former large-scale bioproduction facilities for
commercial purposes, and it also engages former biological- and
chemical-weapons scientists in drug and vaccine development to
combat highly infectious diseases. The BII has allocated
approximately $50 million since it inception in 2002 ($30 million
emergency appropriation).’*”
The BCR finances research that supports the transition of
chemical and biological scientists to civilian work in public health,
environmental monitoring and remediation, crop and livestock health.
The BCR supports the Department of Health and Human Services
Biotechnology Engagement Program for human health research
projects at the State Research Centre of Virology and Biotechnology,
Vector, and the State Research Centre for Applied Microbiology,
Obolensk.
The BII focuses on developing drugs and vaccines to combat
highly infectious diseases, and it is active in these areas in the ISTC. It
also converts large biological production facilities in Russia into
commercial entities, and has sponsored through the ISTC an exchange
of Russian specialists in training and conferences in the US.'** It
should be noted that the proposed new US performance measure for
Science Centers, the BCR, and the BII is the number of Russian and
other Eurasian scientists relevant to proliferation that are engaged in
US-funded civilian research projects and that have graduated into
financial self-sustainability.
The new global Biosecurity Engagement Program (BEP)
engages bioscientists worldwide and focuses on the _ global
bioterrorism threat. The programme seeks to engage bioscientists to
improve biosecurity and biosafety, as well as to increase laboratory
capacity to combat infectious disease. The programme began in 2006
with a budget of $3.9 million. In addition, within the Department of
Defense, the Biological Threat Reduction Program (BTRP)
established activities to combat “the risk of bioterrorism and prevent
the proliferation of biological weapons (BW) technology, expertise,
and extremely dangerous pathogens.”'* The BTRP was launched to
CONTAINING BIOLOGICAL RISK:
BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS — 125
prevent the sale, theft, diversion, or accidental release of bioweapons-
related materials, technology, and expertise. One of the goals was to
consolidate especially dangerous pathogens into safe, secure central
reference laboratories.
Therefore, it is essential to consolidate and secure dangerous
pathogens, as well as to implement measures of biosafety, good
laboratory practice, and good manufacturing practice, which would
contribute to the possibilities for developing commercial opportunities
in the pharmaceutical industry.
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Concerning the Laws and Customs of War, Brussels, 27 August 1874, http://www.icre
.org/ihl._nsf/FULL/135?OpenDocument.
* International Committee of the Red Cross, Convention (II) with Respect to the Laws
and Customs of War on Land and its annex: Regulations Concerning the Laws and
Customs of War on Land, The Hague, 29 July 1899, http://www.icrc.org/ihLnsf/FUL
L/150?OpenDocument.
* International Committee of the Red Cross, Convention respecting the Laws and
Customs of War on Land and its annex: Regulations concerning the Laws and
Customs of War on Land, The Hague, 18 October 1907, http://www.icrc.org/ihl_nsf/F
ULL/195?OpenDocument.
° International Committee of the Red Cross, Protocol for the Prohibition of the Use of
Asphyxiating, Poisonous or Other Gases, and of Bacteriological Methods of Warfare,
Geneva, 17 June 1925, http://www. icre.org/ihl.nsf/FULL/280?OpenDocument.
° [bid
” J. Goldblat, Arms Control: A Guide to Negotiations and Agreements (Oslo:
International Peace Research Institute, 1994), p. 92.
* See “Biological Weapons Program” on the website of the Federation of American
Scientists, http://www.fas.org/nuke/guide/japan/bw/.
° D.R. Franz, Defense Against Toxin Weapons (Fort Detrick, Maryland: US Army
Medical Research Institute of Infectious Diseases, 1997), http://www.usamriid.army.
mil/education/defensetox/toxdefbook.pdf.
'0 President Richard Nixon, “Remarks Announcing Decisions on Chemical and
Biological Defense Policies and Programs”, 25 November 1969, http://www.fas.org/b
we/nixon_bw_renounce.pdf.
126 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
'! United Nations, “Extracts from the Report of the Secretary-General: Chemical and
Bacteriological (Biological) Weapons and the Effects of Their Possible Use”, New
York, 1969, http://www.unog.ch/80256EDD006B8954/(httpAssets)/83669D9CB32C
9F33C125718B0034C413/$file/Extract_ UNSG-1969. pdf.
'2 Convention on the Prohibition of the Development, Production and Stockpiling of
Bacteriological (Biological) and Toxin Weapons and on Their Destruction, http://disar
mament.un.org/wmd/bwe./BWC%20text-English. pdf.
'? See “Status of Multilateral Arms Regulation and Disarmament Agreements” on the
website of the UN Office for Disarmament Affairs, http://disarmament.un.org/Treaty
Status.nsf.
'4 Convention, op. cit., note 12.
'S Goldblat, op. cit., note 7, p. 93.
'© M. Moodie, “The Soviet Union, Russia and the Biological and Toxin Weapon
Convention”, The Nonproliferation Review, Spring 2001, http://cns.miis.edu/pubs/npr/
vol08/8 1/8 lmoodie.pdf.
'7 K. Nixdorff and W. Bender, “Biotechnology, Ethics of Research and Potential
Military Spin-off’, International Network of Engineers and Scientists Against
Proliferation, Jnformation Bulletin, No. 19, March 2002, http://www.inesap.org/bullet
in19/bull 9art05.htm.
'8 Convention, op. cit., note 12.
'? Protocol to the Convention on the Prohibition of the Development, Production and
Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their
Destruction, BWC/AD HOC GROUP/CRP.8, 3 April 2001, http://www.opbw.org/ahg
/docs/CRP8.pdf.
20 JR. Bolton, “US Statement to the Fifth BWC Review Conference”, 19 November
2001, http://www.acronym.org.uk/bwe/revconus.htm.
*! J. Borrie, “The Limits of Modest Progress: The Rise, Fall, and Return of Efforts to
Strengthen the Biological Weapons Convention”, Arms Control Today, October 2006,
http://www.armscontrol.org/act/2006_10/BWC.asp?print.
* Center for Strategic and International Studies, “Resuscitating the Bioweapons Ban:
U.S. Industry Experts’ Plan for Treaty Monitoring”, November 2004, http://www.csis.
org/media/csis/pubs/041117_bioweapons.pdf.
* See the website of the Biological and Toxin Weapons Convention, http://www.opb
w.org/.
** Bradford Project on Strengthening the Biological and Toxin Weapons Convention
(BTWC), http://www.brad.ac.uk/acad/sbtwe/.
*> BioWeapons Prevention Project, http://www.bwpp.org/.
*° The Australia Group, http://www.australiagroup.net/index_en.htm.
*7 See the working paper delivered by Iran at the Conference, BWC/CONF.VI/WP.24,
23 November 2006, http://www.opbw.org/.
8 Australian Government, Department of Defence, http://www.defence.gov.au/strateg
y/dtcc/regimes.htm.
*° Sixth Review Conference of the States Parties to the Convention on the Prohibition
of the Development, Production and Stockpiling of Bacteriological (Biological) and
Toxin Weapons and on Their Destruction, Secretariat, “Final Document”.
BWC/CONF.V1/6, Geneva, 20 November - 8 December 2006, http://www.opbw.org/.
Ibid.
CONTAINING BIOLOGICAL RISK:
BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS — 127
3! Ibid.
* Resolution 37/98D, http://daccessdds.un.org/doc/RESOLUTION/GEN/NR0/425/76
/JIMG/NR042576.pdf?OpenElement.
** Resolution 42/37C, http://daccessdds.un.org/doc/RESOLUTION/GEN/NRO/512/69
/IMG/NRO51269.pdf?OpenElement.
** Document A/44/561, http://documents-dds-ny.un.org/doc/ UNDOC/GEN/N89/234/
36/img/N8923436.pdf?OpenElement.
*> United Nations Security Council Resolution 620, http://www.un.org/Does/scres/198
8/scres88.htm.
°° Center for Strategic and International Studies, “Strategic Study on Bioterrorism”,
14 June 2006, http://www.sgpproject.org/bio%20studyreport | 4June06.
*” Center for Strategic and International Studies, “Global Partnership Scorecard”, July
2006, http://www.sgpproject.org/publications/GPScorecard2006. pdf.
*8 Tbid., p. 1.
*° Y. Sandoz, “ICRC Involvement in Banning or Restricting the Use of Certain
Weapons”, presentation to the 17" Annual Seminar for Diplomats on International
Humanitarian Law, United Nations and New York University School of Law, 9
February 2000, http://www.icre.org/web/eng/siteeng0.nsf/html/S7JQAN.
*° International Committee of the Red Cross, “Appeal on Biotechnology, Weapons
and Humanity”, 25 September 2002, http://www.icrc.org/Web/eng/siteeng0.nsf/htmlal
VSEAMTT.
*! Tbid.
*? International Committee of the Red Cross, “Biological weapons: ICRC calls for
concerted efforts to prevent use”, 20 November 2006, http://www.icrc.org/web/eng/sit
eeng0.nsf/html/ihl-weapons-news- !Open
® International Committee of the Red Cross, “Preventing hostile use of the life
sciences: From ethics and law to best practice”, ! l November 2004, http://Awww.icrc.o
eb/Eng/siteeng0.nsf/html/bi logy- : ice-
a T. Clancy, Executive Orders (New York: G.P. Putnam, 1996).
* C. Chyba and A.L. Greminger, “Biotechnology and Bioterrorism: An
Unprecedented World”, Survival, Vol. 46, No. 2, Summer 2004, pp. 143-144,
http://cisac.sranford.edu/docs/honorsprogram/readin hyba&Greninger2.pdf.
© §.W. Carus, “Bioterrorism and Biocrimes: The Illicit Use of Biological Agents
since 1900”, Center for rn a National Defense —
Working Paper, February 2001, http://www.ndu. tercounter/Full
’ Pan American Health Organization, pe The Threat in “~ ae
Hemisphere”, 13" Inter-American Meeting at the Ministerial Level on Health and
Agriculture, 24-25 April 2003, http://www.paho.org/English/HCP/HCV/rimsa13-18-
e.pdf.
48 United Nations, Security Council Resolution 1373, 28 September 2001, http://www
.un.org/News/Press/docs/200 1l/sc7158.doc.htm.
® Ibid.
°° United Nations, Security Council Resolution 1535, S/RES/1535 (2004), 26 March
2004, http://www.securitycouncilreport.org/atf/cf/%7B65BEFCF9IB-6D27-4E9C-8CD3
-CF6E4FF9I6FFI%7D/CTED%20Res%201535.pdf.
>! United Nations, Security Council Resolution 1540, S/RES/1540 (2004), 28 April
2004, http://disarmament2.un.org/Committee1540/Res1540(E).pdf.
128 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
0 a A RS ee
»? Ibid.
* Ibid.
4 Ibid.
*> United Nations General Assembly, “Uniting against terrorism: recommendations
for a global counter-terrorism strategy”, A/60/825, 27 April 2006, http://www.unodc.o
rg/images/A60285.pdf.
°° UN Action to Counter Terrorism, “United Nations General Assembly Adopts
Global Counter-Terrorism Strategy”, http://www.un.org/terrorism/strategy-counter-
terrorism.html.
*” [bid.
8 Ibid.
»° Ibid.
°° Ibid.
°! Interpol, “Bioterrorism Incident Pre-Planning & Response Guide”, 2007, http://ww
w.interpol.int/Public/BioTerrorism/BioterrorismGuide.pdf.
® Inter-American Committee Against Terrorism, CICTE Informe 40, November 2006,
http://www.cicte.oas.org/Database/Informe%2040%20-%20ENG.doc.
°? World Health Organization, “Deliberate use of biological and chemical agents to
cause harm: Public health response”, Report by the Secretariat, A/55/20, 16 April
2002, http://www.who.int/gb/ebwha/pdf_files/)\WHA55/ea5520.pdf.
°4 World Health Organization, “Global public health response to natural occurrence,
accidental release or deliberate use of biological and chemical agents or radionuclear
material that affect health”, WHA15.66, 18 May 2002, http://www.who.int/gb/ebwha/
pdf_files/WHA55/ewha5516.pdf.
°° World Health Organization, Health Aspects of Biological and Chemical Weapons
(Geneva: WHO, 1970), first edition, http://www.who.int/csr/delibepidemics/biochem 1
stenglish/en/index.html.
°° See the section “Preparedness for Deliberate Epidemics” on the website of the
World Health Organization, http://www. who. int/csr/delibepidemics/en/.
°7 See the section “Specific diseases associated with biological weapons” on the
website of the World Health Organization, http://www.who. int/csr/delibepidemics/dis
ease/en/.
°° World Health Organization, Terrorist Threats to Food: Guidelines for Establishing
and Strengthening Prevention and Response Systems (Geneva: WHO, 2002), http://w
ww.who.int/foodsafety/publications/fs_management/terrorism/en/.
Commission of the European Communities, Health & Consumer Protection
Directorate-General, “Programme of Cooperation on Preparedness and Response to
Biological and Chemical Agent Attacks [Health Security]”, G/FS D(2001)GG,
Luxembourg, 17 December 2001, http://ec.europa.eu/health/ph_threats/Bioterrorisme/
bioterrorism01_en.pdf.
” Ibid.
”! Europa, “Commission Activities in the Fight against Terrorism”, MEMO/07/98,
Brussels, 12 March 2007, http://europa.eu/rapid/pressReleasesAction.do?reference=M
EMO/07/98&format-HTML&aged=0& language=EN& guilanguage=en.
” European Commission, DG Research, Directorate E: Biotechnology, Agriculture
and Food Research, “Report of the Conference on Ethical Implications of Scientific
CONTAINING BIOLOGICAL RISK:
BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS 129
Research on Bioweapons and Prevention of Bioterrorism, Brussels, 3-4 February
2004”, http://ec.europa.eu/research/biosociety/pdf/proceedings bioterrorism.pdf.
* Europa, “Commission Adopts a Green Paper on Bio-Preparedness”, [P707/1065,
Brussels, 11 July 2007, http://europa.eu/rapid/pressReleasesAction.do?reference=IP/0
7/1065&format=-HTML&age.
* OECD International Futures Programme, “Promoting Responsible Stewardship in
the Biosciences: Avoiding Potential Abuse of Research and Resources, Chairman’s
Summary”, Frascati, Italy, 17-19 September 2004, http://www.oecd.org/dataoecd/30/5
6/33855561 pdf.
” Ibid., p. 5.
”® Ibid., p. 6.
” Organization for Security and Co-operation in Europe, “The Bucharest Plan of
Action for Combating Terrorism”, MC(9).DEC/1, 4 December 2001, http://www.osce
.org/documents/cio/2001/12/670_en.pdf.
’’ Organization for Security and Co-operation in Europe, Bishkek International
Conference on Enhancing Security and Stability in Central Asia: Strengthening
Comprehensive Efforts to Counter Terrorism, “Programme of Action”, 13-14
December 2001, http://www.osce.org/documents/cio/2001/12/677_en.pdf.
” Organization for Security and Co-operation in Europe, “OSCE Charter on
Preventing and Combating Terrorism”, MC(10).JOUR/2, 7 December 2002, http://ww
w.osce.org/documents/cio/2002/12/672_en.pdf.
*° Organization for Security and Co-operation in Europe, Decision No. 1,
“Implementing the OSCE Commitments and Activities on Combating Terrorism”,
MC(10).DEC/1, 7 December 2002, http://www.osce.org/documents/sg/2002/12/671
en.pdf.
‘! “Black ICE: After-Action Report”, http://www.state.gov/documents/organization/7
9521 pdf.
*? NATO, Partnership Action Plan against Terrorism, Prague, 22 November 2002,
http://www.nato. int/docu/basictxt/b021122e.htm.
83 G8 Information Center, “G8 Action Plan on Nonproliferation”, Sea Island, 9 June
2004, http://www.g7.utoronto.ca/summit/2004seaisland/nonproliferation. html.
Ibid.
*° See the section “GHSI Background” on the website of the Global Health Security
Initiative, http://www.ghsi.ca/english/background.asp.
8° Global Health Security Initiative, “Seventh Ministerial Meeting on the Global
Health Security Initiative”, Tokyo, 7 December 2006, http://www.ghsi.ca/english/stat
ementtokyoDec2006.asp.
*” International Society for Infectious Diseases, ProMED-mail, http://www.promedma
il.org/pls/promed/f?p=2400: 1000.
*8 Ibid.
*° See the section “History” on the website of the Inter-American Committee against
Terrorism, http://www.cicte.oas.org/English/history.htm.
*° Inter-American Committee against Terrorism, “Declaration of San Carlos on
Hemispheric Cooperation for Comprehensive Action to Fight Terrorism”, 24 March
2006, http://www.cicte.oas.org/Database/Sexto_Periodo_Declaration%20o0f%20San%
20Carlos%201C00563%20E.doc.
*! bid.
130 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
——— a EE
2 Association of Southeast Asian Nations, “Declaration of the 8th ASEAN Health
Ministers Meeting”, Yangon, 21 June 2006, http://www.aseansec.org/ 18494 pdf.
93 :
Ibid.
4 Center for Strategic and International Studies, op. cit., note 36.
°° EU Joint Action in Support of the Biological and Toxin Weapons Convention,
“Report of the regional seminar for West and Central Africa”, http://www.euja-
btwc.eu/node/221.
© See the section “Strategic National Stockpile” on the website of the Centers for
Disease Control and Prevention, 14 April 2005, http://www.bt.cdc.gov/stockpile/.
97 ‘
Ibid.
*8 M. Lallanilla, “Is the United States Ready for a Bioterrorist Attack?”, ABC News, 4
December 2004, http://abcnews.go.com/Health/story?id=295052&page=1.
*»° US Food and Drug Administration, “The Bioterrorism Act of 2002”, http://www.fd
a.gov/oc/bioterrorism/bioact.html.
10° The White House, “President Signs Public Health Security and Bioterrorism Bill”,
12 June 2002, http://www.whitehouse.gov/news/releases/2002/06/20020612-1.html.
'°! See “Registration of Food Facilities’ on the website of the US Food and Drug
Administration, 3 July 2007, http://www.cfsan. fda.gov/~furls/ffregsum.html.
102 1) A. Shea and S.A. Lister, “The BioWatch Program: Detection of Bioterrorism”,
19 November 2003, http://www. fas.org/sgp/crs/terror/RL32152.html.
13 The White House, Project BioShield, http://www.whitehouse.gov/infocus/bioshiel
d/.
'°4 S§. Kuhr, “The American Experience: Lessons Learned Since 2001”, in National
Institute for Research Advancement-Japan Society, “Bioterrorism & Consequence
Management: New Approaches to U.S.-Japan Security Cooperation”, 2003, pp. 6-7,
http://www.japansociety.org/shop/bioterrorism_consequences.pdf.
105 «War-Gaming the War on Terror: Pitting World Leaders Against a Handful of
Terrorists with a Quiet but Deadly Weapon”, ABC News, 5 March 2005, http://abcnew
s.go.com/Nightline/print?id=509123.
'°6 See the section “Analysis and Lessons” on the Atlantic Storm website, Center for
Biosecurity, University of Pittsburgh Medical Center, March 2005, www.atlantic-
storm.org/conclusions.html.
'07 See the section “Le Plan Biotox” on the website of the Government Portal, Prime
Minister, http://www.premier-ministre.gouv.fr/information/actualites 20/lutte bioterr
orisme_plan_ intervention 38441.html?var_recherche=biotox.
108 J-C. Desenclos, “InVS is Involved in National Plan against Bioterrorism”,
Eurosurveillance Weekly, Vol. 5, No. 45, 8 November 2001, http://www.eurosurveilla
nce.org/ew/200 1/rtf/011108.rtf.
1 Ibid.
'!° BioSecurityCodes, “France”, http://www. biosecuritycodes.org/fran.htm.
''! C. Kittredge, “France awaiting bioterror plan”, The Scientist, 25 November 2003,
http://www. borrull.org/e/noticia.php?id=24 135&id2=1954.
"2 Biotox, http://www.sante.gouy.fr/htm/dossiers/biotox/cont_variole.htm.
'13 N. Miyasaka, “Bioterrorism and Japan: A Security Studies Point of View”, in
National Institute for Research Advancement-Japan Society, op. cit., note 104, pp. 14-
17, http://www.japansociety.org/shop/bioterrorism_consequences.pdf.
CONTAINING BIOLOGICAL RISK:
BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS 131
''4 M. Sugishima, “Aum Shinrikyo and the Japanese Law on Bioterrorism”,
Prehospital and Disaster Medicine, July-September 2003, p. 182, http://pdm.medicin
e.wisc.edu/18-3pdfs/179Sugishima.pdf.
IS “Des poissons cobayes contre le bioterrorisme”, Agence France-Presse, 24 July
2006, http://www.cyberpresse.ca/article/20060724/CPMONDE/607240569/5279/CP
MONDE.
"© BioSecurityCodes, “Japan”, http://www. biosecuritycodes.org/japan.htm.
'!? Center for Biosecurity, University of Pittsburgh Medical Center, op. cit., note 106.
''8 See “Welcome to WHO’s Public Health Mapping and GIS Programme” on the
website of the World Health Organization, http://www.who.inU/health_mapping/en/.
'!? See “Epidemic and Pandemic Alert and Response” on the website of the World
Health Organization, http://www.who.int/csr/en/.
'2° See “Global Outbreak Alert & Response Network” on the website of the World
Health Organization, http://www.who.int/csr/outbreaknetwork/en/.
'2! See “The operational response to SARS” on the website of the World Health
Organization, http://www.who.int/csr/sars/goarn2003_4 16/en/.
'22 See “Biosafety and Laboratory Biosecurity” on the website of the World Health
Organization, http://www.who.int/csr/bioriskreduction/biosafety/en/.
'3 United Nations Educational, Scientific and Cultural Organization, Division of
Ethics of Science and Technology, “Interim analysis of codes of conduct and codes of
ethics”, September 2006, http://unesdoc.unesco.org/images/00 14/00 1473/147335E.pd
as Committee on Agriculture, “Biosecurity in Food and Agriculture”, Rome, March-
“pe 2003, ftp://ftp.fao.org/unfao/bodies/coag/coag17/Y 8453e.doc.
ail ree Portal on Food Safety, Animal & Plant Health, http://www.Ipfsaph.or
g/En/default.jsp.
'27 “Terms of Reference of the Working Group on Biosafety”, ftp://ftp. fao.org/es/esn/f
ood/biosafety_tor.pdf.
'28 See “Codex Task Force” on the website of the Food and Agriculture Organization
of the United Nations, http://www.fao.org/ag/agn/food/risk biotech taskforce _en.stm.
'29 See “AGAAnimal Production and Health”, on the website of the Food and
Agriculture Organization of the United Nations, http://www.fao.org/ag/againfo/home/
en/home.html.
'3° International Phytosanitary Portal, The International Plant Protection Convention,
https://www.ippc.int/servlet/CDSServlet?status=ND MiY2PWVuJj SomM
zc9a29z.
3! Ibid.
'32 Food and Agriculture Organization of the United Nations, International Code of
Conduct on the Distribution and Use of Pesticides, http://www.fao.org/docrep/005/y4
SAde/y454Ge00. htm.
3 M.J.W. Cock, “Biosecurity and Forests: An Introduction — with particular
emphasis on forest pests”, Food and Agriculture Organization of the United Nations,
Working Paper FBS/2E, December 2003, ftp://ftp.fao.org/docrep/fao/006/J1467E/J14
67E.pdf.
'94 See the section “Objectives” on the webpage of the World Organisation for Animal
Health, http://www.oie.int/eng/OIE/en_objectifs.htm?e1d1.
132 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
'35 World Organisation for Animal Health, “Improving animal health worldwide is a
priority”, updated on 9 August 2007, http://www.oie.int/eng/edito/en_lastedito.htm.
© World Trade Organization, “Agreement on the Application of Sanitary and
a” Measures”, http://www.wto.org/english/docs_e/legal_e/15sps_01_e.ht
i See the section “Objectives” on the website of the World Organisation for Animal
Health, http://www.oie.int/eng/OIE/en_objectifs.htm.
'38 See the website of the Codex Alimentarius Commission, http://www.codexaliment
arius.net/web/index_en.jsp.
°° World Organisation for Animal Health, “OIE mandates support Biological and
Toxin Weapons Convention’s crucial objectives”, December 2006, http://www.oie.int
/eng/press/en_061213_BTWC.htm.
'4° See the section “Avian Influenza” on the website of the World Organisation for
Animal Health, http://www.oie.int/fr/info_ev/fr_ai_events.htm.
'41 See the section “Terrestrial Animal Health Code” on the website of the World
Organisation for Animal Health, http://www.oie.int/eng/publicat/en_code.htm.
'4? See the website of the Convention on Biological Diversity, http://www.biodiv.org/
convention/convention.shtml.
‘8 See the section “What’s New” on the website of the Convention on Biological
Diversity, http://www. biodiv.org/default.shtml.
'44 See the section “Background” on the website of the Convention on Biological
Diversity, http://www.cbd. int/biosafety/background.shtml.
' Cartagena Protocol on Biosafety to the Convention on Biological Diversity,
Montreal, 2000, http://www.cbd. int/doc/legal/cartagena-protocol-en.pdf.
'° Rio Declaration on Environment and Development, June 1992, http://habitat.igc.or
g/agenda2 1/rio-dec.html.
'47 See the section “Capacity Building” on the website of the Convention on
Biological Diversity, http://www.biodiv.org/biosafety/issues/cap-build.shtm].
* See the section “About the GEF” on the website of the Global Environment
Facility, http://www.gefweb.org/interior.aspx?id=50/.
' “The Global Project for Development of National Biosafety Frameworks”,
Biosafety Protocol News, Vol. 1, No. 1, 16 October 2006, http://www.biodiv.org/doc/
newsletters/bpn/bpn-issue0 1 rtf.
'° United Nations Industrial Development Organization, Voluntary Code of Conduct
for the Release of Organisms Into the Environment, http://www.biosafety.gov.cn/ima
ge200105 18/5079. pdf.
'5! “Decision No. 1786/2002/EC of the European Parliament and of the European
Council of 23 September 2002 Adopting a Programme of Community Action in the
Field of Public Health (2003-2008)”, Official Journal of the European Communities,
http://eur-lex.europa.eu/LexUriServ/site/en/oj/2002/1_271/1 27120021009en0001001
L pdf.
'? Commission of the European Communities, “Communication from the
Commission to the Council, the European Parliament, the Economic and Social
Committee and the Committee of the Regions, Brussels”, 16 May 2000, http://europa.
eu/eur-lex/en/com/pdf/2000/en_SOOPC0285.pdf.
CONTAINING BIOLOGICAL RISK:
BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS _ 133
'3 A. Boin, M. Ekengren, and M. Rhinard (eds.), Protecting the European Union:
Policies, Sectors and Institutional Solutions (National Defense College of Sweden-
Leiden University, October 2006), p. 82, http://www.eucm.leidenuniv.nl/content_docs
/eucm_report_ili_october2006_web_publicationversion.pdf.
'S4 See the section “ECDC Activities” on the website of the European Centre for
Disease Prevention and Control, http://www.ecdc.eu.int/activities.html.
Ibid.
'S° B. Sundelius and J. Grénvall, “Strategic Dilemmas of Biosecurity in the European
Union”, Biosecurity and Bioterrorism, Vol. 2, No. 1, January 2004, pp. 17-23, http://
www.medscape.com/viewarticle/472895.
'S? International Centre for Genetic Engineering and Biotechnology, http://www. icgeb
trieste.i/ GENERAL/centrint.htm.
'S8 United Nations General Assembly, “Implementation of General Assembly
resolution 58/200: Science and technology for development”, A/60/84, 2 August
2005, p. 12, http://stdey.unctad.org/docs/a-60-184 pdf.
'%° Ibid.
'© Tbid., p. 13.
'®! Meeting of the States Parties to the Convention on the Prohibition of the
Development, Production and Stockpiling of Bacteriological (Biological) and Toxin
Weapons and on Their Destruction, “Existing Codes of Conduct which Refer to
Biological and Toxin Weapons”, BWC/MSP/2005/MX/INF. i,43 _ 2005, http://w
WW.O1 bw.org/new_process/mx2005/bwe .2005_mx E.
'° Ibid.
'* Ibid.
'®5 World Medical Association, “The WMA Declaration of Washington on Biological
Weapons”, September 2001, http://www.wma.net/e/policy/bLhtm.
'© See the section “SCRES Standards for Ethics and Responsibility in Science” on the
website of the International Council for Science, http://www.icsu.org/2_resourcecentr
e/Resource. php4?rub=7&id=78.
'€7 International Federation of Pharmaceutical Manufacturers and Associations, “New
IFPMA Code of Pharmaceutical Marketing Practices”, 3 January 2007, http://www.if
.org/News/new aspx.
8 “Kampala be The Global Bargain for Biosecurity and Bioscience”, o
October 2005, http://www.icsu-africa.org/Resource_centre/KampalaCompactoct05.
f
19 Thid.
179 ©. Lindgren, “Report of the Hearings regarding the HLG for the Alliance of
Civilisations”, 17 July 2006, p. 48, http://www.unaoc.org/repository/hearings report.p
™ See the section “Overview: Global Health Security Initiative (GHSI)” on the
website of the Control Global Health Security Initiative, http://www.ghsi.ca/english/b
ackground.asp.
Iz n-
173 93
Ibid.
'4 The Strengthening the Global Partnership, “Global Partnership Scorecard”, July
2006, http://www.sgpproject.org/publications/GPScorecard2006. pdf.
134. GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
'75 International Science and Technology Center, “A decade of Service — About
ISTC”, http://www. istc.rw/ISTC/sc.nsf/html/public-info-what-is-istc. htm.
'7° International Science and Technology Center, “ISTC Fact Sheet”, http://www. istc.r
u/istc/sc.nsf/html/public-info-fact-sheet.htm.
' This is a rough estimate provided by the Office of the Deputy Executive Director,
ISTC, 28 May 2007.
178 «FR dible Vaccines from Transgenic Plants”, ISTC Project No. 2176, http://www.ist
c.ru/ISTC/sc.nsf/html/projects.htm? open&id=2176.
'? Figures from the Deputy Executive Director of the ISTC, 25 May 2007.
'8° International Science and Technology Center, op. cit., note 175, p. 14.
mw See the Science and Technology Center in Ukraine website, www.stcu.int.
Ibid.
'83 “New Nunn-Lugar Biological Agreement Signed in Ukraine”, Nunn-Lugar Report,
August 2005, p. 1, http://lugar.senate.gov/reports/Nunn-Lugar Report _2005.pdf.
= Tbia. p. 2.
'§ See the section “Research Partnerships” on the website of the Science and
Technology Center in Ukraine, http://www.stcu.int/offer/commercialcontrres/index.ph
p.
'8° “
It is important to introduce “mandatory training for all
professionals working in the life sciences (in academia, for
governments, and in the private sector)”.°° In addition, appropriate
awareness-raising programmes need to be developed for
policymakers, industry, editors, journalists, and the public.°’ Studies
have shown that a public that is aware of, and informed about, existing
initiatives and their goals can help achieve them. An aware and
educated public can foster the political will and changes in attitudes
and behaviours that are vital to implementation of any comprehensive
policy or strategy.
It is widely accepted that scientists have an obligation to do no
harm: “They should always take into consideration the reasonably
foreseeable consequences of their own activities. They should always
bear in mind the potential consequences — possibly harmful — of their
research and recognize that individual good conscience does not
justify ignoring the possible misuse of their scientific endeavor, and
refuse to undertake research that has only harmful consequences for
humankind”.** They should always strive to be fully aware of the
potential consequences of their research. Moreover, the global
decision-making community has to make awareness-raising among all
actors concerned one of the top priorities of a global biosecurity
Strategy. Without awareness, “finding solutions for transnational
threats and problems are unlikely to be as effective as they could
be”.
5. Aiming at Transparency and Open Dialogue Between Major
Actors
All actors involved in the global management of biosecurity-related
issues — including the policymaking, science, industry, and security
communities — have until now suffered from a lack of dialogue. In the
realm of biosecurity, decisionmakers have to take difficult decisions in
situations where there is both a lack and a surplus of information. It is
often difficult to determine what information is relevant. The results
of global decisions — or non-decisions — have direct negative
consequences on the functioning of the whole biosecurity regime.
146 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Although it is very difficult to build a coherent information strategy
on a global level, as various actors are likely to have conflicting views
of the problem, it should be a major goal of the new global biosecurity
paradigm. Such an information strategy should be built on a
foundation of transparency and open dialogue.
By open and honest dialogue we understand open lines of
communication and information-sharing. A lack of dialogue is usually
reflected in a lack of shared values. That is why there is an urgent
need for a commonly-agreed upon, consultative platform to facilitate
such a dialogue at the global level.°° Transparency can be understood
as “the free exchange of information, samples, and experts”.®’
Transparency is critical to establishing and maintaining integrity and
to producing reputable results. It can ease fears of conflicts of interest
and reveal whether impartiality is truly genuine or merely imposed
from above. Transparency can act as an external constraint promoting
discipline among major biosecurity actors. Transparency serves three
different purposes: “It deters violations of agreed-upon norms. It also
reassures states and societies that others are not misusing technologies
and goods for prohibited purposes. And it may also reveal problems in
a security regime that actors have not recognized before...
Transparency has positive effects on foreign relations, arms control
and disarmament, and verification. It promotes a peaceful application
of technology, and this includes the promotion of trade for peaceful
purposes. Transparency allows peer review and free scientific
exchange and thereby improves the quality of science. It further
allows an informed public debate.”
There are several ways to promote transparency:
“Transparency is fostered first and foremost by the collection,
processing, analysis, and dissemination of relevant information. The
timely, accurate, and comprehensive reporting by leading states is
another important factor that promotes transparency... And a last
factor in encouraging transparency is the removal of obstacles to
reporting, such as complicated reporting forms.’ So much of
bioscience information is in the public domain. One single agency
cannot inspect tens of thousands of the life sciences laboratories
around the world. What we can do, “indeed the one strategy that
makes sense, is to expand and illuminate the pursuit of this science, to
enhance its transparency worldwide”.“ Therefore. transparency and
open dialogue are the key tools in any effort to establish a viable
global biosecurity strategy and ensuring biological security at all
THE HUMAN DIMENSION OF BIOSECURITY 147
levels. As we have seen in the case of the elimination of past Soviet
bioweapons programmes under the G8 Global Partnership and US-
Russian bilateral efforts, much remains to be achieved. Progress in
this area would certainly be facilitated by increased transparency and
dialogue between Russia and its partners.
6. Fostering a Culture of Shared Responsibility
In the last decades, “international diplomacy has undergone deep
changes in terms of both its nature and scope. These changes have
been characterised by an intensification and diversification of relevant
constituents and actors, the increased complexity of relevant subject
matter, and a broadening of the diplomatic agenda to include areas
with a strong connection to science and technology policy, standard
setting, and rule making”.®°
One of the examples — the Pugwash Conferences on Science
and World Affairs, which celebrated their 50" anniversary in 2007 —
can be regarded as a great example of fostering a culture of shared
responsibility for the future of humanity. “The purpose of the
Pugwash Conferences is to bring together, from around the world,
influential scholars and public figures concerned with reducing the
dangers of armed conflict and seeking cooperative solutions for global
problems.”’’ The first historic conference was initiated by Joseph
Rotblat and Cyrus Eaton in 1950 at Eaton’s summer home in
Pugwash. It became the forerunner of a series of meetings that are
credited with providing the basis for a number of ground-breaking
multilateral treaties, including the Anti-Ballistic Missile Treaty, the
Strategic Arms Limitation Talks (SALT) Accords, and the Chemical
Weapons Convention.” The mission of the Pugwash Conferences is
“to bring scientific insight and reason to bear on threats to human
security arising from science and technology in general, and above all
from the catastrophic threat posed to humanity by nuclear and other
weapons of mass destruction”.©” The Pugwash Conferences are one
remarkable illustration of the engagement and leadership role that
academics can play in framing public policy and raising awareness as
“the salvation of this human world lies nowhere else than in the
human heart, in the human power to reflect, in human modesty, and in
human responsibility”.””
In 1995, Joseph Rotblat and Pugwash were jointly awarded
the Nobel Peace Prize. In his speech “Remember Your Humanity”,
148 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Professor Rotblat emphasised: “With the global threat resulting from
science and technology, the whole humankind needs protection. We
have to extend our loyalty to the whole human race. ... The quest for a
war-free world has a basic purpose: survival. But if in the process we
learn how to achieve it by love rather than by fear, by kindness rather
than by compulsion; if in the process we learn to combine the essential
with the enjoyable, the expedient with the benevolent, the practical
with the beautiful, this will be an extra incentive to embark on this
great task. Above all, remember your humanity.””!
Remembering our humanity is highly relevant in the age of
biology. It is widely recognised that, “A culture of fear may breed
compliance, but does little to engage bioscientists in a culture of
responsibility based on shared values and consensus.” Therefore,
with all the potential dangers posed by the rapid advancement of the
life sciences, biotechnology, nanotechnology, synthetic biology, and
genetics, it is imperative to foster a strong culture of shared
responsibility based on the utmost values of humanity.
REFERENCES
' United Nations, A more secure world: Our shared responsibility, Report of the
Secretary-General’s High-level Panel on Threats, Challenges and Change (New York:
United Nations Department of Public Information, 2004), p. viii, http://www.un.org/se
cureworld/report2.pdf.
2 C. Juma and L. Yee-Cheong, “Reinventing Global Health: the Role of Science,
Technology, and Innovation”, Millennium Project, Vol. 365, 19 March 2005, p. 1105,
os A crea ee ger eer a orem sci_tech.pdf.
id.
* UN Millennium Project, Task Force on Science, Technology and Innovation:
Applying Knowledge in Development (London: Earthscan, 2005).
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Communication from the Commission to the European Parliament, the Council, the
Economic and Social Committee and the Committee of the Regions, COM, 2002,
Vol. 27, p. 26, http://ec.europa.eu/biotechnology/pdf/com2002-27_en.pdf.
° National Intelligence Council, Mapping the Global Future: Report of the National
Intelligence Council’s 2020 Project Based on Consultations With Nongovernmental
Experts Around the World (Pittsburgh, PA: Government Printing Office, 2004), p. 34,
http://www. foia.cia.gov/2020/2020.pdf.
’ Canadian Program on Genomics and Global Health, “DNA for Peace: Reconciling
Biodevelopment and Biosecurity”, Toronto, 2006, p. 5, http://www.utoronto.ca/jcb/ho
THE HUMAN DIMENSION OF BIOSECURITY 149
me/documents/DNA_Peace.pdf.
* E. Dowdeswell, P.A. Singer, and A.S. Daar, “Increasing Human Security Through
Biotechnology”, /nternational Journal of Biotechnology, Vol. 8, Nos. 1/2, 2006, p.
122.
2 European Commission, op. cit., note 5, p. 11.
'° A. Sunderland, “Biotechnology: The Underutilised Tool in the Fight for Global
Health and Security”, Journal of Commercial Biotechnology, Vol. 9, No. 1, 11-12
September 2002, p. 11.
'" Ibid.
'2 World Health Organization, “Scientific Working Group on Life Science Research
and Global Health Security, Report of the First Meeting”, WHO/CDS/EPR/2007.4,
Geneva, 16-18 October 2006, p. 6, http://www.who.int/csr/resources/publications/deli
berate/-WHO _CDS_EPR_2007_4n.pdf.
'* “Empowering People at Risk: Human Security Priorities for the 21% Century”,
Working Paper for the Helsinki Process, Report of the Track on “Human Security”,
2005, p. 15, http://www.helsinkipr fi/netcomm/ImgL ib/53/1 :
f.
* Juma and Yee-Cheong, op. cit., note 2.
5G. Conway and C. Gardner, “Affordable, essential new health technologies: a view
from the Rockefeller Foundation”, Global Forum Update on Research for Health
2005, p. 76, http://www.globalf health.org/filesupld/global_update1/G1
e3.pdf.
'© Helsinki Process, “Helsinki Process on Globalization and Democracy”,
http://www.helsinkiprocess.fi/netcomm/ImgLib/24/89/HP_kalvot.ppt.
"7 Canadian Program on Genomics and Global Health, op. cit., note 7, p. 9.
'§ “Kampala Compact: The Global Bargain for Biosecurity and Bioscience”, 1
October 2005, http://www.icsu-africa.org/Resource_centre/KampalaCompactoct05.pd
f.
'9 Ibid.
2° Canadian Program on Genomics and Global Health, op. cit., note 7.
21 ;
Ibid.
6 Ibid., p. 4.
27 “ Anti-terrorism ‘on collision course’ with biotech for the poor”, OneWorld.net, 11
July 2007, http://uk.oneworld.net/article/view/128283/1/.
Ibid.
29 N.R.F. Al-Rodhan, The Role of Education in Global Security (Genéve: Editions
Slatkine, 2007), p. 107.
39 United Nations Educational, Scientific and Cultural Organization, “What is the
United Nations Literacy Decade?”, http://portal.unesco.org/education/en/ev.php-URL
ID=27158&URL_ DO=DO_ TOPIC&URL SECTION=201 html.
*! Ibid.
2 Thid.
150 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
3 United Nations Educational, Scientific and Cultural Organization, Literacy as
Freedom: A UNESCO Rounda-table (Paris: UNESCO Publishing, 2003), p. 7, http://un
esdoc.unesco.org/images/0013/0013 18/13 1823¢.pdf.
34 A Sen, “Reflections on Literacy”, in ibid., p. 21.
> UN Department of Economic and Social Affairs, Division for Sustainable
Development, “Frequently Asked Questions”, http://www.un.org/esa/sustdev/help_fa
q.htm.
°° See the section “GHESP — Global Higher Education for Sustainability Partnership”
on the UNESCO website, http://portal.unesco.org/education/en/ev.php-URL_ID=347
01&URL_DO=DO_ TOPIC&URL SECTION=201 html.
57 See the website of the Global Virtual University, http://www.gvu.unu.edu/.
°8 The Ubuntu Declaration on Education and Science and Technology for Sustainable
Development, http://www.environment.gov.za/Sustdev/documents/pdf/UbuntuDeclar
ation.pdf.
°° H. van Ginkel, “Mobilizing for sustainable development”, in United Nations
Educational, Scientific and Cultural Organization, Final Report of the Meeting of
Higher Education Partners (World Conference on Higher Education + 5) (Paris:
UNESCO, 2004), p. 87, http://unesdoc.unesco.org/images/0013/001352/135213e.pdf.
“° United Nations General Assembly, “United Nations study on disarmament and non-
proliferation education”, Resolution 57/60, November 2002, http://disarmament.un.or
g/vote.nsf/9 1laS5e1 195dc97a630525656f005Sb8adf/b16778d8c4eb63c785256c4d0052ad
44? OpenDocument&ExpandSection=5#_ SectionS.
*! The Royal Society and Wellcome Trust, “Do no harm: reducing the potential for the
misuse of life science research”, report of a Royal Society and Wellcome Trust
meeting held at the Royal Society on 7 October 2004, p. 5, http://www.royalsoc.ac.uk
/displaypagedoc.asp?id=13647.
* Ibid.
* Ibid.
“* National Research Council of the National Academies, Biotechnology Research in
an Age of Terrorism (Washington, DC: The National Academies Press, 2003), p. 111,
http://books.nap.edu/openbook.php?record_id=10827&page=111.
SM. Stebbins, “Filling Communication Gaps in Biosecurity”, Carnegie Endowment
for International Peace, 22 June 2007, http://www.partnershipforglobalsecurity.org/Pr
ojects/Biological?o20Threat%20Reduction%20Project/index.asp.
“© United Nations Educational, Scientific and Cultural Organization, “Constitution of
the United Nations Educational, Scientific and Cultural Organization”, Manual of the
General Conference (Paris: UNESCO, 2002), 2002 edition, pp. 7-22, http://unesdoc.u
nesco.org/images/0012/001255/125590e.pdf# constitution.
47 AH. Zakiri, S. Johnston, and B. Tobin, “The Biodiplomacy Initiative: Informing
Equitable and Ethical Decision-Making for Present and Future Generations”, Work in
Progress, Vol. 17, No. 2, Summer 2005, p. 3, http://www.unu.edu/hq/ginfo/wip/wip |
7-2-summer2005.pdf.
“8 World Health Organization, op. cit., note 12, p. 7.
% Thid.
°° Ibid.
>! Thid.
» Tbid., p. 10.
THE HUMAN DIMENSION OF BIOSECURITY 151
*3 National Research Council of the National Academies, op. cit., note 44, p. 4, http://
print.nap.edu/pdt/0309089778/pdf image/4.pdf.
Ibid.
* Stony Brook Forum on Global Security, “Preparing Experts to Combat
Bioterrorism: Bridging the Science-Policy Divide”, Conference Report, 7 November
2003, p. 2, http://www.sunysb.edu/sb/nyc/globalsecurity/ConferenceReport.pdf.
*© World Health Organization, op. cit., note 12, p. 7.
*? Ibid.
8 RM. Atlas, “Securing Life Sciences Research in an Age of Terrorism”, Jssues in
Science and Technology, New Visions for National Security, Fall 2006, http://www. iss
ues.org/issues/23.1/atlas.html.
°° N_R.F. Al-Rodhan and L. Watanabe, A Proposal for Inclusive Peace and Security
(Genéve: Editions Slatkine, 2007), p. 37.
°° Meeting of the States Parties to the Convention on the Prohibition of the
Development, Production and Stockpiling of Bacteriological (Biological) and Toxin
Weapons and on Their Destruction, “Report of the Meeting of Experts”,
BWC/MSP/2005/MX/3, 5 August 2005, http://www.opbw.org/new
bwe_msp.2005_mx_ 3 E.pdf.
*! 1. Hunger, “More Transparency for a Secure Biodefense”, in A. Wenger and R.
Wollenmann (eds.), Bioterrorism, Confronting a Complex Threat (Boulder, Colorado:
Lynne Rienner Publishers, 2007), p. 185.
* Ibid., pp. 183-184.
® Ibid., p. 183.
* “ Anti-terrorism ‘on collision course’ with biotech for the poor”, op. cit., note 27.
®° See the section on “The Biodiplomacy Initiative” on the website of the United
Nations University/Institute of Advanced Sciences, http://www.ias.unu.edu/research/b
iodiplomacy.cfm.
°° The Pugwash Conferences on Science and World Affairs, http://www.pugwash.org.
°” See the section “About Pugwash” on the website of the Pugwash Conferences on
Science and World Affairs, http://www.pugwash.org/about. htm.
° Ibid.
°° See the section “Mission Statement” on the website of the Pugwash Conferences on
Science and World Affairs, http://www.pugwash.org/about/mission.htm.
”° Vv. Havel, Address to a Joint Session of the US Congress, Washington DC, 21
February 1990, http://old.hrad.cz/president/Havel/speeches/1990/2102_uk.html.
4 “Joseph Rotblat — Nobel Lecture”, Oslo, December 1995, http://nobelprize.org/cgi-
bin/print? from=/nobel_prizes/peace/laureates/19 lat-lecture. html.
” JE. Fischer, Stewardship or Censorship? Balancing Biosecurity, The Public's
Health, and The Benefits of Scientific Openness (Washington, DC: The Henry L.
Stimson Center, 2006), p. 76, http://www.stimson.org/globalhealth/pdf/Stewardship.p
df.
CHAPTER 7
GOVERNANCE OF RESEARCH IN THE LIFE SCIENCES
1. Knowledge and Transparency: A Call for a Global Approach to
Ensuring that Science Is Not Misused
Scientific knowledge has been racing at an unprecedented pace,
bringing opportunities to combat disease and help many people.
However, the problem of dual use raises ethical, moral, legal,
political, and policy implications: “[W]hile we continue to marvel at
new scientific discoveries and enjoy the benefits of innovative
technological developments grounded upon scientific advances, there
is a growing unease about science and mounting concern about its
adverse consequences”. '
The life sciences and biotechnology-related knowledge can
facilitate the resolution of various global problems, ranging from
infectious diseases to economic and social development. The recent
“achievements of molecular biology and genetics over the last 50
years have produced advances in agriculture and industrial processes
and have revolutionized the practice of medicine. The very
technologies that fueled these benefits to society pose a potential risk
as well — the possibility that these technologies could indeed be “used
to create the next generation of biological weapons”.’ Policymakers
are concerned that research results, knowledge, or techniques have the
potential to “facilitate the creation of ‘novel’ pathogens with unique
properties or create entirely new classes of threat agents”. As we have
already stated, there are many countries pursuing biotechnology
research at the highest level. “The techniques, reagents, and
information that could be used for offensive purposes are readily
available and accessible. Moreover, the expertise and know-how to
use or misuse them is distributed across the globe.”
The main advances in recombinant DNA research has
spawned an active discussion on the potential impact of discoveries in
the life sciences on global security. In the early 21" century, with
154 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
further advances leading to obtaining a human genome sequence draft,
which opened a portal to vast post-genomic possibilities, combined
with the threat posed by bioterrorism, the openness of the life sciences
research community became again a subject of discussion. Since life
sciences research is a truly global enterprise, all effort to address the
dual-use dilemma must also be global. Scientists progressively
recognise that research is not a value-free activity and, therefore, must
be governed by major ethical principles: “For the scientists and
technicians involved in cutting-edge research and development in
biology, biotechnology, medicine, and agriculture, this duality creates
both uncertainties and ethical dilemmas.”
The biological risks resulting from inappropriate use of
modern biotechnologies are always increasing. “Historically, the only
actors considered able to afford the costs of developing biological
weapons were states ... but the globalisation of dual-use biological
technologies through legitimate activities has altered this perception
and consequently required governments to increasingly seek to enrol
actors not normally associated with security in their efforts to reduce
the threat.”° The regulation of dual-use biotechnology research has
become “a highly contentious technical, political, and societal issue”.’
The overlap between science and security policy has escalated since
2001. As a consequence of events such as the failure of the
international negotiations to strengthen the BWC in July 2001 and the
2001 anthrax incident in the United States, “the historically close
relationship between the life sciences and biological weapons
development has been recast as one of the most significant policy
[issues] of the day”.
In addition, the policy-making and scientific community
started to question whether certain information should be publicly
available. The potential threat from the misuse of current and future
biological research is a challenge that requires a serious response.
However, it is recognised that there is no one-size-fits-all policy
solution to the problem posed by the proliferation of dual-use
technologies. As a result, a number of policy measures designed to
prevent the use of disease for hostile purposes have been introduced,
including those that address the practice and governance of scientific
activities. At the same time, there is an urgent need for international
consensus and consistent guidelines for overseeing research in
advanced biotechnology. Governments, international organisations,
industry, the entire global scientific community are facing this
GOVERNANCE OF RESEARCH IN THE LIFE SCIENCES 155
challenge. Efforts to meet it ought to be expanded, strengthened, and
most importantly, harmonised.”
Essentially, governance measures for biological science
should be viewed as a common effort, and not as a single policy or
institutional measure. Some such mechanisms would include, for
example, an increased awareness of biosecurity risks among scientists
and scientific leadership and a bottom-up governance system of
biological science and research.'® One of the best solutions would be
to encourage scientists to think carefully about their work and its
security implications, and to act accordingly: “The best way to keep
the pursuit of knowledge open and free is for researchers to exercise a
demonstrable sense of responsibility.”'' This may require scientists to
ask and answer difficult questions. “But if scientists don’t learn to do
this for themselves, the hard question will come instead from outside
parties, as happened recently with a modelling paper on botulinum
toxin, whose publication was delayed following concern from the US
government.”
While there are deeply conflicting opinions within the life
sciences community on whether or not there should be restrictions on
the search for new knowledge, “the need to place limits in certain
instances on the application of that knowledge is broadly accepted.
And there is widespread agreement that all research in the life sciences
must be conducted in a safe and ethical manner.”’ The increasing
global diffusion of biological technologies raises the question of
governance of global science. In this context, it is essential that risks
are “properly identified, understood and effectively managed”."
Direct and practical steps should be taken to integrate
mandatory biosafety/biosecurity curricula in undergraduate and
graduate teaching in the field of the life sciences. More importantly,
the global community ought to develop guidelines for life science
research oversight. Such guidelines should contain peer-review
processes; risk-benefit assessment methodologies that include ethical,
legal, and social implications; and a strategy for their application,
education, training, and raising awareness. The principal “objective of
such research oversight should be to ensure that research is undertaken
safely and securely, and maintains public trust”.'° All key
stakeholders, ranging from governments, international organisations,
non-governmental organisations, security experts, and industry, to
professional societies and academia, have to agree on a shared vision
of such principles.
156 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
2. Biosecurity and Secrecy
For many scientists, the debate on how best to balance the potential
benefits of an unrestricted flow of scientific information against any
conceivable threat to global security has taken on great importance.
“A principal challenge facing policymakers is how to strike a balance
between open innovation and security to maintain progress in
scientific research. The policy goal should be to derive the ‘dual
benefits’ of security and technological advances.””°
It is widely accepted that science advances at its best in an
open environment where findings are accessible and transparent.'’
However, the open science model might not be universally appropriate
if knowledge is to be misused for malevolent purposes. “The current
challenge posed through the dual use dilemma in life science research
forces policymakers to consider the grey areas between classified and
open source boundaries on sensitive information generated by public
and private labs.”'* The prospects of applying a classification regime
to life science research (similar to the one in atomic science) causes
great concern for many, especially in the United States: “The prospect
of applying government restrictions raises concern at the outset
because there are already concerns that the government is over-
classifying information to the detriment of much _ needed
transparency.”’? “Unlike nuclear science, however, much of biotech
science is in the public domain and relatively inexpensive to pursue,
and therefore guarding against malevolent uses requires a different
approach.”””
A need to secure information should be reconciled with the
need for a balance between secrecy and openness. It is important to
bridge the divide: “In the absence of cooperation between the private
sector and the government, the government may need to utilize both
traditional and novel approaches to reach its national security
obligations in the information society.”*! Although it is sometimes
difficult to comprehend why science and secrecy are incompatible, the
reason lies in the following: “Scientific culture is by nature oriented
toward disclosure. Because the research venture grows by
accumulation of information, it depends on the free availability of
previous work through publication. Security requirements, on the
other hand, often dictate concealment. ... When the two cultures mix.
the contrasts between them are dramatically enhanced, sometimes
creating conflict.”””
GOVERNANCE OF RESEARCH IN THE LIFE SCIENCES 157
Biological research is a global enterprise. Rapid technological
advances have lowered barriers to the dissemination of basic research
capabilities. “Bioscience research not only tends to idealize openness
and collaboration among colleagues but often depends on it.”
Mechanisms for sharing scientific information include: presentations
at conferences or visits to other research institutions; research
collaborations that involve the exchange of materials, ideas, or
analyses; visits of collaborating scientists between laboratories; and
most importantly, publication in peer-reviewed journals, which
constitutes the backbone of contemporary biosciences research. A
2002 Morgan Stanley media report titled Scientific Publishing:
Knowledge is Power estimated that science, technology, and medical
journals constitute a $7-billion global industry.” Collectively,
commercial publishers, university presses, and professional societies
publish about 1.2 million articles a year in about 16,000 periodical
journals.” The sharing of scientific findings, data, and materials
through publication is at the heart of scientific advancement.
One has to take into consideration the question of secrecy
versus scientific freedom. Researchers have been struggling with the
issue of whether to make publicly available or keep protected
scientific information they develop in their laboratories. Starting from
the early 1970s, “fears that recombinant DNA experiments might
transform benign microorganisms into new and insidiously deadly
pathogens began to escalate concomitantly among scientists as well as
policymakers”.*° The bioscience community agreed to assume a
voluntary moratorium on such research, and later, a group of scientists
developed “a system for matching the hypothetical risk of different
classes of experiments to the appropriate containment levels”.”’
The secrecy policy is especially being debated in the United
States. The post-9/11 secrecy policy has placed new restrictions on
foreign students and researchers. Some authors strongly believe that it
is damaging for US scientific enterprise, especially if one takes into
account the fact that more than one-third of United States Nobel
laureates are foreign-born; 38 percent of science and engineering
doctorates in the workforce are foreign-born; and nearly 30 percent of
the scientific and medical professionals at the National Institutes of
Health are foreign nationals.”*
The US federal government classified a record 15.6 million
documents in 2004, according to a report by the non-profit Fund for
Constitutional Government.”’ In general, the regulatory framework for
158 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
biosafety in the United States relies largely on legally voluntary
compliance and local oversight, reinforced with funding and
accreditation pressures.’ Major approaches to knowledge control
include export controls (which represents the traditional approach to
national security) and pre-publication restrictions.’’ In March 2003,
President Bush issued Executive Order 13292, which specified that
categories eligible for classification include “scientific, technological,
or economic matters related to the national security, which includes
defense against transnational terrorism”.
Several meetings and reports sponsored by the United States
National Academies of Science played a role in developing self-
regulation systems. In addition, the National Academies sponsored
two studies that specifically addressed issues central to security and
the biological sciences: 1) Biotechnology Research in an Age of
Terrorism; and 2) Seeking Security: Pathogens, Open Access, and
Genome Databases.’ The first study was analysed in the previous
chapters of this book. The second study focused on genome data, “a
source of raw material that, although not inherently dangerous, can be
enabling for potentially destructive agendas”.”° In its full examination
of genomic research, the National Academies Committee stressed that
the practicality of trying to contain genome data remains doubtful,
even if the risks outweighed the benefits.*°
3. Proposing a New Code of Conduct for Scientists
Biosecurity-related problems are truly complex, which is why: “There
is no technical solution to the problem... It needs an ethical, human,
and moral solution if it’s going to happen at all.”’’ Creating and
maintaining an ethical scientific community with an acute
consciousness of security risks should serve as the first line of defence
against biosecurity concerns. Biosecurity needs to become part of the
culture of ethics. Top-down legislative and regulatory approaches are
never self-executing and should be accompanied by bottom-up codes
of conduct in the scientific community.
A code of conduct refers to “non-legislated guidelines which
one or more organizations and individuals voluntarily agree to abide
by, that set out the standard of conduct or behavior with respect to a
particular activity”, * “a formal statement of values and professional
practices of a group of individuals with a common focus”, or “a
formal set of conventional principles and expectations that are
GOVERNANCE OF RESEARCH IN THE LIFE SCIENCES 159
considered binding on any person who is a member of a particular
group, whether or not membership in that group is voluntary”.*° Codes
are not procedural guidelines; rather, they provide general guidance
for responsible and ethical behaviour. As we can see, ensuring that the
life sciences are standing on solid moral ground will require a
complex, multifaceted, and integrated response from a wide variety of
actors at the “individual, institutional, societal, and global levels. It
will require integrity, honesty, trust, courage, and restraint”.“' We
believe that a globally acceptable code of conduct should be based on
values of humanity (recognition of the equal value of every human
being), humaneness (compassion for the pain and suffering of others),
and empathy (the ability to feel the emotions and experiences of
another person from that person’s point of view). However, those
values coincide with individual and collective self-interest since the
spread of diseases could affect everyone.
Codes can be voluntary, binding, or obligatory. Codes can be
further characterised by their objectives and the level at which the
code is binding: 1) aspirational (codes of ethics) codes are a set of
ideas that practitioners should uphold; 2) educational/advisory (codes
of conduct) codes provide guidelines, raise awareness, and debate; 3)
enforceable (codes of practice) codes prescribe or proscribe certain
acts.** Codes of ethics establish “an organizational basis for future
action by initially affirming the prohibition against the development of
bioweapons”.”’ Codes of conduct provide “elaboration of [the]
individual and collective responsibilities of those associated with ...
life science work; set a basis for a long-term discussion about what
needs to be done, in particular by challenging [the] existing agenda
and framing of issues”.** Codes of practice incorporate biological-
weapons and biosecurity concerns within day-to-day work
procedures.*” Some of the examples of codes of conduct for the life
sciences include the Nuremberg Code“ and the Belmont Report.*’
Why is code of conduct so important? “A code of ethics offers
several benefits. It would underscore the importance of ethics reviews
of proposed scientific research and monitoring of ongoing research,
especially research involving humans or animals as subjects. It can
also establish a basic presumption of scientific openness and
transparency, while allowing for exceptions when there is a real risk
that scientific knowledge could be used to cause serious harm.
Moreover, a code of ethics could help protect ‘whistle blowers’ who
bring ethical breaches to the attention of the relevant authorities or the
160 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
public. Finally, it could allow for conscientious objection to
participation in certain research”.** Because governments do not have
the necessary capacity to oversee all scientists and experiments
throughout the world, some of the benefits of codes of conduct as
underlined by the United States Delegation to the 2005 BWTC
Experts Group Meeting are the following:
1) Codes offer the “greatest opportunity for improving the
security of research at the level of individual scientists” (they
increase understanding of biosecurity, serve as a persistent
reminder of moral and ethical responsibilities, and create a
culture of responsibility and accountability);
2) They “set professional standards that may have legal
implications”.
The third Meeting of Experts from states parties to the
Biological Weapons Convention held in Geneva from 13 to 24 June
2005 and the third Meeting of states parties held in Geneva from 5 to
9 December 2005 actively discussed the topic of the content, adoption,
and dissemination of codes of conduct for scientists.°° “Codes were
considered to be most effective if they, and their underlying
principles, are widely known and understood... States Parties agreed
on the importance of codes being: compatible with national legislation
and regulatory controls and contributing to national implementation
measures; simple, clear and easily understandable both to scientists
and to wider civil society; relevant, helpful and effective for guiding
relevant actors in making decisions and taking action in accordance
with the purpose and objectives of the Convention; sufficiently broad
in scope; and regularly reviewed, evaluated for effectiveness, and
revised as necessary.””|
Taking into account the development of new life sciences and
information technologies, as well as the degree of power generated by
them, the question of responsibility of scientists towards society is
absolutely central. The power of science to result in harm has grown
greatly. The adoption of codes of conduct is essential in order to
ensure that science is not used for malicious purposes. As one
example, “‘synthetic biology’ involves the creation of living material
from its DNA components, so that an interested party can re-engineer
life in the manner of his or her choosing. The technology making this
possible will most likely become common within the next several
GOVERNANCE OF RESEARCH IN THE LIFESCIENCES 161
years at a substantially reduced cost”.* Globally, some of the
principal biological science topics include genetics, human cloning,
and stem-cell research.
Despite the widespread endorsement given to the formulation
of a new code of conduct, there is a lack of generally accepted
agreement. “While the scientific community has engaged in the
process of developing codes of conduct, these efforts remain light-
touch and lack verifiable reliability.’ In the last few years, the
problem of the adoption of a code of conduct has been on the top of
the policy agenda of many institutions. One of the global institutions
that is actively involved in ethical and moral policymaking is
UNESCO. It has also focused on the creation of codes of conduct and
codes of ethics for scientists. Its Bioethics Committee (IBC) produced
the Universal Declaration on Bioethics and Human Rights in October
2005.** The Declaration strives to make an authoritative statement of,
and guide to, global bioethics values. According to UNESCO,
bioethics is “the process of reflection over ethical issues raised in our
relationships with other living organisms; the consideration of the
ethical issues in spheres including environmental ethics, health care
ethics, social ethics, and in the use of technologies that affect life; and
the love of life”? The main ethical commitments included in the
Declaration are as follows:
1) “Commitment to a culture of non-violence and respect for life;
2) “Commitment to a culture of solidarity and a just economic
order;
3) “Commitment to a culture of tolerance and a life of
truthfulness; and
4) “Commitment to a culture of equal rights and a partnership
between men and women, and between all peoples and
groups.””°
The positive side of bioethics “lies in it its ability to normalise
the trading of values between conflicting cultural positions so that an
ethical solution is produced that can then be translated into legitimate
regulatory policy. Its claim is to neutrality, impartiality and the
application of rational principles that reduce different value positions
to a common bioethical currency.””’
Another institution actively working on codes of conduct is
the US National Science Advisory Board for Biosecurity. It has a
162 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
working group to develop a code of conduct with a goal of fostering
“a culture of responsibility among life scientists who are potentially
conducting dual-use research”.* Some of the most important ethical
principles focus on: “awareness about dual-use research; forethought
in research planning and conduct; consideration for the safety and
security of others; training and educating students and technicians;
compliance with applicable guidelines and rules; responsible
communication practices”.””
4. The International Council for the Life Sciences
One of the most active non-governmental organisations focusing on
the ethical implications of biological research is the International
Council for Life Sciences (ICLS). It was launched in April 2005 to
identify and manage biological risks while providing “a much-needed
forum to engage organizations and individuals from the governmental,
academic and private industry sectors of the international life-sciences
community”. The ICLS was created by two independent research
groups: the former Chemical and Biological Arms Control Institute
and the International Institute for Strategic Studies in the US, with the
support of the Nuclear Threat Initiative.°’
The mission of the Council is “to help ensure global public
health, safety, and security by safeguarding the opportunities offered
by advances in the life sciences and their application through the
promotion of best practices, standards, and codes of conduct”.®’ The
main goals of the Council are to: “contribute to improved quality of
life and enhanced public safety and security”; “[p]romote engagement
of the life-science community worldwide on issues of public safety
and security”; “[flacilitate effective partnerships between the various
elements of the life sciences community, including private, industry
academia and government”; and “[s]erve as an authoritative source of
objective consideration and analysis of global biological risks in
relation to advances in the life sciences and their application”.®’ By
subscribing to its Charter, members agree to:
e “International and National Laws and Regulations Observe,
promote and cooperate to help develop effective national and
international laws, regulations, and policies in relation to the
life sciences in support of the mission of the Council.
GOVERNANCE OF RESEARCH IN THE LIFE SCIENCES 163
e “Personnel Exercise the highest standards in the recruitment,
training and management of personnel during and after
employment, with special attention on those individuals with
access to information, materials and technology that could
have significant adverse effects on public health, safety and
security if misused or not employed safely and appropriately.
Members of the Council will be expected to have a code of
conduct for their staff to promote the objectives of the
Charter.
e “Information Ensure the security of information by observing
relevant international and national laws and regulations in
handling information, which could have a significant negative
impact on public health, safety and security; and also to
contribute to developing, in cooperation with governments,
effective and responsible procedures for the release of such
information into the public domain.
e “Safe and Secure Operation of Facilities Observe the highest
possible standards for the safe and secure operation of all
facilities, including materials in transit, in the interest of
public health and environmental safety; and to contribute to
the development of more effective international and national
laws, regulations, guidelines, policies and standards in this
regard.
e “Governance of Research and Development Activities Take
full account of public health, safety and _ security
considerations when planning and conducting research and
development activities and to support and contribute to
effective and responsible international and national entities
engaged in developing and promoting codes of conduct in this
regard.
e “Risk Evaluation and Mitigation Facilitate the development
of measures to evaluate and mitigate the risks arising from the
misuse of the life sciences and cooperate to support an
international response in cases of major natural biological
outbreaks [bold and italics in original].”™
The ICLS “serves as a global forum for facilitating
partnerships among all sectors of the life sciences community to
address and manage the full spectrum of biological risks”. Currently,
in addition to fostering its relationship in Russia, Central Asia,
164 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Western Europe and North America, the ICLS has been focusing on
building its network in South Asia, Southeast Asia, the Pacific, the
Middle East, the Persian Gulf region, and North Africa.
In November 2006, the ICLS, in partnership with the I.M.
Sechenov Moscow Medical Academy, the Centre of Modern Medical
Technology (NP TEMPO), and the Global Partnership Program of
Foreign Affairs Canada, established the International Advisory Group
on Biosafety and Biosecurity (IAG). This standing group “was
developed to provide sustained engagement on biosafety and
biosecurity in Russia and Central Asia”.®’ It consists of 18
international and 18 Russian experts. Its first meeting took place in
Heidelberg, Germany, on 30-31 March 2007 and the second one was
organised in Moscow on 17-19 October 2007. Therefore, the main
objective of the International Council for the Life Sciences has been to
sensitise government leaders, as well as the scientific and the business
communities, about biological risks through outreach conferences and
training programmes.
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' United Nations Educational, Scientific and Cultural Organization, “Message from
the Director-General of UNESCO on the occasion of World Science Day for Peace
and Development”, 10 November 2003, http://www.unesco.org/science/index_wsd.sh
tml.
* National Research Council of the National Academies, Biotechnology Research in
an Age of Terrorism (Washington, DC: The National Academies Press, 2003), p. 1,
http://books.nap.edu/openbook. php?record id=10827&page=1.
Ibid.
‘ Tbid., p. 2, http://books.nap.edu/openbook.php?record_id=10827&page=2.
> Tbid., p. 19, http://books.nap.edu/openbook.php?record_id=10827&page=19.
° C. McLeish and P. Nightingale, “Biosecurity and the Governance of Science” (this
paper has been submitted and is under review for forthcoming publication in Research
Policy), p. 12, http://www.sussex.ac.uk/Units/spru/events/ocs/viewpaper.php?id=217.
’ National Research Council of the National Academies, op. cit., note 2, p. 18,
http://books.nap.edu/openbook.php?record_id=10827&page=18.
® McLeish and Nightingale, op. cit., note 6, p. 2.
° National Research Council of the National Academies, op. cit., note 2, p. 2.
http://books.nap.edu/openbook.php?record_id=10827&page=2.
'° G. Kwik, J. Fitzgerald, T.V. Inglesby, and T. O’Toole, “Biosecurity: Responsible
Stewardship of Bioscience in an Age of Catastrophic Terrorism”, Biosecurity and
GOVERNANCE OF RESEARCH IN THE LIFE SCIENCES 165
Bioterrorism: Biodefence Strategy, Practice, and Science, Vol. 1, No. 1, 2003, pp. 32-
34, http://www.liebertonline.com/doi/pdf/10.1089/153871303605 14805.
'' “Towards better biosecurity”, Nature, Vol. 440, No. 7085, 6 April 2006, p. 715,
hitps/fwww nature. com/nature/ journal/vy440/n7085/full/440715a.html.
Ibid.
'? World Health Organization, “Scientific Working Group on Life Science Research
and Global Health Security, Report of the First Meeting”, WHO/CDS/EPR/2007.4,
Geneva, 16-18 October 2006, p. 10, http://www.who.int/csr/resources/publications/del
iberate/(WHO CDS EPR 2007 4n.pdf.
Miss Taylor, “Safeguarding Advances in the Life Sciences”, EMBO reports, Vol. 7,
No. S1, 2006, p. S63, http://www.iclscharter.org/images/Safeguarding advances in
the life _sciences.pdf.
'S World Health Organization, op. cit., note 13, p. 8.
'© Organisation for Economic Co-operation and Development, Workshop on
“Biosecurity of Microbial Biological Resources — Complementing Innovation”,
Chairman’s Summary, Moscow, 20-21 September 2006, p. 7, http://www.oecd.org/dat
aoecd/24/14/37819508.pdf.
'7 B.J. Gorman, “Biosecurity and Secrecy Policy: Problems, Theory, and a Call for
Executive Action”, I/S: A Journal of Law and Policy, Vol. 2, No. 1, 2006, p. 58,
http://is-journal.org/V02101/2ISJLP0S3.
'8 Tbid.
"? Ibid., p. 59.
2 “Bioethics report urges G8 to be aware of bio-tech terrorist threats”, Civil G8, 2006,
http://en.civilg8.ru/ 756.php.
71 Gorman, op. cit., note 17, p. 98.
22 D. Kennedy, “Science and Secrecy”, Science Magazine, Vol. 289, No. 724, 4
August 2000, http://www.sciencemag.org/cgi/gca? gca=289%2F5480%2F724&sendit.
x=31 &sendit.y=8.
J.E. Fischer, Stewardship or Censorship? Balancing Biosecurity, The Public’s
Health, and The Benefits of Scientific Openness (Washington, DC: The Henry L.
Stimson Center, 2006), p. 6, http://www.stimson.org/globalhealth/pdf/Stewardship.pd
f.
4 Morgan Stanley, “Scientific Publishing: Knowledge is Power”, 30 September 2002,
p. 2, 2, http//www,econ.ucsb.edu/~tedb/Joumnals/morganstanley.pdf-
> “Scientific publishing: Access all areas”, The Economist, 5 August 2004,
http://www. iata.csic.es/~bibrem/hist T S/displa html.
26 Fischer, op. cit., note 23, p. 12.
27 Tbid., pp. 12-13.
8 R. Bailey, “Science, Not Secrecy: Impeding research doesn’t enhance homeland
security”, Reason Online, 22 June 2005, -//www.reason.c ews/show/34
ml.
9 A. Lipowitz, “Classified documents on the rise”, WashingtonTechnology, 7 April
2005, http://www.washingtontechnology.com/online/1_1/25966-1.html.
3° Pischer, op. cit., note 23, p. 13.
3! Tbid., p. 51.
32 The White House, Office of the Press Secretary, Executive Order 13292, 25 March
2003, http://www.fas.org/sgp/bush/eoamend.html.
166 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
33 National Research Council of the National Academies, op. cit., note 2, http://www.
nap.edu/catalog/10827.html.
4 National Research Council of the National Academies, Seeking Security:
Pathogens, Open Access, and Genome Databases (Washington, DC: The National
Academies Press, 2004), http://books.nap.edu/catalog.php?record_id=1 1087.
® Ibid., p. 2.
°° Ibid.
57 M. Nass, “Will anthrax vaccine help prevent biological warfare?”, Defense Systems
International, Autumn 1998, pp. 35-39, http://www.anthraxvaccine.org/CV/Defense
Systems _International.html.
8 World Health Organization, “Biorisk Management: Laboratory Biosecurity
Guidance”, WHO/CDS/EPR/2006.6, September 2006, p. iv, http://www.who.int/csr/r
esources/publications/biosafety/ WHO CDS _EPR_ 2006 _6.pdf.
*° T. Holohan, “Codes of Conduct for the Life Sciences: Past, Present, and Future”,
BWC Experts Group Meeting, June 2005, http://www.state.gov/documents/organizati
on/50055.pdf.
*° Organisation for Economic Co-operation and Development, International Futures
Programme, “What are Codes?”, http://www.biosecuritycodes.org/codes.htm.
‘' M. Somerville, “Epilogue: The Troublesome Ethics of “Biosecurity”, McGill News,
Fall 2005, http://www.mcgill.ca/news/2005/fall/epilogue/.
“ B. Rappert, “Biological weapons and the life sciences: the potential for professional
codes”, Disarmament Forum: Science, Technology, and the CBW Regimes, United
Nations Institute for Disarmament Research, 2005, p. 55, http://www.unidir.org/pdf/ar
ticles/pdf-art2218.pdf.
3 Ibid.
* Ibid.
* Ibid.
*° National Institutes of Health, The Nuremberg Code, reprinted from Trials of War
Criminals before the Nuremberg Military Tribunals under Control Council Law No.
10 (Washington, DC: Government Printing Office, 1949), Vol. 2, pp. 181-182,
http://ohsr.od.nih.gov/guidelines/nuremberg.html.
“” The National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research, “The Belmont Report: Ethical Principles and Guidelines for the
protection of human subjects of research”, 18 April 1979, http://ohsr.od.nih.gov/guide
lines/belmont. html.
“8 Somerville, op. cit., note 41.
° Holohan, op. cit., note 39.
°° United Nations Department for Disarmament Affairs, “The Biological Weapons
Convention: Background Information”, p. 4, http://www.unog.ch/80256EDD006B895
4/(httpAssets)/699B3CA8C061D490C 1257188003B9FEE/$file/B WC-Background _]
nf.pdf.
*! Thid., p. 5.
* Somerville, op. cit., note 41.
8 Organisation for Economic Co-operation and Development, op. cit., note 16, p. 3.
4 United Nations Educational, Scientific and Cultural Organization, Universal
Declaration on Ethics and Human Rights, http://portal.unesco.org/en/ey.php-
URL_ID=31058&URL_DO=DO_TOPIC&URL_SECTION=201.html.
GOVERNANCE OF RESEARCH IN THE LIFE SCIENCES 167
*’ United Nations Educational, Scientific and Cultural Organization, International
Bioethics Committee, “Towards a Declaration on Universal Norms on Bioethics,
Extraordinary Session of IBC”, SHS/EST/04/CIB-EXTR/INF 1, Paris, 27-29 April
2004, pp. 12-13, http://unesdoc.unesco.org/images/0013/001344/134423m.pdf.
*© Ibid., p. 194.
*’ B. Salter and C. Salter, “Bioethics and the Global Moral Economy”, Global
Biopolitics Research Group, Working Paper No. 3, October 2005, p. 17, http://www.i
oh.uea.ac.uk/biopolitics/workingpapers_pdf/wp3.pdf.
*8 National Science Advisory Board for Biosecurity, “Codes of Conduct Working
Group Progress Report”, 30 March 2006, http://www. biosecurityboard.gov/meetings/
2005 11/NSABB-Codes%200f%20Conduct™%20Progress%20Report.pdf.
? Ibid.
© Taylor, op. cit., note 14. p. S63.
°! See the section “History of the ICLS” on the website of the International Council
for Life Sciences, http://www.iclscharter.org/history html.
” Taylor, op. cit., note 14, p. S62.
63 .
Ibid.
* International Council for the Life Sciences, “The Charter”, Deecmpber 2005,
http://www.iclscharter.org/im HARTER _12Au 5.
® International Council for the Life Sciences, “ICLS Global Network”, ICLS NE WS,
Vol. 1, No. 1, Autumn 2007, p. 2, http://www.iclscharter.org/images/ICLS News Fal
| 07.pdf.
I
nternational Council for the Life Sciences, “First Meeting of the International
Advisory Group, 30-31 March 2007, Heidelberg, Germany”, CLS NEWS, Vol. 1, No.
L Autumn 2007, p. 2, http://www. iclscharter.org/images/ICLS_ News Fall 07.pdf.
CHAPTER 8
HARMONISATION OF EXISTING BIOSECURITY
STANDARDS AND REGULATIONS
1. General Overview
The global harmonisation of biosecurity standards should be seen as a
process. Most national and international legislation to date has focused
on biosafety and not biosecurity. Recently, a few international
organisations have launched initiatives in the biosecurity field;
however, they remain uncoordinated and incomplete. No uniform
global biosecurity standards currently exist on which individual states
can base national legislation and regulatory structures. In order to
develop such standards, governments, the international scientific
community, industry, the security community, academia, and non-
profit organisations should work closely together to develop
comprehensive approaches to biosecurity. We have to keep in mind,
though, that model legislation can be problematic because some
countries may have incompatible legal systems. “National legislation
and regulations concerning biological security are important but their
impact is limited because of no international harmonization.”' Such a
lack of global harmonisation “has given rise to serious gaps and
vulnerabilities that must be addressed as part of a coordinated global
strategy ... . To ensure a degree of uniformity and accountability in
national implementation of ... voluntary standards, ... an international
oversight mechanism [should] be created. This mechanism, which
might be coordinated by a small secretariat, would invite the
participating states to submit written reports on implementation of
biosecurity standards”.
Developing national and international biosecurity-related
norms is complicated by the fact that pathogenic micro-organisms are
naturally occurring. They are difficult to detect, have global reach, and
replicate. The problem of invasive/alien species must be addressed at
all levels. “Their potential impacts cover a broad range of sectoral and
170 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
social factors from the environmental (provoking species extinctions
and consequent ecosystemic damage) to commercial (bringing about
the destruction of local commercial systems based on agricultural or
natural products) to social (altering human-ecosystem relationships
and dependencies).”” Legislation tackling the problem of pathogenic
micro-organisms and invasive species includes:
1) The Convention on Biological Diversity;’
2) The International Plant Protection Convention (IPPC);°
3) The Ramsar Convention on the Conservation of Waterlands;°
4) The African-Eurasian Waterbirds Agreement (AEWA);’
5) The Convention on International Trade in Endangered Species
of Fauna and Flora (CITES));*
6) The Global Strategy for Plant Conservation;”
7) The International Maritime Organization’s Convention for the
Control and Management of Ships’ Ballast Water and
Sediments."°
2. Harmonising National Legislation
At the national level, so far just France, the United Kingdom, and the
United States have developed national legislation that specifically
addresses issues related to biosecurity. At the regional level, the EU
has a regulatory framework that covers all aspects of the utilisation of
biological materials, as well as certain aspects of transboundary
movements. Within the EU regulatory framework, “there are on the
one hand regulations that apply to all countries of the EU and on the
other hand directives that need to be transcribed by Member States
(MS) into national legislation creating differences among the MS”."'
The European Union regulatory framework includes regulations and
directives addressing the following areas related to biosafety and
biosecurity:
1) Genetically Modified Organisms: Directive 90/219/EEC and
Directive 98/81/EC on the coordinated use of
microorganisms; Directive 2001/18/EC on the deliberate
release into the environment of genetically modified
organisms; Regulation (EC) 1829/2003 on_ genetically
modified food and feed.
HARMONISATION OF EXISTING BIOSECURITY STANDARDS AND REGULATIONS 171
2) Worker protection (related to the use of human and animal
pathogens): Directive 89/391/EEC on the introduction of
measures to encourage improvements in the safety and health
of workers at work and Directive 2000/54/EC on _ the
protection of workers from risks related to exposure to
biological agents at work.
3) Plant pathogens and protection of the environment: Council
Directive 2000/29/EC and Directive 95/44/EC.
4) Dual use: Council Regulation (EC) No. 1334/2000 setting up
a Community regime for the control of exports of dual-use
items and technology; Council Regulation (EC) No.
1504/2004 amending and updating Council Regulation (EC)
No. 1334/2000.
5) Environmental liability: Directive 2004/35/EC_ on
environmental liability with regard to the prevention and
remedying of environmental damage.
6) Transboundary movement of GMOs: Regulation (EC) No.
1946/2003 on transboundary movements of genetically
modified organisms. '”
Unfortunately, there is “no policy coherence in_ bio-
preparedness in general across Europe, whether the issue is one of
vaccine production, security at bio- and virological laboratories or
national immunization policies”.'’ This is why the European
Commission adopted its Green Paper mentioned in Chapter 5.
The United States’ legal biosecurity framework is founded on
mainly disconnected or weakly connected government and private
initiatives.'* The principal US laws in the field of biological safety and
security include:
1) The Biological Weapons Anti-Terrorist Act (BWAT) signed
into law on 22 May 1990. The BWAT implements the
Biological Weapons Convention and protects the United
States from biological terrorism by prohibiting certain conduct
pertaining to biological weapons, including “knowingly
developing, producing, stockpiling, transferring, acquiring,
retaining, or possessing any biological agent, toxin, or
delivery system for use as a weapon, or knowingly assisting a
foreign state or any organization”."°
172 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
2) The USA Patriot Act, signed into law on 26 October 2001.
The Act “deters and punishes terrorist acts in the United
States and around the world [and] enhances law enforcement
investigatory tools”.'° It also “prescribes penalties for
knowing possession in certain circumstances of biological
agents, toxins, or delivery systems, especially by certain
restricted persons”’’ according to the Congressional Research
Service Summary.
3) The Public Health Security and Bioterrorism Preparedness
and Response Act, signed on 12 June 2002. It “improves the
ability of the United States to prevent, prepare for, and
respond to bioterrorism and other public health
emergencies”. '® It authorises funds to evaluate preparedness
for public health emergencies.
4) The Smallpox Emergency Personnel Protection Act, signed
into law on 30 April 2003. It “provides benefits and other
compensation for certain individuals with injuries resulting
from administration of smallpox countermeasures”. ”
5) The Project BioShield Act, signed into law on 21 July 2004. It
“amends the Public Health Service Act to provide protections
and countermeasures against chemical, radiological, or
nuclear agents that may be used in a terrorist attack against the
United States by giving the National Institutes of Health
contracting flexibility, infrastructure improvements, and
expediting the scientific peer review process, and streamlining
the Food and Drug Administration approval process of
countermeasures”.~”
The USA Patriot Act of 20017’ and the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002” “establish
the statutory and regulatory basis for protecting biological materials
from inadvertent misuse. Once fully implemented, the mandated
registration for possession of certain pathogens (the ‘select agents’),
designation of restricted individuals who may not possess select
agents, and a regulatory system for the physical security of the most
dangerous pathogens within the United States will provide useful
accounting of domestic laboratories engaged in legitimate research
and some reduction in the risk of pathogens acquired from designated
facilities falling into the hands of terrorists.” From the US
standpoint, it is important to ensure that implementation of existing
HARMONISATION OF EXISTING BIOSECURITY STANDARDS AND REGULATIONS — 173
US legislation “must not be overly restrictive given the critical role
that the development of effective vaccines, diagnostics, therapeutics,
and detection systems, along with a responsive public health system,
will play in providing protection against bioterrorism — and other
serious health threats”.
2)
o> 24
As of September 2007, pending US legislation includes:
The Pandemic and All-Hazards Preparedness Act;
The Biodefense and Pandemic Vaccine and Drug
Development Act of 2006;
The Project BioShield Material Threats Act;
The Responsible Public Readiness and Emergency
Preparedness Act;
The Biodefense and Pandemic Vaccine and Drug
Development Act of 2005;
The National Biodefense and Pandemic Preparedness Act;
The Project BioShield II Act;
The Homeland Security Food and Agriculture Act; and
The Protecting America in the War on Terror Act.”°
US Executive Orders and Directives are as follows:
United States Policy on Chemical Warfare Program and
Bacteriological/Biological Research, Executive Order (from
the National Security Council), signed on 25 November 1969.
Through this Executive Order, the Chemical and
Bacteriological/Biological Warfare Program was split into
two entities, the Chemical Warfare Program and _ the
Biological Research Program. The objective of the Chemical
Warfare Program was to deter other nations from using their
chemical weapons. Regarding the Biological Research
Program, the US renounced the use of biological weapons,
lethal and otherwise, and focused its research on defensive
purposes.”°
United States Policy on Toxins, Executive Order (from the
National Security Council), signed 20 February 1970. In this
Executive Order, the US renounced the offensive production,
stockpiling, and use of chemical and biological toxins and
confined military research in toxins to defensive purposes. ,
174. GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
3) National Policy on the Transfer of Scientific, Technical, and
4)
5)
Engineering Information, Presidential Directive, 21
September 1985. This “establishes national policy for
controlling the flow of science, technology, and engineering
information produced in federally funded fundamental
research at colleges, universities, and laboratories”.~* This
policy indicates that products of research are usually not
restricted. If national security requires control of such
research, then it will be controlled through classification.
Defense of United States Agriculture and Food, Presidential
Directive, 30 January 2004. This establishes “a national policy
to defend the agriculture and food system against terrorist
attacks, major disasters, and other emergencies”. Fulfilling the
national policy requires recognition of important agriculture
and food infrastructure and ensuring their protection;
development of mechanisms that provide early warning to
threats; reduction of weaknesses during production and
processing; enhancement of product screening procedures;
and response and recovery.”
Biodefense for the 21 Century, Presidential Directive, signed
on 28 April 2004: by evaluating biodefence programmes and
initiatives, this Directive identifies future priorities and
integrates the work of national and homeland security,
medical, public health, intelligence, diplomatic, and law
enforcement communities. The classified version contains
specific directions on how departments and agencies are to
implement this biodefence programme.”
It is important to mention here that the European Union and
the United States have divergent biological-security priorities, as
reflected in their biosecurity standards and regulations: “While
Washington is pushing ahead with high levels of government
spending and close public-private coordination to protect the US
population against bio-attacks, policy in the EU still lacks focus and is
splintered into separate national policies, despite universal concern
among EU and national experts that their continent is highly
vulnerable to attack.””!
HARMONISATION OF EXISTING BIOSECURITY STANDARDS AND REGULATIONS — 175
3. Life Sciences/Biotechnology-related Legislation
The increasingly rapid advance of science “owes much to a research
culture in which knowledge and biological materials are shared among
scientists and people move freely between universities, government
agencies, and private industry”.* In this context, the national and
global legislation covering the biosecurity aspects of the life sciences
and biotechnology-related research is essential. The life sciences and
biotechnology are multidimensional, so their governance requires the
participation of various institutions.’ As we have already seen in
Chapter 5, international intergovernmental organisations involved in
establishing regulations and developing strategic frameworks in the
realm of biotechnology include:
1) The Food and Agriculture Organization and the International
Fund for Agriculture Development (IFAD), the body
responsible for governing biotechnology applications in food
and agriculture, including fisheries and forestry all over the
world. It looks into technical, legal, and other normative sides
of biotechnology.
2) The World Trade Organization governs trade aspects of food
and agriculture commodities. It is one of the most critical
players in the global trade of genetically modified food, which
has been one of the most controversial trade issues at the
global level.
3) The medical side of biotechnology falls within the scope of
responsibilities of the World Health Organization. One of the
six core tasks of the WHO’s secretariat is to stimulate the
development and testing of new technologies. The WHO
established the Human Genetics Project (HGP).
4) The environmental aspects of biotechnology are covered by
the United Nations Environment Programme. The UNEP’s
instruments include: the Convention on Biological Diversity
and the Cartagena Protocol on Biosafety (adopted on 29
January 2000).
5) The United Nations Industrial Development Organization is in
charge of the issues of biotechnology related to industry.
6) UNESCO is an organization that globally promotes
biotechnology through education.
176 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
At present, several organisations are addressing the problem
of dual-use technologies. The WHO has published biosecurity
guidelines. Interpol has been working on the issue as well. As
mentioned earlier, the United Nations Secretary-General also
addressed this concern in a report on bioterrorism preparedness. The
main active national institution is the United States National Science
Advisory Board for Biosecurity (NSABB),* which was created “to
provide advice to federal departments and agencies on ways to
minimize the possibility that knowledge and technologies emanating
from vitally important biological research will be misused to threaten
public health or national security”. The NSABB assesses the
national-security implications of dual-use research in the life sciences
and develops additional guidelines for the institutional biosafety
committees that currently oversee recombinant-DNA research.*° The
NSABB’s recommendations are advisory and not binding on US
government agencies, which reflects major limitations that constrain
its ability to find a balance between the issues of security and
scientific progress.°’ “Unlike physicists during the Cold War,
however, biologists lack much awareness of the dual-use implications
of their work, so it is an open question whether voluntary oversight
mechanisms will be sufficient to safeguard national security.”**
With the globalisation of cutting-edge research in the life
sciences, such countries as China, Cuba, India, Malaysia, Singapore,
South Africa, and South Korea, as well as others, aspire to follow the
lead of the United States and the European Union. This poses a
problem of an uneven mix of national regulations and “leaves major
gaps in biosecurity”.°” One of the international legal mechanisms
trying to address this issue is UN Security Council Resolution 1540 of
28 April 2004.*° “The potential of this measure might remain
untapped”, until the leading countries “agree on a set of specific
biosecurity measures required under Resolution 1540 and offer
realistic incentives and inducements for all countries to fulfil their
obligations”.*' In this respect, one of the necessary measures would be
to require member states to enact national implementing legislation.
One way in which states have tried to overcome the dilemma
of dual use has been “through supply side technology controls such as
export controls”.** One of the examples of such international export
control regimes is the Australia Group (see Chapter 5), “an informal
arrangement which aims to allow exporting or transshipping countries
to minimise the risk of assisting chemical and biological weapon
HARMONISATION OF EXISTING BIOSECURITY STANDARDS AND REGULATIONS — 177
(CBW) proliferation’*’ that is composed of a committee of 40
countries and the European Commission. Through a non-legally
binding agreement, members limit the export of materials and
technologies relevant to the production of chemical and biological
weapons to proliferant countries. However, “given the dual-use nature
of the materials controlled under this agreement and the global
expansion of the biotechnology and pharmaceutical sectors, scholars
strongly doubt the effectiveness of export controls over the long
term”.“* In addition to scholars, some other actors doubt the long-term
effectiveness of the Australia Group and other similar arrangements.
In particular, there can be an alternative supplier cartel of states
outside of the Australia Group. As was noted earlier, a number of
developing countries are making great strides in biology and
biotechnology. Their interests sometimes run counter to those of
Western countries, which could also be a cause of concern.
There have been recent attempts to find solutions that go
beyond traditional policy options and offer more dynamic solutions to
the problem of dual use and proliferation. One such initiative is the
Proliferation Security Initiative (PSI) launched in 2004. Its main
objective is “to stop shipments of weapons of mass destruction
(WMD), their delivery systems, and related materials worldwide”.”
Another measure previously mentioned, UN Security Council
Resolution 1540 adopted in 2004, requires all member states to
“refrain from providing any form of support to non-state actors that
attempt to develop, acquire, manufacture, possess, transport, transfer
or use nuclear, chemical or biological weapons and their means of
delivery”.*° This Resolution addresses non-state threats, including the
transfer of dual-use technologies, by requesting states to adopt and
enforce necessary national laws. However, there is a problem of
“harmonising various provisions regarding the definition of crimes,
the rights of the accused, judicial assistance etc., purely national
criminal statutes do not convey the universal condemnation implicit in
international criminal law”.*
4. Biosecurity-related Legislation in International Law
Legislation and regulations related to biosecurity can be found in
international law. Some of the important international regulations in
the field of biosafety and biosecurity include:
178 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
I)
2)
The Cartagena Protocol on Biosafety of the Convention on
Biological Diversity, which represents the first (and only)
global agreement on genetically modified organisms.” * The
Protocol’s diplomatic origins can be traced to the 1992
Summit of the UN Conference on Environment and
Development. The Conference adopted the Convention on
Biological Diversity (CBD), whose main objective is the
sustainable use of biological diversity. It also “sets principles
for the fair and equitable sharing of the benefits arising from
the use of genetic resources, notably those destined for
commercial use”.“” The Convention operates under the UNEP.
As of today, it is probably the most all-encompassing
international agreement that has ever been adopted. A
Subsidiary Body on Scientific, Technical and Technological
Advice (SBSTTA), together with the CBD Conference on the
Parties, also addresses topics of relevance to the Biological
Weapons Convention, such as biological control and alien
invasive species.’ The Protocol includes as one of its
objectives protection from the possible impact of LMOs on
human health. It was negotiated to address the potential risks
posed by cross-border trade and accidental releases of living
modified organisms.’ The Conference of the Parties to the
Convention on Biological Diversity adopted the Cartagena
Protocol on Biosafety as a supplementary agreement to the
Convention on 29 January 2000. The Protocol seeks to protect
biological diversity from the potential risks posed by LMOs
resulting from modern biotechnology. “The aim is to ensure
that recipient countries have both the opportunity and the
capacity to assess risks involving the products of modern
biotechnology.”*”
The United Nations Economic Commission for Europe
(UNECE) Convention on Access to Information, Public
Participation in Decision-making and Access to Justice in
Environmental Matters, usually known as the Aarhus
Convention,’ was signed on 25 June 1998 in the Danish city
of Aarhus. The main objective of the Convention is to grant
the rights concerning access to information and public
participation in governmental decision-making processes on
subjects related to the local, national, and transboundary
environment.’ As of May 2007, 18 communications from the
HARMONISATION OF EXISTING BIOSECURITY STANDARDS AND REGULATIONS 179
public -— many originating from non-governmental
organisations "— had been lodged with the Convention’s
Compliance Committee.”
3) The UN Model Regulations on the Transport of Dangerous
Goods “have been developed by the United Nations Economic
and Social Council’s Committee of Experts on the Transport
of Dangerous Goods in the light of technical progress, the
advent of new substances and materials, the exigencies of
modern transport systems and, above all, the requirement to
ensure the safety of people, property and the environment”.”°
Most regional and national regulatory schemes for hazardous
materials are harmonised to a greater or lesser degree with the
UN Model Regulations.
4) International laboratory biosecurity guidelines and manuals:
the WHO’s Laboratory Biosafety Manual’ and “Biorisk
management: Laboratory biosecurity guidance”.°* They strive
to develop “an internationally harmonized regime for control
of pathogens within and between laboratories and facilities”.*’
5. Strengthening the Biological and Toxin Weapons Convention
As stated before, the Biological and Toxin Weapons Convention is the
most important legal instrument in the field of global biological
security. Unfortunately, as we have seen, one of the major weaknesses
of the BWC is that it does not contain adequate measures or formal
mechanisms for verifying that the states parties are complying with its
prohibitions.’ Efforts over the past two decades to establish such a
verification system have been largely unsuccessful. States parties have
agreed to a number of politically binding confidence-building
measures (CBMs) to bolster the treaty, such as filing annual reports on
biodefence activities and unusual outbreaks of disease, but only a
limited number of countries have complied.°' In legal terms,
confidence-building measures refer to “a mechanism whereby parties
to the Biological and Toxin Weapons Convention (BWC) voluntarily
exchange data each year on several topics relevant to the treaty,
including high-containment laboratories, biodefense programmes, and
unusual outbreaks of disease”.°’ There have been a record number of
CBM returns in both in 2006 and 2007, indicating that the CBMs are
gaining in relevance.
180 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
At the global level, it is imperative for states to strengthen the
Biological Weapons Convention. Although the provisions of the
Convention bind only its states parties, it is a very important tool for
controlling the global spread and deployment of biological weapons.
On 25 July 2001, the US administration announced its withdrawal of
support of a protocol to the BWC that “would have included legally
binding provisions that specified measures to investigate alleged
violations of the treaty and unusual outbreaks of disease, and to
institute transparency of certain microbiology and biotechnology
activities”.°’ US administration officials claimed that “the proposed
inspection system would not be effective at detecting treaty violations
and posed an unacceptable risk of compromising sensitive biodefence
information and commercial trade secrets belonging to the
pharmaceutical and biotechnology industries”.
As an alternative to a multilateral agreement to strengthen the
BWC, the United States suggested that states parties pass national
legislation that “would punish treaty violators and help to prevent
bioterrorism”.” In November 2002, “the Fifth Review Conference of
the BWC adopted a work programme consisting of three annual
meetings of expert groups and states-parties in 2003-2005. The aim of
these meetings is ‘to promote common understanding and effective
measures’ on five measures that could be taken at the national level to
strengthen the BWC: penal legislation, pathogen security regulations,
enhanced international procedures to investigate and mitigate the
alleged use of biological weapons, improved mechanisms for global
infectious disease surveillance and response, and scientific codes of
conduct”.
With the aim of strengthening the Biological Weapons
Convention, the policy-making community needs to: “Actively pursue
universalization. Develop mechanisms for continually assessing,
updating and harmonizing implementation ... . Develop mechanisms
for involving multiple actors in the BWC process, and for integrating
and coordinating their activities. Begin to tackle the most significant
but difficult challenges (compliance, transparency, biodefence and
other dual-use research, and economic development) ... ”.°’
Some of the above-mentioned priorities were tackled at the
last Meeting of Experts from States Parties to the Biological Weapons
Convention, which was held in Geneva from 20 to 24 August 2007.
The Meeting discussed such topics as “[w]ays and means to enhance
national implementation, including enforcement of national
HARMONISATION OF EXISTING BIOSECURITY STANDARDS AND REGULATIONS 181
legislation, strengthening of national institutions and coordination
among national law enforcement institutions; and [rjegional and
subregional cooperation on implementation of the Convention”. In
addition, it covered in depth such issues as: 1) the scope and diversity
of relevant measures; 2) methods for managing national
implementation; 3) mechanisms to enforce national implementation
measures; 4) international and regional cooperation and assistance;
and 5) transfer and export/import control regimes.”
Given the failure of the Fifth BWC Review Conference in
2001 to reach consensus on a final declaration, the public’s
expectations for the Sixth Review Conference in 2006 were rather
pessimistic. The outcome, though, had positive aspects. As was
expected by many observers, the Conference did not consider a
verification protocol. The mandate of the Ad Hoc Group was not
renewed. One important accomplishment was to conduct a full review
of the articles of the BWC for the first time in ten years. Such a review
was not completed at the 2001 Review Conference because of the
deadlock over the mandate of the Ad Hoc Group.” Taking into
account the dramatic advances in the life sciences over the past
decade, many of which have implications for the biological-weapons
threat, the comprehensive review of the treaty was quite important.
With respect to new measures to strengthen the BWC, the Final
Declaration includes a mandate for a new series of annual meetings of
states parties prior to the next conference in 2011, and the creation of
a small Implementation Support Unit (ISU).’' As a follow-up to the
Sixth Review Conference’s recommendation, the ISU became
operational on 26 June 2007.”” The ISU’s mandate incorporates the
activities of the BWC meeting secretariat that operated from 2003 to
2005, but it differs in “having a clearer role and mandate, extended
responsibilities for universalisation activities and liaison with other
organisations, and formal responsibility for the confidence-building
measures”.’”? The ISU may assist with some of the problems in this
regard, but it has a rather limited mandate.
Therefore, the new intersessional work programme for 2007-
2010 adopted by the Sixth Review Conference will primarily focus on
biosecurity and national implementation of the BWC. The following
topics will be discussed at the four planned intersessional meetings
before 2011: 1) enhancing national implementation; 2) measures to
improve biosecurity, including the security of laboratories; 3)
scientific codes of conduct; 4) peaceful scientific cooperation,
182 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
including disease surveillance; and 5) assistance to any country that is
the victim of biological weapons.’ More precisely, the first two sets
of annual meetings, in 2007 and 2008, will address domestic
implementing legislation and enforcement, regional and subregional
cooperation in implementation, pathogen security measures, education
of scientists, oversight of dual-use scientific research, and professional
codes of conduct.” In 2009, the meetings will focus on issues related
to international assistance and exchanges in the use of biological
science and technology for peaceful purposes, as well as the
promotion of national capacity-building in the detection and response
to outbreaks of infectious disease. The 2010 meeting will discuss the
provision of assistance in case a state party is attacked with biological
or toxin weapons, including improved national capabilities for disease
surveillance, detection, and diagnosis.”°
The states parties also agreed to multiply efforts, regionally
and multilaterally, to convince non-parties to join the Convention. The
EU has already been active in this regard.”’ Finally, a compromise was
reached between the US approach, mainly advocating national
implementation plans, and the Iranian position, calling for states to
increase the exchange of equipment, material, and expertise in order to
promote peaceful applications of biological science. According to the
Final Document of the Conference,’® States parties will need to ensure
that “the promulgation of science and technology is fully consistent
with the peaceful object and purpose of the Convention”, and national
implementation measures will be discussed as part of the
intersessional programme.” Altogether, one can say that real progress,
albeit limited, was achieved in promoting compliance with the
Convention.
Although there are different views on the outcomes of the
Sixth Review Conference, they appear insufficient to some observers.
Since the collapse in 2001 of efforts to negotiate a legally binding
verification protocol, certain observers consider that “the member
states have become resigned to a ‘policy of small steps’ with respect
to strengthening the convention. ... In the face of grave threats to
international security, the states parties to the BWC could agree only
to keep talking for another five years without making decisions. ...
There were also several missed opportunities, such as the failure to
strengthen the CBMs [confidence-building measures] or to discuss
new approaches to monitoring compliance.”*”
HARMONISATION OF EXISTING BIOSECURITY STANDARDS AND REGULATIONS — 183
As proposed by Andrew J. Grotto and Jonathan B. Tucker,
within the framework of the Biological Weapons Convention, the
following recommendations strengthening biological disarmament
measures need to be taken into account:
e ‘“Reaffirm the understanding that the prohibitions in the BWC
apply to pathogenic microorganisms synthezised in the
laboratory. ...
e “Strengthen the annual confidence-building-measure data
declarations under the BWC. ...
e “Establish a small Scientific Advisory Committee for the
BWC. ...
e “Update the existing mechanism for conducting field
investigations under the auspices of the UN Secretary
General. ...
e “Seek a UN Security Council resolution requiring that any
credible allegation of the use of biological weapons be placed
automatically on the council’s agenda. ...
e “Seek a UN Security Council Resolution branding specific
acts involving biological weapons as international crimes,
comparable to aircraft hijacking or torture.”*!
Therefore, strengthening the Biological Weapons Convention
is recognised to be one of the most important challenges facing the
global biosecurity community. As one observer put it, “policy efforts
[are] producing a new world of biosecurity governance radically
different from the one reflected in the BWC’s arms control approach.
This new governance world involved more actors and initiatives
addressing a broader and more diverse range of issues.”*”
6. Attempts to Unify Global Biosecurity Measures and Responses
Several politically controversial attempts have been made to unify
global biosecurity measures and responses in a biosecurity protocol,
similar to a biosafety protocol. As demonstrated above, the
fragmented global biosecurity structure is marked by sectoral
approaches. A loose international framework for biosecurity presently
exists in various international agreements. Flexibility is vital,
however, in the field of the life sciences.
184 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
After the collapse of the Verification Protocol negotiations in
2001, several biosecurity governance initiatives emerged in various
forums outside the Biological Weapons Convention framework.”
Moreover, “some of the topics addressed at the meetings of States
Parties to the Convention, such as infectious-disease surveillance and
scientific codes of conduct, brought into the process new stakeholders
that had not previously been involved in biological arms control”,
including international scientific societies, and international
organisations such as the World Health Organization.* The major
“problem with the various ad hoc biosecurity initiatives is that they
are poorly coordinated” and often represent parallel, overlapping
activities.”
One of the most recent initiatives related to strengthening the
global biosecurity system is the United Nations plan to establish “a
dedicated unit to help combat the threat of bioterrorism”.*° Its broad
mandate would be to “advise on how to enforce strict rules prohibiting
development of biological weapons” and to consider “how to increase
security around recent scientific advances”.*’ Despite these recent
initiatives, much remains to be done to unify various attempts and
ensure a systemic approach to address the issue of global biosecurity
and to develop a globally accepted biosecurity strategy.
Today, the perception of the potential military utility of
biological weapons has changed, largely due to recent developments
in molecular biology and genetic engineering. “Since the advent of
genetic engineering, four categories of manipulations or modifications
of microorganisms and their products have been the subject of
discussion: |. the transfer of antibiotic resistance to microorganisms;
2. modification of the antigenic properties of microorganisms; 3.
modification of the stability of the microorganism toward the
environment; and 4. the transfer of pathogenic properties to
microorganisms. All four kinds of manipulations are possible and are
being carried out daily in research laboratories.”** That is why
strengthening and harmonising the global biosecurity framework is,
although challenging, absolutely imperative.
Currently, some of the existing regulations overlap. In
addition, there is a lack of consistency in definitions, which creates
conflicting requirements. The key biosafety and biosecurity aspects
that are covered by existing regulations are: access to facilities;
inventory of materials; monitoring of exposure of personnel;
prevention of unintended environmental releases; emergency and
HARMONISATION OF EXISTING BIOSECURITY STANDARDS AND REGULATIONS — 185
spills control; waste management; and transportation of material.
Agreed global biosecurity standards would help — strengthen
international law against the acquisition and use of biological
weapons. Jonathan B. Tucker has proposed “a roadmap for the
negotiation of global biosecurity standards, suggesting that they
should include not only emergency response plans in case of
biosecurity breaches, but also the following preventive elements: (1)
mechanisms to account for pathogens that are being stored, used
during experiments, or transferred or exported; (2) the registration and
licensing of facilities that work with dangerous pathogens; (3)
physical security at these facilities; and (4) procedures for screening
laboratory personnel [italics in original]”.®”
Therefore, taking into account the fact that the existing
biological security regime comprises a collection of cooperative and
coercive national and international control measures, including
international agreements, multinational organisations, national and
international laws, regulations, policies, norms and rules, intended to
prevent the spread of dangerous weapons and technologies (with the
BWC serving as the normative foundation of the regime), a review of
the existing regulatory framework with a view to its harmonisation
would be of a great value.
REFERENCES
' World Health Organization, “Scientific Working Group on Life Science Research
and Global Health Security, Report of the First Meeting”, WHO/CDS/EPR/2007.4,
Geneva, 16-18 October 2006, p. 12, http://www.who.int/csr/resources/publications/del
iberate/(WHO CDS _EPR_2007_4n.pdf.
? J.B. Tucker, “Biosecurity: Limiting Terrorist Access to Deadly Pathogens”,
Peaceworks, No. 52, 2003, p. 7, http://www.usip.org/pubs/peaceworks/pwks52. pdf.
> T.R. Young, “National and Regional Legislation for Promotion and Support to the
Prevention, Control, and Eradication of Invasive Species”, The World Bank,
Biodiversity Series, Paper No. 108, February 2006, p. 1.
* The Convention on Biological Diversity, http://www.cbd. int/doc/default.aspx.
> The International Plant Protection Convention, http://www. ippc. int.
° The Ramsar Convention on the Conservation of Waterlands, http://www.ramsar.org.
’ The African-Eurasian Waterbirds Agreement, http://www.unep-aewa.org.
* The Convention on International Trade in Endangered Species of Fauna and Flora,
http.//www.cites.org.
186 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
® The Global Strategy for Planet Conservation, http://www.cbd.int/programmes/cross-
cutting/plant/default.asp.
'° The International Maritime Organization’s Convention for the Control and
Management of Ships’ Ballast Water and Sediments, http://www.imo.org/Convention
s/mainframe.asp?topic_id=867.
'' European Biosafety Association, “Biosafety and Biosecurity within the Context of
the European Regulatory Framework”, http://www.ebsaweb.eu/ebsa_media/Downloa
ds/EBSAActivities/EBSA_BiosecurityinEurope-view_image-1-called_by-ebsa.pdf.
'2 See “Biosafety Regulation in the European Union” on the ICGEB Biosafety
website, http://www. icgeb.trieste.it/~bsafesrv/bsfeurop.htm.
'? B. Tigner, “Europe’s bio-threat readiness questioned”, JSN Security Watch, 12 April
2007, http://www.isn.ethz.ch/news/sw/details.cfm?id=17470.
'4 R. Murch, D. Franz, and P. Singer, “Global Biosecurity: The Vital Role of
Academic Leadership”, Occasional Paper No 1, Virginia Tech’s National Capital
Region, Fall 2005, http://www.biosecuritycodes.org/docs/VTBioSecurity pdf.
'S 101% US Congress, “The Biological Weapons Anti-Terrorist Act of 1989”, Public
Law 101 — 298, 23 January 1989, http://thomas.loc.gov/cgi-bin/query/C?c101:./temp/
~cl101n6RoLd.
'© 107" US Congress, “Uniting and Strengthening America by Providing Appropriate
Tools Required to Intercept and Obstruct Terrorism (USA Patriot Act) Act of 2001”,
Public Law 107 — 56, 26 October 2001, http://frwebgate.access.gpo.gov/cgibin/getdoc
.cgi?dbname=107_cong public laws&docid=f:publ056.107.pdf.
17
'® 107" US Congress, “Public Health Security and Bioterrorism Preparedness and
Response Act of 2002”, Public Law 107 — 188, 12 June 2002, http://frwebgate.access.
gpo.gov/cgi-bin/getdoc.cgi?dbname=107_ cong public laws&docid=f:publ188.107.p
df.
' 108" US Congress, “Smallpox Emergency Personnel Protection Act of 2003”,
Public Law 108 — 20, 30 April 2003, http://frwebgate.access.gpo.gov/cgi-bin/getdoc.c
gi?dbname=108 cong public _laws&docid=f:publ020.108.pdf.
* 108" Us Congress, “Project BioShield Act"", Public Law 108 — 276, 21 July 2004,
Ai / in/ j
docid= =f:publ276. 108.pdf.—
71 107" US Congress, op. cit., note 16.
2 Public Health Security and Bioterrorism Preparedness and Response Act, op. cit.,
note 18.
3 National Research Council of the National Academies, Biotechnology Research in
an Age of Terrorism (Washington, DC: The National Academies Press, 2003), p. 2,
http://books.nap.edu/openbook.php?record_id=10827&page=2.
4 Tbid., pp. 2-3.
> See the section “U.S. Legislation, Executive Orders, and International Treaties” on
the website of the Federation of American Scientists, http://www.fas.org/biosecurity/r
esource/legislation.htm.
*° United States National Security Council, “United States Policy on Chemical
Warfare Program and Bacteriological/Biological Research", 25 November 1969, http:
//www.fas.org/biosecurity/resource/documents/nsdm-35.pdf.
HARMONISATION OF EXISTING BIOSECURITY STANDARDS AND REGULATIONS — 187
>? United States National Security Council, “United States Policy on Toxins”, 20
February 1970, http://www.fas.org/biosecurity/resource/documents/nsdm-44.pdf.
* United States National Policy on the Transfer of Scientific, Technical, and
Engineering Information, 21 September 1985, http://www.fas.org/irp/offdocs/nsdd/ns
dd-189.htm.
*° Homeland Security Presidential Directive, HSPD-9, “Defense of United States
Agriculture and Food”, 30 January 2004, http://www.fas.org/irp/offd
9.html.
*° “Biodefense for the 21 Century”, http://www. fas.org/biosecurity/resource/docume
nts/hspd-10.pdf.
* Tigner, op. cit., note 13.
*? National Research Council of the National Academies, op. cit., note 23, p. 18.
33M. Bhardwaj, “Global Institutionalization of Governance of Biotechnology and
Universality of Ethical Principles”, Eubios Journal of Asian and International
Bioethics, Vol. 14, 2004, p. 210, http://www.eubios.info/EJ146/ej146g.htm.
** National Science Advisory Board for Biosecurity, http://www.biosecurityboard.Go
“i.
© Ibid.
3© Institutional Biosafety Committees, Office of Biotechnology Activities, http://www
4.0d.nih.gov/oba/IBC/IBCindexpg. htm.
37 A J. Grotto and J.B. Tucker, “Biosecurity: A Comprehensive Action Plan”, Center
for American Progress, June 2006, p. 11, http://www.americanpro ; iosecu
rity_a_ comprehensive action _plan.pdf.
°8 Thid.
» Ibid.
* United Nations, Security Council Resolution 1540, S/RES/1540 (2004), 28 April
2004, http://disarmament2.un.org/Committee 1540/Res1540(E).pdf..
*! Grotto and Tucker, op. cit., note 37, p. 11.
*° C. McLeish and P. Nightingale, “Biosecurity and the Governance of Science” (this
paper has been submitted and is under review for forthcoming publication in Research
Policy), p. 7, http://www.su : its/ ev /vie ;
*® See the website of the Australia Group, http://www.australiagroup.net/en/intro. htm.
“ K. Hoyt and S.G. Brooks, “A Double-Edged Sword, Globalization and
Biosecurity”, International Security, Vol. 28, No. 3, Winter 2003/04, p. 127.
*° US Department of State, Proliferation Security Initiative, 28 July 2004, http://www
.State.gov/t/isn/rls/other/34726.htm.
“© United Nations Security Council, op. cit., note 40.
*” McLeish and Nightingale, op. cit., note 42, p. 10.
“8 Secretariat of the Convention on Biological Diversity, “Sustaining life on Earth:
How the Convention on Biological Diversity promotes nature and human well-being”,
April 2000, p. 8, http://www.cbd.int/doc/publications/cbd-sustain-en.pdf.
” Ibid.
°° Tbid., p. 13.
*! Thid., p. 16.
»? Ibid.
188 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
*3 The United Nations Economic Commission for Europe Convention on Access to
Information, Public Participation in Decision-making and Access to Justice in
Environmental Matters, http://www.unece.org/env/pp/documents/cep43e.pdf.
54 ;
Ibid.
°° See “The Aarhus Convention” on the European Commission website,
http://ec.europa.eu/environment/aarhus/.
°° United Nations Economic Commission for Europe, UN Model Regulations on the
Transport of Dangerous Goods, “Nature, Purpose and Significance of the
Recommendations”, http://www.unece.org/trans/danger/publi/unrec/rev13/13nature_e
-html.
*? World Health Organization, Laboratory Biosafety Manual (Geneva: WHO, 2003),
second revised edition, http://www.who.int/csr/resources/publications/biosafety/who
cds_csr_lyo_ 20034/en/.
*§ World Health Organization, “Biorisk management: Laboratory biosecurity
guidance”, WHO/CDS/EPR/2006.6, September 2006, http://www.who.int/csr/resourc
es/publications/biosafety/WHO CDS EPR _2006_6.pdf.
°°? National Research Council of the National Academies, op. cit., note 23, p. 3.
°° World Health Organization, op. cit., note 1, p. 12.
a Tucker, op. cit., note 2, p. 13.
® Grotto and Tucker, op. cit., note 37, p. 47.
% R.A. Zilinskas, “Rethinking Bioterrorism”, Current History, Vol. 100, No. 650,
December 2001, p. 442.
°4 Tucker, op. cit., note 2, p. 14.
°° Ibid.
° Ibid.
°7 A. Pearson, “Increasing the Relevance of the BWC for 21" Century Biological
Challenges”, Partnership on Global Security, Meeting on Constructing an Improved
Global Biosecurity Framework, 22 June 2007, http://www.partnershipforglobalsecurit
y.org/Projects/Biological%20Threat%20Reduction%20Project/index.asp.
8 United Nations Office in Geneva, “Biological Weapons Convention Experts
Meeting Concludes”, 24 August 2007, http://www.unog.ch/80256EDD006B9C2E/(ht
ip NewsBy Year_en)/EC3FF1F841COFDA0C1257341004CD9E6?OpenDocument.
Ibid.
”° “The Sixth Review Conference of the Biological Weapons Convention: Success or
Failure?”, Center for Nonproliferation Studies, 4 January 2007, http://cns.miis.edu/pu
bs/week/070104.htm.
"| Tbid.
” «Eye on...the BWC Implementation Support Unit”, What Bugs You? BWPP
Newsletter, No. 1, July 2007, p. 2, http://www.bwpp.org/documents/WB Y00107-
2007.pdf:
® Ibid., p. 3.
a Pearson, “Modest Progress at the Sixth Review Conference”, BWC Observer, 11
December 2006, http://www.bwc06.org/uncategorized/modest-progress-at-the-sixth-
review-conference/.
”> Thid
® Ibid.
HARMONISATION OF EXISTING BIOSECURITY STANDARDS AND REGULATIONS 189
” Council of the European Union, “Six-monthly Progress Report on the
implementation of the EU Strategy against the Proliferation of Weapons of Mass
Destruction (2006/11)”, Brussels, 9 January 2007, http://register.consilium.europa.eu/
df/en/07/st05/st05183.en07.pdf.
* Pearson, op. cit., note 74.
” J. Fox, “BWC Conference Hailed as a Success”, Global Security Newswire, 15
December 2006, http://www.nti.org/d_newswire/issues/2006_12_11.html.
*° “The Sixth Review Conference of the Biological Weapons Convention”, op. cit.,
note 70.
*! Grotto and Tucker, op. cit., note 37, pp. 18-19.
*? DP. Filder, “From Biological Arms Control to Biosecurity Governance: What Role
for the BWC?”, Center for Arms Control and Non-proliferation, Biological and
Chemical Weapons Program, http://www.bwc06.org/resources/200611_bwe_rc6_pap
er_fidler_ biosecurity governance.doc.
* “The Sixth Review Conference of the Biological Weapons Convention”, op. cit.,
note 70.
** Ibid.
8° Ibid.
asf Boyle, “UN Picks Novartis Boss to Combat Bio-terrorism”, The Business, 23
May 2007, http://www.thebusinessonline.com/Document.aspx?id=FCCB0993-9107-
44F3-A24E-2DD66EF32F0C.
*” Ibid.
8 K. Nixdorff and W. Bender, “Biotechnology, Ethics of Research and Potential
Military Spin-off’, International Network of Engineers and Scientists Against
Proliferation, /nformation Bulletin, No. 19, March 2002, http:/Awww.inesap.org/bulleti
n19/bull 9art05. htm.
* Tucker, op. cit., note 2, pp. 6-7.
CHAPTER 9
GLOBAL BIOSECURITY GOVERNANCE:
SEARCH FOR A NEW PARADIGM
1. Defining the Theoretical Foundations of a Global Biosecurity
Paradigm
The list of 21" century challenges to global security is growing longer
and ever more complex. As stated before, one of those challenges,
global biosecurity, is gaining a more prominent place on the global
policy agenda. The complexity of the dangers associated with global
biosecurity requires that policymakers adopt a truly comprehensive
approach to tackling them. The potential risks of natural or
deliberately induced outbreaks of infectious diseases require a
globally designed strategy of biosecurity. The potential proliferation
of biological weapons and the threat of bioterrorism, combined with
the rapid progress in biotechnology and the challenges related to the
dual-use dilemma (focused on both the promise and the peril of the
advances in the life sciences), make future biological threats and
biosecurity issues an important part of the security agenda. Taking
into account the lack of globally accepted biosafety and biosecurity
standards, its multidisciplinary nature, the fact that only a small
number of countries have introduced legislation that specifically
addresses the problems related to biosecurity, and the current weak
political agreement about specific efforts to strengthen the Biological
and Toxin Weapons Convention, there is an urgent need to find a new
way of resolving the above-mentioned issues.
Based on the theories of multilateralism, global governance,
and global public policy networks, we propose a new global
biosecurity paradigm. The intellectual and theoretical background of
the proposed paradigm is rooted in the theories of multilateralism and
global governance. That is why, before presenting our new paradigm,
we would like to offer a detailed analysis of the main concepts and
assumptions that lie at the heart of those theories. Multilateralism can
192 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
be defined as “the management of trans-national problems with three
or more parties but operating with a series of acceptable
generalized principles of conduct”.’ According to John Ruggie, such
principles of multilateralism as “indivisibility, non-discrimination, and
diffuse reciprocity should lead to collective trust”.”
Contrary to the old (top-down) multilateralism, the new
(bottom-up) multilateralism’ broadens our understanding of the nature
of global governance. Top-down multilateralism has been “driven by
an understanding of governance as effectiveness and efficiency, not
governance as greater representation, accountability and justice [italics
in original]”.* A renewed sociological approach to multilateralism
stems from the conviction that, under changing conditions and
redefined objectives, the multilateral institutional arrangements ought
to have more flexible and adaptive capacities.” Consequently, the
multilateral nature of international institutions enhances their
durability and ability to adapt to change, as it helps in stabilising the
consequences of change.° Such new multilateralism ought to be built
on a new ethical and practical commitment to inclusiveness, equality,
and flexibility, which is highly relevant for our new biosecurity
paradigm. In addition, such core principles of multilateralism as
representation, indivisibility, trust, and adaptability to change
constitute important principles of the proposed paradigm.
There is a very close link between multilateralism and global
governance. “Recent trends in international governance indicate that
the focus has shifted from intergovernmental activities to multisectoral
activities — from governance at the international level to governance
across different levels, and from a largely formal, legalistic process to
a less formal, more participatory and integrated approach.”’ In
International Relations literature, the term was first used by James
Rosenau.* Taking into consideration the gradual shift of authority to
subnational, transnational, and non-governmental levels, the ontology
of global governance focuses its attention on political actors,
structures, processes, and institutions that “initiate, sustain, or respond
to globalizing (and localizing) forces”.’ Global governance
encourages non-traditional actors (such as non-governmental
organisations and networks) to participate in world affairs as
“mobilising agents broadening and deepening policy understanding
beyond the traditional, exclusivist, international activities of states and
their agents [italics in original]”.'° There are several reasons why
global governance has become such a widely used concept.
GLOBAL BIOSECURITY GOVERNANCE: SEARCH FOR A NEW PARADIGM ~ 193
Traditional models of public policy have basically failed to capture the
shifting nature and roles of the public and private sectors.'' In order to
be successfully resolved, global policy problems ought to be managed
simultaneously by both state and non-state actors, and in this context,
the increasing role of multi-level governance structures has to be
recognised.”
Since the nature of the global governance concept is rather
complex, it has been defined in many different ways. According to the
Commission on Global Governance that was established by the United
Nations, global governance can be defined as “the sum of the many
ways individuals and institutions, public and private, manage their
common affairs. It is a continuing process through which conflicting
or diverse interests may be accommodated and co-operative action
taken. It includes formal institutions and regimes empowered to
enforce compliance, as well as informal arrangements that people and
institutions either have agreed to or perceive to be in their interest.”’°
Other definitions conceptualise global governance as “a process of
interaction between different societal and political actors and the
growing interdependence between them”;'* “the rules and standards
elaborated to regulate issues and relations that are likely to have [an]
impact on an international scale”;'? or “certain developments and
institutions beyond the state which try to regulate and control the new
forces of globalisation”.'° In sum, the concept of global governance
encompasses a variety of arrangements that explore the possibility of
representative and legitimate decision-making at the global level.
Divergent theoretical approaches reflect clear differences in
evaluating the scope and possibility of global governance. The
realist/neorealist approach to the study of international politics is
based on the following key assumptions: 1) nation-states are principal
actors of world politics; 2) nation-states are essentially rational actors;
and 3) national security is always the top national priority.'’ “States
are assumed to be rational, unitary actors pursuing essentially the
same goals of national interest. ... [A] system of competing nation-
states is basically an anarchic system ...”'*. International relations are
constantly marked by a continuous struggle for power.'”
According to this approach, while cooperation among self-
interested actors is possible, it would be cooperation reflecting power
hierarchy among nations — “cooperation under anarchy””” — aimed at
managing the balance of power “to avoid the triumph of a dominant
power”.”' In the context of such anarchy, “the reason that nations
194. GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
build an international institution is power hierarchy among nations
[italics in original]”.”7 Cooperation is basically structured on serving
the short-term interests of nation-states. It is suggested by neorealism
that international institutions play an insignificant role in maintaining
international peace and security. They are intergovernmental 1 in nature
and act exclusively in favour of the nation-states’ interests.’ Realist
scholars doubt the possibility of establishing global institutions that
can prescribe behaviour to states and constrain their actions.”
Another theoretical approach to the study of global politics,
namely neoliberal institutionalism, aims to explain a framework under
which international cooperation can take place. It focuses its analyses
on the way global institutions and regimes operate, as well as the
conditions under which they come into being.” According to
neoliberals, nation-states have mutual interests in_ the
institutionalisation of international politics.”° International cooperation
is potentially beneficial for them. Institutions, defined by Robert
Keohane as “persistent and connected sets of rules (formal and
informal) that prescribe behavioural roles, constrain activity, and
shape expectations”,”’ can take three forms: 1) formal
intergovernmental and cross-national non-governmental organisations;
2) international regimes (defined as “sets of implicit or explicit
principles, norms, rules, and decision-making procedures around
which actors’ expectations converge in a given area of international
relations””*); and 3) conventions. Actors’ beliefs, their perceptions that
define interests and expectations, and the strategy of reciprocity
constitute the main components of the neoliberal approach to the study
of international co-operation.”
Another theoretical approach, social constructivism, has
broadened the understanding of the nature and roles ascribed to global
institutions and regimes. This socio-cultural and historically sensitive
approach is advocated by a number of authors.*° According to them,
“{e]pistemologically, the world and our representation of it are not
isomorphic; our concept of reality is mediated by prior assumptions,
expectations, and experience.”*' As reality is socially constructed,
ideas influence leaders at all levels. According to constructivism, the
emphasis on the converging expectations, shared principles, and
norms gives global institutions an intersubjective quality (as reflected
in their shared understandings of desirable and accepted forms of
social behaviour).** Social structures and agents mutually constitute
GLOBAL BIOSECURITY GOVERNANCE: SEARCH FOR A NEW PARADIGM _ 195
each other. As a result, actors not only reproduce normative structures,
but also act as their change-agents.””
Constructivism brings a _ broader’ vision of the
institutionalisation of world politics. From its standpoint, the “material
world shapes, and is shaped by, human action”.°’ Social
constructivism stipulates that all institutions are based on collective
understandings and argues for an active intersubjective process of
reasoning, value-building, and collective identification. While
neoliberal institutionalism offers a behavioural approach to studying
international cooperation, institutions, and regimes, social
constructivism understands them as “fundamentally cognitive entities
that do not exist apart from actors’ ideas about how the world
works”.*° According to constructivism, global governance results “in
the establishment and operation of social institutions resolving or
alleviating collective-action problems in a specific issue-area”.*°
Global governance, as understood by social constructivist theorists,
perceives the main actors of world politics as change-agents that
actively participate in the creation of normative and _ institutional
structures. In addition, the constructivist assumption that institutions
are based on collective understanding, mutual trust, and shared
socially constructed values is important for our future analysis.
Taking all of the above into account, we can conclude that
global governance as viewed by the social constructivist approach
places new and more demanding requirements and normative
constraints on participation in the public sphere. “No state, no matter
how powerful, can by its own efforts alone make itself invulnerable to
today’s threats.”’ The governance approach allows us to take into
account a broad multiplicity and diversity of actors, ranging from
sovereign states to global institutions and various representatives of
civil society, including those of private-sector and non-governmental
organisations. Basically, the global governance approach allows us to
complement state-based perspectives with a focus on new societal
forces and new types of actors.°* These new actors can make the
decision-making process of global institutions “more transparent to
the wider public and formulate technical issues in accessible terms”.””
In addition, non-state actors can expose global institutions to public
scrutiny and “can force them to engage with certain issues they would
have otherwise ignored”.“°
The idea of nation-state sovereignty has not disappeared
despite the processes of globalisation and increasing interdependence,
196 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
resulting in the establishment of a significant number of global
regulations, institutions, or norms. But “the global nature of the
designated issues implies the normative demand that they should be
handled by mechanisms and rules at the global level and with global
reach”.*! Certain issues, such as that of biosecurity, happen to be of a
global kind with a global reach and spread well beyond the realm of
state sovereignty. Since many global problems cannot be resolved by
states alone, “the need of a more efficient regulation is stressed and
found in the rules and mechanisms of global governance”.*” A
structural shift in governance is occurring in those problem areas that
the nation-state is unwilling or unable to address.*” As suggested by
Konrad Spath, issues ranging from poverty and exclusion, global
migration, and HIV/AIDS, to global biosecurity are in great need of
globally designed mechanisms of management.** Global governance
regimes “may yield unprecedented forms of trust and solidarity among
a variety of social actors (government officials, experts, NGOs,
stakeholders, etc.) with diverse (national/sectoral) perspectives on a
certain issue”.””
Therefore, constructive solutions to ever more complex global
problems cannot be provided by states alone. They must be dealt with
collectively: “the phenomenon of governance is driven by collective-
action problems that go beyond the problem-solving capacity of single
states”.“° An innovative approach to collectively addressing global
security issues is reflected in the Multi-sum Security Principle, which
states that: “In a globalized world, security can no longer be thought
of as a zero-sum game involving states alone. Global security, instead,
has five dimensions that include human, environmental, national,
transnational, and transcultural security, and, therefore, global security
and the security of any state or culture cannot be achieved without
good governance at all levels that guarantees security through justice
for all individuals, states, and cultures [italics in original].”*’ Non-
state actors will continue to grow in significance in global negotiation
processes, “as issue-linked coalitions increasingly operate across
borders to set [agendas], and by extension, require governments to
generate policy compliance mechanisms”.”®
What has to be remembered is that the institutions and actors
of global governance are diverse and the scope of the regulatory
framework differs significantly across issue areas.*” In his report “We
the Peoples”: The Role of the United Nations in the 21" Century, Kofi
Annan underlined: “If we are to get the best out of globalization and
GLOBAL BIOSECURITY GOVERNANCE: SEARCH FOR A NEW PARADIGM _ 197
avoid the worst, we must learn to.govern better, and how to govern
better together. That does not mean world government or the eclipse
of nation-states. On the contrary, states need to be strengthened. And
they can draw strength from each other, by acting together within
common institutions based on shared rules and values. These
institutions must reflect the realities of the time, including the
distribution of power. And they must serve as an arena for states to co-
operate with non-state actors, including global companies. In many
cases they need to be complemented by less formal policy networks,
which can respond more quickly to the changing global agenda.”””
Governance is a process of decision-making (including
policies and institutions), as well as a process by which decisions are
implemented. The ideals of good governance are based on numerous
ethical principles. As suggested by Minakshi Bhardwaj, some of the
major ideals of good governance include:
1) Participation (the ideal of participation “is based on the
ethical principle of respect for autonomy” and recognises the
capacity of the participants to actively influence the decision-
making process);
2) Transparency (this ideal “is based on the right to information,
which is an extended vision of the right to education and the
right to know. It is also related to the utilitarian objective of
impartiality, aligning with good and mature moral judgement
for choices to be made”);
3) Responsiveness (this ideal “is based on the deontological
theories that institutions holding authority of decision-making
should respond to the needs of people within a reasonable
timeframe”. It also stems from the Kantian theory of duties
according to which an act is morally praiseworthy only if it
derives neither from self-interested motives nor a natural
disposition, but rather from duty);
4) Equity and inclusiveness (this ideal “is based on the ethical
principle of justice that requires that all groups, particularly
the most vulnerable have opportunities to improve or maintain
their well-being”);
5) Concept of efficiency (this “is based on Mill’s utilitarian
philosophy, which claims that good is characterised by
seeking ... the greatest amount of happiness for the greatest
number of people”). *|
198 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
All these ethical principles are highly relevant to our new
global biosecurity paradigm and constitute its moral foundations. In
addition, central to the concept of global governance are the questions
of legitimacy and accountability. The power of global institutions “is
largely a function of the legitimacy of those institutions. An institution
that is perceived as legitimate is treated with more respect, is endowed
with a corporate existence beyond the units that make it up, and finds
compliance with its rules more easily secured than in the absence of
legitimacy”.’ Legitimacy can be understood as a general compliance
of actors involved with “decisions of a political order that goes
beyond coercion or the contingent representation of interests”.”°
Importantly, “legitimacy as a device of social control has long-run
efficiency advantages over coercion”.”*
Legitimacy results from a mutual agreement among all agents
involved. “Global governance regimes are said to draw their
legitimacy from the deliberative quality of their decision-making
process: it is not designed to aggregate self-interests, but rather to
foster mutual learning, and to eventually transform preferences while
converging on a policy choice oriented towards the public interest.”
It relies on a participatory approach to rule-making. Legitimacy is the
perception that “authorities with capacities to execute decisions
(agency) derive their authority from a foundational idea rooted in
widely shared values”’® Such factors as openness, integrity, and
inclusiveness of the process can reinforce legitimacy. It is important to
assure that legitimacy is “derived from inclusive consultative
processes across a range of interrelated issues”.”’
Emerging patterns of governance operate at multiple levels.
They involve strategic interactions among entities that are not
arranged in formal hierarchies, which might result in a so-called
accountability gap (a situation “in which actual practice differs
substantially from a desirable state of affairs”).°* Institutionalised
accountability refers to a situation where “the requirement to report,
and the right to sanction, are mutually understood and accepted”.””
Accountability is essential to maintain the confidence of the public, as
well as the credibility of an institution. For global governance
institutions to be accountable, agents whose actions have a significant
“impact on the lives of people in other societies would have to report
to those people and be subject to sanctions from them”.°’ However,
the normative problem here arises from the fact that, in many
GLOBAL BIOSECURITY GOVERNANCE: SEARCH FOR A NEW PARADIGM 199
instances, we are facing an accountability gap, which refers to
accountability to people not belonging to the actual acting institution.
We have to also remember that, in addition to being
accountable and legitimate, the global governance system has to be
flexible, responsible, coherent, and dynamic. It has to adapt to the
pace of technological, social, and economic changes. “Rules must
seek long-term benefits for the majority of people, and ensure
adequate protection for minorities that might suffer from adverse
effects.”°' Global governance has to also be grounded in sound
inspiring /eadership: “Linking leadership, vision, institutions and
results can enhance accountability legitimacy of the international
system.”
With the ever-increasing complexity of global challenges,
there is an ongoing search for new models of governance. Traditional
governance models include: commissions, a catalyst for action
through focused debate and discussion (e.g., the Weapons of Mass
Destruction Commission); treaties, legal mechanisms (e.g., the
Biological and Toxin Weapons Convention). Emerging models of
governance focus today on networks, which are diverse in purpose
and approach, and which attempt to be inclusive, participatory, and
legitimate. Global public policy networks, which lay at the core of
multilevel diplomacy, could offer a promising answer to the growing
organisational vacuum at the global level. Global issues networks (as
suggested by Jean-Francois Rischard) can offer a conceptual
framework for tackling problems that are too complex for one country
or one group of actors to address alone. Any viable solution must be
multifaceted, inclusive, and global in its nature.
2. Proposing a New Paradigm
Given the complexity of ensuring biosecurity and taking all of the
above into account, we deem it useful to propose a new global
biosecurity governance paradigm (please see Figure 1).
200 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Figure 1: A Global Biosecurity Governance Model
ACTORS: STRUCTURE:
Governments Network-based
Private industry Horizontal
Science Flexible
Academia Open
Non-profit Integrative
organisations
A GLOBAL
BIOSECURITY
GOVERNANCE
MODEL
STRATEGY: LEGAL
Global FRAMEWORK:
Cross-cultural Harmonised
Transparent Legitimate
Multidisciplinary Coherent
Reconciliatory Built upon common
definitions
We believe that the multilevel, multistakeholder, and multidisciplinary
nature of the problem requires that a new global biosecurity paradigm
be built on the following pillars:
Proposing a new form of global biosecurity governance in the
form of a global biosecurity network, with the goal of tackling
the whole range of the biosecurity-related issues. The
proposed structure of global biosecurity governance should be
horizontal, flexible, integrative, accountable, and adaptive to
changes, and based on the principles of inclusiveness,
participation, equity, and representation;
Fostering a multistakeholder approach to global governance of
biosecurity, involving governments, industry, international
governmental and non-governmental organisations, science,
and academia;
GLOBAL BIOSECURITY GOVERNANCE: SEARCH FOR A NEW PARADIGM 201
e Developing a global biosecurity strategy that is cross-cultural,
transparent, multidisciplinary, based on a collective process of
decision-making, shared vision, and open dialogue between
all stakeholders involved in the process, individual and
corporate responsibility, as well as reflecting the compromise
between the issues of academic openness, security, secrecy,
and profit;
e Designing a_ global biosecurity legal and _ regulatory
framework that is harmonised, legitimate, coherent, and based
on shared, mutually defined, and agreed-upon values, and
built upon common concepts and definitions;
e Building a culture of responsibility, integrity, and trust as a
solid moral foundation of the new global biosecurity
paradigm.
3. Towards a Global Biosecurity Network
With an ever-increasing complexity of global challenges, there is a
constant search for new, more effective models of governance. Global
public policy, issues-related networks (which constitute the core of a
new multilevel paradigm of diplomacy) could offer a promising
answer to the growing organisational vacuum at the global level:
“Global issue networks can transcend the limits imposed by
contemporary territorial and hierarchical institutions that were never
constructed to address these inherently global changes.” The
decision-making sphere is slowly redirecting its attention towards
such networks, where different agents agree to commonly shape
global policy agendas. Global networks help to cross traditional levels
of governance, as they engage actors from across sectors — such as
public governmental, industry, academia, international organisations,
private and public non-profit bodies — to come together to address
complex global challenges.
These networks recognise their interdependence in responding
to global challenges that no single party could tackle alone: “Actors,
including states ... are no longer able to achieve their objectives in
- isolation from one another. Diplomacy is becoming an activity
concerned with the creation of networks, embracing a range of state
and non-state actors focusing on the management of issues that
demand resources over which no single participant possesses a
monopoly.”
202 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Such an emerging governance framework can offer a viable
solution to addressing major global biosecurity-related challenges. No
single actor has the necessary knowledge and capacity to successfully
address the issue. The policy community, especially government
policymakers, has usually little familiarity with, and limited
understanding of, the security problems created by the use of
biological weapons.” On the contrary, the industry and scientific
community that is at the forefront of the creation of biological
knowledge is often well ahead at the global decision-making realm. In
addition, civil society — the societal conscience of the world — is also
barely represented at global forums looking for a comprehensive
solution to enhancing global biosecurity. Biosecurity cannot be
achieved with any single law or programme: “Biosecurity cannot be
provided without active cooperation between states, businesses, and
academia, since much of the required know-how and material reside
in the private sector. Accordingly, flexible knowledge networks
involving state and private actors are key factors in managing
biological risks.”°’ The focus on networks in 21" century decision-
making is increasing because “networks are where people engage,
networks are where work happens, and networks are where knowledge
lives”.
Contemporary networks include the “scale, scope and type” of
transgovernmental ties, the “wider array of functions” performed, and
the fact that they have “spread far beyond regulations to judges and
legislators”. For a network to be legitimate, a high degree of
stakeholders’ involvement is key. At the same time, an extended
number of participants may result in several potential problems. ”° For
example, “the need for compromise and consensus might favor the
lowest common denominator as the eventual policy outcome. At the
same time, a network’s informal structure and reliance on consensus
may offer decision blockades and veto positions for even their
smallest actors.”’' In addition, increased involvement of private and
public stakeholders does not imply replacing governments. “States
must be willing to invest substantial resources into these new forms of
governance. In return, networks can help states and their international
organizations achieve their missions, maintain their competence, and
serve their citizens.”””
Unlike traditional intergovernmental organisations, global
public policy networks “are evolutional in character”.’”’ They are also
flexible in structure, as they “can get to people who don’t have much
GLOBAL BIOSECURITY GOVERNANCE: SEARCH FOR A NEW PARADIGM =. 203
voice in the world today”.’’ Some of the main networks’ functions
include providing platforms for facilitating the setting of global
standards and regulations, coordinating resources, monitoring and
implementing existing international treaties.” In order to be legitimate
and sustainable in the long run, global public policy networks require
a hierarchical form of leadership. The power of knowledge is also
critical to global policy networks. “The scientific and technical
challenges of the coming decades will grow only more grave and
incessant. Scientific complexity will be increasingly important for
policymakers to understand and to communicate competently to the
public. Policymakers must better incorporate scientific advice into
their decision-making.””° That is why the role of knowledge-based
experts — so-called epistemic communities — is very important “in
articulating the cause-and-effect relationships of complex problems,
helping states identify their interests, framing the issues for collective
debate, proposing specific policies, and identifying salient points for
negotiation”.’’ This is essential with respect to global biosecurity
decision-making, taking into account the implications produced by
current knowledge creation in the life sciences.
Essentially, global public policy networks are interdisciplinary
in their nature. In the 21" century, it will be crucial to use an
interdisciplinary approach to facing global challenges: “Most of the
issues that vex humanity daily ... cannot be solved without integrating
knowledge from the natural sciences with that of social sciences and
humanities.”’* This is especially relevant to our discussion of global
biological security, as it has been suggested that, to tackle problems
that are too complex for one country or one group of actors to address
alone, governments, businesses, and civil society should be brought
together. In addition, a global biosecurity network should provide a
platform for a global bargain of making technology available for
development while protecting it from misuse.
Kofi Annan, the former UN Secretary-General, underlined in
his report “Uniting against terrorism”: “What we need now is a forum
that will bring together the various stakeholders — Governments,
industry, science, public health, security, the public writ large — into a
common programme, built from the bottom up, to ensure that
biotechnology’s advances are used for the public good and that the
benefits are shared equitably around the world. Such an effort must
ensure that nothing is done to impede the potential positive benefits
from this technology.”” In addition to biological-weapons-related
204 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
threats, challenges posed by advances in the life sciences encourage us
to seriously consider an outlined network-type solution. This idea has
been reinforced by the United States National Academies, which
suggested in their report Globalization, Biosecurity, and the Future of
the Life Sciences to establish “a decentralized, globally distributed,
network of informed and concerned scientists who have the capacity
to recognize when knowledge or technology is being used
inappropriately or with the intent to cause harm”.””
Studies show that the importance of global networks is to
increase dramatically in the future.*’ One of the key advantages of
global policy networks is that they try to make intense and often
creative use of new communications and information technologies.
These networks have proven themselves to be effective “in bringing
together diverse and sometimes opposing groups to discuss common
problems that no one of them can resolve by itself; and in marshalling
resources — intellectual, financial, and physical — to bring together on
those problems”.*’ They act as platforms for open and flexible
dialogue, capable of adjustment to a changing environment. They
value a culture of trust, integrity, responsibility, inclusiveness,
transparency, and justice.
One recent example of the successful role of global networks
in addressing global health and security issues is the network formed
under the auspices of the World Health Organization — uniting
governments, international organisations, § non-governmental
organisations, and multinational companies — to respond to the SARS
outbreak of 2003.° The WHO had proposed revising the international
regime of infectious-disease control to incorporate non-governmental
information in global surveillance, “in essence to switch from
international governance to global governance by expanding the
sources of information to include state and non-state actors”.™* This
approach proved to be vital in combating the SARS outbreak,
especially in China.
The WHO independently issued a global alert and made
geographically specific travel recommendations, without express
authorisation from the states directly affected. In that particular case,
“national sovereignty and international health governance had given
way to GHG [global health governance]”.® A key factor in the defeat
of SARS was the WHO’s Global Outbreak Alert and Response
Network (GOARN),” a flexible and_ sensitive global disease
surveillance system. This is “a global system that compiles disease
GLOBAL BIOSECURITY GOVERNANCE: SEARCH FOR A NEW PARADIGM =. 205
surveillance information from a wide range of official and unofficial
sources and includes a response network of more than 140 partner
organizations around the world that can move rapidly to contain
disease outbreaks in their respective regions, providing the world’s
first line of defense against emerging infections”.*’ This system is a
great example of direct networking involving various actors, including
scientists and representatives of governmental and non-governmental
organisations.
In a highly interconnected world that micro-organisms can
travel around faster and further then ever before, global networks such
as this one will be vital for limiting the human damage from diseases
emerging and re-emerging in the future. “Global responses that
transcend international institutions would also function defensively
against large-scale bioweapons attacks using highly contagious
agents.”** What is important for this research is openness and
transparency, which are “vital for maintaining confidence in
cooperative efforts”.*”
Although, until today, biosecurity-related meetings have
mostly reflected the top-down, exclusive process of policymaking,
based on hierarchical relations, rather than network-based, it is crucial
to move beyond the traditional paradigm of diplomacy and global
problem-solving. Importantly, there are a number of biosecurity-
relevant networks among the parties to the BWC. They do not cover
all spectrums of biosecurity-related issues, but attempt to address
some of them in an innovative way. One example is the so-called
horizontal network in the Australia Group, an agreement within which
representatives of 40 countries plus the European Commission share
information on the proliferation of chemical and biological agents and
technologies and on their national export controls.”
Other examples of existing horizontal networks include the
Proliferation Security Initiative (a US-inspired initiative within which
participating countries cooperate to interdict the transportation of
weapons of mass destruction and related materials),’' the G8 Global
Partnership (which consists of the countries that have donated
financial support to former Soviet countries to support the destruction
of weapons of mass destruction and associated facilities),”* and the
Global Health Security Initiative (an informal partnership formed to
strengthen health preparedness and response globally to a range of
threats, including bioterrorism). > In addition, some examples of civil
society networks working on the issues of biosecurity are the Pugwash
206 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Conferences on Science and World Affairs’ and the BioWeapons
Prevention Project (BWPP).”°
Given the complexity of contemporary global problems, some
analysts have started advocating “multistakeholder diplomacy”
(MSD): “Actors, including states — commonly identified as the
generators of diplomacy are no longer able to achieve their objectives
in isolation from one another. Diplomacy is becoming an activity
concerned with the creation of networks, embracing a range of state
and non-state actors focusing on the management of issues that
demand resources over which no single participant possesses a
monopoly.””° The concept of multistakeholder diplomacy dissociates
diplomacy from preoccupations with its role within the state system
and looks at what contemporary diplomacy actually involves.
Fundamentally, a “multistakeholder approach is rooted in inclusion
rather than exclusion; initiatives are not always government-led;
stakeholders are included based on their interests and expertise, rather
than simply based on principles of sovereignty; and diplomats act as
mediators and facilitators rather than as gatekeepers”.”’ At the centre
of MSD is the network: “In contrast to the traditional, hierarchical
model of diplomacy that stresses the centrality of intergovernmental
relations, MSD is a reflection of a much more diffuse, network
model.””®
According to the US National Intelligence Council’s recent
report Mapping the Global Future, Report of the National Intelligence
Council’s 2020 Project Based on _ Consultations with
Nongovernmental Experts Around the World: “the dispersion of
technologies, especially information technologies, will place
enormous new strains on governments. Growing connectivity will be
accompanied by the proliferation of virtual communities of interest,
complicating the ability of states to govern. ... With the international
system itself undergoing profound flux, some of the institutions that
are charged with managing global problems may be overwhelmed by
them.””? A global biosecurity network could bring together the wide
range of necessary audiences to create blueprints for responding to
various biological threats. It can help to foster much-needed solutions
to global biosecurity. By involving collective thinking about the
evolving threats and political and legal measures to tackle them, the
global biosecurity network can gain much-needed global credibility.
GLOBAL BIOSECURITY GOVERNANCE: SEARCH FOR A NEW PARADIGM = 207
4. Redefining the Roles and Responsibilities of Actors Involved
Building bridges among all actors concerned is one of the milestones
of the proposed biosecurity paradigm. As defined in the previous
chapter, a major characteristic of the multistakeholder approach to
global problem-solving is the creation of networks consisting of
governments, private industry, and various public institutions,
including academia and broader civil society. Multistakeholder
interaction can bring innovative and constructive solutions to the
problem of global biosecurity. Humanity is confronted with ever more
complex security problems, including that of biological security. The
locus of power and influence is shifting. The interconnectedness of
problems created by globalisation and new technology demands
genuine partnership of actors not restricted to states alone.
As we have seen, “[n]o state, no matter how powerful, can by
its own efforts alone make itself invulnerable to today’s threats.”'”°
The global governance approach chosen as the theoretical foundation
of this book allows us to take into account a broad multiplicity and
diversity of actors, ranging from sovereign states to global institutions
and various representatives of civil society, including those of private-
sector and non-governmental organisations. Basically, the global
governance approach makes it possible to complement state-based
perspectives with a focus on new societal forces and additional actors
shaping the rules, norms, and control mechanisms of a global
governance system. These new actors can make the decision-making
process of global institutions “more transparent to the wider public
and formulate technical issues in accessible terms”.'°' In addition,
non-state actors can expose global institutions to public scrutiny and
“can force them to engage with certain issues they would have
otherwise ignored”.'”
The idea of nation-state sovereignty has not disappeared
despite the processes of globalisation and increasing interdependence,
resulting in the establishment of a significant number of global
regulations, institutions, or norms. But “the global nature of the
designated issues implies the normative demand that they should be
handled by mechanisms and rules at the global level and with global
reach”.'”’ Certain issues, such as that of biosecurity, happen to be of a
global kind with a global reach and spread well beyond the realm of
state sovereignty. Since some problems are global and governments
are increasingly unable to handle them alone, “the need of a more
208 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
efficient regulation is stressed and found in the rules and mechanisms
of global governance”. A structural shift in governance is occurring
in those problem areas that the nation-state is unwilling or unable to
address.'°° Issues ranging from poverty and exclusion, global
migration, and HIV/AIDS, to global biosecurity are in great need of
global management and need to be submitted to global mechanisms
and institutions. Global governance regimes “may yield
unprecedented forms of trust and solidarity among a variety of social
actors (government officials, experts, NGOs, stakeholders, etc.) with
diverse (national/sectoral) perspectives on a certain issue”’. +
Therefore, constructive solutions to ever more complex global
problems cannot be provided by states alone. They must be dealt with
collectively: “the phenomenon of governance is driven by collective-
action problems that go beyond the problem-solving capacity of single
states”.'°’ Non-state actors “will continue to grow in significance in
inter-governmental negotiation processes, as issue-linked coalitions
increasingly operate across borders to set [agendas], and by extension,
require governments to generate policy compliance mechanisms”.'”*
What has to be remembered is that the institutions and actors of global
governance are diverse and the scope of the regulatory framework
differs significantly across issue areas.’ In his report “We the
Peoples”: The Role of the United Nations in the 21° Century, Kofi
Annan underlined that “we must learn to govern better, and how to
govern better together”.''" This has direct implications for the
successful governance of global biosecurity.
5. Defining a Global Biosecurity Strategy
Contemporary global policymaking is characterised by complexity:
any policymaking situation comprises many “problems and issues
[which] tend to be highly interrelated. Consequently, the solution to
one problem requires a solution to all other problems. At the same
time, each solution creates additional dimensions to be incorporated in
the solutions to other problems. Few, if any, problems can be isolated
effectively for separate treatment”.''’ The nature and implications of
such complexity suggest some new criteria for the design of real-
world problem-solving methods. As suggested by Richard Mason and
lan Mitroff, some of these criteria are: 1) participative: 2) allowing
space for debate, and 3) integrative. |!”
GLOBAL BIOSECURITY GOVERNANCE: SEARCH FOR A NEW PARADIGM = 209
The United Nations Development Programme (UNDP) has
suggested that today we are facing several policy deficits at the
following “gap” levels:
e “A jurisdictional gap — While policy issues are global in
nature, policy-making is still primarily national in focus and
scope.
e “A participation gap — While we are living in a multi-actor
world, global cooperation is still primarily intergovernmental.
e “An incentive gap — While cooperation works only if it offers
a clear and fair deal to all parties, today’s international
cooperation is often stalled by concerns about equity and
fairness [italics in original].”'"
Biosecurity is interdisciplinary in nature and impinges on
many different policy fields, government agencies, industry, and
private institutions, necessitating a considerable coordination effort. In
order to successfully tackle all biosecurity-related challenges, a
successful global biosecurity strategy must be aware of the existing
jurisdictional, participation, and incentive gaps, and strive to
constructively overcome them. “Successful management of biological
risks poses comprehensive challenges to public, private, and
international actors at all levels of politics (local, national,
international) in terms of coordination and cooperation.”'"
Establishment of a global biosecurity strategy to promote global
research and development collaboration by harmonising commercial
and research regulations may be very challenging to implement. But a
common-ground solution may be found. Taking into account the
complex nature of threats to biological security, a comprehensive
biological-security strategy requires all those involved to show
flexibility, openness, and creativity in developing viable solutions.
Today, we can confidently speak about the lack of a
comprehensive strategy for global biological security. A broad array
of mutually reinforcing actions, implemented in a manner that engages
multistakeholder communities, will be required to address the issue of
global biosecurity constructively. Part of the problem stems from the
fact that the professional worlds of bioscience and global security do
not interact very much or demonstrate a good understanding of each
other’s concerns. Those in the security community should articulate
their analysis and information about the dangers of the misuse of
210 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
biological research to biologists. At the Green Cross International
Forum held in Geneva on 8 November 2006, on “Developing a
Comprehensive Global Biosecurity Regime”, the Director-General of
the United Nations Office at Geneva underlined: “Biological weapons
represent a genuine threat to national and international security. ...
The global challenge requires a multifaceted solution. Addressing
threats posed by the misuse of biological agents requires a concerted
response at international, national, facility and individual levels. We
need to tackle it individually and collectively — working together and
with other partners." ”
There is a visible difficulty in agreeing on common visions
and standards of biosecurity. But taking into account the magnitude of
the challenge, a global biosecurity regime that establishes a uniform
set of security regulations may offer a sustainable solution. As
recommended by David R. Franz, Peter A. Singer, and Randall S.
Murch, a global biosecurity strategy should be guided by the
following principles:
e “Biosecurity is a global problem that must be addressed with
the mindset of a global challenge
e “Biosecurity is a multi-disciplinary challenge that requires
cross-disciplinary solutions
e “Biosecurity must be based upon common definitions,
language and terms of reference to facilitate communication
and progress among an integrated biosecurity community and
its stakeholders
e “A global strategy for biosecurity should be developed with
the primary goal of the reduction of the severity and
likelihood of biological catastrophes through anticipation,
prevention, preparedness, intervention and recovery, whether
they are intentional, accidental or natural in origin
e “Academia, government, non-profits and industry are
important stakeholders in the solution of this critically
important global challenge
e “All sectors must work together to foster a culture of
advocacy, research and policy formulation to reduce threats
and increase opportunities that come from new life science
knowledge and technology
GLOBAL BIOSECURITY GOVERNANCE: SEARCH FOR A NEW PARADIGM _ 211
e “Academia should not simply be reactive ... but should
position itself to be proactive and visionary to contribute to
effective solutions
e “The pursuit of truth and excellence in science, scholarship
and learning must be paramount.”''°
In the framework of global biosecurity strategy, the major
issues under discussion include regulation of commercial gene
synthesis, codes of conduct for scientists, security versus
transparency, international biosafety and biosecurity laboratory
standards, oversight mechanisms for dual-use biological research,
reconciliation of biosecurity concerns and global development goals.
In addition, national, regional, and global linkage mechanisms are
weak and uncoordinated, which is why some type of “connective
tissue is needed”.''’ Government/diplomatic, national security and
defence, law enforcement, public health/medical, scientific, and
industry communities need to know about other communities, and
how their actions impact on each other.''* All these communities have
different cultures, assumptions, priorities, and languages, which is
why it is crucial to find a common denominator, discourse that could
be defined and accepted by all concerned parties.
Some of the key elements of the proposed global biosecurity
strategy would include:
1) Global in its outlook, cross-cultural, built on a solid human
and ethical foundation;
2) Comprehensive, based on an open-ended and complexity-
sensitive way of thinking, flexibility, openness, and creativity;
3) Interdisciplinary, based on an open-ended shared learning
process;
4) Participative, cooperative, inclusive;
5) Inherently transparent;
6) Making full use of information and communication
technologies that play a key role in the proposed global
biosecurity network that would operate as a complex web of
partnerships and alliances;
7) Facing all interlinked global biological governance challenges
such as preventing the use of biological weapons, promoting
biological science, and advancing biological development.
212 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
“(Genetically engineered] DNA has no respect to natural law,
and terrorism has no respect of man-made law. No regulatory system,
however well-intentioned and complex, can possibly deal with this
combination. Only an entirely new paradigm for the biosciences and
global security can guarantee ‘apocalypse never’. We should pursue
4. 99119
it.
6. Designing a Global Legal and Regulatory Framework
The central problem related to the governance of a global legal and
regulatory regime for biosecurity is the reconciliation of the political
demands from science, industry, and civil society. The “biological
challenge is relatively new, and neither a commonly accepted view of
the problem nor a shared strategy or set of policies to respond
effectively characterizes perceptions. ... Significant differences
continue to exist about both the nature of the challenge and the
appropriate set of policy responses”,'” including those related to
global norm-setting. In order to construct a solid biosecurity
regulatory regime, it is important to identify shared priorities; find
cooperative solutions, and develop a common strategy.'*!
During the meeting of the New Defence Agenda’s
Bioterrorism Reporting Group and the Chemical and Biological Arms
Control Institute in 2005 in Brussels, some experts emphasised the
importance of a “shared intellectual infrastructure” that would contain:
“a shared view of the problem faced
“sufficient common ground to allow collaboration
“common concepts and assumptions
“mutual terminology
“shared tools — military, diplomatic and economic”.
122
The proposed intellectual framework could be applied to a
legal biosecurity regime, as it would reconcile the divergent demands
from science, industry, and civil society. In the framework of such a
legal/regulatory framework, “[jJoint pursuits should include focused
initiatives in areas including policy development, research,
development, testing, and validation programs; common systems for
knowledge management, technology transfer, and training”. '*°
One of the principal challenges in designing a global legal and
regulatory regime is establishing harmonised international standards
GLOBAL BIOSECURITY GOVERNANCE: SEARCH FOR A NEW PARADIGM = _.213
for the oversight of sensitive research in the life sciences that could be
a threat to public health and global security. Despite the benefits of
new biological technologies, they could, however, be misused to
create biological weapons. For example, “the ability to synthesize
strands of DNA from the off-the-shelf chemical ingredients and
assemble them into viral genomes has made it possible to recreate
infectious pathogens in the laboratory”.'** To date, scientists have
managed to synthesise poliovirus and the Spanish Flu virus (the 1918
pandemic strain of influenza), and it may only be a matter of time
before it is possible to synthesise more complex pathogens, such as
the smallpox virus.’ Although there is an active debate on the
destruction of the last smallpox holdings, there is reluctance to destroy
them before there is a complete genome mapping, which, of course,
might make it possible to artificially recreate the virus, which in turn
appears to make the question of destruction controversial. In addition,
genetic engineering technology might also be used to enhance a
pathogen’s virulence or its ability to cause illness or death. There is a
broad agreement that research posing a threat to global security should
be designated as dual-use. That is why it is important to strengthen
export controls on dual-use technologies that could be diverted for
biological-warfare purposes.
At the global level of biotechnology governance, a broad
distinction can be drawn between regulatory actions designed to
enable and enhance global biotechnological trade (the interests of
industry) and those that focus on the protection of social and human
rights (the interests of civil society). In the case of the former, the
World Bank, the International Monetary Fund (IMF), the World Trade
Organization, and specialised agencies of the United Nations have
worked diligently over the past two decades to promote a regulatory
culture capable of sustaining a global biotechnology industry.'*° For
example, the World Intellectual Property Organization (WIPO) was in
favour of patents for biotechnological inventions.'*’ In 1993, the UN
Convention on Biological Diversity included a new provision which
stated the following: “For technology that is subject to patents and
other intellectual property rights, access and transfer shall be provided
on terms which recognize and are consistent with the adequate and
effective protection of intellectual property rights.””'**
On 11 November 1997, the General Conference of UNESCO
adopted the Universal Declaration on the Human Genome and Human
Rights, which set out both the principles and the mechanisms of an
214 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
alternative political imperative of regulation. It established a set of
rights-based regulatory criteria that could be used to define the way in
which human genetics research and its industrial applications should
be conducted.'!*? The Declaration advocates a coherent system of
values, by stating that it forms part of a “framework of thinking,
known as bioethics, which relates to the principles that must guide
human action in the face of the challenges raised by biology and
genetics”.'°” It was a product of UNESCO’s International Bioethics
Committee. The Declaration underlines that, not only should
researchers take responsibility for the moral, human, and ecological
implications of their research (Article 13), they should also work
within a framework of ethics committees that must fulfil the following
conditions: “They must be independent of the political, economic,
scientific and especially medical authorities. Their composition must
be multidisciplinary in order to enable an understanding of the
diversity of the questions raised at the scientific, philosophical, legal,
economic, and social levels. Finally, they must be pluralistic in order
to permit the expression of the main forms of ethical and cultural
sensibility.”’*'
Another key challenge in designing a global biosecurity legal
regime is establishing harmonised international standards for securing
dangerous pathogens in research laboratories and culture collections.
Such guidelines should include: an agreed list of select agents that
serves as the basis for regulation; rules for registering and licensing
facilities that work with select agents; standards and procedures for
controlling access to pathogens, including physical security measures;
accounting mechanisms to track pathogens that are stored, used in
experiments, transferred, or exported; procedures for checking the
trustworthiness of scientists and technicians who wish to work with
select agents.”
With the aim of harmonisation of a biosecurity legal regime, it
is imperative to strengthen biological disarmament measures.'*’ Most
importantly, it is necessary to reinforce existing legally binding
measures, such as the Biological Weapons Convention. In addition to
setting up the formal verification and compliance mechanisms, some
other key areas of focus of the Biological Weapons Convention
include, as suggested by Michael Moodie:
I)
2)
3)
4)
5)
6)
GLOBAL BIOSECURITY GOVERNANCE: SEARCH FOR A NEW PARADIGM =. 215
Safe and secure operations of facilities. “[T]his is the area in
which standards are perhaps most developed, particularly with
respect to ‘biosafety’”.
Pathogen security. Some of the main topics here include
“national measures for oversight of pathogenic material that
focus on legal, regulatory, and administrative systems;
facilities; personnel; transport and transfer; oversight; and
enforcement”.
Laboratory capability. This is a central “component of disease
surveillance, preparedness, and response”.
Personnel-related risks. Some of the key risks include
“unauthorised access, creating the potential for theft or other
misuse”.
Knowledge and information management. It relates to “the
risks attached to the global diffusion of knowledge in the life
sciences”. Which is why it is essential to develop a set of
standards regarding management of sensitive information.
Governance of research. This “relates to conduct and
publication of life sciences research with security
implications”. '**
The global public policy community should strive to bridge
the existing gap between multiple overlapping global biosecurity
norms and regulations. It has to do its best in order to develop unified,
comprehensive, nationally and globally accepted legislation that will
effectively protect and enhance biosecurity in the interest of
humankind and other living species.
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” Ibid., p. 14.
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°! The Evian Group, op. cit., note 15, p. 3.
°° Bradford, op. cit., note 56, p. 25.
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Ibid., p. 2.
°° Be Hocking, “Multistakeholder Diplomacy: Forms, Functions and Frustrations”, in
J. Kurbalija and V. Katrandijev (eds.), Multistakeholder Diplomacy: Challenges and
Opportunities (Geneva: DiploFoundation, 2006), p. 13.
°° M. Moodie, “Confronting the Chemical and Biological Weapons Challenge: The
Need for an Intellectual Infrastructure”, Fletcher Forum of World Affairs, Vol. 28,
No. 1, Winter 2004, p. 44, http://fletcher.tufts.edu/forum/archives/pdfs/28-1pdfs/moo
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°° A.-M. Slaughter, A New World Order (Princeton: Princeton University Press,
2004), pp. 10-11.
” T. Benner, W.H. Reinicke, and J.M. Witte, “Global Public Policy Networks,
Lessons Learned and Challenges Ahead”, The Brookings Institution, http://www.broo
GLOBAL BIOSECURITY GOVERNANCE: SEARCH FOR A NEW PARADIGM _.219
kings.edu/press/review/spring2003/benner.htm.
"\ Ibid.
” Ibid.
” Ibid.
"4 Rischard, op. cit., note 63, p. 3.
> Benner et al, op. cit., note 70.
Soe Chyba, “Toward Biological Security”, Foreign Affairs, Vol. 81, No. 3,
May/June 2002, p. 136.
” Haas, op. cit., note 31, p. 2.
’S E.0. Wilson, Consilience: The Unity of Knowledge (New York: Alfred A. Knopf,
1998), p. 13.
” “Uniting against terrorism: recommendations for a global counter-terrorism
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*° Committee on Advances in Technology and the Prevention of Their Application to
Next Generation Biowarfare Threats, Development, Security, and Cooperation Policy
and Global Affairs Division, Board on Global Health, Institute of Medicine, Institute
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Globalization, Biosecurity, and the Future of the Life Sciences (Washington, DC: The
National Academies Press, 2006), p. 11.
*! The Evian Group, op. cit., note 15, p. 4.
*? W.H. Reinicke and F. Deng, “Critical Choices: The United Nations, Networks, and
the Future of Global Governance”, The International Development Research Center,
2003, http://www.idre.ca/en/ev-34 .
°C. Enemark, “Infectious Diseases and International Security, The Biological
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** Tbid., p. 119.
*° Ibid.
%° World Health Organization, Global Outbreak Alert and Response Network, http://w
ww.who.int/csr/sars/goarn/en/.
*7 A J. Grotto and J.B. Tucker, oe A Comprehensive Action Plan”, Center
for American Progress, June 2006, p. 48, http://www.americanprogress.org/kf/biosecu
rity_a_ comprehensive action plan.pdf.
*§ Enemark, op. cit., note 83, p. 119.
* Ibid.
* The Australia Group, http://www.australiagroup.net/.
°! The Proliferation Security Initiative, http://www.state.gov/t/np/c10390.htm.
* The G8 Global Partnership, http://www.state.gov//np/cl12743.htm.
* The Global Health Security Initiative, http://www.ghsi.ca/english/index.asp.
* The Pugwash Conferences on Science and World Affairs, http://www.pugwash.or
g/.
* The BioWeapons Prevention Project, http://www.bwpp.org/about.html.
°° Hocking, op. cit., note 65, p. 13.
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of Sussex, Science and Technology Policy Research, http://www.sussex.ac.uk/Units/s
pru/nonstateactors/uploads/NetworksPaper.pdf
220 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
* Hocking, op. cit., note 65, p. 20.
»? National Intelligence Council, Mapping the Global Future, Report of the National
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10° United Nations, op. cit., note 37.
101 Nanz and Steffek, op. cit., note 39, p. 323.
102 Tbid., p. 324.
103 Spath, op. cit., note 16, p. 7.
14 Thid., p. 9.
'°5 Halabi, op. cit., note 43, p. 25.
106 Nanz and Steffek, op. cit., note 39, p. 322.
102 Spath, op. cit., note 16, p. 2.
'°8 Higgott, op. cit., note 4, p. 35.
'° Higgott, op. cit., note 49, p. 27.
110 Annan, op. cit., note 50, p. 5.
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De Wit and R. Meyer (eds.), Strategy: Process, Content, Context, An International
Perspective (London: Thomson Learning, 2004), third edition, p. 27.
'!2 Tbid., p. 31.
'13 United Nations Development Programme, Human Development Report 1999 (New
York: Oxford University Press, 1999), p. 111, http://hdr.undp.org/reports/global/1999/
en/pdf/hdr_1999_full.pdf.
'l4 Wenger and Bonin, op. cit., note 67, p. 1.
"5 United Nations Office in Geneva, “Message of Director-General of UNOG to
Roundtable Debate on Developing a Comprehensive Global Biosecurity Regime”, 15
November 2006, http://www.unog.ch/80256EDDO006B9C2E/(httpNewsBy Year_en)/8
ADDD32680931A33C1257227003A3C42?0OpenDocument.
16 R. Murch, D. Franz, and P. Singer, “Global Biosecurity: The Vital Role of
Academic Leadership”, Occasional Paper No. 1, Virginia Tech’s National Capital
Region, Fall 2005, http://www. biosecuritycodes.org/docs/VTBioSecurity.pdf.
'!7 G. Epstein, “The Many Faces of Biosecurity”, Center for Strategic and
International Studies, Workshop on Developing Options for Global Biosecurity, 6-7
March 2007, http://www.partnershipforglobalsecurity.org/Documents/epstein_revised
2007-03 -06.pdf.
118 pp.
'!9 R. Square, “Biological Weapons and New Genetics — Avoiding the Threat”, 18
May 2001, http://www.btinternet.com/~nlpwessex/Documents/Bio-terrorism.htm.
2° M. Moodie, “Introduction”, in New Defence Agenda and Chemical and Biological
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States Work Together?”, Report of the Fourth Meeting of the New Defence Agenda’s
Bioterrorism Reporting Group and the Chemical and Biological Arms Control
Institute, Brussels, 25 April 2005, p. 5, http://www.isn.ethz.ch/pubs/ph/details.cfm?In
g=en&id=13505.
'21 RS. Murch, “Participant Contributions”, in New Defence Agenda and Chemical
and Biological Arms Control Institute, ibid., p. 63.
GLOBAL BIOSECURITY GOVERNANCE: SEARCH FOR A NEW PARADIGM 221
'*> “Executive Summary”, in New Defence Agenda and Chemical and Biological
Arms Control Institute, ibid., p. 18.
' Ibid., p. 60.
'24 Grotto and Tucker, op. cit., note 87, p. 9.
'5 Ibid., p. 10.
‘8 R. McNally and P.R. Wheale, “The Consequences of Modern Genetic
Engineering: Patents, Nomads and the Bio-industrial Complex”, in P. Wheale, R. von
Schomberg, and P. Glasner (eds.), The Social Management of Genetic Engineering
(Aldershot: Ashgate Press, 1998), pp. 303-330.
'27 World Intellectual Property Organization, “WIPO Patent Agenda”, http://www.wip
o.int/patent/agenda/en/.
'28 United Nations Environment Programme, Conference of the Parties to the
Convention on Biological Diversity, “Preparation for the Seventh Meeting of the
Conference of the Parties”, UNEP/CBD/COP/6/2, 22 January 2002, p. 12, http://www
.cbd.int/doc/meetings/cop/cop-06/official/cop-06-02-en.doc.
'29 United Nations Educational, Scientific and Cultural Organization, The Universal
Declaration on the Human Genome and Human Rights, 11 November 1997,
http://portal.unesco.org/en/ev.php-URL_ID=13177&URL_DO=DO_ TOPIC&URL S$
ECTION=201.html.
9 Ibid.
1 Ibid.
'? Grotto and Tucker, op. cit., note 87, p. 13.
'3 Tbid., pp. 18-19.
4 M. Moodie, “Biological Threats to Security: Harmonizing International Standards
for Biosecurity”, p. 2, http://www.un-globalsecurity.org/pdf/moodie.pdf.
CHAPTER 10
CONCLUSIONS
1. Mapping Future Biosecurity Threats
Today’s world is becoming increasingly more interdependent. In its
Global Risks 2007: A Global Risk Network Report, the World
Economic Forum named the following among the core global risks to
the international community over the next 10 years: international
terrorism, proliferation of weapons of mass destruction, emergence of
risks associated with nanotechnology, breakdown of critical
information infrastructure, as well as pandemics.' Importantly, “risks
do not manifest themselves in isolation: their drivers, triggers and
consequences are interconnected”.’
The future biosecurity threats associated with the proliferation
of biological weapons or international terrorism will maintain their
relevance on the global policy-making agenda. “India, China,
Singapore, Korea, South Africa and Brazil are all at various stages of
becoming powerhouses in the biological sciences. Even ... Cuba has
developed a strong biotechnology capacity. It has, for example,
developed the world’s first vaccine against meningitis B. This global
dispersion of science mandates a global approach to ensuring that
science is not misused.” As suggested by Steven M. Block, some of
the imagined future biological threats could include:
Binary biological weapons;
Designer genes and other life forms;
Gene therapy used as a weapon;
Stealth viruses;
Host-swapping (zoonotic) diseases; and
Designer diseases.‘
Pathogens are not the only biological security problem. The
advancing technology landscape has an uncertain future and
224 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
unpredictable dual-risk implications. Future biosecurity-associated
threats are greatly exacerbated by the explosion in life science
knowledge, technology, and applications that have extensive dual-use
implications. Knowledge and technology are widely available and
accessible. The pace of discovery in the life sciences will continue and
increase in the foreseeable future. For example, some of the future
dual-use risks might be envisioned as following: 1) scientists might be
able to synthesise complete microbial genomes by 2010; 2) complete
genomes of some viruses may be able to be synthesised in the very
near future; and 3) life science technologies will proliferate further.”
In addition, bioregulators and all research concerning the
immune system could also pose a serious dual-use risk. DNA
shuffling will allow biologists to generate novel proteins, viruses,
bacteria, and other organisms with desired properties within a much
shorter period of time than before.° Virologists can use this technology
to optimise viruses for gene therapy and vaccines. Similarly, dual-use
risks can be considered in other technologies, including DNA
synthesis, bioprospecting, combinatorial chemistry, rational drug
design, synthetic biology, genetic engineering of viruses, RNA
interference, high-affinity binding reagents, computational biology
and bioinformatics, systems biology, genomic medicine, modulators
of homeostatic systems, aerosol technologies, microencapsulation
technology, and gene therapy targeting biologically active materials to
specific locations in the body.
2. Future Policy Directions
The report of the UN Secretary-General’s High-level Panel on
Threats, Challenges and Change, A more secure world: Our shared
responsibility, concluded that we need to pay much closer attention to
biological security.’ While biosecurity threats and challenges relate to
people and their motivations, deliberate and accidental situations,
knowledge, technology and _ materials, biosecurity-related
opportunities and solutions stem from deep and broad knowledge of
threats and challenges, scholarship, analysis and planning, education,
training and communication, creativity and innovation, system
integration, leadership, visions, and strategies.
The biggest challenge facing the global decision-making
community in the field of global biological security is the fact that
there is no consistent global perspective or enforceable global legal
CONCLUSIONS 225
and regulatory system in place. In this book, we are proposing such a
perspective in the form of a new global biosecurity paradigm.
Biosecurity is a very complex and dynamic problem. As a result, it
requires a multidisciplinary, multidimensional, cross-cultural,
participatory, and transparent set of policy solutions. They must be
built on an ethical foundation and be truly global in their outlook,
showing respect for every actor’s value system and worldview.
Measures to assure global biosecurity need to be complementary and
integrated.
As discussed in this book, the proliferation of weapons of
mass destruction to states, or non-state actors, combined with the rapid
development of new technologies and the related dual-use problem, is
a major global threat concern that only global cooperation and
coordination can prevent. Rapid advances in biological science and
technology are changing the nature of threats to global biosecurity.
“Indeed, a nation’s level of technological achievement generally will
be defined in terms of its investment in integrating and applying the
new, globally available technologies — whether the technologies are
acquired through a country’s own basic research or from technology
leaders.”* Genetic engineering has made it possible to make natural
diseases “more lethal, contagious, or environmentally persistent;
capable of evading detection and diagnosis”; and able to defeat
existing drugs and vaccines.’ Unfortunately, industry, science, and
civil society engagement in addressing these issues is fragmented and
mostly reactive.'°
The complexity and diversity of the problem set of biosecurity
requires a new approach to tackling it. In this study, we proposed a
new global biosecurity paradigm for addressing the whole range of
biosecurity-related challenges. By building this paradigm on the
theoretical/conceptual foundation of multilateralism, global
governance, and global public policy networks, we recommend that
global biosecurity governance be approached from a_ holistic,
participatory, and inclusive perspective. At the centre of the discussed
paradigm, we propose to establish a global biosecurity network
(GBN). As mentioned by Charlotte Steck, a network can offer an
innovative solution to complex global problems, by actively engaging
various actors'' while providing a genuine, non-threatening, impartial
global space for assessing threats. A GBN can help to manage
relationships that can otherwise disintegrate into misunderstanding or
counterproductive confrontation.
226 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
As suggested by the study “Critical Choices: The United
Nations, Networks, and the Future of Global Governance”, global
public policy networks fulfil the following functions, which are
generally complementary and mutually reinforcing:
“They contribute to establishing a global policy agenda, and
then they offer mechanisms for developing a truly global
public discourse in which to debate that agenda;
“They facilitate processes for negotiating and setting global
standards;
“They help develop and disseminate knowledge that is crucial
to addressing transnational challenges;
“They help create and deepen markets;
“They provide innovative mechanisms for implementing
global agreements; and
They address the participatory gap by creating inclusive
processes that build trust and social capital in the global
public space by furthering transnational and transsectoral
discourse and interaction.”
As accurately observed by Charlotte Steck, the following key
features and ideal-type characteristics have been associated with
global public policy networks:
Interdependence: “Cooperation in networks is based on the
principle that individually no single group can address or
solve the issue at stake”’’ (the ability of any single actor to
achieve its agenda is dependent on the action and support of
all other actors);
Openness, flexibility, and learning capability: “Network
structures are able to adapt and evolve. Furthermore, their
evolutionary character and flexible structure allows for
openness” ", accommodating new players during the process.
Complementarity: Networks “are sustained by the diversity of
their constituency”. They facilitate the discussion of
controversial issues and provide a favourable framework for
political reflection. “Governance through global public policy
networks provides mechanisms that facilitate the transfer and
application of knowledge and other resources among various
CONCLUSIONS 227
actors in the network and eventually benefit outside actors as
well so 15 :
e Diversity: It reflects “[t]he trilateral nature of global public
policy networks, involving the public sector, civil society, and
business”. '°
e Speed: “Global public policy networks provide for rapid
responses. ... They are equipped to quickly identify issues,
outline a vision, options, and an action plan.””"”
e Legitimacy: “Global public policy networks respond to the
need for delegating policy processes to the governance levels
that can most effectively formulate and implement policy
solutions.” They provide a means of implementing
agreements and policies at various levels of decision-making.
Their open architecture allows participation at multiple levels,
“leading to greater legitimacy and ultimately to the
development of common global norms.”'*
The characteristics of interdependence, diversity, flexibility,
complementarity, speed, and legitimacy can ensure a solid foundation
for the proposed GBN. The often divided communities of national and
global policymakers, industry, science, and civil society can work
more constructively under the unifying umbrella of this network. By
fostering an open and transparent dialogue, they can work towards
finding a common denominator in addressing global biosecurity-
related problems. By being actively engaged in governance of global
biosecurity, all these actors can be motivated to find a viable set of
solutions. The main strength of the proposed paradigm will be
reflected in the commitment of different partners and the goals that
have jointly been set. Legitimacy, accountability, and coherence
resulting from such forms of biosecurity governance can assure a
range of biosecurity solutions that would be innovative and
sustainable in the long term. By working together, all actors concerned
should be able to design a global biosecurity strategy based on a
shared vision and common understanding of the problem and develop
comprehensive, inclusive, globally accepted legislation to effectively
protect and enhance biosecurity.
The proposed new global biosecurity paradigm promotes
multistakeholder dialogue at the global level in order to bridge
divisions between multiple actors and search for a common ground on
pressing biosecurity challenges. It can make a real difference in
228 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
addressing complex biosecurity-related problems through joint and
well-coordinated action. “Whilst governments can agree on norms and
legal action, business actors often have the technical solutions and
know-how to address the problem efficiently. Civil society, typically,
has as its strengths the ability to coordinate the civic dialogue on
priorities and to mobilise awareness and political will. If combined,
the common action of these different stakeholders could manifest a
new era in formulating and implementing the global agenda.””” It is
important to mobilise multistakeholder dialogue and to generate the
required political momentum to build a sound global system for
biosecurity governance.
A GBN can also resolve the issue of a strong deficit of
coherence. It can overcome the _ pressing problem of
compartmentalisation at both the national and global levels. The
“fragmentation of negotiation and decision-making is increasingly
dysfunctional in a world faced by interdisciplinary challenges”.*° As
demonstrated in this book, many actors working in the field of
biosecurity try to resolve various issues in a largely independent
manner. This lack of coherence can affect the future outcome of the
proposed policies.*’ A unified, horizontal GBN can successfully
resolve this coherence deficit. It can also improve the present
accountability and transparency deficits by strengthening the voices of
diverse groups on governance of global biosecurity in the 21“ century.
In addition, globalisation has led to the need for global
decisions to be built on a solid ethical foundation, as decisions
affecting one culture or nation “might have consequences contrary to
the policies or doctrines of another country”.” Therefore, in order to
achieve the goal of sustainable biosecurity, the global community
should nurture an ethically conscious culture of biosecurity. Only by
adopting a new biosecurity paradigm will we be able to face the
challenges of global biosecurity in a constructive and original way.
3. Policy Recommendations
The following recommendations provide the global decision-making
community with an opportunity to design a new biosecurity paradigm
and tackle major biosecurity-related challenges in an inclusive and
creative way:
CONCLUSIONS 229
Create a global biosecurity network (GBN) that could offer
a promising answer to the existing organisational vacuum at
the global level. No single actor has the necessary knowledge
and capacity to successfully address the issue. A GBN could
provide a forum for analysis, discussion and negotiation, and
the elaboration or better implementation of relevant principles
and norms.
Foster a multistakeholder approach to tackling global
biosecurity issues. Engage governments, international and
non-governmental organisations, industry, science, and
academia. Clearly define their roles and responsibilities in the
process.
Build capacity for participation in global biosecurity
policymaking. Use a wide range of tools for participation and
consultation at the global level, including in developing
countries.
Design a global biosecurity strategy based on a shared
vision and common understanding of the problem by all
divergent communities able to develop coherent and
comprehensive global biosecurity policy.
Ensure that policymaking is more transparent, with clear
lines of accountability of all parties concerned.
Bridge the noticeable gap between global agendas on
biosecurity and priorities at the national level.
Analyse legally binding national and international policy
instruments designed to address major biosecurity-related
issues for the purpose of identifying cross-jurisdictional gaps.
Develop comprehensive national and global legislation
(specifically suited to the individual needs of each state) to
effectively protect and enhance biosecurity. This should focus
on monitoring and enforcement of the existing legal
mechanisms and on creation of the new ones.
230 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
10.
11.
2:
1a
14.
PS:
16.
i.
Strive to agree upon common definitions and discourses of
all biosecurity-related problems.
Address the issue of effectively regulating life sciences and
biotechnology-related research and products.
Educate the scientific community of life scientists about the
nature and the challenges of the dual-use dilemma in
biotechnology and their responsibilities to address and
manage its risks.
Promote a dual-benefits policy by crafting and
implementing multidisciplinary approaches to biological
security that serve to strengthen non-proliferation while
promoting the development of life sciences technologies that
contribute to society as a whole.
Develop sound policy guidelines associated with the
establishment, management, and governance of microbial
genetic databases.
Promote a culture of awareness and shared responsibility
throughout the global life science and biotechnology industry.
Introduce a review process both at the research stage and at
the stage of publication, with an emphasis on voluntary self-
governance by the scientific community.
Establish a global ethical oversight structure to regulate
life sciences and biotechnology-related research and ensure
that science is not misused.
Develop and enforce a new code of conduct for scientists
based on the values of humanity, humanness, and empathy.
This should aim to diminish the dangers associated with the
dual use of new technologies.
18.
20.
21.
pon
oa
24.
CONCLUSIONS 231
Strengthen the Biological Weapons Convention to make it
a more effective global instrument of global biosecurity
governance by developing a compliance and verification
mechanism in consultation with academia and the industry.
. Develop global standards for biological risk assessment.
Create new incentives for private-sector and academia
investment in the development of antimicrobial drugs.
Create an internationally harmonised regime for control
of pathogens within and between laboratories and facilities.
Address the human dimension of biosecurity as reflected in
the challenges of poverty, exclusion, and development. Work
on promoting biotechnology to fight poverty and exclusion.
Use the Millennium Development Goals as a strong
motivating force.
Make education, training, and communication a priority
within the new global biosecurity paradigm.
Foster a culture of shared responsibility for the future of
humanity.
In the 21" century, the challenges posed by the potential
proliferation of biological weapons, the global risks of natural or
deliberately induced outbreaks of infectious diseases, the dual-use
character and the dynamic nature of new technologies, combined with
the lack of globally agreed-upon biological norms and standards
guarantee that effective governance of biological security will require
a new comprehensive approach to tackling it. This should be rooted in
collaborative, mutually respectful action on the part of all actors
dealing with biosecurity concerns. In this context, we sincerely hope
that our proposed global biosecurity governance paradigm can help
the decision-making community in building such a solid biosecurity
governance system.
232 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
REFERENCES
' World Economic Forum in Collaboration with Citigroup, Marsh and McLennan
Companies, Swiss Re, Wharton School Risk Center, Global Risks 2007; A Global
Risk Network Report (Geneva, World Economic Forum, 2007), p. 6, http://www.wefo
rum.org/pdf/CSI/Global_Risks_2007.pdf.
* Ibid., p. 13.
3 “Anti-terrorism ‘on collision course’ with biotech for the poor”, OneWorld.net, 11
July 2007, http://uk.oneworld.net/article/view/128283/1/.
4 §.M. Block, “Living Nightmares: Biological Threats Enabled by Molecular
Biology”, in S.D. Drell, A.D. Sofaer, and C.D. Wilson (eds.), The New Terror:
Facing the Threat of Biological and Chemical Weapons (Stanford: Hoover Institution
Press, 1999), pp. 52-71.
> Ibid; K. Furukawa, “Challenges of Biosecurity from Japan’s Perspectives”, Regional
Biosecurity Workshop, p. 9, http://www.cissm.umd.edu/papers/files/singapore_ works
hop07_furukawa.pdf.
° Committee on Advances in Technology and the Prevention of Their Application to
Next Generation Biowarfare Threats, Development, Security, and Cooperation Policy
and Global Affairs Division, Board on Global Health, Institute of Medicine, Institute
of Medicine and National Research Council of the National Academies,
Globalization, Biosecurity, and the Future of the Life Sciences (Washington, DC: The
National Academies Press, 2006), p. 147.
’ United Nations, A more secure world: Our shared responsibility, Report of the
Secretary-General’s High-level Panel on Threats, Challenges and Change (New York:
United Nations Department of Public Information, 2004), p. viii, http://www.un.org/se
cureworld/report2.pdf.
* National Intelligence Council, Mapping the Global Future, Report of the National
Intelligence Council’s 2020 Project Based on Consultations with Nongovernmental
Experts Around the World (Pittsburgh, PA: Government Printing Office, 2004), p. 35,
http://www. foia.cia.gov/2020/2020.pdf.
° J.B. Tucker, “Biosecurity: Limiting Terrorist Access to Deadly Pathogens”,
Peaceworks, No. 52, 2003, p. 11, http://www.usip.org/pubs/peaceworks/pwks52.pdf.
'° Organisation for Economic Co-operation and Development, “Implementing
Biosecurity as a Complement to Innovation in the Biosciences”, Partnership for
Global Security, Washington, DC, 6 March 2007.
'' C. Streck, “The Role of Global Public Policy Networks in Supporting Global
Institutions: Implications for Trade and Sustainable Development”, SUTRA, p. 17.
http://www.agro-montpellier.fr/sustra/research_themes/global_governance/papers/Ch
arlotte_Streck.pdf.
'? 'W.H. Reinicke, F. Deng, J.M. Witte, T. Benner, B. Whitaker, and J. Gershman.
Critical Choices: The United Nations, Networks, and the Future of Global
Governance (Canada: The International Development Research Center, 2003),
http://www.idre.ca/en/ev-34663-201-1-DO_TOPIC.html.
' C. Streck, “The Role of Global Public Policy Networks in Supporting Global
Institutions: Implications for Trade and Sustainable Development”, SUTRA, p. 8,
http://www.agro-montpellier.fr/sustra/research_themes/global_governance/papers/Ch
arlotte_Streck.pdf.
CONCLUSIONS 233
'* Ibid.
'S Ibid.
'© ©. Streck, “Global Public Policy Networks as Coalitions for Change”, Global
Environmental Governance, p. 4, http://environment.yale.edu/documents/downloads/
o-wstreck.pdf.
“Progress Report: April 2007”, p. 5, www.helsinkiprocess. fi/netcomm/ImgLib/33/257
/HP_valiraportti.pdf.
?° Helsinki Process on Globalisation and Democracy, “Governing Globalization —
Globalizing Governance, New Approaches to Global Problem Solving”, p. 13, http://
www.helsinkiprocess.fi/netcomm/ImgLib/24/89/Track | pdf.
2! Ibid., p. 5.
2 TF. Budinger and M.D. Budinger, Ethics of Emerging Technologies: Scientific
Facts and Moral Challenges (New Jersey: John Willey & Sons, 2006), p. 1.
ee ee ee /
en
_
_ es ers ee
_—
INDEX
A
Aarhus Convention (United
Nations Economic
Commission for Europe
(UNECE) Convention on
Access to Information,
Public Participation in
Decision-making and Access
to Justice in Environmental
Matters), 178
ABC News, 34
Africa, 95, 101, 106, 111, 118,
164
sub-Saharan, 118
African Center of Legal
Excellence, 118
African-Eurasian Waterbirds
Agreement (AEWA), 170
AIDS, 57, 106, 118, 196, 208
Alexander II, 82
American Biological Safety
Association (ABSA), 28,
109
Amerithrax, 34
Amherst, Jeffery, 31
Annan, Kofi, 93, 196, 203, 208
Anthrax (Bacillus anthracis),
15, 29, 32-34, 42-44, 83,
96, 104-105, 121, 154
Anti-Ballistic Missile Treaty,
147
Strategic Arms Limitation
Talks (SALT) Accords,
147
Aquatic Animal Health Code,
112
Army Anti-Epidemic
Prevention and Water
Supply Unit, 32
Armenia, 121
Asia, 95, 111
Central, 163
South, 164
Southeast, 164
Association of Southeast
Asian Nations (ASEAN), 17,
100
Atlantic Storm, 103, 106
Australia Group, 87, 176-177,
205
Australian bat lyssavirus, 49
Avian flu (H5N1), 121
Azerbaijan, 122
B
Basel Convention on the
Control of Transboundary
Movement of Hazardous
Wastes and Their Disposal,
109
Belarus, 121
Bhagwan Shree Rajneesh, 33
Biocatalysis, 56
Bio-Chem Redirect Program
(BCR), 123
Biodefence, 42, 86, 174, 179-
180
Biodevelopment, 18, 139-140
Biolndustry Initiative (BID),
123-124
Bioinformatics, 55, 57, 59, 68,
138, 140, 224
Biological resource centres
(BRCs), 26, 68, 70
Biological Threat Reduction
Program (BTRP), 124
236 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Biological weapons (BW), 13,
17, 25, 27, 30, 39, 43, 60,
71, 81- 89, 94, 99, 101,
105, 117-118, 120, 122,
124, 139-140, 144, 153-
154, 171, 173, 177, 180-
185, 191, 202-203, 210-
211, 213, 223, 231
proliferation, 13-14, 16, 25,
99, 101, 122-124, 171,
77291. 205, 223,251
Biological Weapons Anti-
Terrorist Act (BWAT), 171
Biology, 55-59, 63, 71, 148,
154, 177, 184, 214, 224
molecular, 58, 153, 184
cellular, 63
synthetic, 71, 148, 160, 224
Bioproliferation, 118
Bioprospecting, 224
Biosafety, 13-14, 17, 23-25,
27-28, 43, 86, 101, 107-
110, 113-114, 116-117,
123-125, 155, 158, 164,
169-170, 175, 179, 183-
184, 191, 211, 215
definition, 23
Biosafety Clearing-House, 113
Biosecurity Engagement
Program (BEP), 123-124
Biosecurity
awareness, 143
definition, 24-28
legislation, 16, 81, 120, 170-
171,177
regulations, 101,117, 174,
215
standards, 18, 169, 174, 191,
210-211
BioShield Project, 103
Biotechnology, 13, 16-17, 39,
41-42, 44, 57-60, 62-63,
66-69, 71, 74, 86, 88-91,
94, 101, 109-111, 113-114,
116, 121-122, 124, 137-
141, 143, 148, 153-154,
158, 175, 177-178, 180,
191, 213, 223, 230-231
Biotechnology Research in an
Age of Terrorism, (Fink
Report), 60, 66, 158
Bioterrorism, 13-14, 17, 25,
28, 40, 60-62, 70, 91-93,
95, 97, 99-105, 117, 119,
122, 124, 139-140, 144,
154, 172-173, 176, 180,
184, 191, 205, 212
BioWatch Program, 103
BioWeapons Prevention
Project (BWPP), 86, 206
Bishkek Program of Action, 98
Black Death, 30-31
Black Sea, 31
Botulism (Clostridium
botulinum toxin), 44
Brain imaging, 71
Brazil, 59, 223
Brucellosis (Brucella species),
46
Brussels Declaration, 17, 82,
212
Bucharest Plan of Action for
Combating Terrorism, 98
Bush, George W., 102, 158
i
Canada, 59, 89, 99, 120, 122-
123, 164
Canadian Program on
Genomics and Global
Health, 139
Cancer, 57
Carnegie Corporation of New
York, 25
Cartagena Protocol on
Biosafety, 113, 175, 178
CARTaGENE, 68
CBS News, 34
Center for Strategic and
International Studies (CSIS),
86, 89, 101
Chemical and Biological Arms
Control Institute (CBACI),
162, 212
China, 30, 100, 138, 176, 204,
223
China Plague, 30
Cholera, 48
Clancy, Tom, 91
Climate change, 14
Code of conduct, 18, 72, 74,
86, 97, 109, 111, 114, 116-
118, 141, 158-163, 180-
182, 184, 211, 230
Code of Conduct for Scientists
in Relation to the Safe and
Ethical Use of Biological
Sciences, 116
Code of Pharmaceutical
Marketing Practices, 118
Codex Alimentarius
Commission, 112
COGENE, 68
Collection of Biosafety
Reviews, 116
Colombia, 49
Comprehensive Nuclear-Test-
Ban Treaty (CNTBT), 121
INDEX 237
Computer-brain interfacing, 71
Conference for the Supervision
of the International Trade in
Arms and Ammunition, 82
Convention for the
Supervision of the
International Trade in Arms,
Munitions and Implements
of War, 82
Convention on Biological
Diversity, 23, 58, 109, 113,
170, 175, 178, 213
Convention on International
Trade in Endangered Species
of Fauna and Flora (CITES),
170
Convention on the Prohibition
of the Development,
Production and Stockpiling
of Bacteriological
(Biological) and Toxin
Weapons (Biological and
Toxin Weapons Convention
(BWC or BWTC), 15-17,
71, 84-90, 93, 99, 101,
112, 117, 144, 147, 154,
160, 171, 178-185, 191,
199, 205, 213-214, 231
Ad Hoc Group, 85-86, 181
compliance mechanism, 16,
85, 179, 182, 214, 231
confidence-building
measures (CBMs), 16, 85,
179, 181-183
Review Conferences, 85-88,
90, 180-182
states parties, 84-89, 117,
160, 179-182, 184
238 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Council for International
Organizations of Medical
Sciences (CIOMS), 72
Counter-Terrorism Committee
Executive Directorate
(CTED), 92
Cryptosporidium parvum, 48
Cuba, 176, 223
Cybercrime, 94
D
Daar, Abdallah S., 140
Dakar, Senegal, 101
Daschle, Tom, 34
Declaration of Helsinki, 72
Dengue virus, 49
Diabetes, 57
DNA (deoxyribonucleic acid),
43, 55-56, 58, 61, 63-66,
71, 139, 153, 157, 160,
176, 212-213, 224
nanotechnology, 56, 63
recombinant technology, 56,
61
sequencing, 63-65
shuffling, 63, 65-66
silencing, 63, 65
synthesis, 63, 65, 71
DNA for Peace: Reconciling
Biodevelopment and
Biosecurity, 139
Dual use, 16, 27, 41-42, 60,
62, 70, 74, 86-88, 143,
153-154, 156, 162, 171,
176-177, 180, 182, 191,
211, 213, 224-225, 230-
231
E
Eaton, Cyrus, 147
Ebola, 34, 42, 45, 106
Economic Community of West
African States (ECOWAS),
17, 101
Ecosystem, 24, 170
Education for All (EFA), 141
Epsilon toxin of Clostridium
perfringens, 46
Equine encephalitis, 48-49
Equine morbillivirus, 49
Escherichia coli (0157:H7),
46, 49
Ethics, 62, 68, 70, 72, 74, 90,
109, 143-144, 158-159,
161, 214
Eurasia, 118
Euro-Atlantic Partnership
Council (EAPC), 98
EuropaBio, 25, 59
Europe, 31, 59, 101, 116, 164,
171
European Association for
Bioindustries, 25, 59
European Bioinformatics
Institute (EBI), 68
European BioSafety
Association (EBSA), 25, 28,
109
European Centre for Disease
Prevention and Control
(ECDC), 115
European Commission (EC),
74, 87, 97, 99, 114-115,
171, 177, 205
European Commission’s
Green Paper on Bio-
preparedness, 114
European Federation of
Biotechnology, 109
European Group on Ethics in
Science and New
Technologies, 74
European Health Strategy,
European Molecular Biology
Laboratory (EMBL), 114
European Union (EU), 17, 25,
59, 96-97, 105, 114-116,
120, 122, 170, 174, 176,
182
EU High Level Committee
on Health, 115
EU High Level Group on
Health Services and
Medical Care, 115
EU Programme of
Cooperation on
Preparedness and
Response to Biological
and Chemical Agent
Attacks, 96
EU Public Health
Programme, 114
Evian Summit, 99
F
Federation of American
Scientists, 17, 100
International Society for
Infectious Diseases, 100
Program for Monitoring
Emerging Disease
(ProMED-mail), 17, 100
Fink, Gerald, 60
Finland, 89, 120-121
France, 17, 89, 99, 103, 105,
120, 170
French War, 31
INDEX 239
Fund for Constitutional
Government, 157
G
G8, 17, 41, 89, 99, 120, 123,
140, 147, 205
G8 Global Partnership Against
the Spread of Weapons and
Materials of Mass
Destruction, 123
Gene (genomic) sequencing,
39, 64-65, 138, 140
Genetic engineering, 23, 39,
42, 56, 60, 62-63, 116,
184, 213, 224-225
Genetic manipulation, 41, 88
Genetically modified
organisms (GMOs), 23, 26,
60, 109, 114, 116, 170-
171, 178
Geneva, Switzerland, 82, 84,
160, 180, 210
Geneva Protocol, 15, 17, 82-
84, 88
GenomEUtwin, 68
Genomics, 17, 55, 57-58, 62-
65, 139
Georgia, 121-122
Germany, 99, 121, 164
Glanders (Burkholderia
mallei), 47
Global biosecurity network
(GBN), 200-201, 203, 206,
211, 225, 227-229
Global Conference on
Bioterrorism, 95
Global Environment Facility
(GEF), 114
Global governance, 16, 140
240 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Global governance continued
191-193, 195-196, 198-
200, 204, 207-208, 225-
226
biosecurity governance, 16,
18, 199-200, 231
Global Health Security Action
Group, 119
Global Health Security
Initiative (GHSI), 17, 99-
100, 119, 205
Global Higher Education for
Sustainability Partnership
(GHESP), 142
Global Outbreak Alert and
Response Network, 108, 204
Global public policy networks,
191, 199, 202-203, 225-
227
Global Strategy for Plant
Conservation, 170
Global Virtual University, 142
Golden Rule, 70
Green Cross International
Forum, 210
H
Hague Conventions, 17, 82
Hague Peace Conference, 82
Hantavirus, 106
Helleborus plant, 30
Helsinki Process on Global
Governance and
Development, 139
Helsinki Process on Human
Security, 139
Hepatitis B, 57-58, 121
Herkley, Karl, 58
Hippocratic Oath, 70
HIV, 106, 118, 121, 196, 208
Human Development Report,
137
Human Genome Project
(HGP), 64
I
Implementation Support Unit
(ISU), 181
India, 33, 138, 176, 223
Indian War, 31
Inter-American Committee
Against Terrorism (CICTE),
100
International Air Transport
Association (IATA), 109
International Centre for
Genetic Engineering and
Biotechnology (ICGEB),
116
International Civil Aviation
Organization (ICAO), 109
International Code of Conduct
on the Distribution and Use
of Pesticides, 111
International Committee of the
Red Cross (ICRC), 15, 17,
90, 108
Appeal on Biotechnology,
Weapons and Humanity,
90
International Consortium on
Law and Strategic Security,
118
International Council for the
Life Sciences (ICLS), 18,
162-164
International Council for
Science (ICSU), 118
International Criminal Police
Organization (Interpol), 17,
94-95, 100, 176
Bioterrorism Prevention
Unit, 95
International Ethical
Guidelines for Biomedical
Research Involving Human
Subjects, 72
International Federation of
Pharmaceutical
Manufacturers
and Associations, 118
International Fund for
Agriculture Development
(IFAD), 175
International Futures
Programme (IFP), 97
International HapMap Project,
68
International Health
Regulations (LHR), 100, 107
International Maritime
Organization (IMO), 170
International Maritime
Organization’s Convention
for the Control and
Management of Ships’
Ballast Water and
Sediments, 170
International Monetary Fund
(IMF), 213
International Plant Protection
Convention (IPPC), 111, 170
International Science and
Technology Center (ISTC),
18, 120
International Society for
Biosafety Research (ISBR),
116
INDEX 241
ISBR continued
Environmental Biosafety
Research, 116
International Weapons Control
Center, 118
Invasive species, 26, 111, 170,
178
Italy, 31, 99, 116
J
Japan, 17, 32, 34, 49, 83, 99,
100, 105, 120, 122
Japan Bioindustry Association,
59
Japanese encephalitis, 49
Johns Hopkins University, 103
Joint FAO/WHO Food
Standards Programme, | 12
K
Kampala Compact: the Global
Bargain for Biosecurity and
Bioscience, 118, 139
Kananaskis Summit, 89
Kazakhstan, 121
Kellman, Barry, 118
Keohane, Robert, 194
Kyrgyzstan, 121
L
Latin America, 95, 118
League of Nations, 82-83
Leahy, Patrick, 34
Life sciences, 13-14, 17, 27-
29, 41, 43, 55-57, 59, 60-
61, 66-69, 88, 117, 121,
123, 137-138, 140-141,
143-144, 153-155, 159-
160, 162-163, 175-176
242 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Life sciences continued
181, 183, 192, 203-204,
213, 215, 224, 230
Living modified organism
(LMO), 113, 178
M
Malaysia, 49, 176
Marburg, 45
Markov, Georgi, 33
Massachusetts Institute of
Technology (MIT), 60
Melioidosis (Burkholderia
pseudomallei), 47
Mexico, 99, 138
Microbial genome databases,
17, 67-68
Middle East, 164
Millennium Development
Goals (MDGs), 137, 139,
141, 231
Millennium Project Task Force
on Science, Technology, 137
Moldova, 122
Montreal, Canada, 113
Mousepox, 15
Multistakeholder diplomacy
(MSD), 206
Multi-sum Security Principle,
196
N
Nanotechnology, 17, 60, 62-
63, 66, 123, 148, 223
Napoleon, 32
NBC News, 34
Neoliberal institutionalism,
194-195
New Defence Agenda’s
Bioterrorism Reporting
Group, 212
New York, USA, 25, 32, 34,
103
New York City Office of
Emergency Management,
103
New York Post, 34
Nobel laureates, 147, 157
Nipah virus, 49
Nobel Peace Prize, 147
Noble, Ronald K., 95
Non-governmental
organisations (NGOs), 81,
86, 107-108, 121, 155,
162, 179, 192, 194-196,
200, 204-205, 207-208,
229
North American Indian
populations, 31
North Atlantic Treaty
Organization (NATO), 17,
98-99, 105
Norway, 121
Nuclear Non-proliferation
Treaty (NPT), 90
Nuclear Threat Initiative
(NTI), 162
Nunn-Lugar legislation, 41,
120
Nuremberg
Code, 72, 159
Trials, 82
O
Organisation for Economic
Co-operation and
Development (OECD), 17,
26, 68-70, 97-98, 105
Organization for Security and
Co-operation in Europe
(OSCE), 17, 98, 105
Organization of American
States (OAS), 17, 100
P
Pan American Health
Organization (PAHO), 91
Paris, France, 112
Pathogen, 14-15, 23-28, 40-43,
49, 61, 64, 81, 87, 89, 93,
101, 103-107, 112, 122,
124-125, 138, 140, 153,
157-158, 171-172, 179-
180, 182, 185, 213-215,
225, 2a
Plague (Yersinia pestis), 29-
32, 42, 44, 107
Plague of Justinian, 30
Polio, 39
Prague Summit, 98
Project BioShield Act, 172
Proliferation Security Initiative
(PSI), 177, 205
Proteomics, 63, 65
Protozoa, 25
Psittacosis (Chlamydia
psittaci), 47
Public Health Security and
Bioterrorism Preparedness
and Response Act, 102, 172
Public Population Project in
Genomics (P3G), 68
Pugwash Conferences on
Science and World Affairs,
147
INDEX 243
Q fever (Coxiella burnetii), 34,
47, 83
R
Ramsar Convention on the
Conservation of Waterlands,
170
Research
governance of, 18, 163, 215
Ricin toxin, 47
Rio Declaration on
Environment and
Development, 113
Rio Earth Summit, 113
Rischard, Jean-Francois, 199
RNA (Ribonucleic acid)
interference (RNAi), 56, 65,
224
Rockefeller Foundation, 138
Rosenau, James, 192
Rotblat, Joseph, 147-148
Ruggie, John, 192
Russian Federation, 25, 32, 85,
89, 101, 120-121, 123-124,
147, 163
S
Salmonella typhimurium, 33
Science and Technology
Center in Ukraine (STCU),
18, 120, 122-124
Sea Island Summit, 99
Senegal, 101
Severe Acute Respiratory
Syndrome (SARS), 30, 100,
106, 108, 204
Shigella, 46
Silk Road, 31
244 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
Singapore, 176, 223
Singer, Peter A., 210
Smallpox (variola major), 15,
31, 39, 42, 45, 65, 83, 104-
105, 119, 172, 213
Smallpox Emergency
Personnel Protection Act,
172
Social constructivism, 195
South Africa, 176, 223
South America, 49
South Korea, 121, 176
Spanish Flu, 30, 42, 213
Spath, Konrad, 196
Staphylococcal enterotoxin B,
47
Steck, Charlotte, 225-226
Stem-cell, 58, 161
Stockholm International Peace
Research Institute (SIPRI),
26
Stony Brook Forum on Global
Security, 144
Swamp fever (malaria), 32,
118
Sweden, 32, 89, 115, 120-121
Swiss-Prot, 68
Switzerland, 121
T
Tajikistan, 121
Tetanus, 39
Transatlantic Biosecurity
Network, 103
Tucker, Jonathan B., 183, 185
Tularemia (Francisella
tularensis), 45
Typhoid, 15, 33
Typhus fever (Rickettsia
prowazekii), 48
U
Ubuntu Declaration, 142
Uganda, 118
Ukraine, 18, 31, 120, 122-123
Unit 731, 32
United Kingdom (UK), 49, 59,
83, 85, 89, 99, 170
United Kingdom Biobank, 68
United Nations (UN), 17, 93-
94, 109, 117, 141-142,
179, 184, 193, 196, 208,
213, 226
Charter, 88, 92
General Assembly, 88-89,
93-94, 117
resolutions, 15, 84, 89, 142
Secretary-General, 84, 88-
89, 93-95, 176, 203
Security Council (UNSC),
42, 83, 89, 92-93
Resolution 1373, 92
Resolution 1535, 92
Resolution 1540, 42, 94,
176-177
United Nations Children’s
Fund (UNICEF), 108
United Nations Commission
on Global Governance, 193
United Nations Committee
of Experts on Transport of
Dangerous Goods, 108
United Nations Conference
on Environment and
Development, 178
United Nations Counter
Terrorism Committee, 92, 99
United Nations Development
Programme (UNDP), 137,
209
United Nations Disaster
Management and Training
Programme (DMTP), 96
United Nations Educational,
Scientific and Cultural
Organization (UNESCO),
109, 143, 161, 175, 213
UNESCO’s Bioethics
Committee, 161, 214
United Nations Environment
Programme (UNEP), 108-
109, 113, 175, 178
United Nations Food and
Agriculture Organization
(FAO), 25, 109-112, 175
FAO Emergency Prevention
System for Transboundary
Animal and Plant Pests
and Diseases, 111
FAO Working Group on
Biosafety, 110
United Nations Global
Counter-Terrorism Strategy,
93
United Nations High
Commissioner for
Refugees (UNHCR), 108
United Nations High-level
Panel on Threats, Challenges
and Change, 13, 137, 224
United Nations Industrial
Development Organization
(UNIDO), 108, 114, 116,
175
UNIDO’s Voluntary Code of
Conduct for the Release of
Organisms Into the
Environment, 114
INDEX 245
United Nations Literacy
Decade (2003-2012), 141
United Nations Model
Regulations on the Transport
of Dangerous Goods, 108,
179
United Nations Office at
Geneva (UNOG), 210
United Nations University
(UNU), 62
United States (US), 17, 24-25,
32-34, 39-40, 48, 59, 62,
83-86, 89, 96, 99, 102-103,
105-106, 120, 122-124,
154-158, 160, 162, 170-
174, 176, 180, 182, 205
Patriot Act, 172
United States Centers for
Disease Control and
Prevention (CDC), 102, 115
United States Customs and
Border Protection, 102
United States Department of
Agriculture (USDA), 24,
102, 1212423
United States Department of
Health and Human Services
(HHS), 61, 102, 123-124
United States National
Academies of Science, 27,
41, 158
United States National
Association of State
Departments of Agriculture
(NASDA), 24
United States National
Defense University, 91
United States National
Intelligence Council (NIC),
67
246 GLOBAL BIOSECURITY: TOWARDS A NEW GOVERNANCE PARADIGM
United States National
Pharmaceutical Stockpile
(NPS), 102
United States National
Research Council, 143-144
United States National
Science Advisory Board for
Biosecurity (NSABB), 27,
44,461; 176
United States Public Health
Security and Bioterrorism
Response Act (Bioterrorism
Act), 102, 172
United States Strategic
National Stockpile (SNS)
102
United States — Swiss
International Coordination
Exercise in 2006 (Black
ICE), 98
Universal Declaration on
Bioethics and Human
Rights, 161
Universal Declaration on the
Human Genome and Human
Rights, 213
Universal Postal Union (UPU),
109
University of Bradford
Project on Strengthening the ,
> ©
Biological and Toxin *- “+
Weapons Conventions, 86
University of Pittsburgh
Center for Biosecurity
University of Toronto
Joint Centre for Bioethics,
137, 139
Uzbekistan, 122
V
Venezuelan equine
encephalitis, 48
Vibrio cholerae, 48
Viral encephalitis
(alphaviruses), 48
Viral hemorrhagis fevers, 46
W
Washington, DC, USA, 86,
174
Washington Declaration, 117
Weapons of Mass Destruction
Commission, 199
Web 2.0, 67
Whitehead Institute for
Biomedical Research, 60
Whooping cough, 39
World Animal Health and
Welfare Fund, 112
World Bank, 213
World Commission on the
Ethics of Scientific
Knowledge and Technology
(COMEST), 109
World Economic Forum
(WEF), 29, 223
World Health Organization
(WHO), 17, 23, 26, 40, 94-
97, 99, 103, 105, 107-110,
112, 115, 175-176, 184,
204
WHO’s Global Outbreak Alert
and Response Network
(GOARN), 108, 204
World Intellectual Property
Organization (WIPO), 213
World Medical Association,
72, 117
INDEX
World Organisation for
Animal Health (OIE), 112
OIE’s Terrestrial Animal
Health Code, 112
World Summit for Sustainable
Development (WSSD), 141
World Trade Organization
(WTO), 112, 175, 213
World War I, 82
World War II, 83
X
Xenotransplantation, 58
Y
Yeltsin, Boris, 33, 85
ZL
Zoonoses, 26, 49, 109
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