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Please enter a valid web address * About * Blog * Projects * Help * Donate * Contact * Jobs * Volunteer * People * Sign up for free * Log in Search metadata Search text contents Search TV news captions Search radio transcripts Search archived web sites Advanced Search * About * Blog * Projects * Help * Donate Donate icon An illustration of a heart shape * Contact * Jobs * Volunteer * People Full text of "Global Biosecurity " See other formats . f i / ar : , YE 7 , ar , cy ; ph ee Pd , ee ofa ae teed kh, . 1. : ; Pee he ton ee we Pky -* q fis’ ; ft : sy = cee Cad bP ORE MY > » i . i > Towards a New Governance Paradigm — 7 > a - ; d E 4.6 5? Fe ee ? } PATE TA ad, a tied (AF . . a Oe od , Md _ , f , ba 4 7 . , , ees ’ 7A v4 @ AD pat rae , rey? p ey x Had Jey pee , tg fe SE 969 ene “vst. f , , ; pay Pera Be ¢ Le ¢ ; ‘ » ve? 45 * / 5 4 Pi , P Ve ar) ote e» 7 j ‘ ‘ ) , ata : Fy , Ly Pes } : hy iy : > i 5 , ony y "9 =" rt ,4 AA : ; oP , , Pe ta N tad Se af yt? ’ y ; : or 4 ; : vy pF yg bey hoe a Ames ‘Aero Ne Pg See ie GA m4 , r > > ty » > J ; 9 “e . 1 NATIONAL LAW SCHOOL | OF INDIA UNIVERSITY | BENGALURU oe Please remember that this resource is meant for many other users like you, so do not tamper, tear or damage. We believe that it is an individual responsibility to care for library documents and other resources of institution. Please do check before you borrow, because you have to compensate if the material is returned in a damaged condition. _ 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, avan R National 1 20 Melgiri» aW Library rer vee Ov NOON eneeeniy 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 REFERENCES ' 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. “No Biosecurity without Biosafety: Biodefence Research Endangers the Public”, ISIS press release, 16 March 2005, http://www.i-sis.org.uk/Biosecurity Biosafety php. See Appendix 14A, “Enhancing bio-security: the need for a global strategy”, in R. Roffey and F. Kuhlau, SJPRI Yearbook 2006, Armaments, Disarmament and International Security (Oxford: Oxford University Press on behalf of Stockholm International Peace Research Institute, June 2006), p. 732, http://www.sipri.org/conte nts/expcon/cbw-yb2006 14a.pdf. R.M. Salerno and J.G. Koelm, “Biological Laboratory and Transportation Security and the Biological Weapons Convention”, SAND No. 2002-1067P, February 2002, p. 3s http://cns.miis.edu/research/cbw/biosec/pdfs/sandia.pdf. See the section “Policy and Regulation” on the website of the Third World Network’s Biosafety Information Centre, 5 July 2007, http://www.biosafety-info.net/s ection.php?sid=10. ” 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 toPower.pdf. Roffey and Kuhlau, op. cif., note 4, p. 732. ° L.A. Meyerson and J.K. Reaser, “Biosecurity: Moving Toward a Comprehensive Approach”, BioScience, Vol. 52, No. 7, July 2002, p. 594. ' National Association of State Departments of Agriculture, The Animal Health Safeguarding Review: Results and Recommendations (Washington, DC: NASDA, 2001), p. 1, http://citnews.unl.edu/i e/inthenews/re es/safe animal health. ? FN. Hegngi, “Overview of Biosecurity and Avian Influenza”, CDC/NIOSH/OSHA /USDA/INDUSTRY AI Symposium, 3 November 2004, http://www.cdc.gov/flu/pp/bi osecurity_on farm 11 2004.pdf. '3 Salerno and Koelm, op. cit., note 5, p. 7. '$ MJ. Zuckerman, “Biosecurity: A 21" Century pool nee Carnegie Challenge, p. 2, http://www.carnegie.or iosecuri lenge 'S European Union, “EU Paper on Biosafety and Biccseamae BTWC 6th Review Conference, Germany, 19 September 2006, p. 3, http://www.opbw.org/rev_cons/6re/d ocs/adv/BWC.Conf.VI_ EU_WP_01_ en.pdf. '© 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 Background Paper on three Agreements on Biotechnology, Health, and the Environment, and Their Potential Contribution to Biological Weapons Control”, October 2003, p. 2. 2° R. Roffey, “From bio threat reduction to cooperation in biological proliferation prevention”, Stockholm International Peace Research Institute, Background Paper 4, Conference on “Strengthening European Action on WMD Non-proliferation and Disarmament: How Can Community Instruments Contribute?”, Brussels, 7-8 December 2005, p. 27, http://www.pugwash.se/SIPRIEUPilotBioCTRRoffeyBP4.pdf. Dp. Kobyakov and V. Orlov, “The G8& Global Partnership on Weapons of Mass Destruction: What Next?”, GCSP Occasional Papers, No. 47, June 2005, p. 15, http:// www.isn.ethz.ch/pubs/ph/details.cfm?Ing=en&id=15553. 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, http://www. partnershipforglobalsecurity.org/Documents/gillespiepgsmarch2007.pdf. *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 Guidelines on Biosecurity for BRCs (Paris: OECD, 2007), p. 8, http://www.oecd.org/d 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 REFERENCES ' J. van Aken and E. Hammond, “Genetic engineering and biological weapons”, EMBO reports, Vol. 4, Supplement 1, June 2003, www.pubmedcentral.nih. gov/article render.fegi?artid=1326447. * See S. Squassoni, “Nuclear, biological and chemical weapons and missiles: Status and trends”, CRS Report for Congress, July 2004, RL30699. > R.J. Frerichs, R.M. Salerno, K.M. Vogel, N.B. Barnett, J. Gaudioso, L.T. Hickok, D. Estes, and D.F. Jung, “Historical Precedence and Technical Requirements of Biological Weapons Use: A Threat Assessment”, Sandia National Laboratories, May 2004, p. 11, http://www.terrorisminfo.mipt.org/pdf/Historical-Precedence-T echnical- Requirements-Biological-Weapons-Use.pdf. * J. Mackby, “Strategic Study on Bioterrorism”, Swedish Institute of International Affairs, Center for Strategic and International Studies, Russian Institute of World Economy and International Relations, Swedish Defence Research Institute, June 2006. > “Preventing the Entry of Weapons of Mass Effect Into the United States”, Homeland Security Advisory Council Weapons of Mass Effect Task Force, 10 January 2006, http://www.dhs.gov/xlibrary/assets/hsac_wme-report_20060110.pdf. ° Mackby, op. cit., note 4, p. 16. 7 World Health Organization, “Biorisk Management: Laboratory Biosecurity Guidance”, WHO/CDS/EPR/2006.6, September 2006, p. 3, http://www.who.int/csr/re 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 oject.org and www.nti.org. * 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 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. 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 Intertwined”, Science Progress, 16 October 2007, http://www.scienceprogress.org/20 07/10/dual-use-dangers/. '© K. Nixdorff, “Assault on the Immune System”, in United Nations Institute for Disarmament Research, Disarmament Forum: Science, Technology and the CBW Regimes (United Nations, 2005), p. 30, http://www.unidir.ch/pdf/articles/pdf-art22 16. df. 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 European Commission, “Life sciences and biotechnology — A strategy for Europe”, 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. 7, http://ec.europa.eu/biotechnology/pdf/com2002-27_en.pdf. 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, http://www.nap.edu/catalog.php?record_id=10827. 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 CONTAINING BIOLOGICAL RISK: BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS 83 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 CONTAINING BIOLOGICAL RISK: BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS _ 85 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 CONTAINING BIOLOGICAL RISK: BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS = 87 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 CONTAINING BIOLOGICAL RISK: 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 CONTAINING BIOLOGICAL RISK: BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS 91 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 CONTAINING BIOLOGICAL RISK: BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS 93 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 CONTAINING BIOLOGICAL RISK: BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS = 95 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: CONTAINING BIOLOGICAL RISK: BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS 97 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. CONTAINING BIOLOGICAL RISK: BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS 99 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 CONTAINING BIOLOGICAL RISK: BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS _ 101 [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. CONTAINING BIOLOGICAL RISK: BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS _ 103 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. CONTAINING BIOLOGICAL RISK: BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS _ 105 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 CONTAINING BIOLOGICAL RISK: BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS _ 107 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 CONTAINING BIOLOGICAL RISK: BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS _ 109 (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 CONTAINING BIOLOGICAL RISK: BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS | II11 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 CONTAINING BIOLOGICAL RISK: BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS — 113 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 CONTAINING BIOLOGICAL RISK: BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS _ 115 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 CONTAINING BIOLOGICAL RISK: BIOSECURITY-RELATED NATIONAL AND INTERNATIONAL NORMS 117 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 CONTAINING BIOLOGICAL RISK: 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. REFERENCES ' T. Taylor, “Safeguarding Advances in the Life Sciences”, EMBO reports, Vol. 7, No. S1, 2006, p. 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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. 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'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. 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'®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). : European Commission, “Life sciences and biotechnology — A strategy for Europe”, 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. REFERENCES ' 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. REFERENCES ' J.G. Ruggie, “Multilateralism: the Anatomy of an Institution”, in J.G. Ruggie (ed.), Multilateralism Matters: The Theory and Praxis of an Institutional Form (New Y ork: Columbia University Press, 1993), p. 11. 2 Ibid. > A.F. 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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. 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Enemark, “Infectious Diseases and International Security, The Biological Weapons Convention and Beyond”, Nonproliferation Review, Vol. 12, No. 1, March 2005, p. 118. ** 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. 7 T). Feakes and C. McLeish, “Biosecurity, Stakeholders and Networks”, University 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 Intelligence Council’s 2020 Project Based on Consultations with Nongovernmental Experts Around the World (Pittsburgh, PA: Government Printing Office, 2004), pp. 12-13, http://www. foia.cia.gov/2020/2020.pdf. 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. "1! R. Mason and I. Mitroff, “Complexity: The Nature of Real World Problems”, in B. 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 Arms Control Institute, “Countering Bioterrorism: How Can Europe and the United 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 ased: Approval: Ny Gratis: ial Acc No.: VZobUS Price: “Narayan Rao Melgiri” National Law Library AS _ Bangalore 247 E * NATIONAL LAW SCHOOL OF INDIA UNIVERSITY LIBRARY NAGARABHAVI, BANGALORE - 560 072. This book must be returned by the date stamped below P.T.O. Achevé d’imprimer en 2008 sur les presses de l’imprimerie Slatkine a Genéve (Suisse). 522 88%%n q NNN ee a ‘ ’ Spay oe" ~ 2 ASS, on a pAT AS ’ - “es q' . i . ’ cheep) Y rN ts : " vs sa ME RS OS, . wh as 4 VW Grz Bb ters hae” é ? 7 ’ * pm, oy *., ee NT St Pied +3 capable of addressing the comp virripn dara ory get pelle to as ae a i ary The 00k oullines a new ity governance. at is integr york: ‘based, flexible, open, cross-cultural, transparent, o siguiente coed 6 enejoges wide xy of overnments and nor profi it organisations fo private industry, ~ ia: This 1 son adds on mee perspec — and com- TS to 7 con rl nthe Jnternotionel Security Progr at rhe C Center br 3 : es fe Meehingien. DE, United States. the. ialeriational polly coven: to take | sity. The {justifiably} ambitious recommenda: - 3 basis for action. 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