SIPRI PROJECT “ADDRESSING FUTURE CHALLENGES TO THE BIOLOGICAL AND TOXIN WEAPONS CONVENTION IN CONNECTION WITH SCIENTIFIC AND TECHNOLOGICAL DEVELOPMENTS” Convergence between Chemistry and the Life Sciences – Points for Consideration Ralf Trapp 1. Who has said what about the convergence between chemistry and biology / the life sciences (or more broadly speaking convergence in the life sciences)? Alexander Kelle, Belfast University Workshop Report 20061 Some key areas of the revolution in the life sciences threaten to expand not only the range of toxic chemicals that could be misused for malign purposes but also our knowledge of the targets of potentially harmful biologically active chemical substances in the human body. In decades to come, this can be expected to shift the “focus of the proliferation problem from the chemical or biological warfare agent as object of malign manipulation to the physiological target in the human body as the object of attack.” Given a plethora of research activities over the last decade, such targets in the nervous, immune and neuro-endocrine immune systems today are much better understood and thus more susceptible to potential misuse. US National Academies, NRC, Lemon&Relman Report 20062 Knowledge, materials, and technologies with applications to the life sciences enterprise are advancing with tremendous speed, making it possible to identify and manipulate features of living systems in ways never before possible. Moreover, other fields not traditionally viewed as biotechnologies—such as materials science, information technology, and nanotechnology—are becoming integrated and synergistic with traditional biotechnologies in extraordinary ways enabling the development of previously unimaginable technological applications. It is undeniable that this new knowledge and these advancing technologies hold enormous potential to improve public health and agriculture, strengthen national economies, and close the development gap between resource-rich and resource-poor countries. However, as with all scientific revolutions, there is a potential dark side to the advancing power and global spread of these and other technologies. For millennia, every major new technology has been used for hostile purposes, and most experts believe it naive to think that the extraordinary growth in the life sciences and its associated technologies might not similarly be exploited for destructive purposes. John Hart and Ronald Sutherland, OPCW Academic Forum 20073 It is evident that barriers between biology and chemistry are continuing to disappear. This has implications for both the CWC and the 1972 Biological and Toxin Weapons Convention (BTWC). Although making more operational the connection in terms of scope of coverage between the two regimes is not acceptable politically, scientific and technological developments (including in the chemical industry) may make some degree of linkage in treaty implementation technically desirable and more politically compelling over time. Such a linkage or overlap also has uncertain institutional implications. The pace of change in the life sciences, in particular, is extremely high including, for example, in the field of agriculture, veterinary sciences and pharmaceuticals. The potential to synthesize a vast number of chemicals is increasing. The chemical industry is also increasingly versatile in terms of how it is organized and operated and the ability to produce a wide variety of chemicals on demand at short notice. 1 Peter Clevestig and John Hart, Working Paper, Polish Academy of Sciences Workshop Warsaw 20074 When reviewing the research which has awarded scientists the Nobel Prize in the fields of chemistry and medicine during the last three decades there is an evident increasing overlap of applications in medicine and life sciences by discoveries in chemistry. Perhaps this can be explained as an increasing focus on biochemistry for complementing the ever-expanding fields in biology, where chemical interactions have aided our understandings of the fundamental processes of life. Such processes are always chemical in nature but have always been put in relation to a larger picture, specifically in the term of function in relation to structure, and into the contexts of origin, environment and evolution. However, some research fields in the life sciences have an increased stake in chemistry, and are in many respects more potent to instigate dual-use concern than other life science fields. IUPAC Report for the 2nd CWC Review Conference 20075 Science and technology continue to advance rapidly in areas that directly relate to the scientific foundations of the CWC. A key feature in this process is that chemistry and biology are converging, thus reinforcing the importance of the overlap between the prohibitions and requirements of the CWC and the Biological Weapons Convention (BWC) Three aspects converge in this regard: the ability to synthesize and test large numbers of new chemical entities for biological activity; significant advances in the understanding of complex life processes in a post-genomic area; and the ability to model life processes and develop synthetic and virtual replicas of living organisms. All this is further amplified by an increasing integration of chemistry into biology, together with engineering and the information sciences. The expected benefits from these developments are significant, for example, in areas such as public health, food production, and pest control. However, there is also an increased potential for new chemicals with possible CW utility to be discovered by chance or developed by design. The advances in the life sciences may also lead to new risks in this regard. While this risk is moderated by the fact that considerable time and effort are still required to turn a candidate novel agent into an effective weapon, it also emphasizes the need to ensure that the prohibitions in the CWC and its implementation by States Parties be comprehensive and apply to all toxic chemicals and their precursors, whether listed in the Schedules or not. OPCW Scientific Advisory Board report for the 2nd Review Conference 20086 An important trend in the life sciences is the increasing convergence of chemical and biological systems, which results from an increasing understanding of complex life processes in the postgenomic era, along with the emerging ability to replicate life processes. These advances will undoubtedly lead to major benefits to humankind in the medical and other sciences, but there is also a clear potential for abuse. These developments reinforce the overlap between the Convention and the Biological and Toxin Weapons Convention, as does the increasing number of toxins and potentially toxic bioregulators being characterised. New biologically active molecules are being discovered at an unprecedented rate. For example, parallel synthesis and high-throughput screening are producing data on millions of compounds. The tools for such techniques are becoming widely available and could be selectively targeted at toxic molecules. Pharmaceutical and pesticide companies now hold huge databases of biological data that could be a source of prototypes for new chemical-warfare agents. It should, however, be noted that most of this data is now being generated through the use of in vitro assays and that relatively few investigations progress to the study of a compound’s toxicity in vivo. It should also be noted that the discovery of large numbers of biologically active compounds before highthroughput screening was introduced has had relatively little impact on the development of new chemical-warfare agents. Moreover, a major offensive programme would be required in order to convert a new biologically active toxic compound into a chemical weapon. 2 One area in drug research that is causing some concern involves compounds that could be developed legitimately within the constraints of the Convention as non-lethal agents for lawenforcement purposes. Such compounds clearly have dual-use potential. The accelerated discovery of drugs has resulted in the identification of many new compounds that act very selectively on the central nervous system, both regionally and with regard to receptor subtypes. It remains to be seen what challenge, if any, one or another of these compounds could pose to the Convention. It should be noted here, too, that although many extremely potent compounds that act on the central nervous system were discovered in period from the 1950s to the 1970s, only two types, anticholinergics and opioids, appear to have been developed into chemical warfare agents or non-lethal agents for use in law-enforcement. InterAcademy Panel on International Issues et al., International Workshop in Preparation of the 7th BWC Review Conference (Beijing 2010)7 Life sciences research is an increasingly global enterprise in which rapid advances promise important contributions to health, food, and energy challenges. However, concerns have also been raised that some of the tools, techniques, and materials developed to tackle these needs could be potentially misapplied. The workshop provided an opportunity for the international scientific community to discuss the implications of recent developments in science and technology that might be relevant to the development of biological weapons or to detection, diagnostics, or therapeutics that could affect potential prevention and response to biological attacks. 2. Why and how does this matter for CBW arms control? Historically, chemical and biological weapons were considered one type of weaponry. Our understandings or “poison” and “disease” were closely linked. Proposals for norms that attempted to regulate their (non)use in war addressed both agent types together (in fact, our scientific understanding would not have allowed their separation until the beginning of the 20th century). The partition of the CBW arms control agenda into two, covering separately chemical weapons and biological weapons, was done for pragmatic reasons at the end of the 1960ies. It reflected the political realities at the time in terms of what was achievable with regard to WMD arms control. Also, and despite similarities and close interactions, it reflected certain differences in the institutional structures that had evolved in science and technology and in the industries that supported the military use of chemical and biological agents as weapons. Since the beginning of the 1970ies, the two regimes have developed in separation from one another (except for the coverage of toxins which are governed under both regimes). Today, the global chemical weapons regime is set out in the Chemical Weapons Convention (CWC), with prohibitions on the development, production, stockpiling, acquisition, transfer and use of toxic chemicals as chemical weapons. The CWC establishes an international verification regime with declarations and a variety of verification measures, including routine on-site inspections and “special” inspections (challenge inspections and investigations of alleged use) to resolve compliance concerns and provide unequivocal evidence for any breaches of the treaty. It establishes an international agency to implement these verification measures and other implementation functions—the OPCW. The Biological and Toxin Weapons Convention (BWC) provides for a similar set of prohibitions (except that the prohibition on use of biological and toxin weapons 3 is implicit only—it has been formally recognised however by the parties of the treaty as part of the treaty norms, in a common understanding). At the international level, however, there is no institutional structure comparable to the OPCW, and there is no dedicated routine verification system. Compliance concerns need to be resolved through mechanisms of the United Nations and its Security Council. Allegations of BW use can also be investigated by the UN Secretary General under authority given to him/her by the UN General Assembly in the 1980ies. Both treaties are firmly anchored in science and technology. Their implementation requires measures by the States Parties (and in the case of the CWC by the OPCW) that aim at controlling activities and facilities involved with relevant materials, equipment and technologies that are of a ‘dual-use’ nature. Scientific and technological advances often require adaptations of the practical implementation systems. Such adaptation is essential to ensure the viability and applicability of the regimes in changing circumstances. Convergence is one of the drivers for the accelerating pace of advances in the life sciences. New scientific discoveries and breakthroughs often occur when hitherto distinct scientific disciplines start interacting and pooling theoretical concepts, understandings and experimental methods. As a consequence, science convergence makes unexpected breakthroughs and discoveries more likely (and their nature less predictable). This can create new risks and challenge existing implementation practices and understandings. 3. What is the likely impact of the convergence trends on arms control, and specifically on the BWC? Convergence in the sciences and technologies underlying the two regimes (CWC, BWC) may have an impact at different levels. Questions to consider may include: o With regard to the scope of prohibitions: does the CB conversion create gaps between the CW and BW regimes (either in terms of legal coverage or with regard to the practical application of control measures), and if so what is the remedy? o What new risk spectrum is emerging as a result of the CB convergence? o What are effective and appropriate measures to govern and control these processes and prevent the misuse of new discoveries (by States, by non-State actors) for hostile purposes? o Which opportunities will these trends create for the implementation of the two treaties, for ensuring compliance, and for creating benefits for society in the form of, for example, new goods, better services, new technologies, increased trade and economic growths and development? With regard to the prohibitions stipulated by the CWC and the BWC: o CB convergence reinforces the overlap between the two regimes (regarding the prohibition of toxins); 4 o But how far does the concept of “toxins” as applied in the BWC extend to biomolecules such as bioregulators, as well as their synthetic derivatives and analogues? o On the part of the CWC, how much bias results from the emphasis that verification (and some national implementation) systems place on scheduled chemicals? CB convergence affects the national implementation of both treaties. Here are some issues that may need to be analysed specifically in the context of the BWC: o How does legislation cope with the CB convergence, and (how) can control lists, review mechanisms and other regulatory and administrative mechanisms and tools keep up with new developments. o Should / can the CB convergence be reflected in institutional arrangements at the national level (e.g., a single authority for CW and BW arms control or WMD in general, combined or coordinated national control measures, interagency coordination issues, stakeholder outreach and awareness raising activities). Under the BWC, there is no international system to verify compliance (there is, however, the UN Secretary General’s mechanism to investigate alleged CBW use). Under the CWC, a routine verification system has been established, but this is largely prioritised around the CWC’s Schedules of Chemicals. Advances in science and technology that reflect the CB convergence largely happen in what the CWC calls “Other Chemical Production Facilities” (OCPFs). This verification system for OCPFs has at least 2 shortcomings with regard to CB convergence: it lacks focus because the nature of the chemicals manufactures is not revealed in declarations, and the thresholds for inspection are such that most facilities that manufacture chemicals of interest in the present context would remain under the radar screen of verification (not liable for inspection). Several questions then arise: o Can and should the CWC routine verification system be adapted to meet the challenges emanating from CB convergence? o What are the prospects of creating a verification system under the BWC? o What other compliance assurance mechanisms are available in case both answers are negative? Does the absence of international verification under the BWC matter? A key aspect of preventing future break-out attempts from the CWC and BWC regimes, and of averting the acquisition and use of chemical and biological weapons by terrorists or organised crime, is the strength of the defences against these weapons. Effective prevention, across-the-board preparedness, robust response and rapid recovery capacities all have a dissuasive effect on decisions to opt for the acquisition and use of CB weapons. 5 What, then, is the likely impact of the CB convergence on CB defence? o Research at the interface of chemistry and biology is likely to bring about new insights of how diseases work—which could lead to new treatments, and make available new molecules that could be effective prophylactics and treatments. In a broader sense, advances in science and technology including in nanotechnology and biotechnology are expected to enhance capabilities with regard to detection and identification, physical protection, medical countermeasures and decontamination. o The hope is that public health systems will be able to reap benefits from these new developments. Strong public health systems are an essential defence against biological (and chemical) warfare. o In addition, the investments into bio-defence programmes over recent years (since 9-11 and Amerithrax) aimed to strengthen defences against the use of biological and toxin agents. These programmes have certainly made use of new scientific and technological discoveries. On the positive side, the advances in the life sciences create new opportunities for enhanced international cooperation: o Seen by many developing countries as the flip side of BW disarmament, there are strong expectations that the revolution in the life sciences will lead to wider and deeper international cooperation, help improve public health systems and increase international exchanges in biological knowledge, materials, equipment and technologies. o Research and development at the interface of chemistry and biology are not the domain of developed countries. Much of it is basic and applied research, and spun off from it are practical applications in such areas as medicine, crop control, plant protection, animal welfare and energy production. These applications are closely linked to development goals such as improved health, longer life expectance, the fight against malnourishment and poverty, energy sufficiency and measures to contain the impact of global warming. Many countries around the globe are developing these branches of science and technology, international exchanges are numerous and intensive, trade in relevant products is expanding and globalisation contributes to the global distribution and diffusion of these capacities and technologies. Traditional non-proliferation concepts are increasingly missing the point. o The goal has to be how to manage expanding exchanges and collaboration in such a way that the new technologies are exclusively used for beneficial purposes. Policies that aim at strengthening compliance with the BWC need to be built around cooperative approaches that combine the promotion of international cooperation with governance measures to manage the risks. Finally, the cross-over between chemistry and biology creates challenges and opportunities with regard to the institutionalization of BW arms control: o Advances in the life sciences are happening at a fast pace. Perhaps more importantly, research at the interface of chemistry and biology is likely to lead 6 to surprises and unintended discoveries the direction and timing of which are hard to predict. o That calls for a different approach with regard to science and technology monitoring and assessment: whilst formal reviews (e.g., as part of the preparation and conduct of review conferences) remain important, they no longer suffice to guard against sudden changes in the S&T landscape. Something like an “early-warning system” may be needed. There may be reason to aim for: (a) A stronger mandate for the ISU to support such S&T monitoring and to alert States Parties of developments that may require their action; (b) A more systematic interaction between the BWC community and the professional life science community (e.g., through the IAP); (c) A stronger engagement with the industry, and (d) More flexible mechanisms to evaluate the impact of new S&T developments by the States Parties. 4. What should the 7th Review Conference do about it? This of course is the subject of discussions at the workshop. Measures that the 7th Review Conference could decide on, and where the EU may wish to develop common positions and policies, could relate to, for example: A further strengthening of the institutional support structures for the BWC at the international level, and in this context a more systematic approach towards science and technology monitoring and impact assessment; A further strengthening of governance and compliance mechanisms, including the development of a stronger relationship of the BWC policy community with the relevant sectors of industry and the scientific community; Technical assistance to strengthen national implementation capacity (going beyond framework legislation and addressing practical needs); Measures to strengthen governance in the life sciences (e.g., awareness raising, education, outreach, regulatory mechanisms based on catch-all principles), combined with measures to promote international cooperation in the field; Closer cooperation and coordination between the BWC community and the OPCW. References Alexander Kelle “The Changing Scientific and Technological Basis of the CBW Proliferation Problem – A Workshop Report”, Queen’s University Belfast 2006 2 National Academy of Sciences, “Globalization, Biosecurity, and the Future of the Life Sciences”, Committee on Advances in Technology and the Prevention of Their Application to Next Generation Biowarfare Threats, National Research Council Washington DC 2006 1 7 Ronald Sutherland and John Hart “Chemical industry verification under the CWC: scientific and technological developments and diplomatic practice” Paper presented at the OPCW Academic Forum 1819 September 2007 4 Peter Clevestig and John Hart “Implications of the Convergence of Biology and Chemistry in Arms Control”, Working Paper submitted to the conference “The Advancement of Science and the Dilemma of Dual Use: Why we can’t afford to fail”, Polish Academy of Sciences, Warsaw 9-10 November 2007 5 Mahdi Balali-Mood, Pieter S. Steyn, Leiv K. Sydnes, and Ralf Trapp “Impact of scientific developments on the Chemical Weapons Convention”, IUPAC Technical Report, Pure Appl. Chem., Vol. 80, No. 1, pp. 175–200, 2008. 6 “Report of the Scientific Advisory Board on Developments in Science and Technology for the Second Special Session of the Conference of the States Parties to Review the Operation of the Chemical Weapons Convention (Second Review Conference)”, OPCW Document RC-2/DG.1, Annex, 28 February 2008 7 http://dels.nas.edu/Past-Events/Trends-Science-Technology-Relevant/DELS-BLS-09-06 3 8