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2 Plenary and Working Group Presentations and Discussions Summary of Plenary Presentations Plenary 1: Introduction to the Forum The plenary discussions at the 2nd International Forum on BioÂ security began with an overview of the issues to be dealt with during the meeting. Roderick Flower (William Harvey Research Institute, Queen Mary, University of London) introduced the Forum and highlighted the goals, objectives, and structure of the meeting. He placed the 2nd Forum into the context of a selected time line of international biosecurity ini- tiatives undertaken since 2001, including release of several influential studies, convening the 1st International Forum on Biosecurity in 2005 and a Royal Society-hosted meeting in 2006, production of the Statement on BioÂsecurity by the InterAcademy Panel on International Issues (IAP) and the development of further initiatives such as a code of conduct for biosecurity produced by the Royal Netherlands Academy of Arts and Sciences (KNAW) in 2007. The talk highlighted the progress made by the international scientific community in considering dual use issues in the life sciences, the challenges that remained to be addressed, and some of the opportunities that might be presented by the current intersessional process of the Biological and Toxin Weapons Convention (BWC). Robin Coupland (International Committee of the Red Cross [ICRC]), Ottorino Cosivi (World Health Organization [WHO]), and Alexandre Bartsev (Organisation for Economic Co-operation and Development [OECD]) next formed an introductory panel to provide further context in 23
24 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY which to locate the Forum discussions and possible frameworks within which to consider dual use life sciences issues. Drs. Coupland and Cosivi focused on public health approaches to the potential risks posed by the misuse of products of life sciences and bio- technology, particularly infectious microorganisms. Both the ICRC and the WHO have focused their efforts on analyzing risk factors, effects, and preventive measures. The ICRC has developed the concept of a âweb of prevention,â in which complementary and interacting efforts from multi- ple stakeholders combine to offer protection from an outbreak of disease. The presentation drew an analogy to the multiple layers of protection that help prevent or reduce injuries from fires, including smoke alarms, flame-retardant materials, sprinkler systems, and dedicated fire depart- ments. The talk also highlighted the role of the scientific community in fostering a safety and security culture and in raising awareness among scientists of potential risks related to the development, production, and delivery of microbial agents. Ottorino Cosivi provided Forum participants with a complementary framework used by the WHO in considering global health security. This consisted of a series of interlocking puzzle pieces representing contribu- tions from the areas of ethics, policy, collaborations and support, and labo- ratory safety and security, which together combined to form the norms, standards, and supporting activities to help manage health security risks. Risk management in this public health context could also be viewed as a matrix in which diverse actors on individual to international levels (including scientific associations, public health laboratories, publishers, funding partners, security communities, and the public) each undertake a range of activities to address components of this puzzle. As an intergovernmental body, WHO has focused many of its efforts on assisting member countries by working to develop risk assessment methodologies and to produce a tool kit of resources with multiple risk management options. WHO has formed a scientific working group on life science research and global health security that recommended five areas for action: education and training, disease outbreak preparedness, risk assessment methodology development, stakeholder engagement, and capacity building. WHO held a regional workshop in Thailand in Decem- ber 2007 that recommended further actions by both WHO and its member countries in many of these areas. âWHO (World Health Organization). 2007. Scientific Working Group on Life Science Research and Global Health Security: Report of the First Meeting. Geneva: WHO. WHO/CDS/EPR/2007.4 Available at: http://www.who.int/csr/resources/publications/deliberate/WHO_CDS_EPR_2007_4. â Research Policy and Management of Risks in Life Science Research for Global Health Security, Bangkok, Thailand, December 10-12, 2007.
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 25 Finally, Alexandre Bartsev spoke to the Forum about how OECD has incorporated biosecurity into several of its recent initiatives. The OECD considers having effective biosecurity procedures to be an enabling tool for economic development and innovation in science and technology. It supports the concept of Biological Resource Centers (BRCs) serving as important repositories of materials and information and has devel- oped best practice guidelines for biosecurity at such Centers. The OECD guidelines address maintenance, access, and distribution of biological materials held in BRC collections; the guidelines include recommenda- tions for undertaking risk assessments and for developing risk manage- ment procedures for pathogens with dual use potential. While the OECD currently consists of 30 industrialized nations, additional countries are in the process of accession and this organization has increased engagement with other rapidly developing countries, including China, India, and Brazil. OECD member countries will report to the Council in 2010 on the implementation of the BRC biosecurity guidelines; the OECD considers prospective member countriesâ implementation of relevant OECD acts and guidelines, including those on BRC biosecurity, as part of the acces- sion process. To assist member countries, the OECD will convene an inter- governmental forum to consider some of the issues remaining with regard to biosecurity risk assessments for microorganisms, including assessment methodologies, how to share and communicate assessments, how to con- sider local differences in risks and how to balance governance, so as to best enable continued science and technology innovation. Looking to the future, the OECD plans to hold a workshop in 2009 with the U.S. National Science Foundation. The workshop will focus on the biosecurity implica- tion of emerging technologies such as synthetic biology, and will explore ways to incorporate biosecurity practices into the internationally mobile scientific workforce. Plenary 2: Emerging Life Science and Technology: Challenges and Opportunities for Biosecurity The second plenary session of the Forum also looked to the future of the life sciences and addressed some selected highlights of recent scientific work. The three panelists for this session were Jason Chin (Cambridge University), JÃ¶rg Stelling (ETH-Zurich), and Jane Calvert (Edinburgh University). â OECD (Organisation for Economic Co-operation and Development). 2007. OECD Best Practice Guidelines on Biosecurity for BRCs (Biological Resource Centers). Paris: OECD. Available at: http://www.oecd.org/dataoecd/6/27/38778261.pdf. Accessed December 11, 2008.
26 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY Jason Chin spoke to the Forum about some of his work in synthetic biology, particularly on designing biological entities with new functions. He explained that the complexity of biological systems has led synthetic biologists to seek ways to reduce some of this complexity and introduce design principles by creating discrete modules to perform particular func- tions. The hope is that such modules could then be built up into larger assemblies to perform larger and more complicated functions. Analo- gies can be drawn to building circuits from combinations of resistors and capacitors, and then assembling such circuits into more and more complicated systems until a computer is constructed. Discrete biological modules have already been created to function as on/off toggle switches, oscillators, and edge detectors, for example. Although synthetic biology is still a fairly new field, it builds on advances in areas such as molecular biology and genetics and in technolo- gies such as rapid DNA synthesis. Improvements in rapid DNA synthesis and assembly and in the fidelity of synthesized and amplified DNA are both important developments for synthetic biology, allowing functional DNA products to be generated from databases or novel sequences. Tech- niques for generating mutations within DNA and for selecting mutations that lead to desirable phenotypes are also useful. However, the success rate is still very low and there are still limits on the DNA that can be suc- cessfully encapsulated into particular cell membrane shells. With further technological developments, the creation of a synthetic bacterium may be only several years away. However, Dr. Chin highlighted the conceptual difference between modifying something that already exists and creating something totally new. JÃ¶rg Stelling continued the discussion by considering the ways in which bioinformatics and computational tools contribute to designing new systems in biology, and the limits of these tools. The desired charac- teristics of a designed synthetic circuit include robustness (insensitivity to perturbations and noise), stability within the context of a biological system, tunability to control desired properties, and construction feasibil- ity. Dr. Stelling highlighted two large challenges that remain in working with biological systemsâthe complexity of such systems and the still incomplete characterization of all of the system components and their properties. Dr. Stelling presented a time-delay-switch circuit as an example. He compared a representation of a simple electronic circuit diagram with the biological version that consists of multiple interacting modules with overlapping functions. Principles of computational modeling and design can produce mathematical equations to describe how to characterize and fine-tune the biological âcircuit,â but they are complicated by the pres- ence of unknown parameters, lack of quantitative characterization for many components, and nonlinear behavior. Although such model-based
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 27 rational design of complete biological circuits is feasible in principle, it is currently only possible for simple designs. Rational, computational model-based design in biology poses some challenges that are new com- pared to traditional engineering disciplines. The expression of biology in terms of mathematical equations scalable to more complex systems remains the key challenge. The presentation ended with a quotation from the statistician G.E. Box that âall models are wrong; the practical question is how wrong do they have to be to not be useful.â Finally, Jane Calvert addressed the Forum to place some of the devel- opments in systems and synthetic biology into the broader context of changes in the life sciences. Dr. Calvert highlighted how systems biology, which studies the ways in which molecules work together in complex systems, opened the path to synthetic biology which aims to create and build new organisms. Both fields also consider the concept of modularity, where a discrete component is separated and studied from its surround- ing environment, leading to a goal in synthetic biology, standardized bio- logical parts. However, biological systems may also display principles of âemergence,â where a systemâs properties may turn out to be greater than the sum of the properties of its individual components. This property may then complicate the synthetic design goals of creating systems by linking together individual parts. A fundamental question also remains regarding the extent to which biology, with its inherent complexity and âmessiness,â can be made into a fully quantitative field analogous to other branches of traditional engineering. Dr. Calvert stressed that both fields of systems and synthetic biology have become highly interdisciplinary and can draw on expertise outside of traditional life sciences departments. The presen- tation raised the question of whether new types of academic structures would be needed to house this type of cross-disciplinary research. The new developments in these fields also raise interesting questions about data sharing and intellectual property. Electronic information, such as DNA sequences or computer code, is often the material being shared rather than physical samples. An âopen sourceâ ethic currently exists in some parts of the field, embodied by groups such as the BioBricks Reg- istry of biological parts. Having such open source biological information available to the research community might speed developments in the field in the same way that an open-source computer code can speed com- puter software developments. Another interesting question to consider is how easy synthetic biol- ogy currently is for nonexperts to perform. Despite the successes achieved in student competitions such as iGEM, practical applications remain â The 2008 International Genetically Engineered Machine (iGEM) competition Web site is available at: http://2008.igem.org. Accessed December 11, 2008.
28 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY some time away and, as the two previous presenters also highlighted, the inherent complexity of biological systems remains a great challenge. How- ever, the synthetic biology community has taken several steps to openly discuss and write about potential risks that might be posed by techno- logical developments in the field. Ethics-related sessions are included at the annual International Meeting on Synthetic Biology (SynBio), and the social science community has engaged the scientific community in considering the issues posed. In general synthetic biologists favor a self- g Â overnance model. However, such self-governance may not be as accept- able to all members of the NGO and public communities, some of whom have called for having a more inclusive public debate on the technologies and have pointed to a need to develop additional strategies to manage the potential risks that could arise from this technology. Plenary 3: Introduction of the Breakout Sessions After listening to the introductory panel survey several possible ways that the international community might think about life sciences and biosecurity issues, and also to the presentations highlighting scientific advances in emerging fields such as computational, systems and synthetic biology, the Forum participants considered the topics of the three working groups: (1) education and awareness, (2) oversight models, and (3) science advising. The chairs of each working group briefly summarized the objec- tives for their groups as well as some recent developments of relevance to their topics, so that all Forum participants would have a good sense of the workshop themes. Leiv Sydnes (University of Bergen and past President of the Interna- tional Union of Pure and Applied Chemistry [IUPAC]), Chair of working group 1 on education and awareness-raising, spoke on building a culture of responsibility. He highlighted some of the links between chemistry and biology and spoke of several ways in which the Chemical Weapons Con- vention (CWC) has brought chemical safety and security responsibilities into greater focus for practicing chemists. Industry initiatives including Responsible Care, REACH, and SAICM, have also contributed to a greater emphasis on chemical safety and will lead to enhanced under- standing of the toxicology of many chemicals being used. There has also been a greater focus on chemical safety and security as part of university â More information is available at: http://www.responsiblecare.org. Accessed December 11, 2008. â Registration, Evaluation, Authorisation and Restriction of Chemical Substances. Available at: http://ec.europa.eu/environment/chemicals/reach/reach-intro.htm. Accessed December 11, 2008. â Strategic Approach to International Chemicals Management. Available at: http://www.chem. unep.ch/saicm/. Accessed December 11, 2008.
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 29 chemistry education than has been the case in biology. Dr. Sydnes spoke of the need for collective understanding and acceptance of the reasons for building a culture of responsibility among practicing scientists to make such a culture an integral part of each given discipline. He highlighted several features of an effective culture of responsibility, including: wide- spread acceptance of the scientific basis for professional responsibility; risk assessment as an integrated aspect of the profession; the inclusion of ethics; and continuous evaluation and adjustment as necessary. He con- cluded by suggesting several types of educational measures that might contribute to the development of cultures of responsibility, including greater focus on ethical considerations as part of school curricula at mul- tiple levels, and greater incorporation of risk assessments into research projects as appropriate. In a similar manner, he suggested that greater awareness of the BWC and CWC and their implications might be useful tools to help educate both chemical and biological scientists. David Franz (Midwest Research Institute), Chair of working group 2 on oversight models, spoke to the Forum next. Dr. Franz emphasized that the key challenge in considering standards and methods for research oversight is to protect scientific creativity and discovery, while simulta- neously reducing the chances of the misuse of science to cause harm. He then explained the background of the creation and mission of the U.S. National Science Advisory Board for Biosecurity (NSABB), an advisory group created by the U.S. government and managed by the National Institutes of Health (NIH). The NSABB consists of 25 voting members appointed by the Secretary of Health and Human Services, and its charges include making recommendations to the U.S. government on criteria for identifying dual use research of concern (DURC), guidelines for over- sight of dual use research, needs in biosecurity education, creation of a scientific code of conduct, policies governing publication, communication and dissemination of dual use research, and strategies for engaging the international community in a dialogue on dual use biology research. The NSABB undertakes its mission through working groups on these various topics, and holds periodic public meetings to discuss the issues and prog- ress. Dr. Franz presented the definitions of dual use research and dual use research of concern adopted by the NSABB, as well as highlights from the Draft Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the Potential Misuse of Research Information sub- mitted by the NSABB to the U.S. government. This document considers â More information about the NSABB is available at: http://oba.od.nih.gov/biosecurity/. Ac- cessed on December 13, 2008. â Available at: http://oba.od.nih.gov/biosecurity/pdf/Fframework%20for%20transmittal%200807_ Sept07.pdf. Accessed December 11, 2008. DURC is a more limited category than the NSABBâs original charter, which was intended to cover general issues related to dual use research.
30 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY DURC to be only a small subset of dual use research. Oversight should focus on effective identification of such research followed by responsible conduct of research and dissemination of research results, not on prohib- iting or restricting the research itself from being carried out. He raised several broad questions for working group 2 to consider, including what was needed versus what was being done, key international challenges, and areas of scientific consensus. He concluded with a suggestion that perhaps consensus could be found on the global nature of science, the rapid pace of scientific developments and the many benefits provided by these scientific advances, the need for a culture of responsibility and awareness, and the need for multiple approaches to address biosecurity and dual use issues. Finally, Angelo Azzi (Tufts University and President of the Interna- tional Union of Biochemistry and Molecular Biology [IUBMB]), Chair of working group 3, spoke about the roles of the scientific community in providing advice on biosecurity policy issues. Dr. Azzi explained that IUBMB, like IUPAC, was interested in codes of conduct. He suggested that life science organizations consider drafting a universal code of conduct as a unique document to be made available to everyone. He explained that IUBMB has used science as a vehicle to reach out to many countries including Iran, where IUBMB recently held a conference. IUBMB can also help contact and inform publishers and journal editors about these issues. Dr. Azzi also emphasized that it is important to present a clear case as to why the life sciences community is undertaking work on bios- ecurity issues. Bertrand Russell and Albert Einstein, for instance, were motivated to write their Manifesto in reaction against the proliferation of the hydrogen bomb. Dr. Azzi suggested that the community could create similar statements to better illustrate the level of danger from dual use biotechnology. He also suggested that realistic scenarios and better risk assessment tools could be helpful in presenting the problem. The concept of biosecurity can be used to move from a culture of fear to a culture of peace. Plenary 4: Awareness About and Attitudes Toward Biosecurity Plenary session 4 explored the results of several recent projects. Li Huang (Chinese Academy of Sciences [CAS]) discussed the history of biosecurity activities through the IAP, including the production and dis- semination of the 2005 IAP Statement on Biosecurity. The IAP, then consist- ing of 93 academies of science throughout the world, formed a Biosecurity Working Group (BWG) in 2004 composed of the academies of science of China, Cuba, the Netherlands, Nigeria, the United States, and the United Kingdom. The working group drafted a biosecurity statement, which
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 31 was launched in 2005, and has been endorsed by 69 of the IAP member academies (see Appendix D). It has also cosponsored several meetings including the first and second International Forums on Biosecurity, is planning to conduct biosecurity surveys in sub-Saharan Africa, and is developing an online biosecurity resource tool kit for member academies to help further their own national activities. The BWG followed up the biosecurity statement launch by conduct- ing two surveys of IAP member academies to examine ways in which academies have made use of the statement. The IAP statement consisted of a set of guiding principles that should be considered in developing biosecurity codes of conduct; and the results of the two surveys show that it has been translated into 8 languages, has been posted on numerous academiesâ Web sites, and presented to national authorities by 20 acad- emies. Furthermore, seven academies have subsequently developed their own code of conduct and others have held conferences on topics related to biosecurity. Dr. Huang also reported to the Forum several of the issues that the IAP BWG had encountered as it developed and disseminated the biosecu- rity statement. Some member academies felt that biosecurity as conceived in the IAP statement was not a high priority, or that natural biorisks were of far greater immediate concern than was laboratory biosecurity. Issues were also raised about risks from possible restrictions on sharing bio- logical knowledge and information, and that such restrictions would be counterproductive to the goal of global biosecurity. In addition, there was concern about confusion over biosecurity terminology stemming from differing understandings and uses of the term. Dr. Huang reported on recent initiatives from the CAS as an exam- ple of one academy that has undertaken additional biosecurity-related activities. The CAS has established biosafety committees and training programs at each of its life science institutes, has actively participated in international biosecurity discussions through groups such as the IAP and the WHO, and through two workshops: the CAS-COMEST symposia on ethics in science in Beijing and Shanghai in 2005,10 and the upcoming international biosecurity workshop to be held in Beijing in late 2008. The U.S. National Academies also has an active program of engage- ment in biosecurity activities. Recently, for example, the National Acad- emies and the American Association for the Advancement of Science (AAAS) undertook a survey project on scientistsâ attitudes about bioÂ security. Ronald Atlas (University of Louisville) served as the chair of the 10â COMEST is the World Commission on the Ethics of Scientific Knowledge and Technol- ogy of the United Nations Educational, Scientific, and Cultural Organization (UNESCO). More information on CAS activities is available at: http://english.cas.cn/.
32 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY National Academies committee undertaking this work, and spoke to the Forum about the project. 11 The study was undertaken to help address the lack of quantitative data on life scientistsâ attitudes toward biosecurity and dual use biology. By conducting surveys to gauge scientistsâ views on potential biosecurity risks and the roles that various groups should play, and then relating these to particular subpopulation demographics, the study committee hoped to enable the design of effective methods to engage these various groups of life scientists in biosecurity concerns. The Web-based survey was conducted on a sample of 10,000 life scientist members of AAAS. Questions on the survey assessed respon- dentsâ perceptions of: the risk of bioterrorist acts, whether the respondent believed that the current research that he/she conducted was dual use, acceptance of options to address potential dual use issues, whose respon- sibility it should be to address such issues, and whether the respondent had personally taken any actions in response to concerns about dual use research. The 20 percent response rate (typical of Web-based surveys) lim- ited the ability to generalize from the results. However, Dr. Atlas reported that the study committee was currently analyzing interesting trends in the data and looked forward to the public release. When finalized, the report will be made available on the National Academies Web site.12 Finally, Brian Rappert (University of Exeter) spoke about the project that he and Malcolm Dando (University of Bradford) had been undertak- ing along with additional international colleagues. The project explores the construction of effective biosecurity education methods, the purposes of such education, and how education might best engage its intended audiences. To help answer such questions, multiple seminars have been conducted in locations around the world. At the time of the presentation the group had conducted 26 seminars in life sciences departments in the United Kingdom and had conducted more than 70 seminars in the United States, South Africa, the Netherlands, Finland, Japan, Israel, India, Argen- tina, Uganda, Kenya, Ukraine, and Australia. The seminars developed by the group seek to bring biosecurity dis- cussions directly to researchers and students, and are usually held as part of regular university departmental seminars. They are also structured 11â The Committee on Assessing Fundamental Attitudes of Life Scientists as a Basis for Biosecurity Education. More information is available at: http://www8.nationalacademies.org/ cp/projectview.aspx?key=48852. Accessed December 11, 2008. The report of the survey results and analysis was still in progress at the time of the Forum, and official results could not be released to the group. 12â Information about how to obtain the report, as well as information about other proj- ects and events, is available on the National Academies Biosecurity Web site http://www7. nationalacademies.org/biosecurity/.
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 33 to engage seminar attendees and to foster conversation about topics on which there may not be consensus, such as the extent to which publica- tion of dual use research should be restricted. Dr. Rappert reported on the broad results from the seminars. He indicated that, in general, partici- pants felt that potential dual use experiments should or would be done, that the publication of research results should not be restricted, and that additional oversight was unlikely to be viable or desirable. He further reported that the interactive nature of the seminars demonstrated the importance of the process of active discussion and deliberation, as most participants initially felt that biosecurity was not an important issue, but became more engaged with the issue through participation. The results highlight the need for further education and awareness raising. Finally, Dr. Rappert reported on continuing activities and initiatives in several of the countries visited as part of the seminar series, including the development of an educational module in South Africa and the imple- mentation of additional biosecurity legislation in Australia. Looking to the future, he concluded by suggesting that further dual use education could serve different purposes in different contexts. In countries where biosecu- rity concern is currently high, such education might help support national calls to action. In countries in which there is some degree of awareness of biosecurity, it might help promote partnerships among countries and promote existing resources. Finally, in countries with no current interest in biosecurity, education could serve as the means to raise the issue and begin the process of engagement. Plenary 5: The 2008 BWC Intersessional Meetings Ambassador Georgi Avramchev (Permanent Mission of the Republic of Macedonia to the United Nations Office at Geneva and Chair of the 2008 Meetings of the Biological Weapons Convention) described his vision for the upcoming BWC meetings. He emphasized the importance that he placed on including the voices of the international scientific community in the discussions. The Ambassador summarized the BWC provisions and described the current intersessional process, which has proven to be a valuable mechanism to address technical topics agreed on by States Parties to be of particular importance. Although the intersessional meet- ings do not negotiate international treaty commitments, they serve to help bridge differences of opinion among member states by promoting common understanding, discussion, and an atmosphere of collaboration. The meetings have also proven to be valuable in broadening the participa- tion and engagement of stakeholders beyond the diplomatic and security communities, and particularly expert communities in the life sciences, agriculture, public health, and education.
34 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY The Ambassador expressed his hope that the scientific community would provide valuable input into the topics to be considered over the next several years, while paying particular attention to the 2008 work program. The discussions at the August 2008 Meeting of Experts will consider: (a) national, regional, and international measures to improve biosafety and biosecurity; and (b) oversight, education, awareness raising, and adoption and development of codes of conduct. The December 2008 Meeting of States Parties will consider the results of the August technical discussions in the broader context of the BWC. The Ambassador endorsed the goals of the Forum in encouraging communication and cooperation among international scientific experts and organizations and in putting the issue of biosecurity on such groupsâ agendas. He expressed his hope that this would raise awareness and strengthen the important engagement of scientific experts with the work of the BWC. The Ambassador also spoke about his plans for the upcoming meetings, and of several proposals to States Parties to make them even more effective. These included a proposed online resource for States Par- ties to share national approaches to dealing with biosecurity, biosafety, and oversight issues, in the hope that such an option might improve efficiency of information exchange among States Parties and increase available discussion time during the Meeting of Experts. Poster sessions and discussion panels of experts have also been considered, and the Ambassador looked forward to the additional side events that serve as opportunities for experts to interact and for stakeholder communities to inform delegations. The Ambassador focused many of his remarks on concrete ways the scientific community might effectively contribute to the work of the BWC. In particular, he suggested holding events, both within the scientific community and as side events at the BWC meetings in order to: discuss biosafety, biosecurity, oversight and outreach; continue to produce reports and documents on such issues, which also served as valuable resources for the BWC Implementation Support Unit to draw on in preparing the background papers for the meeting; placing biosecurity issues on the agendas of scientific organizations; contacting national ministries of for- eign affairs about meeting preparations; and participating in other ways, such as by serving on a BWC discussion panel or presenting a poster. The Ambassador also thanked the organizers and participants for the valu- able contributions that their discussions at the Forum would make to his preparations for the upcoming 2008 BWC meetings.
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 35 Summary of Breakout Sessions Summary of Working Group 1: Education and Awareness Raising Chair: Leiv Sydnes Rapporteur: Alastair Hay Summary prepared by Jo Husbands Background Working group 1 discussed how to improve awareness among sci- entists about issues related to the use of the life sciences by states or terrorists for biological weapons. The groupâs suggestions are intended to help foster and sustain a culture of responsibility within the scientific community about the risks of misuse and the roles that scientists can play to help reduce them. To provide background for the discussions, several individuals were invited to make presentations about their activities. Working Group Presentations Dual Use Seminars. A series of presentations highlighted the lessons learned by collaborators in the course of an international project, âThe Life Sciences, Biosecurity, and Dual Use Research,â organized by Brian Rappert (University of Exeter) and Malcolm Dando (University of Brad- ford) (see Plenary 4 for more information). The project, sponsored by the Alfred P. Sloan Foundation, has conducted more than 70 seminars with over 1,600 total participants in a dozen countries during 2006 and 2007. Several of the projectâs international partners made presentations about their experiences with those seminars, as well as broader biosecurity issues in their countries. Katsuhisa Furukawa (Research Institute of Science and Technology for Society) began with an overview of Japanâs experience, the âtabooâ on biological weapons because of Japanâs use of them in World War II, and the role of biological scientists in Aum Shinrikyo. In Japan, biosecurity is a relatively new issue and is not considered to be a major risk relative to other security threats; therefore, activities there are focused largely on raising awareness of the issue. A recent law has substantially increased the requirements for security at Japanese laboratories. The remaining challenges are: â¢ How should the knowledge and expertise associated with dual use research be managed? â¢ What responsible management structure should be instituted at universities and academic institutions?
36 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY A continuing problem, however, is that the focus remains more on agents and equipment rather than on knowledge and techniques. Dr. Furukawa provided additional details about Japanese government policies and actions. With regards to engaging scientists and officials, he found substantial reluctance on their part to consider the possible nega- tive sides of advanced research. It was effective, however, to use examples of advanced research experiments to raise dual use concerns. He found that visits by experts and scholars, as well as general interaction with the international scientific community, were helpful in raising interest. Dr. Furukawa also identified several additional steps that could be taken: â¢ The exchange of experience and information about effective guide- lines to identify dual use experiments of concern. â¢ The creation of an educational module by gathering specific case studies of the misuse of scientific research to inform science students and researchers about the dual use challenges. It is also desirable to use such educational modules to educate other stakeholders, such as managers and administrators in universities, research institutions, and companies, as well as stakeholders in the government and media, when appropriate. â¢ The exchange of information about the efforts to address the chal- lenge associated with the access to research programs at universities by those individuals about whom there is potential concern for misuse, including those foreign students from countries that pose proliferation concerns. â¢ A more coordinated Asian region approach to assisting other coun- triesâ efforts on biosecurity. Animesh Roul (Society for the Study of Peace and Conflict) com- mented that, like Japan, bioterrorism risks in India were considered less urgent threats than terrorism involving nuclear and chemical materials and facilities. Biosecurity is also very much concerned with risks to agri- culture, and most of the potentially relevant regulation in India relates to pests or diseases that threaten crops or livestock. Through the seminars that he had helped organize in several uni- versities and research institutes, Mr. Roul concluded that most Indian biological scientists were: (1) very confident about their work ethics and responsibilities; (2) quite averse to the idea that there was something that they needed to learn and absorb, especially since it might restrict their research; (3) skeptical about possible misconduct by their own col- leagues and scientists generally; and (4) convinced that the bioterrorism/ biodefense issue was basically a Western (particularly U.S.-generated) concept and phobia. Mr. Roul found that, although the level of acceptance of dual use
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 37 concerns was low, there was a prospect for progress on increased aware- ness of this issue in the future. Senior/retired scientists were generally more interested and accepting of the dual use threat issue. Interactive seminars are always helpful in getting answers and ideas, but to develop that awareness further, focused discussions and workshops could be used to engage scientists. He concluded that a great deal of work remained toward raising the awareness level within the scientific community. ChandrÃ© Gould (Institute for Security Studies [ISS]) described the biosecurity efforts in South Africa, as well as the lessons learned from seminars and meetings that she had helped organize in Kenya and Uganda. In the South African case, she noted that, although the govern- ment had put national measures in place against biological weapons and was actively engaged on the international level, bioterrorism was not regarded as a significant risk. There was also limited outreach capacity and little engagement with the scientific community. She also described a variety of activities and involvement by parts of civil society, although engagement was low relative to other biotechnology issues, such as con- cerns about genetically modified organisms (GMOs). Dr. Gould helped organize several seminars for Rappert and Dando, and found that previous contacts with the universities made the task easier, although she nonetheless found it difficult to convince several universities and departments of the importance and relevance of dual use issues. The involvement of academics from outside the country made the topic more attractive for South Africa, although slow responses compli- cated logistical arrangements. She reported that the seminars had evoked a mixed response from institutions in terms of research oversight and policy responses to biosecurity issues. The most positive response came from the National Institute for Communicable Diseases. This was the third of several meetings and led Dr. Gould to conclude that repeated interactions built trust, interest and buy-in. In Kenya and Uganda, Dr. Gould and her colleagues found that âbios- ecurityâ was a term associated with GMOs, which complicated discus- sions. Again, she found that logistical issues presented significant chal- lenges; the presence of an ISS office in Nairobi was essential, as well as local assistance and buy-in. Here the contacts that Rappert and Dando had made with a leading Ugandan scientist at the 2006 Royal Society workshop on trends in life sciences that were relevant to the BWC, proved to be extremely helpful. It proved difficult to convince several universi- ties and departments of the importance and relevance of dual use issues, and there was also sensitivity from some about becoming involved in a national security issue (as was also true in South Africa). In spite of these obstacles, Rappert and Gould were able to conduct a series of very effective meetings involving policy makers and civil
38 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY society representatives. They were also able to use the time in Kenya and Uganda to develop additional contacts, including Ugandan parliamentar- ians. These discussions helped lay the groundwork for a workshop on biosafety and biosecurity organized by the Uganda National Academy of Sciences (see working group 3), which brought together scientists and policy makers from eastern and southern Africa, and stimulated further collaboration among a number of organizations in the region. Recently, Dr. Gould has been engaged in developing an educational module on dual use issues relevant to specific national circumstances, including national regulatory environments. In the future, she will con- tinue collaborating on policy discussions and development in other coun- tries with the contacts that she has developed. Given the reluctance of many scientists to become engaged in dual use issues, she emphasized the importance of repeat visits and relationship development. She noted the frequent difficulty of identifying the right people to talk to on the first visit. Dr. Gould concluded by saying that international policy develop- ment is a slow and sometimes painful process. Lessons from Biological Weapons Programs for Education and Awareness RaisÂ ing. Iris Hunger (University of Hamburg) started by discussing the cur- rent focus on scientists as an important target for biological weapons control efforts. This is illustrated by the focus of the 2008 BWC interses- sional meetings, cooperative threat reduction programs directed at former weapons scientists, and various national measures to restrict scientific activities, such as increased controls on dangerous pathogens. She drew on a number of case studies to ask whether this focus was justified. She asked if it was indeed true that scientists had a decisive influence on the initiation, shape, and elimination of bioweapons efforts? Among the possible âproactiveâ activities of scientists, based on an analysis of several historical cases, she cited: lobbying for the establish- mentâor for the terminationâof a biological weapons program; the unre- quested development of proposals for enhanced or new types of biologi- cal weapons; and the conscious distortion of technical and scientific data to hasten or hinder a weapons program. Dr. Hungerâs research found that there were cases (South Africa and Japan) where a single scientist or physician essentially started and ran a biological weapons program. There was also a case (Germany) where scientists did lobby for a weapons program, but were largely unsuccess- ful. She found that often scientific advisory bodies worked on the basis of responding to questions, instead of setting an independent policy agenda. There were also several instances (the United States and the United King- dom) of scientific advice being ignored, and scientists complaining about not being taken seriously. She cited a case (the Soviet Union) where sci-
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 39 entists successfully proposed and pushed for new types of weapons. She also cited a case (the United States) where a group of scientists was instrumental in ending a weapons program. Her research has led her to three hypotheses: Hypothesis 1: (a) Scientist-based approaches are most promising if aimed at identifying biological weapons programs (âwhistle blowingâ) and slowing and stopping them. (b) Scientist-based approaches are less promising if aimed at preventing weapons activities; that is, stopping a country or a nonstate actor from developing weapons. Hypothesis 2: (a) Scientists contribute to bioweapons efforts through (i) conscious participation, (ii) negligence (âI knew, but I did not careâ), and (iii) willful ignorance (âI did not knowâ). (b) Scientist-based approaches are most promising if aimed at preventing scientists from becoming bio- weaponeers, because of a lack of knowledge. Hypothesis 3: Scientist-based approaches are most promising if aimed at democratic societies and/or open scientific communities. These hypotheses have implications for any program that aims to raise awareness or provide education about dual use issues. An Example of Education Modules: IUPAC and the Organization for the ProÂ hibition of Chemical Weapons (OPCW). Alastair Hay (University of Leeds) presented an example of an educational module developed to address dual use issues for undergraduates in chemistry. The module is a joint effort between IUPAC and OPCW. The module is intended to raise aware- ness about the Chemical Weapons Convention. Dr. Hay cited some of the following challenges to the education and outreach efforts related to the CWC: â¢ Relevance and ownership by teachers and students in many countriesââthe CWC is âsomeone elseâs problemâ â; â¢ Concerns about the negative impact on the public image of chemistry; â¢ Limited knowledge of the CWC and dual use issues among chem- istry teachers at all levels; â¢ Little attention to ethical issues of any sort in the curriculum; â¢ Remoteness of the CWC structure to the educational system. The approach that the IUPAC education group has taken is to place chemical and biological weapons in the larger context of multiuse chemi- cals. The developers of the educational module consider it essential to start with the beneficial aspects of multiuse chemicals and then move on
40 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY to the issues of abuse and misuse. The module is targeted at chemists and chemistry educators in the domain of influence of IUPAC and OPCW. The project considered it important to pilot materials with educators and to evaluate them from the beginning, in order to refine materials and approaches. The materials are designed to be delivered over the Web and were piloted in several countries to address language issues. The project also sought to enlist partners for broad dissemination. The module moves from the beneficial effects of natural and manu- factured chemicals to familiar examples of misuse such as ephedra and methamphetamine. It emphasizes that the choices about beneficial use, misuse, or abuse lie in our own hands. The role for science education is thus to consider issues of access to information and the risks of diversion of readily available materials. This leads to questions of who has respon- sibility with the aim of fostering understanding and ownership of ethical responsibility. The module then turns to chemical weapons, again empha- sizing the multiple uses of the basic chemicals, and providing examples of both historical (World War I) and more recent use (civilian areas in Iran and Iraq). The project is now completed and the materialâtext and picturesâis available on the Web along with four background papers in six languages.13 Building a Culture of Responsibility. Gerald Epstein (Center for Strategic and International Studies [CSIS]) gave a presentation with two goals: (1) to recap the development to date of a âculture of responsibilityâ or gov- ernance within the synthetic genomics community; and (2) to describe a new CSIS project to broaden the culture of responsibility beyond synthetic genomics, and to extend it outside the scientific community. Synthetic genomics is the ability to construct and âbootâ long strands of genomic material, and thereby to construct organisms (viruses and eventually higher life forms) within specified genomes. He reminded the group that synthesis is not the only way to construct genome-length strands of DNA, and that synthesis technologies are pervasive in biologi- cal applications other than constructing genomes. In terms of the attitudes of the synthetic genomics community toward governance, Dr. Epstein commented that many leading synthetic genomics researchers have ini- tiated and/or participated in governance activities. Some researchers, however, have a problem with âarbitraryâ focus on one way to construct genomes while ignoring others, and some worry about catering to what they feel to be unwarranted public perceptions. 13â Website for âRaising Awareness: Multiple uses for chemicals and the chemical weapons convention (IUPAC Project 2005-029-1-050)â is available at: http://www.multiple.kcvs.ca/. Ac- cessed on December 11, 2008.
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 41 Dr. Epstein reviewed a variety of governance proposals and studies, both from inside and outside of government, though to date most of the work has been on the outside. He asked whether there is a âwindow for governanceâ in the development of a technology where effective gover- nance mechanisms might be desirable. This window would occur some- where between when the technology is nascent and controls are infeasible or unnecessary (âtoo early to tellâ), and when it has matured and become so pervasive that control is impossible (âtoo late to changeâ). Dr. Epstein commented that, next to nanotechnology, synthetic genomics may be the most assessed and analyzed field that does not yet exist. It is already impossible to have an internal, scientific community- only discussion of potential governance mechanisms. The press and key stakeholders are watching very closely, but the problem of defining who is a âstakeholderâ is a major issue. This is relevant to broader aspects of creating a culture of responsibility for the life sciences, which must also address issues of awareness and education within the community, engagement with other communities and governments involved in man- aging relevant risks, engagement with other stakeholders and the public, and participation in global governance. Dr. Epstein emphasized the many facets of the deliberate use of biol- ogy to cause harm and the many communities that would have to be engaged in preventing, detecting, and responding to incidents. Each com- munity must see how its activities play a role in reducing biothreats; each community must understand how biothreat reduction activities could affect its own mission, if at all; and each community needs to know about other communities, and how their actions impact on one another. Yet none of the communities has the reduction of biothreats as its primary mission. Traditional top-down, hierarchical governance structures are poorly suited for issues such as biorisk management, which Dr. Epstein argued are highly decentralized, highly interdisciplinary and cross-community, rapidly evolving and highly S&T dependent, significantly driven by non- state actors, global more than international, and which lack consensus as to the nature and magnitude of the problem. The new CSIS project, the Global Forum on Biorisks, is intended to address this problem. The forum is based on the belief that, whatever the answers are, they will arise from a bottom-up, decentralized process of engagement, interaction, assess- ment, and analysis among all relevant professional communities around the world. The project is implementing a highly interactive, professional community-based Web portal to facilitate these interactions. Dr. Epstein believes that it will be an ideal environment in which to continue the kinds of discussions taking place in the forum, and invited the partici- pants to join when the forum is up and running later in the year.
42 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY Working Group Discussions The working group discussed questions and issues raised by the pre- sentations, as well as reflected on several questions that were posed to the group to help initiate dialogue. The questions were: â¢ What kinds of awareness raising and educational activities are needed? What are some examples of current projects and activities? â¢ What particular challenges are faced by those trying to develop a âculture of responsibilityâ? â¢ What are some of the lessons learned from your work and what advice would you give to others planning activities? â¢ Are there particular unmet needs or opportunities on which groups might focus? Results The group made two general suggestions. First, along with the other working groups, group 1 noted the difficulties posed by the many different meanings of the term âbiosecurity.â This can lead to substantial confusion and the group suggested, therefore, that when biosecurity was discussed, the issues should be presented in simple, easily understood terms. For example, biosecurity could be broadly defined as âmeasures to reduce the risk from the natural, accidental, and deliberate spread of disease.â Second, the group supported, to varying degrees, ongoing activities to develop and promulgate codes in the life sciences. The members of the group did not agree about how much codes of conduct would contrib- ute to efforts to prevent misuse in this area, given historical experience. They did agree that codes of conduct as part of a broader approach to biosecurity, could help both to raise awareness and to foster a culture of responsibility in the scientific community, and thus could contribute to educational efforts. There was strong support for the IAP Statement on Biosecurity (see Appendix D) as providing essential principles that any code of conduct should include. The group, therefore, encouraged governments to support initiatives to implement the Statement through the development of new codes by national scientific bodies, such as acad- emies and professional societies, or the modification of existing codes to include biosecurity issues. There was also discussion about the impor- tance of encouraging participation by as many stakeholders as possible in the process of drafting codes of conduct, so that, through discussion, they will share and enhance awareness of the issues. In addition, the view was also expressed that each stakeholder institution should be encour-
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 43 aged to develop its own codes, applicable to its own circumstances, and articulated to its own audiences. The group also made suggestions for actions in four specific areas: Awareness Raising. The group agreed that it was vital to raise awareness among scientists, and life scientists in particular, about: (a) the threats from natural, accidental, and deliberate spread of disease; (b) the his- tory of biological warfare and biological weapons programs; (c) the dual use dilemma posed by life sciences research; (d) the prohibitions and obligations imposed by the BWC; and (e) national laws and regulations intended to mitigate the risk that life sciences might be misused. There was also discussion that such awareness-raising efforts should not neces- sarily be limited to scientists alone, but should include other stakeholders, such as managers and administrators in universities, research institutions, and companies, as well as stakeholders in the government and media. The group suggested that a program to raise awareness should be developed in such a way that it could benefit from and support the BWC process. Because awareness raising is a continuing process that will have to be sustained over many years, it is important to involve governments, since they can provide resources and support, even if the efforts are car- ried out by independent scientific bodies. An endorsement by the BWC process could help commit member states to this effort. Education. The Group made a number of suggestions related to education. First, the scientific community needs to ensure that ethics training was mandatory and is supported by adequate resources. Good teaching mate- rial with appropriate case studies will be needed to support this training. The materials will need to include the issues identified as important under âawareness raising,â as well as materials related to a scientistâs per- sonal responsibility for the conduct of his or her own research or research that she/he supervises. Although some materials exist for these purposes, education packages need to be developed, and the Group suggested that strong support, including essential financial resources, be dedicated to these endeavors. General ethics training is already provided for scientists by many uni- versities and some of this material may be useful for education. As educa- tion efforts continue and new programs are developed and implemented, there will be a need to share best practices. The Group therefore suggested that a clearinghouse or repository be established to identify useful edu- cational resources and to share best practices and lessons learned from different training experiences.
44 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY Industry and the Private Sector. The group concluded that there is a need to expand the engagement of industry and the private sector in the aware- ness-raising process. Many of these organizations have experience with training and can contribute to education. The group suggested that, where possible, CEOs and senior scientists in industry be approached and encouraged to become involved. Resources. In 1986, the 2nd BWC Review Conference identified the impor- tance of education and awareness for the successful implementation of the Conventionâs goals. Current evidence suggests that awareness of the BWC and the challenges of biosecurity remain low within the life sciences com- munity. As mentioned above, raising awareness will take considerable time and resources. In particular, funding will be needed to design appro- priate teaching materials and to assess their efficacy. The group suggested that the States Parties to the BWC should provide sustained funding for education modules and awareness raising, and that these Parties should commit at the 7th Review Conference in 2011, to report annually on their efforts to promote education. Finally, the group suggested that a task force be established under the auspices of the IAP Biosecurity Working Group to consider: â¢ Where and how best to establish and operate a clearinghouse; â¢ How to achieve the objectives for education, for awareness raising and for involving industry and the private sector; and â¢ How to secure resources to fund the various initiatives. Highlights of the group discussions and suggestions were presented by Alastair Hay to the entire Forum in one of the final plenary sessions. Summary of Working Group 2: Oversight of Research Chair: David Franz Rapporteur: Neil Davison Summary prepared by Ben Rusek Background During the proceedings of working group 2, Chair David Franz guided the group on a discussion of important issues related to research oversight. Several individuals were invited to make presentations about their activities, so as to provide background for the discussions.
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 45 A Prototype Protective Oversight System. Elisa Harris (Center for Interna- tional and Security Studies at the University of Maryland [CISSM]) pre- sented her projectâs proposed system for oversight of dual use research. She explained that increasing attention to the dual use problem has raised questions about the adequacy of existing oversight. Concerns about new dangers can arise from unexpected results, from misuse of legitimate research, and from the blurred line existing between offensive and defen- sive research. Recent examples include experiments involving mousepox, polio virus, and influenza.14 Ms. Harris said that any measures taken to address dual use issues must be balanced between protecting the right of scientific investigation and enforcing the norm against the destructive applications of biology. It is also important to reassure scientists that they would not be subject to excessive regulation, and to reassure society that the power of biology was being used appropriately. As Ms. Harris explained, the essential features of the CISSM model are: it is narrowly focused and excludes most biomedical/pathogen research; it is readily implemented and the definitions of covered activi- ties are provided in checklist form; it is a practical response to the threat and combines agent- and activity-based approaches; and it is a tiered design with local review being most predominant. Licensing or registra- tion of certain personnel and facilities and independent peer review of certain research projects are key elements. The proposed system would apply to all relevant institutions: government, academic, and industry. CISSM also proposes oversight methods on the national and interna- tional level. National review bodies would oversee and approve research of moderate concern (e.g., work with specific listed agents, particularly activities that enhance virulence, transmissibility, or weaponization). The proposed global implementing body would oversee and approve research of extreme concern (e.g., work involving the most dangerous of currently known pathogens, or possibly resulting in the creation of a significantly more dangerous pathogen). Ms. Harris recognized that the international oversight arrangements were not going to happen overnight. She discussed some of the incremen- tal steps that would need to take place in order to move toward the CISSM model. These included implementing codes of conduct and education and 14â Jackson, R.J., A.J. Ramsay, C.D. Christensen, S. Beaton, D.F. Hall, and I.A. Ramshaw. 2001. Expression of mouse interleukin-4 by a recombinant ectromelia virus suppresses cytolytic lymphocyte responses and overcomes genetic resistance to mousepox. Journal of Virology, 7(3):1205-1210; Wimmer, E. 2006. The test-tube synthesis of a chemical called poliovirus. EMBO Reports 7(Special Issue):S3-S9; Tumpey, T. M., C.F. Basler, P.V. Aguilar, H. Zeng, A. SolÃ³rzano, D.E. Swayne, N.J. Cox, J.M. Katz, J.K. Taubenberger, P. Palese, and A. GarcÃa-Sastre. 2005. Characterization of the reconstructed 1918 Spanish influenza pandemic virus. Science 310(5745):77-80.
46 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY training programs, including dual use review requirements in national biological safety programs, harmonizing national laws and regulations, building on existing WHO guidelines for lab biosafety and biosecurity, and developing dual use guidelines for member states. Israeli Perspective on Biotechnological Research Oversight. David Friedman (Institute for National Security Studies, Tel-Aviv University and the Israel Academy of Sciences and Humanities) explained that Israel is in the top 10 countries in the life sciences and in the top three in some life science fields, and that Israeli scientists are very concerned about biosecurity issues. He explained that a steering committee on issues in biotechnology in the age of terrorism was established in Israel to address the problem of biosecurity threats. Its members were appointed jointly by the president of the Israel Academy of Sciences and Humanities and the head of the Israel National Security Council (NSC). The report resulted in changes to Israelâs existing legislative infrastructure and made eight key recommendations: 1. Publicize the ongoing effort to raise awareness and understanding of the risks associated with the biological threat in general, and with dual use biological research in particular, among Israelâs life and medical sci- ence community. 2. Implement legislation designed to prevent the seepage of organ- isms, material and information to potential terrorist elements and formu- late specific long-term comprehensive biosecurity legislation. 3. Adapt existing biosafety oversight procedures to also ensure bios- ecurity and delegate responsibility for the enforcement of biosecurity to existing institutional biosafety committees (renamed âbiosafety and biosecurity committeesâ) in the academic sector. 4. Create an itemized core list of dangerous agents (adopted from the U.S. Department of Health and Human Services select agents list). The list should be reviewed and updated annually, as required. 5. Establish a system to oversee and approve dual use research proj- ects by an internal mechanism based on the judgment of the academic community. 6. The Israel Science Foundation and government research founda- tions must require, as part of their approval process, biosecurity approval from the institution in which the research will be conducted. 7. Establish a system to oversee the Israeli import of dual use biologi- cal laboratory equipment and biological agents, as well as the sale of these items in the local market. 8. Establish a biosecurity regime or National Biosecurity Council under the Ministry of Health (MOH).
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 47 Dr. Friedman explained that the committeeâs report and recommenda- tions were approved by the NSC and by the Israel Academy of Sciences and Humanities. A deliberation is taking place in the MOH regarding the implementation of the recommendations. The Committee for Science and Technology of the Israeli parliament is discussing enacting a law regard- ing research with pathogenic strains based on the committeeâs recommen- dations. Dr. Friedman reported that he was also taking part in preliminary deliberations to establish awareness, consciousness and education pro- grams (workshops, symposia, etc.) for the life sciences community. Dual Use Education and Review Within a U.S. University Consortium. Ruth Berkelman (Emory University) discussed efforts on research oversight undertaken by the Southeastern Regional Center of Excellence for Emerg- ing Infectious Diseases and Biodefense (SERCEB), which is one of the 10 regional centers of excellence for biodefense policy sponsored by the U.S. NIH. SERCEB consists of six primary universities: Duke University, the University of North Carolina, Emory University, Vanderbilt University, the University of Alabama, and the University of Florida. The steering committee is composed of one researcher from each of these schools (plus the University of Michigan). SERCEB conducts relevant biosecurity activities under its Policy, Eth- ics, and Law (PEL) core theme.15 It includes education and awareness raising (biosecurity, dual use, biosafety), dual use review, science in the event of an emergency, emerging infections, and global health and policy engagement. The key oversight effort under this theme is the SERCEB PEL Dual Use Educational Module. The module was developed as a tool to teach scientists (senior scientists, students, and laboratory technicians) about biosecurity and the dual use dilemma. It walks the user through a scenario of a Ph.D. candidate facing dual use concerns in thesis work and provides the user with background on legal, ethical and policy implica- tions. It was launched in 2005, has had more than 650 users to date, and is currently under additional revision. Three of the six universities have launched dual use modules and the others are examining the issue. In addition, a dual use review of all SERCEB-funded projects takes place through the SERCEB Steering Committee. The steps in the review process are: 1. The steering committee receives research proposals for funding, flagging those proposals that could have dual use potential. 2. The committee sends proposals to the PEL core; PEL core members 15â Available at: http://www.serceb.org/pel. Accessed December 11, 2008.
48 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY review the proposals individually (considering experiments of concern and NSABB criteria), before sharing thoughts collectively. 3. The committee receives PEL suggestions and/or follow-up ques- tions and sends them to investigators. 4. The committee urges investigators to address PELâs concerns before disbursing funds. Dr. Berkelman concluded by stating that despite national guidelines or laws governing dual use research, it will still be important to continue to educate scientists on the topic. Addressing Risks of Research Misuse: A Funderâs Perspective. David Carr (The Wellcome Trust) discussed research oversight from the perspective of a major biological science funding body. First he presented several reasons for the Wellcome Trustâs attention to biosecurity. He listed new legislation on antiterrorism and export control, ongoing parliamentary attention, the involvement of UK Foreign and Commonwealth Office staff with the BWC codes of conduct discussions, and other international developments. The 2001 terrorist attacks and the Fink report and subsequent U.S. policy were also important developments.16 Mr. Carr explained that the Wellcome Trust released a position state- ment on bioterrorism and biomedical research in November 2003.17 He favors a system of self-governance in the scientific community. Self-gover- nance would be the most effective, appropriate and sensitive system and would best reduce the risk of misuse, without imposing onerous regula- tion. The Wellcome Trust system employs the strong existing funding framework based on peer review, where the host institution is responsible for ensuring that the requirements of all regulatory authorities are met. For the rare cases in which additional ethical and social issues are raised, advisory mechanisms are in place. In 2005, the three largest funders of life sciences research in the United Kingdomâthe Biotechnology and Biological Sciences Research Â Council (BBSRC), the Medical Research Council (MRC), and the Wellcome Trustâ signed a follow-on policy statement.18 It made changes to the proce- dures in the 2003 key statement in four areas. It added: (1) guidance for 16â The Fink report, Biotechnology Research in an Age of Terrorism, takes its name from the committeeâs chair, Gerald Fink of MIT. (National Research Council. 2004a. Washington, DC: The National Academies Press). 17â The statement is available at: http://www.wellcome.ac.uk/About-us/Policy/Policy-and- Â osition-statements/WTD002767.htm. Accessed on December 11, 2008. p 18â The statement, Managing Risks of Misuse Associated with Grant Funding Activi- ties, is available at: http://www.wellcome.ac.uk/About-us/Policy/Policy-and-position-statesments/ WTX026594.htm. Accessed December 11, 2008.
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 49 applicants through the introduction of an added question on application forms; (2) guidance for referees with explicit mention of research misuse as an issue to consider; (3) guidance for funding committees, including a process for assessing cases where concerns were raised; and (4) modifica- tion of good practice guidelines to include specific references to research misuse. Mr. Carr explained that the policy has been in place for three years with some evidence that it has increased the number of people who were considering the risks of research. The Wellcome Trust has received a range of responses to the application-form questions, and he saw that as evidence that the policy was encouraging at least some applicants to con- sider if risks were associated with their proposals. So far a small handful of cases have been flagged for further consideration internally, but none have raised risk-benefit concerns that have impacted funding decisions. The Wellcome Trust has not formally assessed the impact of the statement on awareness raising, but hopes that it has contributed. Mr. Carr con- cluded by saying that dual use risks need to be considered by scientists at all levels of the research process. Working Group Discussions After the formal presentations, David Franz led the working group through a discussion of biosecurity definitions, elements of biological research oversight that were under way and that were proposed, the best principles for research oversight, international challenges to oversight, and possible next steps for the oversight of dual use research. The group discussed several research oversight methods that could be employed by interested groups. The group agreed that any oversight mechanism must not unduly limit scientific research and scientific progress and noted that the majority of research in the life sciences would not fall into the dual use category. The aim should be to focus on research with the highest potential for risk, such as the seven experiments of concern cited in the Fink report.19 The key is to reduce riskâincluding risk from unanticipated resultsâbut not to stifle research. This can only be done in a dynamic fashion through regular re-evaluation of current activities and evaluation of new science and technology developments. Novel education and awareness raising methods (as discussed in working group 1) were important to under- pin any potential oversight measures. A âtoolkitâ of different types of measures could be designed to help governments, organizations and 19â NRC (National Research Council). 2004a. Biotechnology Research in an Age of Terrorism. Washington, DC: The National Academies Press, p.12.
50 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY individuals accomplish this. Oversight measures should coincide with a certain amount of self-governance and self regulation. The elements of an oversight toolkit could include methods for pre- liminary research review, review before dissemination and/or communi- cation of results of proposed research of concern, pathogen controls, per- sonnel and facility accreditation, and limits on technology (knowledge, materials, equipment) transfer. The group reviewed several oversight mechanisms proposed or already under way around the world. For example, the group discussed the statement released by journal editors in 2003,20 and heard insights from the forthcoming NA/AAAS survey. Dr. Franz led the discussion on the oversight methods proposed by the NSABB, of which he is a member, and mentioned that the NSABB oversight framework was awaiting a U.S. government response/decision.21 The group saw some common elements among the methods pre- sented. All showed a strong influence from the Fink report recommenda- tions. The oversight methodologies focused on the areas of highest poten- tial risk (although disagreements about risk categorizations remained). Each recognized the importance of education and awareness raising and all of the systems built on existing ethical and biosafety policies and pro- cedures already in place. The group also identified some significant differences in the approaches. Some emphasized self-governance, and this was evident in the systems employed by the Wellcome Trust, BBSRC, MRC and SERCEB. The NSABB, CISSM, and the Israel Academy/NSC proposal tended to make binding regulations the primary barrier to misuse. Several partici- pants focused on the mechanism of reviewing research before the dissemi- nation and communication of the research results/data, as an additional layer of protection to capture unexpected dual use results that might be dangerous. Results Principles for Research Oversight. After addressing existing mechanisms, the group discussed some broad principles important for research oversight. Again members emphasized that it was most critical to balance the risk of stifling research with the benefit of increased scrutiny of research. This 20â Journal Editors and Authors Group. 2003b. Statement on the consideration of biodefense and biosecurity. Nature 421:771. 21â More information is available at: http://www.oba.od.nih.gov/biosecurity. The oversight framework is available at: http://www.oba.od.nih.gov/biosecurity/pdf/Framework%20for%20tran smittal%200807_Sept07.pdf. Accessed December 11, 2008.
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 51 balance could be tilted positively by involving scientists in the process and raising awareness of the dual use research risk. Since 21st century biological science is truly a global undertaking and pathogens do not respect international boundaries, many participants noted that oversight needed to take a more global perspective. Some degree of non-discrimi- natory harmonization and integration in conformity with international and/or regional guidelines, and in conjunction with national oversight, would help this effort. A toolkit of measures for countries to draw upon could be constructed as follows: At the individual researcher level, basic awareness of the problem is critical, and voluntary oversight linked to funding could help educate. At the institutional level the focal point would be peer review and oversight. The national focal point would be oversight. The regional and international focal point would be guidelines. International Challenges to Oversight. The group identified several key unanswered questions and international challenges. 1. Institutional arrangements: What role should international bodies (e.g., WHO guidelines) play? Should responsibility for oversight at the international level be given to existing institutions, or should new institu- tions be created? 2. Capacity building: How can one ensure support for research, disease surveillance and public health and assistance to countries to implement dual use research oversight measures? 3. Harmonization across borders: How can a level playing field be assured when the choice of elements in the biosecurity toolkit may vary from country to country? 4. Risk assessment and prioritization: How does dual use risk measure against other concerns, for example biosafety and endemic disease? 5. Globalization and market forces: How can scientists be prevented from avoiding research in dual use areas because of perceived overregula- tion, and be dissuaded from outsourcing to escape regulations? Other questions raised by the group include: Do some oversight mea- sures miss certain sectors such as industry, public health, and government (including military research)? How does one put a perceived legitimate oversight system in place for biodefense research (where the majority of dual use research takes place), and ensure secrecy as well as transpar- ency? Is it possible to monitor and evaluate (or ensure compliance and enforce) oversight? What are the mechanisms for follow-up? By whom? What are the consequences for violation/noncompliance? How does one treat whistle blowing or early âinterventionâ and focus on awareness
52 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY among researchers and adherence to existing rules, while avoiding a cul- ture of suspicion? What kind of publication/dissemination guidelines for review and dissemination are needed at the individual and institutional levels prior to publication review? The group agreed that research oversight, if done correctly, could have positive effects. Transparent oversight can improve societal support for responsible research. Self-governance steps already taken by scientists can preempt top-down overregulation. Good biosecurity can be good for business. The group suggested that scientists are used to regulation, but that they have an aversion to additional regulation perceived to be unrea- sonable; scientists are open to reasonable and feasible regulation, but only in an area where a tangible risk exists. Suggestions for Next Steps in Oversight. David Franz suggested that incre- mental steps are important and that good suggestions had been made during the discussions that could help in the process of establishing over- sight measures. The discussions also highlighted a number of common measures found in the various proposals. Moreover, those implementing regulatory systems should also remember that âperfect is the enemy of the good.â International organizations such as the WHO, UN Food and Agricul- ture Organization (FAO), the World Organization for Animal Health (OIE), OECD, and IAP have the convening power to bring together stakeholders and they can make an important contribution. The group suggested that the IAP produce a statement on research oversight as a follow-up to the 2005 IAP biosecurity statement. In addition, organizations could build dual use review into existing biological safety mechanisms, building on quality guidelines like Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Management Practice (GMP) to move toward âGood Biosecurity Practiceâ (GBP). Research oversight would benefit from adapting existing review mechanisms such as institutional biosafety committees that handle research involving recombinant DNA. The group suggested involving existing and relevant stakeholder organizations, for example the European Biosafety Association and the American Biosafety Association and others. The group also suggested some novel alterna- tive methods and tools to link awareness raising and oversight, such as: an online advice portal for scientists on how to handle potential dual concerns in their research; improvements to OECDâs biosecurity codes website;22 a biosecurity âWikipedia;â biosecurity posters for laboratories and special pages for journals that present the issue; and a systematic 22â Available at: http://www.biosecuritycodes.org. Accessed December 11, 2008.
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 53 evaluation of the effectiveness of existing approaches to create more les- sons learned and best practices. Highlights of the group discussions and suggestions were presented by Neil Davison to the entire Forum in a plenary session. Summary of Working Group 3: Science Advising Chair: Angelo Azzi Rapporteur: Ralf Trapp Summary prepared by Katherine Bowman and Ralf Trapp Background Working group 3 focused its discussions on the role of the international community in providing scientific advice on issues related to biosecurity. To facilitate discussions among participants, several of the working group sessions incorporated brief presentations. The first talks were designed to highlight a few of the international governmental organizations that might serve as potential venues for addressing biosecurity-related issues and that might be valuable partners for the scientific community in con- sidering these topics. Additional presentations highlighted recent biologi- cal and chemical security activities that had been undertaken by national academies of science and scientific unions in partnership with national and international organizations. UNESCO.â Lucy Hoareau (Division of Basic and Engineering Sciences, UNESCO) provided the group with background on UNESCO and on some of the potential opportunities that the organization may provide for the scientific community to consider biosafety and biosecurity. She began by highlighting the Science Agenda - Framework for Action23 that arose from the 1999 World Conference on Science for the Twenty-First Century: A New Commitment, sponsored by UNESCO and the International Council for Science (ICSU). The Conference, held in Budapest, Hungary, provided guidelines for actions addressing: (a) Science for Knowledge; Knowledge for Progress; (b) Science for Peace and Development; and (c) Science in Society and Science for Society. Dr. Hoareau noted UNESCOâs role in pro- viding scientific assistance and engaging with policy makers and govern- ments, as well as in working to achieve knowledge transfer and network 23â UNESCO (United Nations Educational, Scientific, and Cultural Organization) and InterÂnational Council for Science. 1999. Science AgendaâFramework for Action. Adopted by the World Conference on Science, July 1. Available at: http://www.unesco.org/science/wcs/eng/Â framework.htm. Accessed December 11, 2008.
54 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY building. She also emphasized the interdisciplinary nature of many of the activities in which UNESCO is engaged and the collaborations that arise between various UNESCO divisions, UN sister agencies such as the FAO, the WHO, and partners in the nongovernmental community. Dr. Hoareau highlighted several UNESCO programs that might pro- vide opportunities to consider topics in biosecurity, bioethics, and bio- safety. For example, the UNESCO Division of Science Policy and Sustain- able Development works on policy guidelines and methodologies for the formulation of science policy, particularly to support sustainable devel- opment and peace. The Division of Basic and Engineering Sciences also maintains the International Basic Sciences Program, a platform for interna- tional cooperation; its aim is to strengthen national capacities in the basic sciences and science education. The ethics of science and technology is also a priority theme for UNESCO. John Crowley of UNESCOâs Social and Human Sciences Sector noted that UNESCO incorporates several poten- tially relevant initiatives including the Bioethics Program, COMEST, and the Global Ethics Observatory databases, which can serve as resources to the community and to member states. Recently, an interagency task group has also been established among WHO, FAO, and UNESCO on biotech- nology, and this might provide yet another forum to raise and discuss issues related to biosafety and biosecurity. During the group discussions, it was also pointed out that it could be useful if a statement from scientific bodies was made to the UNESCO Director General that further activities by UNESCO in the area of biosecurity would be relevant. WHO.â Ottorino Cosivi had spoken during the first plenary session about the spectrum of risks posed to global health security in the 21st century and on efforts that WHO has made to support the elimination of chemical and biological weapons and to promote global health security. Although not making a second formal presentation to the working group, Dr. Cosivi further highlighted the need to speak about a range of biological risks and the likelihood that the prioritization of biological risks will vary from country to country. From this starting point more focused efforts could then be made on managing these risks. OECD.â Alexandre Bartsev (OECD) also spoke to the Forum in Plenary 1 on the roles that the OECD has assumed in addressing both biosecurity and emerging technology. Within the working group, Dr. Bartsev contrib- uted several further comments on the ways in which biosecurity may help to create an environment of trust. This could, in turn, help promote indus- try investment as part of the cycle from basic science research through innovation. Addressing security issues could thus help to provide part of the enabling environment for research and development.
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 55 BWC Implementation Support Unit. As a complement to the plenary presen- tation delivered by Ambassador Avramchev, Chair of the 2008 BWC inter- sessional process Piers Millett (UN Office for Disarmament Affairs, BWC Implementation Support Unit) highlighted the desire to make the BWC process more inclusive and to continue to incorporate scientific input. He reported that scientists already had roles as members of the national del- egations from many of the larger member states. He noted that progress within the BWC has benefited from scientists participating as experts, and pointed to the ability of scientific side events to be organized in conjunc- tion with Convention meetings. International scientific bodies and NGOs may also attend sections of Convention meetings as observers, although Dr. Millett cautioned that there could be the perception that some NGOs might come with their own agendas, which could make member states suspicious of their motives and could make it harder to achieve goals. Biotechnology Research Center, Tripoli, Libya.â The group heard a brief pre- sentation from Mohamed Sharif (Biotechnology Research Center). Libya has partnered with UNESCO and recently established the Biotechnology Research Center, as well as a Bioethics and Biosafety Committee. The Cen- ter has initiated collaborations with laboratories and institutions in other countries and was holding national conferences and training programs, while also focusing on issues of laboratory safety. Dr. Sharif highlighted the growth of the biological sciences around the world, and the value that counties with less-developed biological sciences initiatives derived from international collaborations as they worked to build their programs, and the need to provide training in both biological techniques and in labora- tory safety and ethics. OPCW and IUPAC.â Ralf Trapp discussed the structure of the OPCW, which administers the Chemical Weapons Convention, and how science advising works in this context. The OPCW includes a Scientific Advisory Board composed of experts from States Parties to the Convention, and this provides an integrated mechanism to feed scientific input directly into the Convention review conferences. However, there was a desire to extend the source of science advice beyond the Scientific Advisory Board and to incorporate expert perspectives from the broader chem- istry community. IUPAC, as a neutral, international, nongovernmental body of chemists, was thus able to effectively partner with the OPCW and has hosted two workshops on trends in science and technology relevant to the CWC. One workshop was held in 2002 prior to the First Review Conference, and one was held in 2007 prior to the Second Review Conference (see Chapter 1). Dr. Trappâs remarks pointed out an
56 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY opportunity in which an international science union was able to provide advice to a policy community in the context of a treaty organization. The partnership also catalyzed an internal process within IUPAC that has led to many further activities addressing issues related to dual use of chemicals and scientific responsibility. Uganda National Academy of Science (UNAS).â Patrick Rubaihayo (UNAS) spoke to the group about a regional workshop UNAS organized in March 2008 on biosafety and security in the life sciences and on providing the opportunity for African scientists to have a voice in such discussions. In surveying existing Ugandan laws on biosafety, UNAS found that they did not address biosecurity concerns. The workshop raised the question of whether countries in East Africa need to adapt existing safety laws and/or create new legal and policy frameworks to capture aspects of biosecurity. Issues of enhancing compliance with existing regulations and incorporat- ing education on biosecurity were also raised. The workshop highlighted the need to reach a common understanding of the scope of biosafety and biosecurity. Although laboratory biosafety and biosecurity are required, workshop participants felt that the primary security risk within Africa arises from natural sources such as disease outbreaks, rather than from research facilities. The issue of intellectual property rights and concerns of biopiracy also loomed large for many African scientists, because of the lack of capacity on the continent and the need to form partnerships with more developed countries. Dr. Rubaihayo explained that the African participants wished to implement safety and security curricula and standards quickly in order to catch up with the developed world, but lacked infrastructural, human, and financial capacity; and they would need assistance in achieving these goals. He felt that it might be particularly valuable for the developed world to create educational and training materials that could be shared with the developing world to facilitate this process, and that the African science academies should assume more prominent roles in spearheading safety and security awareness and in advising their governments. Royal Netherlands Academy of Arts and Sciences (KNAW).â Finally, Koos van der Bruggen (KNAW) spoke to the working group participants on biosecurity activities that had been undertaken by KNAW. The KNAW has served as the lead academy for the IAP Biosecurity Working Group and played an active role in the formulation of the 2005 IAP Statement on Biosecurity. Following the release and dissemination of this statement, the Dutch Ministry of Science asked KNAW to prepare a code of conduct on biosecurity for scientists and organizations involved with dual use research in the Netherlands. In preparing this code, KNAW held extensive
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 57 discussions with stakeholders and produced a document of principles that could be translated by each particular organization into its own appro- priate context. The code was published in October 2007 and is available online.24 Follow-on activities such as presentations, articles, and a movie are being prepared. Dr. van der Bruggen explained that, although such a code did not replace existing laws and might not prevent intentionally malicious behavior, it can serve as a useful tool to raise awareness and stimulate discussions. Participants in working group 3 commented that a theme that had emerged from several of the group presentations was that the process of developing a product related to ethical principles could sometimes be even more valuable than the content of the final product. Working Group Discussions The working group discussed questions and issues raised by the presentations, as well as reflected on several suggested questions that were posed to the group to help initiate dialogue on these topics. These questions were: 1. What are the different ways in which scientific groups can provide scientific advice on issues related to biosecurity? Which organizations might be interested in having input from the scientific community and where are there such opportunities? 2. What are some examples in which the scientific community has been able to provide advice on biosecurity-related topics to other govern- mental and nongovernmental, national, and international groups? How did these opportunities arise and how can they be built upon? What were the challenges and lessons learned? 3. Where are there unmet needs and are there ways that the scientific community could start moving to help address these? Starting Points on the Role of Science Advising. The working group took as its common starting point that the scientific community should provide advice about how to deal with the benefits and potential risks of advances in biology, biotechnology, and the life sciences, including biosecurity mat- ters. Such advice should begin by highlighting the benefits of scientific development and should also be provided within a wider context of biosafety for the following purposes: 24â Royal Netherlands Academy of Arts and Sciences. 2007. A Code of Conduct for Biosecu- rity. Report by the Biosecurity Working Group. Amsterdam: Royal Netherlands Academy of Arts and Sciences. The code is available at: http://www.knaw.nl/cfdata/publicaties/detail. cfm?boeken__ordernr=20071092.
58 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY â¢ To build consensus on key issues within the science community, promote proper scientific/ethical conduct, and prevent hindrances of scientific progress; â¢ To advise policy makers (in different policy areas) on benefits and potential risks, and in this context, on sensible and necessary courses of action; â¢ To inform, educate, and engage with the public about the risks, and about what is, or should be, done to manage these risks. The group also considered some of the general aspects that will be needed to provide effective science advice. The participants agreed that science advice happens at different levels, from the personal to the institu- tional to the national level, as well as regionally and internationally. Thus, the messages that come from the scientific community need to be sincere, consistent, evidence-based, and targeted to the intended audience(s). Effective and relevant policy advice from the science community pres- ents concrete national, regional, and international political strategies and objectives. Science advice will need to be tailored to the expectations, perceptions, experiences, needs, priorities, and political desires of a given context. The science community will also need to get the additional seg- ments of the community, including politicians, parliamentarians, and the general public on board. Context for Science Advice on Biosecurity.â Group discussions returned several times to the varying definitions and interpretations of the term biosecurity. However, the group agreed that biosecurity can be broadly understood as an integrated and interdisciplinary approach to manage biological risks. Biosecurity is therefore about risk perceptions, risk assess- ment, risk management and risk communication. Science advice has a role to play in all of these areas and scientists need to be involved as part of the policy-shaping processes. For science advice to be effective, however, it is often necessary to be clear about what is meant by âbiosecurity,â since the term means different things to different communities. Within the context of the working group discussions at the Forum, the group agreed that the term was referring to a particular set of measures to address the risks emanating from the life sciences, and in particular was addressing scenarios where large num- bers of people, animals, plants, or significant parts of the environment, are at risk. It was also understood that the concept of biosecurity is not limited to issues relating to biological weapons or bioterrorism, but must proceed from the recognition of the existing biological risks under given circumstances. It was felt that the argument for enhancing biosecurity needed to
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 59 build on well-known historical examples of the risk of abuse of the life sciences for malign purposes, which might include the history of biologi- cal weapons and of past biological weapons programs. However, science advice must also account for other evidence (e.g., the cross-border spread of particular animal or plant diseases with severe economic impact), and both current national and regional perceptions and strategies. Within Africa, for example, biotechnology is seen as a strategic opportunity to address key development challenges such as poverty, population growth, and malnutrition. Science advice on biosecurity should be âpackagedâ into this context, in order to be taken seriously by policy makers and populations. It was pointed out that biosecurity could be a facilitating condition for innovation cycles and thus for economic development, and, therefore, it should not be viewed solely in terms of cost. An opportunity exists to gain much-needed political support, if biosecurity can be inte- grated into the wider policies of developing countries toward achieving the Millennium Development Goals. In 2007, for example, the Ministers of Foreign Affairs of Brazil, France, Indonesia, Norway, Senegal, South Africa, and Thailand issued the Oslo Ministerial DeclarationâGlobal Health: A Pressing Foreign Policy Issue of Our Time, as part of their initiative on Global Health and Foreign Pol- icy.25 The declaration recognized the importance of health issues in policy discussions and the interplay of health with other challenges; the theme on âCapacity for Global Health Securityâ included item 7.2, namely: âRecognize that the potential of biotechnologies to help developing coun- tries achieve the Millennium Development Goals should not be eclipsed by otherwise legitimate security concerns: establish robust governance mechanisms to prevent misuse of the biological sciences, without hinder- ing their positive contribution to development.â The working group emphasized that advice on biosecurity needed to be multidisciplinary and multisectoral, and had to appreciate that bioÂ security is a multistakeholder issue, and hence has to be inclusive. At the international level, this requires coordination and collaboration among the different organizations that have relevant mandates. This could include the UN system and its specialized agencies, as well as organiza- tions outside the UN family such as the OECD, ICRC or OPCW. At the national level, the involvement of many stakeholders in government, sci- ence, industry, the NGO community and civil society at large is required, and the communication barriers between these different actors have to be broken down. The group also agreed that, since the responsibilities for 25â Ministers of Foreign Affairs of Brazil, France, Indonesia, Norway, Senegal, South Africa, and Thailand. 2007. Oslo Ministerial DeclarationâGlobal Health: A Pressing Foreign Policy Issue of Our Time. Lancet 369(9570):1373-1378.
60 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY biosecurity exist at the levels of the individual, the institution, and nation- wide, advice should be targeted to the respective audience(s). Measures to deal with the risks should therefore be complementary, should address ethical matters as well as proper professional conduct more generally, and should be complemented by regulatory instruments and guidelines. Ways and Means of Science Advising.â The group noted that a variety of ways of providing effective scientific advice have been developed and can operate at the several different levels required. At the national level, advice is being provided by science academies, professional scientific associations and societies, expert committees, and national commissions and advisory boards (e.g., national science and technology ethics commissions, research policy committees). In addition, the working group suggested that scientists should be directly included in national delegations attending negotiations in the area of biosecurity, or areas that are relevant to it. At the national level, it is important for the scientific community to be involved in the review of existing regulatory frameworks within which biosecurity objectives can be accomplished, and for the scientific community to participate in any necessary adapta- tion of existing regulations and guidelines, or in the creation of additional regulatory mechanisms. It was felt by the group that such reviews will need to be repeated and updated periodically to take account of new developments. At the regional level, science advice is needed when regional pri- orities, policies, and capacity-building projects are being discussed and implemented. Regional organizations are important in shaping effective policies and in organizing regional collaborations. Biosecurity should be incorporated into the policy agendas of regional organizations, and regional resources and capacities in the field of biosecurity should be enhanced. At the international level, a number of organizations have mandates with regard to providing, or facilitating the provision of, advice on bios- ecurity, and these groups may also facilitate capacity building. These include UNESCO, WHO, FAO, OIE, the International Cooperative Bio- diversity Groups, the United Nations Environment Program, the BWC Implementation Support Unit, OECD, and others. International organiza- tions, including specialized agencies, can play important roles with regard to involving the scientific community and in seeking their advice, and providing the governments of their member states with advice based on sound scientific principles and evidence. At the academic level, organizations such as ICSU, the IAP, and the Academy of Sciences for the Developing World (TWAS) bear a specific responsibility for developing and channeling science advice. International
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 61 disciplinary science unions also have important roles to play, given their wide geographical participation and legitimacy. Science unions, as well as international scientific bodies such as ICSU, IAP, and TWAS, can help create broad consensus within the scientific community itself. This is essential for consistent and relevant advice to policy makers, as well as for outreach and education directed at the scientific community and the public. The working group noted that international scientific consen- sus does not necessarily exist on the advantages and risks created by developments in the life sciences. Such dialogues among the scientific community should be played out not only within the policy sphere, but also addressed within the international scientific community as it moves toward achieving a level of consensus. Unions as well as ICSU, IAP, and TWAS can also help promote com- mon standards (including on professional ethics), foster the education of future generations of scientists and engineers, and inform both policy makers and the public. They can do this in collaboration with other inter- national agencies, but equally important is their ability to work through their own national constituent bodies to transmit these messages in a tailored and relevant fashion. Unions, as well as interacademy bodies, also can be effective channels to involve industry in the development of policy advice. Treaty-based institutional mechanisms such as the Scientific Advisory Board of the OPCW, or national governmental science advisory bodies involved in the CWC context, or in the BWC processes, have also been effective. The involvement of scientists as delegation members, or by serv- ing in capacities such as members of NGOs, scientific associations, or as individuals, has proven useful. The group noted that there is a need for effective and targeted out- reach and communication of biosecurity issues. Given the diverse audi- ences seeking or requiring advice, the variety of publications and other communications (e.g., press, electronic media, and the Internet) ought to be tailored to these different audiences. Such audiences will include scien- tists, media, policy makers, and the âgeneral public.â There is also a need for education and training programs, including education and training for practicing scientists and other practitioners, training at the university level for upcoming generations of scientists, and also education for policy and law-makers. It would be desirable to share existing resources such as training materials, educational videos, and other tools on a wider basis. The working group also recognized that resources may need to be devoted to assist developing countries in building their capacities to pro- vide scientific advice.
62 THE 2ND INTERNATIONAL FORUM ON BIOSECURITY Some Pitfalls. The working group noted that, at the moment, there appears to be a lack of coordination among the various efforts to address biosecu- rity. There is no coherent international strategy, and a lack of collaboration among the different actors. There is a danger that efforts are being dupli- cated and a stock-taking exercise would be desirable to review which efforts are actually under way, and how effective they are. The group also emphasized that no single international organiza- tion can cover all issues related to biosecurity, let alone the overall issues related to risk assessment, management, and communication related to advances in the biosciences. The same applies at the national level. There is a need for coordination, networking, and information sharing. In some instances, for example, interministerial mechanisms may be needed. Dur- ing the discussions, it was noted that South Africa, for example, is already working to develop networks among groups such as university research directors, and has created the National Science and Technology Forum as a mechanism to bring together some of the relevant constituents. On the other hand, it must be understood that enhancing and enforc- ing regulatory frameworks, providing science advice, adopting ethical codes, and providing education and outreach can achieve only so much, and that these efforts cannot and should not be expected to completely deter or prevent acts of malevolence. Results The working group proposed the following four suggestions. 1. There is a need for better coordination at the international level. The United Nations should facilitate this and take the lead; it can and should bring together the major stakeholders, including industry, the scientific community, civil society and governments, into a common pro- gram aimed at ensuring that advances in the life sciences are used only for the benefit of humankind. Under a broad umbrella such as the UN could provide, it would be easier to synchronize the diverse and multifaceted efforts of specialized agencies, organizations such as the OECD, and many other international actors and to address these issues on the basis of well- established interagency coordination mechanisms. 2. Consideration should be given to the organization of sessions, side-events or other forums on biosafety and biosecurity issues in the context of forthcoming meetings. Some examples of possible opportuni- ties include:
PLENARY AND WORKING GROUP PRESENTATIONS AND DISCUSSIONS 63 â¢ World Conference on Science (Budapest + 10) in late 2009; â¢ Global Ministerial Forum on Research for Health (Bamako, Mali) in November 2008; â¢ UNESCO World Commission on the Ethics of Scientific Knowledge and Technology (extraordinary session November 2008 in Paris, France, and an ordinary session June 2009 in Singapore); â¢ UNESCO International Bioethics Committee (ordinary session November 2008 in Paris, France); â¢ World Social Science Forum of the International Social Science Council (Bergen, Norway) in May 2009. 3. There is a need for improved networking and for building net- works of networks at national, regional and international levels. Different communities that have a contribution to make to biosecurity should be brought together, including life sciences, security and law enforcement, policy makers, lawyers, and others. ICSU, IAP, and TWAS should take the lead to create such networks of networks. Science unions should get involved as well, and can work through their national constituencies to promote biosecurity in the local/regional context and within a broader perspective on risk assessment, management, and communication regard- ing advances in the life sciences. 4. The existing connecting points between science and policy mak- ing at the national levels should be used and, where necessary, should be energized, in order to promote better communication and cooperation between the scientific and policy communities. Highlights of the group discussions and these four results were pre- sented by Ralf Trapp to the entire Forum in a plenary session.