THE LIFE SCIENCES, BIOSECURITY AND DUAL USE RESEARCH IN ISRAEL – AN OVERVIEW (2004 – 2010)

1. THE LIFE SCIENCES, BIOSECURITY AND DUAL USE RESEARCH IN ISRAEL – AN OVERVIEW (2004 – 2010) CENTER FOR INTERNATIONAL AND SECURITY STUDIES AT MARYLAND Biosecurity Workshop College Park, Maryland – October 1-3, 2010 David Friedman, Ph.D Senior Research Associate Institute for National Security Studies (INSS), Tet-Aviv Univ.

2. BIOSECURITY - DEFINITION • “Biosecurity” - the sum total of measures meant to prevent deliberate attempts to obtain dangerous biological agents or technologies and information that will grant the capability to make biological weapons (biosecurity is all actions that must be taken to deny access by unauthorized actors to dangerous biological agents and information and technology that these actors can use to manufacture bioweapons)

3. MILESTONES • 2001 - Events • 9/11 • Anthrax Envelopes • 2001/2 – US Legislation • USA Patriot Act of 2001 – Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 • Public Health Security and Bioterrorism Preparedness and Response Act of 2002 • 2004 – Fink Report

4. OVERVIEW • 2004 – INSC Survey (Biomedical Research) • 2006/7 – Steering Committee on Biological Research in Age of Terrorism (COBRAT) • 2008 – The Regulation of Research into Biological Disease Agents Act • 2009/10 – Implementation • Institutional organization • Education & Awareness

5. INSC Survey & Study (2003/4) • Israel conducts world class biomedical research. • Research universities (7), Research Institutes (government & private), Medical Centers, Biotech Industry. • Almost 500 focal points of biomedical research, development and manufacture of potential relevance to biological weapons. • 50-100 laboratories work on micro organisms often virulent.

6. INSC Survey & Study (2003/4) Cont. • Biosafety – Work with dangerous biological agents is regulated under extensive Biosafety legal infrastructure. • Biosecurity • There is no awareness of the need for Biosecurity within Israel’s civilian life-sciences research community. • Israel has no legal and/or regulatory infrastructure directed specifically towards Biosecurity. • Institutions where biomedical research and work is performed are not subject to inspection by any single Israeli authority or ministry. • At the national level there is no system of control or supervision of biomedical research laboratories, nor is sufficient information about any dangerous biological agents used, the types of research performed, or the technologies employed.

7. Cobrat objectives (2006/7) The Committee was established to address the problem of Biosecurity. Its members were appointed jointly by the President of the Israel Academy of Sciences and the Head of the Israel National Security Council. • Changes required in Israel’s existing legislative infrastructure. • Compilation of a list of biological agents and fields of research that should be subject to inspection and supervision. • Establishment of a regimefor tracking, supervision, oversight and legal/regulatory enforcement (Biosecurity) - physical & knowledge. • Examination of the need for a national inter-ministerial body and or a national professional commission to guide, follow and maintain biosecurity.

8. COBRAT RECOMMENDATIONS (2006/7) • Awareness, consciousness and education • Legislation (Biosecurity) - 2 stages • Oversight and supervision mechanisms • Oversight and approval of publication of information generated by dual-use research • Consideration of biosecurityissues by funding agencies • National responsibility for biosecurity

9. THE REGULATION OF RESEARCH INTO BIOLOGICAL DISEASE AGENTS ACT, 2008 • The law applies to all institutions and laboratories, in all sectors, that have in their possession disease-causing biological agents as listed in the law. • The Minister of Health will be in charge of enforcing this law. • Possessing, conducting research or working with these biological agents requires an authorization from the Ministry of Health. • Possessing, conducting research or working with these biological agents must be performed so as not to impinge upon safety or security concerns. • No one shall conduct research whose sole purpose is to cause or exacerbate a disease or illness or to impair the ability to prevent or treat it.

10. A person or institution that has conducted a research study for which permission did not have to be obtained under the Act, but which has made findings of a nature to increase the virulence or the contagiousness of disease agents not included in the list, or findings of a nature to alter the host range of the said disease agents, so that the disease can pass to humans, shall halt the research and submit a request to the ‘institutional committee’. • All institutions will establish an ‘institutional committee’ whose purpose is to supervise the research conducted in that institution. The committees will comprise scientists as well as security and safety personnel from the institution. • A council for biological disease-agent research will be created to advise the Minister of Health and will comprise professionals and members of relevant government ministries. The council’s responsibilities will be to advise the Minister of Health regarding research authorization, to supervise the various institutions, and to promote training workshops and courses.

11. NATIONAL OVERSIGHT Head NSC Minister of Health President IAS Council Research Universities Medical Centers BioTech Industry Ministry of Industry , Trade and Labor Ministry of Health Legislation and Regulation - Health and Safety

12. INSTITUTIONAL OVERSIGHT President Council VP R&D Institutional Committee R&D Authority R&D fund (ISF) Head of department Scientist

13. IMPLEMENTATION (2009/10) • Institutional organization • Authorization process allowing institutes to posses and/or conduct research with biological disease agents has launched. • Institutes have established their internal committees. • Nationwide workshop have taken place with the participation of Council members and members of the institutional committees. • Current and future steps: preparation of institutional regulations and procedures.

14. IMPLEMENTATION (2009/10) – CONT. • Education & Awareness • Survey – investigate the relevance of courses in bioethics, biosecurity and biosafety within Israel’s research universities (D. Friedman supported by Sloan Foundation). • Syllabi of 35 courses in faculties of life science in 6 research universities were examined – no academic course that is designed to educate life scientists or students on biosecurity was found. • Seminars on the subject of dual-use research and biosecurity were given in 10 life science faculties in 6 research universities, and a questionnaire was distributed (D. Friedman supported by Sloan Found.) • Current and future steps: analyze questionnaires and build a lesson plan or course syllabus.

15. SUMMARY AND CONCLUSION • A top-down approach, whereby official agencies initiate assessment and research of the issues, leading to legislation, which is subsequently followed by structured education at university level, and finally, the launching of public campaigns • The assessment and research is independent and conducted by senior scientists from the academic life-science community, rather than government officials • Cooperation between the INSC, which represents the interests of national security, and the Israeli Academy of Science, which stands for pure academic research • The support of public officials, such as members of Parliament • The establishment by law of a professional advisory council that is responsible for implementation and supervision of the law • The legislation regulates not only research with specifically listed biological-disease agents but also dual-use research • Although research institutes are regulated by the Council for Dangerous Biological Agents they each have the mandate to work as an independent entity; a configuration which significantly reduces bureaucracy.

16. Thank You