The H5N1 case: A virologist s view

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1 The H5N1 case: A virologist s view Jan Wilschut Department of Molecular Virology University Medical Center Groningen Groningen, The Netherlands Meeting of States Parties - Side Event Geneva, 11 December 2013

2 Ron Fouchier Erasmus Medical Center Rotterdam

3 Yoshihiro Kawaoka University of Wisconsin Madison

4 US National Science Advisory Board for Biosecurity December 2011 Papers should be published, but without full experimental details and methodology and without specific mutation data Details of the studies should only be shared with a limited number of third parties on a need-to-know basis First occasion in history in which full publication of results of a scientific study would be restricted because of reasons of biosecurity

5 26 December 2011 Debate Persists on Deadly Flu Made Airborne 7 January 2012 An Engineered Doomsday

6 Outbreak of H5N1 in poultry markets in Hong Kong 1997: 18 people infected, 6 deaths

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8 Receptor binding specificity of influenza virus is major determinant for pathogenesis and virus transmission [Kawaoka et al., 2007]

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10 Resurrection of the Spanish Flu virus Phyllis Burns 1918 Brevig Mission Alaska

11 Airborne Transmission of Influenza Virus

12 December 20, 2011 the NSABB recommended that the manuscripts not include the methodological and other details that could enable replication of the experiments by those who would seek to do National Science Advisory Board for harm Biosecurity (NSABB)

13 Dutch government ruled that an export license would be required for publication of the paper Exclusion:

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15 PIP framework; improve international collaborations Important contribution to public health surveillance of H5N1 viruses and to a better understanding of the properties of these viruses Continued emphasis on assuring and reinforcing safety and security (but excellent in NL & US labs) Extend research pause to re-review biosafety and biosecurity conditions (short term urgent action) Publish full details Publishing redacted manuscripts not possible with current international legal frameworks Broader issues require global discussions (beyond scope of current H5N1 issue)

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18 No Consensus among Scientists Dilemma: Right to Know vs. Risk of Knowing

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23 Interview

24 Interview Ron Fouchier December 2, 2013 Q: Why did you do the GOF-studies on H5N1? What was your driving force? A: Research was not a Fouchier show, it was a research agenda that was internationally agreed upon by many stakeholders, including NIH and WHO. There was general consensus that the work was urgent and important from the perspective of pandemic preparedness.

25 Interview Ron Fouchier December 2, 2013 Q: Why did so much commotion arise when in fact there was a Code of Conduct in place from the start of the work? Has the Code of Conduct worked? A: Yes, the Code of Conduct has worked very well. Through the Code, scientists are much more aware of the biosecurity risks of their work. We were fully aware of the potential risks of GOF-experiments with H5N1. Accordingly, we have informed all parties involved and we have conducted the research under very stringent biosafety and biosecurity conditions with approval of both Dutch and US authorities.

26 Interview Ron Fouchier December 2, 2013 Q: Why then, and when, did it go wrong? A: This occurred at the level of publication of the results. The debate became vicious when the NSABB judged that our results should not be published in full. This recommendation underscored and in my view exaggerated the biosecurity risks of the work. In addition, NSABB s recommendation to disclose the details of our study on a need-to-know basis was legally impossible. The NSABB advice was dominated by the biosecurity perspective, and there is a large gap between scientists and biosecurity experts. This gap should be bridged.

27 Interview Ron Fouchier December 2, 2013 Q: How do you judge the actual concerns of the NSABB? Was there a real biosecurity risk? A: No, the risk was minimal. It is too complicated to make a novel influenza virus. One needs a lot of expertise. Also, potential bioterrorists do not need our results, everything is out there already. There are much easier ways to generate a biological weapon.

28 Interview Ron Fouchier December 2, 2013 Q: If, in your judgment, there was no real biosecurity risk, why did you speak about a stupid experiment and bad news during your presentation on Malta? Did you not fuel the fire yourself? A: I should have phrased this differently. I should have spoken about a non-rational experiment in stead of a stupid experiment. I certainly did not mean stupid in the sense that it was stupid that we did the experiment, that we should not have done it. And I still believe that an airborne transmissible H5N1 is bad news, that is a reason for concern.

29 Interview Ron Fouchier December 2, 2013 Q: How about the issue of the export license? A: The European Council regulation was not intended for this purpose. A requirement for an export license for scientific publications interferes fundamentally with the freedom of speech and with academic freedom. Also, it impedes the free flow of information in the interest of human health. In addition, it will not work, it is random, and there is no international agreement on it.

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31 Virus papers get green light, but controversy highlights lack of global rules on biosafety and. biosecurity

32 It is from this perspective that the European Society for Virology on October 16, 2013, has addressed the President of the European Commission with a proposal for establishment of a European NSABB Likewise, the Dutch minister of Education, Culture and Science has asked the Royal Academy of Arts and Sciences (KNAW) in the Netherlands to re-evaluate the Code of Conduct for Biosecurity and to advise on how to deal with dual-use research.

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