Lifting the Moratorium on “Gain-of-Function” Scientific Research on Highly Pathogenic Avian Influenza H5N1

Toward the end of 2011 and the beginning of 2012, a global health and security controversy erupted about scientific research on highly pathogenic avian influenza H5N1 that, in brief, managed to increase the transmissibility of the H5N1 virus. Scientific, health, and national security experts hotly debated whether conducting and publishing such “gain-of-function” research was appropriate. Part of the security concerns involved fears that this kind of research could provide governments and terrorist groups with blueprints for making biological weapons, and the Biological Weapons Convention (BWC) became part of the discourse about the research controversy and what to do about it.

In response to the controversy and the difficult questions it raised, the international community of influenza researchers agreed to a voluntary moratorium on similar research until the issues had been examined and the benefits of such research were better understood. In January 2013, a group of 40 influenza researchers announced they were resuming their research, arguing the moratorium had served its purpose and that they had a public health responsibility to continue this type of research. More specifically, these scientists asserted that researchers who have approval from their national authorities to conduct such research under appropriate biosafety and biosecurity standards can and should proceed with their work. This action was taken before the U.S. government finalized a new framework for assessing future “gain-of-function” influenza research discussed at a meeting of stakeholders in December 2012.

However, as noted in media reports about this action, it is not clear that the acrimonious debate produced consensus on key questions the controversy raised. Having followed this debate closely since it erupted, it is not clear to me how international consensus could have been produced on these questions without stronger international governance mechanisms. The involvement of the World Health Organization (WHO) has been both controversial (e.g., its widely criticized meeting in February 2012 among stakeholders) and necessary (e.g., in developing non-binding biosafety guidelines for such research, which WHO released in July 2012).

In terms of the BWC, this problem proved awkward because the BWC permits peaceful scientific research, and no one questioned the peaceful motives of scientists conducting “gain-of-function” research on H5N1. The BWC process had discussed “dual use” challenges posed by advances in the biological and life sciences for years, but, when the H5N1 controversy rumbled on at the same time as the BWC review conference in December 2011, the review conference made no particularly useful contribution to the debate. For many experts, this outcome reinforced the view that the BWC is not an effective forum for tackling how the “dual use” problem intersects with the threat of biological weapons proliferation or bioterrorism.

Although many people involved in this debate believe that the debate itself has been productive, identifying any material change in how “gain-of-function” research on H5N1 is handled is difficult. Before the controversy erupted and the moratorium put in place, national governmental authorities made decisions about whether to approve such research and under what conditions it must be conducted. As noted above, the scientists supporting the end of the moratorium viewed national governmental approval and regulation of research projects sufficient for moving ahead. Plus ça change, plus c’est la même chose?

The next important development in this saga will come when the U.S. government releases its finalized framework for assessing whether to approve and fund “gain-of-function” research on H5N1. The U.S. has been the biggest funder of this research in the past, so, assuming the U.S. government continues to have this funding power, its new rules could exert influence well beyond the American scientific research community. With the public comment period on the proposed framework now over, the US government plans to finalize its new rules in the next few months. Stay tuned . . .