Technical consultation on H5N1 research issues - consensus points
Two recent research studies examining some factors affecting transmissibility of influenza A(H5N1) viruses prompted WHO to convene a technical consultation on 16–17 February 2012. The participants at this meeting reached consensus on the following points.
- Recent work discussed at this meeting underscores that influenza A(H5N1) viruses remain an important risk for causing a future pandemic. Therefore, research on these viruses, including on transmissibility and pathogenicity, remains critical to close important gaps in knowledge in order to reduce the danger posed; such research should continue. The PIP Framework, which was adopted by all WHO Member States in 2011 now provides a global framework for the sharing of influenza viruses with human pandemic potential and the sharing of benefits arising from such sharing. Implementation of this Framework is integral to global pandemic preparedness and response. Future research projects should involve countries from which source material were obtained.
- The two studies that were conducted to better understand the transmissibility of H5N1 influenza viruses have shown that these viruses have the potential to become more transmissible among mammals. In light of the continuing evolution of H5N1 viruses, the results of these studies provide an important contribution to public health surveillance of H5N1 viruses and to a better understanding of the properties of these viruses.
- At the same time, these studies have raised important and valid concerns about whether they increase risks to the safety of humans. Concerns which have been raised include the potential misuse of the results or methods as well as potential breaches in biosafety and biosecurity related to pathogens. These concerns highlight how important it is that researchers are aware of such issues, exercise judgement about the conduct of their research, dissemination of the results, and for institutional bodies reviewing such studies to identify and address potential concerns about "dual use". Such safeguards already exist, but continued emphasis should be placed on assuring and reinforcing safety and security.
- The laboratory-modified H5N1 viruses are currently stored in well-established research facilities with high security and high safety (BSL3+). There have been no safety breaches related to the storage of the laboratory-modified H5N1 viruses at these facilities. At the same time, the biosafety and biosecurity conditions under which further research is conducted on the laboratory-modified H5N1 viruses should be fully addressed by relevant authorities. This is a matter of urgency and should be achieved as quickly as possible. In the interim, the laboratory-modified H5N1 viruses should remain in their present locations. In addition, the current moratorium on research to enhance the transmissibility of H5N1 influenza viruses and the further research on the laboratory-modified viruses should continue until the conditions have been determined. Other research on H5N1 viruses should not stop.
- There is a preference, from a public health perspective, for full disclosure of the information in these papers. However, there are significant social concerns surrounding this research. Two critical issues that must be addressed before publication of the papers are: (1) a focused communications plan to increase public awareness and understanding of the significance of these studies and the rationale for their publication, and (2) a review of the essential biosafety and biosecurity aspects of the newly developed knowledge.
- Participants discussed the concept of publication of redacted manuscripts with a mechanism for providing the restricted information to legitimate recipients. The group recognized the difficulty of rapidly creating and regulating such a mechanism in light of the complexity of international and national legislation. A consensus was reached that the redaction option is not viable to deal with the two papers under discussion in view of the urgency of the above mentioned public health needs. The participants noted there may be a need for such a mechanism in the future.
- Apart from consideration of these two manuscripts, participants acknowledged the existence of broader issues requiring more detailed exploration and advised that these be considered in subsequent consultations involving other stakeholders.