Gain-of-Function Research Summary of the Second Symposium, March 10-11, 2016 (2016) / Chapter Skim
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4 International Policy
4 International Policy
Pages 53-70
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From page 53... ...
This session would provide background and insights about the international dimensions of GOF research and illustrate the ways in which various organizations outside the United States have been contributing to the discussions from the beginning. Ruxandra Draghia-Akli from the Health Research Directorate of the European Commission introduced the European Union (EU)
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From page 54... ...
; or no clearance, meaning that the project will not be funded. There has also been specific dialogue with stakeholders in the European Union on GOF research, including the European Society for Virology, which has a common policy for scientific research and publications; the Foundation for Vaccine Research, which has called for a comprehensive risk–benefit assessment of GOF studies of concern; and the European Academies Science Advisory Council (EASAC)
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From page 55... ...
Its report also offered recommendations about what further analysis would be necessary to assess future options for research with potentially pandemic pathogens. The report also identified which of the European Union's current regulations applied to GOF research, how national- and EU-level responsibility should be divided, and what best practices already exist at the national level that could inform other countries.
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It requires raising awareness among research ers and their institutions, thereby necessitating education. • Attention to biosafety issues is needed at all stages of the research life cycle.
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Dr. Vöneky presented five recommendations for future GOF research based on the findings of the GEC report (see Box 4-2)
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Codes of conduct could be adapted to address GOF issues, including thresholds for GOF studies of concern. Strengthening the role of research funding in ensuring responsible conduct -- Funding of GOF research should require adoption and adherence to the above code of conduct.
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She believed that soft measures, such as requirements connected to funding, might be less suitable in the EU context. She suggested that measures to evaluate and manage risks associated with GOF research would need to be either codified by states into appropriate laws and regulations or contained with other legal frameworks such as constitutions or international treaties because of competing interests between the rights and freedoms of science and scientists and rights associated with the right to life and health for other parts of the population.
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One panelist felt that the European Union was likely to be flexible about approaches to the biosecurity aspects of GOF research, but noted that given the highly developed arrangements already in place there may be less opportunity to influence biosafety policy. The complexity of the European regulatory architecture was also noted, with one panelist suggesting that additional measures were added but rarely replaced existing arrangements.
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Harvey Fineberg, chair of the Symposium Planning Committee, noted that in certain cases -- such as for the approval of medicines, drugs, and other medical devices -- there was still a notable degree of difference in what is approved, and when, despite a comparatively common agreement on the characteristics to be assessed, relatively straightforward measurements, and well-established decision-making processes. Other participants noted that in the European context, while risk assessment might be carried out collectively, regulatory approval still happened at the national level.
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From page 62... ...
There were also discussions of whether a formal approach was needed, requiring international instruments, or a more informal approach might be more suitable, perhaps through appropriate guidelines such as those used to underpin international efforts on infection prevention and control. Participants also discussed the value of strengthening a culture of responsible research among relevant scientific communities, noting that they had key insights into the risks associated with GOF studies of concern.
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From page 63... ...
The plenary on the first day provided participants with an awareness of the international context within which the GOF controversy has evolved. The purpose of this session was to look ahead, to explore the potential for increasing international coordination of policy and practice for GOF studies of concern.
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Gabriel Leung from The University of Hong Kong began by considering GOF research in context. He noted that this was a discussion of risk to humans and, to a lesser extent, ecological security.
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region lags behind other parts of the world in addressing issues in life sciences research. BOX 4-4 Issues for Further Consideration When Considering Opportunities for International Harmonization of Approaches to GOF Research • there any unique value or value-added from GOF studies of concern or can Is alternative methods exhaustively derive the same knowledge set?
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have generated considerable discussion and debate among virologists, public health scientists, and experts in the United States and certain other parts of the world, a considerable need for raising awareness about GOF research persists in the MENA. This is needed for laboratory directors and policy makers as well as for life scientists.
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Dr. Selgelid suggested that WHO was the most legitimate international body to make decisions about GOF research.
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. The institute proposed to "price the expected value of any damages that could result from GOF research into the price of the grant being considered.
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Keiji Fukuda from WHO stressed the importance in successful international efforts of a common understanding of the nature of the risk being addressed. He offered the negotiation of the International Health Regulations, the WHO Pandemic Influenza Preparedness Framework, and measures to address antimicrobial resistance as examples.
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The potential for additional oversight measures for GOF studies of concern to reduce interest in GOF research was raised again. Some participants pointed out that in some cases, such as certain types of research involving human subjects, this was acceptable and appropriate.
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