Regulating Dual-Use Research in Europe

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Science  24 Jan 2014:
Vol. 343, Issue 6169, pp. 368-369
DOI: 10.1126/science.343.6169.368-b

The European Society for Virology (ESV), which represents scientists active in basic, medical, veterinary, plant, and environmental aspects of virology, has been following with particular interest the debate on “gain-of-function” studies catalyzed by the H5N1 influenza virus transmission studies from the Dutch group led by Ron Fouchier and published by Science in June 2012 (1). The Dutch government insisted that Fouchier ask for official permission (an export permit) before publishing his research abroad, on the basis of European Council regulation EC 428/2009, which was issued in 2009 to prevent the spread of nuclear, chemical, and biological weapons. Although Fouchier complied before the Science paper was published, Erasmus MC Rotterdam sued the government over the requirement for an export permit, based on the fact that the Annex to Council regulation EC 428/2009 contains an exclusion clause for basic scientific research and information already in the public domain. The appeal was recently rejected by a district court, and the case is now being brought before Amsterdam's Court of Appeal.

The News of the Week story “Virologist appeals decision on H5N1 export rules” (8 November 2013, p. 676) stated that the ESV has “sided with Fouchier.” Roughly 90 viruses and microorganisms that can cause disease in humans, animals, and plants are listed in the Annex to Council regulation EC 428/2009. ESV's position stems from the concern that results from scientific work carried out in Europe on these organisms would require an export permit before they can be published in international scientific journals.

This prospect raises a number of serious issues. Under what circumstances should this EC regulation be applied to biomedical research? Who is going to decide when the EC regulation does or does not apply? What should be considered “basic scientific research,” and who is going to judge this criterion? (This is not a trivial question, especially in the European Union context, where, in theory, there might be 28 different interpretations of the same regulation.) Does this create the potential for discrimination among scientists working in different European States and between European scientists and those in the rest of the world? Does this decision apply only when specific results are going to be published in journals outside Europe, or does it apply universally?

It may be that controversial questions related to this issue were ignored for too long, allowing a precedent to be set prematurely. We are overdue for discussions on how to regulate the dissemination of “sensitive” data in a way that does not compromise biosecurity, while maintaining the principle that acquiring important and meaningful knowledge cannot simply be stopped. ESV believes that export control does not represent the best way to deal with this issue.

Our intention is not to criticize or to disregard the work of jurisprudence experts. We believe that the European Commission should take steps to promote a common understanding of the current regulation by existing working groups or by a new advisory committee created to deal with the dual-use research in a harmonized and balanced way throughout Europe. In the meantime, we have expressed our willingness to provide law officers with proper scientific advice, making available the expertise of our many European scientists.


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