Understanding the Dutch export licence requirement for publishing life science research

[Cross-posted from The Trench]

During the Meeting of Experts of states parties to the Biological and Toxin Weapons Convention (BTWC) last August, the Netherlands organised or co-hosted three side events relating to safeguarding the life sciences. A significant incident, in which the Dutch virologist Ron Fouchier and his team were required to obtain an export licence to publish their research on how they had mutated H5N1 into an aerosol-transmissible avian influenza virus variant, undeniably informed the need to clarify national policies and approaches to biorisk management. A month earlier the Appellate Court had annulled the ruling by a lower court in support of the government position on procedural grounds. Does this annulment validate the Dutch government’s position or does it imply that the whole debate about the publication of so-called dual-use research in the life sciences is back to square one? Moreover, in the meantime the debate had evolved from a terrorist proliferation risk to one of health security in which the ethics and utility of this type of gain-of-function research stand central. In other words, do biosafety worries warrant biosecurity policy measures, such as the imposition of non-proliferation export controls?

Some background to the Netherlands decision

In September 2011 the European Scientific Working Group on Influenza (ESWI) held its fourth conference in Malta. Europe and the world were then confronting an outbreak of avian influenza caused by the H5N1 virus. Its rapid spread among birds over long distances caused governments worldwide to order drastic measures in efforts to stem the epidemic. Over 500 humans (representing some 60% of all people who had contracted the disease) had already died, but all deaths thus far had resulted from direct interaction with fowl and not from human-to-human transmission.

In Malta Ron Fouchier announced that he and his team at the Erasmus Medical Center in Rotterdam had succeeded in transforming H5N1 into a viable aerosol virus. According one conference report he applied rather colourful language: his team ‘mutated the hell out of H5N1’. The discovery that it required as few as three single mutations to gain the ability to latch onto cells in the nasal and tracheal passageways, he described as ‘very bad news’. Transmission among ferrets, a mammal that offers the best laboratory model to study influenza in humans, still did not occur easily when, in Fouchier’s recorded words, ‘someone finally convinced me to do something really, really stupid’. They provoked two further mutations by transferring mutated viruses from the nose of one sick ferret to that of a healthy one, in the process creating the viable aerosol virus.

Initial articles on the gain-of-function research did not suggest any link with bioterrorism, but sometimes carried dramatic titles evoking cataclysmic consequences reminiscent of the 1918 Spanish flu epidemic that killed tens of millions worldwide. However, Fouchier’s dramatic speech caught the attention of counter-terrorism officials on both sides of the Atlantic. When he offered his research results for publication in Science, the  US National Science Advisory Board for Biosecurity (NSABB) intervened and eventually accepted publication provided some methodological details were removed from the text. (A parallel paper on H5N1 submitted to Nature by a team led by US scientist Yoshihiro Kawaoka fared a similar fate.) NSABB considered the biosecurity risks outweighed any scientific merit in this type of research: rogue laboratory researchers or terrorists might wish to unleash the deadly virus on the human race to devastating effect.

NSABB’s intervention caused controversy with one side calling it censorship and the other side up in arms that publication had been authorised at all. In the United States, self-publication on the internet was not legally restricted at the time. In the Netherlands too the affair had caught the attention of authorities, many of whom wanted to block publication outright, but lacked the appropriate legal tools to do so. The only way to appraise the risks for malfeasance posed by information in the research manuscript was to implement non-proliferation export controls, which according to European Union regulations must be enforced for applied (but not fundamental) research in the life sciences.

The Netherlands decision caused shockwaves among European life scientists. After initial defiance, Fouchier and his team eventually applied for and received an export licence. Otherwise he might have faced up to six years imprisonment and $102,000 in fines.  The Erasmus Medical Center subsequently took the government to court to have the principle of export licences for scientific research overturned. On 20 September 2013 the District Court of North Holland ruled in favour of the government, but on 15 July 2015 the Appellate Court in Amsterdam annulled the ruling, saying that the case was without merit in view of the application and granting of an export licence. Put differently, the lower court should have never taken up the case. As presented during the BTWC Meeting of Experts in August 2015, the Dutch Government believes that the juridical process vindicated its approach to research with potential dual-use implications.

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