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Flu Researcher Ron Fouchier Loses Legal Fight Over H5N1 Studies

25 September 2013 2:45 pm
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National Institutes of Health

Dismissed. A Dutch court has rejected a challenge to rules that required researchers to get an export permit before sending papers on the H5N1 avian influenza virus (above) to the U.S.-based journal Science.

Virologist Ron Fouchier has suffered a loss in a legal battle with the Dutch government over the publication of his controversial H5N1 influenza research. On Friday, a Dutch district court ruled that the government was right to ask Fouchier to obtain an export license before sending two hotly debated papers out for publication. The ruling, published yesterday (Dutch), could provide new roadblocks for Fouchier’s research in the future.

At issue is Fouchier’s hotly debated paper showing that a few mutations can make H5N1, a virus that normally infects birds, transmissible through the air between ferrets, which was published in Science in June 2012. The fight also involved an accompanying paper published in the same issue in which Fouchier and others tried to gauge the likelihood that such viruses arise spontaneously in nature.

The Dutch government considered sending the papers to Science a form of “export” and required Fouchier to formally ask official permission first. In doing so, the government correctly interpreted E.U. regulations aimed at preventing the proliferation of weapons of mass destruction and so-called “dual use” technology that could be used for good or evil, the court in Haarlem said.

The decision means that future H5N1 transmissibility studies—which Fouchier resumed after a worldwide moratorium ended in January—would require an official stamp of approval as well. The same could be true for similar studies involving H7N9, a strain that emerged in China this spring, because the government could consider any studies that give the virus new capabilities as providing dual use findings.

Fouchier was unavailable for comment today, but he has said in previous interviews that the Dutch government is infringing on academic freedom and putting him and other scientists in the Netherlands at an unfair disadvantage compared to scientists from other countries.

Fouchier’s H5N1 work triggered a worldwide furor in late 2011, along with a similar study by Yoshihiro Kawaoka of the University of Wisconsin, Madison, and the University of Tokyo, when the U.S. National Science Advisory Board for Biosecurity (NSABB) judged that it should not be published without striking the most sensitive details. In the wrong hands, the NSABB reasoned, the studies could be used to turn H5N1 into a bioweapon. The board reversed that decision in March 2012 and gave the papers a green light.

But while the Kawaoka paper was published online in Nature in early May 2012, Fouchier’s study was held up longer because of the Dutch government’s position.

Fouchier applied for an export license under protest and received it on 27 April 2012, allowing the paper to finally be published. But Erasmus MC also filed an appeal against the government’s decision; when the government rejected it, it took the issue to the district court.

The government based its decision on E.U. regulations issued in 2009 that aim to prevent the spread of nuclear, chemical, and biological weapons. Those rules put limits on the export, trade, and transfer of a range of materials, including dangerous flu viruses, and also apply to technical know-how that could be used to make such weapons.

Erasmus MC and Fouchier argued that the rules don’t apply to Fouchier’s papers because an Annex to the document carves out exceptions for ″basic scientific research″ and for information already ″in the public domain.″ The ferret studies were basic scientific research, Fouchier’s lawyer argued, because the researchers sought to better understand mammalian transmissibility of an influenza strain; meanwhile, the methods used in the study to generate mutants had been described before and were well-known.

The court, which heard arguments in the case on 29 August, did not buy this line of reasoning. Making H5N1 airborne was not just basic research, but was a “practical goal,” the judges said; and while the methods had been described before, the researchers had “taken steps and made choices that have led to entirely new outcomes.” To avoid hollowing out the regulations, any exceptions “should be interpreted strictly,” the court said, adding that it’s not up to individual researchers to decide whether their work is basic research.

The court acknowledged that its decision could cause delays in the dissemination of scientific information but said this “disadvantage” is outweighed by the importance of preventing proliferation.

Fouchier and Erasmus MC have 6 weeks to take their case to the Court of Appeal in Amsterdam.

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