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Court upholds need for export permits for risky flu research

The researcher who created mammalian-transmissible strains of the H5N1 avian flu virus, raising fears they could cause a pandemic, has failed in an attempt to overcome government restrictions on the publication of his papers (see Nature‘s mutant flu special).

Ron Fouchier, of the Erasmus Medical Center in Rotterdam, the Netherlands, lost a court case in which he tried to have publication of papers describing the production of such strains exempted from government export controls, which require researchers to obtain an export permit before publishing.

Fouchier says that he and his colleagues will meet with lawyers next week to decide whether to appeal against the 20 September ruling by the district court of the North Holland region of the Netherlands. They have six weeks in which to act. “We do not want to give up,” says Fouchier, adding that he cannot yet say whether he will pursue an appeal until the meeting with his lawyers.

The Dutch government last year told Fouchier he had to apply for an export permit before being able to publish a paper on his engineered strains in Science. It argued that 2009 European Union (EU) legislation on export controls require an export permit for ‘dual-use’ materials and information that can have both legitimate and malicious uses — including dangerous pathogens such as H5N1.

Fouchier had at first threatened to defy the government and publish the paper without applying for an export permit but reluctantly gave in after the government warned that he could face up to six years in prison, plus fines, for doing so. The government finally granted him a permit in April last year.

Fouchier said at the time that all the paper’s co-authors and the board of directors of their institutions had agreed to seek a permit only “under protest”. At the same time, they initiated a legal challenge to dispute the necessity of them having to apply for one. Fouchier argued that the research fell under two exceptions in EU export control law, including one for “basic scientific research” that was “not primarily directed towards a specific practical aim or objective”. The paper also fell under another exception for information that is in the public domain, he argued, on the grounds that the methods were already well known. Fouchier also argued that the obligation to apply for a permit hampered access to the results of scientific research.

The court noted that the law was intended to counter the proliferation of weapons of mass destruction, including biological weapons, and that H5N1 was among those dangerous organisms specified in the law — akin to the US Commerce Control List. It ruled that because the researchers showed how to convert an avian flu into a mammalian-transmissible virus, that was by definition a practical purpose going beyond basic research.

The court also ruled that the study went beyond known methods, by selecting and detailing the specific changes necessary to obtain mammalian-transmissible strains, so was therefore not already in the public domain. That a top journal such as Science was willing to publish the paper also indicated its novelty, it added.

All this pointed to there being a legal requirement to apply for an export permit so that proliferation risks could be assessed, said the court in its ruling. It argues that the export permit system does not have any impact on most research, and causes only a few weeks delay during review of the application. Any such drawback is outweighed by the need to counter any proliferation of biological weapons, it said. Fouchier says that while the export-control review process is eight weeks, it can be extended, and that it also offers officials the option of blocking publication.

Fouchier says that he finds the court’s arguments “weak”. “They are of the opinion that our work is not basic scientific research,” he says. “They claim our goal was to make a dangerous virus airborne. However, the goal was to increase fundamental understanding of airborne transmission of bird flu virus.”

He asserts that the court’s rejection of his argument (that the methods were already in the public domain because he had only added to them), would mean that only researchers following published procedures would benefit from this exception to the export control rules.

Fouchier was one of 22 flu researchers who in August argued for the need to perform similar experiments to genetically engineer versions of H7N9 — which emerged earlier this year in China — that are more transmissible and pathogenic in mammals (see ‘Handle with care‘). The ruling suggests that any European researchers wanting to publish such work would first need to obtain export permits.

In one sense, the court’s conclusions are a reaffirmation of existing legislation in the face of a challenge, rather than setting any new precedent. Fouchier argues, however, that it “provides an opportunity for European governments to control and censor scientific publications, which in my opinion is unacceptable”.

The court argued that, more broadly, decisions on what is and what is not research with potential consequences for international proliferation cannot be left to individual researchers without compromising states’ obligations under United Nations Resolution 1540, passed in 2004, which requires states to adopt legislation to counter the proliferation of nuclear, chemical and biological weapons. “Apparently, the court thinks that export control officers are in a better position to judge scientific publications,” says Fouchier.

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    Michael Kovari said:

    I don’t claim to be an expert on this, but based on this post, Fouchier’s arrogance and recklessness is scary. Read these quotes first,
    “Fouchier had at first threatened to defy the government and publish the paper without applying for an export permit ..”
    “…the obligation to apply for a permit hampered access to the results of scientific research.”
    “..for European governments to control and censor scientific publications, which in my opinion is unacceptable,”
    and the biscuit is taken,
    “Apparently, the court thinks that export control officers are in a better position to judge scientific publications,” says Fouchier (who apparently believes he is above the law and the best person to decide on his paper is him).

    Now think Tuskegee, but with a bioweapon.

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