In the eye of the storm. Flu researcher Ron Fouchier has been proactive in discussing the nature and benefits of his research.

Dirk-Jan Visser

Dutch appeals court dodges decision on hotly debated H5N1 papers

AMSTERDAM—For more than 3 years, virologist Ron Fouchier has battled the Dutch government over a fundamental question in the balance between academic freedom and biosecurity: Did he need a government license to publish his hotly debated gain-of-function (GOF) studies on the H5N1 influenza strain?

Yes, a Dutch court ruled in 2013, in a decision that dismayed Fouchier and raised questions about how the publication of sensitive studies is handled in the Eurpoean Union.

Now, the Court of Appeal in Amsterdam has tossed out that verdict. But it's a pyrrhic victory for Fouchier. Rather than ruling on the fundamental issue, the court said Fouchier and his employer—Erasmus MC in Rotterdam, Netherlands—didn't have standing to sue the Dutch government, putting them back at square one.

"I'm disappointed," Fouchier says. "They didn't want to touch the hot potato and passed it on instead."

The Court of Appeal decided the case on 18 June, but released the verdict (in Dutch) only yesterday. In accordance with Dutch judicial practice, all names in the text have been redacted, along with details about the technology and the virus strain that Fouchier used.

Here's the back story: A huge debate erupted after Fouchier submitted a paper to Science in late 2011 that showed how, with only a few mutations, a lab-created H5N1 flu strain could infect ferrets via airborne transmission. So as not to give bioterrorists any ideas, the U.S. National Science Advisory Board for Biosecurity (NSABB) initially recommended not publishing the key details in Fouchier's paper. (It said the same about a similar study by Yoshihiro Kawaoka of the University of Wisconsin in Madison submitted to Nature around the same time.)

NSABB eventually reversed that decision, but by then the Dutch government had stepped in: Publishing the H5N1 paper amounted to exporting dangerous knowledge outside the European Union, it said. It told Fouchier to apply for an export license before sending a second, revised version of his manuscript to Science's editorial office. Eager to get the paper in print, Fouchier and Erasmus MC did so, but under protest. The license was granted and the paper was published in Science in June 2012. The team also applied for, and obtained, a license for a companion paper published in the same issue of Science and for a 2014 follow-up paper in Cell.

After the first papers were published, Erasmus MC lodged a formal objection against the Dutch government to protest the license requirement. The government turned down that claim in December 2012, after which the institute took the case to the District Court. Erasmus MC lost again in September 2013. The next month, the case moved to the Court of Appeal, where it has been in limbo for nearly 20 months.

At the heart of the issue is whether Fouchier's scientific manuscripts need an export license under E.U. regulations issued in 2009 that aim to prevent the proliferation of nuclear, biological, and chemical weapons. Those rules ban shipping a long list of goods, pathogens, and technologies that could be used for nefarious purposes. But this was the first time anywhere in Europe that the rules had been used to control the publication of a scientific paper.

Erasmus MC argued that the E.U. regulation doesn't apply to the H5N1 work because it makes an exception for ″basic scientific research″ and for information already in the public domain. Fouchier's work was basic research and his methods weren't new, it argued. The District Court rejected that defense, arguing that making H5N1 an airborne virus was not basic research, but instead a “practical goal.”

The Court of Appeal decided it didn't need to wade into this thorny discussion. It argued that after it had obtained a license to send the manuscript to Science in 2012, Erasmus MC no longer had a legal interest in pursuing the case. The government should not have taken Erasmus MC's complaint into consideration, and the District Court should not have upheld the government's rejection of the complaint, the appeals court said. If Erasmus MC had wanted to object to the government's policies, the court seems to argue, it should have done so instead of applying for a license—it shouldn’t have done both.

"I hadn't expected this outcome," says Koos van der Bruggen, a biosecurity expert and independent consultant who co-authored a 2013 report on dual-use issues published by the Royal Netherlands Academy of Arts and Sciences. But Van der Bruggen says he understands that the court chose to avoid what is essentially a political issue. "They decided not to take the place of the executive or legislative powers," he says. For Fouchier, the only good thing is that the District Court's verdict has been annulled, he adds.

"Erasmus MC regrets that after a long procedure there is no ruling on the merits and remains convinced that for strictly fundamental research, an export license is not needed," an Erasmus MC press officer said in an email to ScienceInsider.

Both parties have until 30 July to lodge an appeal with the Supreme Court of the Netherlands; the Erasmus MC spokesperson says the institute is still exploring its legal options. A spokesperson for the Ministry of Foreign Affairs, which is in charge of export control policy, says the ministry is still studying the verdict.

There are other avenues to obtain clarity on the core issue, says Fouchier, but none are very appealing. Whenever a similar GOF paper is ready for publication, for example, Erasmus MC could refuse to apply for an export license and sue the government instead. But that could leave the paper unpublished, possibly for years if there is a new appeal. Alternatively, Fouchier says he could submit his next paper without a license and see if the government prosecutes him. "If it were just me, I would do that," Fouchier says. "But there are co-authors and Erasmus MC board members who would be liable as well."

For the moment, Fouchier doesn't have any new GOF work to publish. Last year, the U.S. government unexpectedly decided to halt the funding of such studies, asking researchers to pause their work and ordering a review of the risks and benefits—a process that is still ongoing. Fouchier, who has an important grant from the National Institutes of Health for his flu work, has stopped his project as well. Although he could resume the research with Dutch or European funding, "I don't think it's wise to bite the hand that feeds me," he says.

*Updated, 17 July, 8:30 a.m.: This story has been updated to include a response from the Dutch Ministry of Foreign Affairs.