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Reality check: The CDC published is Virology paper BEFORE the NSABB started this "controversy" and the CDC acheived transmission WITHOUT passage in ferrets.

The composition of the NSABB board needs to be reviewed. It currently lacks expertise in analysis of PUBLISHED scientific literature on H5N1 transmission.

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Expert slams process for releasing bird flu studies; 'kicked can down the road'

By: Helen Branswell, The Canadian Press

13/04/2012 7:45 PM | Comments: 0

A member of the U.S. biosecurity panel that recently lifted its objections to the publication of two controversial bird flu studies has slammed the way the decision was reached, saying the meeting held to reconsider the issue was "one-sided" and designed to produce the eventual outcome.

Michael Osterholm, a flu expert and a member of the National Science Advisory Board for Biosecurity, warned that the decision to recommend the two studies could be published in full merely "kicked the can down the road" towards what may be another standoff with one of the scientists involved in this affair.

Osterholm revealed that Ron Fouchier, the Dutch virologist who led one of the studies, told the NSABB at a closed-door meeting in late March that he had discovered another mutation that makes it easier still to engineer H5N1 flu viruses that transmit from mammal to mammal.

"This work ... surely must be considered as a candidate for the next manuscript to be before the NSABB for review," said Osterholm, whose term on the board is coming to an end.

His letter was obtained by the news department of the journal Science. They published it on their website, ScienceInsider.

The letter was addressed to Dr. Amy Patterson, associate director for science policy at the National Institutes of Health, and the official to whom the NSABB reports. It was copied to members of the 21-person board and to NSABB staff.

Osterholm wouldn't comment on the sharply worded seven-page letter, which read like a minority report. (The NSABB's full report has not yet been made public.)

"I have no comment beyond: the letter speaks for itself," Osterholm told The Canadian Press.

In the letter, Osterholm, who is the director of the Center for Infectious Diseases Research and Policy at the University of Minnesota, suggested experts who made presentations to the board about various aspects of the issue had an interest in the outcome of the meeting.

"I believe there was a bias toward finding a solution that was a lot less about a robust science- and policy-based risk-benefit analysis and more about how to get us out of this difficult situation," he wrote.

The controversy has dragged on since last fall, enmeshing influenza researchers, two prominent scientific journals, the U.S. government and even the World Health Organization in a messy fight where it seemed capitulation, not compromise, was the inevitable outcome.

The controversy started when research teams led by Fouchier at Erasmus Medical Centre in Rotterdam and Yoshihiro Kawaoka of the University of Wisconsin-Madison tried to publish scientific papers revealing they had managed to mutate H5N1 viruses to the point where they could transmit easily among ferrets.

Ferrets are used a stand-in for people in this type of work because they are considered the best animal model for predicting how flu viruses will act in humans.

Currently H5N1 viruses in the wild decimate poultry flocks, but do not readily infect mammals. Occasional human cases occur, but spread from person to person is believed to be rare and transmission quickly peters out.

Fouchier and Kawaoka have been working — with funding from the U.S. National Institutes of Health — to try to see what it might take to make the virus transmissible among mammals. Their proof that H5N1 can make these changes means the virus must be considered a pandemic threat.

The journals Science and Nature have accepted the studies for publication. But the papers were referred to the NSABB because of fears the information in them qualified as so-called "dual use research of concern" — legitimate science that could be used for dangerous purposes.

Fouchier would not comment on Osterholm's letter, which said the Dutch scientist had discovered a mutation that makes H5N1 viruses transmit by aerosol without requiring the virus to be passaged. Passaging is the scientific process of serially infecting animals in an attempt to force mutations, a labour-intensive and time-consuming step.

In an email, Fouchier noted Dutch export control law currently bars him from publishing or talking publicly about his H5N1 transmission work.

Late last fall the NSABB recommended that the Fouchier and Kawaoka papers be published in abbreviated or redacted form only. Acting on that advice, the U.S. government asked the journals to publish without the details of how the work was done.

But a meeting organized by the World Health Organization in February concluded that publishing redacted versions of the papers was unworkable.

When material is withheld for security reasons, export control laws in the United States and the Netherlands come into play. Those laws could conceivably prevent Fouchier from sending his study to his U.S.-based publisher, Science, or Kawaoka from sending his to U.K.-based Nature.

And those laws would prevent the information in the studies from being shared across borders with public health authorities or influenza scientists with a legitimate need to see the complete material.

At a second meeting held March 29 and 30, the NSABB changed its position, voting unanimously that Kawaoka's paper should be published in full. In a 12-to-6 vote, it also agreed that Fouchier's paper should be published.

Osterholm was one of the six who objected to full publication of Fouchier's paper.

———

Online:

Osterholm's letter can be found on the ScienceInsider website at:

http://news.sciencemag.org/scienceinsid ... 1212_3.pdf

http://www.brandonsun.com/world/breakin ... 77185.html

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The U.S. biosecurity panel that recently lifted its objections to the publication of controversial bird flu studies has raised additional concerns about one of the papers, work conducted by a Dutch research team.

In its report to the U.S. government, posted online over the weekend, the National Science Advisory Board for Biosecurity waived its earlier objections to the study led by Yoshihiro Kawaoka at the University of Wisconsin-Madison.

But the board said the second study, by Ron Fouchier of Erasmus Medical Centre in Rotterdam, needs clarifications before it can be published and suggested additional information that was not in the study the board vetted should not be added to the final document.

"Importantly, the Board also noted that additional information that would enable the construction of an H5N1 virus that is both highly pathogenic and transmissible between mammals through the air should not be included in the manuscript," it stated.

The lingering controversy over the work began late last fall when the NSABB advised the U.S. government to ask the journals planning to publish the studies to withhold key portions so others could not repeat the work. The U.S. government followed the advice and the journals and authors reluctantly agreed, on the proviso a system be set up to allow the withheld information to be shared with public health authorities and other flu researchers on a need-to-know basis.

The studies show how H5N1 flu viruses can be mutated to the point where they can transmit through the air from ferret to ferret, mammals that are used as a proxy for humans in influenza research.

The report, which goes to U.S. Health Secretary Kathleen Sebelius, was posted online Saturday by the National Institutes of Health, the body under which the NSABB operates. The NSABB was set up in the wake of the 2001 anthrax attacks in the United States. Its mission is to advise on so-called dual-use research of concern -- legitimate research that could also pose a public health threat in the wrong hands.

At least several members of the 21-member board were caught off-guard by the report's release, saying they weren't informed and did not have a chance to approve the final wording of the document. They asked not to be identified.

It had been thought the report would only be made public after Sebelius announces whether she is going to accept the board's recommendations.

The report was released the day after publication of a leaked letter from one member of the NSABB slamming the meeting at which the final decision was reached. The news departments of the journals Science and Nature received the letter via anonymous email.

It was written by Michael Osterholm and addressed to Dr. Amy Patterson, associate director for science policy at the National Institutes of Health, and the official to whom the NSABB reports. It was copied to members of the 21-person board and to NSABB staff.

The letter was sharply critical of a meeting held March 29 and 30, called so the NSABB could reconsider modified versions of the two studies. Osterholm, a flu expert and director of the Center for Infectious Diseases Research and Policy at the University of Minnesota, said the information presented at the late March meeting was "one-sided" and designed to produce the eventual outcome.

For instance, he noted the board was told of the importance of the information for surveillance of H5N1 viruses that might be evolving towards person-to-person transmissibility in the wild. But it did not receive briefings on the state of existing surveillance efforts and the likelihood mutating viruses could be picked up in real time. Experts have suggested surveillance is too spotty and too slow to identify evolving viruses in time to take action.

"The agenda was not designed to promote a balanced reconsideration of the manuscripts," he wrote. Osterholm has refused to comment on the letter, saying only that it speaks for itself.

Reached Sunday for comment, NSABB member Dr. David Relman said the issues raised in the letter "are legitimate and deserving of serious attention."

Relman is a researcher in the departments of medicine, and microbiology and immunology at Stanford University. He and Osterholm were among six members of the board that voted against full publication of Fouchier's study.

In his letter, Osterholm warned that the decision to recommend full publication of the two studies merely "kicked the can down the road" towards what may be another imminent standoff with Fouchier, revealing that the Dutch scientist disclosed at the March meeting that he has found a mutation that makes generating a mammal-to-mammal transmissible H5N1 virus significantly easier.

"This work ... surely must be considered as a candidate for the next manuscript to be before the NSABB for review," said Osterholm, whose term on the board is coming to an end.

The NSABB's report did not specifically state that this is the addition information Fouchier should not put into his paper, which is to be published by Science.

But the report said that information on how to produce an H5N1 virus that was both highly pathogenic and transmissible through the air "could conceivably be directly misused to threaten public health or national security and additional considerations regarding communication would be necessary."

The report contained a section outlining the views of the minority members on the vote regarding Fouchier's work. Where the majority said the information in the studies couldn't be misused over the near-term, the six dissenting members said the details of Fouchier's study could be used to endanger public health or national security. They also questioned whether the information it contains will help in surveillance for H5N1 viruses that are mutating towards human-to-human spread in the wild.

"The evolutionary paths taken by naturally occurring H5N1 viruses may not be similar to those selected under these laboratory conditions," they said, adding that "excessive attention to these mutations might distract attention from others that are of greater significance in the wild."

The full report said that the board still believes the manuscripts present dual-use research concerns, but members had been persuaded the risks of not publishing were also serious.

"The Board's discussions underscored the risks associated with not sharing the information, which could jeopardize pandemic influenza preparedness efforts. Specifically, there was concern that the United States would be perceived as redacting information with potential public health benefits and that this could undermine valuable international collaborations," the report said.

In its recommendations, the report called for the U.S. to work with other governments to devise policies for oversight of dual-use research, particularly "gain-of-function" research aimed at giving a pathogen increased virulence or the ability to infect new hosts.

And it also called on the U.S. to quickly develop a mechanism whereby scientific information that needs to be kept out of the literature for security reasons can be shared on a need-to-know basis.

Currently export control laws are triggered if information must be withheld for security purposes. As this controversy has dragged on, it has become clear that those laws would have made it impossible to share the data in the Kawaoka and Fouchier papers, if they were redacted. Following the March meeting one member of the NSABB said the board would have preferred to hold to the recommendation that the studies be redacted, but had come to the conclusion that path wasn't feasible at this time.



Read more: http://www.ctv.ca/CTVNews/Health/201204 ... z1sEZBvcTY

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Could Bird Flu Be a Weapon? Dutch Law May Keep Flu Research Bottled Up




Publication of the controversial mutant avian flu papers have hit yet another roadblock. In March, a US advisory panel reversed its prior decision to take out experimental details from two reports about research that seemed to turn the H5N1 bird flu virus into a more virulent and deadly form. Under the original decision, some redacted information would have been available only to accredited researchers.

But in a new, international twist, one of the papers is encountering another obstacle: NPR reported that the Netherlands-based team behind one of the studies is being stifled by Dutch law, which limits the export of technology that could be weaponized. So now there are two main questions about whether the flu research would be published for all to see: how dangerous the virus is, and whether the Dutch law would apply to this research.



Humans, This Mutant H5N1 Virus Will Not Kill You

Last year, two research teams submitted papers that showed how H5N1 could be made contagious between ferrets, which are the best stand-in for humans when it comes to flu research. (The wild H5N1 virus only spreads from bird to human, so an airborne human-to-human virus could be much deadlier in the hands of bioterrorists.) Nature accepted one paper from a team at the University of Wisconsin, and Science accepted the paper from a team led by Ron Fouchier at Erasmus Medical Center in the Netherlands. In November, Fouchier said the mutant H5N1 is “probably one of the most dangerous viruses you can make,” which predictably created a media storm. The potential publication of these papers had been up in the air for the past few months.

(For comprehensive background information, check out this excellent primer at Nature News or this write-up of why the US National Science Advisory Biomedical Board reversed its decision to limit access to the flu findings, both by Discover Blogger Ed Yong.)

The two teams used different techniques; Fouchier’s Science study was more ominous in that his mutant H5N1 virus killed the ferrets—but only if the virus was directly implanted into the ferret’s trachea or nasal tissue. As an airborne disease, it was not deadly, but this distinction was not clarified until March. The US advisory board seems to have reversed its previous decision based on some new evidence, reports Yong, but what that evidence actually is will have to wait until publication…if that ever happens.

Bureaucratic Limbo

Because of the original decision to give the information only to accredited reseachers, according to the NPR report, Dutch export laws on potential weapon technology have kicked in:


“The more complex part of export controls is when it comes to information, rather than equipment,” says Alice Gast, president of Lehigh University, who recently co-chaired an expert panel that examined how these laws affect science.

Information produced by basic research is normally exempt, says Gast, who explains that “the fundamental research exemption is valid as long as you are freely and openly sharing the results of the research.”

But if researchers agree to limit access, for whatever reason, that exemption no longer applies.

Even when the US advisory panel met to discuss the papers, “special export licenses had to be obtained from the US and Dutch governments so the international experts at the meeting could read new versions of the research reports—and they only could see paper copies that they then had to return.” Fouchier himself has confirmed that the export law is preventing him from talking about his research or submitting a revised manuscript to Science. He is supposed to meet with the Dutch government on April 23 to discuss the fate of his paper.
http://blogs.discovermagazine.com/80bea ... ottled-up/

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Apr 16, 2012 (CIDRAP News) – The US National Science Advisory Board for Biosecurity (NSABB) says in a new report that one of two controversial H5N1 avian flu studies needs some clarifications before publication and that some additional information the board heard from the lead author should not be included in the paper.

Over the weekend the NSABB released a report offering new details on its meeting held Mar 29 and 30, when the board reversed its earlier recommendation against full publication of H5N1 studies led by Ron Fouchier, PhD, of Erasmus Medical Center in the Netherlands and Yoshihiro Kawaoka, DVM, PhD, of the University of Wisconsin. The studies describe lab-modified H5N1 viruses that can spread in ferrets by the airborne route.

The board in December had recommended withholding key details of the two studies out of concern that someone could use the data to create and unleash a highly dangerous virus. After the authors provided additional data on their findings, the board met to reconsider the recommendation.

At the meeting, the board unanimously endorsed publication of Kawaoka's revised manuscript in full. On Fouchier's manuscript, the panel approved publication of the "data, methods, and conclusions" on a 12-6 vote, but said the manuscript needed some revisions, according to the new report.

"The Board identified a number of scientific clarifications that should be made prior to publication of the manuscript," the report says, without describing them.

The recommendation continues, "Importantly, the Board also noted that additional information that would enable the construction of an H5N1 virus that is both highly pathogenic and transmissible between mammals through the air should not be included in the manuscript. Such information could conceivably be directly misused to threaten public health or national security and additional considerations regarding communication would be necessary."

This sounded like a reference to the same data that was mentioned by NSABB member Michael T. Osterholm, PhD, MPH, last week in a leaked letter in which he charged that US government officials picked the meeting agenda and speakers with the aim of getting the board to reverse its original recommendations. Osterholm was one of the six members who voted against full publication of Fouchier's findings.

In the letter, Osterholm wrote, "We heard from Dr. Fouchier that he has already identified an additional mutation (not included in his current manuscript) that results in ferret-to-ferret transmission (mammalian transmission) without the need for repeated passage of the virus in ferrets. This work, which may have been supported by NIH funds, surely must be considered as a candidate for the next manuscript to be before the NSABB for review."

Osterholm declined to comment today on whether he was referring to the same information as cited in the NSABB recommendation. His letter asserted that the NSABB recommendations "just kicked the can down the road to the next manuscript."

Limited sharing mechanism still sought
In other recommendations detailed in the new report, the NSABB said the US government "should expeditiously develop a mechanism to provide controlled access to sensitive scientific information."

The board's earlier recommendation had said such a mechanism should be used to convey the unpublished details of the two studies to responsible scientists on a need-to-know basis, but deliberations by experts convened by the World Health Organization in February led to a conclusion that it wasn't possible to devise such a mechanism quickly.

US and Dutch regulations restricting the exporting of sensitive information have been cited as one of the obstacles to such a system.

The other recommendation in the new report says the US government "should continue to develop national, and participate in the development of international, policies for the oversight and communication of dual use research of concern."

The NSABB makes its recommendations to the National Institutes of Health (NIH), part of the US Department of Health and Human Services, which must decide whether to forward them to the two journals expecting to publish the papers—Science and Nature. HHS officials have not yet made a decision about the recommendations, NIH spokeswoman Renate Myles told CIDRAP News today.

In an Apr 14 statement, NIH Director Francis Collins, MD, PhD, said, "A final recommendation of these two revised manuscripts regarding the transmissibility of the H5N1 avian flu virus in ferrets will be made by the HHS Secretary and brought to the broader US government."

More on the rationale
Also in the new report, the NSABB offered more details on the rationale for reversing its earlier recommendation and on the thinking of those who voted against full publication of Fouchier's study.

The reasons the board cited for endorsing publication include:

The mutations described in the studies "do not appear to result in H5N1 viruses that are both highly pathogenic and transmissible between ferrets through the air."
The data "may benefit public health and surveillance efforts."
Not publishing the information could endanger global pandemic influenza preparedness efforts.
The studies were conducted under "rigorous biosafety conditions."
Those who opposed full publication of Fouchier's data, according to the report, concluded that:

The mutations described in the study "appear to result in modified H5N1 viruses that are transmissible between ferrets by respiratory route" and that seem to be as pathogenic as the parental H5N1 strains.
"While the data in the two manuscripts may benefit public health and surveillance efforts, these data may not be directly relevant or immediately helpful to the current public health or surveillance infrastructure."
See also:

New NSABB report

Apr 14 Francis Collins statement

Apr 13 CIDRAP News story "NSABB member says officials stacked deck for board's H5N1 decision"

Mar 30 CIDRAP News story "NSABB reverses recommendation on H5N1 studies"

NSABB statement released immediately after Mar 29-30 meeting

Apr 10 CIDRAP News story on export control issue
http://www.cidrap.umn.edu/cidrap/conten ... nsabb.html

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A member of the NSABB biosecurity board that recently reviewed H5N1 data criticizes the process.

By Sabrina Richards | April 17, 2012


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Colorized transmission electron micrograph of Avian influenza A H5N1 viruses (seen in gold) grown in MDCK cells (seen in green).Wikimedia Commons, CDC


The process leading to the US biosecurity board recommending full publication of two controversial H5N1 flu papers has been criticized by a board member in a letter sent to the National Institutes of Health last week (April 12). Influenza epidemiologist Michael Osterholm of the University of Minnesota, Twin Cities, outlined his criticisms to Amy Patterson, associate director for science policy at the NIH, reported Nature.

The US National Science Advisory Board for Biosecurity (NSABB) had previously recommended that the two controversial H5N1 papers, which detailed mutations that allow for ferret-to-ferret aerosol transmission, be published in redacted form, a recommendation that was rescinded at last month’s meeting. Osterholm himself voted for publication of one paper, but was concerned that modifications to the second paper did not adequately address bioterrorism concerns. In the letter, Osterholm elucidates his concerns that the risks were given short shrift and that the meeting was designed to encourage full publication of the H5N1 papers.

While Osterholm said he sees no “sinister motive” behind the meeting’s agenda, he wrote, “…I believe there was a bias toward finding a solution that was a lot less about a robust science- and policy-based risk-benefit analysis and more about how to get us out of this difficult situation.” Some proponents of full data disclosure argue that it will aid in virus surveillance, but Osterholm wrote that no virus surveillance experts were invited. Instead he saw an “‘involved influenza research community’ telling us what they should and shouldn’t be allowed to do based on their interested perspective.”

Susan Ehrlich, a retired judge and NSABB member who voted against full publication of the second paper, told Science that Osterholm’s letter “thoughtfully presents very valid points, ones that warrant further and serious discussion.”

Read more expert opinions about the risks of such research in this month’s featured debate about scientific transparency and public health protection.
http://the-scientist.com/2012/04/17/flu ... riticized/

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White House Responds to Congressman's Questions About H5N1 Flu Papers

by David Malakoff on 17 April 2012, 1:56 PM| 0 Comments
White House science adviser John Holdren.

Credit: The White House Office of Science & Technology Policy

White House science adviser John Holdren has replied to questions asked last month by Representative Jim Sensenbrenner (R-WI) about how the Obama Adminstration has handled the controversy surrounding two studies that showed how to make the H5N1 avian influenza virus transmissible between mammals.

On 1 March, Sensenbrenner—a former head of the House of Representatives committees on science and the judiciary, and currently vice chair of the House Committee on Science, Space, and Technology, sent a "fact-finding letter" to Holdren. It asked a number of questions about how the government reviews potential "dual-use research of concern" (DURC) that might be used for good or evil. It also observed that the Obama Administration's handling of the flu papers controversy "appeared ad hoc, delayed, and inadequate."

In his 9 April response, Holdren wrote that "the circumstances surrounding the recent review of H5N1 manuscripts are unprecedented." It marked the first time a government advisory body, the National Science Advisory Board for Biosecurity (NSABB), had recommended withholding information from a scientific paper, he added. "Thus, the [U.S. government] until now had not needed to have a system in place specifically for restricting dissemination of the results of DURC." But NSABB ultimately supported publication of the papers, he noted, after government reviews revealed "serious legal and procedural hurdles to the establishment of such a dissemination system that could not be overcome on a timescale that would be relevant to the publication of these papers." The government has issued a new policy for reviewing taxpayer-funded research for DURC potential, he noted.

In a statement, Sensenbrenner said he was only partly satisfied:
In his response, Dr. Holdren wrote that, until now, the United States government has "not needed to have a system in place" for restricting dissemination of dual use research or concern because this is the first time the NSABB recommended restricting publication. I believe the Administration needs to be more proactive than that and prepare for possible threats before they occur. The new policy is a good, if belated, first step, and I will be watching its implementation closely.
http://news.sciencemag.org/scienceinsid ... html?rss=1

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Mutant-flu researcher plans to publish even without permission


Virologist plans to defy Dutch government over export permit requirement for avian flu paper.
Declan Butler

17 April 2012

Dutch authorities say work on an avian flu virus that is transmissible between mammals cannot be published without an export permit.
Ron Fouchier, a researcher at the Erasmus Medical Center in Rotterdam, the Netherlands, whose work on H5N1 avian flu virus has been at the centre of controversy, says that he is prepared to defy government demands and submit the work to Science without seeking the export permit that the Dutch government says is required.

A government official says that such an action could incur penalties including up to six years' imprisonment.

Fouchier’s paper is one of two reporting the creation of forms of the H5N1 virus capable of spreading between mammals. The other, by Yoshihiro Kawaoka of the University of Wisconsin, Madison, and his colleagues, has been submitted to Nature.

In December, the US National Science Advisory Board for Biosecurity (NSABB) said that experimental details of the two studies should be redacted from any publications, on the basis of concerns that the information could be used by bioterrorists. The board also feared that publishing the details would prompt more laboratories to work on the viruses, making an accidental release more likely.

The NSABB revised its position on 30 March, voting 12-to-6 in favour of publishing a revised version of Fouchier’s paper and unanimously for full publication of a revised version of Kawaoka’s paper. The decision came after a two-day meeting with the researchers and other flu experts to assess revised versions of the manuscripts (see “US biosecurity board revises stance on mutant-flu studies”).

Fouchier has complained in recent weeks that despite the NSABB decision in favour of publication, the Dutch government’s export controls have prevented him from submitting to Science and from publicly presenting data on his revised manuscript. By contrast, Kawaoka gave a presentation of his data just after the NSABB meeting (see "Mutations behind flu spread revealed".)

Jan van Diepen, a spokesman for the Dutch Ministry of Economic Affairs, Agriculture and Innovation, says, however, that the government has not received an application from the Erasmus Medical Centre for an export permit for the revised paper, and so has been unable to decide whether to grant a permit.

Matters seem likely to come to a head next week. The Dutch government is planning a meeting on 23 April to assess the risks and benefits of publishing the research. The meeting will bring together 30 or so government experts in areas of biosafety, public health and virology from many of the countries involved, such as the United States, Japan, the Netherlands, United Kingdom, Vietnam and Indonesia, the last two of which supplied the H5N1 viral isolates used in the research.

Fouchier and his collaborators will also attend, as will journal editors and representatives of the World Health Organization, the European Commission and the Biological and Toxin Weapons Convention.

“After this conference, and when an application [for an export permit] is received, the Dutch government will decide on an export licence,” says van Diepen, adding that although the NSABB decision will “carry weight” in the discussions, the Dutch government wants to make up its own mind on whether to allow publication.

But Fouchier says that he intends to submit his paper to Science after the meeting without applying for an export permit. “Science can publish any paper submitted to them, according to their First Amendment right,” says Fouchier. “That means that if the Dutch government would want to stop publication, they cannot do so after we formally submit to Science.”

Whether the paper falls under export-control laws is unclear. The Netherlands implements European Union (EU) legislation on export controls, which require an export permit for ‘dual-use’ materials and information — those that could have both legitimate and malicious uses — including those relating to dangerous pathogens.

The EU law allows an exception for “basic scientific research” that is “not primarily directed towards a specific practical aim or objective”. It also allows exceptions for information that is “in the public domain” or “the minimum necessary information for patent applications”.

Fouchier has publicly defended his work both as basic scientific research and as having practical benefits for flu surveillance and vaccines. He says that the Erasmus Medical Center has obtained legal advice that export-control laws do not apply to the manuscript. “We will not apply for an export permit, as we are convinced we do not need one,” he says.

The Dutch government sees matters differently.

“A detailed analysis of the legislation, and in particular the provisions and definitions on technology transfers, have convinced us that the basic scientific research exemption is not applicable,” says Cindy Heijdra, a spokeswoman for international trade at the Dutch Ministry of Economic Affairs, Agriculture and Innovation, adding that the ministry’s legal counsel believes that export controls apply to the Fouchier work.

She confirms that no permit application has been received from Fouchier’s institution, but adds that the ministry “expects one shortly”.

Asked the hypothetical question of what would happen if the researchers sought to publish the revised paper without seeking a permit, Heijdra said: “Transferring technology without the required export licence is an infringement of export-control legislation under the Economic Offences Act. The maximum penalty, in case of premeditation or severe negligence, is six years' imprisonment or a €78,000 [US$102,000] fine.”

The 23 April meeting “will provide an opportunity to carefully discuss various aspects — public health, science, security, non-proliferation — of the publication of the results of the H5N1 studies in an international setting with the countries and parties most involved”, says Heijdra. “This is essential for the Netherlands, for we want to make sure that any decision on the publication of this research, such as the granting or not granting of an export licence, is as well informed and careful as possible.”

If the governments lifts the export control restrictions on Fouchier's work following the meeting, he would be free to submit his work without needing a permit. But if the Dutch government does insist on a permit, Fouchier is adamant that he will publish. “We simply will never apply for an export permit on a scientific manuscript for publication in a journal. We do not want to create a precedent here,” he says. “We might end up in court indeed if they insist on censorship.”
Nature
doi:10.1038/nature.2012.10469
http://www.nature.com/news/mutant-flu-r ... on-1.10469

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The Dutch government is now competing with the US NSABB for H5N1 bioterrorist of the year award, The full (18 member?) board unanimously recommended censoring the Kawaoka paper, and then unanimously vote for unrestricted publication.

The full board is competing with the 6 members who voted to restrict the Fourchier paper, even though the recipe (A/Indonesia/5/2005 with HA changes, Q226L and G228S, and PB2 E627K passaged 10 X in ferrets) is well known, and all three changes were already PUBLISHED by the CDC in their H5N1 transmission paper in Virology BEFORE the NSABB entered the contest.

Now The Netherlands is joining the competition, by trying to censor the above PUBLIC data by claiming technology transfer of technology that has already transferred.

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Full NSABB recommendations

http://www.nih.gov/about/director/03302 ... ations.pdf

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