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Virus sharing debate raises intellectual property concerns

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  • Virus sharing debate raises intellectual property concerns

    By HELEN BRANSWELL


    (CP) - The dispute over whether countries afflicted with H5N1 avian flu are owed some compensation for sharing viruses with the World Health Organization's collaborating laboratory network could derail a decades-old system that is the cornerstone of seasonal flu vaccine production, experts fear.

    During the recently concluded World Health Assembly - the annual meeting of the WHO's 193 member states - it became clear some countries are keen to explore whether they have intellectual property rights to viruses circulating within their borders and if those rights exist, what benefits might flow from them.

    The protracted debate over virus sharing, deferred to an international working group that will meet this summer, raises concerns that the longstanding system that allows the WHO's labs to monitor for flu drug resistance, watch for emerging pandemic threats and make seed strains for seasonal and pandemic flu vaccines could sink into a morass of ownership squabbles and disputes.

    "The changes that are proposed for the WHO collaborating system and the system that served to underpin the development of (influenza) vaccines worldwide for the last 50 years could collapse," warns one influenza community insider who doesn't want to be named.

    Another, Dr. Angus Nicoll of the European Centre for Disease Control , agreed the threat exists.

    "That certainly is a possibility and will be a very worrying one. And that's why, I think, the WHO has put so much effort in to head it off," Nicoll said in an interview from Stockholm.

    Several developing countries fighting H5N1 outbreaks have voiced concern in the past that if the virus sparks a pandemic they will have little or no access to limited global supplies of expensive antiviral drugs and vaccines.

    But the country worst hit by H5N1, Indonesia, took the concerns a step further, announcing earlier this year that it was withholding its viruses from the WHO network until the system was changed to allow countries to have a say in how their viruses are used.

    That move is said to have been triggered by that country's realization that it would not get preferential access to or prices for vaccines made with Indonesian viruses.

    In the lengthy committee deliberations on virus sharing at the World Health Assembly, issues that make many in the scientific community uneasy were raised, including whether it is legal to patent whole viruses - as they arise in nature, not manipulated using patented scientific processes.

    There were even questions about whether patents could be obtained on individual genes from flu viruses.

    Such discussions bring into play complex and potentially science-slowing issues like the possible demand for royalties and whether the protections offered countries under the International Convention on Biodiversity extend to viruses.


    "We don't believe it is applicable," Dr. David Heymann, the WHO's senior official for pandemic influenza, says of the convention.

    Heymann admits, though, that the WHO needs to study the issue to see why Indonesia and some of its supporters believe the convention does give countries rights over viruses.

    "I think the jury's still out on that," he says of suggestions that these demands - and any changes that may occur as a result of them - could threat the ability of WHO's influenza advisers to monitor emerging new strains of flu and select the ones that go into each year's flu shots.

    Developing countries - with many pressing priorities on their limited health budgets - have never expressed interest in seasonal flu vaccine and there's no indication that has changed with this dispute over pandemic vaccine, Heymann said.

    "The issue fundamentally is different."

    Others aren't so sure. If a country is owed benefits because its viruses are used to make pandemic vaccine, why wouldn't it be entitled to some kind of compensation if its viruses are used to make seasonal flu vaccine?


    "Needless to say when you start getting into issues of intellectual property and patents it gets a lot more complicated," Dr. Arlene King, the Public Health Agency of Canada's top official for pandemic planning says of the whole intellectual property debate.

    "And I think that's why the agreement in the end was that there would need to be an expert report commissioned on things like patent issues related to viruses, genes, etc., " she said.

    King attended the World Health Assembly. She worked on the panel that spent hours drafting the resolution that referred the issue to the working group tasked with trying to hammer out new rules to govern virus sharing this summer.

    From her vantage point, she feels the resolution's call for a review of how the collaborating laboratory system works - including how those labs share viruses and information and how scientific credit is accorded - is "not an unreasonable request."

    "I'm optimistic that this won't interrupt our system of freely sharing viruses for seasonal flu vaccine," King insists.

    "I don't think the intent here is to stop the functioning of our system. I think the intent to this resolution is to ensure that the mechanisms that are at play are transparent and that there is maybe recognition that we are living in a different world than we were," when the virus-sharing system was devised.

    Nicoll says he hopes the review doesn't focus on claims of ownership, using an example to illustrate what a quagmire a system of virus ownership could create.

    In the scenario he cites, a woman from country X is infected through contact with a goose. She travels to country Y, where she dies. A specimen from her lungs is sent to country Z, where a laboratory isolates a virus.

    Who owns the virus? The lab in country Z? The hospital in country Y? Her survivors or the government of country X? The man who owned the goose?

    "It is important concept to get away from, the dead end of: Whose virus is it anyway?" Nicoll warns.

    "The next major advancement in the health of American people will be determined by what the individual is willing to do for himself"-- John Knowles, Former President of the Rockefeller Foundation

  • #2
    Re: Virus sharing debate raises intellectual property concerns

    Another part of this debate might be a nation's liablity if their refusal to share causes millions of preventable deaths.

    If my neighbor's house is threatened by a fire that could be extinguised by my hose and water supply, I don't wait to negotiate compensation for my water and hose - I PUT OUT THE FIRE.

    .
    "The next major advancement in the health of American people will be determined by what the individual is willing to do for himself"-- John Knowles, Former President of the Rockefeller Foundation

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