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Bird flu virus sharing dispute raises questions of IP rights to viruses
National Post/CP - Published: Monday, June 18, 2007
ORONTO (CP) - Efforts to resolve demands of developing countries for fair access to pandemic influenza vaccines have raised the thorny issue of whether countries can hold intellectual property rights to viruses - the implications of which could be far-reaching in the world of research and vaccine development, a senior World Health Organization official admitted Monday.
"One of the basic issues that will be grappled with is who owns these viruses, and who has rights to these viruses," Dr. Keiji Fukuda, head of the WHO's global influenza program, said at a major international conference on influenza taking place in Toronto.
"In the old world of influenza, this was not a question . . . . In the new world of H5, it is extremely fundamental. When looked at from that angle, what you quickly begin to understand is that we are talking about a larger discussion of intellectual property rights."
A system where countries were deemed to hold rights to wild viruses - viruses that had not been enhanced or manipulated using molecular techniques in a laboratory - could set off a chain of repercussions, Fukuda and others at the conference acknowledged.
Currently there are intellectual property rights accrued when laboratories use patented processes to enhance or manipulate viruses. But naturally occurring viruses have not been treated as the property of countries.
Among the potential ripples from such a development include the possibility that countries could demand royalty payments if their viruses were used to make the annual flu shot, others fear.
"It could spread to seasonal (vaccine), I agree," said Dr. John Wood, a virologist and vaccine expert with Britain's National Institute for Standards and Controls.
[b]"It does worry me. Because it just makes the whole thing murkier. And it's difficult enough already."[/b[]
Doris Bucher runs the laboratory at New York Medical College that makes the seed strain viruses used by most of the world's vaccine manufacturers to produce annual flu vaccine. The work is done using a process called reassortment to layer some genes from newly emerging viruses on genes from a older virus that grows very well in eggs, the traditional medium for flu vaccine production.
The vaccine industry pays for the cost of the work, but Bucher's lab does not charge any royalty fees.
"I think we're setting a very good example," she said.
Building intellectual property rights into that process could trigger a ripple effect, said Bucher, a microbiologist.
"It's that sort of blow back, you know? If we expect royalties, then whoever made the (virus) isolate should expect royalties," she said.
"It would slow down the process. It would raise the price of vaccine."
Vaccines made to protect against other diseases could also be targeted if a precedent were set in flu vaccine, as could other issues of scientific research.
"Yes, this goes way beyond influenza," Fukuda admitted.
The negotiations flow from Indonesia's boycotting of the WHO's free virus sharing system in a protest over pandemic vaccine access. The country insists it should be given preferential access and pricing for vaccines made from its viruses.
Its health minister, Dr. Siti Fadilah Supari, announced in early February that Indonesia would not share viruses with the WHO until rules were changed to allow it to set limits on who could use its viruses and for what purposes.
Since then, Supari has gone back and forth on that position. At last month's World Health Assembly - the annual meeting of the WHO's 193 member states - she announced Indonesia would resume sharing and revealed that the country had sent samples from two patients to a WHO laboratory in Japan for virus isolation.
But no further samples have been sent out since then and it remains unclear how soon Indonesia will resume ongoing and prompt sharing.
The dispute was the focus of protracted discussion at the World Health Assembly, with Indonesia and its supporters pressing the argument that the International Convention on Biodiversity may give affected countries intellectual property or IP rights over viruses gathered within their borders
Challenges under the convention could mire this dispute in legal battles for years.
Fukuda said he is hopeful countries involved in the talks have realized that it would be better for all to come to a fair but speedy resolution to the question of what countries affected by H5N1 should be able to expect in return for providing viruses to the WHO.
"Nobody wants to go into a long, theoretical discussion that stretches over years, as intellectual (property) issues can," he told reporters at a news conference.
"H5 cases are occurring now. People are getting sick now. Maybe there will be a (pandemic risk) transforming event. How are we going to handle that?"
The WHO needs viruses so that it can monitor the dangerous virus for changes that might increase the risk it could trigger a flu pandemic. As well it shares some of the viruses with vaccine makers for production of vaccine.
A WHO working group is trying to hammer out a compromise agreement that would see the concerns of developing countries addressed so as to ensure continued sharing of viruses from countries affected by H5N1 avian flu.
The working group is to finalize recommendations at a meeting in Singapore in early August. Those recommendations are then expected to be sent on to an intergovernmental committee of the WHO in the fall for endorsement.
credits Christian