An excellent story from Bloomberg News by John Lauerman brings us up to date on an issue we raised yesterday concerning giving breaks on biologicals (like vaccines) to countries who deposit sequence data in publicly accessible databases like Genbank:
Poorer countries where bird flu is spreading may license virus strains isolated from their residents and poultry as a way to leverage better access to drugs and vaccines that come from studying those strains.
The plan is being advanced by a new program, announced today, that urges participating countries to place genetic information about their individual bird flu strains into central databases in return for rights that will allow the countries to control who uses the data. (Bloomberg News)
This is close to a suggestion we made in our previous post and we are glad that experts in public interest intellectual property issues were there ahead of us. Viral strains have not usually been licensed, no matter their country of origin, because this was an obstacle to the periodic revision of seasonal influenza vaccines, which are based on worldwide surveillance of circulating viruses. Bit the concern that in a pandemic developing countries will not be able to afford vaccines made from seed strains they contributed, however, has prompted some new thinking:
The new program will collaborate with Cambia, a Canberra, Australia-based non-profit research organization, and Science Commons, based in Cambridge, Massachusetts, to write agreements and patents that will allow the flu strains to be shared, said Peter Bogner, the program’s director.
“Intellectual property is the most important part of this,” he said yesterday in a telephone interview. Bogner said his background is in licensing media, and that he became involved in a healthcare project for the first time because of the threat of a pandemic.
Countries that join the data-sharing program will post their genetic sequence data in public databases, such as those at GenBank, run by the U.S. National Institutes of Health, and the European Molecular Biology Laboratory, Bogner said. Companies that want to use the viruses will be able to obtain them from laboratories that do bird flu testing, such as those affiliated with the World Health Organization.
The new program’s approach appears to offer benefits for all parties that might be involved, said Michael Gollin, founder of Public Interest Intellectual Property Advisors in Washington, which also gives assistance to developing countries on intellectual property rights.
“f the countries that have the viruses can get preferential treatment on access to vaccines and drugs, then there’s incentive to participate,” said Gollin, who said he has helped Kenyan tribes negotiate rights to a molecule used in a fabric softener, among other projects. “The leverage seems to be there.”
According to a news article in Nature accompanying the letter outlining the new Global Initiative on Sharing Avian Influenza Data (GISAID; see our post here), the moral force behind this development was Italian virologist Ilaria Capua, who rebelled against the “old boy” system of holding flu sequences in secret:
Instead of placing her flu sequence data in the WHO-linked, password-protected database, she chose to enter it into the publicly available GenBank, and called on colleagues to do the same. “When you’re facing a pandemic, you have to get your priorities straight,” she says.
The idea of favouring freely available databases then started to gain ground. Capua joined forces with well-connected Peter Bogner, who runs an advisory group called The Bogner Organisation in Santa Monica, California. Bogner travelled around the world talking to scientists and policymakers about the issue. The avian flu expert group formed by the World Organisation for Animal Health and the Food and Agriculture Organization of the United Nations, called OFFLU, subsequently endorsed the idea. (Nature)
There still seems to be a lot to work out, however, and there is real urgency to get it done. At least an agreement in principle is needed quickly, made publicly by vaccine manufacturers and pledging favorable treatment in the event a viral isolate is used for commercial purposes. In addition, there needs to be a public commitment that any final agreement would be retroactive to the present, so there would not be an incentive to withhold data pending a formal and binding agreement.
There is a simple description for what Ilaria Capua did. It’s called leadership. Now WHO, CDC and the community of flu scientists have an important role to play in getting an agreement in principle done with all possible speed. It’s time for some real leadership and statesmanship by the international public health community. With some notable exceptions like Capua, we’ve seen precious little leadership to this point.