The World Health Organization has brokered a deal resolving a long-running dispute between poorer countries and developed nations over access to emerging flu viruses and vaccines against them.
Under the agreement, finalized Saturday after an all-night final bargaining session, vaccine manufacturers commit to setting aside at least 10 percent of the world's flu vaccine production for developing nations when the next flu pandemic strikes. Poorer countries would either get vaccine free or pay reduced prices for it.
In return, developing nations agree to routinely share samples of mutating flu viruses with the WHO. That's an essential piece of the world's surveillance mechanism for viruses with pandemic potential and is critical to the development of effective vaccines.
The dispute was triggered back in 2007, when Indonesia refused to share samples of the highly lethal H5N1 bird flu virus because, it said, there was no assurance it would get access to vaccine developed as a result.
Indonesia's fears were borne out in the pandemic of 2009-2010. That pandemic was caused, as it turned out, by a new swine flu virus rather than H5N1. Mexico, where the pandemic virus first emerged, "had a terrifically difficult time getting access to the pandemic vaccine," Dr. Keiji Fukuda, the WHO's top flu expert, tells Shots. "It was really a problem for them."
That's because rich countries had signed agreements with vaccine manufacturers that tied up virtually the entire planet's flu vaccine output.
It took four years of negotiations to break the deadlock over the no-vaccine/no-virus issue. Recent history was a catalyst. "We went through a pandemic not so long ago, so the issues were no longer theoretical," Fukuda says.
In addition, Fukuda says nations realized that the opportunity to reach an agreement might slip away. That added pressure because without continuous sharing of notoriously mutable flu viruses, the world could be surprised again by a new pandemic strain. And the next one could be far more lethal than the 2009 H1N1 strain.
The agreement, which the World Health Assembly is expected to ratify next month at its annual meeting in Geneva, commits pharmaceutical companies to choosing two of six options.
Manufacturers can donate at least 10 percent of "real-time pandemic vaccine production" to WHO, or they can reserve at least that much "at affordable prices" for WHO to distribute.
They can donate an unspecified number of antiviral treatment courses to WHO or reserve some quantity of antivirals at reduced prices.
Manufacturers can grant licenses to companies in developing countries on "fair and reasonable" terms to make flu vaccines, antiviral drugs, diagnostic tests or adjuvants (immune-boosting vaccine additives).
Or manufacturers can grant royalty-free licenses to counterparts in developing countries to make such products.
The aim of those last two options is to spread flu vaccine manufacturing capacity more broadly. Now it's almost entirely based in developed nations.
Fukuda says manufacturers have also agreed not to file patents on flu viruses they obtain from laboratories working with WHO. He says the agreement "recognizes that if you are sharing something for public health purposes, the labs will treat it as a public health good," not a marketable commodity.
Manufacturers have also committed to funding half the WHO's Global Influenza Surveillance and Response Program, which had a 2010 budget ot $56.5 million.
As with all WHO agreements, the new document is studded with terms such as "should urge" and "may grant." But Fukuda says Indonesia, which forced the whole issue, was "overall quite pleased" with the outcome.