Big Pharma backs deal to boost flu pandemic readiness

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A woman receives a H1N1 influenza vaccine shot from a medical staff at a hospital in Nonthaburi province, on the outskirts of Bangkok January 11, 2010. REUTERS/Chaiwat Subprasom

By Stephanie Nebehay

GENEVA | Sat Apr 16, 2011 10:42am EDT

(Reuters) - Virus samples will be shared globally in exchange for vaccines produced from them under a landmark deal to improve preparedness for a flu pandemic, diplomats at the World Health Organization said on Saturday.

In a statement to Reuters, the International Federation of Pharmaceutical Manufacturers and Associations, which represents 26 research-based drugmakers, welcomed the plan and confirmed the commitments its members had undertaken as part of it.

Negotiators ended an all-night session with a draft agreement accepted by all countries, including the United States, the last to join the consensus, diplomats said.

"The negotiations are finished. The framework was agreed," an aide to Mexico's ambassador Juan Jose Gomez Camacho, co-chairman of the closed-door talks, told Reuters.

Health ministers were expected to adopt the framework deal, which lays down participation by the drug industry, at the WHO's annual meeting being held May 16-24.

Countries would share virus samples with the WHO's network of laboratories in return for affordable vaccines derived from them. The industry has pledged to donate drugs and know-how, covering half of the $58 million annual cost of boosting defenses in the poorest nations, according to senior envoys.

Negotiations began four years ago among the WHO's 193 members after the deadly H5N1 bird flu virus emerged in southeast Asia. A year later, Indonesia stopped sharing flu virus samples with the WHO, demanding its share of vaccines.

Indonesia joined in the consensus reached, diplomats said.

SECURING THE WORLD

The IFPMA, whose Big Pharma members span Europe, Japan and the United States, said it was studying the plan that would need "fine-tuning" in the coming year.

GlaxoSmithKline, Novartis and Sanofi-Aventis, are among major flu vaccine makers, and along with Tamiflu-maker Roche, are IFPMA members.

But negotiators appeared to have "reached a decision that will result in an effective global system to prepare for potential future influenza pandemics, recognizing a shared responsibility to help secure the world against future pandemic influenza outbreaks," the Geneva-based IFPMA said in a statement sent to Reuters by an authorized industry source.

In talks with negotiators, its members had pledged to "reserve at least 10 percent of pandemic vaccine manufacturing capacity on a real-time basis, for donation to the WHO and/or supply at tiered prices, to developing countries," it said.

They would also reserve at least 10 percent of antiviral manufacturing capacity for donation on the same basis.

"It is crucial that the system allow for rapid access to pandemic viruses and for benefits to be allocated to those countries most in need," the IFPMA said.
"IFPMA members will continue to ensure that intellectual property rights do not present a barrier at the next pandemic."

During the H1N1 swine flu pandemic in 2009-2010, many developing countries complained they had no life-saving antivirals or vaccines to combat the new virus.

The WHO helped distribute 78 million vaccines, donated by rich nations and drugmakers, to 77 developing countries, but regulatory and other hurdles slowed the process.

The pharmaceutical industry has pledged to step up its role.

"Industry agreed what its role will be. They will be able to choose between donations and intellectual property," a diplomatic source told Reuters early on Saturday.

This meant drug companies could donate significant amounts of vaccines or antivirals, or transfer technology, he said.

Drug companies say current production capacity for pandemic flu vaccine is 1.1 billion doses.

(Editing by Sophie Hares)