As if you didn’t know already, the H5N1 strain of avian flu has been sweeping through poultry populations in Asia since 2003, infecting humans and killing at least 65 people, mostly poultry workers. The virus does not pass from person to person easily, but experts fear the virus could mutate. The 1918 influenza pandemic killed more than 40 million people. Subsequent pandemics in 1957 and 1968 had lower death rates, but caused extreme disruption.

Now, some health experts believe governments should consider forcing compulsory licensing. That is, to ignore Roche’s patent protection on the drug to make up for the Swiss company’s inability to cope with demand during a pandemic. The drug is already in short supply following fears of a possible epidemic. But the Swiss pharmaceutical company Roche Holding AG, which makes Tamiflu, has refused to license generic versions of the drug despite pressure from several countries and United Nations Secretary General Kofi Annan.

Cipla Ltd., the third-largest drug company in India, said it plans to bring a generic version of the anti-influenza drug Tamiflu into the market early next year, filling any potential shortages in event of a bird flu epidemic. Cipla Chairman, Y.K. Hamied, told Reuters: “We have finalized a process a few weeks ago, and now we are starting manufacture.” However Roche has said the 10-step year-long production method of Tamiflu was too complex to be outsourced to other companies to boost supplies, and it would take other companies up to three years to be ready to produce the drug.

Roche will not be able to meet demand for its antiviral drug Tamiflu if an avian flu pandemic breaks out. Although Roche is well aware of the likelihood that demand for Tamiflu would surge during a bird flu pandemic, not just in Hong Kong, but worldwide, the company insists there is no shortage at present. But for the past few years, it has been advising health administrations around the world to stock up on this antiviral neuraminidase inhibitor. Few governments have been heeding Roche’s advice.

Roche claims it takes about 12 months to produce Tamiflu, which is one of the company’s more complex drugs. At present, the company requires 12-18 months to supply new orders and the supply of the drug worldwide is enough to treat only about 40 million people. Industry analysts expect the sudden demand for Tamiflu to generate windfall profits for Roche, although the company is also donating three million packs of Tamiflu to the WHO for use anywhere in the world. David Salisbury, head of immunization for the Department of Health in England, said: “We are getting 800,000 more doses of Tamiflu every month, so we will have the level we believe appropriate if we have a pandemic in this country. “The US will have something like one twenty-fifth of what we’re building up in our stockpile.”

Roche has quadrupled production capacity since 2003, and it plans to double capacity again by next summer. Roche produces Tamiflu at three sites in Europe and one in the U.S.

Gilead Sciences, the U.S. company that invented Tamiflu and licensed the drug to Roche in 1996, is unimpressed by the Swiss firm’s supply efforts. In June, Gilead sent to Roche a request to end the licensing agreement and recover its rights to the drug. These is a possible alternative to Tamiflu in Relenza (zanamivir), another neuraminidase inhibitor that GlaxoSmithKline produces under license from Biota, an Australian antiviral drug discovery company. Like Gilead, which licensed Tamiflu to Roche, Biota is not happy with the way the larger company is promoting the drug.

So far no one seems ready to step over the line and trigger a patent lawsuit but if a pandemic begins (or even appears to be beginning), I think all bets will be off regarding patent protection.

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One Comment

  1. Q: If a bacterial population doubles every hour, and it fills a test tube in 24 hours, then how far has it grown in by the 22nd hour?

    Q: If that test tube hold a deadly bacterium, how much political attention will it receive by the 22nd hour?

    In these two questions lies the difference between public health truth (as well known by the Microbiologists) and political/pulic perception of risks. The scientist understands the growing risks; the body politic does not.

    So the UN has approached Kofi Annan to help? Why not ask Saddam, as he has far greater experience with mass destruction!

    Free markets, as much as I support them, are supposed to give way in deference to public health. The CDC must be given leave to do their job, even if Washington is weighing the risks of another Swine Flu political disaster as the alternative. But ensuring the manufacture of “the most complicated process” drug in the world falls to generic, unregulated, unknown facilities, is frankly, to invite more unknown side-effects that the threat itself.

    Our governments need to be authorized to listen to their public health officials, and to give them the “bio-wartime” powers they require to build the necessary tools and supplies for this combat. Just like they did for the levees in New Orleans.