Roche - Producers of Tamiflu

Roche and wrong
The threat of a flu pandemic requires action from the drugs industry




The going rate for a course of Tamiflu on internet auction sites yesterday was around £100, not a bad mark-up for a five-day, ten-pill treatment that generally sold for around £16. Tamiflu, contrary to what close observers of the Conservative leadership contest may believe, is the drug of most interest in the world today. Known generically as oseltamivir, it is an antiviral that offers one line of defence against avian flu. It is not a cure, nor is it certain to provide protection. It also has to be administered swiftly to have any effect. But faced with the threat of a flu pandemic, the world does not have the luxury of time or choice. The signs that Roche, the Swiss company that holds the patent for Tamiflu, is prepared to talk to generic drug companies about ramping up production is heartening. But, given the time lag involved in such production, deals such as this need to be signed with the utmost haste if they are to be remotely worthwhile.
Tamiflu is not a vaccine. That cannot be developed until — and it appears a question of when rather than if — the deadly H5N1 bird flu virus mutates into a form that can be passed human-to-human. But it can prevent infection or, if given to the infected, reduce symptoms and limit complications. It is a simple tablet, compared with other antivirals, such as Relenza, which needs to be inhaled precisely. And it is being produced as fast as Roche can manage. By next summer, output will have increased eightfold since 2004. Despite these efforts, the result is Lilliputian compared to demand. Forty governments have bulk orders for Tamiflu, including Britain’s for 14.6 million courses. But the production process is long and complex. The drug is derived from an acid produced by the Chinese star anise plant, although there is now a synthetic version. Manufacture involves a ten-step process that includes an intricate “explosive” step which few companies can currently emulate. It can take a year. It would take Roche approximately a decade to provide cover for a fifth of the world’s population. And the world does not have that time. Such complications underline the need for speed. Generic drug companies, which have vastly greater production capacity, believe they could be manufacturing Tamiflu within a month. For that to happen, though, Roche would have to share its methods, therefore saving the generic firms the extensive tests they would otherwise have to carry out to win approval from drugs authorities.



The pharmaceutical industry does not always get a good press, despite its work over decades producing drugs that keep us happy, pain-free and alive. Drug companies invest billions of pounds in research and development that they should rightly be able to recoup through selling a new drug under patent. Research would otherwise grind to a halt and we would be without dramatic announcements such as this week’s news that Herceptin might provide a cure for breast cancer. But these are not normal times. The world is overdue a flu pandemic, and all the signs are that one is building, with potentially devastating consequences. Roche can make a difference if it acts now. Others need to get involved. The Government must urgently find what extra production capacity exists in Britain. But the onus is on Roche. It can retain its status as sole manufacturer once Tamiflu stockpiles have built up. And it will hardly be worse off. But if it fails to act honourably, history will be extremely harsh.