Queuing up for bird flu drugs

Late in October, Tony Abbott joined with world health experts in Canada in a failed attempt to agree a global action plan to address the risk that avian flu wwould mutate and run rampant. Amid this failure, it was health ministers from the developing world who presented the clearest and most compelling message about the threats posed by avian flu.

Their message was simple. Avian flu threatens to have a much greater impact on poor and developing countries. Their countries have poor health systems already overburdened. It is not yet clear that poor countries will be able to get the medicine they need. And even then, can it be made cheap enough for their citizens to afford it?

The most effective drug currently available for avian flu is oseltamivir or Tamiflu. This is an antiviral drug recommended by the World Health Organisation for use in the event of a flu pandemic. Tamiflu doesn’t cure avian flu but it eases the symptoms. It works by blocking the action of an enzyme of the surface of the virus, preventing the virus from spreading and infecting other cells in the body.

In poor countries, millions of people will be even more at risk to a highly infectious flu than those in rich countries. Poor people simply can’t afford $2 or more for a single Tamiflu tablet, much less the 10-pill treatment. We need more medicine - and we need it made affordable for all.

Tamiflu was discovered and patented by the US firm Gilead. In 1996 Gilead licenced pharmaceutical giant Roche to manufacture and market it. As the patent on Tamiflu has not yet expired, cheaper generic versions cannot be produced and sold by other drug manufacturers.

The World Health Organisation has urged countries to stockpile enough Tamiflu for 25 per cent of their populations in the event of a pandemic. Even though it has massively increased its output and is considering building new manufacturing sites, Roche does not have the capacity to manufacture these amounts.

Developing countries are seriously concerned that as a result of Roche’s inability to meet the demand, their citizens will have no access to treatment. The head of Thailand’s Department of Disease Control is quoted as saying, “Every country is queuing up to buy Tamiflu from Roche and we are afraid we won’t be able to get enough drugs when we need it”.

The only way developing countries are going to get access to Tamiflu is if generic production is allowed either through compulsory licencing (i.e. governments force Roche to licence other manufacturers to produce the drug) or voluntary licencing (i.e. Roche itself voluntarily licences other manufacturers to produce the drug).

Cipla, an Indian drugs manufacturer, has the ability to produce a generic version of Tamiflu. It is planning to begin commercial production by the end of December to market it at “humanitarian prices” in developing countries. Additionally, the Taiwanese and the Thai governments have also said that they are able to produce generic versions.

On October 18, Roche gave some ground by saying, “It would be prepared to discuss sub-licences to increase manufacturing of Tamiflu, provided such groups can realistically produce substantial amounts of the medicine for emergency pandemic use, in accordance with appropriate quality specification, safety and regulatory guidelines”. So far, it has not granted a licence to anyone.

With Tamiflu, the problem is that a single company owns the drug but can’t produce enough of it. The wider problem is that, for many killer diseases, enough medicine exists to help millions of people, but patents grant monopolies that allow the owner to charge what they like. The net result is the same: people are denied access to the medicine that might save them. Expensive new drugs - for whatever condition - are beyond the ability to pay of developing country governments.

Big pharmaceutical companies, governments and the World Trade Organisation (WTO) could do a great deal to help improve access to medicines in poor countries. This includes offering lower prices for essential drugs in a systematic and transparent way and relaxing patent rules and related intellectual property protection in poor countries so generic manufacturers can produce and market affordable versions of new drugs.

We’ve got the balance wrong between intellectual property rights and public health. More than 30,000 people die every day from diseases such HIV-AIDS, hepatitis and cancers where effective medicines exist but - because of patents - can be too expensive or simply not available. In the worst scenario, avian flu will be no different from AIDS in this respect - the rich will be protected, and the poor will die.