Leading article: The big questions of life, death - and profits

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The Independent Online

Demand for Tamiflu is soaring around the world as concern over avian flu spreads. It is not the only medical defence against a pandemic, but it is the drug of choice because it is easy to store and use. One pill twice a day for five days, taken as soon as the symptoms of flu appear, should save lives.

Pressure is growing on Roche, the manufacturer, to relax its patent on the drug and let other companies help to increase production. Yesterday's interim results show sales of Tamiflu doubled in the third quarter, helping to boost the company's profits by 20 per cent. In a global emergency, it is argued, humanitarian considerations must outweigh narrow concerns over intellectual property and company profits.

There are practical and policy problems with this approach. The manufacture of Tamiflu is long and complex, taking 12 months from harvesting of the raw material - the herb star anise - to finished product. A separate synthetic source of the drug has been developed, but the manufacturing process is equally long. A generic company wishing to enter this field would first have to build the necessary facility and obtain regulatory approval. Even if Roche were to abandon its patent tomorrow, it would be more than a year, and possibly two or three years, before such a company began producing Tamiflu for the global market.

The UK government plans to order 120 million doses of Tamiflu. But what of the rest? The developing world has no means of paying for large stocks of a drug it may never use. Tamiflu has a shelf life of five years, and there is no way of knowing whether the feared pandemic will strike this year, next year or in a decade's time.

Should Roche give up its patent on Tamiflu? We should not forget that the cost of researching and developing a new drug runs into hundreds of millions of pounds. Before a drug is granted a licence it must satisfy exacting safety and efficacy standards which involve enormous expenditure of time and effort. A company must be allowed to earn a reasonable return on such an investment. Over the past 50 years, the profit-based pharmaceutical industry has produced medicines that have transformed healthcare and saved billions of lives.

There are problems when the industry places commercial objectives above human needs. We saw that in the fiasco over Aids drugs for the developing world, and the disaster of Vioxx, the powerful painkiller made by Merck and withdrawn last year after evidence emerged that it can trigger heart attacks. It is also worrying that the industry seems to be lavishing ever more resources on lifestyle drugs like Viagra rather than developing life-saving treatments. The industry needs regulation - some would argue tougher regulation - but on balance it does considerably more good than harm.

Roche has every incentive to boost production of Tamiflu, as there are large profits to be made. But it must grant sub-licences to other manufacturers with the right expertise, to boost production further. It has donated three million courses of the drug to the World Health Organisation and has offered what it says are "significant discounts" to developing countries wishing to build up stockpiles. The discounts on the UK price of £16 per course will have to be very large indeed to make the drug affordable.

The underlying principle must be that the company earns a reasonable return from those countries, including the UK, that can afford to pay, while offering the drug at a heavily discounted rate to those that cannot. This is the right way to maximise the production and distribution of Tamiflu and other life-saving treatments while preserving a profit-based pharmaceutical industry able to innovate and to develop new drugs.

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