The dominance of the global pharmaceutical firms in providing medicine to the world's poor faces its strongest challenge yet at a meeting of World Health Organisation (WHO) in Geneva this week.
The existing system of drug patenting and pricing is fundamentally flawed and does not meet health needs, according to report released to health experts last month.
Delegates at this year's World Health Assembly, which opened yesterday, will vote on proposals that would dramatically increase pressure on the companies, governments and the WHO to reform the system for producing and distributing drugs in the developing world.
However, campaigners fear the report is being undermined after it was not given prime position in the assembly's agenda.
The way in which multinational drug companies protect their patents in order to reap profits was highlighted by the pricing of Aids drugs a decade ago at $10,000 (Â£5,300) to $15,000 a year, beyond the means of countries such as South Africa where the need was greatest.
An international outcry led to a court challenge which resulted in the price of Aids drugs being slashed to $150 a year.
The report, by the Commission on Intellectual Property Rights, Innovation and Public Health, saidthe existing system of research and development "has not yet produced the results hoped for, or even expected for, the people of developing countries".
Its says drugs are priced too high and there is no incentive to research treatments for the developing world, where the need is great but profits are low. Large sums are committed to finding cures for conditions such as baldness, which is not fatal, rather than for tuberculosis, which is.
The first vaccine to prevent cervical cancer was approved by the US Food and Drug administration last week. Its manufacturer, Merck, priced it at $500 for a course of three shots. That puts it beyond the reach of developing countries, where 80 per cent of cases occur.
Ellen 't Hoen, the director of Medecins sans Frontiers' Campaign for Access to Essential Medicines, said tighter regulations imposed by the World Trade Organisation meant countries with an industry in generic drugs were less able to escape patent protection laws than in the past.
"We are in a world today where all new medicines are patentable. That means countries have to deal with one company to try to get lower prices. Countries will probably plead with Merck [over the cancer vaccine] and some will get it cheaper, while some will not. But this is 'Big Pharma' dictating the rules of the game, not governments."
The pharmaceutical industry insists that it needs patent protection to recoup development costs, estimated at Â£500m per drug. But the report says governments should devise an alternative system for drug development and patents on essential drugs should be lifted in poorer countries.
Ms 't Hoen said: "The pharmaceutical industry is a Â£500bn business. It is the most profitable in the world. It needs to earn back its research costs but it does that royally. If it ploughed profits into areas of research ... for the developing world that would make sense but it does not. Tuberculosis kills millions and there is no research agenda to deal with that."
Between 1975 and 2004, only 20 out of more than 1,500 new drugs marketed globally were for tropical diseases and tuberculosis, which account for 12 per cent of the total disease burden.
The World Health Assembly will vote on whether to adopt the report as part of the WHO's mandate. Ms 't Hoen said: "They are unlikely to come up with a blueprint for a global framework but we hope this will be a start."
* An estimated 40 million people have Aids world-wide, 95 per cent of them in the developing world. New, cheaper drugs now need to be distributed to those who need them
* Leishmaniasis affects two million a year and kills 60,000. Resistance to Pentostam is growing and new drugs are needed
* Malaria kills more than one million people a year, 90 per cent of them children. Combination therapy is the treatment of choice, but many nations can't pay the Â£1.30 cost per adult.
* Tuberculosis kills an estimated two million people a year. Multi-drug-resistant TB is growing, but there has been little research since the 1960s.
- 116 Human Rights
- 182 Health