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13/10/2000
FREE HEALTH VERSUS DRUG TRIPS 

Does the patenting of essential drugs help or hinder the health of the world's poorest people? EuropaWorld Editor, Peter Sain ley Berry looks at both sides of the debate.

According the World Health Organisation estimates a third of the world's population lack access to adequate health care. How then should the profits of the pharmaceutical industry, for the most part located in the developed world, be balanced against the health of some of the planet's poorest people?

This is the difficult question that many people are struggling to come to terms with. It is a question that concerns the pharmaceutical industry itself, development NGOs, world institutions like the WTO, and governments both in donor and beneficiary nations. Like all such seemingly simple and obvious questions, the realities are more complex than the headlines.

At the heart of the issue is whether poor nations should be allowed to expropriate patents in order to provide cheaper medicines to their people.

From the 1 January 2000, developing nations have been required to implement TRIPS, the World Trade Organisation's Agreement on Trade-Related Aspects of Intellectual Property Rights. This imposes obligations on member countries to recognise and strengthen patent protection on pharmaceuticals. The object of TRIPS is ostensibly to regularise the protection of intellectual property recognising that pharmaceutical companies need to make ever increasing investments in research and development in order to tackle new health challenges. 

But many public health activists fear that the effect will be to put millions of people in developing countries beyond the reach of essential drugs and healthcare. Not so, says Brian Ager, Director-General of EFPIA, the European Federation of Pharmaceutical Industries and Associations. Welcoming the European Commission's initiative for accelerated action on major communicable diseases (see EuropaWorld 29 September 2000), he insisted that access to healthcare was primarily a poverty and development issue. Patients in developing countries would not, he said, see an improvement in access to medicines without suitable public healthcare infrastructure, sufficient financing of healthcare needs and a strong political will by national governments to provide treatment.

In Ager's view the TRIPS Agreement is in danger of being unfairly targeted, particularly as 90% of the pharmaceutical products on WHO's Essential Drug List are not patented and therefore subject to generic competition. "Nevertheless many of these products do not reach the poorest in practice", he said, stressing that more focus should be put on this aspect of the debate. While this may be the case, health activist and writer Cecilia Oh reckons that many patients in developing countries are still dying because the drugs they need are patented and too expensive.

These patented drugs include treatment for tuberculosis and AIDS as well as the Hepatitis-B vaccine, she says. One year's worth of standard treatment of anti-retroviral drugs costs between US $4,000-$6,000 according to statistics presented at the recent International AIDS conference in Durban, South Africa - a price out of the reach of most of the developing world. A key factor in determining the cost of a particular drug is the patent on it. But other costs are also involved. The European Commission points out that "the larger part of the ultimate consumer price (of a medicine in developing countries) can consist of import duties, taxes, distribution costs and dispensing fees" - issues over which the pharmaceutical industry has no control.

An important aspect of the debate is the extent to which the developing countries should be allowed and encouraged to build up their own pharmaceutical sectors. One criticism of TRIPS is that it allows very wide protection of both the product and the way of making the product as well. This can hinder the development of indigenous pharmaceutical industries by forcing them to pay for licences. Moreover, there is no 'quid pro quo' in TRIPS that might place an obligation on rich nation pharmaceutical companies to place some of the research activity in developing countries.

Although many such countries would like to see essential and life saving medicines excluded altogether from the patent process, this is probably not going to happen. Indeed just such a proposal was defeated during the recent UN World Summit for Social Development. The final text did however affirm the right of countries to 'freely exercise' all their legal options. The effect of this would be to allow countries to licence drugs compulsorily and without the patent holder's consent in cases such as national emergencies or to remedy anti-competitive practices. Hitherto the use of compulsory licensing by developing countries has resulted in all kinds of pressure to desist, including the threat of legal challenge and trade sanctions. This may now change.

While defending its intellectual property rights - the 'key to medical progress', according to Brian Ager - the pharmaceutical industry is becoming more sensitive to world health problems. Five of the largest companies recently announced an initiative to accelerate access to HIV/AIDS related care and treatment in developing countries. Other initiatives are taking place in education, medicines and vaccines and R & D in neglected diseases.

But the solutions to the problems of the health of the world's poorest people self-evidently do not lie with the pharmaceutical industry alone. As Brian Ager concludes, "political leaders and other stakeholders on the ground need to identify key diseases, effective interventions and countries in need so that the pharmaceutical industry can assess how best to contribute with tailor-made solutions within its field of competence." One thing is certain, however. The debate is set to continue. 

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