TRIPS Flexibility Must Be Promoted

In the September issue of The British Journal of General Practice, Jeremy Strachan, secretary of the British Medical Association (former lawyer and ex executive-director with Glaxo Wellcome) asks why countries have signed up to TRIPS if it is so iniquitous1. The answer is simple: if you want to be a member of the World Trade Organisation (WTO), you have no choice. Many developing countries signed up to The World Trade Agreements in the hope of increasing markets in areas of interest such as textiles and agriculture, with little idea of how TRIPS would impact on health. As of 1992 (before TRIPS), 48 countries (including Finland, Spain and Portugal) chose to exclude pharmaceutical products from patentability. A producer who has a market monopoly is free from market competition and, unless pricing policies are in place, can charge whatever price the market will bear. While patents do not give the owner the right to charge whatever price he chooses, they do give the opportunity to do so by providing a market monopoly. In Brazil, the price of AIDS drugs fell by 82% over five years as a result of generic competition, while the price of drugs that had no generic competitor remained stable, falling only 9% over the same period2. TRIPS contains flexibility designed to balance public and private interests. However, this is under-appreciated by Western governments and the pharmaceutical industry, who push for a much stricter interpretation, forcing countries to exclude those elements that allow for public health to be protected. South Africa was taken to court by the pharmaceutical industry for attempting to pass a law that was perfectly compliant with TRIPS, that prevented implementation of health legislation for more than three years. Thailand has been pushed by the US for the last 10 years to adopt patent laws much stricter than required by the World Trade Organisation3. Similar struggles are currently underway in many less-developed countries. At the next WTO ministerial conference in November in Doha, Quatar, developing countries have proposed a ministerial declaration stating that 'nothing in the TRIPS agreement shall prevent countries from taking measures to promote and protect public health'. The minimium that industrialized countries can do is support this call. Patents are an incentive for innovation, but the public has little influence over what is being invented. Drug research and development, almost exclusively confined to the private sector, is driven by profit prospects rather than public health needs. Patent protection has increased over the last 20 years, but an analysis of the new chemical entities brought onto the market in this period shows that the mean innovation rate has fallen, with an increase in the number of 'me-too drugs' of little or no therapeutic gain. Millions continue to die from tuberculosis and malaria diseases every year, but virtually no new drugs have been developed in over 30 years4. The pipeline for drugs for tropical infectious diseases, which kill around 14 million people every year, is virtually empty. Exacerbating this neglect, drug resistance is wiping out drugs that were once effective. High pricing can be overcome under the current system if countries are allowed to prioritise health wherever patent monopolies are a barrier to drug access. The lack of drug research and development into 'non-profitable' infectious diseases that take millions of lives every year will require a new strategy. A compulsory research obligation could be framed that would require industry to reinvest a percentage of pharmaceutical sales into R&D for neglected diseases, either directly or through public programmes. Such a mandate, framed in a global treaty, would correct the current imbalance between private sector rights and obligations under present international agreements and provide legal options to make drugs for neglected diseases global public goods. Public-sector not-for-profit R&D capacity should also be promoted. Ninety per cent of all biomedical research and 60% of all the profits for pharmaceutical drugs are in the USA, while Africa represents around 1% of drug sales worldwide. Of the 1,393 new drugs approved in the last 20 years, only 1% of are for tropical diseases which account for almost 10% of the global disease burden. The medical profession must pay serious attention to the way medicines are researched, developed and sold, and the global laws that surround this increasingly inequitable process. Nathan Ford, Médecins Sans Frontières, London, UK Footnotes: 1. Strachan J, Patents, prices, and public health. [Commentary].Br J Gen Pract 2001: 51: 773. 2. 't Hoen E, Moon S. Pills and pocketbooks: equity pricing of essential medicines in developing countries. Geneva: Médecins Sans Frontières, April 2001. 3. von Schoen Angerer T, Wilson D, Ford N, Kasper T. Access and Activism: the provision of antiretroviral in developing countries. AIDS 2001; 15 (supp 4) 4. Fatal Imbalance: the crisis in research and development for drugs for neglected diseases. Médecins Sans Frontières/Drugs for Neglected Diseases Working Group, Geneva, October, 2001. Available at www.accessmed-msf.org