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Breaking the Patents: Why drug companies are scrambling for cover in the struggle for AIDS treatment in AfricaBy Neville GabrielLiberalised trade regimes operating under the forces of globalisation have been destroying local industries in developing countries for many years. These same regimes are now threatening their own masters. Such is the case of a consortium of the world's biggest pharmaceutical companies, which took the South African government to court recently for legislation that would allow the government and health care professionals to import and use cheaper generic AIDS drugs. (The companies have since withdrawn their court challenge). They have found that an international trade agreement does, indeed, allow for the production and use of cheap generic substitutes in certain cases.]AIDS is a devastating condition that destroys the souls of millions of Africa's youth before finally taking their lives. But a new wave of social justice activism is gripping people living with HIV and AIDS. They know that treatment could make a remarkable difference to their lives, and they now know that it is possible to get access to treatment. People living with the disease and their supporters were out in the thousands in South Africa on March 5 to shame the drug companies for blocking access to cheaper drugs. Africa has 13 per cent of the world's population and 83 per cent of all HIV/AIDS infections. South Africa has about five million people living with HIV/AIDS, mostly in poor, densely populated areas. The overwhelming majority cannot afford anti-retroviral treatment or treatment for opportunistic diseases related to AIDS that enabled rich countries to turn the disease from a killer into a manageable disease. In 1997, Dr Nkosazana Zuma, then Minister of Health, introduced an amendment to the Medicines and Related Substances Control Act, signed into effect by President Nelson Mandela. The amendment made three new provisions. Firstly, a transparent pricing mechanism for AIDS drugs would be established. Secondly, it would be compulsory for health care professionals to prescribe cheaper generic substitutes instead of expensive brand-name medicines, once the brand's patent had expired. Thirdly, patented medicines could be imported from other countries where the same medicine is sold much cheaper than in South Africa (i.e. parallel importing). Patents refer to the license given exclusively to one company to sell a particular drug for an extended period of time. The expectation was that the Zuma clauses would drastically reduce the price of AIDS treatment in South Africa. Similar arrangements in Brazil, for example, reduced the cost of AIDS treatment by an average of 80 per cent. Telling the Truth About TRIPSHowever, 40 of the world's biggest pharmaceutical companies, including GlaxoSmithKline, Bristol-Myers Squib, Boehringer-Ingelheim, Roche, and Merck, clubbed together to block these developments. They took the South African government to court, arguing that the new law contravenes the World Trade Organisation (WTO) international agreement on Trade-Related Intellectual Property Rights (TRIPS). They also argued that the new laws violate their constitutional property rights. (The companies have since withdrawn their case).The South African Constitution clearly states that international agreements, such as TRIPS, are subject to the scrutiny of Parliament (Section 231). It also obliges the state to take measures to ensure progressive access to health care by all citizens (Section 27). The TRIPS agreement, it turns out, does allow for parallel importing (Article 6), and goes even further to allow the compulsory production of cheap generic substitutes for patented drugs where and when there is a serious public health crisis (Article 31). Former U.S. Vice-President Al Gore did an about face and acknowledged this after being repeatedly confronted by protesters during his presidential campaign, and the Clinton administration conceded as much. Nonetheless, current U.S. President George Bush has strongly backing the pharmaceuticals. Already in 1999, the Human Development Report of the United Nations Development Programme (UNDP) called for "more understanding of the economic and social consequences of the TRIPS agreement… The relentless march of intellectual property rights needs to be stopped and questioned. Developments in the new technologies are running far ahead of the ethical, legal, regulatory and policy frameworks needed to govern their use." The World Health Organisation (WHO) too, in an unprecedented move, threw its weight against the pharmaceuticals, insisting that South Africa is not breaking TRIPS. Patents, Profits, and the PeopleThe TRIPS argument, it would seem, is a smokescreen. The pharmaceuticals' court challenge was more about defending big profits and elitist power internationally. Africa, which represents only 1.3 per cent of the global pharmaceutical market, poses no real threat to the pharmaceuticals' profits if the drugs were provided cheaper here.The case's withdrawal has set a precedent for other countries to import cheaper patented drugs from around the world in situations of urgent need, breaking the pharmaceuticals' absolute control over drug pricing in particular countries and their stranglehold over the ability of developing country governments to deal effectively with AIDS and other health crises. The drug companies are notorious for the disparities in medicine prices across the world, determined secretly and exclusively by the companies themselves to maximise their profits. For example, drugs produced in India to treat AIDS-related meningitis cost 15 times less than the price of the same drugs in the United States. The case, then, is historic in redefining whether new technologies are used to maximize the profits of big business or whether they are used to improve the lives of millions of people. The patents debate goes beyond health care to ownership of genetically modified seeds and agricultural products in relation to food security, computer technologies in relation to access to information, and human genetic codes and engineering techniques in relation to bodily integrity and human identity. The pharmaceuticals have argued that they need to recoup the high research and development costs that went into producing the drugs, and to ensure that work on better drugs continues. But most of the AIDS-related drugs in question were developed with public funds through government programmes and were subsequently patented by the pharmaceutical companies, says the Treatment Action Campaign (TAC), a coalition of civil society organizations demanding access to treatment. Also, the drug companies make enough profits on other medicines, says TAC. The case has cast the drug companies under serious public scrutiny. Had the case continued, the companies would have been forced to explain how they acquired their patents and disclose how much profit they make on particular drugs. The debate would have been charged with life and death urgency rather than the sterile, technical arguments that the pharmaceuticals would have preferred. The question is blatant: are patent rights that make essential medicines unaffordable justifiable, when the AIDS pandemic is obliterating the poor in Africa? Free Drugs?For all its significance, though, the case will not be the last salvo in the standoff between the drug companies, government, and AIDS treatment activists. AIDS drugs, even if drastically reduced in price, will remain unaffordable on a mass scale in Africa.Nor are offers of free drugs from the drug companies to be trusted. Drug companies' use of unsuspecting AIDS patients in developing countries to test new drugs offered free, as well as the dumping of low quality and old drugs on developing countries wrapped as free gifts, are well documented. Many children died in Nigeria after Pfizer tested unsafe AIDS-related meningitis drugs on them without their knowledge - for free. In any event, donations do not provide sustainable solutions to the problem. The government must go further to produce AIDS-related generics locally for free distribution where it is urgently needed. That is when the real test will come for the pharmaceuticals . . . and the government. Neville Gabriel, a South African, is Secretary for Economic Justice at the Southern African Catholic Bishops' Conference.
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