WTO deadlines: why developing countries must act now to protect access to medicines.

Within the next 12 months there are intellectual property deadlines looming for developing countries that could have a significant impact on their future access to medicines. These relate to the World Trade Organisation’s (WTO) Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement. This Agreement outlines the intellectual property obligations for all 144 WTO members, including intellectual property over medicines. It was negotiated during the Uruguay Round from 1986 to 1994. UnderTRIPS, inventors can apply for aminimumof 20 years’ patent protection for a new drug. The first deadline comes in July of this year, when part of the TRIPSAgreement will be amended. The amendment will take into account debate that has occurred since the creation of the TRIPS Agreement and which has further defined how and when the Agreement should be used to address public health needs. This has important implications for the future access to medicines by the developing world. To understand these implications, first some background. There has been much debate since the creation of the TRIPS Agreement as to whether medicines sit comfortably next to all other products when it comes to patent regulation. On one hand, the inventor of a new medicine needs to be able to protect their right to recoup the investment on research aswell as profit from their invention. On the other hand, shouldn’t the public health needs of a population take precedence over the need to protect intellectual property rights? InDoha, Qatar, inNovember 2001,WTOmembers agreed that the TRIPSAgreement ‘can and should be interpreted and implemented in amanner supportive ofWTOMembers’ right to protect public health and, in particular, to promote access to medicines for all’.1 The Doha Declaration confirmed, among others things, that member states could grant permission, using a ‘compulsory licence’, to allow the production or importation of generic medicines for that country without the consent of the patent holder. This provision is so-called ‘compulsory’ as the patent holder has no say in whether the patent is overridden, but nevertheless receives adequate compensation. The existence of generic competition has been a key way of driving down the price of medicines, thereby overcoming a significant barrier to drug access. For example, since the introduction of generic competition, the internationally available price for an antiretroviral (ARV) triple-combination has fallen from US$10 000 in 2000 to US$132 in late 2003 — representing a 98% decrease in price.2 This drastic reduction in ARV prices has increased the feasibility of governments and donors providing treatment for hundreds of thousands of people living with HIV/AIDS in the developing world. The use of compulsory licensing to ensure generic competition, which in turn results in lowerpriced drugs, is only one example of how the ‘safeguards’ that exist under TRIPS, can reduce a major barrier to drug access. However at more recent WTO meetings, countries such as the United States, under heavy pressure from the US proprietary pharmaceutical industry, have sought to place additional stipulations on how the TRIPS Agreement will be amended. These stipulations seek to create many additional bureaucratic barriers to overcome in order for developing countries to produce, import or export generic medicines. Thus, in the lead-up to the deadline for an amendment of the TRIPS Agreement in July (this may be extended), it is up to both developing and developed countries to test if the TRIPS ‘safeguards’ and the proposed amendments to the Agreement, really will ensure practical, sustainable and affordable access to medicines. For example, if the price of a patented medicine in a country puts it beyond the reach of a majority of the population, can a government easily issue a compulsory licence to access a more affordable generic version? This question was almost put to the test in October last year, when the South African Competition Commission ruled that GlaxoSmithKline and Boehringer-Ingelheim were charging excessive prices for their antiretrovirals. This ruling created the possibility that a compulsory licence could have been issued to allowgeneric productionof the drugs.However before this occurred, the two companies agreed to allow generic production of the antiretrovirals.3 Meanwhile in another test of the proposed amendments to the TRIPS