Access to AIDS Medicines Stumbles on Trade Rules: Developing Countries Have Several International Trade Law Provisions at Their Disposal to Help Them Buy Life-Saving Medicines at Affordable Prices for Public Health Needs, Particularly HIV/AIDS. but Only a Few Countries Are Using These Because of Red Tape and Political Pressure. WHO Is Helping Countries Navigate the Procedural Maze

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Developing countries are failing to make full use of flexibilities built into the World Trade Organization's (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to overcome patent barriers and, in turn, al low them to acquire the medicines they need for high priority diseases, in particular, HIV/AIDS.

First-line antiretroviral (ARV) drugs for HIV/MDS have become more affordable and available in recent years, but for patients facing drug resistance and side-effects, second-line ARV drugs and other newer formulations are likely to remain prohibitively expensive and inaccessible in many countries. The problem is that many of these countries are not using all the tools at their disposal to overcome these barriers.

Medicines protected by patents tend to be expensive, as pharmaceutical companies try to recoup their research and development (R&D) costs. When there is generic competition prices can be driven down dramatically.

The TRIPS Agreement came into effect on 1 January 1995 setting out minimum standards for the protection of intellectual property, including patents on pharmaceuticals. Under that agreement, since 2005 new drugs may be subject to at least 20 years of patent protection in all, apart from in the least-developed countries and a few non-WTO Members, such as Somalia.

Successful AIDS programmes, such as those in Brazil and Thailand, have only been possible because key pharmaceuticals were not patent protected and could be produced locally at much lower cost. For example, when the Brazilian Government began producing generic AIDS drugs in 2000, prices dropped. MDS triple-combination therapy, which costs US$10 000 per patient per year in industrialized countries, can now be obtained from Indian genetic drugs company, Cipla, for less than US$ 200 per year. q-his puts ARV treatment within reach of many more people.

Several newer AIDS drugs and formulations of existing drugs are urgently needed in developing countries but are not available because pharmaceutical companies are choosing not to sell them, and no generic versions of these are available. For example, there is a new formulation of the ARV combination therapy lopinavir/ritonavir, which unlike its predecessor does not need refrigeration. This would be useful in Africa, where temperatures are high and electricity supplies irregular, but Medecins Sans Frontieres (MSF) says it is not available there at all.

Another example is Gilead Sciences' Tenofovir, a brand-name drug which has significantly fewer side-effects than some older ARVs and was added to WHO's list of prequalified medicines, recommended for UN agencies to purchase for use in developing countries. Tenofovir is, however, virtually unavailable in Africa although it can be an effective second-line ARV, according to Ellen 't Hoen, Director of Policy and Advocacy at MSF. Most AIDS patients eventually need to switch to second-line treatment because of side-effects and drug resistance. However, according to MSF, while the US company has announced a price of US$ 208 per person per year in 97 countries, the product is only registered in 10 of those. Many developing countries cannot pay the normal price for this drug. For example, in Brazil it is US$ 2600 per patient per year and that is the price for just one of three drugs in combination treatment.

Following the TRIPS Agreement, there was growing concern and evidence that patent rules might restrict access to affordable medicines for people in developing countries, particularly for HIV/MDS, tuberculosis and malaria. "Ibis led to the November 2001 Doha Ministerial Declaration which stated: "The (TRIPS) Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all." The Declaration refers to a number of flexibilities, including the right to grant compulsory licences and to permit parallel importation (see box). …