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Since the late nineties, the effects of globalization on the prices of drugs and on the investment in research and development of new products of pharmaceutical interest have become the focus in the debate on access to drugs in the poorest countries. The global AIDS crisis blew up the topic into the public domain because it affected in a deeply unequal way to rich and poor countries. While most people living with HIV worldwide live in Africa, antiretroviral therapy was only available then for people in developed countries. Its high cost put it beyond the reach of most affected countries. The threat to life posed by HIV infection made the struggle for global access to antiretroviral therapy a human rights issue.
After ten years of activism to promote global access to antiretrovirals, estimates claim that there are now some four million people worldwide undergoing treatment, mostly in heavily affected countries. The cost per patient has dropped from over $ 10,000 a year to 89. The main factor for the fall in prices was the competitive presence of generic drugs in the worldwide antiretroviral market. The presence or absence of generic versions on the market is linked to the existence of patents. The criteria for patentability and patent conditions have tightened since the adoption of the TRIPS agreement by the World Trade Organization (1995).The TRIPS agreement requires all Member States to consider drugs as mere technology products, subject to the same rules of patentability as any other. The immediate effect of the implementation of TRIPS in the pharmaceutical field is limiting the possibilities of a State to attract cheaper generic versions of essential drugs. In 2001, the Doha Declaration on the TRIPS Agreement and Public Health was an important step in recognizing the need to put serious health issues before commercial ones. The Declaration also clarified the conditions of applicability of the exceptions recognized in TRIPS as compulsory licensing. Still, it took five or six more years for medium income countries like Thailand and Brazil to give the first compulsory licenses for essential drugs, resisting commercial pressure and resulting in dramatic price reductions.
Although the scope of TRIPS on access to drugs is not yet clear, these agreements have boosted the degeneration of the intellectual property rights concept. The patent system, on being created to encourage research and development of new products, was conceived as a public protection policy for the sake of society. With TRIPS, patents became a tool for global business interests.
The problem of access to drugs is obviously far beyond the case of AIDS. Malaria, resistant tuberculosis, trypanosomiasis, Chagas disease, leishmaniasis, and even pediatric AIDS, have come to be called neglected diseases. These are diseases that cause very high mortality and morbidity in tropical and subtropical areas of the planet. However, investment in developing new methods for diagnosis, treatment and prevention is and has been insignificant just because of the lack of market incentive to recoup the investment. Thus, only 10 out of the 1,393 new products coming to market between 1975 and 1999 were of interest to treat tropical diseases. Three more were useful for treating tuberculosis.
The problem of the lack of access to essential drugs has so far been embraced by creating ad hoc solutions in particular contexts, which have undoubtedly served to introduce some improvements. Citizen mobilization has obviously been the main engine, causing reactions from the defense of human and constitutional rights, the humanitarian aid, the consumer protection or the study of the adverse effects of globalization.
However, the creation of innovative alternatives to meet the prevailing global system failure in poor countries is urgent. Today’s work aims at promoting that the translation of the TRIPS agreements into national patent laws grants each patent office the greatest possible degree of flexibility in addressing issues of public health interest, such as limiting the patentability conditions or promoting opposition to patents. It also encourages the routine use of compulsory licenses and the creation of patent pools.
Meanwhile, the World Health Assembly is already searching for proposals to encourage research and development of new drugs following public health criteria, recognizing that the key point is to dissociate investment in R & D from the final product cost. Actions take place from non-profit initiatives, such as the Drugs for Neglected Diseases Initiative, and from the creation of prizes for research in these and other issues. There is a proposal to develop an international treaty on research and development that fundamentally changes the manner of functioning of the pharmaceutical market.
In any of these areas, there is still much work to do to achieve a new system that stops to fail the poorest. |
