From TRIPS to "TRIPS Plus" provisions. Patents protection and public health promotion in developing countries: raising the stakes for drugs accessibility
MetadataShow full item record
According to the latest UNAIDS estimation (2008), about 33.2 million people are living with HIV/AIDS in the world in 2007, mostly in developing countries. More than 2.5 million people were newly infected this year and 2.1 million people died of AIDS. Due to prevention programme and changes in behaviour, the epidemic seems to peak in the 90s. Yet, the Sub-Saharan region still bears the largest burden with 22 million people infected. Zimbabwe, Namibia, South-Africa, Botswana, Lesotho, Swaziland and Zambia are particularly hit by the epidemic where between 15 and 26% of adults are infected by HIV/AIDS. Beside, due to the demographic factor, more and more people are infected and prevalence rate are growing in East and South-East Asia. Today, 4.9 million people live with HIV/AIDS in this region, especially in India and China. Concerning Latin America, 1.7 million adults and children are infected. Whether no vaccine exists to cure the infection, about a score antiretrovirals (ARVs) treats the infection and enables people to live with the infection. Among the first drugs available, AZT was used to treat the infection and prevent the transmission from mother to child during the delivery. Since the 80s, many treatments were developed to treat HIV/AIDS. Significant improvements have been made since the single therapies developed in the late 80s to the multi-therapies recently developed to overcome the occurrence of resistance to treatments. Nowadays, patients benefit from single, bi and tri-therapies, suffer less from resistances and improve the quality of their everyday life. Accordingly, the access to ARVs has become crucial in developing countries where the epidemic causes dramatic socio-economic impacts as estimate the micro and macro-studies released on households and economic growth (Over, 1992, Ainsworth, 1993, Bonnel, 2000, Dixon & alii, 2001, Drouin & al., 2003). On the whole, the HIV/AIDS epidemic reminds that the accessibility issue is not new in developing countries. Since the 1970s, the World Health Organization (WHO) has been working for the “right of all to health” by essentially increasing the access to essential drugs for people in poor countries. In this perspective, the first list of essential drugs was laid down in 1977. The list elected the least expensive products that could cure the most predominant diseases in developing countries. Since then, drug is defined as a specific and essential good, which had to be made accessible for the greatest number at a reasonable price. To specifically achieve the accessibility to medicines for patients infected by HIV/AIDS in developing countries, the WHO and the United Nations for AIDS (UNAIDS) have launched the “3 by 5” initiative in 2003. The goal is to provide ARVs to three million infected people in low and middle-income countries by the end of 2005. It is a step towards the larger goal of ensuring universal access of HIV/AIDS treatments for all who need them as a human right in poor countries where national health coverage are definitely lacking. For that reason, the WHO issues and revises comprehensive guidelines for a public health approach of ARVs procurements in countries where resources are limited (WHO, 2006). Concretely, in those guidelines, every public health authorities can find information about when beginning an anti-AIDS treatment, which first line regimen may be the more suitable for adolescents, adults or pregnant women regarding mainly the potency of all therapies, their side effects and their prices. WHO indicates also when patients must switch to another therapy because of resistance to a first line regimen or intolerable side effects. Tri-therapies are highly recommended since drug resistances are notably reduced. Yet, the access to medicines in developing countries hit by dramatic epidemics such as HIV/AIDS actually questions the patent status of these life-saving drugs. Therefore, the recent evolutions of intellectual property rights (IPRs) regimes in the world matter. Accordingly, the paper intends to discuss the influence of IPRs evolution on drug accessibility in developing countries. Precisely, building on a review of the two main sources of IPRs evolution in the world, i.e. Trade Related aspects of Intellectual Property rights (TRIPs) agreement and the USA Free-Trade Agreements (FTAs), the paper indicates how international agreements may seriously undermine accessibility and affordability in developing countries. The argument stresses on the fact that many provisions may help to extend market exclusivity holds by firms, prevent the competition of generic makers and at last defer the launch of more affordable medicines in developing countries. The objective, principles and flexibilities of the TRIPs agreement will be first presented (§2). Beyond the obligation to settle a strong IPRs regime, concerns about public health are expressed and flexibilities are provided for circumstances where drug accessibility is crucial, especially in developing countries. Then, the content of some USA FTAs will be examined. In particular, the provisions devoted to patent extension and generic competition prevention will be listed as means that may roughly damage drug accessibility. Finally, some evidence concerning the link between IPRs regime, competition and drug accessibility will be reminded. Building on Indian case studies, elements about the drastic decrease of ARVs prices due to the generic competition will be related. Besides, impediments to the supply of affordable ARVs in Thailand will be described.