The controversy over intellectual property rights for pharmaceuticals, and access to medical treatments in developing countries has been the subject of many public debates recently. The core challenge of this debate is to ensure access to pharmaceuticals in developing countries while at the same time encouraging research and development (R&D) for new treatments. In order to provide remuneration for pharmaceutical companies, investments in R&D, and pharmaceutical patents are protected under the WTOs Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) since 1995, which provides patent protection for 20 years. The problem with patent protection is that the high price pharmaceutical companies charge for their products, makes buying crucial drugs unaffordable for many people in developing countries, and who could have afforded them, had they been sold at or near their marginal cost. That is why a number of flexibilities or safeguards to protect public health have been incorporated into the TRIPS Agreement, allowing countries to override TRIPS requirements in order to protect public health. However, governments have proven to be reluctant to exercise such rights. The TRIPS Agreement in connection with access to AIDS treatment in developing countries has, without a doubt, been the most debated aspect in this context, as the arrival of the international patent system coincided with the global development of the AIDS epidemic. In this paper, we will narrow down the topic by focusing on the flexibilities incorporated into the TRIPS Agreement, in order to see whether they leave sufficient room for access to affordable medicines in developing countries.
[...] In a first part, the exact provisions of TRIPS for pharmaceutical patent protection will be outlined. Secondly, the evolution of the interpretation of flexibility rights of TRIPS will be examined by looking at the different declarations adopted by the WTO which culminated in the amendment 2005. Finally, we will depict the problems developing countries encounter in exercising their flexibility rights and summarize other factors impeding access to medication in these countries. I. Patent protection for pharmaceuticals under the TRIPS Agreement 1. [...]
[...] Eligible importing countries include least-developed countries or a country that can demonstrate insufficient or no manufacturing capacity for the purpose of meeting its needs. The Decision was designed to address the public health problems recognized in Paragraph 1 of the Doha Declaration on TRIPS and Public Health, which says that WTO ministers “recognize the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.” 3. The Decision of the General Council of 6 December 2005 on an Amendment of the TRIPS Agreement In a last step, the provisions laid out by the ‘General Council Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health' were incorporated into the TRIPS Agreement in form of an amendment which was adopted on 18 December 2005. [...]
[...] Consequences on developing countries' access to medication The disparity in pharmaceutical access between developed and developing countries is immense. Developing countries make up approximately 80% of the world's population but only represent approximately 20% of global pharmaceutical consumption. The consequences of the TRIPS Agreement are one of the elements constraining drug access in developing countries. To take the example of TRIPS and HIV, studies show that both the international focus and the generic competition decrease prices (statistically), while if the drug is patented in the purchasing country, this increases (statistically) the antiretroviral drugs' prices. Increased prices make drugs less affordable for people in developing countries, thus restraining drug access. [...]
[...] The most effective public health safeguard, compulsory licensing has never been invoked by any country. As mentioned before, failures to use Paragraph 6 are partly due to the complexity of the process, lack of technical capacity in potential importing countries, and fear of reprisal. The question to be asked is, if countries are unable not make use of compulsory licences which would improve the situation of access to medication for their people, does this not indicate some sort of a failure of the WTO's intellectual property rights system? [...]
[...] A patented invention can be used for research purposes where the aim is to understand more fully the invention as a basis for advancing science and technology. On the other hand, generic companies can use this provision, which is often referred to as ‘Bolar provision', to obtain product approval before the expiry of the patent term, thus facilitating immediate entry into the market after patent expiration. Finally, among other provisions outlined in the agreement, Articles 31(k) and 40 offer flexibility to member countries to prevent or remedy anti-competitive practice. Even though these flexibilities were incorporated in the TRIPS Agreement from 1994, some governments were unsure of how they would be interpreted, and how far their right to use them would be respected. [...]
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