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Lack of access to medicines could be either because they are not available or because even when available, they are not affordable to most patients in a country as the prices are disproportionately high compared to average income levels in the country. The focus of the criticism of the current pharmaceutical innovation model is the alleged use (or misuse) of the intellectual property system that allows the originator to control both the availability and affordability of essential medicines during the patent or market exclusivity term. However, patents are found to be uniquely important to capture profits from innovation in the chemicals and pharmaceutical sectors. In an attempt to balance market and public health objectives, the WTO TRIPS Agreement obliges the acceptance of product and process patents for pharmaceuticals while permitting several solutions, such as compulsory licensing or parallel imports, to attenuate problems of availability and affordability. These TRIPS solutions were the result of hard-fought North-South negotiating battles during the Uruguay Round and have been reiterated in 2001 through the Doha Declaration on the TRIPS Agreement and Public Health. A new TRIPS provision, Article 31bis, permits 100 per cent exports of pharmaceutical production under special compulsory licences to countries that have no manufacturing capacity. Perceived gaps in the TRIPS text are sought to be filled in by the demandeurs for stronger intellectual property protection through provisions in Free Trade Agreements (FTAs), on test-data protection, patent-term extension and patent linkage, among others. Properly balancing market and public health objectives may entail an international agreement in future to encourage differential pricing of patented medicines that would ensure affordable prices in all countries. |
