Abstract

Implementation of TRIPS agreement and DR-CAFTA in the national legislation of six countries regarding the consequences for access to medicines

Presented by Joachim Rüppel (Germany).

J. Rüppel

Medical Mission Institute, HIV/AIDS, Health Services and Public Health, Würzburg, Germany

Background: Until the World Trade Organization (WTO) was founded in 1995, developing countries had considerable leeway to formulate their own set of intellectual property rights (IPR) considering national priorities. With the adoption of the TRIPS Agreement as a constitutive part of WTO rules these countries were confronted with the obligation to adapt their national legislation to the new international standards. In the following years several countries accepted regional or bilateral trade agreements which aggravated the WTO requirements. Up to now there is a lack of systematic information on the concrete results of the imposed legal reforms and its implications for the access to antiretroviral therapy.
Methods: A study was conducted on the implementation of the TRIPS Agreement and the DR-CAFTA in all five member states of the latter in Central America and the Dominican Republic. The investigation focused on patent rights and protection of test data, since these types of IPR are of major relevance for financial sustainability of treatment programs. The key aspects were analysed methodically contrasting the respective provisions of the evolving national laws with the international obligations.
Results: Notwithstanding wide variations, the national legislations and implementation rules of all six countries studied contain provisions which restrict the scope of action for policies to protect public health more than would be required by mandatory standards of the international agreements. Especially, they limit the legal grounds upon which compulsory licences can be granted and impede the effective application of this fundamental instrument to achieve critical price reductions. Thus the use, to the full, of the flexibilities guaranteed by the TRIPS Agreement and the Doha Declaration is obstructed by internal hindrances.
Conclusions: The public discussion and thoughtful revision of national laws ostensibly enacted to comply with external obligations represents a crucial first step for promoting access to newer urgently needed antiretroviral drugs.
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