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).
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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