Research Paper 59, December 2014

Transition Period for TRIPS Implementation for LDCs: Implications for Local Production of Medicines in the East African Community

Article 66.1 of the WTO TRIPS Agreement grants the least developed countries (LDCs) a transition period during which they do not have to provide intellectual property rights protection according to the minimum requirements of the TRIPS Agreement. This transition period has been granted to LDCs to ensure that LDCs are not constrained by the existence of IP rights from taking suitable measures to develop a sound and viable technological base in different industrial sectors. The TRIPS Council has extended this transition period three times, including a specific extension for pharmaceutical products, and it is possible to seek further extensions of this period. This paper analyzes the implications of the transition period available for local production of pharmaceuticals in LDCs that are Partner States of the East African Community (EAC) – Burundi, Rwanda, Uganda and the United Republic of Tanzania. The paper analyzes the critical challenges for local production of pharmaceutical products in these countries and how the transition period can be utilized fully to address these challenges. Though the EAC Partner States rely predominantly on imported generic medicines, there is a need for local production of medicines as reliance on imports may not be sustainable for these countries. However, the LDCs from the EAC Partner States have only recently began using the TRIPS transition period and Tanzania has still not introduced the transition period under its national law. Moreover, most of the LDCs from the region are contracting parties to the Harare Protocol under which ARIPO grants pharmaceutical patents that are excluded under respective national laws and would be void ab initio. However, the grant of such patents to come into effect in these countries could create confusion. In this context, the paper recommends that all LDC Partner States of the EAC should make use of the general transition period until 2021; that Tanzania should start using the transition period; and that LDCs should seek an extension of the transition period for pharmaceutical products, which expires in 2016. Moreover, national laws should declare any patent granted by ARIPO on pharmaceutical products to be void ab initio and a similar amendment could be moved in the Harare Protocol.

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