Trips & Public Health
| Author | Commonwealth Secretariat |
| Pages | 433-438 |
Page 433
The 30 August WTO General Council Decision, WT/L/540, "Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health"
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Commonwealth Heads of Government at Aso Rock welcomed the 30 August 2003 WTO agreement on affordable drugs and called for its interpretation and implementation in a manner that makes appropriate drugs available at low cost to poor countries. Heads of Government recognised:
"that diseases such as HIV/AIDS, malaria and tuberculosis are not only health problems but are also development issues. ... [and called] for reforms at the national level to create effective health delivery systems, as well as adequate external support to achieve this." (Aso Rock Declaration).
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Commonwealth developing countries are among the highest HIV/population ratio worldwide: "the threat from HIV/AIDS is especially great in Sub-Saharan Africa, which has two-thirds of the world's 40 million persons living with HIV/AIDS, and in the Caribbean." (Aso Rock Declaration) Commonwealth developing countries with insufficient or no manufacturing capacities in the pharmaceutical sector - mainly small states and least developed countries (LDCs) - require technical assistance at both the national and regional level, if they are to benefit from the Decision.
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The 30 August 2003 WTO General Council Decision, WT/L/540, "Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health" addresses the instruction of the WTO Ministerial Conference to find an expeditious solution to the problem of the difficulties that Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face in making effective use of compulsory licensing under the TRIPS Agreement. WTO Ministers at Doha agreed "that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all."
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The 30 August Decision is designed to be part of the wider national and international action to address problems associated with access to medicines. Many fear that the problems encountered in making drugs available to those who need them at affordable prices may be further exacerbated with the end of WTO transitional arrangements for the extension of product patent protection to pharmaceuticals in 2005 (LDCs are excepted until 2016). The TRIPS Agreement allowed countries that had not provided patent protection for pharmaceutical products at the time of its entry into force in 1995 a 10-year grace period, at the end of which (1 January 2005) they were required to introduce a national system for granting product patents.
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Significantly, concerns have been expressed over the fact that with the expiry of the 2005 deadline, India is now obliged to provide a product patent protection and to review an estimatedPage 434 70001 mailbox patent applications that production of generic versions of medicines in India will be adversely affected, and consequently, its supply to other developing countries. It is worth noting that Indian generic manufacturers are currently the main suppliers of affordable antiretroviral and other HIV-related medicines to many developing countries, and comprise the majority of generic firms on the WHO Prequalification List for antiretroviral products.2
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WT/L/504 offers an important avenue for addressing Members' concerns. The effectiveness of the Decision in fulfilling its objectives will depend on how far in practice the concerned exporting and importing countries are able to implement these procedures effectively.
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The Decision elaborates a system that would permit countries with insufficient or no manufacturing capacities in the pharmaceutical sector to import cheaper generic versions made in other countries under compulsory licenses. The system also provides for rules that would enable countries belonging to regional economic groupings (of which at least half of the members are LDCs) to export products imported under the system to other countries in the region and, where the potential exists, gradually develop a pharmaceutical industry that could produce drugs that are needed for the treatment...
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