Are affordable pharmaceuticals within reach for developing countries - Clarifying the access situation of today and projecting beyond the Paragraph 6-Agreement
(2005)Department of Law
- Abstract
- The increasing spread of global pandemics such as HIV/AIDS, tuberculosis (TB) and malaria, in particular in developing countries, has forced the engagement of industrialized countries and pharmaceutical companies. Because medicines to cure these diseases are often under patent protection, they are not affordable for people in developing countries where health crises prevail. In November 2001, WTO Members created the so-called Doha Declaration, which was the result of developing countries' efforts to internationally claim the right to prioritize public health before intellectual property rights. The declaration re-established the available mechanisms for obtaining the lower-priced generic drugs through compulsory licensing, provided by the... (More)
- The increasing spread of global pandemics such as HIV/AIDS, tuberculosis (TB) and malaria, in particular in developing countries, has forced the engagement of industrialized countries and pharmaceutical companies. Because medicines to cure these diseases are often under patent protection, they are not affordable for people in developing countries where health crises prevail. In November 2001, WTO Members created the so-called Doha Declaration, which was the result of developing countries' efforts to internationally claim the right to prioritize public health before intellectual property rights. The declaration re-established the available mechanisms for obtaining the lower-priced generic drugs through compulsory licensing, provided by the TRIPS Agreement, and highlighted the importance of supporting health objectives when interpreting the TRIPS provisions. Although the Declaration did not introduce any legal novelty, it represented a benchmark for the developing countries, which had frequently been impeded by pharmaceutical companies and industrialized countries when trying to apply TRIPS compliant compulsory licensing mechanisms. Such mechanisms do, however, have a substantial limitation&semic namely the export restrictions imposed on a product that is produced under a compulsory license. This pivotal issue was left unresolved at the Doha-round with the paradoxical consequence that the poorest countries lacking medical manufacturing capacities were left with little chance to obtain affordable pharmaceuticals. The problem, which was recognized in Paragraph 6 of the Declaration, was however not resolved until August 30, 2003, due to much disagreement between Members having contradictory interests. Though not yet implemented into the TRIPS Agreement, the ''Paragraph 6-Agreement'' has already given rise to much debate. In general, the outcome can be characterized as liberal as it allows unrestricted export of generics produced under compulsory licenses. On the other hand, the outcome can also be seen as restrained since the deal comes with several practical requirements and numerous administrative procedures, which complicate the practice of the system. Despite its flaws, the Para. 6-Agreement together with the Declaration have overturned the international attitude to developing countries' right to obtain affordable pharmaceuticals. Several options are now available for poor nations, whether concerning the acquisition of generics or brand name pharmaceuticals. In the latter case, parallel import stands as an open alternative but this might deter innovative drug companies from substantially pressing down prices for developing countries, so-called ''price-differentiating''. Although at the time of reaching of the Para. 6-Agreement, the aim was to manage the implementation of the text into TRIPS by the end of 2004, that deadline has now been overrun. The expectations are now that this will be achieved in the next year. In the meanwhile, several actions can be taken by all parties - developing and developed countries, pharmaceutical companies, funds organs and health organizations - in order to escalate the processes of making essential medicines accessible for poor people. (Less)
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http://lup.lub.lu.se/student-papers/record/1556726
- author
- Channual, Anny
- supervisor
- organization
- year
- 2005
- type
- H3 - Professional qualifications (4 Years - )
- subject
- keywords
- Immaterialrätt
- language
- English
- id
- 1556726
- date added to LUP
- 2010-03-08 15:55:20
- date last changed
- 2010-03-08 15:55:20
@misc{1556726,
abstract = {{The increasing spread of global pandemics such as HIV/AIDS, tuberculosis (TB) and malaria, in particular in developing countries, has forced the engagement of industrialized countries and pharmaceutical companies. Because medicines to cure these diseases are often under patent protection, they are not affordable for people in developing countries where health crises prevail. In November 2001, WTO Members created the so-called Doha Declaration, which was the result of developing countries' efforts to internationally claim the right to prioritize public health before intellectual property rights. The declaration re-established the available mechanisms for obtaining the lower-priced generic drugs through compulsory licensing, provided by the TRIPS Agreement, and highlighted the importance of supporting health objectives when interpreting the TRIPS provisions. Although the Declaration did not introduce any legal novelty, it represented a benchmark for the developing countries, which had frequently been impeded by pharmaceutical companies and industrialized countries when trying to apply TRIPS compliant compulsory licensing mechanisms. Such mechanisms do, however, have a substantial limitation&semic namely the export restrictions imposed on a product that is produced under a compulsory license. This pivotal issue was left unresolved at the Doha-round with the paradoxical consequence that the poorest countries lacking medical manufacturing capacities were left with little chance to obtain affordable pharmaceuticals. The problem, which was recognized in Paragraph 6 of the Declaration, was however not resolved until August 30, 2003, due to much disagreement between Members having contradictory interests. Though not yet implemented into the TRIPS Agreement, the ''Paragraph 6-Agreement'' has already given rise to much debate. In general, the outcome can be characterized as liberal as it allows unrestricted export of generics produced under compulsory licenses. On the other hand, the outcome can also be seen as restrained since the deal comes with several practical requirements and numerous administrative procedures, which complicate the practice of the system. Despite its flaws, the Para. 6-Agreement together with the Declaration have overturned the international attitude to developing countries' right to obtain affordable pharmaceuticals. Several options are now available for poor nations, whether concerning the acquisition of generics or brand name pharmaceuticals. In the latter case, parallel import stands as an open alternative but this might deter innovative drug companies from substantially pressing down prices for developing countries, so-called ''price-differentiating''. Although at the time of reaching of the Para. 6-Agreement, the aim was to manage the implementation of the text into TRIPS by the end of 2004, that deadline has now been overrun. The expectations are now that this will be achieved in the next year. In the meanwhile, several actions can be taken by all parties - developing and developed countries, pharmaceutical companies, funds organs and health organizations - in order to escalate the processes of making essential medicines accessible for poor people.}},
author = {{Channual, Anny}},
language = {{eng}},
note = {{Student Paper}},
title = {{Are affordable pharmaceuticals within reach for developing countries - Clarifying the access situation of today and projecting beyond the Paragraph 6-Agreement}},
year = {{2005}},
}