Compulsory Licenses

Research Paper 85, April 2019

Access to Medicines: Experiences with Compulsory Licenses and Government Use – The case of Hepatitis C

This South Centre research paper discusses first, the limitations of the current research and development (R&D) model and its implications for access to medicines. Second, it considers the tension between intellectual property rights applied to medicines and States’ observance of the fundamental right to health. Third, it examines the case of access to medicines for the treatment of Hepatitis C, illustrating the barriers to access created by intellectual property and the high prices normally associated with its exercise. Fourth, it presents the background, main aspects and obstacles to the achievement of the objectives of the Doha Declaration on the TRIPS Agreement and Public Health (2001). To conclude, this paper examines the experiences of compulsory licensing and government use of patents in Latin America (particularly in Ecuador, Peru and Colombia).

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Policy Brief 57, January 2019

Will the Amendment to the TRIPS Agreement Enhance Access to Medicines?

An amendment to the TRIPS Agreement by incorporation of the text of the decision of the WTO General Council on 30 August 2003 (as article 31bis) has been made in response to the problem identified in paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. This paragraph sought a solution to situations where patented pharmaceuticals which are not available in a country with no or insufficient manufacturing capacity can be supplied by a foreign provider. As originally adopted, the TRIPS Agreement did not allow the grant of compulsory licenses for exports only, thereby preventing generic manufacturers from exporting the required products to countries unable to produce them. While the new article 31bis is a step forward as it reflects public health concerns, it would be necessary to streamline the procedures to effectively ensure broader access to pharmaceutical products at low cost and in a timely manner.

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Research Paper 90, December 2018

Compulsory Licensing Jurisprudence in South Africa: Do We Have Our Priorities Right?

Compulsory licences are generally available on a variety of grounds, most notably on patents where the patentee is found to have abused its rights in one manner or another. This research paper attempts to review South African case law on applications for compulsory licences since the inception of the current legislation, analyse the interpretations placed on the relevant sections, and draw conclusions about judicial reasoning, impediments to the grant of such licences, and generally the courts’ approach to disputes relating to patents.

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Documento de Investigación 85, Mayo 2018

Acceso a medicamentos: experiencias con licencias obligatorias y uso gubernamental – el caso de la Hepatitis C

El acceso a medicamentos está fuertemente condicionado por su precio y por los mecanismos de financiamiento que pueden aplicarse en cada país. […] Un factor determinante en la fijación del precio de los medicamentos es el grado de competencia existente en una particular clase terapéutica, la que a su vez es influenciada por la existencia o no de derechos de propiedad intelectual, como patentes de invención.

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Research Paper 77, May 2017

Access to Hepatitis C Treatment: A Global Problem

“Viral hepatitis is an international public health challenge, comparable to other major communicable diseases, including HIV, tuberculosis and malaria. Despite the significant burden it places on communities across all global regions, hepatitis has been largely ignored as a health and development priority until recently”. – WHO, Global Health Sector strategy on viral Hepatitis 2016-2021: Towards ending viral hepatitis

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Policy Brief 37, March 2017

The Need to Avoid “TRIPS-Plus” Patent Clauses in Trade Agreements

A recent article in a prestigious journal reminds us of how the intellectual property chapter of free trade agreements can prevent the sick from getting treatment.  This article also critiques the TPP clauses and warns that they should not be translated to national laws or copied into other FTAs being negotiated. 
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Analytical Note, March 2017

The TRIPS and WTO Negotiations: Stakes for Africa

This paper discusses the current negotiation issues in the context of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and the position the African Group has taken in these negotiations. (more…)

Research Paper 74, February 2017

Mitigating the Regulatory Constraints Imposed by Intellectual Property Rules under Free Trade Agreements

IP provisions in FTAs may have implications on a wide range of public policy areas. A vast academic literature has addressed the “flexibilities” available under the TRIPS Agreement and the negative impact of FTAs in relation to access to medicines. (more…)

Statement, January 2017

South Centre Statement on the Amendment to the WTO TRIPS Agreement to Ease Access to Affordable Medicine

An amendment to the TRIPS Agreement that aims to facilitate the access to affordable medicines has entered into force upon approval by two thirds of the WTO members. The amendment reflects the recognition by WTO Members of the need for the continued enhancement of global intellectual property rules to allow Members to systematically take measures to protect public health.

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