Generic Medicines

Policy Brief 61, May 2019

The US-Mexico-Canada Agreement: Putting Profits Before Patients

In the US-Mexico-Canada Agreement (USMCA, NAFTA 2.0), the U.S. Trade Representative negotiated intellectual property provisions related to pharmaceuticals that would enshrine long and broad monopolies. This policy brief focuses primarily on the negative effects of the USMCA intellectual property provisions on access to medicines in the U.S.  Such effects may be even worse for Canada and Mexico. The impact of this trade agreement goes well beyond the three countries involved as this is the first one negotiated by the Trump Administration and is likely to set a precedent for future trade agreements.  A careful review of the USMCA text raises very serious concerns about the impact that this agreement would have on the  generic/biosimilar industry and therefore on access to more affordable drugs throughout the world.

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Policy Brief 59, April 2019

The ‘obvious to try’ method of addressing strategic patenting: How developing countries can utilise patent law to facilitate access to medicines

The current patentability standards for pharmaceutical inventions, as well as strategic patenting used by pharmaceutical companies, have substantially impacted access to affordable medicines. This has been especially detrimental for developing countries, which are under significant pressure to remain compliant with their international and bilateral obligations, while also providing their people with essential drugs. In order to improve access to medicines, developing countries may choose from a range of various mechanisms that may help to facilitate such access, while also allowing them to remain compliant with their international and bilateral obligations. This policy brief suggests that one of such mechanisms is to strengthen the obviousness requirement by applying the ‘obvious to try with a reasonable expectation of success’ test to pharmaceutical follow-on inventions. It is argued that the application of this test may be an effective tool in addressing the negative effect of strategic patenting. It may help to prevent the extension of patent protection and market exclusivity of existing drugs by pharmaceutical companies and, as a result, may open such medicines up to generic competition.

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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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Statement, September 2018

South Centre Statement for the Informal Consultation on the Roadmap on Access to Medicines

The draft roadmap is an important work in progress that needs to be further detailed with clear deliverables and timelines. The roadmap will need to ensure complementarity of its work and the implementation of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA).

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Policy Brief 50, August 2018

The International Debate on Generic Medicines of Biological Origin

The debate on generic medicines is not new. What makes it different today is that attacks levelled against biological generic products are couched in even more “technical” and abstruse language. The high price of biological drugs stems mainly from the introduction of barriers to the entry of generics into the market. In any debate on the feasibility of producing biological generic products identical to the ‘original’ ones, it should be made clear that what are at stake are not identical products but therapeutic equivalents.

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Research Paper 82, November 2017

The International Debate on Generic Medicines of Biological Origin

The debate on generic medicines is not new. What makes it different today is that attacks levelled against biological products are couched in ever more “technical” and abstruse language that confuses even the World Health Organization (WHO).

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Book by the South Centre, 2002

Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement 

This study focuses in depth on the specific issue of marketing approval protection under the TRIPS Agreement and its interpretation, an issue of major practical importance for the developing countries. This book is co-published by the World Health Organization and was produced with the support of the Rockefeller Foundation.

Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement 


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