Biosimilars

Statement, May 2019

South Centre Statement on Access to Biosimilars/Biogeneric Medicines at the WHA 72

The revision of the guidelines on similar therapeutic products mandated by Resolution WHA67.21 is crucial for promoting the availability of and access to biosimilars. The reduction in prices ensuing from the introduction of these products has become essential to address public health needs in developed and developing countries. The WHO Document A72/59 under consideration by the WHA 72 (agenda item 21.3) states in paragraph 80 that “WHO expert committees have approved guidance on (…) biotherapeutics, including an update of the 2009 similar biotherapeutic products guidelines”. This statement is not accurate, as the guidelines were not updated as mandated by Resolution WHA67.21. Below is the South Centre statement in relation to this issue.

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Statement, May 2019

South Centre Statement at the Meeting of the Non-Aligned Movement (NAM) Health Ministers

Dr. Carlos Correa, Executive Director of the South Centre, stressed the need to preserve the World Health Organization (WHO) as a public, independent agency that effectively addresses the health problems of developing countries, at the Non-Aligned Movement (NAM) Health Ministers Meeting held on the occasion of the 72nd World Health Assembly. Below is the statement of the South Centre delivered at the Palais des Nations, Geneva on 21 May 2019.

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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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South Centre Quarterly Report, October-December 2018

South Centre Quarterly Report, 1 October to 31 December 2018

This report summarizes the programmatic activities of the South Centre during the period 1st October to 31 December 2018. It is intended to provide information, organized by Program and themes, about recent developments in the areas covered by the South Centre’s Work Program and publications made and meetings organized or co-organized by the Centre to examine particular issues or to provide analytical support for international negotiations taking place in various fora. It also informs about external conferences and other meetings where the Centre has participated.

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South Centre Quarterly Report, July-September 2018

South Centre Quarterly Report, 1 July to 30 September 2018

This report summarizes the programmatic activities of the South Centre during the period 1 July to 30 September 2018. It is intended to provide information, organized by Program and themes, about recent developments in the areas covered by the South Centre’s Work Program and publications and meetings organized or co-organized by the Centre to examine particular issues or to provide analytical support for international negotiations taking place in various fora. It also informs about external conferences and other meetings where the Centre has participated.

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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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