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.
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.
Colombia’s Biogenerics Regulation A Preliminary Court Decision in favour of Public Health
By Carolina Gómez
The Council of State of Colombia’s recent ruling on the abbreviated pathway for marketing authorization of biogenerics is a valuable step towards acceptance and uptake of biogenerics, favoring public health, access and market competition.
In 2014, after several years of discussion and heated debate, Colombia issued a regulation for sanitary registration of biotechnological medicines, including biogenerics. The regulation explicitly included an abbreviated pathway for the registration of biogenerics, which allows for reduction or, in some cases, even waivers of comparative efficacy clinical trials. PK/PD and inumunogenicity studies are required. (more…)
South Centre Quarterly Report, 1 January to 31 March 2019
This report summarizes the programmatic activities of the South Centre during the period 1st January to 31st March 2019. 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.
Will the Amendment to the TRIPS Agreement Enhance Access to Medicines?
By Dr. Carlos M. Correa
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.
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.
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.
Statement by the South Centre to the Nelson Mandela Peace Summit
At the Nelson Mandela Peace Summit , the South Centre highlighted Nelson Mandela’s battle against apartheid, which was a main obstacle to social development, and against actions by pharmaceutical companies to enforce intellectual property standards that would prevent access to HIV/AIDS drugs.
