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.
The Use of TRIPS Flexibilities for the Access to Hepatitis C Treatment
In late 2013, a new Hepatitis C treatment called direct-acting antivirals (DAAs) was introduced in the market at unaffordable prices. The eradication of the disease is possible if medicines can be purchased at AFFORDABLE prices within health budgets. IF THIS IS NOT THE CASE, governments should consider the use of the TRIPS flexibilities to facilitate access to the treatment.
The South Centre is pleased to announce that it is scaling up its services to developing country governments in the area of intellectual property rights and public health, thanks to the support of Unitaid. The project “Expanding the use of TRIPS flexibilities to promote affordable access to medicines” will allow the South Centre to roll out a number of training activities at regional and national level and a global advisory service on the use of TRIPS flexibilities for public health.
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).
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.
Major Outcomes of the 71st Session of the World Health Assembly of WHO
The 71st session of the World Health Assembly (WHA) of the World Health Organization (WHO) took place from 21 to 26 May 2018 in Geneva, Switzerland. The Assembly adopted several decisions and resolutions including the adoption of the General Programme of Work (GPW) of WHO for the period 2019-2023, as well as decisions on addressing access to medicines and vaccines and their global shortage, and the recommendations of an overall programme review of the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA-PHI). (more…)