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 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
By Dr. Germán Velásquez
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.
This update provides a snapshot of the activities of the Development, Innovation and Intellectual Property Programme during the month of 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).
On World AIDS Day, threat to access to medicines looms large
By Shailly Gupta
Today millions of people living with HIV in South-East Asia are receiving treatment and leading healthy lives thanks to affordable generic antiretroviral (ARVs) medicines. Governments and treatment providers across Asia, such as the government of Indonesia and Médecins Sans Frontières (MSF), patients across our missions in many countries, depend on an uninterrupted supply of affordable generic HIV medicines to reduce new HIV infections and AIDS-related deaths in the region. But as the trade negotiators from 16 countries gather in Indonesia next week to deliberate the terms of a trade agreement — the Regional Comprehensive Economic Partnership agreement (RCEP), access to low-cost generic medicines is under grave threat. (more…)
His rivals called him a “pirate” but grateful millions whose lives were saved by his cheap generic medicines consider him a Robin Hood—Yusuf Hamied, leader of India’s giant company, Cipla.
As the northern Indian state of Rajasthan rolls out an ambitious universal healthcare plan, the discontent of the state’s doctors stands in stark contrast to the joys of the 68 million people who will benefit from the scheme.
Staring with Malaysia in 2003, many Asian countries are now taking actions to promote cheaper medicines through compulsory licensing, with Indonesia being the latest case. (more…)
India to increase supply of free generic medicines: some key issues
By Nirmalya Syam
Recent reports indicate that the Indian government plans to increase manifold its spending on procurement of generic medicines for supply free to patients. This is welcome news. However, it is important to ensure future supply of generic medicines by addressing the present problems facing the Indian drug industry.
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.
