The following are some areas of KEI research, analysis and advocacy as regards medical research and development. More details will be added later.
Costs of development of new drugs
Reform of Incentives to Stimulate R&D
KEI provides evaluation of various incentive measures, and proposes a variety of reforms, including but not limited to those that de-link R&D costs from product prices.
KEI Statement on World Health Assembly resolution on Consultative Expert Working Group on Research and Development: Financing and Coordination
A number of developing countries worked together to push the World Health Assembly to create a member state process to consider the implementation of the CEWG. The most important CEWG recommendations are to begin work on a new WHO Convention on R&D financing, and to de-link R&D costs from drug prices.
Open letter to those who collectively produced the May 23, 2012 statement to the WIPO SCP on the topics of patents and health (Copy of US statement available here: https://www.keionline.org/node/1416).
May 25, 2012
To each and everyone who worked on the SCP submission:
This letter outlines our concerns to the May 23, 2012 statement to the 18th Session of the World Intellectual Property Organization (WIPO) Standing Committee on the Law of Patents (SCP), on the agenda for patents and health.
This is a brief note regarding the WHA negotiations on the proposed treaty for medical R&D, and in particular, the elements which deal with financing R&D. I’ll skip the history and earlier context of the negotiations, and focus on the main issues in play this week.
The following is the statement read today by USPTO during a meeting of the WIPO Standing Committee on the Law of Patent, on the agenda item for patents and health. I’ll provide more commentary later, but in general, this was seen an aggressive attack on a proposal for work by the Development Agenda Group (DAG), and on the notion that countries should grant compulsory licenses on patents to address concerns over access or affordability of drugs.
[Update: KEI wrote to USPTO about the submission: /node/1420]
On Wednesday, 23 May 2012, Chile delivered the following statement on patents and health at the 18th session of the WIPO Standing Committee on the Law of Patents (SCP). In particular, Chile made a strong case for the WIPO SCP to study existing flexibilities in the international patent system. Continue Reading →
The World Heath Organization is now debating proposal in a report form a Consultative Expert Working Group (CEWG) on R&D for a new medical R&D treaty, focusing on the special health needs of developing countries. The following table shows how much money various regions and countries would be obligated to spend on R&D, under the treaty proposal, which is .0001 of GDP, of which 20 percent would be invested through pooled funding mechanisms.
This was the 3,500 word statement of Senator Bernie Sanders during Senate HELP committee markup of the PDUFA legislation. The statement covers a lot of ground, and illustrates why consumer groups love Bernie Sanders, while making one wonder why other Senators have not been more supportive of the consumer protection issues that Sanders discusses. Here are some highlights:
The proposal for a new extended monopoly for antibiotics and antifungal drugs is a “huge giveaway” that will lead to high prices and harm consumers.