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.
On May 23, 2012, the World Health Assembly began discussion of Agenda Item 13.14, the report of the Consultative Expert Working Group (CEWG) on Research and Development Financing and Coordination.
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]
The USPTO statement follows:
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.
Continue ReadingSenator Sanders has offered an amendment to the Food and Drug Administration Safety and Innovation Act of 2012 that would require drug sponsors to disclose the costs of pre-clinical research, clinical trials and related R&D, as well as grants, economic incentives that subsidize drug development costs, and also report quarterly sales and revenues, register all clinical trials at www.clinicaltrials.gov, and report detailed descriptions of each clinical trial participant’s results.
During the week of 14 May 2012, the Republic of Kenya submitted a resolution to the 65th session of the World Health Assembly entitled, “WHO Convention on Research and Development Financing and Coordination”. The resolution will be published by the World Health Organization (WHO) as a conference paper for discussion in Committee A under agenda item 13.14 Consultative Expert Working Group on Research and Development: Financing and Coordination. It is expected that this agenda item on the CEWG will be brought forward for early discussion at the Assembly.
This is the latest draft of my written testimony for the May 15, 2012 Senate HELP hearings on S.1138, the Prize Fund for HIV/AIDS.
Some additional relevant data are available on the following pages
/prizes
/hiv
Continue Reading
The World Intellectual Property Organization (WIPO) will convene the 18th session of the WIPO Standing Committee on the Law of Patents (SCP) from 21 May 2012 to 25 May 2012 (during the same week as the 65th session of the World Health Assembly). The agenda of the SCP is reproduced below.
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: