In preparation for the 65th World Health Assembly, held in Geneva from 21 May 2012 to 26 May 2012, the World Health Organization (WHO) prepared a document (A65/29 Add. 1, 5 April 2012) entitled “Voluntary contributions by fund and by donor for the financial period 2010-2011. Continue Reading →
This is a rough list of the recent ICE press releases mentioning counterfeit and pharmaceutical. It is quite clear that the overwhelming majority of counterfeit busts involve Viagra and other erectile dysfunction drugs, a problem that will probably resolve itself once the Pfizer patents on Viagra expire.
In my quick read of the ICE press releases, I found just 12 pharmaceutical counterfeiting cases in the ICE press releases from 2009 to May 2012, with 14 defendants.
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.
The EU has provided KEI with a copy of the EU statement delivered at the 65th World Health Assembly on Wed, May 23, 2012, on the WHO Consultative Expert Working Group on R&D Financing. In a nutshell, the EU position is to “generally support” the US led position, and to slow everything down. Here are some of the main points:
We recognise that current measures are insufficient, although we also cherish the collective efforts that have been made with respect to the issue so far.
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 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.
Senator 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.
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.