Author: James Love

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.

• 13 of the 14 defendants were men.

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Despite very tough laws on the books in the US for counterfeiting, which include possible life sentences for some offenses, and the very aggressive federal PR campaign against counterfeit drugs, the US is not always that tough on the trade in counterfeit drugs. In this recent case, Curtis Henry was sentenced to three years probation.

http://www.ice.gov/news/releases/1205/120518rochester.htm

News Releases
MAY 18, 2012
ROCHESTER, NY
Upstate New York man sentenced for importing counterfeit pharmaceuticals

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Donald McNeil has an article in the New York Times that appeared in print on May 22, 2012 (page D6 of the New York edition) with the headline: “Malaria: Fake and Substandard Drugs Grow as Threat to Fight Disease.” A web version is available here: http://www.nytimes.com/2012/05/22/health/policy/fake-and-substandard-drugs-grow-as-threat-to-fight-malaria.html

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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.

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Here is the resolution that was adopted.

/wp-content/uploads/Item13.14_AdvanceDraftResolution.pdf

Among the key parts of the 2 page resolution are the following:

1. WELCOMES the analysis of the CEWG report and expresses its appreciation to the Chair, Vice Chair and all the members of the Working Group for their work;
2. URGES Member States:2
(1) to hold national level consultations among all relevant stakeholders in order to discuss the CEWG report and other relevant analyses resulting in concrete proposals and actions;
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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.

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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.

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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.