240 Wikileaks cables on pharmaceutical data exclusivity

August 29, 2011
From KEI staff review of Wikileaks cables (/wikileaks)

The following are the cables identified in an August 29, 2011 search of the wikileaks cables, from http://cablesearch.net, using the search terms data exclusivity and pharmaceutical. This search identified 240 cables. Some 40 countries are mentioned in the cables. More than half of the cables involve 5 countries: Turkey (76), Taiwan (21), El Salvador (11), Honduras (11) and Tunisia (10).

Misc notes on the new Wikileaks cables

These are some notes on some of the new Wikileaks cables. (Much more at /wikileaks)

May 18, 2009. Pfizer meets asks US embassy to intervene in Philippines debate over drug prices. Embassy agrees to tell Philippines government that “imposition of price controls . . . would be unacceptable..”

http://wikileaks.org/cable/2009/05/09MANILA1060.html

Subject: Health Department Patent Remedies to Cut Drug Prices

¶1. (SBU) Summary: The Philippine Department of Health is close to
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From Wikileaks, a US government cable on its involvement to shape Guatemala legislation on pharmaceutical IPR

August 28, 2011
From KEI staff review of Wikileaks cables (/wikileaks)

Among the many new cables released by Wikileaks is this gem, a detailed account of the U.S. government pressure on the Guatemala legislature to shape legislation on pharmaceutical test data IPR.

http://wikileaks.org/cable/2005/03/05GUATEMALA659.html

C O N F I D E N T I A L SECTION 01 OF 05 GUATEMALA 000659

SIPDIS

E.O. 12958: DECL: 03/11/2010
TAGS: ETRD KIPR PGOV PREL GT
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ADAP waiting lists continue to grow; 9,217 individuals on waiting lists, 64% are African American or Hispanic

The number of patients sitting on AIDS Drug Assistance Programs (ADAP) wait lists, denied the life-saving treatment they need, have risen dramatically over the past two years. ADAPs are critical in providing HIV/AIDS treatment to low-income, uninsured, or underinsured patients within the United States and its territories. As noted in an earlier KEI blog, in January 2010, 361 individuals were on ADAP waitlists; that number grew to 7,873 across eleven states as of May 5, 2011 (a 2100% increase over less than sixteen months).

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Approval, ownership, market structure, and placement on WHO EML for 100 new cancer NMEs on NCI alpha list

KEI research associate Paul Miano has written the following paper: Cancer: Approval, ownership, market structure, and placement on WHO Model Essential Medicines List, for 100 new molecular entities (NMEs) on the NCI alpha list of cancer drugs and vaccines. KEI Research Note 2011:1,

A full copy of the paper is available in PDF format here.

The following is from the introduction (sans footnotes, which are in the PDF version):

Introduction and Summary

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In the first 7 months of 2011, the FDA has approved 18 new molecular entity pharmaceutical drugs (and no biologic NMEs)

In the first seven months of 2011 (January 14 to July 20) , the US FDA has already approved 18 new molecular entity drugs. These are some notes on the approvals:

  • All of the NME products are considered pharmaceutical drugs, and received approval under FDA procedures for New Drug Applications (NDA).
  • Despite the trends indiciating shifts to biologic products from pharmaceutical drugs, none of the 2011 products introduced to date were biologics.
  • One third (6 of 18) received Priority review status. 12 of 18 received Standard review status.
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Medicines Patent Pool agreement with Gilead contains flexibilities including termination provisions and severability of licenses

On 12 July 2011, the Medicines Patent Pool (MPP) and Gilead announced an agreement for Gilead to license patents for tenofovir (TDF), emtricitabine (FTC), elvitegravir (EVG), cobisistat (COBI) and a four drug combination of these drugs. KEI’s initial comments on the agreement are available here. Continue Reading

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Decision for WIPO GA 49: Matters Concerning the IGC on IP and genetic resources, traditional knowledge and folklore

After ten years of deliberations, the 19th session (18-22 July 2011) of the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC/GRTKF) submitted a Decision for approval to the WIPO General Assembly (26 September-5 October 2011) that could pave the way for the General Assembly in 2012 to convene a Diplomatic Conference on an international legal instrument(s) for the protection of genetic resources, traditional knowledge and traditional cultural expressions (TCEs).

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