Special301
In Poland, an Ambassador (and former George W Bush roommate) demolishes PhRMA's 2009 Special 301 filing (Wikileaks cables)
Submitted by James Love on 6. September 2011 - 20:26From KEI staff review of Wikileaks cables (http://keionline.org/wikileaks)
This cable signed by US Ambassador to Poland Victor H. Ashe provides a through and very tough critique of PhRMA's submission to the 2009 Special 301 list. Ashe rejects every one of PhRMA's main points, and explains why continually putting Poland on the Special 301 list is counter productive.
Special 301 Cables: Countries G to Y
Cables mentioning "Special 301" - Context and More Countries - http://keionline.org/node/1244
G
Germany | Embassy Berlin | Feb 23, 2007 | Mission Germany Submission For 2007 Special 301 Review
Ghana | Embassy Accra | Feb 12, 2008 | 2008 Special 301 Review - Ghana
Cables mentioning "Special 301" - Details of US trade pressure on IPR
Below are links to two web page pages that have links to 973 U.S. Department of State cables identified on September 5, 2011, using the http://cablegatesearch.net/ tool for searching 251,287 Wikileaks cables, and the search term, "special 301."
The two web pages with the cables are here:
Cables mentioning Special 301 Review
Submitted by James Love on 5. September 2011 - 16:35Country Embassy Date Cable
Algeria | Embassy Algiers | Feb 19, 2008 | Microsoft's Ipr Woes
Algeria | Embassy Algiers | Feb 24, 2008 | Algeria: 2008 Special 301 Review
Algeria | Embassy Algiers | Mar 29, 2009 | E-barbary Coast: Profits And Piracy In The Algerian Software Market
White House and European Commission trade official oppose waiver of drug patents for Least Developed Countries (LDCs)
Submitted by James Love on 11. June 2011 - 9:36KEI Policy Brief 2011:1
June 11, 2011, Revised August 15, 2011
The USTR Special 301 Report, some initial reactions
Submitted by James Love on 2. May 2011 - 15:25KEI comments on USTR 2011 Special 301 Review
Submitted by Manon Ress on 15. February 2011 - 15:53KEI's comments on the USTR 2011 Special 301 Review are available here.
For further background on the 301 process, see: http://keionline.org/ustr/special301
KEI Statement on USTR 301 list
Submitted by James Love on 30. April 2010 - 10:51USTR has released its 2010 Special 301 list. Closely following the IIPI and the PhRMA asks, the Special 301 Priority Watch List countries are: Algeria, Argentina, Canada, Chile, China, India, Indonesia, Pakistan, Russia, Thailand, and Venezuela. Among high income countries, Finland, Norway and Spain made the Watch list this year. Sweden was off.
PhRMA's asks regarding special 301, drug pricing and reimbursement
Submitted by KEI Staff on 17. March 2010 - 12:43Below are asks from the 2010 PhRMA submission to the USTR Special 301 list on the topic of drug pricing and reimbursement decisions, and described as 'Market Access Barriers.' In its assertions, PhRMA attack countries for government price negotiations, making use of reference pricing, the insufficient involvement of pharmaceutical companies in setting government pricing policies and the composition of drug formularies, among other things.
CHINA
PhRMA pushes for data exclusivity in 2010 Special 301 comments
Submitted by Malini Aisola on 1. March 2010 - 18:11The Pharmaceutical Research and Manufacturers of America (PhRMA) 2010 Special 301 submission (a 200 plus page document) systematically lists in great detail, grievances against 41 countries for, in its view, the insufficient implementation and enforcement of national IP legislation.
A primary focus of attention and frequent "area of concern" in the submission is the inadequate protection of pharmaceutical regulatory data. Regulatory data refers to test and clinical trial data generated by drug developers and submitted as requisite evidence of safety and efficacy for the successful registration of a product. While data protection can take many forms, data exclusivity regimes grant a period of exclusive rights to the originator during which generic manufacturers are banned from relying on the original data to meet registration standards of safety and efficacy. In its submission, PhRMA relentlessly advocates for, indeed makes demands of several countries to implement data exclusivity provisions that go far beyond their obligations under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
As noted by KEI and others in submissions to USTR, a number of public health and development NGOs have been highly critical of data exclusivity regimes, citing the large barriers to the introduction of generic medicines, and the conflicts between data exclusivity and medical ethics, when generic firms are required to replicate experiments with humans where the results of trials are already known. KEI will focus on the issue of pharmaceutical test data protection in its testimony on the Special 301 list on March 3, 2010.
Below are country-specific statements on this subject from PhRMA's submission:
PhRMA has singled out THAILAND by recommending that it be identified as a Priority Foreign Country
In 2007, implementing Ministerial regulations of the Trade Secrets Act of 2002 were issued by the Thai FDA. While the regulations provide trade secret protection that prohibits disclosure of confidential information, the regulations fail to prohibit the Thai FDA or generic drug applicants, for a fixed period of time, from relying on the originator’s regulatory data to approve generic versions of the originator’s product. That protection (referred to as Data Protection) should be established by Thailand to ensure unfair commercial use of innovators’ data does not occur.
PhRMA encourages Thailand to (1) implement new regulations that do not permit generics producers to rely directly or indirectly on the originators’ data, unless consent has been provided by the originator, for the approval of generic pharmaceutical products during the designated period of exclusivity; (2) bring Thailand’s regulations in line with international best practices by making clear that trade secret protection is provided to all confidential material whenever it is received by officials; (3) extend data protection to new dosage forms, new indications, etc; and (4) require Thai FDA officials to protect information provided in confidence by the originator by ensuring that information is not improperly made public or made available for use or reliance by a subsequent producer of a generic pharmaceutical product.
