Special301
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.
Global Health Organizations Submission to USTR Special 301
Submitted by Judit Rius on 19. February 2010 - 8:52On February 18, 2010, 12 NGOs working on Access to Medicines submitted joint comments to the 2010 Special 301 Process
The submission is available here.
And a summary below:
SUBMISSION OF GLOBAL HEALTH ORGANIZATIONS:
KEI comments on U.S.T.R. Special 301
Submitted by James Love on 18. February 2010 - 16:02KEI is one of several public health groups working with Sean Flynn on filing comments in the current U.S.T.R. request for comments on the Special 301 process (Federal Register Notice USTR-2010-0003-0129). In addition, KEI filed these comments:
KEI comments on Special 301
18 February 2010
KEI provides the following comments regarding the 2010 Special 301 Review, including but not limited to the Identification of Countries Under Section 182 of the Trade Act of 1974.
Our comments include the following points:
USTR's new hearings on 301 list
Submitted by James Love on 12. January 2010 - 21:10USTR has issued an announcement for new procedures including public hearings on the 2010 Special 301 list. This is an effort to make the 301 process somewhat more open, and to provide more formal opportunities to both supporters and critics of USTR's bilateral trade pressures to make their case. USTR's actions are welcomed by several NGOs that have been critical of the unilateral trade pressures initiative, as it seems to provide the beginning of a more mature discussion about the objectives of trade policy, and the evidence to support different positions.
1999 USTR Special 301 Report
Submitted by James Love on 16. September 2009 - 13:48OFFICE OF THE UNITED STATES TRADE
REPRESENTATIVE
Executive Office of the President
Washington, D.C.
20508
99 - 41
For Immediate Release
April 30, 1999
Contact:
Jay Ziegler
Helaine Klasky
Amy Stilwell
(202) 395-3230
EMBARGOED UNTIL 1:00 P.M. EST
2000 USTR Special 301 Report
Submitted by James Love on 16. September 2009 - 13:172000 SPECIAL 301 REPORT
1997 USTR Special 301 Annual Review
Submitted by James Love on 16. September 2009 - 11:4730 April 1997
USTR REPORT ON SPECIAL 301 ANNUAL REVIEW
FACT SHEET
"SPECIAL 301" ON INTELLECTUAL PROPERTY RIGHTS
ACTIONS TAKEN
Acting United States Trade Representative Charlene Barshefsky today announced the Administration's decision with respect to this year's review under the so- called "special 301" provisions of the Trade Act of 1974, as amended (Trade Act).
The U.S. Special 301 Reports, 1989 to 2010
The USTR's Special 301 Report has been issued every year beginning in 1989. The Executive Summary of the 2009 report says:
Public Health Consumer Groups respond to 2009 USTR Special 301 Report
Submitted by Judit Rius on 30. April 2009 - 13:50Public Health and Consumer Groups respond to 2009 USTR Special 301 Report
Essential Action, AU Program on Information Justice and IP, Knowledge Ecology International, Forum on Democracy and Trade, Health GAP and Oxfam America
FOR IMMEDIATE RELEASE | April 30, 2009
Contact Info for each organization below with each quotation
