NAFTA provisions on enforcement of intellectual property rights
In looking at how enforcement norms are being changed in ACTA, it is helpful to review the enforcement chapter of NAFTA.
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ACTA: the new institution
KEI has access to yet undisclosed sections of the negotiating ACTA text. The text is organized in 6 chapters. The longest is Chapter 2 on “legal framework for enforcement of intellectual property rights.” The second longest is Chapter 5, on “Institutional Arrangements.” In ten pages of text, the ACTA negotiators have set out a plan to create a new institution to administer, implement and modify ACTA. Continue Reading
PhRMA’s asks regarding special 301, drug pricing and reimbursement
Below 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
Medical professional and patient group funding by drug and medical device companies
2010
- Amy T Wang, Christopher P McCoy, Mohammad Hassan Murad and Victor M Montori, “Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review,” British Medical Journal, cite as BMJ 2010;340:c1344, doi:10.1136/bmj.c1344, 18 March 2010.
Jeffrey Kindler rewarded by Pfizer for his influence with governments
On July 28, 2006, Jeffrey Kindler replaced Hank McKinnell as CEO of Pfizer. That day the Pfizer stock price closed at $26.11. With the stock trading today at a little more than $17, it would seem that shareholders have lost a significant amount of their investment. Nonetheless, Kindler is doing well.
PhRMA’s revolving door
The following are a few notes on PhRMA’s revolving door with the federal government.
Billy Tauzin. Former member of Congress from Louisiana.
Chris Singer. Previously served as a professional staff member for the U.S. House Appropriations Committee.
Brian Toohey. Former Desk Officer and Deputy Director in the European Office of the U.S. Department of Commerce.
Six Myths about the treaty for people with disabilities that should be debunked next week?
Next week (March 8-12) delegates from various developing countries will gather in Washington, DC for a week long “INTERNATIONAL TRAINING FOR DEVELOPING COUNTRIES AND COUNTRIES IN TRANSITION ON EMERGING ISSUES IN COPYRIGHT AND RELATED RIGHTS AND ISSUES PERTAINING TO BLIND AND VISUALLY IMPAIRED PERSONS” co-organised by the US Copyright Office and WIPO. We hope that at least 6 Myths about the treaty for people with disabilities proposed by Brazil, Ecuador and Paraguay will be clearly debunked once and for all during the training.
Indian NGOs confront GWU Law School efforts to push maximalist IPR norms in India
The ties between Universities and businesses are often complex and blurred. Private companies or trade associations fund research and seminars, and have consulting relationships with faculty members, trying to shape public policy and judicial decisions on a wide range of issues. A particularly interesting industry/university connection concerns something called the “India Project,” that is associated with the George Washington University (GWU) Law School.
Copyright lobby (IIPA) demands that USTR punish governments who ‘consider’ mandating open source software
On February 18, 2010, the International Intellectual Property Alliance (IIPA), a trade association whose members include the Business Software Alliance (BSA), the Motion Picture Association of America (MPAA) and the Recording Industry Association of America (RIAA) prepared a 498 page submission to the Office of the United States Trade Representative (USTR) detailing their concerns with 39 countries or territories which the IIPA believed were not providing adequate and effective protection of their Continue Reading
PhRMA pushes for data exclusivity in 2010 Special 301 comments
The 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.