On 19 May 2010, Global Health Progress (GHP) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) hosted a luncheon at the Vieux Bois in Geneva on the margins of the 63rd World Health Assembly for a targeted audience of over 90 persons including Ministers of Health, Ambassadors and senior officials from the Africa.
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
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.
In the United States, tax exempt non-profit organizations are subject some some requirements for financial disclosure via the IRS form 990, which is available to the public. The disclosure requirements cover most U.S. based trade associations, including the Pharmaceutical Research and Manufacturers of America (PhRMA), the trade association for some 28 "member" companies.
According to a report by Duff Wilson in the Sunday New York Times, Much of PhRMA's $150 million in advertising will be spent pushing Senator Baucus's version of the health "reform" legislation.
Wednesday, 09 July 2008
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) ANTI-COUNTERFETING TRADE AGREEMENT (ACTA) COMMENTS
March 21, 2008
The following discusses the 2009 PhRMA submission for the USTR Special 301 list on Thailand. Thailand is one of three Asian countries (China, Philippines and Thailand) that were singled out by PhRMA for the harshest treatment. The submission on Thailand covers several topics, including these:
One of the more aggressive PhRMA submissions to the USTR Special 301 list is the section on the Philippines. Excerpts, which are given below, illustrate the breath of PhRMA’s demands on the USTR.
These are a few quick points about the PhRMA submission.
1. PhRMA asks that ACTA “Establish liability for Internet Service Providers and Other Operators that Facilitate Trade in Counterfeit Medical Products.”
This is potentially quite an important and controversial recommendation. PhRMA wants to make telecommunications companies liable if one of their customers sells counterfeit products.
Richard Kjeldgaard, a former Senior Counsellor in the Biotechnology and Genetic Resources Division of the World Intellectual Property Organization (WIPO) and now employed by the U.S. based Pharmaceutical Research and Manufacturers of America (PhRMA) performed his role as “bouncer” admirably today at a luncheon organized by the Biotechnology Industry Organization.