In a stunning 633 to 13 vote, the EU Parliament voted for a resolution on ACTA that addresses a wide range of criticisms that civil society groups have made of the process and substance.
The KEI statement on the EU vote follows:
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.
On January 6, 2010, Senator Ron Wyden sent a letter to the USTR asking a number of questions about the U.S. negotiating objectives in ACTA. On February 28, 2010, USTR responded. The USTR response focused mostly on the official U.S. “asks,” rather than the state of the negotiating text, which also reflects also the views of other parties. For this reason, the USTR letter to Wyden only tells part of the story about what ACTA may do.
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.
On 12 February 2010, the Council of the European Union distributed a table drawn up by the Commission Services, outlining the positions of various counties regarding civil enforcement and the special requirements relating to the Internet. A copy of this 44 page document was leaked on March 1, 2010, and is attached to this blog. A text version of the table is available from swpat.org.
On 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 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:
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.
As mentioned, before WIPO is holding a symposium on February 8, 2010 on the “Evolution of the Regulatory Framework of Test Data – From the Property of the Intellect to the Intellect of Property”. The symposium will be held from 9:30 AM to 5 PM in Room B of WIPO headquarters.
The program of the symposium can be found here: http://www.wipo.int/edocs/mdocs/mdocs/en/wipo_ip_lss1_ge_10/wipo_ip_lss1_ge_10_inf_1_prov.pdf
After a around 10 hours of informal consultations today, it appears that the 14th session of the WIPO Standing Committee on the Law of Patents (SCP) has not reached consensus on new items for the Committee’s consideration. From sources close to the negotiation, much of the wrangling dealt with whether to preserve the non-exhaustive nature of the list of issues identified at SCP 12 and SCP 13. Continue Reading