Malini Aisola's blog

Agenda of 10th Round ACTA negotiations, August 16-20, Washington DC

USTR will host the next round of ACTA negotiations that will take place all of next week, August 16-20, in Washington DC. According to USTR yesterday, the negotiators "expect to cover all issues" and the agenda would be made available in a day or so.

Here is a proposed agenda that we have obtained from another source.

ANTI-COUNTERFEITING TRADE AGREEMENT (ACTA)
PROPOSED AGENDA
10th Round of Negotiations
August 16th-20th, 2010, Washington, DC

ACTA's Washington DC conclave: Is this Round 10?

According to an informed source, USTR intimated that next week's ACTA meeting in Washington DC will be attended by all the negotiating parties and that discussions would include all issues under consideration in ACTA. We are still awaiting a response from USTR regarding the attendees, scope and purpose of the meeting but this new information seems to be indicative of nothing short of the next ACTA round.

Earlier, US government officials had informed that the an intersessional meeting would be held the week of 16 August in Washington DC.

ACTA briefing by De Gucht in the European Parliament

This week, the European Commission conducted two briefings for members of the European Parliament.

On Monday, July 12, members of the European Parliament's INTA Committee (Committee on International Trade) were briefed by EU ACTA negotiators Luc Devigne and Pedro Valesco in a private, closed meeting.

Today, July 13, Karel De Gucht, EU Commissioner for Trade held a public briefing in the LIBE Committee (Committee on Civil Liberties, Justice and Home Affairs). The video is now available here

WIPO 1988 documents of the Committee of Experts on Measures Against Counterfeiting and Piracy

WIPO documents related to the April 25-28, 1988 session of the Committee of Experts on Measures Against Counterfeiting and Piracy are available here.

The consolidated file includes an agenda, a February 18 document on "Model Provisions for National Laws" (document C&P/CE/2), a February 18 memorandum on "Provisions in the Paris, Berne and Neighboring Rights Conventions" (document C&P/CE/3), and a report of the meeting that was adopted on April 28, 1988.

Comments and signatories sought for communique on ACTA and the public interest

This week, over 90 academics, practitioners and public interest organizations from five continents gathered at a meeting convened by American University's Program on Information Justice and Intellectual Property (PIJIP) to analyze the official text of the Anti-Counterfeiting Trade Agreement (ACTA). The text was released for the first time in April, 2010, after years of secretive negotiations.

WTO responds to concerns of the European Parliament on ACTA

In a letter dated 4 May 2010, the Director General of the World Trade Organization (WTO), Pascal Lamy has responded to questions and concerns of the European Parliament regarding the Anti Counterfeiting Trade Agreement (ACTA).

ACTA New Zealand meeting agenda

The 8th round of the Anti Counterfeiting Trade Agreement (ACTA) negotiations is scheduled to take place in Wellington, New Zealand from April 12-16, 2010. The March 3 draft agenda obtained by KEI provides details of the program, venue and logistics, and also notes that:

New Zealand intends to hold a function for stakeholders and delegates on the evening of Tuesday 13 April from 18.00, which will be an opportunity for stakeholders to meet and interact with ACTA negotiators.

The USPTO-Pfizer collaboration to change India's laws on patents and test data

The United States Patent and Trademark Office has a joint program with Pfizer to fund and manage seminars in India on "misconceptions of evergreening" and "the importance of regulatory data protection and patent linkage." KEI has submitted a FOIA request to USPTO on this topic, and received a small installment of documents on Friday. Attached to this blog are 4 pages of documents that we received from two meetings held in Mumbai, India on September 9, 2009. Ten journalists and 15 NGOs attended the meetings.

USTR responds to Senator Wyden's letter on ACTA

Ambassador Ron Kirk has issued a response to Senator Wyden's letter dated January 6, 2010. The official press release from Senator Wyden's office follows:

U.S. Senator Ron Wyden

FOR IMMEDIATE RELEASE CONTACT: Jennifer Hoelzer (Wyden): (202) 224-3789
March 2, 2010

Wyden Gets Some Answers on ACTA Negotiations

USTR Responds on Range of Issues, including Internet Access and Drug Sales

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.

Dec 9, 2009 Wikileaks documents related to the WHO EWG

On December 9, 2009, Wikileaks posted five sensitive documents related to the WHO Expert Working Group (EWG) on R&D Financing:

  • a non-public draft report of the WHO EWG
  • a non-public Comparative Analysis done by the EWG
  • the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Overview of the EWG Comparative Analysis
  • an IFPMA summary slide on the EWG Draft Report
  • Open Letter to the WHO EB from Cecilia López Montaño, EWG member

    The following is a letter sent by Cecilia López Montaño, a member of the WHO Expert Working Group on R&D Financing to the WHO Executive Board:

    Bogotá. Colombia. January 15th 2010

    Dear members of the Executive Board:

    I am Cecilia López Montaño, senator of the Colombian Congress and member of the Expert Working Group on Research and Development Financing of the World Health Organization, in representation of the point of view of developing countries, I assume.

    A closer look at the WHO EWG endorsed proposals on funding product development partnerships

    The World Health Organization's Expert Working Group on R&D Financing spent scant attention on how to raise money, but showed considerable interest in how to spend it. The clear favorite approach is to give grants to product development partnerships -- the approach that has now become the most conventional approach, and one not surprisingly endorsed by the PDPs themselves, and also by the Gates Foundation and the IFPMA -- two groups that are often seen as devoted to protecting the status quo in terms of intellectual property and business models for innovation.

    Senator Wyden's letter to the USTR on ACTA

    Senator Wyden has written to the USTR posing 11 questions aiming to clarify the specific objectives of the Anti Counterfeiting Trade Agreement (ACTA). The next round of negotiations are scheduled to take place in Mexico during the week of January 25. The letter is available here.

    EU proposal calls for deletion of "treaty" for persons with disabilities at SCCR 19

    Below is the language of paragraph 7 of the draft conclusions of SCCR 19 contained in the "Draft Conclusions Version 2.0" document distributed this morning:

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