On Wednesday, May 18, 2011, eight civil society organizations submitted joint comments and recommendations on the Trans-Pacific Partnership Agreement (TPPA). The document covers five broad areas including transparency, general public health safeguards, patent provisions, enforcement provisions, and pharmaceutical pricing provisions, and was distributed to US Government officials in the Department of Commerce, Office of the US Trade Representative, US Patent and Trademark Office, Department of State and Department of Health and Human Services as well as various Congressional offices.
Briefly, these comments and recommendations included:
- Versions of the negotiating text for the intellectual property chapter, and any other sections of the text that will impact health and access, should be made public once they have been widely circulated to the parties in the negotiation
- Parties to the negotiations should invite public comment on the text of the agreement, including areas that could be extended to incorporate positive measures to improve health
- Parties to the negotiations should provide access to the negotiating venues
General Public Health Safeguards
- The US should not propose norms requiring parties to the negotiation, particularly developing countries, to adopt levels of patent protection that exceed those required by the WTO TRIPS Agreement
- US should recognize flexibilities and goals acknowledged in the Doha Declaration on the TRIPS Agreement and Public Health and the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property
- Norms that prejudice access to medical technology or care should not be part of a mandatory protocol
- US should not impose obligations concerning subject matter or standards for the granting of patents
- US should not require TPPA members to create systems of exclusive rights to rely on test data to register new drugs and vaccines
- Patent linkage is not an appropriate intellectual property norm
- US should not require TPPA parties to enact or extend patent terms beyond what is required in TRIPS
- Procedures for addressing challenges to patentability should be left to each individual country
- Parties to the TPPA should not be required to ratify or accede to the Patent Cooperation Treaty of 1970
- Parties to the TPPA should not be required to “make all reasonable efforts” to ratify or accede to the Patent Law Treaty of 2000
- Ex-officio border measures, particularly those concerning in-transit merchandise, are inappropriate enforcement mechanisms
- Presumptions regarding patent validity are best determined by the national legislation of each individual country rather than imposition of a one-size-fits-all regime
- The use of suggested retail price or “other legitimate measure of value submitted by the right holder” may not be the most appropriate mechanism to determine damages for IP infringement
Pharmaceutical Pricing Provisions
- The US should not seek to include pharmaceutical pricing provisions in the TPPA
KEI co-signed these comments with MSF, HAI Global, Health GAP, Oxfam America, Public Citizen, and UAEM. The National Legislative Association on Prescription Drug Prices joined the portion of the comments dealing with recommendations regarding potential pharmaceutical pricing provisions in the TPPA.
On the other side of these recommendations, one day prior to this joint civil society submission, a group of 28 senators, led by Senator Orrin Hatch (R-Utah) and Senator Maria Cantwell (D-Wash), sent a letter to President Obama calling for “the highest standards of protection for intellectual property rights” in the TPPA. Senators Hatch and Cantwell were joined by Republicans John Thune (SD), Scott Brown (MA), Dan Coats (IN), Jon Kyl (AZ), Chuck Grassley (IA), John Cornyn (TX), Tom Coburn (OK), John Barrasso (WY), Richard Lugar (IN), Rob Portman (OH), Mike Enzi (WY), Mark Kirk (IL), Pat Roberts (KS), Marco Rubio (FL), Pat Toomey (PA), Roger Wicker (MS), Roy Blunt (MO), Richard Burr (NC) and Democrats Chris Coons (DE), Joe Lieberman (CT), Mark Udall (CO), Patty Murray (WA), Michael Bennet (CO), Mark Pryor (AK), Tom Carper (DE), and Mark Warner (VA).
These senators cited expectations that the TPPA will be expanded to include new countries in Asia that are not currently parties to the negotiation, as well as that the TPPA is expected to create norms for future trade agreements, as reasons for implementing strong IP provisions. The letter argues for strong IP provisions that build of the US-Korea Free Trade Agreement (KORUS) and “must be clear, specific and enforceable . . . [and] must also be applicable to all TPP participants without exception.” Furthermore, the letter directly states that “Biopharmaceutical innovators . . . are disadvantaged in countries where the regulatory data protection rules and patent enforcement rules do not reflect standards of protection similar to those found in U.S. law.”
The letter by the 28 Senators thus urges for aggressive and enforceable IP provisions to be included in the TPPA “without exception” and shows a deep disregard for public health safeguards or the development concerns for low- and middle-income countries.
Given the fact that the TPPA is expected to be expanded to include other countries that are not currently party to the negotiations and set precedents for future trade agreements, it is absolutely critical for the US Government to ensure that the negotiations are handled in a more transparent manner and to seriously consider the public health concerns. The norms that emerge from the TPPA will greatly impact not only the health and lives of those residing in the current TPPA negotiating countries, but to those well beyond their borders. Members of both the U.S. Legislative and Executive branches should keep these public health concerns in mind as they consider the provisions of the TPPA and other trade agreements.