Abstract: The challenge of providing access to high-priced patented medicines is a global problem affecting all countries. A decade and a half ago the use of flexibilities contained in the World Trade Organization Agreement on Trade Related Aspects of Intellectual Property Rights, in particular compulsory licensing, was seen as a mechanism to respond to high-price medicines for the treatment of HIV/AIDS in low- and middle-income countries. Today a number of upper-income European Union (EU) Member States are contemplating the use of compulsory licensing in their efforts to reduce expenditure on pharmaceutical products.
[Fifa Rahman and Joel Lexchin, The Malaysia Online, Link] On November 16, 2015 at the launch of the Intellectual Property Rights Index (IPRI) 2015 in Kuala Lumpur, IDEAS Malaysia, a libertarian think tank and proponent of the TPPA spoke about its October 2015 report “The Trans-Pacific Partnership: Seizing the Opportunities, Losing the Myths.”
IDEAS Malaysia attempted to debunk the legitimate concerns of the Malaysian AIDS Council, the World Health Organisation, Nobel prizewinner Médecins Sans Frontières (Doctors without Borders), the American Medical Students Association, among many other bodies working in public health and access to affordable medication, that TRIPS+ provisions in the TPP would reduce access to medicines and drive drug costs up. IDEAS, on the other hand, claims that there would be no increase in medicine prices under the TPP.
This morning, trade ministers from the twelve countries negotiating the Trans Pacific Partnership jointly announced that “we have successfully concluded the Trans-Pacific Partnership.” The U.S. Trade Representative has also released a summary of the agreement that has been reached.
Negotiations over data protection of biologic medicines held up the conclusion of the TPP for much of the weekend. According to the Wall Street Journal, the “complicated” deal requires countries to provide five years data exclusivity, and gives the option to use regulatory structures to grant additional exclusivity up to another three years. During the press conference this morning, USTR Froman said that the compromise recognizes all countries are committed to incentivizing innovation in this sector, but that they do this through different systems (see video).
At last week’s round of Trans Pacific Partnership (TPP) negotiations in Salt Lake City, access to medicines campaigners reported that the U.S. administration tabled a new proposal aimed at protecting brand name biologic drug companies from generic competition through a twelve year period of data exclusivity (a form of protection separate and in addition to patent protection already granted biologic products).
This proposal – if it becomes part of the final agreement – would lead to longer monopolies on expensive new medicines abroad, while blocking the administration’s own proposal to reduce the term of data exclusivity granted in the United States to seven years. Powerful groups in the U.S. have campaigned against it, while the industry and Congressional leaders have advocated for it.
The Hill reports that the American Association of Retired Persons (AARP) has sent a letter to the Obama Administration warning that it opposes the inclusion of a 12 year period of data exclusivity for biologic drugs in the Trans Pacific Partnership. The group’s State and National Group Executive Vice President Nancy LeaMond wrote in a letter to US Trade Representative (USTR) Michael Froman that “AARP strongly believes the final trade agreement should not bind the U.S. to a 12-year market exclusivity period for brand-name biologic drugs.”
[Forthcoming paper, Summer 2013, Currents International Trade Law Journal] Abstract: Countries may choose various methods of data protection in order to comply with the TRIPS Agreement. Policymakers should consider the effects of data exclusivity on prices and investment relative to other types of data protection. The data presented here suggest there is no relationship between whether or not a country has data exclusivity, and the amount of investment in the country by the pharmaceutical industry. On the other hand, empirical evidence in previous papers has shown that data exclusivity does drive prices higher.
Full paper available on SSRN at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2259797
Sen. Max Baucus (Chairman of the Senate Finance Committee) and Sen. Orin Hatch (the Committee’s Ranking Minority Member) wrote Acting U.S. Trade Representative Demetrios Marantis on March 22 asking for “comprehensive, strong, binding and enforceable” intellectual property protections in the Trans Pacific Partnership. Specifically, the letter from Sens. Baucus and Hatch asks that USTR seek “commitments from our trading partners that reflect the level of protection under U.S. law, for example 12 years of regulatory data protection for biologic pharmaceuticals.”
On March 1, the trade agreement negotiated among the European Union, Peru, and Colombia went into effect in the EU and Peru. The EC press office reports that Colombia is still in the process of ratifying the agreement, and is expected to complete ratification this year. The full text of the trade agreement is here – and the intellectual property provisions are found in Articles 202 through 257.
[Reposted from keionline.org] On Tuesday, 5 February 2013, the Secretariats of the World Health Organization (WHO), the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO) released their joint publication, Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade. This 251-page report covers a lot of ground.
In the words of secretariats, “The book’s focus is on advancing medical and health technologies (“innovation”) and ensuring they reach the people who need them (“accessibility”). A huge amount of analytical and factual material is available on access to medicines and other medical technologies, and on innovation. Here, it is brought together in one concise volume.”
[Reposted from kieonline.org] The World Trade Organization (WTO) held its fourth review of Israel’s trade policies and practices on 30 October 2012 and 1 November 2012. The review is based upon a report by the WTO Secretariat (WT/TPR/S/272) and a report by Israel (WT/TPR/G/272). According to the WTO, the minutes of the meeting and the questions and answers will be made available by the Secretariat in 6 weeks. The current chair of the Trade Policy Review Body (TPRB), Ambassador Eduardo Munoz Gomez (Colombia) highlighted agriculture, market access, contingency trade remedies, and incentives as issues meriting “further attention and reflection by the Israeli authorities, while we have taken note of the detailed comments by Israel this morning” (Source: Concluding remarks by Chairperson, http://wto.org/english/tratop_e/tpr_e/tp372_crc_e.htm).
Specifically, on intellectual property, the Chair noted that “Members took note of the significant developments in the area of intellectual property. However, a number of questions and remaining concerns over intellectual property protection were raised, particularly regarding patents, copyright, and enforcement”.
Health advocates have asked the EU not to include data exclusivity requirements in the “Deeply Comprehensive Free Trade Agreement” that is being negotiated between the EU and Moldova. Article 9 of the agreement is rumored to contain an obligation for at least eight years of data exclusivity, as is standard in other European trade agreements. The TRIPS Plus provision would prevent generic firms from gaining regulatory approval without repeating costly clinical trials, effectively keeping generics off the market.
A recent letter from Anna Zakowics (European AIDS Treatment Group) and Lella Cosmaro (AIDS Action Europe) to Trade Commissioner Karel De Gucht points out
I am a public health professional representing the organization Center for Health Policies and Studies (PAS), an NGO working in policy analysis and research in health in Moldova. In June 2012 we became aware of the intention of the government to change patent legislation by introducing data exclusivity as an additional IPR measure in addition to TRIPS provisions and started to inquire as to the origins of this initiative.
The Republic of Moldova, a country in the Eastern European region, has started in 2011 the process of confidential negotiations for Deep and Comprehensive Free Trade Agreement with the European Union (EU). In these negotiations the EU requires the Republic of Moldova to introduce in the national legislation data exclusivity as a new form of protection of intellectual property for the maximum period of 11 years (8+2+1). There was first round of negotiations where Moldova has opposed introduction of data exclusivity because of the impact on price of drugs, but the official answer of DG trade was that EU interpretation of unfair commercial use is in line with TRIPS agreement.