Category Trade Agreements

The TRIPS Agreement Article 73 Security Exceptions and the COVID-19 Pandemic

[Frederick Abbott] Abstract: The COVID-19 pandemic has caused Governments to contemplate measures to override patents and other intellectual property rights (IPRs) in order to facilitate production and distribution of vaccines, treatments, diagnostics and medical devices. This paper discusses whether the COVID-19 pandemic may be considered an “emergency in international relations” and how WTO Member States may invoke Article 73 (“Security Exceptions”) of the TRIPS Agreement as the legal basis for overriding IPRs otherwise required to be made available or enforced. It concludes that the pandemic constitutes an emergency in international relations within the meaning of Article 73(b)(iii) and that this provision allows Governments to take actions necessary to protect their essential security interests.

European Commission Trade Policy Review Includes a Request for Comments on The Digital Transition and Technological Development

Thanks to Ante Wessels for calling to my attention to an EU Trade Policy Review, which aims "to build a consensus around a fresh medium-term direction for EU trade policy, responding to a variety of new global challenges and taking into account the lessons learned from the coronavirus crisis." The review includes a request for comments from the public, with submissions due September 15.

How did fair use get into the Korean Copyright Act?

As I explained in my previous blog post, the open-ended fair use clause in the Korean Copyright Act (“KCA”) was introduced in 2011 in the course of implementing the Korea-US FTA (“KORUS”). Yet, this does not mean that KORUS mandates legislation of fair use. Instead, KORUS restricts the scope of fair use. Footnote 11 of KORUS §18.4:1 mentions fair use, but it’s purpose is to make clear that any limitation or exception to the reproduction right to temporary storage is restricted to the controversial three-step test, and even when Korea or the US introduces or maintains fair use, the three-step test prevails... Therefore, it is fair to say that the fair use clause of KORUS is a sort of by-product produced in a way that Korean government blinds dark sides of the overly expansive KORUS protection of copyright in temporary storage.

South Centre Policy Brief 76: Evolution of Data Exclusivity for Pharmaceuticals in Free Trade Agreements

[Wael Armouti] Abstact: Free trade agreements (FTAs) introduce higher intellectual property (IP) protection than those established in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS-plus provisions) that deprive the parties from benefits of the use of flexibilities found in the TRIPS Agreement to protect public health. One such TRIPS-plus requirement is that of data exclusivity. It establishes that the government should provide an exclusivity period for the test data developed by the originator company, on the grounds of an incentive rationale and considerations of fairness. The negative impact of the data exclusivity approach in developing countries means that the entry of cheap generic products is delayed, even under a compulsory license, which will affect access to affordable medicines. Countries that have already signed the FTAs can mitigate its effects on public health by limiting the scope of and providing exceptions to data exclusivity in national legislation.

USTR Should Seek Language in the Upcoming US-Kenya Trade Agreement That Protects the Right to Research

... U.S. negotiating objectives should be interpreted to include protection of the right to research, as it is a protection granted under U.S. law. The U.S. should negotiate language in the intellectual property chapter of the US-Kenya Trade Agreement that protects the right to research. The Covid-19 pandemic has highlighted the need for researchers to access to the latest scientific knowledge, as well as access the underlying data. In recent months, publishers have temporarily opened access to a range of scientific publications in order to provide researchers around the world with the information they need to search for treatments and vaccines for this one grave disease. But researchers’ need for access to previous scientific works is not new, and it is not temporary. When the current pandemic has run its course, researchers everywhere will still need access to the world’s stock of scientific knowledge in order to meet other challenges.

Eighteen Years After Doha: An Analysis of the Use of Public Health TRIPS Flexibilities in Africa

[Yousuf A Vawda and Bonginkosi Shozi] Abstract: As we observe the 18th anniversary of the Doha Declaration on the TRIPS Agreement (Agreement on Trade-Related Aspects of Intellectual Property Rights) and Public Health, it is appropriate to take stock of intellectual property developments and endeavour to present a comprehensive account of the situation in the African continent in respect of the implementation of TRIPS flexibilities, specifically those regarding access to medicines. This research paper provides an overview of the extent to which selected African countries have adopted legal and policy frameworks with regard to TRIPS flexibilities, examines the actual use of these flexibilities in enabling access to medicines in those countries, and suggests some recommendations for optimising the use of the flexibilities in pursuing public health imperatives.

Letter to the Prime Minister of India from Organisations and Experts Working on Access to Healthcare and Medicines

[34 Civil society groups and individuals] ... we are concerned with demands of the United States to do away with the price controls on medical devices as part of the ongoing negotiations on US India trade deal. We are also apprehensive of the US pressure on India, which has been exerted continuously and will surely intensify following the deal, for increased intellectual property (IP) protections through amendments to the IP Acts. In this regard, we note that the Department for Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce and Industry, recently held a meeting with stakeholders to review India’s existing IP Acts. During the meeting participants from law firms representing their foreign multinational pharmaceutical companies have insisted on removing public interest safeguards in the Patents Act such as provisions restricting the scope of patentability, local working as a ground for granting of a compulsory license, pre-grant oppositions etc.

Analyzing the Impact of Trade and Investment Agreements on Pharmaceutical Policy: Provisions, Pathways and Potential Impacts

[Deborah Gleeson, Joel Lexchin, Ronald Labonté, Belinda Townsend, Marc-André Gagnon, Jillian Kohler, Lisa Forman, and Kenneth C. Shadlen] Abstract: Trade and investment agreements negotiated after the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have included increasingly elevated protection of intellectual property rights along with an expanding array of rules impacting many aspects of pharmaceutical policy. Despite the large body of literature on intellectual property and access to affordable medicines, the ways in which other provisions in trade agreements can affect pharmaceutical policy and, in turn, access to medicines have been little studied. There is a need for an analytical framework covering the full range of provisions, pathways, and potential impacts, on which to base future health and human rights impact assessment and research.

Report and Webinar: Rethinking Trade Treaties & Access to Medicines

The Boston University Global Development Policy Center is hosting a webinar on Wednesday, November 13 from 9-11AM to launch the latest GDP Center report Rethinking Trade Treaties and Access to Medicines: Toward a Policy-Oriented Research Agenda hosted by the Trade & Medicines Working Group. The report synthesizes the state of knowledge on trade and investment treaties on access to medicines and advances a policy oriented research agenda intended to help policy-makers, civil society, and others make more informed decisions as they debate contemporary trade and investment treaties.

How Will Recent Trade Agreements that Extend Market Protections for Brand-Name Prescription Pharmaceuticals Impact Expenditures and Generic Access in Canada?

[R.F. Beall, L. Hardcastle, F. Clement and A. Hollis] Abstract: Canada recently entered into two multinational trade agreements (i.e., the Canada, United States, and Mexico Trade Agreement; and the Comprehensive Economic and Trade Agreement with the European Union). The resulting federal policy changes will prolong periods of market protection afforded to eligible brand-name prescription drugs by extending competition-blocking patent and data exclusivity terms. While previous studies have analysed these two policy changes in isolation, it remains unknown what the total combined impact will be in a typical year.