Category Access to Medicine

Manufacturing for Export: A TRIPS-Consistent Pro-Competitive Exception

[Carlos M. Correa and Juan I. Correa] The paper discusses the flexibilization of the sui generis system of supplementary protection certificates (SPCs) under European law recently introduced to allow for the manufacturing, stockpiling and export of covered products. Against this background, it examines the viability under the Agreement on Trade-related Aspects of Intellectual Property Rights (the TRIPS Agreement) of an exception allowing for the manufacture and export of patent-protected products. It concludes that such an exception would promote competition and enhance access to medicines (including biologicals) for the general public while being consistent with Article 30 of the TRIPS Agreement if read in accordance with the principles of interpretation of customary international law.

Civil Society’s Meaningful Engagement in the Patent System for a More Profound Real-World Impact

[Muhammad Zaheer Abbas] Abstract: The current COVID-19 pandemic has put the problem of equitable access to health technologies in the limelight because governments across the globe are struggling to meet the health needs of their populations. Patent exclusivities add to the cost of healthcare by allowing supra-competitive prices of protected technologies. There is a pressing need to mobilize all means and resources to promote price-reducing generic competition. Civil society organizations can make an enormous difference by successfully opposing questionable patents. Patent opposition is an administrative safeguard which procedurally enables community organizations to play this crucial role as defenders of the public interest. This paper supports the adoption of the patent opposition procedural safeguard as it provides civil society organizations with an affordable and practically feasible mechanism to challenge validity of questionable patents.

Inequitable by Design: The Law and Politics of Global COVID-19 Vaccine Access – And a Way Out

[Ximena Benavides] Abstract: ...This Article analyzes the power dynamics of vaccine manufacturing and distribution of U.S. pharmaceutical companies in the context of global COVID 19 vaccination. Drawing on the health-justice and law-and-political-economy scholarship of the last decade, this Article demonstrates how a “patent culture” shaped by intellectual property law fundamentally neglects health-equity principles as it politicizes healthcare access. These contemporary frameworks suggest that the global COVID-19 vaccine-access problem is the result of avoidable policy choices of big manufacturers and affluent governments. Despite a long history of inequities in access to healthcare, policy choices—as predicted by Hart’s inverse equity theory—have favored a purposely inequitable-by-design vaccination program driven by the wealth and power of those allowed to control vaccine production and supply globally.

WHO and MPP Announce Agreement with NIH for COVID-19 Health Technologies

[Medicines Patent Pool] WHO’s COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool (MPP) today finalised a licensing agreement with the United States National Institutes of Health (NIH) for the development of several innovative therapeutics, early-stage vaccines and diagnostic tools for COVID-19. The licences, which are transparent, global and non-exclusive, will allow manufacturers from around the world to work with MPP and C-TAP to make these technologies accessible to people living in low- and middle-income countries and help put an end to the pandemic. The 11 COVID-19 technologies offered under two licences include the stabilised spike protein used in currently available COVID-19 vaccines, research tools for vaccine, therapeutic and diagnostic development as well as early-stage vaccine candidates and diagnostics.

19 Vaccines as Global Public Goods: Between Life and Profit

[Katiuska King Mantilla and César Carranza Barona] Abstract: In the context of a health emergency like the COVID-19 pandemic, the global availability of and access to vaccines are imperative. This research paper provides an analysis from the perspective of international political economy, of the financing of COVID-19 vaccines and of the market strategies adopted by some of the companies that developed them. It notes that the development of vaccines was supported by substantial public funding from countries that later received preferential access to those vaccines through advance purchases. Despite such public support, the vaccines were not deemed as public goods but remained under the control of their developers.

An Examination of Selected Public Health Exceptions in Asian Patent Laws

[Kiyoshi Adachi] This study examines the variations within Asia of two exceptions to patent rights that are commonly justified under Article 30 of the World Trade Organization (WTO) Agreement on Trade-related Aspects of Intellectual Property Rights (the TRIPS Agreement), namely the research and experimentation exception and the regulatory review (or “Bolar”) exception. Both these exceptions are important in the context of the 2001 Doha Declaration on the TRIPS Agreement and Public Health insofar as they are designed to provide flexibility to protect public health and support countries’ overall scientific and technological aspirations. The study examines, from a comparative perspective, examples of these respective exceptions in patent legislation in South, Southeast and East Asia, and identifies peculiarities in the variations among countries in these sub-regions.

What Is the Impact of Intellectual Property Rules on Access to Medicines? A Systematic Review

[Brigitte Tenni, Hazel V. J. Moir, Belinda Townsend, Burcu Kilic, Anne‑Maree Farrell, Tessa Keegel and Deborah Gleeson] Abstract: It is widely accepted that intellectual property legal requirements such as patents and data exclusivity can affect access to medicines, but to date there has not been a comprehensive review of the empirical evidence on this topic. The World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires Member States to implement minimum standards of intellectual property protection including patents for pharmaceutical products, but also contains ‘flexibilities’ designed to address barriers to access to medicines. National intellectual property laws can also include TRIPS-plus rules that go beyond what is required by TRIPS. We aimed to systematically review literature that measures the impact of intellectual property rules on access to medicines, whether implemented as a result of TRIPS, TRIPS-plus provisions in other trade agreements, or unilateral policy decisions.

Reverse Payment: A Comparative Study

[Garry Gabison and Zaakir Tameez] Abstract: This Article compares reverse payment settlements, also known as pay-for-delay deals, in the United States and Europe. These deals occur where a branded drug manufacturer sues, settles with, and pays a generic manufacturer to delay the entry of its generic. Unlike the United States, which has a decentralized drug purchasing system, European healthcare systems such as those in France and the United Kingdom wield monopsony buying power over drugs. We investigate whether regulator and monopsony power can neutralize these anticompetitive agreements.

Lessons From the Pandemic for LDCs: Implementing Intellectual Property Flexibilities

[Sangeeta Shashikant] The global crisis of COVID-19 has underscored the vital importance of utilizing, to the fullest extent, policy space in the area of intellectual property. Since the onset of the pandemic, many countries around the world have had to confront various challenges of access including to tools protected by intellectual property (IP). These include copyrighted materials as learning shifted to online platforms, and affordable health products and technologies to prevent and treat the infection. The pandemic has also accentuated the significance of local production as limited supplies of critical commodities are rapidly snapped up by developed countries. Since March 2020, the least developed countries (LDCs) have perhaps struggled the most with limited financial resources, facilities and technological capacity to contain the pandemic and deal with its socioeconomic impacts.

Statement on the Leaked Covid-19 TRIPS Waiver Proposal

[Sean Flynn] The proposal to reach an agreement on a TRIPS waiver is a bit of a misnomer since it largely affirms and adds new requirements to TRIPS rather than waive its provisions. The proposal fails to accept the requests of researchers and access to knowledge organizations that the waiver extend to all intellectual property for vaccines, treatments and devices needed to combat COVID.

The WTO TRIPS Waiver and Essential Security Rights in 2022

[Dr. Alexander Beyleveld] Almost two years have passed since the start of the COVID-19 pandemic, and we are still far from bringing the pandemic to an end. One of the main reasons for this is the fact that large vaccine inequities remain worldwide. In order to address this problem, a large subset of World Trade Organization (WTO) members are in favour of waiving certain obligations contained in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement). Against this backdrop, this article contemplates the legal necessity of such a waiver given that Article 73 of the TRIPS Agreement contains essential security exceptions which may render the obligations in question inapplicable under the interpretation that the pandemic affects law and public order interests.