Category Access to Medicine

A Review of WTO Disputes on TRIPS: Implications for Use of Flexibilities for Public Health

[Nirmalya Syam] The use of TRIPS flexibilities by WTO members involves interpretation of the obligations under TRIPS which can be challenged under the WTO dispute settlement system. Mutually agreed solutions, panel or Appellate Body decisions adopted in such disputes can thus impact the scope of TRIPS flexibilities to address, among others, public health objectives. This paper explores how the WTO dispute settlement system applies to disputes under TRIPS, and reviews the outcomes of the disputes relating to the implementation of TRIPS obligations in the context of pharmaceutical products.

The Right to Health in Pharmaceutical Patent Disputes

[Emmanuel Kolawole Oke] This paper examines how the courts in three developing countries (Kenya, South Africa, and India) have addressed the tension between patent rights on pharmaceutical products and the right to health. The paper begins by examining the nature of the relationship between patent rights and the right to health. It thereafter explores the justiciability of the right to health in Kenya, South Africa, and India. Furthermore, the paper provides an analysis of how the courts in these three developing countries have adjudicated some of the pharmaceutical patent cases involving tensions between the right to health and patent rights. The paper contends that by incorporating the right to health into the adjudication of patent disputes, courts in developing countries can play a crucial role in improving access to medicines at affordable prices.

Mainstreaming Public Health Considerations in Adjudication of Intellectual Property Disputes: Implications of Specialized IP Courts and General Courts

[Justice (Retd.) Prabha Sridevan] How can the public interest dimension be considered in the adjudication of intellectual property (IP) disputes, in particular those concerning patents on health technologies such as medicines and vaccines? This is the main question addressed by Justice (Retd.) Prabha Sridevan, former Judge of the Madras High Court and former Chairperson of the Intellectual Property Appellate Board (IPAB) of India, as an expert facilitator, at the Asian Regional Course for Judges on Intellectual Property and Public Health organized by the South Centre in August 2021. Justice Sridevan addressed the pros and cons of adjudication through specialized courts vis-à-vis general courts.

A TRIPS-COVID Waiver and Overlapping Commitments to Protect Intellectual Property Rights Under International IP and Investment Agreements

[Henning Grosse Ruse-Khan and Federica Paddeu] This paper considers legal implications that are likely to emerge from the implementation of a TRIPS Waiver decision. Assuming that a Waiver is adopted in the form presented in the May 2021 proposal by South Africa and India et al, we review the interaction between the Waiver and other commitments to protect IP rights under international IP and investment treaties. Our principal research question is to analyze whether domestic measures implementing the Waiver are compatible with the implementing State’s other obligations to protect IP rights established under multilateral IP treaties, IP and Investment Chapters of FTAs as well as BITs.

Utilising Public Health Flexibilities in the Era of COVID-19: An Analysis of Intellectual Property Regulation in The OAPI and MENA Regions of Africa

[Yousuf A. Vawda and Bonginkosi Shozi] Abstract: The paper explores the unique approaches to IP protection in the countries belonging to the Organisation Africaine de la Propriété Intellectuelle/African Intellectual Property Organization (OAPI) and the Middle East and North Africa (MENA) regions; the limited extent to which legal and policy frameworks with regard to TRIPS flexibilities have been adopted and implemented in pursuit of access to medicines in those countries; and makes recommendations in order to optimise the use of the flexibilities in advancing public health objectives. In the context of the COVID-19 pandemic, the impact of IP rights on access, and some approaches to countering the challenges to access are also discussed.

The proposal for waiver of WTO’s TRIPS Agreement to prevent, contain and treat COVID-19: investigating the benefits and challenges for low- and middle-income countries

[Sanath Wijesinghe, Chaminya Adikari, and Ruwanthika Ariyaratna] Abstract: This article examines the benefits of the TRIPS waiver for low- and middle-income countries with particular reference to the challenges that these countries may face in the manufacturing and purchasing stages of COVID-19 vaccines. We assess arguments for and against the TRIPS waiver and suggest actionable solutions that could be provided by global policy actors to enable low- and middle-income countries to overcome such challenges.

Vaccines, Medicines and COVID-19: How Can WHO Be Given a Stronger Voice?

[Germán Velásquez] The considerable health, economic and social challenge that the world faced in early 2020 with COVID-19 continued and worsened in many parts of the world in the second half of 2020 and into 2021. How can an agency like WHO be given a stronger voice to exercise authority and leadership? This book is a collection of research papers produced by the author between 2020 and early 2021 that helps answer this question. The topics address the state of thinking and debate – particularly with regard to medicines and vaccines – that would enable a response to this pandemic or subsequent crises that may emerge.

Competition Law and Access to Medicines: Lessons from Brazilian Regulation and Practice

[Matheus Z. Falcão, Mariana Gondo and Ana Carolina Navarrete] Competition law may play an important role in drug pricing control by containing high prices derived from economic violations. Since the use of competition tools is not limited by the TRIPS Agreement or other international binding disciplines, there is ample policy room to explore how countries, especially in the Global South, can benefit from strengthening their jurisdiction on that matter.

Potential Claims related to IP and Public Health in Investment Agreements: COVID-19, the Proposed TRIPS Waiver and Beyond

[Cynthia Ho] An under-examined issue during the COVID-19 crisis is the potential liability of countries under investment agreements for taking steps to mitigate COVID issues.  This Policy Brief provides an overview of how countries may be liable to companies for taking domestic action to protect public health, including pre-COVID claims related to Intellectual Property (IP), as well as possible claims because of COVID emergency measures, including claims that could result if the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) Waiver was adopted.  The current COVID-19 crisis opens the opportunity to consider and reevaluate the unnecessary threat of international agreements that allow for investment claims and potentially consider their termination.

Copyright in the Time of COVID-19: An Australian Perspective

[Amanda Bellenger and Helen Balfour] Abstract: COVID-19 has raised many challenges in terms of applying Australian copyright legislation and related policies to higher education context. This paper describes the experience of Copyright Officers at Curtin University and Murdoch University from the initial stages of border-control measures affecting delivery of learning materials to students in China, to the wider disruption of the pandemic with many countries implementing lockdown measures, to the current environment where remote delivery is the “new normal.”

Waive Intelletual Property rights and Save Lives

[Srividhya Ragavan] In October of 2020, when India and South Africa proposed a waiver from certain provisions of the TRIPS agreement, it was meant to increase local manufacturing capacity in these countries... The waiver has an additional role to play in the larger trade schema. In enabling vaccination of populations across the globe, the waiver would be critical to normalize global trade.

Vaccine Knowledge Needs to Be a global Public good

[Ellen 't Hoen] The global health crisis caused by the COVID-19 outbreak has laid bare the lack of an effective mechanism for the sharing of IP and technology required to produce the diagnostics, therapeutics and vaccines to respond to the pandemic. The WHO established, in May 2020, well before the first vaccines came to market, the COVID-19 Technology Access Pool (C-TAP): a mechanism to allow the sharing of the IP, knowhow, data and technology that are needed to meet the global need for 11 billion doses of COVID-19 vaccines, as well as diagnostics and treatments. Companies have so far refused to collaborate with C-TAP, citing the age-old talking point that sharing IP is detrimental to future investments in pharmaceutical innovations – even though the development of COVID-19 vaccines has been de-risked with unprecedented amounts of public financing.