Towards a Development-Oriented TRIPS Review Under Article 71.1
By Nirmalya Syam
This paper calls for a comprehensive, development-focused review of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) under Article 71.1, a process that has been mandated but never carried out. It critiques the narrow, compliance-driven approach favored by developed countries, which risks sidelining the broader developmental objectives enshrined in Articles 7 and 8 and reaffirmed by the Doha Declaration on the TRIPS Agreement and Public Health. Through a detailed analysis of the political context, procedural history, and legal mandates, the paper argues that the TRIPS review should center on the real-world impact of the Agreement on developing countries—particularly in areas such as public health, access to medicines, technology transfer, and innovation capacity. It proposes an impact assessment framework grounded in empirical indicators to evaluate how TRIPS has influenced public welfare, policy space, and economic development. Ultimately, the paper urges the World Trade organization (WTO) to fulfill its long-overdue obligation to reassess TRIPS not as a compliance checklist but as a living instrument that must align with global equity and development goals.
UN Human Rights Council Resolutions on Access to Medicines and the Use of TRIPS Flexibilities: A Review
By Nirmalya Syam
This paper reviews almost twenty years of the United Nations Human Rights Council’s (UNHRC) work on access to medicines. The UNHRC has repeatedly framed access to medicines as part of the right to health and has urged States to rely on flexibilities in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) to make essential treatments more affordable. Although the UNHRC has strengthened the human rights foundation for using such flexibilities, its resolutions have produced little change on the ground. The commitments embodied in the UNHRC resolutions stay broad and non-binding, leaving the deep structural barriers in place, including restrictive intellectual property (IP) clauses in trade deals, pressure from powerful States, limited technical and manufacturing capacity, and weak policy coordination within governments. Moreover, several recent resolutions reaffirm the value of IP protection, which creates tension that dilutes the Council’s support for the wider use of TRIPS flexibilities. The paper finds that the main gap between global human rights commitments and national action on advancing access to medicines reflects political choices and structural barriers, and concludes by calling for stronger mandates for States to review access barriers during the Universal Periodic Review, increased technical assistance from the Office of the High Commissioner for Human Rights, more civil society participation, national right-to-health action plans, and systematic monitoring of TRIPS implementation.
Report on Compulsory Licensing Provisions in the National Patent Legislation of 15 Middle-Income Countries:
A Content Analysis and Recommendations
A Report of the Global Economic Governance Initiative of the Boston University Global Development Policy Center
Published by the South Centre and the Global Economic Governance Initiative of Boston University Global Development Policy Center
This study examines compulsory licensing laws in 15 middle-income countries often excluded from voluntary licenses & finds significant untapped policy space to advance access to affordable medicines. It highlights best practices & makes key recommendations to improve patent laws for the use of this important TRIPS flexibility.
Are countries maximizing the policy space they have to grant compulsory licenses to improve access to medicines?
Webinar
Date & Time: Thursday, 13 November 2025, 13h-14h30 (Geneva) / 7h-8h30 (Boston) / 23h-00h30 (Melbourne)
Join the Launch of a Report onCompulsory Licensing Provisions in the National Patent Legislation of 15 Middle-Income Countries, published by the South Centre and the Global Economic Governance Initiative of Boston University Global Development Policy Center.
South Centre Statement to the Intergovernmental Working Group (IGWG) on the WHO Pandemic Agreement
3 November 2025
This statement was delivered at the opening of the Intergovernmental Working Group (IGWG) on the WHO Pandemic Agreement, third session, on 3 November 2025. The South Centre underscored that the first draft Bureau text helps to kick off text-based negotiations, but it does not meet the requirements for implementation of Article 12 of the Pandemic Agreement.
On September 24, 2025, two agreements were announced with generic drug manufacturers in India for the supply of generic lenacapavir at $40 (instead of the original $28,218) per patient per year. However, these generics can only be supplied to the countries included in Gilead’s voluntary license, excluding too many from accessing this price.
This book presents reflections and research that highlight tensions in the negotiations on pandemic preparedness treaties and revisions to the International Health Regulations, underscoring the geopolitical divide between developed and developing countries. It advocates regional health initiatives as a response to the multilateral impasse and reflects on the erosion of foundational public health concepts such as “essential medicines”.
New pandemics are inevitable. How can we best prepare for them and, above all, how can we avoid the mistakes and injustices made during the COVID-19 pandemic?
How can equitable access to medicines and diagnostics be guaranteed when they are produced in a small number of countries? How can we explain the fact that current funding for cooperation in the field of health is in the hands of a small group of Northern countries and foundations from the North? How can the role of the World Health Organization be strengthened? WHO now plays only a minor role in coordinating public health policies. How is it that the concept of “essential medicines”, a major advance in public health policy, is being replaced by that of “medical countermeasures”, a term more in line with the private sectors?
Preparing for future pandemics forces us to ask ourselves: how can we safeguard the general interest, the defense of human rights and public health?
Negotiating Global Health Policies: Tensions and Dilemmas is essential reading for negotiators from the 194 member countries of the World Health Organization (WHO), the World Trade Organization (WTO), and the World Intellectual Property Organization (WIPO) who participate in international negotiations on health and development. Academics and students of medicine, health sciences, law, sociology and political science, as well as intergovernmental organizations and non-governmental organizations who work on access to medicines and global health issues, also would find the book of interest.
Author: Germán Velásquez is Special Adviser, Policy and Health of the South Centre in Geneva, Switzerland. Previously, he was Director of the Secretariat on Public Health, Innovation and Intellectual Property at WHO. He represented WHO at the WTO TRIPS Council from 2001 to 2010. He is the author and co-author of numerous publications on health economics and medicines, health insurance schemes, globalization, international trade agreements, intellectual property and access to medicines.
He obtained a Master’s degree in Economics and a PhD in Health Economics from Sorbonne University, Paris. In 2010, he received a Honoris Causa PhD on Public Health from the University of Caldas, Colombia and in 2015 he received another Honoris Causa PhD from the Faculty of Medicine of the Complutense University of Madrid, Spain.
New Amendments to the International Health Regulations: Strengthening Access to Health Products in Emergencies and Pandemics
By Viviana Munoz Tellez
The International Health Regulations amendments entered into force on September 19, 2025 across most World Health Organization (WHO) Member States. These updates don’t give WHO any new powers but help countries work better together to advance fair and timely access to health products such as vaccines, treatments and diagnostics needed to respond to health emergencies. The real challenge now is implementation and building the necessary capabilities to make these improvements function.
History of the Negotiations of the TRIPS Agreement
By Carlos Correa
When the currently developed countries started their industrialization process, the intellectual property system was very flexible and allowed them to industrialize based on imitation, as it was notably the case of the United States. The international intellectual property system evolved since the end of the XIX Century based on a number of conventions on which the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) was later built on. Developing countries resisted the incorporation into the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) of broad disciplines on intellectual property, as they were conscious that they were disadvantaged in terms of science and technology and that a new agreement, with a mechanism to enforce its rules, would freeze the comparative advantages that developed countries enjoyed. Faced with the threat of not getting concessions in agriculture and textiles -that were crucial for their economies- they were finally forced to enter into negotiations of an Agreement, the terms of which were essentially dictated by developed countries. Coercion rather than negotiations among equal partners seems to explain the final adoption of this Agreement.
The Importance of Balanced Intellectual Property Systems for Patients’ Access to Medicines: An Analysis
By Archana Jatkar and Nicolás Tascón
Access to safe, effective, cost-effective, and quality-assured medicines is fundamental from a patients’ perspective. The International Generic and Biosimilar Medicines Association (IGBA) recently released a reporthighlighting the critical balance between innovation, competition, and timely access to medicines. This article delves into the key findings of IGBA’s report, their implications on patient access to medicines and national healthcare budgets, and the IGBA’s recommendations for improving the global pharmaceutical landscape.
Access to medical products and reproductive rights
Side Event to the 59th Session of the Human Rights Council
23 June 2025
12:00 to 13:00
Room XXVII, Palais de Nations, Geneva, Switzerland
The pursuit of health equity, encompassing fair and just opportunities for all to achieve their full health potential, remains a paramount global challenge. The right to health is a fundamental part of our human rights and of our understanding of a life in dignity. This event will explore the indivisible links between equitable access to medical products, the advancement of sexual and reproductive health and rights (SRHR), and the strengthening of international cooperation as pillars for upholding this fundamental right for everyone, everywhere. The interconnectedness of these themes is central; they are not disparate issues but integral components of a holistic approach necessary to realise comprehensive health equity.
The side event is anticipated to significantly enhance participants’ understanding of the complex, intersecting challenges and opportunities in upholding health equity, particularly through improved access to medical products and the full realization of SRHR. The discussions aim to identify potential policy pathways, innovative approaches, and actionable strategies for key stakeholders to address existing inequities. Furthermore, a crucial outcome will be a reinforced commitment to multilateralism and collaborative action as essential tools for tackling global health challenges and advancing the right to health, with the dialogue contributing valuable insights to ongoing policy debates in relevant international fora, especially concerning the implementation of recent global agreements and agendas, while also strengthening networks and partnerships dedicated to health equity and human rights.
Scope of Compulsory License and Government Use of Patented Medicines
To meet public health needs governments can use compulsory licenses and government use as a tool for procurement and import of patented medicines. These mechanisms are provided for in most laws worldwide. The WTO TRIPS Agreement, as reaffirmed by the Doha Declaration on TRIPS and Public Health, recognises the right of WTO members to grant compulsory licenses and their freedom to determine the grounds upon which such licenses may be granted.
This table provides information of instances of their use.
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