On September 25, 2025, two voluntary licensing agreements were announced between Gilead, the patent holder, and generic drug manufacturers in India for the supply of generic lenacapavir at $40 (instead of the original $28,218) per patient per year. However, too many countries are excluded from the agreements.
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.
Application de l’Exception Bolar: Différentes approches dans le droit de l’UE
Par Dmytro Doubinsky
Ce Document de recherche aborde le problème toujours plus aigu de l’accès aux médicaments essentiels, en se concentrant sur le rôle des droits de propriété intellectuelle, en particulier les droits de brevet, qui restreignent l’accès en permettant des monopoles sur le marché pharmaceutique qui maintiennent les prix des médicaments à un niveau élevé. Le document explore l’exception Bolar, un mécanisme juridique conçu pour permettre aux fabricants de médicaments génériques de demander l’approbation réglementaire avant l’expiration d’un brevet, empêchant ainsi l’extension de facto des monopoles de brevets. L’étude examine la transformation de l’exception Bolar d’un cas juridique spécifique en un instrument important en matière de droit de la propriété intellectuelle, de droit commercial et de droit pharmaceutique. Elle analyse les principaux cadres juridiques internationaux et les directives européennes relatifs à l’exception Bolar et met en évidence les interprétations divergentes de l’exception dans les jurisprudences allemande et polonaise. Grâce à cette analyse comparative, le document encourage une mise en œuvre plus large des exceptions Bolar afin d’améliorer l’accès à des médicaments abordables et de réduire les coûts des soins de santé.
Submission by the South Centre to the Office of the United Nations High Commissioner for Human Rights on Inputs for the comprehensive report on ensuring access to medicines, vaccines and other health products (HRC resolution 50/13)
January 2025
The South Centre has provided input for the OHCHR report on new developments and challenges in ensuring access to medicines, vaccines and other health products.
Application of the Bolar Exception: Different Approaches in the EU
By Dmytro Doubinsky
This Research Paper addresses the growing problem of access to essential medicines, focusing on the role of intellectual property rights, particularly patent rights, in restricting access by enabling pharmaceutical market monopolies that keep drug prices high. The paper explores the Bolar exception, a legal mechanism designed to allow generic drug manufacturers to seek regulatory approval before a patent expires, thus preventing the de facto extension of patent monopolies. The study examines the transformation of the Bolar exception from a specific legal case into a significant tool of intellectual property, commercial, and pharmaceutical law. The paper analyzes key international legal frameworks and European directives related to the Bolar exception and highlights divergent interpretations of the Exception in German and Polish case law. Through this comparative analysis, the paper argues for the broader implementation of Bolar exceptions to improve access to affordable medicines and reduce healthcare costs.
Las nuevas pandemias son inevitables. ¿Cómo podemos estar mejor preparados para ellas y, sobre todo, cómo podemos evitar los errores e injusticias cometidos durante la pandemia de COVID19? Actualmente se están llevando a cabo negociaciones para formular un tratado internacional vinculante sobre prevención y preparación que garantice respuestas más justas a futuras pandemias. Este libro pretende ser una contribución crítica a estos debates en curso.
¿Cómo garantizar un acceso equitativo a los medicamentos y diagnósticos cuando la mayoría de ellos se producen en un número reducido de países? ¿Cómo explicar que la financiación actual de la cooperación sanitaria esté en manos de un pequeño grupo de países y fundaciones del Norte? ¿Cómo reforzar el papel de la Organización Mundial de la Salud, que actualmente desempeña un papel secundario en la coordinación de las políticas de salud pública? ¿Por qué se ha sustituido el concepto de «medicamentos esenciales», gran avance de la política de salud pública, por el de «contramedidas médicas», término más acorde con el afán de lucro del sector privado?
Autor: Germán Velásquez, Asesor especial sobre políticas y salud, South Centre de Ginebra