Addressing Barriers to Accessing Monoclonal Antibodies (mAbs) in Developing Countries: Challenges and Potential Solutions
By Nirmalya Syam
Monoclonal antibodies (mAbs) have revolutionized treatment in oncology, autoimmune disorders, and infectious diseases due to their high specificity and efficacy. However, access to mAbs in developing countries remains severely limited due to high costs, market concentration in high-income regions, regulatory hurdles, and intellectual property barriers. Despite the potential of biosimilars to enhance affordability, their availability remains restricted due to expensive development processes, patent thickets, and complex regulatory requirements. The dominance of multinational pharmaceutical companies in the market further restricts competition, delaying biosimilar approvals and preventing price reductions. Additionally, regulatory agencies in developing countries often lack the resources to expedite biosimilar approvals, further exacerbating delays in access.
Policy interventions such as improved regulatory harmonization, stricter patent examination guidelines, and expanded public investment in mAb production are necessary to address these barriers. The adoption of the revised 2022 WHO Similar Biotherapeutic Products (SBP) Guidelines could streamline biosimilar approval by reducing unnecessary comparative clinical trials. Moreover, technology transfer initiatives and market-shaping incentives, including compulsory licensing, could help lower costs and accelerate the availability of mAbs in underserved regions.
By implementing these strategies, developing countries can bridge the access gap, ensuring that lifesaving mAb therapies reach the patients who need them most. A coordinated global effort involving policymakers, regulators, and industry stakeholders is essential to establishing a sustainable and equitable mAb supply chain.
Global Activism to Make Patented Drugs More Accessible: An ITPC Case Study of Bedaquiline for Treatment of Tuberculosis
By Priti Patnaik
This report documents efforts by civil society organizations (CSOs) in various countries, including Brazil, Ukraine and Thailand, to make Bedaquiline more accessible by using the flexibilities provided in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) – the safeguards in the intellectual property system that take into account public health needs. The case study was undertaken during 2023-2024.
Tuberculosis remains a major global health crisis, with drug-resistant forms requiring newer more effective treatments like Bedaquiline which offers shorter treatment times and fewer side effects than older regimens. The report offers an overview of global and country-specific efforts by CSOs to challenge patents held by Johnson & Johnson on the tuberculosis (TB) drug bedaquiline (BDQ) to improve patient access and affordability. CSOs primarily focused on opposing “evergreening” secondary patents that extend Johnson & Johnson’s monopoly beyond the original patent expiration, arguing that these patents lack inventive merit and artificially inflate prices. Successful actions, such as patent rejections in India and Thailand and Johnson & Johnson’s agreement not to enforce patents in 134 low- and middle-income countries (LMICs), are discussed alongside challenges, including judicial difficulties, insufficient political will, and the strategic importance of pursuing pre-grant patent oppositions.
South Centre and One Health Trust Information Note
March 2026
92 million deaths could be averted by 2050 with improved access to antibiotics and infection care. The time to act is now, and it requires both access and stewardship.
Together with One Health Trust, we highlight key recommendations to make it happen in a pointed brief.
* Available in 3 languages (English, Portuguese and Spanish)
The South Centre carries out multiple activities to support developing countries with policy-oriented research, inputs and advice for negotiations and capacity building. The Report summarizes the South Centre’s activities in 2025 and highlights the contexts in which they were conducted as well as the objectives that were pursued with their implementation.
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.
Independent Panel on Evidence for Action against Antimicrobial Resistance (IPEA): Reflections on the Foundational Documents
By Dr. Viviana Munoz Tellez
The United Nations General Assembly (UNGA) invited the Quadripartite Organizations to establish an Independent Panel on Evidence for Action against Antimicrobial Resistance (IPEA) in 2025. The launch of the IPEA is planned for 10 December 2025 during the United Nations Environment Assembly (UNEA). The Quadripartite organizations (the Food and Agriculture Organization (FAO), the United Nations Environment Programme (UNEP), the World Health Organization (WHO) and the World Organisation for Animal Health (WOAH)) released in November 2025 updated draft documents for the IPEA for additional consultation with Member States and stakeholders. The IPEA will constitute a welcome addition to global Antimicrobial Resistance (AMR) governance, and should be established, starting small and building gradually. Several concerns on the proposed model remain concerning the governance structure, equity in participation, and the independence of the panel. This policy brief provides analysis and recommendations on key issues concerning the draft foundational documents for the IPEA requiring attention.
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.
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.
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.
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.
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