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.
The UN Treaty on Business and Human Rights: Regulating Corporate Power in the Era of Deregulation
South Centre and Friedrich-Ebert-Stiftung (FES) Geneva Office Report, March 2026
By Daniel Fernando Uribe Terán
This study examines how the United Nations Legally Binding Instrument (LBI) serves as a vital tool to preserve state sovereignty and to ensure the primacy of human rights in the era of deregulation.
61st Session of the Human Rights Council Side Event:
Regulating Corporate Power in the Era of Deregulation: Launching the South Centre and FES 2026 Report for the UN Legally Binding Instrument
Co-organized by the South Centre and Friedrich-Ebert-Stiftung (FES) Geneva Office
Date: 26 March 2026
Time: 12:00 – 13:00 CET
Venue: Room Concordia 1, Palais des Nations, Geneva
The South Centre, in collaboration with the Friedrich-Ebert-Stiftung (FES) Geneva, is pleased to invite you to the launch of our new report The UN Treaty on Business and Human Rights: Regulating Corporate Power in the Era of Deregulation.
This study examines how the UN Legally Binding Instrument (LBI) serves as a vital tool to preserve state sovereignty and to ensure the primacy of human rights in the era of deregulation.
Join us in Geneva to discuss concrete solutions to “justice paralysis” and corporate impunity.
Hosted by the South Centre, 5 March 2026, Virtual (Zoom)
On 5 March 2026, the South Centre convened a virtual webinar to mark the conclusion of its seven-year antimicrobial resistance (AMR) programme, supported by the Fleming Fund, Department of Health and Social Care (DHSC), United Kingdom (UK) since 2018. The main objective of the webinar was to present the findings of an Impact Assessment of the programme and to gather reflections from key partners on lessons learned and the way forward. The South Centre emphasised that the end of the Fleming Fund grant marks a transition, not a closure as the organisation remains committed to AMR as a core area of work and is actively seeking new partnerships.
The webinar was opened by Prof. Carlos Correa, Executive Director of the South Centre, and moderated throughout by Dr Viviana Munoz Tellez, Head of the Health, Intellectual Property and Biodiversity programme of the South Centre. Eleven speakers from multilateral institutions, the UK Fleming Fund, government delegations, academics, civil society, and the media shared perspectives and calls to action.
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)
South Centre Statement to the Sixth meeting of the Intergovernmental Working Group on the WHO Pandemic Agreement (IGWG6)
23 March 2026
Will countries at the World Health Organization (WHO) finalize negotiations this week on the Pathogen Access and Benefit Sharing (PABS) System to open way to signature of the Pandemic Agreement? Read the South Centre’s statement to the sixth IGWG:
Sovereignty and self-determination over natural resources in times of conflicts, climate change and (neo)colonialism
Side-Event to the 61st Session of the Human Rights Council
Co-organized by the Special Rapporteur on the Right to Development (Special Procedures, United Nations Human Rights Council) and South Centre
10 March 2026, 12-1pm
Concordia 1, Building A, Palais des Nations, Geneva
As we navigate the 61st session of the Human Rights Council, the South Centre and the Special Rapporteur on the right to development are convening a critical discussion on the intersection of resource sovereignty, conflict, and (neo)colonialism.
In an era defined by climate instability and geopolitical shifts, the right to self-determination over natural resources has never been more relevant. We are honoured to host a distinguished panel of ambassadors and experts to explore these challenges.
The South Centre successful in elevating Global South voices in the fight against antimicrobial resistance, with support from United Kingdom’s Fleming Fund
Geneva | 5 March 2026
As the world intensifies efforts to confront antimicrobial resistance (AMR), one of the gravest global health and development threats of our time, the South Centre has supported low- and middle-income countries (LMICs) to strengthen their positions in global governance and policy processes.
A newly released impact report documents how the South Centre, with support from the United Kingdom’s Fleming Fund, has played a catalytic role between 2018 and 2025 in systematically improving Global South engagement in AMR governance, policy discourse, and civil society – led action.
Contribution to the Report of the UN Secretary-General on the implementation of General Assembly Resolution on the “Necessity of ending the economic, commercial and financial embargo imposed by the United States of America against Cuba”
South Centre
13 February 2026
The illegal blockade against Cuba is a continuing violation of the UN Charter & international law and must be lifted to allow full realisation of human rights and SDGs. See the South Centre inputs to the UN Secretary-General’s report, emphasising urgent need to end the blockade.
The webinar will present key findings from the South Centre’s Antimicrobial Resistance impact report, Elevating Global South Voices in the Fight Against Antimicrobial Resistance: The South Centre’s Impact and Lessons Learned (2018–2025), implemented with the support of the Fleming Fund (UK Department of Health and Social Care).
The discussion will be framed within the evolving global AMR landscape, particularly following the 2024 UN Political Declaration on AMR, and will reflect on how to sustain and scale Global South – led engagement in multilateral processes.
