Access to Medicines and Intellectual Property: taking advantage of TRIPS flexibilities for post-COVID-19 resilience in Africa
By Ismaelline Eba Nguema
The call by India and South Africa for the provisional lifting of patents on pharmaceutical products has had the merit of putting the issue of access to medicines and public health back on the agenda. However, the difficulty of reconciling access to medicines and intellectual property has many factors which cannot be reduced solely to the commitments of WTO member states. A more in-depth analysis reveals the intrinsic limitations of some of its members. These include the weakness of the legislative and regulatory framework in some countries, such as those on the African continent. Consequently, the aim of this article is to demonstrate that effective use of the flexibilities in the TRIPS Agreement is only possible if African countries equip themselves with an appropriate legal framework, in addition to the judicial institutions that are supposed to guarantee the effectiveness of the standards adopted. The methodology used consisted of an exegesis of various documents, including articles, working documents of the TRIPS Council, declarations and resolutions of various bodies, as well as the national case law of certain WTO members, etc. This method led us to conclude that the compatibility between access to medicines and intellectual property is caught between human rights and economic interests. However, for the TRIPS flexibilities to be fully utilized by African countries, they would benefit from reforming their legal frameworks to take advantage of the flexibilities in the TRIPS Agreement.
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.
WTO arbitration on China’s standard patents policy threatens TRIPS balance and national autonomy
By Nirmalya Syam
This article critically examines the WTO arbitration award in China – Enforcement of Intellectual Property Rights (WT/DS611/ARB25), which marks a significant departure from established interpretations of Article 1.1 of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). The arbitrators endorsed a broad “anti-frustration” reading of the provision, effectively imposing cross-border obligations on WTO Members and challenging the autonomy of national courts. Although Article 1.1 of TRIPS was relied upon by the European Union only in conjunction with Article 28, the arbitrators treated it as an autonomous normative foundation for imposing cross-border constraints on members’ judicial measures. The article contends that this expansion of Article 1.1 goes beyond its text and structure, risks undermining legitimate public-interest measures, and opens the door to non-violation type complaints that are excluded from TRIPS. The analysis underscores the need to preserve the balance between IP enforcement and national policy space, especially in disputes involving public policy considerations.
Analysis of Intellectual Property Issues Ahead of the WTO 14th Ministerial Conference
By Nirmalya Syam, Viviana Munoz Tellez
This policy brief analyses the issues pertaining to the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) that were discussed in the General Council meeting on 16-17 December 2025. Despite the strategic importance of these issues, the divergence on TRIPS issues and on the priorities for the future work of WTO among Members did not allow the General Council to decide on any of these matters. None of the issues were noted for decision in the 14th Ministerial Conference (MC14), which is scheduled to be hosted in Yaoundé, Cameroon in March 2026. This reluctance of some Members to engage substantively on intellectual property (IP) issues has become a regular dynamic in the TRIPS Council. However, the MC14 should, at the least, decide to extend the moratorium on TRIPS Non-Violation and Situation Complaints and extend the period for acceptances by Members of the Protocol Amending the TRIPS Agreement. Moreover, there is an understanding that all issues remain on the table, regardless of whether they are taken up at the Conference.
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.
WTO TRIPS Agreement: Insights from a Negotiator at the Uruguay Round of GATT
By Jayashree Watal
This article recounts how the TRIPS Agreement negotiations took place from the perspective of a participant in the negotiations. It outlines India’s concerns with the developed countries’ proposals and notes that most developing countries wrongly thought that TRIPS was about trade in counterfeit goods, a subject that was first broached at the end of the Tokyo Round in 1978-9. On the contrary, Industry associations of the US, EU and Japan had, quite early on in the negotiations in 1988, drawn up a legal text very close to what became the final text of the TRIPS Agreement.
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.
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.
The WIPO Development Agenda: Progress and Challenges in 2025
By Nirmalya Syam
The World Intellectual Property Organization (WIPO) Development Agenda (DA), adopted in 2007, seeks to align intellectual property (IP) policies with the development priorities of member States. Enduring challenges persist despite some progress including the adoption of treaties to facilitate access to copyright protected works for visually impaired and print disabled persons, and the recent treaty on IP, genetic resources and associated traditional knowledge, and the adoption of several projects for implementing different DA recommendations. DA projects, however, have had limited impact on mainstreaming a development orientation in WIPO, there is limited promotion of use of IP flexibilities for development, and WIPO’s technical assistance continues to lack a development orientation. There is also a sustained absence of consideration and reporting of development related issues across WIPO bodies. Divergent interpretations of “development”, weak coordination and monitoring systems, and governance inequities have hindered the DA’s transformative potential. This brief examines these issues and advances recommendations to address the challenges to establish an effective DA.
