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.
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.
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.
What Can Cambodia Learn from Thailand and India as It Prepares to Graduate from Least Developed Country Status?
By Brigitte Tenni, Deborah Gleeson, Joel Lexchin, Phin Sovath, and Chalermsak Kittitrakul
Cambodia is expected to graduate from Least Developed Country status soon, at which time it will be required to make patents available for pharmaceutical products and processes to meet its obligations under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Given its impending transition from LDC status, there is a need to balance Cambodia’s intellectual property (IP) policies and regulations with public health priorities to ensure access to affordable life-saving medicines. This will be critical to achieving universal health coverage, one of the United Nations’ Sustainable Development Goals. This paper examines Cambodia’s IP laws and regulations to identify provisions that could reduce access to affordable generic medicines when it starts granting patents for pharmaceuticals. It systematically compares Cambodia’s IP laws and regulations with those of Thailand and India – two developing countries that have had some successes in preserving access to medicines despite the introduction of pharmaceutical patents. It identifies lessons for Cambodia from the experiences of Thailand and India in implementing TRIPS and using TRIPS flexibilities such as compulsory licensing to ensure access to a sustainable supply of affordable generic medicines. Key recommendations for reform for Cambodia include strengthening the use of preventive and remedial TRIPS flexibilities and removing criminal sanctions for patent infringements. Cambodia should reject any TRIPS-plus provisions in its patent legislation and avoid membership in bilateral or plurilateral trade agreements that include TRIPS-plus provisions as well as signing patent treaties and memorandums of understanding that may facilitate the granting of unwarranted patents.
New US Policy on Exercise of March-In Rights to Curb High Drug Prices: Lessons for the Global South
By Nirmalya Syam
In response to soaring prescription drug costs, the United States government recently announced proposed changes to the exercise of march-in rights under the Bayh-Dole Act, allowing federal agencies to license taxpayer-funded inventions to other parties based on factors such as accessibility and affordability. This article explores the implications of the US policy shift on global pharmaceutical pricing and access, particularly for developing countries. Drawing parallels between the US approach and flexibilities under intellectual property laws such as compulsory licensing and government use authorizations that are allowed under the WTO TRIPS Agreement, the article suggests that similar strategies could be employed by developing nations to address public health needs and economic considerations.
Régimen de licencias obligatorias y uso público no comercial en Argentina
Por Juan Ignacio Correa
Con la adopción del Acuerdo sobre los Aspectos de Propiedad Intelectual relacionados con el Comercio (ADPIC), la Argentina debió adaptarse a las nuevas reglas internacionales en materia de derecho de patentes. Uno de los puntos centrales del Acuerdo es la posibilidad de establecer diferentes formas de licencias obligatorias y uso gubernamental no comercial. Este documento analiza las condiciones previstas en el artículo 31 del ADPIC con ese fin y examina en detalle las diferentes causales de licencias obligatorias contempladas en la legislación argentina y las condiciones aplicables a cada una de ellas, así como para el uso de patentes por parte del gobierno con fines no comerciales. Finalmente, con base en el margen normativo del ADPIC y la legislación vigente, el documento discute el posible contenido de una reglamentación de licencias obligatorias y uso público no comercial que permita a la Argentina utilizar de manera efectiva esas herramientas cuando se presente alguna de las circunstancias previstas en la actual regulación.
Implementation of TRIPS Flexibilities and Injunctions: A Case Study of India
by Shirin Syed
The proponents of intellectual property (IP) have increasingly utilized injunctions with indiscriminate propensity as a strategic tool for IP enforcement, resulting in adverse socio-economic implications, including the enjoyment of human rights. This trend has eclipsed the flexibilities provided in the Doha Declaration on the TRIPS Agreement and Public Health. Although a substantial volume of the literature focuses on the flexibilities of compulsory license or scope of patentability, little attention has been given to the flexibilities related to IP enforcement. Discussing the implications of IP enforcement on public interest, the paper examines the gaps in the articulation of flexibilities of intellectual property rights (IPRs) enforcement, with special reference to injunctions in India. It examines how far the courts consider the implications on the enjoyment of fundamental rights while granting injunctions on patents. This paper argues that the Indian courts have deviated from the cautious approach provisioned under the TRIPS flexibilities that allows the courts to consider the public interest aspect and human rights implications while granting injunctions in patent litigation. Moreover, it asserts that the courts should exercise prudence in granting injunctive relief in cases involving patent infringement, and take into account the potential impact of such relief on the exercise of human rights. This suggests a need for a careful examination of the potential implications of injunctive remedies in such cases.
TRIPS Waiver Decision for Equitable Access to Medical Countermeasures in the Pandemic: COVID-19 Diagnostics and Therapeutics
By Nirmalya Syam and Muhammad Zaheer Abbas, PhD
The Marrakesh Agreement Establishing the World Trade Organization (WTO) allows WTO Members to agree to temporarily waive obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). However, the TRIPS Decision adopted by the 12th WTO Ministerial Conference in June 2022, after lengthy and protracted negotiations lasting for 20 months in the middle of a pandemic, allowed only a fragment of the waiver proposal submitted by India and South Africa. Moreover, since the adoption of the Decision there has been an impasse in the WTO about extending the Decision to COVID-19 diagnostics and therapeutics even though the WTO Members were mandated by the Decision to decide on this matter within six months of the Decision. This research paper analyses the current state of play and concludes that there is a need to immediately and unconditionally extend the Decision to COVID-19 diagnostics and therapeutics. Moreover, the paper suggests options for how the TRIPS flexibilities can be optimally utilized in a pandemic situation without developing countries being resigned to the vagaries of negotiations on a waiver which is supposed to be an urgent emergency solution. In this regard, the paper also suggests options that could be considered for reforming the process of decision-making on a waiver proposal to ensure that decisions on waivers are taken in a timely and expedited manner without being negotiated for an extensive period of time in the midst of an emergency.
Colombia declara de interés público el uso de patente sobre Dolutegravir para incrementar el acceso a tratamiento a personas que viven con HIV
3 de octubre de 2023
El South Centre, el organismo intergubernamental de 55 países en desarrollo, celebra la decisión del Gobierno de Colombia de hacer uso gubernamental no comercial de una patente con el objetivo de garantizar que las personas que viven con VIH reciban tratamientos basados en Dolutegravir (DTG). Estos tratamientos son financiadas con recursos públicos asignados a la salud.
