WTO – Centre on Knowledge Governance

Legal tools that lower medicines prices have expanded access to medicines for over two decades, research reveals

Montgomery Dunn / 28 January, 2026

Compulsory patent licenses effectively leveraged to enable access to medicines This article originally appeared on Medicines Law & Policy. LONDON, UK: Millions of people are priced out of access to life-saving medicines. Use of legal tools to reduce prices has been under-reported and misunderstood to be rare, but new research published in the British Medical Journal Global Health reveals wide use by both high and low-income countries. This has important policy implications at a time when rising medicines prices are a growing global policy concern. The legal tools, contained in the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement and known as ‘TRIPS flexibilities’, have been used hundreds of times to help governments combat health challenges ranging from pandemics like HIV and Covid-19, to rare diseases, to cancers and other non-communicable diseases. One of the key findings revealed in the research is how often wealthy countries employ TRIPS Flexibilities. The research was based on data from the TRIPS Flexibilities Database maintained by Medicines Law & Policy. “Over the last 25 years, the balance of which countries have made use of TRIPS Flexibilities has shifted: high-income countries appear to be simultaneously making use of these tools whilst actively trying to restrict the ability of low-income countries to do the same,” said Dr Montgomery Dunn, the study’s lead author. Titled “TRIPS flexibilities help change policy and practice to increase access to medicines: Evidence from 2001-2024” the research found that over half of the compulsory licences issued in the last decade have been by high-income country governments, in many cases responding to the urgent need for vaccines and treatments for Covid-19. With a compulsory licence, the government can authorise the production of a patented medicine without the patent holder’s consent, thereby opening the market to generic producers. “This underlines what a critical policy tool this flexibility is to treat pressing health challenges, everywhere in the world,” said Dunn. “Public push towards the use of these tools can itself be the stimulus for price reductions,” said co-author Ellen ‘t Hoen, Director of Medicines Law & Policy. Nearly half of the compulsory licences that were not executed were due to an offer from the company to increase access, including via a voluntary license, price reduction or donation, enabling access even with the mere threat of a compulsory licence. But countries seeking to use such measures face political pressure, and may need to overcome additional obstacles such as restrictions on use of data needed to register lower-cost generic medicines. “Use of TRIPS Flexibilities is effective, and when needed, countries must be free to use them to the full,” said ‘t Hoen. “To face current and future health challenges, governments around the world must not only enable the use of TRIPS Flexibilities but also support mechanisms for intellectual property, technology and know-how sharing, such as the Medicines Patent Pool.”

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Tanuja Garde Appointed Director of WTO’s IP Division

InfoJustice Eds. / 16 July, 2025

In July 2025, Tanuja Garde assumed the role of Director of the Intellectual Property, Government Procurement and Competition Division at the World Trade Organization (WTO). She holds a bachelor’s degree in Chemistry from Duke University and a Juris Doctor from the Washington University in St. Louis School of Law. Before joining the WTO, Garde was Vice President of IP and Information Governance at Boeing (2022–2025) and an advisor to the Industry Trade Advisory Committee on Intellectual Property Rights of the Office of the U.S. Trade Representative (2019–2025). According to the WTO website, the division is “responsible for the WTO’s work in trade-related intellectual property rights (TRIPS), government procurement and competition policy,” and “also maintains and develops lines of communication with other intergovernmental organizations, non-governmental organizations, intellectual property practitioners and the academic community.” Garde succeeds Antony Taubman, who directed the WTO division from 2009 to 2024. Before that, Taubman was Director of Global Intellectual Property Issues at the World Intellectual Property Organization (WIPO) (2002–2009).

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WTO: Brazil, India and Peru call for the inclusion of a mandatory disclosure requirement in the WTO TRIPS Agreement

InfoJustice Eds. / 22 June, 2025

This post was originally published on KEI Online by Thiru On 18 March 2025, the World Trade Organization (WTO) published a communication (IP/C/W/719) by Brazil, India, and Peru entitled, “Revising discussions on the relationship between the TRIPS Agreement and Convention on Biological Diversity“. Brazil, India, and Peru have called for the inclusion of a mandatory disclosure requirement in the TRIPS Agreement based on a 2011 proposal (TN/C/W/59) by Brazil, China, Colombia, Ecuador, India, Indonesia, Peru, Thailand, the ACP Group and the African Group in 2011 to amend Article 29 of the TRIPS Agreement. The paper makes no explicit reference to digital sequence information (DSI). While this topic was broached at the March 2025 TRIPS Council meeting, this topic will be addressed at the next TRIPS Council meeting (26-27 June 2025). In the chapeau of the March 2025 paper, the demandeurs (Brazil, India, and Peru) articulated the interplay between traditional medical knowledge, modern medicine, traditional and complementary medicine use, the misappropriation of genetic resources, intellectual property, and biopiracy: 2. A WTO-WIPO-WHO joint study of 2020 titled ‘Promoting Access to Medical Technologies and Innovation’ notes the profound influence of traditional medical knowledge on modern medicine. With 88% of WHO members acknowledging traditional and complementary medicine use, international trade in these products is growing rapidly. However, the study notes that this has come on the back of the rampant misappropriation of genetic resources (GR) and associated traditional knowledge (TK). Some prominent examples of biopiracy include neem (India), turmeric (India), kava (Pacific Islands-Fiji and Vanuatu), ayahuasca (Brazil), quinoa (Peru), and hoodia (South Africa). Assessing the economic loss to developing countries due to biopiracy is a complex task involving multiple factors, such as the loss of intellectual property (IP) rights, restricted access to genetic resources, negative impact on traditional industries, and discouragement of research and development in the country of origin. In relation to biodiversity, the co-sponsors of IP/C/W/719 quoted a WHO Global Report on Traditional and Complementary Medicine from 2019, “developing countries, especially those with rich biodiversity in Asia, Africa, and South America, supply approximately two-thirds of the plants used in western and global medical systems”. Furthermore, the demandeurs noted: While recent data is publicly unavailable, a 1999 report by the United Nations Development Program estimates that if a 2% royalty were charged on genetic resources developed by local innovators in the South, the North would owe over USD 300 million in unpaid royalties for farmers’ crop seeds and more than USD 5 billion in unpaid royalties for medicinal plants. In the 719 paper, Brazil, India, and Peru described the Convention on Biological Diversity (CBD) and the Nagoya Protocol as having a “significant shortcoming” noting that the CBD and Nagoya Protocol do not “link these requirements with the patent system, resulting in the grant of erroneous patents to biopiracy-based inventions and lack of enforcement of the PIC and ABS commitments, particularly in a transboundary context.” 4. The CBD (1992) marked the first step towards recognising the sovereign rights of states over their biological resources. It conditioned access to biological resources and associated traditional knowledge with prior informed consent (PIC) and access and benefit sharing (ABS) with local communities, who are the rightful holders of such knowledge. The Nagoya Protocol, which came into force in 2014, further developed the legal framework established under the CBD to operationalise the requirements of PIC and ABS. A significant shortcoming of the CBD and Nagoya Protocol is that it does not link these requirements with the patent system, resulting in the grant of erroneous patents to biopiracy-based inventions and lack of enforcement of the PIC and ABS commitments, particularly in a transboundary context. The 719 paper points to the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, adopted in May 2024, as the culmination of over two decades of work to address some of the shortcomings in the CBD and Nagoya Protocol. 6. The WIPO treaty requires patent applicants to disclose the source of the genetic resources and traditional knowledge on which their claimed invention is based. The disclosure requirement, if complied with by the applicant, would aid the patent office in conducting a prior art search. It would help prevent the patenting of inventions based on genetic resources and associated traditional knowledge that do not fulfil the requirements of novelty and inventiveness. Genetic resources and associated traditional knowledge obtained from one country are often used as a basis for seeking a patent in another. In such situations, the disclosure requirement would make the patent office the checkpoint to identify instances of transboundary utilisation of genetic resources and traditional knowledge. While hailing the WIPO Treaty on IP, Genetic Resources and Associated Traditional Knowledge, the 719 demandeurs are cognizant that the WIPO treaty “does not offer recourse to international dispute settlement if states fail to establish the disclosure requirement under their domestic patent systems”. The demandeurs call for the amending of the TRIPS Agreement to integrate the mandatory disclosure requirement into the WTO’s institutional architecture, including its binding dispute settlement system. 7. While a progressive instrument, the WIPO treaty could be further strengthened by integrating these commitments under the TRIPS Agreement. First, the WIPO treaty does not offer recourse to international dispute settlement if states fail to establish the disclosure requirement under their domestic patent systems. Second, the WIPO treaty does not address the requirements to obtain PIC under mutually agreed terms (MAT). Hence, even though the treaty introduces the disclosure requirement, it does not provide for compliance with the ABS requirements. The WIPO treaty shifts the burden to ensure compliance on the government agencies and local communities of the provider country, who must monitor published patent applications worldwide to ensure compliance and enforce ABS through PIC under MAT. Thus, amending the TRIPS Agreement to integrate the mandatory disclosure requirement could subject this commitment to the WTO’s legal framework. Further, the TRIPS Agreement could build on the WIPO treaty to require evidence of PIC and benefit-sharing arrangements as a prerequisite for patent grant or commercialization, thereby reinforcing the

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The South Centre Publishes Resources from the "30 Years of TRIPS" Side Event at the WTO on Expectations and Concerns of Developing Countries

InfoJustice Eds. / 2 April, 2025

On March 19th, 2025, an informal group of countries known as “Intellectual Property (IP) for Development” -Bangladesh, Brazil, Colombia, India and Pakistan- hosted an informal side event, on the margins of the regular TRIPS Council session. The South Centre published the following commentary, program, presentations, and photos from this side event at this link, which are also shared below: Delegates and experts were invited to an initial discussion to reflect on the history of the TRIPS negotiations, 30 years after their conclusion. The formal Council for TRIPS session will hear a brief summary of the event and its key takeaways and reflections. The event took place in Room SI at the WTO and online, with participation of over 150 persons. The presentations, program, photos. [and videos] are available below: W718 Side Event draft document Presentation: History of the TRIPS Agreement by Carlos Correa TRIPS Side Event Speech by Jayashree Watal Presentation: Restoring and Adding to the TRIPS Balance by Joshua Sarnoff Presentation: TRIPS restrictions on exports or imports when there is non-voluntary use of a patented invention by James Love Presentation: Non-disclosed information and trade secrets by Ellen ‘t Hoen Presentation: TRIPS and Copyright by Sean Flynn Presentation on Articles 7 and 8 of TRIPS as well as Article 66 of TRIPS by Sangeeta Shashikant Event Photos Google Drive with Video Recordings Programme 1:00 PM – 2:00 PM | Welcome & Light Snacks 2:00 PM – 2:05 PM | Opening Remarks & Introduction –Ambassador Tareq Md. Ariful Islam, Bangladesh 2:05 PM – 2:35 PM | A History of the TRIPS Negotiations –Dr. Carlos Correa, South Centre 2:35 PM – 3:15 PM | Experiences of National NegotiatorsAmbassador Guilherme Patriota, BrazilMs. Jayashree Watal, India 3:15 PM – 4:25 PM | Panel: Key Issues & Provisions in TRIPS NegotiationsModerator: Dr. Viviana Munoz Tellez, South Centre Prof. Joshua Sarnoff (DePaul College of Law)Mr. James Love (Knowledge Ecology International – KEI)Dr. Ellen ’t Hoen (Medicines Law & Policy)Mr. Sean Flynn (American University)Ms. Sangeeta Shashikant (Third World Network – TWN) 4:25 PM – 4:30 PM | Closing & Summary – Amb. Ninad Deshpande, DPR India 4:30 PM – onwards | Farewell & Light Snack

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WTO Event on 30 Years of TRIPS

Justin Diamond / 15 March, 2025

On March 19, 2025, a side event will take place during the regular WTO TRIPS Council session, organized by Bangladesh, Brazil, Colombia, India, and Pakistan. The event will review 30 years of the TRIPS agreement, focusing on its history, national experiences, and impact on public interest and development in member countries. Key segments include a historical overview by Carlos Correa of the South Centre, a discussion on national experiences, and a panel featuring experts from academia and civil society. Virtual participation will be available – for full details, please see the original article published by Knowledge Ecology International below: Bangladesh, Brazil, Colombia, India, and Pakistan to convene WTO TRIPS Council Side event – 30 Years of TRIPS: Expectations and Concerns of Developing Countries Update: On Tuesday, 11 March 2025, the World Trade Organization published an addendum (IP/C/W/718/Add.1) which stated: “By means of a communication dated 10 March 2025, the delegation of Pakistan has requested to be added to the list of sponsors of the submission circulated in document IP/C/W/718.” On Monday, 10 March 2025, the World Trade Organization (WTO) published a communication (IP/C/W/718) from Bangladesh, Brazil, Colombia, and India entitled: “IP and Public Interest – Intellectual Property For Development Group – Side Event: 30 Years of TRIPS: Expectations and Concerns of Developing Countries”. The cover note to the submission notes: “The informal group of countries known as “Intellectual Property (IP) for Development” plans to host an informal side event, on the margins of the regular TRIPS Council session on the afternoon on 19 March, one day before the TRIPS Council session of the 20 and 21 March 2025. The signing Members invite delegates and experts to an initial discussion to reflect on the history of the TRIPS negotiations, 30 years after their conclusion” (Source: IP/C/W/718). The convenors will enable virtual participation; a link will be provided. The group has signalled their intent to promote “a discussion on its evolution and impact will help to improve the available information, providing valuable insights and reflections for assessing the expectations of developing countries and the outcomes of implementation of TRIPS” (Ibid). The hybrid event will take place on Wednesday, 19 March 2025 from 13:00 CET to 16:30 CET in Room S1 of the World Trade Organization. Carlos Correa, Executive Director of the South Centre will provide a history of the TRIPS negotiations including the context, main actors, and the process of the negotiations during the first segment from 14:00 to 14:30 CET. Section 2 of the side event will focus on national experiences; this panel will feature Celso Amorim and Jayashree Watal and will run from 14:30 to 15:15 CET. Celso Amorim is currently Chief Advisor to the President of Brazil for Foreign Policy. Jayashree Watal is currently Visiting Professor at the National Law University, Delhi and an Adjunct Professor at the Georgetown University Law Center. Section 3 of the side event will a panel comprised of experts including Joshua Sarnoff, Raymond P. Niro Professor of Intellectual, Property Law, DePaul College of Law (online), James Love, Director of Knowledge Ecology International (KEI)- (in-person), Ellen ‘t Hoen, Director of Medicines Law & Policy, (in-person), Sean Flynn, Director of the Program on Information Justice and Intellectual Property, American University (in-person), and Sangeeta Shashikant Third World Network –TWN- (in-person). Section 3 will run from 15:15 to 16:15 CET.