access to medicines – Centre on Knowledge Governance

Malaysia exhorts Human Rights Council to prioritize the primacy of public health and human rights over commercial interests

InfoJustice Eds. / 30 June, 2025

This post was originally published on KEI Online by Thiru Balasubramaniam On Tuesday afternoon, 24 June 2025, the Core Group (Bangladesh, Brazil, China, Egypt, India, Indonesia, Senegal, South Africa, Thailand) convened an informal consultation to consider the revised version draft resolution, “Access to medicines, vaccines and other health products in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health” in Room XXVII of the United Nations Palais des Nations. At the informal, Malaysia proposed textual amendments to the resolution and highlighted the limits of certain voluntary licensing arrangements, most notably Gilead and lenacapavir. Malaysia acknowledges that voluntary licensing arrangements have in some instances contributed to expanded access to medicines. However, we must express our reservation that these arrangements have too often failed to ensure adequate, affordable, and timely access to life-saving medical technologies for many developing countries. As noted in the report of the UN Secretary-General’s High-Level Panel on Access to Medicines, right holders frequently retain the unilateral authority to exclude countries from license agreements—effectively denying access to those most in need. This practice fails to meet the principles of equity and solidarity that global health governance aspires to uphold. A stark illustration of this issue is the case of Gilead Sciences and its antiretroviral drug, Lenacapavir. Despite being a promising long-acting injectable treatment for HIV, Gilead’s voluntary license explicitly excluded developing countries, including Malaysia and many others in Asia, Latin America, and Eastern Europe. These are regions with growing HIV burdens and constrained health budgets, yet they are excluded from generic supply due to the originator’s commercial strategy. Such exclusions highlight a systemic problem: when commercial interests are prioritized in voluntary licensing models, the public health needs of developing countries are marginalized. Therefore, we propose language that tackles the structural shortcomings of voluntary licensing, underscores the pressing concerns of many developing countries in accessing life-saving medicines, and advocates for a more equitable, transparent, and needs-driven framework for access to critical medical innovations. In moving forward, we reaffirm the need for legally certain, transparent, and inclusive mechanisms that prioritize public health over commercial discretion—ensuring that no country is left behind in accessing life-saving medicines, vaccines, and technologies. With respect to the draft resolution, Malaysia stated underscored the exigent need for “strengthened international cooperation and solidarity that prioritizes the primacy of public health and human rights over commercial interests”. Malaysia asserted that TRIPS-plus provisions in trade agreements effectively infringe on the right to health and called on developed countries to “refrain from exerting pressure—whether through trade negotiations, diplomatic influence, or investment agreements—on developing countries to adopt intellectual property protections that exceed TRIPS obligations”. We acknowledge the important guidance provided in the 2009 Report of the UN Special Rapporteur on the Right to Health (A/HRC/11/12), which calls upon developing and least developed countries to refrain from introducing TRIPS-plus provisions into national law, and urges developed countries to desist from promoting such provisions through bilateral or regional trade and investment agreements. We express deep concern that TRIPS-plus provisions—including extended patent terms, data exclusivity, patent linkage, and restrictions on compulsory licensing—go beyond the minimum standards required by the TRIPS Agreement, and risk undermining public health safeguards, delaying access to affordable generic medicines, and increasing healthcare costs, thereby infringing upon the right to health, particularly in developing countries already struggling to meet the health needs of their populations. We caution against increasing trends of developed countries to circumvent international based IP rule through bilateral trade agreements to impose their own IP agendas such as TRIPS plus provisions on developing nations, potentially undermining the multilateral system. We further emphasize that developed countries should refrain from exerting pressure—whether through trade negotiations, diplomatic influence, or investment agreements—on developing countries to adopt intellectual property protections that exceed TRIPS obligations. Such practices restrict national policy space, compromise the ability of States to protect public health, restricting access to affordable health products, and risk undermining the integrity of the multilateral rules-based system. Malaysia calls for strengthened international cooperation and solidarity that prioritizes the primacy of public health and human rights over commercial interests. We urge all Member States to ensure that their trade and intellectual property policies are aligned with their obligations under international human rights law, including the right to health, and to reaffirm their commitment to preserving policy space, resisting TRIPS-plus measures, and working toward an international system that places human dignity and health equity at its core. Malaysia proposed the insertion of the following language including a peace clause in Op 4 bis. New PP Acknowledging that voluntary licensing arrangements, while beneficial in some contexts, have often failed to provide adequate, affordable, and timely access to life saving medicines for some developing countries that are usually excluded from the scope of licenses, as right holders reserve the right to identify countries where they intend to sell the product directly or through other agreements; (part from the Report of the UN Secretary General’s High-Level Panel on Access to Medicines) New PP Acknowledging the 2009 Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health that calls for developing and least developed countries to not to introduce TRIPS-plus provisions in their national laws and developed countries should not encourage developing countries and LDCs to enter into TRIPS-plus FTAs and should be mindful of actions which may infringe upon the right to health.; (Ref A/HRC/11/12 pg 29 para 109)New PP Recalling the 2021 Political Declaration on HIV and AIDS that calls for ensuring that intellectual property rights provisions in trade agreements do not undermine existing flexibilities, as confirmed in the Doha Declaration on the TRIPS Agreement and Public Health (A/RES/75/284 para 68(a)) New Op 4 bis: Call upon States to exercise restraint in undertaking international legal obligations which directly or indirectly undermines the freedom to make use of the TRIPS flexibilities and also urges States to monitor the implications of voluntary licenses in facilitating availability, accessibility and affordability

Malaysia-EFTA Economic Partnership Agreement (MEEPA) Would Tie Malaysia’s Hands on Access to Medicines

Brook K. Baker, Prof. Emeritus, Northeastern U. School of Law, Senior Policy Analyst, Health GAP The MEEPA is a tentatively concluded trade agreement between Malaysia and EFTA (the European Free Trade Association of Iceland, Liechtenstein, Norway and Switzerland) that may soon be signed by the Malaysian government. Malaysian negotiators have accepted intellectual property (IP) protections above those required by the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which will adversely and needlessly affect affordable and equitable access to medicines in Malaysia for generations. The Malaysian government should instruct its negotiators to reject all of the TRIPS-plus measures discussed below. The TRIPS-plus demands of EFTA are in line with similar demands from the European Union and the United States in their trade agreements that seek to extend monopoly power for Northern biopharmaceutical companies. These companies seek to expand IP that prevents competition so that they can impose exorbitant (and often secret) prices on middle-income countries like Malaysia. The result is gross profiteering at the expense of governments, insurers, and patients, who are often priced out of the market. Contrary to MEEPA Article 7.1, Malaysia Should be Permitted to Retain its Existing Right to Issue Compulsory Licences for Failure to Work a Patent Locally Article 7.1 of MEEPA would prevent Malaysia from relying on Section 49 of its Patent Law to issue compulsory licences for failure to work the patent through local manufacture when such manufacture is feasible. Article 7.1 of MEEPA states: ‘In line with TRIPS Article 27 (1), importation and offering on the market shall be considered a way of exploiting the patent in the country of importation. Accordingly, a compulsory licence may not be granted on the sole ground that a product protected by a patent or a product incorporating a patented process is being imported and not locally produced or used.’ In contrast, Section 49(1) of the Malaysian Patents Act states: At any time after the expiration of three years from the grant of a patent, or four years from the filing date of the patent application, whichever is the later, any person may apply to the Registrar for a compulsory licence under any of the following circumstances: (a) where there is no production of the patented product or application of the patented process in Malaysia without any legitimate reason; (b) where there is no product produced in Malaysia under the patent for sale in any domestic market, or there are some but they do not meet public demand without any legitimate reason. Article 5A(2) of the Paris Convention, which is incorporated by reference into the TRIPS Agreement via Article 2.1, authorizes countries to provide for compulsory licences in case of failure by the patentee to work the patent domestically. [1] There are time limits affecting when such licences can be issued: the last of either four years from the filing of the patent application or three years after it grant. Although the scope of working rules is not without some controversy,[2] an interpretation that local working requires at least some degree of in-country manufacturing and is TRIPS compliant, at least with respect to the issuance of compulsory licences, has broad support.[3] India, Brazil, Malaysia itself, and other countries, including the Philippines, still have laws allowing compulsory licenses when a patent is not worked via local manufacture or licensed to a local producer.[4] Likewise, Malaysia should fight to retain the right to issue compulsory licences on the grounds that a patent is not manufactured locally even though it is economically feasible to do so. Allowing compulsory licenses for failure to manufacture locally enables Malaysia to secure technology transfer, to expand its biopharmaceutical manufacturing capacity, and to help ensure security of supply, including it cases like the COVID-19 pandemic when foreign producers preferentially supplied high-income country demand. Contrary to MEEPA Article 7.3(a), Malaysia Should Maintain the Right to Have an Exception to Patent Rights for Therapeutic Uses of Patented Products. Article 7.3(a) of the MEEPA IP Chapter permits excluding methods of treatment from patentability: “Each Party may also exclude from patentability: any invention of a method for treatment of the human or animal body by surgery or therapy or for diagnostic methods practised on the human or animal body.” But subsection (a) also adds a disabling exception to this exclusion that would ultimately require Malaysia to issue evergreening use patents on biopharmaceutical products: “This provision (i.e. the exclusion) shall not apply to products, in particular substances or compositions, for use in any of these methods.” Article 27.3(a) of the TRIPS Agreement allows each WTO Member State, including Malaysia, to exclude from patentability: “diagnostic, therapeutic and surgical methods for the treatment of humans or animals.” This exclusion has been consistently interpreted to allow countries to disallow patents on uses, including new uses, of previously patented biopharmaceutical products. As a result, many countries limit patents on new or additional uses of known substances (in the pharmaceutical context new indications), and many experts and expert reports have recommended that low- and middle-income countries adopt per se exclusions for patents on new uses or methods of use.[5] Exclusion of new use or method of use patents is expressly permitted by Article 27.3(a) of the TRIPS Agreement, which permits exclusions of patents on “diagnostic, therapeutic and surgical methods.” Under this approach, “there is no real difference between patent claims relating to the use of a substance and those relating to a therapeutic method: in both cases a new medical activity is claimed, i.e. a new way of using one or more known products.”[6] Andean Community patent law explicitly stipulates that both products and processes already patented and included in the state of the art may not be the subject of a new patent on the sole ground of having been put to a use different from that originally contemplated by the initial patent. India explicitly prohibits patenting of all new uses and methods of use under section 3(d) of its Amended (2005) Patents Act as does Argentina, Pakistan, and the