REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot207710.32687/1561-5936-2026-30-3-325-331Original ArticleImplementation of TRIPS agreement provisions in Malaysian legislation: the practice of compulsory licensingMamedovDevi D.ofc.d.mamedov@gmail.comSaint Petersburg State Chemical Pharmaceutical University, Saint Petersburg, Russia2809202630332533129092026Copyright © 2026,2026In the context of rising prices for innovative medicines, significantly outpacing medical inflation, mechanisms for the use of inventions without the authorization of the patent holder are becoming an important tool for ensuring access to therapy. This article analyzes the implementation of the TRIPS Agreement provisions into Malaysian legislation. Based on the 2003 and 2017 precedents of utilizing compulsory licensing, the article examines the regulatory procedures, grounds for issuing authorizations, and legal consequences, including the reaction of patent holders and the international community. The advantages and regulatory risks of the Malaysian model are identified. The countrys experience is relevant for the improvement of legislation in the Russian Federation.compulsory licensingTRIPS AgreementDoha Declarationmedicinal productsHIV/AIDSpatent lawMalaysiareviewпринудительное лицензированиеТРИПСДохинская декларациялекарственные средстваВИЧ/СПИДпатентное правоМалайзияобзор[Dusetzina S. B., Jazowski S. A., Nayak R. K. et al. Trends in launch prices and price increases for self-administered anticancer drugs in Medicare. JAMA. 2025;334(6):536—538. doi: 10.1001/jama.2025.6366][Saltonstall P., Ross H., Kim P. T. The Orphan Drug Act at 40: legislative triumph and the challenges of success. Milbank Q. 2024;102(1):83—96. doi: 10.1111/1468—0009.12680][Wouters O. J., McKee M., Luyten J. Estimated research and development investment needed to bring a new medicine to market, 2009—2018. JAMA. 2020;323(9):844—853. doi: 10.1001/jama.2020.1166][Li Z., Guo P. Compulsory licensing of pharmaceuticals during public health crisis: a TRIPS framework analysis. Front. Public Health. 2025;13:1630586. doi: 10.3389/fpubh.2025.1630586][Rungpry S. K. Compulsory licensing issues and trends in Asia. Pharm. Pat. Anal. 2013;2(6):681—683. doi: 10.4155/ppa.13.60]['t Hoen E. F. M. The Global Politics of Pharmaceutical Monopoly Power. Diemen; 2009.][Beall R., Kuhn R. Trends in compulsory licensing of pharmaceuticals since the Doha Declaration: a database analysis. PLoS Med. 2012;9(1):e1001154. doi: 10.1371/journal.pmed.1001154][Ling C. Y. Malaysia's experience in increasing access to antiretroviral drugs: exercising the "government use" option. Penang; 2006.][Khor M. Compulsory license and "government use" to promote access to medicines: some examples. Penang; 2014.][Hanim L., Jhamtani H. Indonesia: manufacturing generic AIDS medicines under the government use approach. Third World Resurgence. 2006;(196):30.][Urias E., Ramani S. V. Access to medicines after TRIPS: is compulsory licensing an effective mechanism to lower drug prices? A review of the existing evidence. J. Int. Bus. Policy. 2020;3(4):367—384. doi: 10.1057/s42214-020-00068-4][Pandele Y. The story of a "political drug" against hepatitis C. Geneva; 2021.][Chan H., Hassali M. A., Md Said R. et al. A two-year outcome evaluation of government-led initiative to upscale hospital-based hepatitis C treatment using a standard two-drug regimen in Malaysia. Hepat. Mon. 2021;21(3):e113226. doi: 10.5812/hepatmon.113226]