Ana G. Alba-Betancourt* and Laura E. Vidal-Correa**
The TRIP’S Agreement includes provisions for access to essential medicines in case of public health crises. The Doha Declaration (2001) reinforces these provisions for developing countries, emphasizing that intellectual property (IP) rights should not hinder access to medicines, thus providing mechanisms for compulsory licenses (CL) of patents. However, our research indicates that the application of Doha mechanisms has been limited in practice.
This article examines the state of affairs in some LATAM countries that have issued CL and explores the specific challenges Mexico faces in implementing them. It is important to distinguish between two types of CL: 1) When a company may request a CL to supply the national market -when negotiations with the patent holder fail-; 2) when the government issues a CL in response to a national emergency, allowing a third party to manufacture or import patented products, without the patent holder’s consent. In both cases, providing for fair and reasonable royalties.
Ecuador’s case: The Leading country in Compulsory Licenses granted in LATAM
Between 2013 and 2017, the Ecuadorian Intellectual Property Institute processed 33 applications for CL, granting 10 of them.[1] The Ecuadorian approach to CL represents a significant advancement in public health access, particularly in ensuring that the population has access to affordable medications. In 2021, the Intellectual Property Office of Ecuador issued a CL for Raltegravir for non-commercial public use, allowing its importation from India. The license was granted to a local company that lacked the necessary commercial authorization, but the substance was considered essential for public health.[2]
A key factor in Ecuador’s relative success with compulsory licenses is Resolution 10-04, enacted in 2010, which provides a clear procedural guideline for the concession of the CL for pharmaceutical patents.[3] Additionally, Ecuador has streamlined the process by allowing online applications with a step-by-step guide[4] which we consider to be of great help in the use of the CL mechanism. Ecuador’s approach to CL represents a pragmatic model to use TRIPS flexibility and expand medicine accessibility, with the collaboration of government and private companies.
Brazil’s case: Prepared for Health Emergencies
In 2007, following unsuccessful negotiations with the patent holder to lower the price of Efavirenz, the Brazilian government issued a compulsory license, allowing the production and distribution of a more affordable generic version.[5]
In 2021, in response to the COVID-19 pandemic, the Brazilian Congress passed a law that significantly restructured the country’s approach to CL. Bolsonaro, then-President vetoed several key provisions: a) the requirement for the patent holder to disclose all necessary information for the effective reproduction of the patented invention, including test results, regulatory data for the marketing approval and biological materials essential for the invention; b) a provision declaring that refusal to provide such information would render the patent invalid due to “lack of enablement”; and c) the authority of the legislative branch to grant CL maintaining that such decisions fall exclusively under the jurisdiction of the executive branch.[6] It is said that Brazil uses CL as a bargaining chip in price negotiations with pharmaceutical companies.[7]
Despite this, Brazil remains one of the most prepared LATAM countries to utilize CL as a public health tool.
Colombia’s case: First CL granted by the Government for a national emergency
Resolution 1579 of 2023, granted a CL for Dolutegravir to improve access to HIV treatment for vulnerable populations. The resolution defines public interest in healthcare, particularly addressing the medical needs of migrants.[8]
The issuance of the CL sparked diverse reactions from stakeholders: the ones against it refer that the CL should remain an exceptional measure, when there is a proven emergency, as the license could undermine innovation, harm economic growth and deter foreign investment. Arguments in favour state that the CL is essential to ensure access to HIV treatment for migrants in Colombia, once they regularize their status. Dolutegravir is the most effective drug, causes fewer side effects than alternatives and granting the license allows for treatment continuity.[9]
The Association for a Just Access to Medicine, agrees that Colombian’s CL is an important step forward in getting fair access to medicines.[10]
Mexico’s case: CL a two-sided challenge
In Mexico, compulsory licensing is regulated under the Federal Law for the Protection of Industrial Property (LFPPI), which establishes specific conditions under which the government can authorize the use of a patented invention without the patent holder’s consent[11]. However, Mexico has historically been reluctant to use compulsory licensing mechanisms for patented pharmaceuticals, despite having legal provisions that allow such actions under specific circumstances.[12] For instance, during the AH1N1 influenza outbreak in 2009, although the General Health Council declared a state of emergency, it did not issue a declaration to trigger compulsory licensing for treatments like Oseltamivir and Zanamivir.
In 2020, Mexico reformed its LFPPI to strengthen provisions for compulsory licensing during health emergencies. Despite these legal reforms, the country has not issued any compulsory licenses. Several factors contribute to this cautious approach. One key reason is that the Mexican government has historically prioritized maintaining a favourable investment climate for multinational pharmaceutical companies. Additionally, the lack of a robust domestic pharmaceutical manufacturing infrastructure capable of producing generic versions of patented drugs has limited the practical implementation of CL.[13]
Moreover, Mexico faces a complex challenge in balancing the right to health and access to essential medicines with patent holders’ right. Particularly in the growing field of biological medicines, which are expected to play an increasingly significant role in healthcare. As highlighted by the Commissioner of COFEPRIS in the Strategic Plan for 2024-2030, there is an urgent need to strengthen the regulatory framework to ensure it can accommodate the unique requirements of biologics without restricting access to essential treatments[14]. This challenge is further emphasized by projections from the Mexican Association of Innovative Medicines, which suggest that biologics could represent nearly 45% of new medicine approvals by 2025.[15] The evolving pharmaceutical landscape presents regulatory hurdles, requiring Mexico to strike a delicate balance between fostering innovation and ensuring that intellectual property rights do not create insurmountable barriers to accessing healthcare solutions.
Final remarks regarding Mexico’s state of affairs
Mexico’s approach to IP protection has been significantly shaped by its trade agreements and historical responses to public health crises. Agreements such as North American Free Trade Agreement (NAFTA), United States-Mexico-Canada Agreement (USMCA), and the Global Agreement with the European Union have established strict IP standards, aligning Mexico’s policies with those of its key trading partners. These agreements not only reinforce patent protections but also create a regulatory environment where compulsory licensing is viewed as an exceptional measure rather than a routine policy tool.[16] [17]
Despite having a legal framework that permits CL, Mexico has historically refrained from employing this mechanism, even in public health emergencies where its use would have been justified. The AH1N1 influenza outbreak (2009) and the COVID-19 pandemic (20220) presented clear opportunities for the government to issue CL in the public interest. However, in both cases, Mexico opted for alternative approaches, such as negotiating lower drug prices with pharmaceutical companies and importing medicines through international partnerships, rather than overriding patent rights. This policy approach reflects a strategic commitment to maintaining strong relationships with multinational pharmaceutical firms and avoiding potential trade disputes with key economic partners. Yet, by prioritizing these considerations, Mexico missed a crucial opportunity to leverage its CL framework to enhance domestic access to essential medicines during critical health crises.
[1] Correa, C., Velásquez G., Acceso a Medicamentos, experiencias con licencias obligatorias y uso gubernamental el caso de la hepatitis C. Documento de Investigación 85, South Center, June 2018.
[2] Smart IP for Latin America, Ecuador: Concede licencia obligatoria, 10 april 2021. Available at: https://sipla.ip.mpg.de/es/noticias/detalles/ecuador-concede-licencia-obligatoria.html
[3] See: Resolución No. 10-04 P-IEPI, Instituto Ecuatoriano de la Propiedad Intelectual. Available at: https://www.derechosintelectuales.gob.ec/wp-content/uploads/PDF/instructivo_concesion_licencias_obligatorias.pdf
[4] See: Resolución de concesión de licencias obligatorias sobre patentes de fármcaso y de agroquímicos para personas naturales y jurídicas sean nacionales o extranjera. Portal único de trámites Ciudadanos, Gobierno de Educador. Available at: https://www.gob.ec/senadi/tramites/resolucion-concesion-licencias-obligatorias-patentes-farmacos-agroquimicos-personas-naturales-juridicas-sean-nacionales-extranjeras
[5] Perez Miranda, R., Exigibilidad del Derecho de acceso a la salud y licencias obligatorias en materia de medicamentos, Conferencia Interamericana de Seguridad Social, 2020. Available at: https://archivos.juridicas.unam.mx/www/bjv/libros/13/6333/12.pdf
[6] Rodrigues Pinho, R. and Mesquita F., Brazil: TRIPS waiver and Compulsory license. Kluwer Patent Blog, July 20, 2022. Available at: https://patentblog.kluweriplaw.com/2022/07/20/brazil-trips-waiver-and-compulsory-license/
[7] Le, V.A. (2022). The Brazilian Case Study of Compulsory Licensing. In: Compulsory Patent Licensing and Access to Medicines: A Silver Bullet Approach to Public Health? . Palgrave Macmillan, Cham. https://doi.org/10.1007/978-3-030-84193-5_5
[8] See Resolucion No. 1579 de 2023, Ministerio de Salud y Protección Social. Available at: https://www.minsalud.gov.co/Normatividad_Nuevo/Resoluci%C3%B3n%20No%201579%20de%202023.pdf
[9] Herrera Sierra, L.F., Rincón Florez, S. and Chaparro Casas, C., Resumen y explicacion de la Resolucion No. 1579, October 2 2023, Universidad del Externado de Colombia, Available at: https://propintel.uexternado.edu.co/la-lucha-contra-el-vih-comentarios-for-against-sobre-la-licencia-obligatoria-del-dolutegravir/#:~:text=la%20Resoluci%C3%B3n%20No.-,1579%20del%2002%20de%20octubre%20de%202023.,para%20someter%20la%20Patente%20No.
[10] Asociación Acceso Justo al Medicamento, Sobre la Resolución de aplicación de licencia obligatoria para dolutegravir de Colombia. 29 de abril, 2024. Available at: https://accesojustomedicamento.org/sobre-la-resolucion-de-aplicacion-de-licencia-obligatoria-para-dolutegravir-de-colombia/ [accessed 17th of March, 2025]
[11] Ley Federal de Protección a la Propiedad Intelectual (LFPPI) 2020, [Federal Law for the Protection of Industrial Property].
[12] The South Centre | The Use of Compulsory Licenses In Latin America. (n.d.). Retrieved March 17, 2025, from https://www.southcentre.int/question/the-use-of-compulsory-licenses-in-latin-america/
[13] Alba Betancourt, A. G., Mancini, L., & Vidal Correa, L. E. (2023). Propiedad Intelectual y Acceso a la Salud: Vacunas en Pandemia. In La Propiedad Intelectual en su Faceta Internacional, Reflexiones Plurales. Instituto de Investigaciones Jurídicas, UNAM. https://archivos.juridicas.unam.mx/www/bjv/libros/15/7196/1.pdf
[14] COFEPRIS. (n.d.). Estrategia Nacional de Buen Gobierno en el Sistema Federal Sanitario 2024-2030. Comisión Federal para la Protección Contra Riesgos Sanitarios.
[15] AMIIF Forecast Report, 2023.
[16] Reichman, J. H., Comment: Compulsory Licensing of Patented Pharmaceutical Inventions: Evaluating the Options. Journal of Law, Medicine & Ethics, (2009). 37(2), 247–263. https://doi.org/10.1111/j.1748-720X.2009.00369.x
[17] EU and Mexico Established the Economic Partnership, Political Coordination, and Cooperation Agreement, Global Agreement (2000)
*Ana Georgina Alba Betancourt
Researcher at the Institute of Legal Research, UNAM.
** Laura Vidal Correa
Professor-Researcher at INFOTEC, Mexico.
