Mexico’s response to critical medicine shortages: legal framework and compulsory licensing in the global context
María del Carmen Hernández Aguilar
Arochi & Lindner, Mexico City
Julio J Copo Terres
Arochi & Lindner, Mexico City
The global pharmaceutical landscape presents unprecedented challenges as critical medicine shortages increasingly threaten public health systems worldwide. Mexico, positioned strategically within the international pharmaceutical market and as a key partner in North American trade, faces unique challenges and opportunities in addressing these shortages. According to the World Health Organization (2016), disruptions in essential medicine supply chains affect a growing number of countries, impacting treatments from basic antibiotics to specialised cancer medications. Within this context, Mexico’s evolving regulatory response offers valuable insights into how emerging economies can navigate the complex intersection of international trade obligations and domestic public health imperatives.
Mexico’s regulatory framework has evolved significantly in recent years, particularly through the 2020 reform of the Federal Law on Protection of Industrial Property (LFPPI) and the establishment of the Federal Commission for Protection against Health Risks (Comisión Federal para la Protección contra Riesgos Sanitarios or COFEPRIS) as a robust regulatory body. This comprehensive legislation strengthens provisions for compulsory licensing while maintaining compliance with international obligations. The reform represents Mexico’s strategic response to medicine shortages, expanding the grounds for compulsory licensing during health emergencies and establishing streamlined procedures for licence issuance.
The intersection of intellectual property rights and public health access in Mexico is particularly complex due to its obligations under multiple international agreements. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, implemented through Mexico’s domestic legislation, establishes minimum standards for intellectual property rights protection, including pharmaceutical patents. While this framework aims to foster innovation through patent protection, it has simultaneously created significant access barriers for Mexico’s healthcare system, particularly in providing affordable medications to vulnerable populations.
COFEPRIS plays a vital role in implementing Mexico’s pharmaceutical regulations, working in coordination with the Mexican Institute of Industrial Property (Instituto Mexicano de la Propiedad Industrial or IMPI) to ensure both intellectual property protection and public health priorities are addressed. This institutional framework enables Mexico to respond more effectively to pharmaceutical shortages while maintaining compliance with international obligations, particularly those under the United States–Mexico–Canada Agreement (USMCA).
Mexico’s position within the USMCA framework introduces additional complexities through TRIPS-plus provisions that often exceed TRIPS minimum standards. These provisions, including extended data exclusivity periods for biological drugs and requirements for patent term adjustments, have generated significant debate among public health advocates. Critics argue that such measures may restrict access to affordable medicines, while proponents maintain they are necessary to incentivise pharmaceutical investment in Mexico.
The evolution of Mexico’s pharmaceutical regulatory framework represents a significant case study in balancing public health imperatives with intellectual property protection in an emerging economy context. According to Mexico’s Secretary of Health, Dr Jorge Alcocer Varela: ‘Mexico’s experience demonstrates that effective pharmaceutical regulation requires continuous adaptation to emerging challenges while maintaining clear focus on public health priorities’ (as cited in COFEPRIS, 2023, p 12). His observation is particularly relevant given Mexico’s unique position at the intersection of international trade obligations and domestic health needs.
The empirical evidence from recent years supports this assessment. Between 2020 and 2023, Mexico’s regulatory reforms have produced measurable improvements in pharmaceutical access. According to COFEPRIS data, the average time for generic medicine approval decreased from 36 to 24 months (about two years), while medicine availability in public health institutions improved from 71 per cent to 86 per cent (COFEPRIS Annual Report, 2023). However, as noted by former Supreme Court Justice José Ramón Cossío, ‘the right to health cannot be fully realised without ensuring both physical and economic access to essential medicines’ (Constitutional Health Rights Symposium, 2023).
Mexico’s strategic approach to pharmaceutical regulation offers several key lessons for other emerging economies. First, as demonstrated by the successful coordination between COFEPRIS and IMPI, strong institutional frameworks are essential for effective implementation of regulatory policies. Second, the country’s experience with compulsory licensing provisions, though not yet fully utilised, shows the importance of maintaining legal mechanisms for addressing public health emergencies. Third, as emphasised by Dr Alejandro Svarch, COFEPRIS Commissioner, ‘regulatory efficiency and public health protection are not mutually exclusive goals, but rather complementary objectives requiring careful calibration’ (Regulatory Science Conference, 2023).
The next outlook in Mexico’s pharmaceutical regulatory framework faces several critical challenges. The implementation of USMCA provisions will require continued attention to maintaining policy space for public health interventions. As noted in the recent World Health Organization assessment, ‘Mexico’s experience highlights the importance of preserving regulatory sovereignty while meeting international obligations’ (WHO Country Assessment, 2023, p 45). Furthermore, the growing importance of biological medicines presents new regulatory challenges that will test the adaptability of Mexico’s framework.
The path forward requires sustained commitment to several key priorities. First, as articulated by COFEPRIS’s Strategic Plan 2024–2030, strengthening domestic manufacturing capacity remains crucial for ensuring pharmaceutical security. Second, continued investment in regulatory capacity, particularly in emerging technologies and complex biologics, will be essential. Third, as emphasised by Mexico’s Chief USMCA Negotiator, Kenneth Smith Ramos, ‘maintaining effective use of TRIPS flexibilities while complying with enhanced intellectual property protections requires sophisticated policy implementation’ (International Trade Forum, 2023).
Mexico’s evolving approach to pharmaceutical regulation demonstrates that middle-income countries can develop effective frameworks for balancing innovation protection with public health imperatives. The success of these efforts depends on sustained attention to both domestic capacity building and international cooperation, supported by clear legal frameworks and strong institutional capabilities. As noted by the Director-General of IMPI, ‘our experience shows that protecting intellectual property and ensuring medicine access are not inherently contradictory goals, but rather complementary objectives requiring careful policy design’ (WIPO Regional Forum, 2023).
The future effectiveness of Mexico’s pharmaceutical regulatory system will depend on its ability to adapt to emerging challenges while maintaining its core focus on public health protection. This evolving framework, supported by strengthened institutions and clear legal mandates, positions Mexico as an important model for other emerging economies seeking to navigate the complex intersection of public health, intellectual property protection, and international trade obligations.
Looking forward, Mexico faces several critical challenges in pharmaceutical regulation. The Commissioner of COFEPRIS articulated these challenges in a recent policy document: ‘We must continue strengthening our regulatory framework while ensuring that innovation protection does not create unsurmountable barriers to medicine access’ (COFEPRIS Strategic Plan 2024–2030). This balance becomes particularly important as Mexico develops its biological medicines regulatory framework, with the Mexican Association of Innovative Medicines estimating that biologics will represent 45 per cent of new medicine approvals by 2025 (AMIIF Forecast Report, 2023).
The convergence of pharmaceuticals with digital health technologies and advanced manufacturing presents both opportunities and challenges for Mexico’s pharmaceutical sector. While these advancements promise more efficient drug development and distribution, their implementation must be carefully considered within Mexico’s unique healthcare system constraints and resource limitations. The country’s regulatory framework increasingly acknowledges these technological developments while maintaining focus on ensuring equitable access to essential medicines.
A significant challenge in Mexico has been the delayed entry of generic medicines into the market after patent expiration. Research by the Mexican Institute for Competitiveness (IMCO, 2023) demonstrates that generic medicines in Mexico require an average of two years to enter the market after patent expiration (p 45), significantly longer than comparable markets in other Organisation for Economic Co-operation and Development (OECD) countries (González-Block & Martínez-Valenzuela, 2023, p 158). This delay impacts both public health systems and individual consumers, particularly affecting the most vulnerable populations.
Mexico’s Supreme Court has traditionally held that, while access to health is a human right, its satisfaction is bound by the existence of a basic catalogue of medicines that public institutions must provide. However, recent judicial interpretations suggest a shift toward broader protection of health rights, including access to medicines not listed in the basic catalogue when medically necessary. This evolution is evidenced by 2,148 complaints filed between 2010 and 2018 before the National Human Rights Commission (CNDH), resulting in nine recommendations and five conciliations.
The country’s approach to pharmaceutical regulation has been significantly influenced by its participation in international trade agreements, particularly the USMCA. The agreement includes specific provisions regarding intellectual property protection for pharmaceuticals while also recognising public health safeguards. Article 20.48.3 of USMCA explicitly allows Mexico to adopt measures to protect public health in accordance with the Doha Declaration on TRIPS and Public Health, providing important flexibility in addressing public health crises.
COFEPRIS has implemented several initiatives to accelerate generic medicine approval processes while maintaining strict quality standards. These include streamlined registration procedures for medicines already approved by trusted regulatory agencies and enhanced coordination with IMPI regarding patent issues. However, challenges remain in achieving a balance between expedited approvals and ensuring product safety and efficacy.
Mexico’s experience offers several important lessons for other developing nations. First, strong regulatory institutions are essential for effective pharmaceutical policy implementation. Second, clear legal frameworks for compulsory licensing and other TRI PS flexibilities must be established before they are needed in emergencies. Third, domestic manufacturing capacity development can significantly enhance pharmaceutical security and access.
The path forward for Mexico requires sustained commitment to reform and innovation in its pharmaceutical regulatory system. This includes further strengthening of institutional capacity, enhancement of coordination mechanisms between health and trade authorities, and continued development of domestic pharmaceutical manufacturing capabilities. Success in these areas will require unprecedented collaboration among stakeholders, including government agencies, international organisations, pharmaceutical companies and civil society organisations.
In conclusion, Mexico’s evolving approach to pharmaceutical access and regulation demonstrates how middle-income countries can balance public health imperatives with intellectual property protection while navigating complex international trade obligations. The success of these efforts depends on continued attention to both domestic capacity building and international cooperation, supported by clear legal frameworks and strong institutional capabilities. By pursuing comprehensive reform while maintaining compliance with international obligations, Mexico continues to develop a more equitable and efficient pharmaceutical system that can serve as a model for other emerging economies.