Introduction and Background
The newly appointed head of Mexico’s Federal Commission for Protection against Health Risks (Cofepris), Dr. Víctor Hugo Borja Aburto, has received robust support from Secretary David Kershenobich. This warm welcome stands in stark contrast to the treatment given to former Cofepris head, Dr. Armida Zúñiga, hinting at unspoken events. The recent meeting between health sector authorities, industry representatives, and the new regulator signifies unity and coordinated efforts. Organized by the Secretary of Health, this gathering included key figures such as Subsecretary Eduardo Clark, Santiago Nieto from IMPI, and Concamin President Alejandro Malagón.
Historical Context and Previous Attempts
Dialogue attempts between stakeholders have been made before, but without tangible results, only empty promises. Under President Claudia Sheinbaum’s administration, there is hope for a more effective collaboration to address the national supply shortage and strengthen production, particularly in the opportunity for exporting to neighboring countries.
Relevance of Instituto Mexicano de la Propiedad Industrial (IMPI)
The inclusion of IMPI is crucial as it strengthens the link between Cofepris through the “linkage” concept—connecting patents and health regulations. This is vital for expediting the authorization of affordable therapeutic options, especially in biosimilar medications, where Mexico lags behind countries like the US and Canada. With an aging population and rising chronic diseases, there’s an urgent need for innovation that balances quality and affordability without compromising intellectual property protection.
The Ongoing Supply Chain Crisis
Despite assurances from official reports that the supply situation has improved, the reality paints a different picture. Mexico continues to grapple with chronic shortages of medications, medical devices, curative materials, and other healthcare supplies for seven years now. This has fueled the growth of a black market worth 30 billion pesos annually, driving up out-of-pocket healthcare expenses and exacerbating inequalities as families allocate larger portions of their income to healthcare.
Government and Industry’s Struggles
Both the government and healthcare supply industry remain entangled in persistent shortages. Despite numerous attempts to rebuild trust and collaboration over the past few years, these efforts have proven futile. Birmex’s Program Institutional 2025-2030 acknowledges past supply chain failures and sets ambitious goals, including increasing national capacity for developing and manufacturing strategic biologics and medications, improving acquisition, importation, and supply conditions, enhancing public sector coverage, optimizing consolidated purchase processes, and ensuring quality, efficacy, and safety standards for products.
New Megacompra Initiative
The new megacompra for 2027-2028 appears more structured, with a magnitude that would make it historically significant. It includes 3,831 product keys (medications, curative materials, devices, and reagents), equivalent to 5,964 million pieces, with an estimated value exceeding 485 billion pesos. IMSS, ISSSTE, and IMSS Bienestar are participating, focusing on digital purchases and monitoring. In February, a market research will be launched for international prices; adjudications will occur in phases: 449 patented medications in April, curative materials in May, generic and oncology medications in June, and remaining blocks by August. To filter out non-compliant companies, a “supply compliance certificate” has been introduced, requiring at least 50% of previous deliveries, though the industry warns of potential cost increases.
Industry Developments
Astellas Inaugurates Global Capacity Center in Mexico
Japanese pharmaceutical company Astellas is making significant moves in Mexico by inaugurating its Global Capacity Center (GCC) in the capital. This strategic positioning places Mexico among Astellas’ three global hubs, alongside Poland and India, concentrating crucial functions in medical research, technology, digital transformation, and innovation. The opening event will be attended by government cabinet members, including Economy Secretary Marcelo Ebrard, Health Secretary David Kershenobich, Manola Zabalza Aldama from CDMX’s Economic Development Secretariat, Japan’s ambassador Kozo Honsei, and Takashi Kawano from the Japan-Mexico Chamber of Commerce and Industry.
Halion Appoints Experienced Consumer Goods Specialist in Mexico
Following its split from GSK in 2022, Haleon, a company specializing in over-the-counter (OTC) daily care products like oral health, pain relief, and vitamins under brands such as Sensodyne, Advil, and Centrum, named Andrés González as its Latin America president. This strategic move aims to strengthen the region’s role in Haleon’s global agenda, integrating González into the Haleon Executive Team. With a rich background in mass-consumer companies like Unilever, Quala, and P&G, González’s appointment reflects Haleon’s interest in understanding Latin American consumer needs amidst the growing significance of consumer health in a context emphasizing self-care, prevention, and health education.
Novo Nordisk Replaces Mexico’s Director
Novo Nordisk, a Danish pharmaceutical company, appointed Patricia Field de León as its new General Director in Mexico. This move aims to bolster innovation and expand access to treatments for chronic diseases like diabetes and obesity. After Valney Suzuki’s successful three-year tenure, Field now enters a competitive market in Mexico, crucial for the region. Novo Nordisk seeks a holistic approach by investing in clinical research, digital transformation, and talent. Field, an economist with an MBA and over 24 years of pharmaceutical and consumer goods industry experience, previously led Novo Nordisk’s Colombian branch for three years, promoting sustainability and access in complex regulatory environments. She also held leadership roles at Biogen, AbbVie, and Mars Inc. in Latin America and the US.
