Read the Conversation
Conversation highlights:
- Strategic reset of the pharma sector: From 2018 recognition as a priority industry to renewed alignment under “Plan Mexico” as a core growth engine.
- Shift from disruption to re-engagement: Post-2019 challenges contrast with current reactivation of trust, dialogue, and institutional collaboration.
- Regulatory normalization underway: Clear improvement in agency capacity and backlog reduction (8,000 → 6,000 files), supported by early digitalization efforts.
- Industrial policy meets nearshoring opportunity: Mexico positioned as a potential API and clinical research hub, with growing alignment to U.S. supply chain diversification.
- Execution gap remains the key constraint: Legal certainty, regulatory agility, and planning discipline are identified as the three critical levers to unlock investment and scale.
EF: Looking back over the last ten years of healthcare in Mexico, what would you say have been the three, four, or five major milestones?
RG: A major milestone for the pharmaceutical industry came in 2018, when it was officially recognized as a strategic priority sector for the country. It marked the culmination of an ambition the industry had pursued for roughly 40 years. When I arrived at the Chamber in 2009, this recognition was already one of our core objectives. Achieving it was a turning point. However, by 2019, that status was effectively brushed aside, and the industry came under heavy criticism, making the following years particularly challenging.
Another defining moment was the industry’s response during the pandemic, with vaccines from Moderna, Pfizer, Johnson & Johnson, and AstraZeneca, the latter produced in partnership with Argentina, with the participation of a Mexican company, Laboratorios Liomont. It was a milestone that demonstrated our capacity and commitment. Yet the negative perception did not fully change at that moment. The situation now is different, with the current government. Starting with the Minister of Health, David Kershenobich, we now have an interlocutor who knows the industry well and has worked with us before.
We also have a solid working relationship with the Ministry of Economy. The minister is doing an effective job, including on the complex front of relations with the United States. Together, we are advancing the “Mexico Plan,” under which the pharmaceutical sector is listed as one of 18 key industries. We have regained our status as a priority industry and are now seen as a potential engine of growth. I do not expect tariffs to be imposed on medicines, particularly on patented drugs, which are essential.
In parallel, we are working with the FDA to position Mexico as an alternative supplier of medicines to the United States, streamlining the entry of our products. U.S. authorities have acknowledged that our standards are equivalent to theirs and are looking to reduce their dependence on China and other countries. They also want Mexico to become an important player in the production of APIs, which is a central focus of our current efforts.
EF: What lessons can be applied to continue improving Mexico’s healthcare ecosystem?
RG: Transparency is fundamental to legal certainty. In April last year, a major tender process was launched but subsequently replaced with a broader scheme of more than 400 open processes involving direct awards and smaller tenders. This shift has made the transition more complex and exposed a critical area for improvement for both the country and the industry. The logistics structure has been significantly reconfigured, and it is still adapting. Throughout this process, the essential roles of logistics operators and distributors, including distribution itself, were never fully recognized.
These actors played three key roles. First, they provided distribution. Second, they consolidated supply from multiple providers, enhancing resilience by enabling others to step in if one supplier failed, thereby helping to prevent shortages. Third, and equally important, they acted as a financial buffer, sustaining continuity in the supply chain by absorbing delays in government payments while maintaining timely payments to industry.
Since their removal in 2019, the system has undergone several design iterations, indicating an ongoing process of adjustment rather than a stable, operational model. There remains an opportunity to simplify and stabilize the framework, learn from experience, and better define the role of each actor to improve efficiency and continuity in the future.
EF: What exactly needs to be unlocked? Is the issue with the Procurement Secretariat, with financing, or is it structural? With whom are these conversations taking place?
RG: The tenders are being overseen by Eduardo Clark, who brings a clear perspective to the process. A key positive development is that he now fully recognizes the importance of proper planning and has launched the 2027–2028 tender, which incorporates lessons learned from experience.
He is actively consulting with IMSS, ISSSTE, the Coordinating Commission of National Health Institutes, and state governments to understand their future needs and consolidate demand. The operator will be Birmex, a decision that presents challenges given its track record, but also an opportunity to strengthen its performance and capabilities.
There is still ample opportunity to contribute constructively. We trust that the authorities will be open to listening and that the model can be refined so it works effectively for all stakeholders. Everyone shares an interest in success. The industry exists to serve patients; products are not withheld, and we act in good faith. We are committed to building confidence through transparency, collaboration, and concrete results.
EF: What progress has been made in strengthening regulatory processes and transparency in Mexico’s health system?
RG: On the regulatory side, the situation has improved significantly compared with the previous six years. Under the current administration, knowledgeable, technically trained professionals have been appointed, and that is already making a meaningful difference. They inherited a complex scenario, and it will naturally take time to fully resolve, but there is now an active, constructive dialogue with the industry. The pharmaceutical sector now has a real channel of communication with the authorities. Pending applications have started to move: there were 8,000; now there are 6,000, so 2,000 have been cleared in just one year.
The expectation is that this positive trajectory will continue and even accelerate with digitalization. We have already developed a platform, Pharmatramix, that allows the companies to submit and track all their applications, from backlogged files to new ones. Built in close collaboration with AMIIF, ANAFAM, AFAMELA, and CANIFARMA, this platform will be handed over to the government so it has full, real‑time visibility into the pharmaceutical industry’s regulatory processes. We are now laying the foundations for a more agile, transparent, and predictable regulatory environment.
EF: From a constructive standpoint, what do you think the priorities on the agenda should be? How can we attract innovation, and what role can Mexico play within the global health sector?
RG: Innovation is essential. We have discussed it extensively with the Ministry of Economy. David Kershenobich knows the research and innovation agenda in depth and is actively driving it. The Plan Mexico sets a target of around 2 billion dollars in research investment.
The pharmaceutical industry has already announced new investments in research and innovation; the main challenge now is streamlining regulation. Argentina is a useful reference: authorizing a clinical protocol that used to take months, takes now about 35 days, which gives them a strong competitive edge. Mexico could achieve similar momentum with greater regulatory agility.
The IMSS covers 70 million people; the research potential in that institution alone is enormous. Mexico has solid researchers, infrastructure, and CROs. The foundations are in place; what is needed is consistent public support and fewer regulatory obstacles. The country has significant potential in clinical research.
Another strategic area is API manufacturing in Mexico, not only for the domestic market but for the entire region to reduce imports from China and India and thus strengthen independence in the region.
Besides, Mexico is already the world’s eighth-largest exporter of medical devices and could grow much further with a more enabling regulatory environment. Removing these barriers would allow Mexico to truly take off.
EF: Thinking about the next 10 years: if you had to make three decisions in 2026 that would impact the future of Mexico, what would they be?
RG: The top priority is legal certainty. Mexico is at a critical juncture because the judiciary has lost much of its independence from the government. It is essential to establish a clear legal framework that defines the future of the Supreme Court, legal proceedings, and the judicial system as a whole. Legal certainty must also cover payment practices, ensuring that obligations are met fully and on time.
The second priority is regulatory agility: removing the bottlenecks that currently hold back the pharmaceutical industry in clinical research and the approval of new products to reach the market and benefit patients who need state-of-the-art technology in their treatments.
Finally, planning. Sound planning guarantees timely supply under competitive conditions, enabling better procurement of raw materials and greater stability. This benefits both the public and private sectors. All three could result in Mexico becoming a pharmaceutical hub for APIs and R&D.
EF: Does the Mexican market already have the size and potential to sustain it?
RG: Under the Plan Mexico, the pharmaceutical industry announced significant investments; among others, Bayer in API manufacturing; Boehringer Ingelheim in plant expansion; Neolpharma in APIs; AstraZeneca in research and expansion; and Carnot in building a new facility. Together, these projects total roughly 17 billion pesos, close to one billion dollars.
All of this is feasible, provided the right conditions are in place. Even under the current framework, investment is already flowing; with a clearer and more agile regulatory path, Mexico could accelerate immediately. The outlook is encouraging, as long as decisions move in a constructive direction.
