MEXICO: An Introduction to Life Sciences

Recent Transformation of the Health Regulatory Framework in Mexico

Since 2021, a profound transformation has taken place in Mexico, regarding the health regulatory framework that controls the life sciences industries. This includes:

• health services;
• medical products (medicines and medical devices);
• consumer products (food, beverages and cosmetics);
• chemicals (toxic substances and agrochemicals); and
• restricted goods (tobacco, alcohol and cannabis).

Together, these represent 13% of the Gross Domestic Product (GDP).

At the same time, four convergent regulatory processes were launched towards:

• simplification;
• digitalisation;
• international harmonisation and standardisation; and
• regulatory reliance.

Regarding simplification, many authorisations were transformed into simple notifications, beginning with subsequent renewals of marketing authorisations for medicines and medical devices. A modality of immediate resolution requests (which are now resolved within 24–48 hours) was also introduced, and applies to medicines, medical devices and pesticides. Also, further deregulation mechanisms were deepened, in relation to medical devices.

Regarding digitalisation, the process began with the most common procedures (such as the notice of operation) and later included various forms of authorisation (such as establishment licences, activity permits and product approvals for medical products, agrochemicals, consumer products and health services). It is claimed that more than a third of Federal Commission for Protection against Health Risks (COFEPRIS) procedures have now been digitalised.

Regarding international harmonisation and standardisation, COFEPRIS expanded its membership to key international regulatory forums, such as the International Council for Harmonisation (ICH) and the International Medical Devices Regulators Forum (IMDRF), which directly impacted on the modernisation of technical standards, such as NOM-059 on Good Manufacturing Practices (GMP) for medicines or NOM-241 on GMP for medical devices.

Regarding regulatory reliance, COFEPRIS went through different stages of experimentation. First, after the public health sector experienced major shortages of medical products, COFEPRIS allowed – in an untidy fashion – the importation of medical products that did not have local product approval. Subsequently, Mexico embraced the conceptualisation of regulatory reliance, as proposed by the World Health Organization (WHO) and the Pan American Health Organization (PAHO). This was then formally introduced for approvals of clinical trials. Finally, and very recently, regulatory reliance was also implemented for the approval of medicines and medical devices (in an ambitious way), aiming not to expand prior evaluations completed by other internationally recognised regulators, including members of the ICH, the IMDRF and the WHO-Listed Authorities (WLA).

Meanwhile, major policy changes have occurred, where the pharma and medtech sectors were listed as strategic sectors in the Plan for Mexico, a presidential proposal seeking to reactivate the national economy and industrial infrastructure. This is the first time that a Mexican government has fully recognised the economic and industrial potential of these industries, achieving the highest level of priority in the policy agenda. It stands in stark contrast to the stance towards these industries that the previous federal administration (from the same political party) had taken.

Explosion of Regulatory Litigation

Despite all the promising developments described above, the process has also been painful. The prior federal administration, due to concerns over corruption, had instructed COFEPRIS to distance itself from the regulated industries and had plenty of experienced officers replaced. This resulted in an exponential growth of the backlog of pending approvals. Regulatory delays reached a critical point that forced companies to consider litigation. They began litigating delays of product approvals and ended up challenging the whole spectrum of regulatory decisions.

To put that into context, COFEPRIS handles two major systems:

• a system of inspections and sanctions; and
• a system of authorisations and notifications.

Historically, companies had only litigated sanctions. It was thought that litigating inspections was too difficult and that litigating decisions over approvals could result in some form of retaliation. However, after tasting a large wave of litigation success, achieving great outcomes in shorter periods of time, companies were encouraged to challenge all kinds of decisions.

Plenty of litigation took place in relation to pending approvals, due to the existence of an old default-rule system, designed to fix the occurrence of an administrative silence. When a legal deadline is exceeded, for approving or rejecting a request, one of two things can happen:

• a request is regarded as tacitly approved (known as an afirmativa ficta); or
• a request is regarded as tacitly rejected (known as a negativa ficta).

This default system had existed for a long time but had not been used before.

Both avenues for administrative litigation exploded – ie, nullity trials and amparo trials. Regarding the former, the Federal Tribunal of Administrative Justice – which almost a decade ago had created a Specialised Chamber for Regulatory Matters – had to open a second Specialised Chamber for Regulatory Matters, further consolidating what is called specialised jurisdiction. All of this has fuelled an evolution of health law, both on substantive and procedural issues.

For instance, a key to the significant success regarding the litigation of both inspections and explicit rejections of product approvals has been correctly articulating the notion that the main legal and conceptual foundation of the health regulatory framework is not the vague objective of health protection but the concrete notion of risk, which must be proven. This results from the international and constitutional obligation to take decisions based on science and risk analyses.   

This litigation trend has seen major successes in relation to (among others):

• challenging rejections of GMP certificates for medicines;
• rejection of marketing authorisations for medical devices;
• modification of pharma manufacturing licences;
• closures of hospitals;
• rejection of import permits; and
• removal of illegal safety measures (eg, suspension of activities and products seizures).

Other Regulatory Actions

On a different front – and one which is also key for the life sciences industries – there have been major developments in relation to antitrust law.

In late 2024, the Antitrust Authority filed its first collective action in history against three drug distributors and their industry association, demanding MXN2.316 billion of compensation from the infringing companies as a result of their being found guilty of cartel conduct by agreeing, over a ten-year period, to:

• not distributing medicines on certain days of the year;
• limiting the quantity of medicines supplied to pharmacies; and
• manipulating sales prices and limiting discounts to pharmacies.

Then, in 2025, a new antitrust law was issued, which contains major changes that will impact the life sciences industries. This includes:

• the creation of a new National Antitrust Commission (NAC);
• new strengthened powers for the NAC to conduct inspections, conduct surveys and collect data using broader tools;
• increased penalties for monopolistic practices; and
• a special regime for state-owned enterprises.

To recall, the Antitrust Authority has always identified the life sciences industries – particularly pharma and medtech – as a priority for enforcement. Historically, these sectors constituted testing grounds for any new antitrust tool. For instance, the first criminal action brought against natural persons, for violations of antitrust obligations, was initiated in relation to medtech.