Mexico: Government promotes reforms and amendments to health legislation to strengthen control of health products and services

The current and past government administrations have placed special emphasis on matters related to human, animal, and plant health. These circumstances have led to a significant number of reforms and restrictions on the importation, marketing, and use of diverse products and rendering of services related to these areas.

Recently, a considerable number of reforms to the legal provisions in this field have been proposed, particularly to the General Health Law (LGS). Some of the proposed reforms concern restrictions and prohibitions on specific products and services, while others focus on the health authorities’ activities and the implementation of public health services. Notable topics include digital health, blood derivatives, domestic investments in the pharmaceutical production chain, health supplies and medical devices, as well as the development of scientific research and innovative health products.

These amendments essentially relate to the following products, services, and powers:

• Vapers, precursors, and toxic products

On January 17, 2025, the Decree adding a fifth paragraph to Article 4 and a second paragraph to Article 5 of the Political Constitution of the United Mexican States in matters of health protection was published in the Federal Official Gazette (DOF), with the purpose of prohibiting the production, distribution, and sale of electronic cigarettes, vaping devices, and other similar electronic systems or devices.

This prohibition is based on the alleged toxicity and the impact on public health institutions, which allocate resources to address the risks and to treat patients with conditions derived from the use of these devices, particularly among minors.

It is proposed to add subsection (c) to Article 414 Bis, relating to the possibility to seize these products, as well as adding Article 456 Bis, which criminalizes various activities involving these products and establishes penalties of one to eight years in prison and fines.

Additionally, the decree includes provisions on the illicit use of toxic substances, chemical precursors, and synthetic drugs. It proposes amending Article 234 of the General Health Law (LGS) to add certain substances as narcotics and prevent their illicit trafficking by introducing stricter measures to regulate their use and prevent their diversion.

Furthermore, pesticides that are highly hazardous due to particularly high acute or chronic exposure to human health or the environment are regulated, with the aim of defining criteria for the identification of highly hazardous pesticides (HHPs) based on internationally recognized classification systems, such as FAO-WHO, the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), the United States Environmental Protection Agency (EPA), the WHO International Agency for Research on Cancer, etc., and to restrict the issuance of new registrations.

• Consolidated contracts and administrative benefits

On the other hand, various modifications are proposed regarding consolidated procurement of medicines, high-tech medical equipment, and other health supplies, which will be carried out under the leadership of the Ministry of Health, in accordance with the publication on November 28, 2024, in the DOF which amends the Organic Law of the Federal Public Administration, and establishes new powers of various agencies, including sections VII and XXII of Article 39 of said Law, which establishes that the Ministry of Health is responsible for coordinating and preparing the diagnosis of needs for medicines and other health supplies and high-tech medical equipment.

It also aims to incorporate provisions that allow for the implementation of actions related to the so-called Plan Mexico, which seeks to develop actions that allow for a better relationship with the pharmaceutical industry and promote Mexico as a hub for research and production of medicines and other health supplies.

Within this proposal, a fundamental element is that in the consolidated procurement procedures for medicines, medical devices, and other health supplies, the participation of individuals or legal entities that have investments in the production chain of medicines, medical devices, and other health supplies in the national territory, or that have begun to set up factories, laboratories, or warehouses that form part of this chain, or that carry out scientific research and develop innovative products, is promoted.

Expedited procedures are established for processing applications for health registrations of medicines and health supplies whose manufacturer holds a sanitary license for a manufacturing facility or laboratory producing medicines or biological products for human use within Mexican territory. The proposal also grants powers to the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) to simplify and accelerate procedures, enabling the private sector to comply effectively with regulations.

It is worth mentioning that granting of marketing authorizations for medicines, in which certificates issued by competent authorities in the country of origin will be recognized, provided that mutual recognition agreements are in place. In this regard, the incorporation of the Federal Health System is proposed, establishing COFEPRIS as the entity responsible for coordinating and supervising health control units in the federal entities through the execution of cooperation agreements, for the exercise of powers in matters of regulation, control, oversight, and sanitary promotion, as well as with state laboratories that are part of the National Network of Public Health Laboratories.

• Verification and oversight powers

Health surveillance is strengthened as part of COFEPRIS’ powers, which includes monitoring the safety of products, goods, and services regulated under the General Health Law (LGS), with the aim of ensuring the safety and quality of the products upon which authorizations are granted.

This surveillance includes the exercise of healthy control and will apply to the production, import, and export of food, non-alcoholic beverages, alcoholic beverages, dietary supplements, cosmetic products, hygiene products, and tobacco, as well as the raw materials and, where applicable, additives involved in their production, or any other product for human use or consumption that may pose a health risk to the population.

Additionally, COFEPRIS’ powers are reinforced to allow verification visits to be carried out through electronic means, as well as the processing of procedures before health authorities electronically, with the aim of improving service times for individuals, reducing costs, increasing efficiency and transparency, and improving the quality of services to provide certainty to the industry.

• Hemoderivatives and blood products

The regulation of blood derivatives is incorporated to enable the organization of their production within the national territory as a means of promoting research in this field.

The regulation of blood derivatives is considered crucial to ensuring the safety, efficacy, and availability of products such as coagulation factors, immunoglobulins, and albumin.

The terms “blood products”, “stem cells”, and “residual plasma” are added to the Law to ensure terminological accuracy. Likewise, the definition of stem cell bank is introduced to determine its scope and responsibilities.

Principles to be followed in the donation of blood, blood products, and stem cells are also added, establishing that such donations must be free, voluntary, altruistic, and intended to be repeated, without commercialization or profit in these activities.

Similarly, criteria are included for donor selection and for the person legally authorized to request a blood transfusion, specifying that a physician will be responsible for monitoring the transfusion process and any adverse reactions.

In addition, the Ministry of Health will determine blood distribution in cases of emergency and will establish the rules and conditions to be followed by the National Health System for the availability of blood and blood products.

Within the third paragraph, Article 341 is included, which requires facilities to inform the Ministry of Health about the use and disposition of blood, blood products, and stem cells.

• Digital health

Digital health is incorporated as a matter of general health, and a new chapter is added establishing provisions that constitute the regulatory framework for these services, viewing them as an opportunity to leverage information and communication technologies to optimize healthcare and related fields.

It is proposed to include a new Chapter VI Bis in Title Three, titled “Digital Health”, introducing the concept defined as the application of information and communication technologies in health services, including, among others, telehealth, telemedicine, mobile health, electronic medical or health records, and wearable devices.

This chapter also sets out the objectives of digital health. The Ministry of Health will be responsible for issuing regulations for the implementation, supervision, and continuous improvement of digital health services, as well as the guidelines that public health service institutions must consider for their implementation. Finally, telehealth is defined along with the conditions for its implementation.

In this context, it is proposed to include digital health as part of general health, which would make it possible to generate real-time information to enable more efficient services and inter-institutional management, and to provide inputs that facilitate data analysis and the development of evidence-based public policies. This would apply both to the Ministry of Health and various institutions, with the aim of identifying obstacles in administrative procedures and simplifying them through the digitalization of processes.

• Medical liability

The handling of complaints regarding the provision of medical care services is incorporated through the National Medical Arbitration Commission (CONAMED), with the aim of contributing to the improvement of healthcare service quality and public safety by providing access to alternative dispute resolution mechanisms in this field.

The proposal calls for the inclusion in the General Health Law (LGS) of alternative dispute resolution mechanisms, to promote their application among healthcare service providers and the public, thereby achieving:

• Access to justice in health services matters.
• Defense of human and ethical rights.
• Protection of the balance between rights and obligations.
• Strengthening trust and credibility in the health system.
• Prevention of mass judicialization of the health system.
• Promotion of dialogue and peaceful conflict resolution.
• Reduction in inequalities in access to health services.
• Promotion of the health system sustainability.

The proposal includes incorporating into the General Health Law (LGS) the handling of medical complaints through CONAMED to help improve the quality of health services and patient safety by providing access to alternative dispute resolution mechanisms.

It is proposed to create a specific chapter in Title Three of the Law, “Chapter IV BIS,” titled “On the National Medical Arbitration Commission”, which would regulate alternative dispute resolution mechanisms in the context of the provision of health services. The aim is to ensure that medical complaints are addressed through the National Medical Arbitration Commission to improve the quality of health services and guarantee patient safety.

The proposal also seeks to incorporate alternative dispute resolution mechanisms in health services, as provided in the General Law on Alternative Dispute Resolution Mechanisms, for resolving conflicts arising from the provision of health services.

If the reforms to the LGS are approved as proposed, various positive and negative effects could result in the operations of health-regulated products and services. Some provisions could also be considered contrary to various trade agreements and free trade treaties entered by Mexico (for example, Plan Mexico).

The expansion of authorities’ powers without clear processes and legal grounds opens the possibility for increased verification and restrictions on products that are not currently expressly subject to control by health authorities.