• As of May 22, 2025, various tax incentives granted to individuals and corporations, as well as to permanent establishments of foreign residents that invest in the Economic Development Poles for Well-Being (Polos de Desarrollo Económico para el Bienestar) went into effect.

There are currently 25 “Poles for Wellbeing” in different Mexican states such as Veracruz, Oaxaca, Tabasco, Chiapas, Campeche, Chihuahua, Durango, Hidalgo, Sinaloa, Tamaulipas, Guanajuato, Estado de México, Puebla, Tlaxcala, Michoacán and Quintana Roo, which are aimed at strategic sectors such as agribusiness, aerospace, automotive and electromobility, consumer goods, pharmaceuticals and medical devices, electronics and semiconductors, energy, chemicals and petrochemicals, textiles and footwear, circular economy, clean energy, basic metal industries, paper industry, plastics industry, logistics and metal mechanics.

Through the Presidential Decree published in the Official Gazette on May 22, 2025, different tax incentives were granted to be applied during the years from 2025 to 2030 to those who start operations after this date and to those who already have authorization that accredits them as developers of a Pole that:

• Carry out productive economic activities, as determined in each Declaration of a Development Pole.

The incentives consist of:

• Immediate deduction of 100% of the original amount of investment in new fixed assets used to carry out their productive economic activities or those new fixed assets totally related to the activity of the developers, instead of the percentages established in the Income Tax Law which are lower.

• Additional deduction equivalent to 25% of the increase in the expenses incurred for training received by each of its employees or for the expenses incurred for innovation.

In order to be able to apply the aforementioned incentives, taxpayers must comply with several requirements such as:

• To be up to date in the compliance of their tax obligations.

• Have their tax domicile in the Development Pole for Welfare where they carry out their productive economic activities.

• To have the Collaboration Agreement entered into with the Ministry of Public Education regarding dual education; the Investment Project for the development of inventions susceptible of protection through patents or the registration of utility models, or the Investment Project for obtaining initial certification, as the case may be.

Those who apply any of the incentives may not apply jointly:

• The tax treatment for maquiladoras.
• The optional tax regime for groups of companies.
• The tax incentive for trusts dedicated to the acquisition or construction of real estate.
• The tax incentives for film and theater production and distribution, research and development of technology and high performance sports.

There are certain particular requirements, as well as different conditions established in the Guidelines published on the same date, which must be observed in the application of each of the incentives as appropriate.

_{Santamarina y Steta will be pleased to advise you on the application of these interesting tax incentives in case you are a taxpayer who wishes to invest in any of the areas considered within the Development Poles for Wellbeing.}

• As part of the secondary energy legislation published on March 18, 2025, the Energy Planning and Transition Law was published. Its primary objective is to establish and regulate binding planning in the Energy Sector and the strengthening of the Energy Transition, as well as the Sustainable Use of Energy, compliance with obligations regarding Clean Energy and the reduction of Polluting Emissions, maintaining the competitiveness of the productive sectors, in order to contribute to energy sovereignty, justice and self-sufficiency.

One of the key points of the so-called secondary energy legislation that seeks to implement the Constitutional Reform in relation to strategic areas and companies is binding planning based on a social approach aimed at a just energy transition.

In this context, the issuance of these laws raises a new perspective for organizing the energy sector, starting from the vision of binding planning in terms of the provisions of the Energy Planning and Transition Law ("LPTE”), which implies that this law represents a different vision for our country in terms of planning, by establishing that it will be binding, allowing both the public and private sectors to direct all their energy-related actions toward achieving clear, quantifiable, measurable, and verifiable objectives.

It is important to consider that the LPTE should be understood as the umbrella law that will allow for the integration of public policies within a framework where energy policy is linked to social and environmental policy, with the aim of moving toward the implementation of a cleaner energy matrix and thus laying the foundations for the decarbonization of the energy sector based on clean generation and emissions reduction goals.

We can consider this law's approach to be progressive, since for the first time it integrates the social vision that the energy sector must have in order to fulfill one of the fundamental objectives of the constitutional reform regarding companies and strategic areas.

The energy reform seeks to strengthen the role of social actors in the development of energy projects based on the development of a policy whose priority objective is to achieve a fair energy transition by reducing energy poverty. This concept is essential to be able to speak of the social vision with which this new legal framework is intended to be provided, where elements and tools such as the Social Impact Statement, which has objective criteria for its evaluation and ruling, will allow the communities where the energy projects will be developed to have greater acceptance and involvement, which will allow them to reach a successful conclusion with real social benefits accepted by the actors involved.

Another relevant element of the reform is the necessary link between environmental policy, social policy, and energy policy. This will translate into integration and the possibility of energy projects accessing other types of financing, such as thematic bonds, environmental bonds, social bonds, or ESG financing, a fundamental element in the reconfiguration of the energy model.

The LPTE establishes guidelines that seek to consolidate a sustainable model. In a context where decarbonization is a global priority and where environmental standards define access to financing, the lack of clear incentives for projects aligned with these criteria could hinder foreign investment in energy infrastructure. However, proper implementation of secondary legislation with a focus on a just energy transition will translate into greater investment and expansion of the energy sector.

May 19th 2025

• In accordance with the General Health Law, the Ministry of Health (the “SSA”) is responsible for coordinating research on human beings, which may be authorized for preventive, rehabilitative or research purposes, even when there is insufficient scientific evidence of its therapeutic efficacy or when the therapeutic indications of already known products are intended to be modified. 
• Furthermore, the Law states that the Federal Commission for the Protection against Sanitary Risks (“COFEPRIS”) is responsible for the evaluation, issuance and revocation of authorizations in health matters, as well as acts of authority for the regulation, control and promotion of health. 
• Under this premise, since January 4, 2013, it was published in the Official Gazette of the Federation (“DOF”), the Mexican Official Standard NOM-012-SSA3-2012 that establishes the regulatory criteria of an administrative, ethical and methodological nature for the authorization, execution and monitoring of projects and protocols for research purposes for the use of medicines or materials in human beings.
• However, in an effort to modernize the current regulation to the current conditions of the pharmaceutical market, on March 24, 2025, the same SSA published, in the DOF, the Agreement establishing the criteria for the authorization of research protocols in human subjects that have been previously authorized by a foreign regulatory authority (he "Agreement”), providing for the procedure of “Reliance".

GENERAL CONTENT

The purpose of the Agreement is to establish the list of Foreign Regulatory Authorities (“ARE”) and the criteria for the recognition of the authorization of research protocols issued by an ARE, through the procedure based on trusted regulatory practices, that is, the “Reliance”, as well as the criteria for carrying out such authorization, solely for research on human beings.

It is called "Reliance” the act by which a public institution or body authorized to exercise independent regulatory oversight over the development, production, market authorization and surveillance of medical products within its jurisdiction, called the National Regulatory Authority (“RNA”), takes into account and gives considerable weight to the evaluations carried out by another regulatory authority or reliable institution ARE, resulting in a work of simplification and updating of efforts that allow optimizing resources and reducing costs and management times.[1] regarding research protocols for a new molecule or a new use of an existing drug.

Acceptance of international standards must be based on evidence that the authorizations issued by the ARE have undergone a full and independent review by that authority, and that the ARE's requirements are sufficient to meet the regulatory requirements of the NRA, which will remain responsible for the decisions taken and will be held accountable.

Applications must be submitted through the COFEPRIS platform for procedures and services (“DIGIPRiS”). In addition to the normal requirements for submitting applications, a certified, legalized or apostilled copy with a Spanish translation of the clinical protocol issued by the ARE is required. This copy must have been issued no more than one year ago, along with an English copy of the Protocol and Investigator's Manual, with which the authorization to conduct the clinical protocol was obtained, and the Spanish version approved by the respective committees in Mexico.

Finally, the Agreement indicates that COFEPRIS will consider decisions based on regulatory practices of Reliance of the European Medicines Agency (“EMA”), the United States Food and Drug Administration (“FDA”), the Medicines and Healthcare Products Regulatory Agency (“MHRA”) of the United Kingdom and the Canadian Health Agency (“Health Canada”), and will be empowered to deny authorization of the research protocol in the event of sufficient evidence of a lack of safety, quality, efficacy, purity or stability of the Protocol or of serious risks to the research subjects. 

TRANSITORY

• The Agreement will enter into force 60 business days after the date of its publication in the DOF, that is, on Thursday, June 19, 2025.

We are at your disposal for any information related to the impact or scope of the publication of the Agreement on the Recognition of Research Protocol Authorization.

[1] Federal Commission for the Protection against Sanitary Risks. (2021). Case study: Reliance, COFEPRIS, and the international arena.