CMS Woodhouse Lorente Ludlow > Mexico City, Mexico > Firm Profile

CMS Woodhouse Lorente Ludlow
PASEO DE LA REFORMA 115, 15TH FLOOR
COL. LOMAS DE CHAPULTEPEC
CP 11000, MEXICO
Mexico

Mexico > Energy and natural resources Tier 1

Having historically played a major role in advising the Mexican government on an overhaul of the electricity market and restructuring the Federal Electricity Commission (CFE), CMS Woodhouse Lorente Ludlow is an established powerhouse of the Mexican energy and natural resources space, advising international and national private clients on the full range of matters. Under the López Obrador administration, a focus on energy sovereignty and a protectionist outlook has resulted in an increased contentious workload. Other regular instructions include handling business agreements of all types across electricity generation (both traditional and renewables), and up-, mid- and downstream oil and gas. Practice co-heads Derek Woodhouse and Luis Fernandez Lagunas have extensive experience advising government bodies, as well as companies dealing with such; Woodhouse has notable expertise regarding power generation and PPPs, and Fernandez Lagunas across a range of energy project types. Giancarlo Schievenini is a key contact in transactional and regulatory matters, and senior associate Gabriel Salinas provides additional expert support on electricity matters. Fellow senior associate Manuel Ferrara - formerly at energy regulatory body, CRE - is a litigator with experience in energy-related controversies.

Practice head(s):

Derek Woodhouse; Luis Fernández Lagunas

Testimonials

What makes the CMS team stand out, particularly Manuel Ferrara, is the exhaustive analysis he performs of client documentation, which allows him to fully understand the regulatory status of clients, including technical documentation. Which is extremely important in the regulatory part because the permits that must be requested depend on it. This analysis has helped us to conclude that certain permissions that we considered necessary are not really necessary.

Key clients

Walmart

Suburbia

Troy Energía

Thermion

EDF

CDPQ

CKD IM

Corporación Inmobiliaria Vesta

Thermion

Brillo Desarrollos SPV 7

Promotora Ibe

Vitol Electricidad de México

Banverde Solar I

Liberty GTS

Work highlights

  • Advising Walmart, Suburbia, Troy Energía, Thermion, EDF, CDPQ, and CKD IM, on combatting a CRE (Energy Regulatory Commission) and CFE (Federal Electricity Commission) resolution resulting in transmission fees for legacy projects increasing by 500% – 800%.
  • Advising Vesta on the implementation of an electricity resale scheme according to the electricity industry law within its industrial parks.
  • Assisting Banverde with a credit agreement and in regard to a guaranteed trust agreement.

Mexico > Projects and infrastructure Tier 2

In the words of its clients, ‘professional’, ‘up-to-date’ and ‘highly specialised’ are some of the standout qualities of CMS Woodhouse Lorente Ludlow’s 12-strong team. The group is frequently sought out by private and public sector clients for its wide-ranging projects and infrastructure experience, and assists with PPPs and financing for toll roads, railroads, highways, hospitals and hydrocarbons projects. A recent highlight saw it advise the Mexican government on a new international border crossing between Tijuana and San Diego. Founding partner Enrique Lorente Ludlow steers the practice and specialises in matters ranging from the design, structuring, financing, construction and operation of projects. A pair of younger partners provide key support: Giancarlo Schievenini handles all aspects and stages of infrastructure project development, including financing, and has significant expertise in toll roads concessions; and the ‘always attentiveFernando Nava Herrera, majors on project finance and PPPs and stands out for his ‘personalised service, empathy and skill’. Marcia Santome Sanchez completes the senior team. Senior associate José Antonio Ruiz P, active on project development, regulatory matters and financing, is an additional key contact.

Practice head(s):

Enrique Lorente Ludlow

Testimonials

The firm is up-to-date and highly specialized in infrastructure projects; their work is of a higher standard than that of other firms in the same field.

Enrique Lorente Ludlow and Fernando Nava Herrera – personalized service, empathy and skill.

CMS remains at the forefront; its well-prepared lawyers work as a team and provide exhaustive analyses for PPPs, concessions and public works.

Their knowledge of the subject and the market allows them to have greater business understanding. The diversity in the practice areas that the firm offers allows for a comprehensive service. The partners demonstrate leadership, motivation, commitment to their work and collaboration.

Professionalism and technical knowledge.

Fernando Nava showed interest in the development of the case from the beginning; he was always attentive and clarified the differences between Mexican and US legislation.

Key clients

Grupo Typsa

Grupo INDI

Mota-Engil México

Gobierno del Estado de Durango

Grupo Aeroportuario del Pacífico

Secretaría de Comunicaciones y Transportes

Grupo Osme

Valorum Capital

Súper Carreteras del Norte

NAFIN

Work highlights

  • Advising the Federal Government on various aspects of the Maya Train since 2019, including the design and construction of five sections of the railway track.
  • Currently implementing an urban development instrument with the participation of the National Infrastructure Fund, the Government of the State of Durango and the Municipal Government of Durango for the development of a polygonal area of approximately 30 hectares in Durango.
  • Advising Grupo Aeroportuario del Pacífico on the necessary road works to interconnect the International Airport of Guadalajara, Jalisco with the city of Guadalajara.

Mexico > Life sciences Tier 3

CMS Woodhouse Lorente Ludlow fields a small, four-strong practice in Mexico City but significantly the team sits as part of the international firm’s global life science practice which boasts more than 300 dedicated lawyers. The local practice group primarily handles work from the domestic and international pharma sector, along with clients across the medical devices, food and drink, and chemicals’ sectors, including administrative procedures, regulator-mandated audits, and market approval/launch matters. Practice head Mauricio Gómez Guerrero is a former chief of staff to the Federal Commissioner at COFEPRIS – the federal regulatory entity responsible for protection against health and sanitary risks; his practice focuses on life sciences regulatory matters, along with regulatory enforcement administrative procedures, issues concerning controlled substances, and government affairs strategy. Key support is provided by administrative (and constitutional) litigator, senior associate Manuel Ferrara Ibarra, who works across both the energy and life science sectors; he has particular expertise in both defence strategies before federal and local administrative procedures, and undertaking challenges related to regulatory, administrative and fiscal matters.

Practice head(s):

Mauricio Gómez Guerrero

Testimonials

High knowledge of the subject, specifically in terms of the regulatory issues for the health segment; they stand out for their immediate attention and availability.

Mauricio Gomez Guerrero, partner of the life sciences and healthcare practice, has extensive experience in regulatory health issues, complemented by his experience at COFEPRIS. Immediate and concrete attention.

Key clients

Boehringer Ingelheim

Essity Higiene y Salud México

Celanese Operations Mexico

Rubbermaid Commercial

Novag Infancia

Bioresearch de Mexico

Offenbach Mexicana

GT Technologies

Farmacéuticos Altamirano de Mexico

Randall Laboratories

Work highlights

  • Successfully advised Boehringer Ingelheim on a project and in negotiations with the authorities to evolve a rare disease drug with special authorisation.
  • Representing a client before the Federal Court to file an administrative claim against COFEPRIS.

Mexico > Real estate Tier 3

The ‘multidisciplinary and committed’ group at CMS Woodhouse Lorente Ludlow is lauded by one client as providing ‘an unbeatable service’ in real estate matters. The group advises developers, institutional investors, and lenders on all necessary areas of real estate projects, including the purchase and sale of land, assistance with real estate financing, and the efficient administration of real estate portfolios. The ‘attentive, diligent and friendly’ team of lawyers is led by César Armando Lechuga, wo is highlighted for his ‘proactivity, willingness and skill at conflict mediationLechuga’s practice is focused on the purchase and sale of real estate assets of all kinds, as well as the drafting, negotiation and implementation of transfer of rights contracts. Key partner Enrique Lorente Ludlow represents landowners, developers and investment funds on complex lease arrangements, as well as on the sale and purchase of commercial, industrial, residential and corporate properties. At associate level, Luis Mora y Medrano advises on real estate matters related to the energy segment; he is praised for his ‘great knowledge of the sector. Associate María José Estrada Suárez left the practice in January 2023.

Practice head(s):

César Armando Lechuga Perezanta

Testimonials

Luis Mora and César Armando Lechuga have great knowledge of the sector.

The team is multidisciplinary and committed, and provides an unbeatable service; the lawyers connect with the client.

The team is attentive, diligent, friendly and always available. Personalized service – issues are always resolved in a timely manner.

They are always attentive and it shows that there is a lot of communication within their team. The speed of their responses stands out.

The team coordinates very well. In more complex cases, there is always the support of various team members.

They are efficient lawyers, always trying to be available and proactively looking for solutions.

They are fantastic – very focused on the needs of the client.

‘Luis Mora and César Armando Lechuga – proactivity, willingness, skill at conflict mediation.’

Key clients

Hasta Capital

Opera Desarrolladora

Innokap

Grupo Kino

PGIM

Garret Motion

Union Real Estate Investment

Deka Inmobilien

Grupo Indi

Work highlights

  • Advising Innokap on the day-to-day negotiations and preparation of various agreements with regards to the sale of a property of 69,679 sqm located in Playa del Carmen.
  • Assisted Grupo INDI with the acquisition of the controlling interests of an SPV, acting as trustor and first place beneficiary of a Trust Agreement constituted for the construction and development of a housing project in Mexico City.
  • Assisted Opera Desarrolladora with the negotiation and drafting of an amendment agreement in order to structure the acquisition of future investments.

Mexico > Banking and finance Tier 4

Recognised for being ‘dedicated to its work and always eager to help’, the team at CMS Woodhouse Lorente Ludlow is known for both its lender and borrower-side capabilities, representing major banks and construction firms (among others), as well as advising on acquisition and leveraged finance and syndicated lending transactions. Practice head Raul Zepeda’s experience encompasses a wide range of transactional and regulatory banking and finance work; Enrique Lorente Ludlow majors on project finance; corporate and project finance specialist Cesar Lechuga Perezanta is ‘committed’ and has an ‘ever-pleasant disposition’; Eduardo Saldaña and Alejandro Perera are the names to note at associate level.

Practice head(s):

Raúl Zepeda

Testimonials

The CMS WLL team is very dedicated to the projects assigned to them and they are always willing to support.

Cesar Lechuga is committed and his disposition ever-pleasant.

Key clients

Operadora de Pagos Móviles (Transfer)

Bankaool (Institución de Banca Múltiple)

Tu Dinero Digital

Scotiabank Inverlat (Institución de Banca Múltiple)

BanCoppel (Institución de Banca Múltiple)

Casa de Bolsa Banorte, Grupo Financiero Banorte and Banco Mercantil del Norte (Institución de Banca Múltiple)

Grupo Indi

Davidson Kempner European Partners

Banco Nacional de Comercio Exterior

Banco Inbursa (Institución De Banca Múltiple)

Work highlights

  • Advised Banorte on the negotiation, drafting and execution of a MXN$228m loan agreement.
  • Assisted NAFIN with the due diligence, drafting and negotiation of the restructuring of a syndicated loan agreement.
  • Assisted Banverde Solar with the negotiation and drafting of a contribution agreement to a security trust constituted as guarantee of a syndicated loan agreement to the value of $30m.

Mexico > Corporate and M&A Tier 4

Providing efficient advice applicable to the client’s reality’, CMS Woodhouse Lorente Ludlow continues to grow its young practice that now counts three partners and five associates. While continuing to act on transactional matters throughout the energy sector, and -to a lesser degree- in the infrastructure space, the group has significantly diversified its client roster, with recent matters including mandates from the food, media, pharma and gaming sectors. Most notably, it has been active in a range of tech-related mandates ranging from payment platforms to e-learning and secure networks. ‘An outstanding lawyer’, practice head Giancarlo Schievenini demonstrates ‘excellent negotiation skills’, the ‘ability to work under pressure’ and ‘communicate effectively’, along with ‘knowledge of the market’. Schievenini can also call on senior partner (and head of the office’s banking and finance practice) Raul Zepeda, who has longstanding experience in corporate and transactional matters as part of his wider practice. Key support on corporate transactional matters is provided by semi-senior Bruno Triay (corporate law/M&A – ‘very responsible’) and intermediates Sofía Reyes (M&A, corporate law, project finance and infrastructure – ‘organised and meticulous’), and Eduardo Revilla (corporate M&A, real estate and infrastructure); senior associate Gabriel Salinas is also on hand for M&A in the energy sector.

Practice head(s):

Giancarlo Schievenini

Testimonials

CMS WLL has highly trained lawyers specialised in corporate and financial law, with experience in advising companies on purchase and sale operations of companies, mergers, joint ventures and corporate restructuring. In addition to a solid background in law, the team has negotiation and conflict resolution skills, as well as an ability to understand and manage complex accounting and financial issues. Similarly, the team has excellent communication skills, both among themselves and with clients, and are able to work effectively in high-pressure, low-time situations. In terms of innovation, CMM WLL is up to date with the latest trends and technologies in the legal sector, such as the use of artificial intelligence, blockchain and data analysis. It also offers innovative solutions to problems that arise in corporate transactions.

Our deal has been with Giancarlo Schievenini, whom we consider to be an outstanding lawyer as he has excellent negotiation skills, ability to work under pressure, ability to communicate effectively and knowledge of the market. He is always interested in offering creative and effective solutions to problems that arise in corporate transactions. In addition, it has a wide network of contacts in the sector and a solid reputation in the market.

In addition to having excellent advice, they are strategic and always give us their business imprint. They are very attentive to customer deadlines, always anticipating future actions.

Giancarlo Schievenini and his team provide us with an excellent job, promptly for urgent issues. We greatly appreciate your 24 hour availability. and their subject matter experience. It is a studio that works like the best front line studios in the USA. They are outstanding with clients, coming up with innovative ideas.

The Corporate and M&A team of CMS Woodhouse Lorente Ludlow is made up of lawyers with extensive knowledge in the area, which allows the queries and requirements that are made to be resolved in a fairly agile time and with well-founded explanations.

I believe that the plus that makes Giancarlo Schievenini stand out is that he always attends to all our requirements personally until the conclusion of this, this accompaniment is quite opportune, since Giancarlo’s experience and knowledge in the area makes it easier for us as foreign clients to comply with the obligations that our business has according to the legislation of Mexico. Another point to consider is the agility with which it reviews and resolves our issues. Sofía Reyes, has demonstrated in the time that she has provided her services the extensive knowledge she has about the area. Her constant monitoring of the matters that we have requested has made it easier for us to obtain different documents in record times. I consider that one of her best qualities is being very organised and meticulous in her work and advice. The lawyer Bruno Triay, on the other hand, is a lawyer with extensive experience in corporate and M&A. His best quality is that he is a very responsible person, which he has shown with the issues in which he has supported us.

The firm is efficient, providing efficient advice applicable to the client’s reality. The benefit-cost and service are balanced. The customer service is impeccable, and its partners are constantly available to the customer.

Giancarlo Schievenini (partner), Bruno Triay Robles (associate lawyer), and Manuel Ferrara (associate lawyer) are the lawyers who have provided corporate advice to my company for two years. They have always given me impeccable service, striving to collaborate beyond what was requested. Their closeness to the client and the transparency of their advice make them different, which makes them very efficient and valuable.

Key clients

Webasto

Egis Road

Advance Publications

Mobile Streams

Turnitin

Garrett Motion

Movyon

Klarna

Comcast

Mutares SE & Co. KGaA

Work highlights

  • Currently advising Mobile Streams on the commercial and corporate structure for the implementation of shared revenue agreements with different football teams of the Mexican and Brazilian football leagues, as well as the Mexican National Team, for the production and commercialisation of NFTs and other collectible blockchain products, through exclusivity, sponsorship, and commercialization rights.
  • CMS Mexico (and multiple local firms, along with K&E and CMS UK), advised CC Neuberger Principal Holdings II in the due diligence process and closing on the combination of global visual content creator and marketplace, Getty Images, with CC Neuberger Principal Holdings II (a publicly traded special purpose acquisition company formed through a partnership between CC Capital and Neuberger Berman); upon closing , a newly formed parent company of Getty Images will become a publicly traded company, with its common stock is expected to be listed on the New York Stock Exchange under the symbol “GETY.”
  • Advised the shareholders of Laboratorio Clínico Polab on the sale of the legal entities of the group, assisting with due diligence analysis, the drafting and negotiation of agreements on several matters (such as corporate employment, non-compete and assignment of intellectual property rights related to the sale and purchase); the transaction was successfully completed in mid-2022, with post-completion integration advice during the rest of the year.

Mexico > Tax Tier 5

In October 2023, the former Escalante & Asociados announced its merger into CMS Woodhouse Lorente Ludlow as the latter continues to broaden its service offering as part of the growth of the international player's regional platform. While it remains to be seen how the combination fares, the new department certainly has proven capability as a stand alone practice. A deeply knowledgeable tax all-rounder, department head Ángel Escalante is characterised as 'being a partner who is particularly attentive to his clients, providing concrete and efficient solutions in short periods of time'. The practice assists with a broad range of tax issues (including capability in the international trade area), with contentious tax matters a particular forte - Escalante can draw on lengthy tax litigation experience, as well as handling audits and mutual agreement procedures. In an advisory capacity, the team excels in the real estate sector, double taxation, digital services, project finance and capital markets related tax matters. Associates Angélica Cacheaux and Gabriel Rojas  provide key support. However, Jorge Díaz Carvajal - who had arrived as a partner in June 2022 from Von Wobeser y Sierra, SC, chose to exit with the merger and has established his own practice.

Practice head(s):

Ángel Escalante; Jorge Díaz

Testimonials

They have developed a series of technological tools that have increased the efficiency, precision and speed of legal advice.

The firm is made up of a team that meticulously studies every detail of the issues and the law that applies to them, offering sophisticated solutions at the exact moment and having an integrated vision of law, economics, business and technology.

A firm that stands out for being constantly updated on the latest issues in the practice of the profession, likewise, they keep their clients informed so that they have due compliance with the norm. Your customer service has a human factor that allows you to generate a close relationship.

Ángel Escalante is characterised by being a partner that is particularly attentive to its clients, providing concrete and efficient solutions in short periods of time. Angélica Cacheux is an associate with a high degree of knowledge and specialization in her field, so each document she produces is of the highest quality. Gabriel Rojas is an associate with exceptional theoretical and practical knowledge, which is why his negotiation skills are agile and precise.

It is a very specific practice. Being that tax law is very complex to understand, they manage to synthesize it so that the client can understand what the problem is, the possible solutions and realistic terms. The attention is always personalized, the progress of the issues is communicated as soon as possible and with a clear input.

It is definitely a boutique office. They have extensive knowledge of the implications and consequences of implementing each strategy. They are available and always meet their terms.

It is a specialised boutique office. Angel Escalante is truly technical and far exceeds his peers in other firms. Their team has been strengthened and they have many capabilities. I think we’ll soon be seeing them on the biggest issues in the country.

Ángel Escalante is one of a kind. It has a technical capacity superior to its peers. I consider him to be substantially superior in technical capacity.

Key clients

Peninsula Investments Group

Perrigo México

Tupperware

Grupo Bursátil Mexicano (GBM)

Alloy Merchant Partners

Walmart de México

NAPA México

Orbia Advance Corporatio

Banco Credit Suisse México

Altius México Desarrolladora

Betterware

Instituto Tecnológico Roosevelt

W K Kellogg Foundation

Combe de Mexico

Geodis México

Work highlights

  • Assisted developer Peninsula Investment Group with structuring an efficient international tax framework for its 3rd and 4th private equity funds.
  • Advised the real estate leasing platform Casai on the analysis and implementation of its tax structure in Mexico, including cross-border aspects in the United States and Brazil.
  • Advised GBM Infraestructura on all aspects of its tax structuring.

Latin America: International firms > Projects and energy

CMS  has a large Latin America-based team (across its offices in offices in Brazil, Colombia, Chile, Mexico and Peru) which undertake local law and English law engagements. The firm enhanced this offering through a cooperation agreement with Brazilian law firm FAS Advogados, in cooperation with CMS in 2023. It has a strong record in energy (including oil and gas, electricity and renewables). In the renewables sector, it has made an impression in solar, wind and green hydrogen. It has also worked on headline infrastructure projects in Mexico, Peru and other jurisdictions; a Mexico City-based team advised Grupo Typsa in connection with the design, construction, and maintenance of  ‘El Tren Maya’, a railway that will traverse the Yucatán Peninsula in Mexico. Rio de Janeiro managing partner Ted Rhodes is an experienced figure in oil and gas, and offshore projects and transactions; he has a growing presence in renewables. Daniel Rodríguez is a notable name in Bogota, along with Derek Woodhouse and Enrique Lorente Ludlow in Mexico City, and Carlos Hamann in Lima.

Practice head(s):

Ted Rhodes

Key clients

Prio (ex PetroRio)

Eneva

HydraWell Intervention

Walmart

CDPQ, CKD IM

Autopista del Norte del Grupo Aleatica

Vitol Electricidad de México

Thermion

Lewis Energy

Repsol

Electryon Power Inc

Chevron Petroleum

Enel Green Power

Engie

Perenco

Kimberly Clark

AES

Work highlights

  • Advised Enagás in an ICSID arbitration claim against the Peruvian Government based on the breach of the Bilateral Investment Treaty between Peru and Spain.
  • Advised the German vehicle manufacturer Porsche on the execution of options agreements for the acquisition of green hydrogen production and the purchase of 12.5% of HIF Global.
  • Advised Grupo Typsa in connection with the the design, construction and maintenance of El Tren Maya.

Defending Marketing Authorization of Medicines before COFEPRIS: failure to respond and arbitrary cancelations.

RIGHT TO HEALTH, A HUMAN RIGHT.

Article 4 of the Mexican Constitution considers health as a human right, so the government is obliged to guarantee it to Mexican citizens, primarily by providing access to public health services such as public hospitals; and having a health law legal framework that sets the basis to provide safe and effective health products, services, and treatments. This means the Federal Commission against Sanitary Risks (“COFEPRIS”), the Mexican health authority that authorizes and surveils medicines must be efficient in the evaluation and authorization of medicines and therapeutic alternatives to keep quality medical products in the market and protect the health of Mexicans.

 

THE REGULATORY REGIME.

In Mexico, to be manufactured, imported, and marketed, medicines require marketing authorization of medicines under the General Health Law (“GHL“) and the Health Supplies Regulation (“RHS“), which must be renewed every 5 years.

To renew the marketing authorization of a medicine, it is necessary to request it 150 days before its expiration date. This is intended to give COFEPRIS enough time to evaluate and analyze the request for an extension of the marketing authorization before its expiration date and do not affect the holder. However, COFEPRIS does not currently comply with these timeframe objectives even though they are expressly stated in the law.

On the other hand, there are precedents where it is established that those requests for the renewal of the marketing authorization that have been filed on time and have not been resolved are understood to be approved.

This causes uncertainty in the purchase of products in the public sector such as the Mexican Health and Wealth Fare Services (“IMSS”), Mexican Health and Wealth Fare Services of Government Employees (“ISSSTE”), and Ministry of Defense (“SEDENA”), being these only some examples due to the validity of the products and the capacity to receive them in their warehouse when COFEPRIS has not answered the extension of the marketing authorization of a medicine. This issue is not limited to causing problems in the public sector, as the problem is also transferred to the private market.

In addition, inconsistencies have been detected in the criteria that generate arbitrary refusals without being duly grounded to these extensions of the marketing authorization that lead to the cancellation of it and as a consequence affect the continuity of the supply of medicines at a national level. This is a very serious problem as it jeopardizes the supply of medicines to patients, as well as the production chain and financial planning of companies engaged in the health sector.

 

LEGAL TRENDS AND DEFENSES FOR DEALING WITH REGULATORY UNCERTAINTY.

Some of the successful defense strategies to these problems are:

  1. Administrative appeal.
  2. Administrative Litigation.
  3. Amparo Proceeding.

These means of defense allow to combat arbitrary acts of authority and the lack of response of the same in which is possible to get both provisional and definitive suspensions for the benefit of our clients.

The suspension is a precautionary measure that has the effect of maintaining things in the same state in which the law foresees them until the trial is resolved. This is a great benefit because, as mentioned above, if the authority does not respond, the extension of the marketing authorization is understood to be appropriate, and the product can continue to be commercialized.

Thanks to the suspension, health companies can maintain the production chain of the medicines that submitted the extension of the marketing authorization on time but have not received an answer from COFEPRIS and therefore continue their commercialization under the protection of a judicial resolution that authorizes it.

Likewise, thanks to administrative lawsuits, COFEPRIS has been forced to issue the renewal of the marketing authorization. This results in a great benefit for society because the medicines that people consume remain in the market and the companies dedicated to the health sector are not affected in the production chain or the commercialization.

This strategy has implied significant progress in both the regulatory and judicial spheres, as once again the judiciary has been the one to remedy the deficiencies of the executive branch, i.e. the deficiencies faced by COFEPRIS as an institution.

On the other hand, strategies have been implemented to combat unfair competition in the pharmaceutical sector through investigations and consultations on marketing authorizations, import permits, imports under the agreement of January 28, 2020, interaction with irregular importers and traders, and complaints, among others. These strategies have resulted in the authority issuing health alerts regarding products that pose a risk to the population.

 

CHALLENGES FACING SANITARY REGULATION IN MEXICO.

In Mexico, health regulation faces great challenges, in particular, the pharmaceutical sector, both in the field of medicines and medical devices related to regulatory uncertainty and, as a consequence, corruption.

Currently, several regulatory and operational impediments negatively affect access to medical treatments to the detriment of the health of the Mexican population. One of the major regulatory impediments is the failure of the authorities to comply with the deadlines established by law to resolve user requests.

To provide regulatory certainty, and full compliance with the regulatory framework for protection against health risks, which translates into:

  1. Provide clarity to the user on the authorization requirements and their definition, the internal evaluation process, and the time associated with each of the stages of the evaluation.
  2. Ensure a standardized evaluation based on technical and scientific criteria and not on arbitrary and bureaucratic criteria.
  3. Effective recognition of the decisions of regulatory authorities in other jurisdictions.
  4. To guarantee regulatory harmonization with internationally valid standards to favor industrial development, access to new medical treatments, and competitiveness.

On the other hand, health regulation in Mexico must promote the implementation of the recommendations issued by the World Health Organization so that the procedures, services, and resolutions provided by the health authority are similar to what is done internationally.

In this regard, in 2022 the Ministry of Health announced a regulatory certainty strategy for the pharmaceutical and medical device sector so that by 2030 the challenges mentioned in this section will have been overcome and the regulatory framework for protection against health risks will be fully complied with.