Life sciences in Mexico
Baker McKenzie Abogados, S.C.
Baker McKenzie Abogados, S.C. offers a top-notch practice, with an impressive expertise in the life sciences, healthcare and pharmaceutical industries. Christian Lopez-Silva, who is particularly experienced in the healthcare and biotechnology segments, heads the ‘very senior team’, which focuses on regulatory matters, litigation, dispute resolution, privacy and data securities, as well as associated foreign trade issues. Recent mandates include litigation against health regulator COFEPRIS; advice during regulatory inspections; personal data transfer matters, and market and regulatory analysis related to the emergent cannabis sector. Key support comes from recent senior associate hires David Campos, who arrived in mid-2019 on completion of his global health law LLM; and Victor Gonzalez-Zesatti who joined in February 2020 after a year as a legal consultant to the Presidency. The team also includes a pharmaceutical chemist.
‘It is a very senior team with expertise in all the topics of life sciences, and which is able to provide advice and support based not only on written law, but also as per experience, involvement in the policy making and with the advantage of exploring the cases in a holistic view considering the effective law, the precedents, interpretation of authorities and position of the industry.‘
‘The member of the team with whom I have worked the most is Christian López Silva, in my opinion the most experienced partner for these matters in the firm.‘
Procter & Gamble Mexico
Bristol Myers Squibb
- Advising healthcare start-up Sofia Salud on IT and privacy law and regulatory requirements, related to tele-medicine, the use of e-prescriptions, online purchase of drugs and medical devices, booking the services of clinical labs, and the obtaining and processing of patients/users’ personal data, among other matter.
- Advised Pfizer regarding its multijurisdictional restructuring; and advised both Pfizer and GlaxoSmithKline Consumer Healthcare regarding their joint venture in Mexico.
Full-service mainstay, Galicia Abogados S.C.'s ‘very competent, professional team' has 'great knowledge and experience of local and international health legislation', informed by extensive in-house industry experience. Practice head Bernardo Martínez Negrete is primarily focused on all aspects of the pharmaceutical industry, from M&A to clinical trials. A former regional director at generics company, Teva, newly appointed counsel Lisandro Javier Herrera ‘demonstrates great mastery of the topics' and 'a style of work that easily adapts to the needs of clients’; he maintains a broad life-sciences practice. The team advises an impressive portfolio of clients -particularly from the pharmaceutical industry- regarding regulatory, compliance and day-to-day matters, as well as corporate matters, transactions and dispute resolution. A recent headline mandate saw the practice advise the Asociación Mexicana de Industrias de Investigación Farmacéutica (AMIIF), develop a legal defence strategy in the face of the current administration's reform of the public procurement process for medicines (the first changes in 15 years). Experienced associate Luis Marin Tijerina is also noted.
‘The life sciences practice at Galicia has a very competent professional team, which not only has great knowledge and experience of local and international health legislation, but also all the elements required to serve the needs of its clients and offer innovative, applicable solutions; it also knows how to interpret and adapt in a timely, efficient manner and within the legal framework.’
‘I would like to highlight the high quality and excellent level of legal services provided by Mr Lisandro Herrera, who has provided us with valuable legal support in structuring highly complex projects. He has demonstrated great mastery of the topics, has a style of work that easily adapts to the needs of clients and personally leads projects.‘
‘The life sciences practice stands out for its technical knowledge in health law, for its human quality and for their high sense of ethical responsibility with its clients and with the population. The team’s strengths and skills are the technical soundness of their legal analysis and what sets them favourably apart from other law firms is their concern for clients and the effective guarantee of the right to health protection for the population.‘
‘The plus that makes them stand out is their ability to understand customer needs. Lisandro Herrera is the lawyer who has always treated us with professionalism and technical knowledge of the area.‘
Mexican Health Foundation (FUNSALUD)
Asociación Mexicana de Industrias de Investigación Farmacéutica (AMIIF)
Merck Sharp & Dohme México
Carestream Dental de México
- Advised Mexican health foundation FUNSALUD on the implementation of digital health technology initiatives in Mexico, including the use of drones, e-health, m-health, access to information, robots and internet.
Full-service firm Hogan Lovells fields a knowledgeable, four-strong team which advises across a broad array of work within the life sciences field, ranging from Mexican official standards (NOMs), consumer protection, product liability and sanitary registrations, to overland transport, foreign trade, contracts and patents. It also advises on highly sensitive compliance matters, and the planning and adoption of complex strategies for the regulatory restructuring of business operations. Practice head Ernesto Algaba Reyes (health law and regulatory compliance matters for the pharmaceutical and medical devices industries;) has twenty years in the sector. Key support comes from Cecilia Stahlhut (life sciences and health; particularly the regulation of cosmetics, food, alcohol, tobacco, and consumer products), who was appointed counsel in January 2020.
R. Simplot Company
- Advised CSL Behring on regulatory matters in connection with the company’s business model and activities; and development of a regulatory strategy for the importation and marketing of its product portfolio in Mexico.
- Advised Bacardi on regulatory matters in connection with securing the authorizations applicable to the different stages of the supply chain and marketing of Tequila, for its bottling and marketing in India and France.
- Advised Ocean Spray on food/beverage related matters for the company’s operations in Mexico, including regulatory compliance, development of labels, review of claims, and promotional campaigns.
- Regulatory advisory to Bristol-Myers Squibb aimed at achieveing regulatory compliance of the client’s operations, primarily in relation to public procurement.
- Assisted ConAgra with a high-profile matter concerning food product labelling and involving strategic regulatory advice and litigation.
SOLCARGO's life sciences practice provides complete representation, from regulatory assistance to litigation, for a wide range of clients from industries including pharmaceuticals, beverages, and biotechnologies, among others. The department, which is particularly strong in the protection of clinical data in light of international agreements, is co-led by Guillermo Solórzano (whose broad practice includes life sciences, regulatory and pharmaceutical issues, including associated patent and trade mark litigation, as well as pharmaceutical, sanitary and administrative litigation); and Luis Armando López Linaldi, a specialist in pharmaceutical trade matters, IP and regulatory matters. Recent mandates have included diverse issues such as the distribution of medical prescription drugs; sanitary audits, regulatory compliance, product authorisations; telehealth and, in the corporate segment, advising Sterimed on its acquisition of healthcare manufacturer and distributor, Especialistas en Esterilización y Envase. Experienced senior associates Eréndira Frías (administrative litigation), and Christian Parra Pérez (IP litigation and unfair competition), are also noted. Since publication: as of December 2020, the firm has split into three separate firms;, with the life-sciences team now operating as Solorzano Linaldi.
‘It is important to have the knowledge and opinion of lawyers on one of the most regulated industries in Mexico: pharmaceuticals. These are people with experience and knowledge who provide personalised treatment.’
‘Luis Armando Lopez Linaldi is a partner who is very committed to his customers, and also empowers his team to achieve customers’ goals; he’s very skilled in regulatory affairs.‘
‘We feel very comfortable with Guillermo Solorzano, he always finds the way to get the job done (and done very well).‘
International Maize and Wheat Improvement Center
Sun Pharma de México
Compañía Casa Dragones
Clínica del Manejo de la edad
- Designed a legal strategy to identify and prevent Internet websites from advertising and marketing drugs without complying with the applicable regulation. Assisted IFA Celtics with the defence of administrative proceedings initiated by the Health Authority in connection with the advertising materials for its birth control products.
- Providing the Mexican Asociation of Pharmaceutical Laboratories (AMELAF) with sanitary legal advice concerning proposed legislative amendments to the General Health Law (Ley General de Salud), submitted during 2019.
- Assisted Casa Dragones with the health authority reporting requirements in relation to adjustments to the importation, exportation and marketing of its alcoholic beverages products.
- Advised Protein (Apotex) in a second constitutional appeal challenging the imminent granting of a marketing authorization for a drug with the active pharmaceutical ingredient Tadalafil.
- Advising biotech group Genbio on the structuring and implementation of a strategy to provide operational services to the Mexican Red Cross related to its blood centers, in order to subsequently obtain plasma from such blood and produce blood products.
CMS Woodhouse Lorente Ludlow fields a seven-strong life sciences practice, probably best known for negotiations with and representation before health-related government agencies. Practice head Mauricio Gómez (who handles life sciences regulatory matters, pharmaceutical products, biotech, medical devices, food, beverages and consumer products), can also draw on former experience in different posts at regulator COFEPRIS. Further partner level input comes from corporate practitioner Cesar Lechuga Perezanta and PPP-specialist Marcia Santomé, who was raised to the partnership in mid-2019). The team has experience advising on new businesses and products, regulatory strategies and compliance audits, good manufacturing practices and certifications, premarket approval of products and services, health licenses and advice on approval of labelling and marketing of regulated products and services, from biotech, biologics and medical.
Essity Higiene y Salud
Janssen Cilag México
Johnson & Johnson Companies Mexico
- Advising Celanese on day to day regulatory matters and risk assessments of relevant operations (particularly in relation to controlled and dangerous chemicals), recording obligations and reporting to regulator COFEPRIS.
- Advising Saba, Essity’s brand for feminine hygiene on the permits required for pre-market approval and a Good Manufacturing Practices certificate regarding sanitary aspects.
- Advised Janssen Cilag México regarding the implications for public procurement and health regulations following the change of government in Mexico.
- Provision of training programmes for Janssen, Johnson & Johnson and Johnson & Johnson Medical Devices in relation to the advertising of medicines, medical equipment and cosmetics.
Powerhouse major, Creel, García-Cuéllar, Aiza y Enríquez, S.C., has bolstered its life-sciences practice substantially: the mid-2019 hire of specialised mid-level associate Lizbeth Borquez from Ibarra, del Paso y Gallego; followed by the November arrival of counsel Guillermo Govela, a health regulation and administrative law specialist whose experience includes time at both the Ministry of Health and at pharmaceutical products company Nadro. The pair join a department led by Begoña Cancino (who also heads the IP practice) and which has considerable expertise in data privacy, regulatory matters and administrative litigation. The practice can also draw on the firm's full-service capabilities to offer complete coverage of life-science matters, including from transactional, unfair competition, corporate, regulatory, disputes, IP and trade perspectives. Recent mandates include sanitary due diligence; advisory regarding e-consultations, e-prescriptions, online drug stores, internet hospitals and health data and technology; regulatory compliance and a product recall, among other matters.
Mead Johnson Nutrition
- Counsel to Grupo Celanese in a regulatory review of the health authority permits granted in connection with chemical precursors and essential chemical products used within the client’s industrial processes.
- Counsel to Colgate-Palmolive on a voluntary recall proceeding involving the participation of the Federal Commission Against Sanitary Risks, as well as the consumer protection agency, having previously assisted the client with an internal compliance investigation with a significant sanitary-regulatory component.
- Advised Cornershop on advertising issues regarding foods and beverages, dietary supplements, alcoholic beverages and over-the-counter medicines in the context of the client’s operations in Mexico.
High-profile environmental specialist Leopoldo Burguete-Stanek and senior counsel Enrique Muñoz Guízar (environment, life sciences and health care, consumer protection), who was appointed counsel in July 2020, co-head the life sciences department at González Calvillo, SC, which has a solid reputation, particularly with clients from the pharmaceutical, food and beverages and technology industries. Recent work includes advising Dow Química Mexicana on the registration process before regulator COFEPRIS, as well as acting for Amazon regarding the licenses and permits to sell over-the-counter medicines directly to consumers in Mexico. Carlos Fernando Castilla -also appointed counsel in mid-2020- handles administrative litigation and case management, particularly against COFEPRIS and PROFECO; and associate Georgina Zavala is also noted.
Pioneer (Du Pont Seeds)
IMS Pet Industries
- Advised Dow Química Mexicana on the registration process before the Federal Commission for Protection against Sanitary Risks (COFEPRIS) of different facilities for the storage of diverse chemical substances.
- Counsel to Amazon Mexico on the regularization of the sanitary operational notices and licenses of its different distribution centers in Mexico before COFEPRIS.
- Advised Danone regarding different claims related to sugar added to yogurts and other products containing fruit.
‘Their legal knowledge of the cases and business intelligence’ makes Ibarra, del Paso y Gallego an ‘indispensable’ player in the life sciences sector. The five-strong department is led by Adrián del Paso, best known for his environmental process but with a growing profile and experience in the sector, and who is always ‘ready to dialogue and discuss ideas and different ways of approaching an issue’. Recent mandates include comprehensive due diligence in relation to health and sanitary permits, licenses and authorisations; representations and applications before COFEPRIS, audits and corporate matters, among others. The March-2019 arrival of ‘talented’ IP practice head Juan Manuel Alvarez del Castillo has added patent expertise to del Paso's regulatory / corporate-side practice.
‘The life science area is highly specialized, and it is not easy to find experts in the field, especially for an industry as specialized as pharmaceuticals. The firm is highly knowledgeable on these issues from its partners to its associates who are aware of the matter as well as the new legal challenges facing this area.’
‘Adrian Del Paso: in addition to having solid knowledge of life sciences, the availability of Adrian and his team make it possible to solve complex problems in complex situations, contributing to a cost-effective solution.‘
‘The practice has very professional staff, who are available 24/7/ depending on our legal necessities. Their facilities, and location, make them a useful resource when we need to meet with high profile clients. Their legal knowledge of the cases, business intelligence, notably in the government business segment, make them an indispensable partner. The office management is good: partners are always available to answer any questions, or work with cases in which we need their consultancy/representation in the markets. In our experience we have not found this kind of service, and attention with other legal offices. It is an excellent group of lawyers.’
‘Adrian Del Paso and Juan Miguel are talented, dedicated attorneys, available 24 hours. Personalized service and the disposition of the lawyers. Ricardo Koller Morales: very good service, willingness, immediate and specialized attention. Adrian del Paso: very good service, expert in the field, ready to dialogue and discuss ideas and different ways of approaching an issue.’
National Marrow DonorProgram/ Be the Match
- Advising the National Marrow Donor Program on consultations pertaining to the sensitive personal data of stakeholders (individuals involved/related with the purposes of this organization).
- Advising therapeutic delivery system company, Bio Pellet, on various applications before the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), for the authorizations required to begin operations.
- Advising Unilever with internal legal due diligence process entailing how sensitive personal/medical data obtained by the company is managed.
- Advised medical-device and tech company, Siemens Healthineers in relation to a public tender process for the acquisition of medical devices for hospitals.
Basham, Ringe y Correa, S.C. offers a five-strong life sciences practice which provides both regulatory counsel and litigious capability related to the manufacturing, importation and distribution, marketing, labelling and advertising of pharmaceutical products, medical devices, pesticides, fertilizers, cosmetics, household and veterinary products, seeds, foods, beverages, alcohol and tobacco. Corporate, finance and transaction-focused, Daniel Del Rio's broad practice has given him knowledge of the medical sector; while constitutional and public law specialist Rodolfo Barreda, head of the administrative law practice, has considerbale experience in government procurement, and administrative contract and litigation, particularly in relation to the pharmaceutical sector. The pair co-lead the practice, which is currently advising CBD / THC products distributor, Canopy Growth Corporation on its establishment and registration in Mexico, and on the on-going development of the legal framework for such a market in the country. However, former regulatory specialist senior associate Julio Copo Terrés moved to Mañón Quintana Abogados as counsel, in March 2020.
Canopy Growth Corporation
- Advised LifeScan on various matters including authorizations before the Ministry of Health, the hiring of a technical director, draft SPOs and Work Instructions, and identification of a suitabe third party for logistics and warehousing.
- Advised Cochlear on the incorporation of a local entity, its registration before the Ministry of Health, the drafting of the transfer of rights agreement, execution of the transfer of eleven marketing authorizations to the newly incorporated entity from their former holder and other administrative matters related to the initaition of operations.
A corporate partner with a focus on the regulated sectors, Jorge Benejam is the key contact at DLA Piper Gallastegui y Lozano's nascent life-sciences practice, which is led by name-partner Eduardo Gallastegui; one of the lawyers who participated in the Federal Health Law reform (particularly as regards biotechnological medicines in Mexico), and has amassed considerable experience in the life sciences sector. Fellow corporate and transactional partner Xavier Mangino Dueñas also participates in the practice, which advises clients on obtaining licenses and authorizations, including regulatory approvals, from the relevant authorities; it has been particularly active recently in constitutional amparo appeals against administrative authorisations, as well as clinical trial matters, regulatory advisory on importation and transactional operations.
Genoma Lab International
Laboratorios de Control
Santamarina y Steta advises clients in the pharmaceutical, medical devices, cosmetic, seed, fertilizers, plant nutrients and food industries, among others, on compliance with applicable Mexican law, regulations and standards; administrative litigation, corporate transactions and international trade and commerce matters, related to the life-sciences sector. Alejandro Luna has 20 years' experience in the sector, in addition to corporate governance, international trade and antidumping, franchise and licensing, M&A and joint venture; he has also spent time as external counsel to clients in the pharma and confectionary sectors. Recent matters include internal regulatory and sanitary audits, transactional regulatory strategies, administrative procedures and labelling matters, among others. The practice also has a sub-specialisation focused on the nascent cannabis market sector in Mexico. Key associates support comes from mid-level associate Mariana Larrea.
Holcim México Operaciones
Cales y Morteros
Siemens Healthcare Diagnostics
- On-going regulatory advice to Hershey México regarding the obtaining of various free sale certificates, operation notices, Certificate of Conformity to Good Health Practices, Conformity to Good Sanitary Practices export certificates and advertising notices, before regulator COFEPRIS.
- Legal and regulatory advice to Streigenics with regard to compliance with all the applicable Mexican legislation, such as the General Health Law and Mexican Official Standards, among others.
- Advised Siemens Healthcare Diagnostics on obtainng compliance certification with the Official Mexican Standards office, for more than 1,400 products.
Partners José Alberto Campos (tax and international trade) and Juan Luis Serrano-Leets (the IP, regulatory and privacy aspects of life sciences), co-head the practice at Sánchez Devanny, which has a ‘strong experience in the sector’, and handles matters pertaining to pharmaceuticals, medical devices, food, beverages and dietary supplements, cosmetics, tobacco, alcoholic beverages, hazardous substances, cannabis products, and medical and health related services, among others. Moreover, the team, has a good ‘knowledge of customer needs’ and ‘understanding of political norms'; Campos has extensive experience, while Serrano's past experience includes three years' as head of legal at AstraZeneca Mexico. The team collaborates with the firm's corporate governance and regulatory practice group as regards compliance matters led by Humberto Morales-Barron. The primarily international trade-focused María Luisa Mendoza, who was appointed non-equity partner in January 2020, also participates extensively in life-sciences matters.
‘We have used Sanchez and Devanny not only for their well respected practice in the life sciences field, but they have been able to assist us whenever corporate and/or employment law issues have come up. We specifically work mainly with Jose Alberto Campos Vargas and Maria Luiza Mendoza Lopez. Jose Alberto is our first call for any legal issues with Mexican law, as well as import/export issues. Jose Alberto provides solid advice and when he does not have the answer, he knows the right people to ask. Maria Luiza principally handles our regulatory issues in relation to our product labeling. She has always been responsive and accurate in her advice.‘
‘Very professional team with strong experience in the sector, with high-level relationships that allows us to have information that helps make decisions. An adequate level of treatment when presenting cases to the local authorities, high authorities and international executives, that positively impact the understanding of situations. Knowledge of customer needs, understanding of political norms and way of working in transnational pharmaceutical companies with a clear level of compliance.’
‘The pharmaceutical sector is a highly specialized sector and, in this sense, it requires specific knowledge of the sector and of the legal and regulatory matter related to it. They are competent lawyers who know the matter.’
‘Thanks to the partner Juan Luis Serrano, progress and achievements have reached an important level very quickly. The empathy and knowledge of the work of lawyers in house, make the service provided very punctual and according to the needs.’
British American Tobacco
Mary Kay Cosmetics
- Advised Guayaki Beverages on the organic and sustanability standards required to import and market organic beverages from a customs and regulatory perspective.
- Advised British American Tobacco regarding the legal regime applicable to vaping products, in relation to other regulatory restrictions and litigation against COFEPRIS.
- Advised Capsugel in connection with the importation requirements for diverse capsules used in the dietary supplements industry and applicable tariff classifications.