Services

We have developed and matured the most advanced regulatory capabilities in a law firm in Mexico, due to an interdisciplinary approach and a profound understanding of the theoretical bases of risk regulation and the interaction between science and law.

We assist clients in all aspects of health regulation or regulatory affairs, including (i) responding inquiries of regulatory compliance over specific product categories, (ii) strategically preparing and filing ruling requests on grey aspects of the regulatory framework, (iii) accompanying inspection visits and the resulting inspection process, (iv) challenging judicially unfavorable regulatory decisions and (v) litigating the lack of decisions over pending applications.

In general, we have full experience helping clients navigate both (i) the system of authorizations & notifications, and (ii) the system of inspections & sanctions.

At the same time, having worked in a global full-service law firm, where we advised the leaders in different sectors, we learned to collaborate, connect and align regulatory matters with other key legal fields for healthcare & life sciences clients, such as tax, customs or labor law. That gave us valuable insights on how to identify collaboratively the best business solutions for a client.

We regularly assist clients defend their rights and interests with our skilled representation in administrative litigation.

We specialize in resolving disputes with health regulators, challenging administrative decisions, and navigating the complexities of public law affecting healthcare & life sciences companies.
Our strong theoretical bases on risk regulation, science-based frameworks, constitutional law and administrative law, have allowed us to design and implement highly successful litigation strategies.

We have vast experience challenging regulatory decisions both in relation to (i) the system of inspections & sanctions, and (ii) the system of authorizations & notifications.

We have:

1. Obtained judicial injunctions against safety measures (e.g. a suspension of activities or a seizure of products) imposed during inspection visits to a given establishment (e.g. a manufacturing plant or warehouse).
2. Obtained the annulment of different sanctions (e.g. fines), using novel arguments over different violations of legal principles, in relation to either the inspecting or sanctioning stages, of the specialized administrative procedure applicable in health law.
3. Obtained favorable rulings attacking long-waited pending approvals relating to marketing authorizations, including modifications, renewals and new registrations.
4. Obtained the annulment of revocations of marketing authorizations, related to extemporary renewals, for both drugs and medical devices.
5. Challenged successfully explicit rejections of different authorizations, including sanitary licenses, certificates of good manufacturing practices, import permits, and advertising permits.

We assist clients on privacy protection during all stages of their operations, from developing a basic compliance system, with privacy notices, policies and trainings, to implementing more mature governance programs, risk assessments, impact analysis, and third-party audits. 

We also assist in cases of data breaches, crisis management and administrative procedures initiated by governmental bodies. 

In the healthcare & life sciences industries, privacy is crucial, health data constituting sensitive data, offering both immense challenges and great opportunities. In the healthcare & life sciences industries, privacy is crucial, health data constituting sensitive data, offering both great challenges and immense opportunities. This includes the promising new area of Digital Health.

The two major goals of (i) placing patients in the middle (of the decision-making process) and (ii) getting closer to patients to provide comprehensive services (and not only products); also means having to deal more carefully with their personal data.

We help clients design strategies to protect comprehensively their products, services and operations, from patents, copyright and trademarks to confidential information.

We are particularly familiar with setting up and enforcing, policies and systems on hybrid aspects that are strategic to the healthcare & life sciences industries, particularly in the pharma sector, including (i) the linkage system, which combines patent protection and regulatory approvals, (ii) data exclusivity, which combines regulatory approvals of clinical trials and IP protection, and (iii) the lack of coordination between registered trademarks and distinct denominations of drugs.

We can also assist in relation to substandard or counterfeit products, either to file individual complaints or to set up internally a system for monitoring and taking action, including filing criminal complaints.

Securing access for patients to the most advanced medical treatment is very challenging in Mexico. It requires an effective and balanced strategy that combines methodologies from different disciplines, including legal, economic, medical and public communication tools. At SaúdeLaw we can help healthcare companies align and coordinate their access strategies.

Furthermore, current pressures associated to securing market access will only increase, if we consider the new challenges associated to new technologies, including:

1. Gene, cell and tissue therapies, which are not yet fully regulated;
2. Personalized medicine, which now combines tools from genetics and digital health;
3. Artificial intelligence applied to products and services; and
4. Telemedicine, tele-monitoring and home-care.

These technologies call for innovative and sustainable ways for proposing and procuring access to the relevant products and services.

Also, the historic backlog or full lack of responses, in relation to either the Basic or Institutional Formularies, is now being legally challenged.

To recall, Mexico does not operate in healthcare a pricing &  reimbursement system, but rather a public procurement regime. We assist clients navigate the intricacies of the public procurement processes in Mexico, either for products or services.

We provide insights into bid preparation, compliance, and negotiation strategies for securing government contracts and navigating public sector purchasing.

We are familiar with (i) the dispute settlement mechanisms of the public procurement regime, (ii) the need to defend patented products and (iii) the civil and administrative steps involved in the process to get paid by governmental entities.

We have experience drafting, reviewing or locally adapting all kind of agreements, including, specialized agreements of the healthcare & life sciences industries, such as early licensing agreements, distribution agreements, supply agreements, contract manufacturing agreements, pharmacovigilance agreements, quality agreements, multi-party clinical trial agreements, co-marketing agreements, transitional services agreements and so on. 

There are also elements, increasingly addressed in secondary regulation, that need to be incorporated into private agreements. 

At the same time, regulatory approvals and regulatory roles require certain contractual elements and formalities that we have developed over time.

The healthcare & life sciences industries have long been among the top priorities of the antitrust authorities. We offer expert advice on antitrust matters and economic competition law, related specifically to these industries.

Our proactive strategies prevent and mitigate risks by representing clients before antitrust authorities in investigation and sanction procedures related to cartel conduct, abuse of dominance, vertical restraints and illegal mergers. 

We also represent clients in dominance, barriers to competition and essential inputs proceedings; and advice and represent clients in merger control process, and in obtaining favorable opinions to participate in public bidding processes.

We regularly analyze compliance in relation to projects of particular importance to healthcare & life sciences companies, including Patient Support Programs, inclusions to the Basic Formulary, removal/inclusion to the system of price control for drugs, the design of new distribution models, as well as the design of loyalty programs. 

We offer a broad compliance approach that is not limited to preventing anti-corruption, or to adhering to industry codes of practice.

In the past, this area was limited to evaluating compliance in relation to promotion, advertising or interaction with certain professionals or patients, which is certainly required, but only as an initial stage. The current trend is to promote ethics, integrity and transparency in all business environments.

That requires many steps, including the creation of a compliance culture, which in turn requires clear definition of policies and controls, as well as constant trainings and audits, which are applied internally, but also externally, with suppliers and clients.

In the healthcare & life sciences industries, the other key legal areas, in addition to anti-corruption, that are crucial for a broad compliance approach, include regulatory compliance, privacy and antitrust.

Navigate the complexities of mergers & acquisitions, separations, integrations and corporate restructuring within the healthcare & life sciences sector. 

In all the global and regional M&A deals where we participated before, which re- shaped several markets in Mexico, we integrated successfully the regulatory advice.

Noteworthy, addressing early on the regulatory constraints can align or derail key objectives and ultimately allow, or not, to capture the value originally intended with the transaction.

Build a solid legal foundation for your business with our advice on corporate structure and best governance practices, including strengthening board and committee composition, leadership structures, oversight of risk management, as well  as reviewing bylaws and guidelines, committee charters, policies and codes of ethics. 

We have significant experience assessing compliance against rules for advertising and consumer protection, which involves closely related, yet different notions of promotion, advertising and labeling.

Also, in the healthcare & life sciences industries, it is common to refer to consumer products. However, that may include product categories that are regulated quite differently, such as cosmetics and food & beverages (including dietary supplements), on the one hand, and medical products, such as over-the-counter medicines or relatively simple medical devices, on the other hand. Knowing the regulatory restrictions between all of them can have an impact on the intended strategies to register them (e.g. under umbrella brands), to commercialize them (e.g. in pharmacies or supermarkets), to label them together (e.g. an alcoholic beverage and a soft drink), or to advertise them (in mass media or specialized medical sites).

There are also several commercial aspects, relevant in different degrees to the healthcare & life sciences industries, that are regulated by the consumer protection regime, such as the use of games & raffles, the role of influencers, the implementation of product recalls, or the defense against of collective actions.