Pharmaceutical Industry

Advising the pharmaceutical industry requires interdisciplinary legal work. This sector of the industry can cover different and diverse areas of Law, which requires a complete understanding of the client's business. TozziniFreire is a full-service law firm and is therefore always ready to assist pharmaceutical companies – whether they are national or international – with all legal matters related to their business activities. TozziniFreire's experience in representing, and working for, the pharmaceutical industry speaks for itself. Find below some examples of our work in different areas of Law:

Antitrust

Advising on merger notifications and association agreements before the Brazilian Antitrust Authority (CADE). Reviewing commercial (including pricing and discounts) and distribution policies from a competition perspective. Defense in cartel and unilateral conduct investigations and proceedings conducted by CADE.

Transactional matters

TozziniFreire also has experience in providing legal advice on several mergers, consolidations, acquisitions, and projects involving pharmaceutical companies, with analyses and multidisciplinary work, including the creation of schedules and specific stages based on regulatory conditions and constraints, aligned with contractual, business, and corporate aspects.

Medicine legislation and contractual aspects

TozziniFreire has a dedicated Life Sciences and Health team, specialized in matters involving health surveillance and health, among many other topics.

As medicines are subject to health surveillance, TozziniFreire is experienced in addressing complex legal and regulatory issues involving the pharmaceutical industry and market, by drafting memoranda, opinions, and responses to legal inquiries.

TozziniFreire also assists companies in matters involving contractual and business aspects, always considering the industry and its clients' business models.

Clinical research and issues involving health data

TozziniFreire's scope of practice also covers clinical research, under the regulations of the National Health Council (CNS) and the Brazilian Health Surveillance Agency (ANVISA), among others.

The advisory service provided by the law firm includes the interpretation and implementation of rules for conducting clinical trials, as well as expanded access and compassionate use programs in Brazil and their respective contracts, among other regulatory and contractual matters.

Moreover, TozziniFreire also assists with implementation and advice on several topics related to patient data protection and the industry interaction with healthcare professionals, in line with best practices.

Labor

Many professionals and service providers work in the pharmaceutical sector in a wide variety of roles, from industry to drugstores. Planning for labor and employment issues is part of structuring a business, both operationally and in terms of business costs.

Our team specialized in Labor Law has experience with the sector’s demands and deals with the most current issues involving labor discussions. TozziniFreire also handles cases involving professional councils and requirements for the operation of establishments within the pharmaceutical industry.

Compliance

A pioneer and established market leader, our Compliance & Investigations practice area, led by professionals with different expertise in the private and public sectors, is recognized for focusing on global trends and for its business-oriented approach. TozziniFreire has extensive experience in advising companies, boards of directors and independent committees on the prevention, detection, and remediation of potential violations of anti-corruption legislation, fraud, and other compliance-related matters. Considering TozziniFreire's strong multidisciplinary culture, our partners in the Compliance & Investigation practice regularly interact with several teams within the firm, such as Life Sciences and Health, to offer full services, with a personalized and efficient approach for pharmaceutical companies.

Biodiversity and ABS

The pharmaceutical industry is well-known for being at the forefront of Research & Development (R&D) activities, and when such initiatives, whether in Brazil or abroad, involve assets from Brazilian biodiversity, specific environmental legislation applies from the early stages of research to the development, registration, and marketing of new products. In certain situations, there may also be a duty to share the benefits derived from the sale of these products. Internationally, this is known by the acronym ABS (Access and Benefit Sharing). In addition to national rules, Brazil and 140 other countries have ratified the Nagoya Protocol, a multilateral agreement supplementary to the Convention on Biological Diversity that binds the parties to comply with the legislation of the signatory countries. TozziniFreire has extensive knowledge of the topic and practical experience in providing strategic advisory and litigation legal services.

Government Projects

The different spheres of the Brazilian government are the main clients of pharmaceutical products. We assist clients in highly complex projects involving the supply of these products to government agencies, either through traditional bidding processes or through arrangements involving offset mechanisms, such as technology transfer (PDPs, technological orders) and local content commitments.

Consumer law aspects and traceability

The law firm also has extensive experience in consumer matters, as well as in medicine recalls, with combined actions before the Brazilian Health Surveillance Agency (ANVISA) and the National Consumer Secretariat (SENACON).

In addition to this, our practice encompasses issues relating to pharmacovigilance aspects and medicine traceability, including all regulations involving the distribution of medicines and the notification of adverse events.

Tax, imports, and exports

The pharmaceutical industry requires a team specialized in Tax Law that knows the industry’s taxation and specificities of the business, including regulated prices, an extensive production chain and specific rules. TozziniFreire's tax department is used to conducting work involving the analysis of specific operations and structures of the medicine sector, including tax classification and the Health Surveillance Inspection Fee. Similarly, the law firm has experience in matters involving the import and export of medicines, pharmaceutical ingredients, and other products of interest to the pharmaceutical industry.