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Life Sciences and Healthcare

Brazil Law Firm of the Year, Chambers & Partners 2020

  • Our multidisciplinary and industry focused team with expertise in different practice areas and issues particular to the Life sciences & Healthcare sectors allow us to provide our clients with an unique combination of solid regulatory expertise with transactional and litigation experience.

    Our clients include pharmaceutical and biotech companies, medical device companies, health plans, health maintenance organizations, hospitals, retail clinics, health assistance providers, healthtechs, food and beverage companies and investors.

    Our services include:

    • Mergers & Acquisitions, joint ventures and foreign investments in these sectors;

    • Advice on regulations issued by the Brazilian Ministry of Health (MS), the National Agency for Health Plans (ANS), the National Health Surveillance Agency (ANVISA), the National Counsel of Health (CNS), the Drug Market Regulatory Board (CMED), the National Commission for Incorporation of Health Technologies (CONITEC), health professional councils, such as medicine, pharmacy and nursing, the National Commission for Biosafety (CTNBio), and the Ministry of Agriculture, Livestock and Supply (MAPA);

    • Draft and negotiation of industry-specific agreements among providers in the sectors and stakeholders, including supply, distribution, agency, research and development, licensing, technology transfer, joint development, training, technical services, and business process outsourcing;

    • Assistance with labor and employment negotiations regarding employment health benefits;

    • Assistance with proceedings that require governmental authorizations, including registration of health products, transfer of marketing authorizations, incorporation of new technologies in the public health system, drug pricing, licensure of health plans, mandatory transfer of

  • portfolio of health plan, economic and financial sustainability, bankruptcy and workout plans, as well as general administrative proceedings with health authorities in a federal, state and local levels;• Advice on clinical research matters, including drafting and negotiating related contracts, protocols and consent forms;

    • Digital Health initiatives, healthtechs and related matters, including data privacy,  mHealth, telemedicine, blockchain, big data & analytics, artificial intelligence, virtual trials, wearable devices and bio printing, electronical medical records (EMR), Internet of Things (IoT) medical discount programs and new payment models;

    • Litigation, product liability and recalls;

    • Legal advice on obtainment of operating authorizations, marketing authorizations, registration, enrollments, licenses, consents and certificates issued by health authorities in a federal, state and local levels;

    • Advice on promotion and marketing of regulated products;

    • Public procurement, public-private partnerships (PPPs) and productive development partnerships (PDPs) in the health sector;

    • Biotechnology matters;

    • Controlled products and substances regulated by the Brazilian army, federal and/or local police forces;

    • Assistance with industry-specific compliance matters.

    Our services also include assistance on antitrust, compliance and corporate ethics, corporate governance, financing transactions, insurance, labor and employment, public law, public relations, real estate, tax and other matters that may affect clients from the sector.

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