Life Sciences and Healthcare

Your Life Sciences and Healthcare business in the hands of experts

Demarest’s Life Sciences and Healthcare practice provides integrated legal advice throughout the entire lifecycle of companies, products, and services, covering research and development, marketing, and post-marketing activities.

Our team operates seamlessly across regulatory, transactional, and litigation matters. We assist our clients with strategic operations, interactions with regulatory authorities, and the development of innovative business models and opportunities, combining solid regulatory expertise with transactional experience.

Life Sciences

Innovation and agility are constants in the healthcare, health regulation, and agribusiness sectors, which require companies to rely on specialized professionals to address their diverse challenges.

We provide integrated legal counsel throughout the industry’s entire value chain, covering regulated facilities, activities, and products, such as:

• Medicines (synthetic, biological, biosimilars, herbal, radiopharmaceuticals, dynamized, or medical gases)
• Medical devices (equipment and instruments, in vitro diagnostic products, and software as a medical device – SaMD)
• Cosmetics, perfumes, and personal care products
• Clinical research
• Cannabis-based medicinal products
• Pharmacies and drugstores
• Food, supplements, beverages, and products of animal or plant origin
• Plant health and agricultural inputs, pesticides, agricultural chemicals, fertilizers, bio-inputs, seeds, and seedlings
• Animal health, animal feed, veterinary services and products
• Household sanitizers
• Fumigants
• Biotechnology and biodiversity

Regulatory Activities

• Guidance on licensing, marketing authorization, transfer, and regulatory compliance for facilities and products regulated by ANVISA and MAPA.
• Evaluation of strategies for accessing public and private healthcare markets.
• Support with medicine pricing and the drafting of pricing information documents.
• Clinical research, production, licensing, sales, distribution, and advertising; post-marketing management of adverse events and recalls.
• Consulting on legal compliance and ethical standards of professional conduct.
• Complex contractual models, such as Productive Development Partnerships (PDPs), Public-Private Partnerships (PPPs), and risk-sharing agreements.
• Compliance with health regulations.

Administrative and judicial proceedings

• Prevention and resolution of regulatory disputes in the sector.
• Representation in administrative or judicial proceedings at the federal, state, and municipal levels, such as in notices of violation or writs of mandamus against acts of the government.

Transactional and M&A

• Advice on a wide range of strategic transactions, both domestic and cross-border, including M&As, post-acquisition integration, strategic partnerships, joint ventures, company formations, and investments in and divestitures of companies or assets.
• Access to capital, financing, and initial public offerings (IPOs).

Contracts

• Drafting and negotiation of complex contracts, such as manufacturing and supply agreements, distribution agreements, service agreements, research and development agreements, and toll manufacturing agreements, among others.

Compliance

• Healthcare compliance, including internal investigations and the analysis, prevention, and mitigation of conflicts of interest in interactions with healthcare professionals, patient associations, and others.
• Advice on the promotion and marketing of regulated products or services.

Intellectual Property

• Advice on licensing and assignment of intellectual property rights, technologies, and research and development of products and new technologies.
• Drafting and negotiation of confidentiality agreements and partnership agreements with research institutions.
• Development of strategies for the protection, registration, and maintenance of intellectual property assets, such as patents, trademarks, and industrial designs, and Freedom to Operate (FTO) analyses, in addition to the protection of cultivars and genetically modified organisms (GMOs) before the National Service for the Protection of Cultivars (SNPC).
• Advice on administrative, civil, and criminal measures related to intellectual property rights infringements.

Government contracts and public bidding

• Advice on all aspects of procurement from the government, including traditional public bidding procedures and innovative partnership structures.
• Drafting and negotiation of proposals, evaluation of qualification documents, and challenges to public notices.

 Healthcare

Legal counsel in the areas of healthcare and supplementary health insurance, backed by extensive knowledge of the relationships between suppliers, service providers, healthcare professionals, patients, and the government.

Employing an in-depth understanding of the healthcare sector, its developments, and trends, combined with comprehensive knowledge of industry regulations, we assist our clients in navigating a rapidly evolving global landscape and achieving their business objectives:

• Multidisciplinary team with expertise in healthcare, supplementary health insurance, technology, innovation, and regulation.
• Advisory services for health insurance providers, benefits administrators, startups, healthtech companies, hospitals, and other healthcare facilities.
• Continuous monitoring of ANS resolutions and key industry trends, ensuring legal solutions are aligned with best practices.

Regulatory practice

• Advice on legal and regulatory matters involving health insurance providers, benefit administrators, policyholders, associations, startups, and healthtech companies.
• Licensing procedures with government and regulatory authorities, including the obtainment of licenses, National Health Services Council (CNES) authorization, and the legalization of products and facilities.
• Product modeling, network leasing, pricing, suspension of sales, restructuring of healthcare networks, preliminary investigation notices (NIP), transfer of registration and portfolios, intervention, liquidation, and compulsory sale of portfolios.

Technology, innovation, and digital health

• Consulting for startups and healthtech companies on health data protection, software as a medical device (SaMD), artificial intelligence (AI) in healthcare, electronic health records, and new business models.
• Support for initiatives in digital health, telemedicine, blockchain, big data, and interoperability.

Contracts and relationships with providers

• Drafting and negotiating contracts between health insurers and providers, with a focus on the social function of the contract and legal certainty, in accordance with Law No. 9,656/1998 and ANS regulations.
• Review and negotiation of contracts between health plans and policyholders and drafting of legal opinions on contract interpretation.
• Structuring of partnerships and innovative projects to expand access to healthcare and optimize costs.

Administrative and judicial proceedings

• Representation in administrative and judicial proceedings at all levels (federal, state, and municipal).

Compliance, ESG, and Governance

• Advice on healthcare compliance, including internal investigations, analysis, and the prevention and mitigation of conflicts of interest in interactions with healthcare professionals, patient associations, and suppliers.
• Consulting on ESG practices, ethics, and corporate governance, aligned with industry requirements and market expectations.