Life Sciences & Healthcare practice is focused on a segment with high growth potential but we anticipate many regulatory challenges. The sector encompasses a wide scope of operations such as healthcare services, pharmaceuticals, medical devices, food and beverages, biodiversity and biotechnology, cosmetics, fertilizers, healthtechs, and telemedicine.

Every day, new health-related products arrive on the market. This is the case with gene therapies, bespoke medical devices, telemedicine services, and high-tech pesticides, among others.

Life Sciences & Healthcare is a highly innovative sector which will produce a large volume of investment. However, this will entail important legal challenges, which can only be faced by professionals highly familiarized with the sector, as well as by the work of a multidisciplinary team who specialize in the most diverse fields of law such as regulatory, consumer, antitrust, contracts, intellectual property, criminal and so on. That’s why Lefosse puts all its practices at the client’s service so we can provide the best solutions for their business.

Our services:

• Advisory and litigation (administrative or judicial) related to the provision of services and/or the manufacture, sale and import of regulated products at different levels of Government;
• Consultancy regarding related administrative matters (involving bodies such as INMETRO, IPEMs and CONAR), as well as the corresponding litigation (administrative and judicial) action;
• Acting in litigation against acts of the Public Administration, especially in matters related to inspections of Certification of Good Manufacturing Practices (CBPF), Business Operating Permits (AFE), Local Operating Licenses (LF) and Import Licenses (LI);
• Structuring and consultation related to clinical research and its consequences in the CEP/CONEP system;
• Advising on the definition of drug pricing strategy before the CMED, as well as the preparation and review of Price Information Documents (DIP) and filing of relevant appeals;
• Structuring and execution of due diligence in mergers and acquisitions, joint ventures and foreign investments in the sector;
• Structuring and executing Partnerships for Productive Development (PDPs), partnerships between foreign companies, national companies and the Brazilian Government, which aim to transfer health technologies to the national industry;
• Development and monitoring of specific Compliance Programs for the sector (relationship with government agencies, public and private physicians, health service providers, practices related to performance in tenders);
• Civil litigation related to damages potentially caused by defective products or of inherent risk (civil liability related to the product);
• Recall and administrative and litigation issues related to consumer protection;
• Assistance for companies in participating in bidding procedures, with the preparation of proposals, analysis and compilation of qualification documents, preparation of requests for clarification, challenges to notices, resources, including assistance during the holding of public sessions by the bidding body;
• Legal guidance to private companies during the execution of administrative contracts, including assistance in drafting contractual amendments and defence against the application of contractual and administrative penalties;
• Advising on negotiations with the Ministry of Health related to the direct purchase of medicines, as well as in the structuring of innovative contractual models, which aim to allow the incorporation and acquisition of high-cost medicines by the Brazilian Government (eg, sharing contracts risk and pay-for-performance);
• Advising on digital health initiatives/healthtechs, including consultancy related to health data protection and compliance with applicable regulations, telemedicine, blockchain bigdata analytics health artificial intelligence (AI), wearables, bespoke medical devices, 3D printing, medical records and electronic health records, Internet of things (IoT), patient support programs, discount programs and new payment models;
• Evaluation and structuring of projects for the provision of medical services that may have an impact on the need to register a product and request an Operating Permit before ANS;
• Advising on the negotiation between contracting parties and operators of health plans or insurance for the contracting of business benefits for medical and health assistance;
• Advising on the structuring and/or elaboration of medical-hospital and/or dental assistance contracts, as well as negotiation of their terms and modeling for operators, benefit administrators, policyholders, associations, among others;
• Consultancy and litigation (administrative and judicial) involving questioning and assessments by the Ministry of Agriculture and other agricultural defense authorities;
• Advising on the structuring of new projects, launching and promotional campaigns involving products subject to ANVISA (medical/medical devices) and MAPA (in fresh-food) regulations;
• Advising on issues related to adulteration/falsification of seeds, fertilizers, pesticides, and agricultural products in general (including interaction with public authorities, negotiation with farmers and acting in the corresponding administrative and judicial litigation); and
• Advising on research and development involving Genetically Modified Organisms (as well as protection of cultivars, regularization of bioprospecting, collection, transport and access to the genetic heritage of Brazilian biodiversity).