Life sciences - Healthcare

We support our customers in defining and implementing their strategy for protecting, promoting, and defending their innovations and creations. This involves considering the entry into force of the Unified Patent Jurisdiction (UPJ) and the unitary patent, which present numerous advantages for companies, but also raise questions that need to be answered. We also deal with the tax aspects of innovation (tax credits, location of R&D assets, Nexus, etc.).

We support companies in classifying their products, to help them determine which regulations will apply to them. Taking the example of borderline products, a connected bracelet measuring an individual’s heart rate will be a medical device and not a connected object if its manufacturer assigns it a medical purpose. Its marketing may require clinical trials, which will be considered by the HAS (Haute Autorité de Santé) if reimbursement is sought. However, if this product is required to collect personal health data, GDPR-related aspects will also have to be considered and dealt with.

We help developing companies to raise funds, structure their shareholder structure and manage their investments by the founders. We assist more mature companies with their strategic operations, particularly acquisitions (asset deals, build-ups, etc.), or their shareholders with merger projects, IPOs or sales to other players in the sector.

Whether at the drafting, negotiation or renegotiation stage, our team can support you throughout the life of your contracts and commercial relationships. In addition, our litigation team can assist you with any dispute relating to all your activities and commercial relations.

The promotion of life sciences-healthcare products is strictly regulated by various restrictive standards (public vs/healthcare professionals, reimbursed or not, internet media, medical visits, provision of samples, demonstration materials or, more broadly, provision of benefits, etc.) and the definition of advertising is particularly broad. While this is less the case for “assimilated health products”, it would be advisable, for example, not to offer curative properties (i.e., “cures a sore throat”) to a food supplement, or risk being reclassified as a medicinal product (“any substance or composition presented as having curative or preventive properties […]”) and being subject to minimum criminal penalties. The main aim of our support for manufacturers in these areas is to ensure that their practices are secure by determining whether the tools used are compliant.

Companies manufacturing medical devices are subject to inspections by the ANSM (Agence nationale de sécurité du médicament et des produits de santé) or audits by their notified body, which may require our legal and regulatory assistance when a response to deviations needs to be formulated or the relationship with the supervisory authority becomes delicate.

Litigation involving product liability can affect pharmaceutical companies, and our assistance begins with hearings before the summary courts.

We support our customers in their international expansion, a strategic momentum that creates opportunities but is also fraught with pitfalls. This phase calls for an increase in the company’s in-house skills, as well as greater support from its advisers. We act as a catalyst, facilitator, and creator of added value, providing concrete, practical answers to the questions we are asked.

In the area of personal data, we have developed expertise in the support and deployment of projects relating to the protection of personal data and compliance.

We assist players in the life sciences – healthcare sector with issues relating to payroll flexibility and the protection of employee health and safety. It is essential to have in-depth knowledge of the sector to anticipate needs or, where necessary, respond to the supervisory authorities.

In addition, the internationalisation of this sector also means that support is needed on international mobility issues: travel, secondments and expatriations are all part of personnel management, particularly for managers, with levers for optimisation or constraints (particularly regulatory) that are part of the sector’s specific features.