Expertise
LexCase’s teams have acquired extensive expertise in certain business sectors, in particular with regard to sector-specific practices and regulations.
Life Sciences
The Firm advises and assists its French and international healthcare industry clients throughout the life cycle of their products: from clinical trials to post-marketing litigation, including product liability litigation and litigation with health authorities, thanks to LexCase’s team of lawyers with interrelated expertise. Through our previous experience as in-house lawyers in the health and pharmaceutical sectors, and frequent contact with the French health authorities, regulators, courts, tribunals and specialist commissions, we have intimate knowledge of the actors in this field and detailed experience of relevant procedures, enabling us to manage all your legal issues effectively.
Our team has expertise covering all types of health products and other regulated products
- Drugs, Medecines and Vaccines
- Medical Devices and IVDs
- Cosmetics
- Food supplements
- Frontier products
- Foods for special medical purposes
- Biocides
- Connected Health Solutions
Practices areas :
- R&D and pharmaceutical patents / Clinical trials
- Marketing : marketing authorisation, CE marking (new medical device regulation), definition of borderline products
- Market access : price & reimbursement, early access to medecine scheme
- Anti-bribery, gift regulation & transparency
- Business structures, projects or companies
- E-health : telemedicine, software, websites, data (GDPR), quantified self tracking (remote medical services)
- Contracts with business partners : distribution, subcontracting, national and international marketing
- Hospital public procurement and legal challenges to awards
- Promotion and advertising of medical product information
- Advice and assistance in relation to regulatory inspections
- Vigilance : drafting of appropriate tools / assistance in determining and defining processes
- Health product liability, class actions, image risk management
- Negotiation with authorities, medecine and health regulatory agency decisions
- Commercial and competition law disputes between business operators in the sector
Our Strengths
We are referenced by industry federations (SNITEM, FEBEA, COMIDENT) and actively collaborate with associations in the health field. As French representatives of the Blue Conference (a multi-juridictional network of specialist European law firms in the health sector), listed by Chambers & Partners, LEGAL 500 and Décideurs rankings, we also have a large network of international partners, experts in health law.
What we publish
Chapitre France de “Healthcare Enforcement & Litigation 2024”, Lexology (Getting the deal through), updated September 2023
France: new regulations on shortages of health products and new challenges for the life sciences sector, publication Legal Business – May 2023
Les pénuries de produits de santé : comment sortir de l’impasse ? Publication for Vox Femina in Forbes – January 2023
Panorama 2022 de jurisprudence en matière de responsabilité du fait des produits de santé dans la revue JCP Entreprise et Affaires n° 51-52 publiée par LexisNexis – November 2022
Lutte contre les pénuries de produits de santé : état des lieux d’une réglementation en mutation dans un contexte de crise sanitaire, Panorama de droit pharmaceutique 2020, Revue général de droit médical n°29, 2021
Responsabilité du fait des produits de santé dans le contexte pandémique, Editions Législatives – June 2020
Lancer un projet de e-santé – Acquérir les réflexes juridiques, Editions législatives – December 2019
LexCase lifesciences Department rankings
- Legal 500 2023
- Best Lawyers 2023
- Who’s Who Legal 2023
- Décideurs 2023
- Member of the network Conférence Bleue (band 1 in Chambers) 2023
Responsable(s) du Secteur Life Sciences
