Health law and life sciences
It is essential for national and international stakeholders in the sector (pharmaceutical laboratories, medical device manufacturers, public and private research institutes, academic institutions, biotechnology companies, investors, service providers, and competitiveness clusters) to understand and comply with current regulations to ensure the conformity of their activities and the protection of patients. We support these stakeholders throughout the lifecycle of health products and services (medicines, medical devices, pharmaceutical raw materials, in vitro diagnostic devices, biological and biotechnology-based products, cosmetics, patient health data, clinical trials, e-health, etc.).
Areas of practice in health and life sciences law
Research and development
We assist our clients with all legal aspects related to research and development, whether it involves basic, preclinical, or clinical research. This includes securing contracts with Contract Research Organizations (CROs), structuring and promoting clinical trials or investigations, and managing co-promotion agreements.
Serialization
We provide advice on implementing serialization of health products in compliance with European regulations to combat counterfeiting and ensure the traceability of medicines and medical devices.
Regulatory compliance for products
We assist our clients in ensuring compliance with regulations applicable to health products, including European regulations, the Public Health Code, and the Research Code. This encompasses CE marking, pharmacovigilance, and manufacturing standards.
Regulatory compliance for medical and wellness activities
We guide professionals in complying with regulations for medical, wellness, and cosmetic activities, ensuring adherence to legal standards to guarantee patient and consumer safety.
Digital health
This field includes telemedicine, telecare, artificial intelligence (AI) with human oversight, certified hosting of health data, cloud computing, and edge computing. We advise on legal issues related to personal health data, cybersecurity, and compliance with CNIL and ASIP Santé regulations.
Market access
We assist in obtaining Marketing Authorization (MA) and developing reimbursement strategies with the Health Insurance (Assurance Maladie) and the French Health Authority (Haute Autorité de Santé), facilitating market access for health products.
Product liability
We provide counsel on managing liability risks related to health products, including hidden defects, safety issues, or damages, helping to prevent disputes and protect our clients’ interests.
Public health law and administrative litigation
We represent clients in administrative litigation related to health law before French and European courts, including disputes with regional health agencies (ARS) and the ANSES.
Advertising law for health products and services
We assist with advertising and communication matters concerning health products and services, ensuring compliance with the Charter on the Promotion of Health Products and regulations governing therapeutic, nutritional, and health claims.
Protection of health products and services
We advise our clients on the legal protection of their products and services through patent filings, trademarks, designs, and models. We also provide guidance on patentability in the life sciences sector.
Distribution of health products and services
We provide counsel on the distribution of health products and services, covering contractual aspects with Contract Development and Manufacturing Organizations (CDMOs), platforms, marketplaces, and regulations specific to pharmacies and medical devices.
Liability for health activities
We assist in matters related to medical liability, including obligations for information, safety, compliance with medical confidentiality, and risk management associated with healthcare activities.
Medical devices
We support clients in all legal aspects related to medical devices, from design to market placement, including CE marking, regulatory compliance, and post-marketing obligations.
Examples of support in health and life sciences law
Awards
De Gaulle Fleurance & Associés houses a broad team which handles the full range of issues concerning competition law, IT, and data protection within life sciences. The team regularly appears before the French administrative courts and the French Competition Authority in disputes concerning marketing authorisations and allegations of abuse of dominant position. Jean-Marie Job, Cécile Théard-Jallu, and Francine Le Péchon-Joubert co-lead the practice. Job is particularly well-versed in mandates involving IT contracts, and both personal and commercial data management.
They are especially good in dealing with complex matters at the cross-roads between digital and life sciences. They are used to working on cutting-edge topics.
De Gaulle Fleurance & Associés advises both domestic and international healthcare and pharmaceutical clients, often assisting with regulatory advice. The team acts on the implementation of procurement regulation and data privacy. The law firm also offers assistance with corporate matters, including the negotiation of contracts and collaboration agreements.
De Gaulle Fleurance & Associés houses a broad team which handles the full range of issues concerning competition law, IT, and data protection within life sciences. The team regularly appears before the French administrative courts and the French Competition Authority in disputes concerning marketing authorisations and allegations of abuse of dominant position. Jean-Marie Job, Cécile Théard-Jallu, and Francine Le Péchon-Joubert co-lead the practice. Job is particularly well-versed in mandates involving IT contracts, and both personal and commercial data management.
They are especially good in dealing with complex matters at the cross-roads between digital and life sciences. They are used to working on cutting-edge topics.
De Gaulle Fleurance & Associés advises both domestic and international healthcare and pharmaceutical clients, often assisting with regulatory advice. The team acts on the implementation of procurement regulation and data privacy. The law firm also offers assistance with corporate matters, including the negotiation of contracts and collaboration agreements.
De Gaulle Fleurance & Associés houses a broad team which handles the full range of issues concerning competition law, IT, and data protection within life sciences. The team regularly appears before the French administrative courts and the French Competition Authority in disputes concerning marketing authorisations and allegations of abuse of dominant position. Jean-Marie Job, Cécile Théard-Jallu, and Francine Le Péchon-Joubert co-lead the practice. Job is particularly well-versed in mandates involving IT contracts, and both personal and commercial data management.
