Our areas of expertise
LCH is a law firm dedicated to the healthcare industry. We provide practical legal solutions at every stage of the lifecycle of your healthcare products.
(01)
Compliance in relationships between healthcare stakeholders
We assist healthcare stakeholders in ensuring that their practices comply with the ethical and regulatory requirements governing their relationships, through legal advice, training and the implementation of appropriate procedures.
Our services include :
Compliance with applicable regulations (French Anti-Gift Law – LEA, transparency requirements, professional codes: LEEM, EFPIA, IFPMA, MedTech, etc.)
Drafting and securing contracts between healthcare companies, healthcare professionals, learned societies and associations
Completion of formalities relating to these contracts (LEA and transparency requirements)
L’Assistance during pre-litigation proceedings before public authorities, Regional Health Agencies (ARS) and professional bodies
Les Appeals against refusal decisions particularly under the LEA
La Representation before disciplinary bodies and in litigation (disciplinary, civil or criminal proceedings)
Les Commercial litigation relating to non-compliance with regulatory requirements (unfair competition)
(01)
Healthcare product regulations
We advise on all regulatory matters relating to healthcare products, including medicinal products, medical devices, in vitro diagnostic medical devices (IVDs), foods for special medical purposes (FSMPs), cosmetics, biocides and digital health solutions.
Commercialisation (market access, distribution, consignment sales, general terms and conditions of sale, specific terms and conditions of sale, etc.)
Pharmacovigilance, materiovigilance, vigilance for in vitro diagnostic devices and cosmetovigilance
Market access: early access, pricing and reimbursement regulations, assistance in negotiations with the CEPS
Competition and consumer law applied to the healthcare sector
Digital health (telemedicine, digital medical devices, innovative medical devices (DTx), digital marketing, health data hosting, GDPR and CNIL formalities, etc.)
Assistance during ANSM inspections
Assistance in connection with ANSM health enforcement decisions (market withdrawal, suspension, financial penalties, etc.)
Criminal defence in cases involving breaches of healthcare product regulations
Commercial litigation relating to unfair competition arising from non-compliance with healthcare product regulations
Product liability (patient claims)
Management of disputes outside court proceedings
Assistance and representation in court-appointed expert proceedings, judicial expert assessments and proceedings on the merits
Assistance and representation before the CRCI
Advertising and promotion of healthcare products
Advertising regulations applicable to medicinal products, medical devices, IVDs, FSMPs, cosmetics and food supplements
Medical sales representative charter and implementation of related procedures
Digital Marketing
Review of promotional materials
Submission of advertising approval or authorisation applications to the ANSM
Assistance in connection with ANSM enforcement proceedings (suspension of advertising, financial penalties for breaches of advertising regulations)
Criminal defence in cases involving breaches of healthcare product advertising regulations
Commercial litigation (unfair competition)
Clinical research and studies
Clinical investigations, clinical trials, research involving human participants, observational studies, HAS registries, etc.
Advice on the applicable regulatory framework according to the classification of the study
Drafting contracts relating to the implementation of clinical studies
Criminal defence in cases involving breaches of clinical research regulations
Assistance and representation in legal proceedings involving patient claims
Assistance before regulatory authorities and administrative bodies (ANSM and CPP)