Our areas of excellence
LCH is a law firm dedicated to the healthcare industries: we provide legal and pragmatic solutions at all stages of your healthcare products’ life cycle.
(01)
Compliance in relationships among healthcare professionals
We support stakeholders in the healthcare sector in aligning their practices with the ethical and regulatory requirements governing their relationships, through consulting, training, and the implementation of adapted procedures.
Our interventions cover the following:
Compliance with the applicable regulations (law governing benefits – LEA, transparency, professional codes: LEEM, EFPIA, IFPMA, MedTech…)
Drafting and securing contracts between industry players, healthcare professionals, learned societies, and associations
Completing the formalities related to these contracts (LEA and transparency)
Assistance during pre-contentious phases with authorities, ARS, and professional orders
Appeals against refusal decisions (notably under the LEA)
Defense before disciplinary bodies and in case of disputes (disciplinary, civil, or criminal)
Commercial disputes related to non-compliance with compliance rules (unfair competition)
(01)
Health product regulations
We address all regulatory issues related to health products: medicines, medical devices (MD), in vitro diagnostic devices (IVD), DADFMS, cosmetics, biocides, and digital health solutions.
Commercialization (market launch, distribution, consignment, general terms of sale, value proposition…)
Pharma-material-reacto-cosmeto-vigilance
Market access: early access, pricing and reimbursement regulations, support in discussions with CEPS
Competition and consumer law applied to the healthcare sector
E-health (Telemedicine, digital medical devices, innovative medical devices (DTx), digital marketing, health data hosting, GDPR and CNIL formalities…)
Assistance during ANSM inspections
Assistance regarding health police decisions by ANSM (market withdrawal, suspension, financial penalties,…)
Criminal defense (violations of health product regulations)
Commercial litigation (unfair competition related to non-compliance with product regulations)
Responsibility for defective product liability (patient disputes)
Management of disputes outside judicial proceedings
Assistance and representation in referral-expertise procedures, judicial expertise, and courts of first instance
Assistance and representation before the CRCI
Advertising and promotion of health products
Regulations on advertising for medicines, DM, DMDIV, DADFMS, cosmetics, dietary supplements…
Charter for medical visits and implementation of procedures
Digital marketing
Review of promotional documents
Submission of visa or advertising authorization application files (ANSM)
Assistance regarding ANSM proceedings (advertising suspension, financial penalties for non-compliance with advertising regulations)
Defense in criminal cases (violation of regulations on advertising health products)
Commercial litigation (unfair competition)
Clinical Research and Studies
Clinical investigations, clinical trials, human subject research, observational studies, HAS registers, …
Advice on applicable regulation based on the study qualifications
Drafting contracts related to the setup of studies
Criminal defense (violation of regulations on clinical studies)
Assistance and representation in judicial proceedings (patient damages)
Assistance before authorities/administrations (ANSM and CPP)
