Healthcare industry, institutions and products
LexCase’s public law team has acquired specific expertise in administrative law governing healthcare products, mainly relative to market access, pricing and reimbursement issues.
We provide services in the following areas:
- Hospital procurement and investments: public procurement contracts, outsourcing, real estate investment, precontractual and contractual disputes
- Regulations relative to the marketing of healthcare products: medicinal drugs, medical devices, vaccines, grafts, plant-based specialties, food supplements, etc.
- Issuance, amendments and disputes relative to marketing authorizations
- Registration on the list of reimbursable drugs and products
- Evaluation and reevaluation of healthcare products
- Setting of prices and tariffs; price/volume agreements
- Originator/generic conflicts
- Approvals, control of advertising, and financial penalties
- Negotiations with healthcare authorities (HAS, the French health authority; CT, the HES’s transparency committee; CNEDiMTS, the French national evaluation commission for medical devices and healthcare technologies; CEPS, the French economic committee for healthcare products; ANSM, the French national agency for medicines and health products safety; ARS, the French regional health agencies)