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General Information |
Healthcare Product Regulations
The legal environment surrounding the pharmaceutical industry, such as medical systems, is changing every day: reassessment of the profit/risk ratio, pressure due to restrictions on social spending, increased EU and international restrictions (OMC), the public authorities' growing tendency to unilaterally replace traditional policies by unilateral measures are factors behind the major changes in the legal environment.
These developments subsequently trigger substantial changes in relations between manufacturers, prescribers, distributors (wholesalers or pharmacies) or patients. Companies are consequently required to monitor developments and raise new and increasingly complex questions on a day-to-day basis. Highly specialized advisory services are vital in this new legal environment.
Our practices areas
Providing analysis on regulatory restrictions in general and in particular relating to pharmaceutics, medical systems, veterinary medicines, phytosanitary products, and all related products (cosmetics, food supplements, etc.)
Providing analysis on regulatory restrictions laid down for clinical trials
Providing analysis on legal restrictions with regard to the protection of health-related personal data
Providing analysis and assistance in the scope of promotional and advertising campaigns for healthcare products
Providing assistance relating to setting up business in France, company take-overs or changes in legal form
Examining the validity of decisions taken relating to market licences (prescription restrictions, generic market licences, etc.)
Examining the validity of reimbursement procedures (disclosure notices and notices issued by the Product and Services Assessment Committee (Commission d'Evaluation
des Produits et Prestations - CEPP)
Examining the validity of decisions taken by the Healthcare Products Economic Committee (Comité économique des produits de santé - CEPS) relating to pricing
Providing assistance with managing post-market licences (health research, risk management plans, etc.)
Providing assistance and court representation for industrial liability lawsuits
Providing assistance for sales to hospitals (hospital procurement contracts, hospital pricing practices and sales practices from a competition law perspective, specific
problems relating to the implementation of activity-related pricing and hospital reserve outflow)
Providing assistance in the scope of managing sales policy (choice of distribution channels, management of relations with wholesalers and commercial cooperation agreements, problems specific to distributing medical systems, etc.)
Parallel imports and issues relating to compliance with competition rules
Providing assistance with compliance programme implementation (Product regulation, good promotional
practices, data privacy, foreign corrupt practices act, anti-trust and competition, etc.)
Providing assistance in litigation relating to the various taxes specific to the healthcare product sector (additional tax on direct sales, tax on the promotion of medical information, sales tax, etc.)
We provide strategic advisory services and legal opinions regarding all of the above areas relating to the interpretation of applicable provisions or litigation, including before the Council of State, the European Commission or the European Court of Justice.
Our approach
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Recognised credibility with the public authorities
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Understanding of all issues facing our clients for whom we develop tailored solutions: we go beyond providing expert advice and deal with the issues raised from a strategic perspective and after carrying out an overall assessment of the client's situation and priorities
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Capacity to manage complex matters by multilingual lawyers belonging to an international alliance and mastering the concepts deriving from economic law, public law and European law in order to help companies in the healthcare product sector improve the management of their institutional environment and their relations with the public authorities, competitors, suppliers or customers
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Our teams' access to CMS Bureau Francis Lefebvre's legal expertise (in particular, company law, contract law, employment law) and tax expertise
Methodological rigour: mobilisation of leading expertise and skills in the best interest of the client.
Our clients
A large number of French manufacturers and manufacturers forming parts of international groups of varied sizes in the healthcare product industry and several professional organisations place trust in our firm for our advisory and litigation services.
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