The legal environment of the pharmaceutical industry, such as medical devices, is changing every day. The reassessment of the profit/risk ratio, pressure due to restrictions on social security expenditure, increased European and international restrictions (WTO), the public authorities’ growing tendency to replace traditional policies by unilateral measures are all factors behind the major changes in the legal environment.
These developments subsequently trigger substantial changes in relations between manufacturers, public authorities, 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.
This new legal environment results in highly specialised advice being essential.
Our practice areas
- Providing analysis on regulatory restrictions in general and in particular relating to pharmaceuticals, medical devices, veterinary medicines, phytosanitary products, and all related products (cosmetics, food supplements, etc.)
- Providing analysis on regulatory restrictions applying to clinical trials
- Providing analysis on legal restrictions with regard to the protection of personal health 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 takeovers 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 entitlement procedures (disclosure notices and notices issued by the Product and Services Assessment Committee)
- Examining the validity of pricing decisions taken by the Healthcare
- Products Economic Committee Providing assistance in the management of 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 and commercial practices from a competition law standpoint, specific problems relating to the implementation of activityrelated pricing and release of hospital supplies)
- Providing assistance in the scope of the management of commercial policy (choice of distribution channels, management of relations with wholesalers and commercial cooperation agreements, problems specific to distributing medical devices, 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 with litigation relating to the various taxes specific to healthcare products (additional tax on direct sales, tax on the promotion of medical information, sales tax, etc.)
- Taxation of care facilities and medical analysis laboratories
- Capital transactions relating to care facilities and medical analysis laboratories. We provide strategic advisory services and legal counselling regarding all of the above areas relating to the interpretation of applicable provisions or litigation, including before the French Council of State, the European Commission or the European Court of Justice.
- Recognised credibility with the public authorities.
- 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 standpoint, after carrying out an overall assessment of the client’s situation and priorities.
- Ability to manage complex matters by multilingual lawyers forming part of an international network 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 relations with the public authorities, competitors, suppliers or customers.
- Our teams’ access to CMS Bureau Francis Lefebvre’s other legal expertise (in particular, company law, contract law, employment law) and tax expertise.
- Methodological attention to detail: mobilisation of leading expertise and skills in the client’s best interest.
A large number of French manufacturers and manufacturers forming parts of international groups of varying sizes in the healthcare product industry, and several professional organisations come to our firm for advisory and litigation services.