The legal environment surrounding the pharmaceutical industry, such as medical devices, is changing every day: reassessment of the profit/risk ratio, pressure due to restrictions on social spending, increased EU and international restrictions, 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, health care providers, 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

• Regulatory
  Providing analysis on regulatory rules in general and in particular relating to drugs, medical devices, veterinary medicines, phytosanitary products, cosmetics products and food supplements
  Providing analysis on clinical trials
  Providing analysis on data privacy in the context of health data
  Providing analysis and assistance in the scope of promotional and advertising campaigns for healthcare products
  Providing assistance with managing post-market licences (health research, risk management plans, etc.)
  Examining the validity of decisions taken relating to market licences (prescription restrictions, generic market licences, etc)
  
  
• Corporate transactions/Licensing
  Handling a diverse range of transactions and due diligences for pharmaceutical and health clients
  Providing assistance relating to setting up business in France, company take-overs or changes in legal form
  
  
• Price & Reimbursement
  Examining the validity of reimbursement procedures (scientific assessments and advices issued by the High Authority for Health - HAS)
  Examining the validity of decisions taken by the Healthcare Products Economic Committee (Comité économique des produits de santé - CEPS) relating to pricing
  Providing assistance for sales to hospitals (hospital procurement contracts, hospital pricing practices and sales practices from a competition law perspective)
  
  
• Compliance
  Anti Bribery/FCPA
  Good promotional practices and anti-gifts rules
  
  
• Product liability
  Providing assistance and court representation for industrial liability lawsuits
  
  
• Antitrust/competition
  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
  
  
• Tax/Customs
  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.)
  Providing advice and assistance relating to customs litigation in the field of pharma bulk and finished products

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, European Court of Human Rights or the European Court of Justice.

Our approach

• 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 perspective and after carrying out an overall assessment of the client's situation and priorities
  
• 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
  
• 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 pharmaceutical (drug and vaccine), biotechnology, medical device, and cosmetics companies, as well as hospitals, healthcare providers, research institutions and industry associations place trust in our firm for our advisory and litigation services.
Our clients range from established international drug and device groups with blockbuster products to smaller companies with a very specialised health activity.

Our team

Our dedicated lifesciences team is comprised of lawyers from several different practices who work together to provide a complete approach to our clients.