The legal environment surrounding the pharmaceutical industry is constantly evolving: reassessment of the profit/risk ratio, pressure due to the increase in social spending, increased EU and international restrictions, the public authorities' growing tendency to replace clearly defined policies with measures that are difficult to predict, the heightened demands of patients and patient organisations; all are factors that contribute to the changing legal landscape.

These developments have subsequently triggered substantial changes in the relationships between manufacturers, health care providers, distributors (wholesalers or pharmacies) and patients. ?

Companies are consequently required to monitor or better yet, foresee such developments that raise new and increasingly complex questions. These issues stem from the day-to-day life of the company. Highly specialised advisory services are vital in this new legal environment.

Our practices areas

Regulatory

• Analysis of regulations in general, particularly relating to drugs, medical devices, veterinary medicines, phytosanitary products, cosmetics and food supplements. Analysis of clinical trials. ?
• Analysis of data privacy in the context of health data.?
• Analysis and assistance for promotional and advertising campaigns for healthcare products.?
• Examination of validity of decisions relating to market authorisations (prescription restrictions, generic market authorisations, etc.) ?

Corporate transactions/Licensing

• Handling a diverse range of transactions and due diligence for pharmaceutical companies in the context of acquisition and restructuring operations. Assistance with setting up a business, buying a company or changing the legal form of a company?

Price & Reimbursement

• Examining the validity of reimbursement procedures (scientific assessments and advice issued by the French National Authority for Health - HAS).?
• Examining the validity of decisions taken by the Healthcare Products Economic Committee (Comité économique des produits de santé - CEPS). 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 rules against gifts
• Product liability?Assistance and representation before the courts in product liability law suits? 

Antitrust/competition

• Assistance in managing and defining 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

• Assistance in litigation relating to the various taxes specific to the healthcare product sector (additional tax on direct sales, tax on promotion, sales tax, etc.). Advice and assistance relating to customs litigation in respect of health products.

We provide strategic advisory services and legal opinions regarding all of the above areas. In the litigation area, we represent clients before national jurisdictions (Council of State, administrative tribunals, Tribunal de Grande Instance, jurisdictions competent to hear social security claims, etc.), and supranational jurisdictions (European Court of Human Rights and the Court of Justice of the European Union).

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 precision: 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, public authorities and industry associations place trust in our firm for our advisory and litigation services.

Our clients range from established international drug and medical device groups selling 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 comprehensive approach for our clients.