Life Sciences & Healthcare
Faced with unprecedented challenges, companies in the health sector are now subject to a range of constraints: pressure on costs and selling prices, the growing threat of counterfeits, tightening regulations driven by European and international authorities, etc. In a highly competitive market, the challenge is to remain innovative and efficient. As a player in this field, you intend to adapt to and even anticipate these developments, which raise ever-more complex questions and require extremely specialised advice.
Our team of lawyers covers a large range of different specialisms, is widely recognised for its expertise in regulatory matters and has a very high level of credibility both with public authorities and all sector stakeholders. Whether you are a major international group marketing blockbusters, or a small company with a very specific pharmaceuticals business activity, we can provide you with long-term assistance with advisory and litigation services, both in France and internationally. We operate in many fields: regulations (analysis of legislation, analysis of the legal environment surrounding clinical trials, analysis of issues regarding personal health data, analysis and assistance relating to advertising and promotional campaigns for health products, examination of the validity of decisions concerning market authorisations); corporate transactions/licensing (assistance with all of your external growth, merger and acquisition transactions); pricing and reimbursement (examination of the validity of reimbursement procedures, examination of the validity of decisions made by the Economic Committee for Healthcare Products (Comité économique des produits de santé – CEPS), assistance with sales to hospitals); compliance (anti-corruption/FCPA, good promotional practices and anti-gift law); product liability (assistance and representation before the courts for liability cases); antitrust/competition (assistance with managing and determining commercial policy, parallel imports and issues surrounding compliance with competition rules); and taxes/customs (assistance with litigation regarding the various sector-specific taxes, advice and assistance with customs matters).
In addition to the specific expertise required for these topics, our overall understanding of the scientific, business and ethical elements that underpin your activities allows us to provide the most strategic response to each of your issues.
"A well-rounded team with a strong background in the regulatory aspects of life sciences. Its particular strengths are clinical trials, market authorisations, validity decisions and advertising. The team handles product liability, distribution, antitrust and compliance work for pharma and biotech companies, healthcare providers and public authorities." – Chambers Europe 2015
"CMS has strong regulatory expertise and regularly handles drug and medical device approvals, reimbursements and listings. It also acts in product liability cases. Bernard Geneste, head of this specialism, and Jean de la Hosseraye are the main contacts in this area." – Legal 500 EMEA 2015
Legal 500 Paris 2015 – CMS has "a very high level of expertise in public law" and is among the "few firms in the market who have a perfect understanding of and ability to handle public law in the context of funding".