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Life Sciences & Healthcare

France

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

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".

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19/12/2019
WHAT ARE THE LEG­AL USES OF CAN­NABIS IN FRANCE?
Our law­yers ex­am­ine the cur­rent can­nabis reg­u­la­tion
17 Jan 20
New guid­ance on cy­ber­se­cur­ity for med­ic­al devices pub­lished
In Decem­ber 2019, the Med­ic­al Device Co­ordin­a­tion Group (“MD­CG”) is­sued a new guid­ance to help med­ic­al device man­u­fac­tur­ers meet the cy­ber­se­cur­ity re­quire­ments in the Med­ic­al Devices Reg­u­la­tion (“MDR”)...
01 Jul 19
Best Law­yers 2020
Law firm of the year in con­struc­tion law and in tax...
15 Jan 20
Can newly dis­covered can­nabis com­pounds be pro­tec­ted by pat­ents?
A break­through dis­cov­ery has re­cently hit the news: tet­rahy­drocan­nabi­phorol (THCP) and can­na­bid­i­phorol (CB­DP), two new can­nabin­oid com­pounds, have been dis­covered in Can­nabis sativa and char­ac­ter­ised...
April 2019
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So­cial Me­dia and mHealth Data EMA / HMA Re­port
New and in­nov­at­ive tech­no­lo­gies have led to a huge in­crease in data com­ing from sources that haven’t pre­vi­ously been used with­in the reg­u­lated medi­cines in­dustry. In re­cog­ni­tion of this ex­plo­sion of...
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At the end of Septem­ber, we re­por­ted here on the pub­lic­a­tion of AG Hogan’s Opin­ion on the joint re­fer­rals from the Ger­man Bundes­pat­ent­gericht (case C-650/17) for Mer­ck’s sitaglipt­in product and from...
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The gene ther­apy in­dustry is in an ex­cit­ing phase of growth, un­der­go­ing sig­ni­fic­ant M&A activ­ity, product sales and new mar­ket­ing au­thor­isa­tions that are be­ing is­sued with in­creas­ing reg­u­lar­ity glob­ally....
20/12/2018
Cham­bers Europe 2018
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15 Nov 19
Brexit and data pro­tec­tion: what to do next (when you don’t know what’s...
Whilst the threat of a no-deal Brexit has been aver­ted for now, the fu­ture is by no means cer­tain. We have high­lighted some of the key is­sues for UK-based or­gan­isa­tions, and the EEA or­gan­isa­tions that...