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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

"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".

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24/08/2018
Gov­ern­ment Is­sues Brexit Tech­nic­al No­tice for Life Sci­ences
On 23 Au­gust 2018, the UK Gov­ern­ment (the "Gov­ern­ment") is­sued the first wave of its tech­nic­al pa­pers de­signed to provide guid­ance to com­pan­ies to help pre­pare for a "No Deal" Brexit. In this scen­ario, there will be no "trans­ition peri­od" but rather the UK.
18/05/2018
EU Product Li­ab­il­ity Dir­ect­ive still an ad­equate tool, ac­cord­ing to...
On 7 May 2018, the European Com­mis­sion pub­lished its fifth re­port on the per­form­ance of the EU Product Li­ab­il­ity Dir­ect­ive (Dir­ect­ive/85/374/EEC) in the mem­ber states. The dir­ect­ive in­tro­duced the concept of strict li­ab­il­ity for pro­du­cers of de­fect­ive products.
30/08/2017
The leg­al and reg­u­lat­ory chal­lenges of get­ting a bi­osim­il­ar product...
After a pharma view on bi­osim­il­ars was provided in the pre­vi­ous Ex­pert View column, a leg­al per­spect­ive is provided by Nick Beck­ett, man­aging part­ner at CMS Beijing and glob­al co-head of the firm­'s lifes­ci­ences sec­tor group.
20/07/2017
Entry in­to force of EU Clin­ic­al Tri­als Reg­u­la­tion post­poned to 2019
On 16 June 2017, the European Medi­cines Agency (“EMA”) pub­lished a press re­lease1 an­noun­cing the post­pone­ment of the entry in­to force of the EU Clin­ic­al Tri­als Reg­u­la­tion of 16 April 2016. 2 It was one of the top­ics at the June 2017 meet­ing of the EMA Man­age­ment.
23/06/2017
European Com­mis­sion in­vest­ig­ates po­ten­tial ex­cess­ive pri­cing of life-sav­ing...
On 15 May 2017, the European Com­mis­sion opened a form­al in­vest­ig­a­tion in­to the pri­cing of medi­cines. [1] The Com­mis­sion is in­vest­ig­at­ing wheth­er As­pen Pharma has been im­pos­ing ex­cess­ive pri­cing that con­sti­tutes an ab­use of dom­in­ant po­s­i­tion in vi­ol­a­tion of European.
21/06/2017
The Ver­dict - Round-up of cor­por­ate crime de­vel­op­ments across CMS
We are pleased to send our new is­sue of The Ver­dict, an at-a-glance round-up of re­cent leg­al de­vel­op­ments in re­la­tion to cor­por­ate crime. In this is­sue, the spot­light is on some sig­ni­fic­ant changes to anti-cor­rup­tion laws in the Czech Re­pub­lic, in­clud­ing.
02/05/2017
New reg­u­la­tion on med­ic­al devices
In­tro­duc­tion The cur­rent leg­al frame­work for med­ic­al devices in the European Uni­on is based on the fol­low­ing Dir­ect­ives, ad­op­ted in the 1990s: §  Dir­ect­ive 90/385/EEC, act­ive im­plant­able med­ic­al devices §  Dir­ect­ive 93/42/EEC, med­ic­al devices §  Dir­ect­ive.
06/03/2017
PIP-case: ECJ cla­ri­fies scope of no­ti­fied body’s re­spons­ib­il­it­ies...
In the PIP-case, a French man­u­fac­turer sup­plied thou­sands of wo­men with (al­legedly) de­fect­ive breast im­plants. Amongst oth­ers, pa­tients in Ger­many star­ted lit­ig­a­tion against the no­ti­fied body in ques­tion - TÜV Rhein­land (“Tuv”).
10/02/2017
In­dia Budget 2017 - 2018
On 1 Feb­ru­ary, Fin­ance Min­is­ter Ar­un Jait­ley presen­ted In­dia’s an­nu­al Uni­on Budget for 2017-2018 (the “Budget”) for the fisc­al year be­gin­ning 1 April 2017. The cent­ral aim in this year’s Budget ap­pears to fo­cus on the most vul­ner­able with in­creased spend­ing.
05/12/2016
ABS Reg­u­la­tion - Draft Bi­otech Sec­tor Stake­hold­er Guid­ance
Views are be­ing sought from in­ter­ested stake­hold­ers on European guid­ance for the bi­o­tech­no­logy sec­tor con­cern­ing the EU’s ac­cess to ge­net­ic re­sources and shar­ing of be­ne­fits from util­isa­tion le­gis­la­tion – namely the ABS Reg­u­la­tion.
07/10/2016
Gen­er­al Court of the EU con­firms the Lun­d­beck de­cision of the European...
On 8 Septem­ber 2016, the Gen­er­al Court of the EU ad­op­ted for the first time a judg­ment in a pay-for-delay case in the phar­ma­ceut­ic­al in­dustry. The Court thereby con­firmed the de­cision of the European Com­mis­sion of 19 June 2013 whereby it im­posed a total fine.
30/08/2016
EU Com­mis­sion re­leases draft Pri­vacy Code of Con­duct for mHealth apps
The European Com­mis­sion has draf­ted a code of con­duct on pri­vacy for mo­bile health (mHealth) apps (the “Code”). The Code has been sub­mit­ted to the Art­icle 29 Data Pro­tec­tion Work­ing Group for ap­prov­al.