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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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14 May 2021
Re­cord­ing an as­sign­ment at the European Pat­ent Of­fice
Doc­u­ment sign­ing has presen­ted nov­el chal­lenges in the new re­mote-work­ing en­vir­on­ment. Re­cord­ing an as­sign­ment at the European Pat­ent Of­fice (EPO) can be straight­for­ward provided that the form­al re­quire­ments...
04 May 2021
With Il­lu­mina ac­tion, court to test EU Com­mis­sion's new mer­ger re­fer­ral...
On 29 April 2021, the US life sci­ences com­pany Il­lu­mina con­firmed that it filed an ac­tion be­fore the EU courts ask­ing for an an­nul­ment of the European Com­mis­sion’s de­cision of 19 April 2021 to ac­cept...
20 April 2021
COV­ID-19 vac­cin­a­tion and test­ing in France - em­ploy­ment law per­spect­ive
Vac­cin­a­tion 1. What op­tions does the em­ploy­er have to en­cour­age em­ploy­ees to be vac­cin­ated? Can the em­ploy­er provide a fin­an­cial in­cent­ive to em­ploy­ees?  Cur­rently there is no ob­lig­a­tion in France...
Comparable
06 April 2021
EU is­sues draft of Di­git­al Mar­kets Act aimed at cre­at­ing a new and fair...
The European Com­mis­sion has pub­lished a draft pro­pos­al for a new com­pet­i­tion law frame­work for large on­line plat­forms, called the Di­git­al Mar­kets Act (DMA). The Com­mis­sion pro­posed the DMA due to the...
23 March 2021
The En­larged Board of the European Pat­ent Of­fice has giv­en a mo­ment­ous...
The En­larged Board of the European Pat­ent Of­fice heard or­al ar­gu­ments in Ju­ly 2020 con­cern­ing pat­entab­il­ity of a com­puter soft­ware in­ven­tion.  This rare event was video streamed to over 1600 pat­ent stake­hold­ers...
18/03/2021
Cham­bers Europe 2021
The 2021 edi­tion of Cham­bers & Part­ners Europe guide has been pub­lished. We would par­tic­u­larly like to thank our cli­ents for put­ting their trust in us! Our law­yers’ rank­ings Stéphane Aus­try – Tax:...
05 March 2021
New EPO Guidelines on an­ti­body claims provide fur­ther clar­ity for ap­plic­ants
In­tro­duc­tion The EPO has now pub­lished their re­vised Guidelines for Ex­am­in­a­tion 2021[1] which con­tain new sec­tions de­tail­ing EPO prac­tice in re­la­tion to an­ti­bod­ies for the first time, en­ter­ing in­to force...
24 February 2021
COV­ID and ViCo: EPO re­fer­ral to the En­larged Board of Ap­peal
In the last year, the COV­ID-19 pan­dem­ic has res­ul­ted in a large pro­por­tion of the leg­al sec­tor trans­ition­ing to a ‘work from home’ ar­range­ment, with meet­ings tak­ing place re­motely. Non-es­sen­tial travel...
16 February 2021
Fight­ing poor med­ic­a­tion ad­her­ence in the European Uni­on: The Grav­it­ate-Health...
Nowadays, European cit­izens can ob­tain a great amount of in­form­a­tion (on­line and off­line) about any medi­cine. However, this in­form­a­tion is in many cases un­re­li­able and dif­fi­cult to un­der­stand, en­cour­aging...
11 February 2021
New EPO Guidelines now pub­lished re­gard­ing amend­ing the de­scrip­tion: what’s...
In­tro­duc­tion In Oc­to­ber 2020, CMS pub­lished an art­icle ‘New EPO Guidelines ex­pec­ted re­gard­ing amend­ing a de­scrip­tion: what’s all the fuss about?’, which has been the cata­lyst for dis­cus­sion in the...
13 January 2021
EU­'s Por­tuguese pres­id­ency re­leases new draft of ePri­vacy Reg­u­la­tion
On 5 Janu­ary 2021, the Coun­cil of the EU – with Por­tugal serving as the Pres­id­ent-in-Of­fice – re­leased a new draft ver­sion of the ePri­vacy Reg­u­la­tion, which is meant to re­place the ePri­vacy Dir­ect­ive...
16 December 2020
EU Com­mis­sion pub­lishes pro­posed Data Gov­ernance Reg­u­la­tion
On 25 Novem­ber 2020 the European Com­mis­sion pro­posed new rules on data gov­ernance – a pro­posed Data Gov­ernance Reg­u­la­tion, which is the first of a set of meas­ures an­nounced in the 2020 European strategy...