CMS Nederland Lifesciences

Life Sciences & Healthcare

Netherlands

We work for top 100 enterprise. For example farmaceutical companies ranked in the global top 20. Furthermore, nine out of ten of the global producers of medical instruments are part of our client base. To our lawyers – who often have an in-house history in your industry themselves – your industry has no secrets. The marketing of medicinal products. Public procurement. Pricing and reimbursement. The protection of patents. Or agreements for clinical trials. We know what you are talking about. That is why we assist our top clients with their strategic decisions, the structuring of their business transactions and in legal proceedings.

Our experts, many of whom have worked in-house in your sector, have developed a shared capability in the areas of pharmaceuticals, biotechnology and medical devices. With active memberships in major industry associations such as the ABPI, ABHI, BIVDA, PAGB, EUCOMED and EFPIA, we help shape the legal frameworks impacting the lifesciences sector. We regularly advise our clients on their day-to-day operational needs such as support with advertisement and promotion of medicine, public sector procurement, pricing and reimbursement, patent enforcement, commercial and clinical trial agreements as well as regulatory advice. Equally, when you need lifesciences specialist advice for strategic agreements, planning a corporate transaction or embarking on litigation (whether product liability or otherwise), we have a team that is well versed in the industry issues to help you.

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"They always provide good advice that's commercially sound and legally accurate."

Chambers Global, 2018

"Great knowledge and geographical coverage across Europe."

Chambers Global, 2018

"The client service and responsiveness are exceptional."

Chambers Europe, 2018

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    Pharmaceuticals

    Pharmaceutical and healthcare law focuses on all the special legislation and legal aspects to do with medicine provision, biotechnology and healthcare. Whether it concerns manufacturing, operations, licences, rates, quality, market regulation or care insurance, there is specific legislation for all these areas.

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    30/01/2017
    China Lifes­ci­ences Up­date and Pre­dic­tions for 2017
    June 2017
    CMS An­nu­al Re­view 2016-2017
    Provid­ing you with the ser­vice you need wherever you...

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    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.
    17/04/2018
    NGOs can ask the Com­mis­sion to re­view its de­cision on ge­net­ic­ally...
    The Gen­er­al Court de­cided in its de­cision of 14 March 2018 that non-gov­ern­ment­al or­gan­iz­a­tions (“NGOs”) can ask the Com­mis­sion to re­view its de­cision on au­thor­iz­ing the pla­cing on the mar­ket of ge­net­ic­ally mod­i­fied food and feed.
    25/01/2018
    European Com­mis­sion as­sesses ad­equacy of Gen­er­al Food Law in food...
    In an eval­u­ation of the EU le­gis­lat­ive frame­work for the 2002 Gen­er­al Food Law Reg­u­la­tion (GFLR), the European Com­mis­sion has found that this frame­work ap­pears to ad­dress most cur­rent trends, such as growth, com­pet­it­ive­ness and in­creased glob­al­isa­tion, but.
    28/11/2017
    REACH and Brexit – Some clar­ity gained but more cer­tainty re­quired
    Sev­en­teen months after the UK Ref­er­en­dum on wheth­er to re­main in or leave the EU a num­ber of areas re­main un­cer­tain for busi­ness.   For the chem­ic­als in­dustry[i] whose products form an in­teg­ral part of our daily lives, the status of the corner­stone of the chem­ic­als.
    06/11/2017
    Brexit: State of play for Life Sci­ences com­pan­ies
    With the UK pre­par­ing to leave the European Uni­on (EU) on 30 March 2019, life sci­ences com­pan­ies are plan­ning ahead for changes to the busi­ness and reg­u­lat­ory en­vir­on­ment. Dis­cus­sions at the EU Sum­mit on 19 Oc­to­ber 2017 primar­ily fo­cused on what are re­garded.
    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.
    22/06/2017
    The Court of Justice of the EU held that the Bel­gian gen­er­al pro­hib­i­tion...
    On 4 May 2017, the Court of Justice of the EU answered sev­er­al pre­ju­di­cial ques­tions sub­mit­ted by the Bel­gian tribunal of first in­stance re­gard­ing the ad­vert­ising of the ser­vices of dent­ists. In this judg­ment, the Court held that the Bel­gian le­gis­la­tion im­pos­ing.
    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.
    05/07/2016
    Leg­al de­vel­op­ments in product li­ab­il­ity: With re­strict­ive le­gis­la­tion...
    The med­ic­al in­dustry is un­der in­creas­ing leg­al pres­sure these days ow­ing mainly to a con­sumer-friendly risk en­vir­on­ment. This is evid­ent from re­strict­ive le­gis­la­tion and re­cent land­mark cases, such as the PIP case, con­cern­ing a French com­pany that sup­plied.