Lab

Life Sciences & Healthcare

United Kingdom

Discovery, innovation, market awareness and understanding are key to those life sciences and healthcare entities providing services and finance towards, and developing therapies and services for, the improvement of patient outcomes.

Due to the highly regulated nature of the industry, as an operator, investor, adviser, developer or licensee, you will be dealing with complex legal and regulatory requirements to launch, maintain and deliver your products and services to the market.

Our Life Sciences team is immersed in the sector and we appreciate our clients' technology; we are not just lawyers, we are immunologists, geneticists, chemists and engineers. With this background we are ideally placed to really understand your business, how it is changing and what you want from a trusted advisor. Highly relevant to this sector is our fully integrated European patent attorney practice. Spanning multiple disciplines, both legal and scientific, our lawyers and patent attorneys operate as one team with a common outlook and objective for our clients - providing pragmatic, innovative and effective advice, efficiently.

Our Healthcare team is truly immersed in the sector with over 25 years of advising and shaping the sector through in depth experience, knowledge and sector associations and collaborations. We have significant experience of working within the public and private sectors, giving us a complete perspective of the issues you face, allowing us to offer you commercial and well rounded advice.

With active memberships in major industry bodies such as the ABPI, ABHI, BIVDA, EUCOMED / MedTech Europe, Healthcare UK and the BPF, we help shape the legal and compliance frameworks impacting the life sciences and healthcare sectors.

As well as clients' significant, complex and strategic transactional, financing and structuring matters, we regularly advise on day-to-day business operations, covering areas such as public procurement, tax, competition, IP protection, exploitation and enforcement, product liability, supply chain, outsourcing and other commercial agreements and employment and pensions matters, as well as regulatory, disputes, risk and compliance advice. Truly a full service.

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"A one-stop-shop for us: its remarkable and successful mix of talent makes it stand out from the rest, and makes our lives much easier."

Chambers UK, 2015

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    Biotech

    Recent years have seen an increase in the numbers of biotech IPOs and more investment in the sector, however it can still be challenging accessing the finance necessary to fund R&D and to bring products to the market. As part of the biotech industry you will expect your lawyers to assist you in tackling these difficult financing and market challenges. Our team of sector specialists, including lawyers with technical backgrounds, understands the commercial drivers in this industry and can advise you on the full spectrum of legal matters.

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    Devices & Diagnostics

    In an increasingly competitive healthcare market, medical device and diagnostics companies need to ensure return on investment when developing innovative and reliable medical technologies and services. Devices and diagnostics are subject to complex regulatory and compliance frameworks and are often subject to competitive tendering so you will need lawyers who can reliably advise on pragmatic, compliant solutions.

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    eHealth

    With technology and digital innovation at the forefront of many advancements in the lifesciences industry and in healthcare delivery, organisations look  to consistently push boundaries to bring products and services to both the consumer and professional market. However, the regulation of ehealth solutions, devices and services is often outpaced by the novelty and innovation in the solutions themselves and at CMS, we understand the challenges this presents.

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    Healthcare

    The healthcare sector in the UK and internationally continues to experience a period of dynamic change underpinned by significant legal reforms and devolution to the four British nations. As an owner, operator or service provider in this sector, you are facing a highly regulated environment combined with increased public scrutiny. With increasing opportunities for the private provision of healthcare along with an ageing population, but with shrinking public healthcare budgets, operating within the healthcare sector presents both challenges and opportunities.

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    Pharmaceuticals

    With ever increasing costs of gaining marketing authorisations for new drugs, fewer opportunities for blockbuster products and ongoing pressure on pricing, operating successfully in the pharmaceutical sector can be challenging. Our sector-focused team, many of whom have technical backgrounds, are able to help clients overcome these challenges and maximise the commercial opportunities.

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    High­lights of our ex­per­i­ence in Life Sci­ences & Health­care...
    Law-Now: Lifes­ci­ences
    Vis­it Law-Now for leg­al know-how and com­ment­ary

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    1 May 2017
    CMS, Nabarro and Olswang com­plete largest ever mer­ger...
    Cre­at­ing a new fu­ture-fa­cing firm
    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.