Home / Publications

Publications

Discover thought leadership and legal insights by our legal experts from across CMS. In our Expert Guides, written by CMS lawyers from across the jurisdictions where we operate, we provide you with in-depth legal research and insights that can be read both online and offline. You can also find Law-Now articles with focused legal analysis, commentary and insights to help you anticipate future challenges and much more.


Media type
Expertise
30/07/2021
CMS Life Sci­ences & Health­care Glob­al Bro­chure
With big deals fuel­ling re­cord levels of M&A activ­ity, a steady stream of in­nov­at­ive and dis­rupt­ive tech­no­lo­gies, new and in­creas­ingly com­plex reg­u­lat­ory chal­lenges and a thriv­ing start-up com­munity...
28/07/2021
A leg­al over­view on pub­lic pro­cure­ment for the Life Sci­ences & Health­care...
Nick Beck­ett speaks with Vir­ginie Dor (CMS Bel­gi­um), Bernt Els­ner (CMS Aus­tria) and Car­oline Hob­son (CMS UK).In this epis­ode, we dis­cuss:the im­port­ance of pub­lic pro­cure­ment in the Health­care sec­tor, rep­res­ent­ing ap­prox­im­ately 10% of GDP in the E.U.the chal­lenges for pub­lic pro­cure­ment in ex­treme and un­fore­seen emer­gen­cies, in­clud­ing COV­ID-19the scru­tiny of dir­ect awards and po­ten­tial leg­al chal­lenges and sanc­tion­sthe joint cent­ral­ised pro­cure­ment of vac­cines in short time­frames and the be­ne­fits and pit­falls of such ap­proachin what cir­cum­stances ex­clus­iv­ity, in­clud­ing due to IP rights or tech­nic­al bar­ri­ers, can jus­ti­fy derog­a­tion from pub­lic pro­cure­ment pro­ced­ureswhat changes do U.K. com­pan­ies face in pub­lic pro­cure­ment pro­ced­ures in the E.U., and vice versa, in light of Brexit
28/07/2021
A fo­cus on com­puls­ory li­cens­ing for phar­ma­ceut­ic­al com­pan­ies
Nick Beck­ett talks with Jonath­an Chu (CMS Hong Kong), Sheena Jac­ob (CMS Singa­pore) and Thomas Hirse (CMS Ger­many).In this epis­ode, we dis­cuss:the ra­tionale for com­puls­ory li­cences and the re­quire­ments for grant­ing the samethe rights of pat­ent own­ers faced with the threat of com­puls­ory li­cences­any re­quire­ment for pat­ent own­ers to also provide know-how and tech­nic­al sup­port un­der a com­puls­ory li­cence­lim­it­a­tions on ex­ploit­a­tion un­der com­puls­ory li­cences, in­clud­ing la­belling re­quire­ments and dis­tri­bu­tion chan­nel re­stric­tion­sthe use of com­puls­ory li­cences to deal with the sup­ply of med­ic­al ne­ces­sit­ies dur­ing COV­ID-19the de­bate re­gard­ing the need for COV­ID-19 vac­cine pat­ent waivers
28/07/2021
Di­git­al Health law, reg­u­la­tions and de­vel­op­ments – Part 2
Nick Beck­ett con­tin­ues to dis­cuss di­git­al health with Rob Flaws (CMS Dubai), Ni­all Mc­Al­ister (CMS UK) and Ro­land Wir­ing (CMS Ger­many).In this second in­stal­ment, the team fo­cuses on:  an in­creas­ing de­mand for di­git­al health and in­crease in tele-con­sulta­tions and use of chat­bot­sthe di­git­al­isa­tion of health­care re­cord­sthe ap­proach of Big Tech and their pro­vi­sion of ad­vanced tech­nic­al solu­tionsdata pri­vacy re­quire­ments re­gard­ing the use of im­mense data re­serves in the pro­vi­sion of di­git­al health ser­vicesthe need to in­cor­por­ate hu­man in­sight and over­sight in­to AI sys­tem pro­cesses
28/07/2021
A leg­al frame­work for ad­vert­ising of medi­cines and med­ic­al devices
Nick Beck­ett dis­cusses with Dora Petra­nyi (CMS Hun­gary), Jens Wag­n­er (CMS Ger­many) and Gab­ri­ela Staber (CMS Aus­tria) the ad­vert­ising of medi­cines and med­ic­al devices provid­ing prac­tic­al in­sights and an over­view of the ap­plic­able laws. In the epis­ode, we con­sider:the com­plic­ated and fast chan­ging area of reg­u­la­tion of ad­vert­ise­ments with dif­fer­ent rules in dif­fer­ent jur­is­dic­tion­show to veri­fy that sci­entif­ic evid­ence is suf­fi­cient to sub­stan­ti­ate claim­sthe use of ad­vert­ising in so­cial me­dia and oth­er pro­mo­tion­al cam­paign­sthe ap­proach of the au­thor­it­ies to new entrants to the mar­ket in­clud­ing in times of crisisrisks as­so­ci­ated with com­pet­it­ors or con­sumer pro­tec­tion or­gan­isa­tions fil­ing claim­sthe po­ten­tial im­pact of MDR on ad­vert­ising of med­ic­al devices
28/07/2021
Product li­ab­il­ity & med­ic­al mal­prac­tice in the life sci­ences & health­care...
Nick Beck­ett talks with Alaina Wadsworth (CMS UK), Dav­id Bridge (CMS UK) and Laura Opilio (CMS Italy) on product li­ab­il­ity and med­ic­al mal­prac­tice.In this epis­ode, we dis­cuss:in­ter­na­tion­al per­spect­ives on product li­ab­il­ity riskthe li­ab­il­ity of Health Care Pro­fes­sion­als (HCPs) “play­ing out of po­s­i­tion” dur­ing COV­ID-19the risks for non-Life Sci­ences man­u­fac­tur­ers en­ter­ing the Life Sci­ences spacethe “search for a scape goat” – an easy hunt­ing ex­ped­i­tion?a double track sys­tem in Italy and com­par­at­ive per­spect­ive­sprac­tic­al ad­vice to com­pan­ies to min­im­ise riskoff-la­bel use and rel­ev­ant con­sid­er­a­tions 
28/07/2021
Leg­al and com­mer­cial col­lab­or­a­tion dis­rup­ted: New mod­els and play­ers in...
Nick Beck­ett dis­cusses with Laurent Ro­mano (CMS France), Sarah Han­son (CMS UK/Singa­pore) and Ro­land Wir­ing (CMS Ger­many) com­mer­cial col­lab­or­a­tions.In this epis­ode, we dis­cuss:are old con­tract­ing mod­els dead?soph­ist­ic­ated new forms of col­lab­or­a­tion emer­ginga ser­vice ori­ented di­git­al ap­proach – bey­ond the pill?win-win col­lab­or­a­tions with start-up­strends to in-sour­ing in cer­tain crit­ic­al areasthe de­vel­op­ment of Centres of Ex­cel­lence and op­por­tun­it­ies for pub­lic-private part­ner­ships and con­sor­ti­um
28/07/2021
Telemedi­cine law, reg­u­la­tions and de­vel­op­ments
Nick Beck­ett dis­cusses telemedi­cine with Maria González Gor­don (CMS Spain), Ree­mt Mat­th­iesen (CMS Ger­many) and Valentina Par­vu (CMS Ro­mania). In this epis­ode, we dis­cuss:the sig­ni­fic­ant growth and mar­ket op­por­tun­it­ies that telemedi­cine and di­git­al health apps presenthow bar­ri­ers to the take-up of telemedi­cine have been broken down dur­ing COV­ID-19ex­cep­tion­al per­mit­ted uses of telemedi­cine in cases of emer­gency such as pan­dem­ic­sfrag­men­ted reg­u­la­tion of telemedi­cine and di­git­al health apps in dif­fer­ent jur­is­dic­tions, with the ad­vent of spe­cif­ic reg­u­la­tion in some jur­is­dic­tion­srestric­tions on the ad­vert­ising of telemedi­cine and re­mote treat­ment­show pa­tient data is pro­tec­ted and con­fid­en­ti­al­ity pre­served in use in telemedi­cine
28/07/2021
Di­git­al Health law, reg­u­la­tions and de­vel­op­ments – Part 1
Nick Beck­ett dis­cusses di­git­al health with Rob Flaws (CMS Dubai), Ni­all Mc­Al­ister (CMS UK) and Ro­land Wir­ing (CMS Ger­many).In this epis­ode (Part 1), we dis­cuss:the need for col­lab­or­a­tions and to deal with a po­ten­tial clash of cul­tures in bring­ing the “di­git­al” and “health” sides of the in­dustry to­geth­erthe use of AI in track-and-trace and the search for a vac­cine for COV­ID-19the lack of clar­ity of the defin­i­tion of AIwheth­er the EC White Pa­per suf­fi­ciently provides a com­pre­hens­ive pro­pos­al for reg­u­la­tion of AI, and wheth­er new le­gis­la­tion is re­quired­where li­ab­il­ity rests in re­spect of soft­ware 
28/07/2021
A leg­al roadmap for can­nabis law and reg­u­la­tion
Nick Beck­ett dis­cusses with Laura Opilio (CMS Italy), El­len Gielen (CMS Neth­er­lands) and Shuna Ma­son (CMS UK) how the medi­cin­al can­nabis in­dustry is de­vel­op­ing across Europe, the chal­lenges it faces and what the fu­ture might hold.  In par­tic­u­lar, we dis­cuss in this epis­ode:po­ten­tially the largest can­nabis mar­ket on the plan­et;how Moore’s law seems to ap­ply to the leg­al open­ing up by au­thor­it­ies in Europe;why there is yet to be sig­ni­fic­ant use in prac­tice;what stud­ies are needed to provide the hard sci­entif­ic evid­ence health­care pro­fes­sion­als and au­thor­it­ies need to be com­fort­able with the ef­fic­acy and safety of medi­cin­al can­nabis;wheth­er re­cre­ation­al use in cof­fee shops may be di­ver­ted for med­ic­al use;wheth­er food sup­ple­ments, cos­met­ics, drinks or even ci­gar­ettes could be an al­tern­at­ive means for pa­tients to re­ceive can­nabis for med­ic­al pur­poses.
13/07/2021
Fu­ture of Work
This guide helps you find an­swers to es­sen­tial ques­tions about mo­bile work­ing.
17/06/2021
We­bin­ar Re­cord­ing: Waste man­age­ment in Cent­ral and East­ern Europe I Po­land,...