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Life Sciences & Healthcare

Romania

We work with and have established long-term relationships with the top 100 lifesciences companies in the areas of pharmaceuticals, medical devices, biotechnology, agriculture and food, including the top 20 global pharmaceutical companies and nine out of the top ten global medical device companies.

Our lifesciences teams in Central and Eastern Europe advise leading global business groups in the sector on transactions, commercial agreements, compliance, investigations and litigation, very often across multiple jurisdictions in the region and beyond. We can help you to navigate the regulatory landscape and to ensure compliance with both local laws and global policies.

With over 150 international specialist lawyers across CMS and the support of the Lifesciences Asia-Pacific Network (LAN), we understand the scientific and commercial as well as the legal imperatives affecting your lifesciences business. Our experts, many of whom have worked in-house in your sector, have developed a shared capability in the areas of pharmaceuticals, biotechnology, medical devices and diagnostics.

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.

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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...
10 March 2021
Ro­mania toughens rules for pub­lic pro­cure­ment by state hos­pit­als
In an at­tempt to pre­vent mis­use of pub­lic funds, the Ro­mani­an gov­ern­ment has is­sued new rules to in­crease trans­par­ency in pub­lic pro­cure­ment by pub­lic hos­pit­als. Ac­cord­ing to the new reg­u­la­tions, the...
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...
23 February 2021
Ro­mania launches pub­lic con­sulta­tion on sec­ond­ary le­gis­la­tion on telemedi­cine
On 5 Feb­ru­ary 2021, the Ro­mani­an Min­istry of Health launched pub­lic con­sulta­tions on the draft rules for the im­ple­ment­a­tion of the pro­vi­sions of Gov­ern­ment Emer­gency Or­din­ance no. 196/2020 (GEO 196/2020)...
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
Anti-coun­ter­feit­ing and Il­li­cit Trade
Des­pite COV­ID-19 vac­cines be­ing only a few months old, we are already see­ing the con­fis­ca­tion of coun­ter­feit vac­cines and the il­li­cit trade of genu­ine vac­cines. For those in the life sci­ences and health...
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...
15 December 2020
Five years after Hua­wei ZTE FRAND li­cens­ing ob­lig­a­tions again be­fore the...
On 26 Novem­ber 2020, the Düs­sel­dorf Re­gion­al Court an­nounced that it would sus­pend a pat­ent in­fringe­ment pro­ceed­ing and refer key ques­tions on com­puls­ory li­cens­ing of stand­ard es­sen­tial pat­ents (SEP)...