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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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CMS Ex­pert Guide to a Leg­al Roadmap to Can­nabis
26 May 20
European Com­mis­sion must ad­dress in­tel­lec­tu­al prop­erty and AI
The Com­mit­tee on Leg­al Af­fairs (JURI) of the European Par­lia­ment has pub­lished three draft re­ports re­lat­ing to ar­ti­fi­cial in­tel­li­gence (AI). This note is about the draft re­port on in­tel­lec­tu­al prop­erty...
30 October 2019
CMS ad­vises Ad­vent In­ter­na­tion­al and Zentiva on ac­quis­i­tion...
22 May 20
For­eign in­vest­ments in Ger­man life sci­ence com­pan­ies be­come sub­ject...
In re­sponse to the COV­ID-19 pan­dem­ic, Ger­many has widened the scope of its in­vest­ment con­trol to in­clude nu­mer­ous life sci­ence com­pan­ies. The amend­ments to the For­eign Trade and Pay­ments Or­din­ance ("AWV")...
19 May 20
Ro­mania ap­proves changes to health­care claw-back tax
On 18 May 2020, Law 53/2020 for fin­an­cing cer­tain ex­penses in the health­care sec­tor entered in­to force, which in­cluded re­du­cing the "claw-back tax" to 15% for do­mest­ic drug man­u­fac­tur­ers (both gen­er­ic...
15 May 20
Ro­mania di­als down re­stric­tions and in­sti­tutes new "state of alert"
On 14 May 2020, the Na­tion­al Com­mit­tee for Emer­gency Situ­ation is­sued De­cision no. 24 ap­prov­ing the state of alert on na­tion­al level, as well as spe­cif­ic meas­ures for con­trolling and pre­vent­ing the spread...
13 May 20
Ro­mania ad­opts meas­ure ad­van­cing telemedi­cine, long-dis­tance care
In re­sponse to the cur­rent pan­dem­ic, the Ro­mani­an gov­ern­ment has ad­op­ted meas­ures aimed at fa­cil­it­at­ing long-dis­tance care and telemedi­cine. The latest meas­ures have been taken on 8 May 2020, when the...
04 May 20
EPO Board of ap­peal re­mits to ex­amin­ing di­vi­sion when pri­or art search...
In Mod­el de­term­in­a­tion sys­tem/Ac­cen­ture Glob­al Ser­vices Lim­ited (Case T-1159/15), the board of ap­peal finds that need to per­form a pri­or art search con­sti­tutes a spe­cial reas­on to re­mit the ap­peal ap­plic­a­tion...
30 Apr 20
USPTO finds an in­ven­tion cre­ated by an AI ma­chine is not pat­entable
The US Pat­ent and Trade Mark Of­fice has found that DABUS is not a per­son and so can­not be con­sidered an in­vent­or of a pat­ent. DABUS is an ar­ti­fi­cial in­tel­li­gence (AI) ma­chine. The USPTO ac­cep­ted the in­dic­a­tion...
20 Apr 20
Ro­mani­an com­pet­i­tion watch­dog fol­lows the EU in al­low­ing co­oper­a­tion...
The Ro­mani­an Com­pet­i­tion Coun­cil (RCC) is­sued a pub­lic state­ment con­firm­ing that it is will­ing to ac­cept a cer­tain amount of co­oper­a­tion between com­pan­ies in or­der to over­come or re­duce the neg­at­ive im­pact...
17 Apr 20
Is a pri­vacy-friendly use of mo­bile ap­plic­a­tions to com­bat COV­ID-19...
A Pan-European Ap­proach to the Use of Mo­bile Apps and Mo­bile Data With its Re­com­mend­a­tion of 8 April 2020 on steps and meas­ures to de­vel­op a com­mon ap­proach to the use of mo­bile ap­plic­a­tions and mo­bile...
15 Apr 20
Ro­mania cre­ates ex­ped­ited pro­ced­ure for ap­prov­ing dona­tions of COV­ID-19...
On 13 April 2020, the Ro­mani­an Min­istry of Health is­sued Or­der No 615/2020 amend­ing Or­der No 1032/2011 re­gard­ing the ap­prov­al of the "Norms re­gard­ing the dona­tions of medi­cines, med­ic­al equip­ment, med­ic­al...