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Life Sciences & Healthcare

Bulgaria

We work with and have established long-term relationships with the top 100 life sciences & healthcare 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 life sciences & healthcare 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 Life Sciences & Healthcare Asia-Pacific Network (LAN), we understand the scientific and commercial as well as the legal imperatives affecting your life sciences & healthcare 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 life sciences & healthcare sector. We regularly advise our clients on their day-to-day operational needs, providing support with advertisement and promotion of medicines, public sector procurement, pricing and reimbursement, patent enforcement and commercial and clinical trial agreements, as well as regulatory advice.

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30 October 2019
CMS ad­vises Ad­vent In­ter­na­tion­al and Zentiva on ac­quis­i­tion...
15 Nov 19
Brexit and data pro­tec­tion: what to do next (when you don’t know what’s...
Whilst the threat of a no-deal Brexit has been aver­ted for now, the fu­ture is by no means cer­tain. We have high­lighted some of the key is­sues for UK-based or­gan­isa­tions, and the EEA or­gan­isa­tions that...
01/01/2018
Good medi­cine in­stead of bit­ter pills
Bro­chure Med­ic­al Law
05 Nov 19
Whis­tleblow­ing Dir­ect­ive ad­op­ted by the EU Coun­cil
On 7 Oc­to­ber 2019, the EU Coun­cil ap­proved the word­ing of the "Dir­ect­ive of the European Par­lia­ment and of the Coun­cil on the pro­tec­tion of per­sons who re­port breaches of Uni­on law", also known as the...
15/12/2015
CMS Glob­al Lifes­ci­ences For­um 2015
Shap­ing the fu­ture through in­nov­a­tion and col­lab­or­a­tion
13 Sep 19
SPC Double Whammy - In­ter­pret­ing Art­icle 3(a) of the SPC Reg­u­la­tion
Sum­mary At the end of June, the CJEU heard the joint re­fer­rals from the Ger­man Bundes­pat­ent­gericht (case C-650/17) for Mer­ck’s sitaglipt­in product and from the Eng­lish Court of Ap­peal for Searle’s...
19/02/2015
Un­der the Mi­cro­scope
13 Jun 19
SPC Man­u­fac­tur­ing Waiver to come in­to ef­fect 1 Ju­ly 2019
Gen­er­ics com­pan­ies will soon be able to man­u­fac­ture SPC-pro­tec­ted drugs for ex­port out­side the EU un­der new man­u­fac­tur­ing waiver pro­vi­sions. In the last six months of the SPC life­time, it will also be...
07/08/2014
Get­ting the Deal Through - Phar­ma­ceut­ic­al An­ti­trust
30 May 19
EPO's strict ap­proach to de­cid­ing if a com­pos­i­tion can be­ne­fit from...
The EPO Tech­nic­al Board of Ap­peal (TBA) re­viewed the law around nov­elty of use, and de­term­ined that in the case of Car­di­oPoly­mer, Inc.'s European pat­ent ap­plic­a­tion (EP07837908.8), the claimed chem­ic­al...
27 Mar 19
Judg­ment on Ab­rax­is C-443/17; 21st March 2019
The CJEU de­livered its judg­ment last week on the case of Ab­rax­is v Comp­troller Gen­er­al of Pat­ents con­cern­ing Sup­ple­ment­ary Pro­tec­tion Cer­ti­fic­ates (SPCs) for new for­mu­la­tions of medi­cin­al products. The...
24 Aug 18
Gov­ern­ment Is­sues Brexit Tech­nic­al No­tice for Life Sci­ences
On 23 Au­gust 2018, the UK Gov­ern­ment (the "Gov­ern­ment") is­sued the first wave of its tech­nic­al pa­pers de­signed to provide guid­ance to com­pan­ies to help pre­pare for a "No Deal" Brexit. In this scen­ario,...