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Life Sciences & Healthcare

Poland

We work with and have established long-term relationships with the top 100 life sciences and 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 and 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.

Our co-operation with the team was delightful.
Chambers, 2016

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 and 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 and healthcare 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.

In Poland we are one of the largest players in the market. The close cooperation of almost 150 lawyers in our Warsaw and Poznan offices allows the Life Sciences & Healthcare Practice to offer comprehensive industry-focused advice. Our clients trust us with their toughest business challenges, spanning from clinical trials, pricing and reimbursement, IP, to high profile compliance issues and M&A transactions.

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High­lights of our ex­per­i­ence in Lifes­ci­ences in Po­land

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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...
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...
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...
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,...
18 May 18
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...
17 Apr 18
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...
25 Jan 18
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...
28 Nov 17
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...
06 Nov 17
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...
30 Aug 17
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...