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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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13/06/2019
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 al­low­able to man­u­fac­ture gen­er­ics for stock­pil­ing for “day.
30/05/2019
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 en­tity did not qual­i­fy as a 'sub­stance or com­pos­i­tion'.
27/03/2019
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 Court has ruled that Art­icle 3(d) of Reg­u­la­tion No 469/2009,.
24/08/2018
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, there will be no "trans­ition peri­od" but rather the UK.
18/05/2018
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 of strict li­ab­il­ity for pro­du­cers of de­fect­ive products.
17/04/2018
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 mod­i­fied food and feed.
25/01/2018
Pol­ish reg­u­lat­ors tackle the mar­ket of di­et­ary sup­ple­ments
The Pres­id­ent of the Of­fice of Com­pet­i­tion and Con­sumer Pro­tec­tion (UOKiK) has pub­lished the res­ults of the di­et­ary sup­ple­ments audit car­ried out in 2017 by the Trade In­spec­tion Au­thor­ity. As a res­ult of the audit, about 20% of ex­amined batches were con­tested.
25/01/2018
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 growth, com­pet­it­ive­ness and in­creased glob­al­isa­tion, but.
28/11/2017
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 our daily lives, the status of the corner­stone of the chem­ic­als.
06/11/2017
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 on 19 Oc­to­ber 2017 primar­ily fo­cused on what are re­garded.
30/08/2017
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 sec­tor group.
20/07/2017
Entry in­to force of EU Clin­ic­al Tri­als Reg­u­la­tion post­poned to 2019
On 16 June 2017, the European Medi­cines Agency (“EMA”) pub­lished a press re­lease1 an­noun­cing the post­pone­ment of the entry in­to force of the EU Clin­ic­al Tri­als Reg­u­la­tion of 16 April 2016. 2 It was one of the top­ics at the June 2017 meet­ing of the EMA Man­age­ment.