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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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17 Jan 20
New guid­ance on cy­ber­se­cur­ity for med­ic­al devices pub­lished
In Decem­ber 2019, the Med­ic­al Device Co­ordin­a­tion Group (“MD­CG”) is­sued a new guid­ance to help med­ic­al device man­u­fac­tur­ers meet the cy­ber­se­cur­ity re­quire­ments in the Med­ic­al Devices Reg­u­la­tion (“MDR”)...
15 Jan 20
Can newly dis­covered can­nabis com­pounds be pro­tec­ted by pat­ents?
A break­through dis­cov­ery has re­cently hit the news: tet­rahy­drocan­nabi­phorol (THCP) and can­na­bid­i­phorol (CB­DP), two new can­nabin­oid com­pounds, have been dis­covered in Can­nabis sativa and char­ac­ter­ised...
23 Dec 19
So­cial Me­dia and mHealth Data EMA / HMA Re­port
New and in­nov­at­ive tech­no­lo­gies have led to a huge in­crease in data com­ing from sources that haven’t pre­vi­ously been used with­in the reg­u­lated medi­cines in­dustry. In re­cog­ni­tion of this ex­plo­sion of...
20 Dec 19
‘Dar­unavir’ CJEU re­fer­ral with­drawn - Art­icle 3(a) of the SPC Reg­u­la­tion
At the end of Septem­ber, we re­por­ted here on the pub­lic­a­tion of AG Hogan’s Opin­ion on the joint re­fer­rals from the Ger­man Bundes­pat­ent­gericht (case C-650/17) for Mer­ck’s sitaglipt­in product and from...
17 Dec 19
The rise of pat­ent wars in Europe’s gene ther­apy space
The gene ther­apy in­dustry is in an ex­cit­ing phase of growth, un­der­go­ing sig­ni­fic­ant M&A activ­ity, product sales and new mar­ket­ing au­thor­isa­tions that are be­ing is­sued with in­creas­ing reg­u­lar­ity glob­ally....
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...
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,...