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Life Sciences & Healthcare

Montenegro

With over 150 international specialist lawyers across CMS and the support of the Life Sciences Asia-Pacific Network (LAN), we understand the scientific and commercial as well as the legal imperatives affecting your life sciences & healthcare business. 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 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 we help shape the legal frameworks impacting the life sciences & 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 and compliance. Equally, when you need life sciences & healthcare specialist advice for strategic agreements, planning a corporate transaction or embarking on litigation (whether product liability or otherwise), we have a team that is well versed in the industry issues to help you.

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01/01/2018
Good medi­cine in­stead of bit­ter pills
Bro­chure Med­ic­al Law
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”)...
15/12/2015
CMS Glob­al Lifes­ci­ences For­um 2015
Shap­ing the fu­ture through in­nov­a­tion and col­lab­or­a­tion
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...
19/02/2015
Un­der the Mi­cro­scope
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...