Home / Europe / Ukraine / Life Sciences & Healthcare

Life Sciences & Healthcare

We have established long-term relationships with the top 100 Life Sciences & Healthcare companies in the pharmaceuticals, medical devices, biotechnology, animal health, clinical trial, health tech, cosmetics, agriculture and food industries, including most of 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, regulatory matters, compliance, anti-counterfeiting, investigations and litigation, very often across multiple jurisdictions in the region and beyond. We can help you navigate the regulatory landscape and ensure compliance with both local laws and global policies.

With over 480 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. Our experts, many of whom have worked in-house in your sector, have developed a shared capability in 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 that impact the Life Sciences & Healthcare sector. 

Our Ukrainian office works extensively with global companies from the life sciences sector. For many years, we have successfully supported dozens of leading companies in various fields including pharmaceuticals, medical devices, biotechnology, chemistry, foodstuffs and cosmetics. These include the world’s largest pharmaceutical and medical device companies, as well as the leading industry associations. In the healthcare sector, we advise and represent medical service providers, including hospitals and labs.

Our life sciences team in Ukraine works alongside scientists, academics, regulatory, compliance and IP experts, all of whom have a deep understanding of the sector’s legal and regulatory needs, providing our clients with practical, commercial and sector specific solutions. We regularly advise clients on complex regulatory matters, advertisement and promotion of medicines and medical devices, public sector procurement, pricing and reimbursement, data protection, anti-counterfeiting, compliance, commercial and clinical trial agreements. Equally, when our clients need expert advice on life sciences & healthcare for strategic agreements, or are planning a corporate transaction, we have a team that is well versed in industry issues to help.  

We also take part in litigation, criminal and compliance investigations, and arbitration in the Life Sciences & Healthcare sector. We advise and represent our clients on anti-bribery, white collar crime and compliance issues, providing comprehensive advice, developing policies and guidelines, as well as providing full course training. 

  1. AstraZeneca, Bayer, Johnson & Johnson, Lilly, Novo Nordisk and other leading pharmaceutical companies on designing and drafting a contractual framework to conduct multi-centre clinical trials in Ukraine; advising on various regulatory and compliance aspects of conducting clinical studies in Ukraine
  2. Several global study sponsors and leading CROs in criminal proceedings involving a breach of the established procedure of conducting clinical trials, as well as tax evasion in Ukraine
  3. Lilly on various legal aspects of medicine public procurement, pricing and reimbursement, the introduction and further development of the National Essential Medicines List, and the outpatient reimbursement system
  4. Novo Nordisk, and other leading pharmaceutical companies, on designing and implementing patient support programmes in Ukraine, advising on regulatory (including pricing and mark-up regulations), compliance, data protection, competition and the tax aspects of the programmes
  5. Shire (now Takeda) on the Ukrainian components of USD 2.4 billion oncology business sale to Servier S.A.S., specifically, on the transfer of rights to pegaspargase, a treatment for acute lymphoblastic leukaemia being marketed in Ukraine and procured through an international organisation contracted by the Ministry of Health of Ukraine (implemented by the current CMS Life Sciences & Healthcare team before joining CMS)
  6. Takeda on its EUR 9.6 billion debt-free and cash-free acquisition of Swiss drug company Nycomed A/S, including obtaining the merger control approval
  7. Advent International on the acquisition and subsequent sale of a stake in ISIDA, one of Ukraine’s cutting-edge medical treatment and healthcare providers 
  8. Bayer, Johnson & Johnson, Takeda on the regulatory, competition and compliance aspects of pricing for public procurement of non-National Essential Medicines List medicines, recommending workable options regarding the client’s pricing policy and cooperation with commercial partners in the context of that procurement
  9. AstraZeneca, Bayer, Lilly, Novo Nordisk and other leading pharmaceutical companies on an anticorruption programmes, sponsorship of HCPs, scientific events, sampling, gifts policy, interactions with governmental officials, HCPs and pharmacists
  10. AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Merck KGaA, Novo Nordisk, Pfizer, and other leading pharmaceutical companiesA, on various customs and export control matters, including import and export regimes for medicinal products and other medical goods
  11. Johnson & Johnson, Lilly, Novo Nordisk, and other leading pharmaceutical companies, on ensuring compliant commercial terms, the application of bonuses and compensations in its relations with Ukrainian distributors, based on a comprehensive assessment of competition risks
  12. Eight leading pharmaceutical companies on all key aspects of, and representing as a criminal complainant in, the most significant criminal investigation of medicine counterfeiting in Ukraine 
  13. A leading global research-based biopharmaceutical company in a dispute and its successful resolution with the Ministry of Health of Ukraine, which arose due to a breach of the client’s data exclusivity rights to one of the global best-selling therapies
  14. European Bank for Reconstruction and Development on a project called Advice on Regulatory Improvements in Ukraine's Pharmaceutical Sector PHASES I and II for the benefit of MoH, as a member of the consortium of experts in the international technical assistance project funded by EBRD, aimed at bringing Ukrainian legislation in the pharmaceutical and medical devices sectors in compliance with the EU legislation, as well as building the capacity of the competent Ukrainian authorities
  15. Bayer, Johnson & Johnson, Lilly, Novo Nordisk, Takeda, Teva on various regulatory, compliance, commercial and competition, corporate, data protection, employment, regulatory, tax and customs matters
     

Feed

22/11/2022
Glob­al Life Sci­ences & Health­care For­um 2022: Life Sci­ences are reap­ing...
Di­git­al trans­form­a­tion in life sci­ences is cre­at­ing op­por­tun­it­ies to counter health­care’s most in­tract­able prob­lems from treat­ing rare dis­eases to ac­cel­er­at­ing dia­gnostics and re­du­cing treat­ment back­logs...
17/11/2022
CMS We­bin­ar: Medi­cin­al Products Ref­er­en­cing Pri­cing and De­marc­a­tion on...
In re­sponse to in­creas­ing in­fla­tion and in an at­tempt to re­strict rising prices for medi­cines, the Min­istry of Health­care of Ukraine, on the ini­ti­at­ive of the Na­tion­al Po­lice of Ukraine, began a re­view...
09/11/2022
Glob­al Life Sci­ences & Health­care For­um 2022: The Life Sci­ences sec­tor...
The open­ing of COP27 has brought an in­tense glob­al fo­cus on cli­mate change and the tower­ing de­mands needed to reach car­bon net zero and to pro­tect the en­vir­on­ment. United Na­tions Gen­er­al Sec­ret­ary Ant­o­nio...
03/11/2022
Mil­it­ary re­gis­tra­tion of wo­men in Ukraine man­dat­ory only for med­ic­al pro­fes­sion­als
On 7 Oc­to­ber 2022, the Par­lia­ment of Ukraine ad­op­ted changes to the Law of Ukraine “On Mil­it­ary Duty and Mil­it­ary Ser­vice” in re­la­tion to mil­it­ary re­gis­tra­tion of wo­men. The changes provide for man­dat­ory...
02/11/2022
Glob­al Life Sci­ences & Health­care For­um 2022: The leg­al sec­tor has a key...
The United Na­tions has pledged to use its pur­chas­ing fire­power to ac­cel­er­ate sus­tain­ab­il­ity along the health­care sup­ply chan­nel and called on the leg­al sec­tor to sup­port its ef­forts. Law­yers are crit­ic­al...
05/10/2022
Ukraine ad­opts new le­gis­la­tion on medi­cines
Des­pite the war with Rus­sia, Ukraine works harder than ever to align its le­gis­la­tion with that of the EU, in a bid to ac­cel­er­ate the EU mem­ber­ship. In a long-awaited move, on 28 Ju­ly 2022 Ukraine fi­nally ad­op­ted the new Law on Medi­cines (Law) with a view of har­mon­ising the Ukrain­i­an phar­ma­ceut­ic­al reg­u­la­tion and gov­ernance with the EU ap­proaches. The Law is an over­haul of the Ukrain­i­an phar­ma­ceut­ic­al le­gis­la­tion, with sub­stan­tial changes across most (if not all) areas of reg­u­la­tion (i.e. R&D, man­u­fac­tur­ing, au­thor­isa­tion, cir­cu­la­tion, li­cens­ing, state sur­veil­lance, pro­mo­tion, etc.). The Law will enter in­to force gradu­ally, with suf­fi­cient time for all mar­ket play­ers to be­come fully pre­pared.
04/10/2022
Ukraine ad­opts new le­gis­la­tion on medi­cines
Des­pite the war with Rus­sia, Ukraine works harder than ever to align its le­gis­la­tion with that of the EU, in a bid to ac­cel­er­ate the EU mem­ber­ship. In a long-awaited move, on 28 Ju­ly 2022 Ukraine fi­nally...
22/09/2022
New era of medi­cine law in Ukraine
Des­pite the on­go­ing war with Rus­sia, Ukraine is work­ing harder than ever to align its le­gis­la­tion with that of the EU, in a bid to ac­cel­er­ate EU mem­ber­ship. In a long-awaited move, on 28 Ju­ly 2022 Ukraine fi­nally ad­op­ted the new Law on Medi­cines (the “Law”), with a view to har­mon­ising Ukrain­i­an phar­ma­ceut­ic­al reg­u­la­tions and gov­ernance with EU ap­proaches. The Law is an over­haul of the Ukrain­i­an phar­ma­ceut­ic­al le­gis­la­tion, with sub­stan­tial changes across most if not all areas of reg­u­la­tion (R&D, man­u­fac­tur­ing, au­thor­isa­tion, cir­cu­la­tion, li­cens­ing, state sur­veil­lance, phar­ma­covi­gil­ance, pro­mo­tion, etc.). The Law will enter in­to force gradu­ally, with suf­fi­cient time for all mar­ket play­ers to be­come fully pre­pared. 
15/09/2022
Phar­ma­ceut­ic­al ad­vert­ising reg­u­la­tion and med­ic­al device ad­vert­ising in...
1. Which laws are ap­plic­able re­gard­ing ad­vert­ising of medi­cines and med­ic­al devices? Art­icle 21 of the Law on Ad­vert­ising No. 270/96-ВР dated 3 Ju­ly 1996 (as amended) (the “Law on Ad­vert­ising”)...
13/09/2022
UPC Rules of Pro­ced­ure go in­to force with judg­ments to be made pub­lic
The entry in­to force of the Rules of Pro­ced­ure is part of the fi­nal pre­par­a­tions for the United Pat­ent Court (UPC), which is cur­rently ex­pec­ted to start work in early 2023. After the bod­ies of the UPC...
08/09/2022
Can­nabis law and le­gis­la­tion in Ukraine
Med­ic­al use Ex­cept for the lim­ited use of cer­tain can­nabis-based psy­cho­act­ive sub­stances (Nab­i­lone, Nabix­imols and Dronabin­ol) (the “Al­lowed Sub­stances”) for med­ic­al pur­poses, the med­ic­al use of...
08/09/2022
New Real­ity Dur­ing War­time: Im­port of Med­ic­al Products to Ukraine and Ne­ces­sary...
The busi­ness com­munity in Ukraine con­tin­ues to ad­apt to the real­ity of war­time, which brings new risks and, at the same time, new op­por­tun­it­ies. The phar­ma­ceut­ic­al sec­tor and the sec­tor of med­ic­al products...