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Life Sciences & Healthcare Law Firm in Ukraine

We cover every area of Life Sciences & Healthcare Law.

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
     

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11/04/2024
Navigating clinical trial disclosures: No reasonable expectation of success...
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