Offices – Ukraine
Explore all Offices
Global Reach
Global Reach

Apart from offering expert legal consultancy for local jurisdictions, CMS partners up with you to effectively navigate the complexities of global business and legal environments.

Explore our reach
Insights – Ukraine
Explore all insights
Expertise
Insights
Insights

CMS lawyers can provide future-facing advice for your business across a variety of specialisms and industries, worldwide.

Explore topics
Offices
Global Reach
Global Reach

Apart from offering expert legal consultancy for local jurisdictions, CMS partners up with you to effectively navigate the complexities of global business and legal environments.

Explore our reach
CMS Ukraine
Insights
About CMS

Select your region

Borys Danevych
Partner

Borys Danevych

CEE Head of Life Sciences and Healthcare

Languages
  • English
  • Russian
  • Ukrainian
Social media

Borys Danevych is a Partner and Head of Life Sciences & Healthcare practices at CMS Ukraine and the CEE Head of Life Sciences and Healthcare group. Borys has 20 years of experience working with international pharmaceutical, biotech, animal health, medtech companies, as well as healthcare service providers and health technology organisations. He regularly advises clients on complex regulatory, compliance matters and commercial matters, anti-counterfeiting, pharmaceutical competition and IP, policy dialogue projects and regulatory disputes. Borys also counsels clients on anti-counterfeiting and white-collar criminal investigations in life sciences sector.

As a leading life sciences lawyer in Ukraine, Borys is widely recognised for his work in the sector. Borys is recognised as a “leading individual” in the field of intellectual property and competition by recent Legal 500 ranking. Borys is also a recommended lawyer in Government Contracts and Life Sciences – Regulatory fields by recent Lexology Index report, by indicating that he „inspires confidence in clients dealing with biotech, medical R&D and healthcare matters”.

Over the past decade, Borys has been focused on enhancing legislation and regulations in a number of pivotal sectors, including pharmaceuticals, medical devices, veterinary products and healthcare services guaranteeing compliance with EU standards and best international practices. Furthermore, his advice has encompassed market access for health technologies, intellectual property, medical cannabis, rehabilitation and prosthetics.

Relevant experience

  • Advised Superhumans Centre on establishment and development of a modern non-profit centre for rehabilitation, prosthetics and reconstructive surgery, including advice on regulatory, commercial and compliance issues, as well as assistance in obtaining USD 25 million of war risk insurance from the US DFC
  • Advised and represented a large group of leading multinational pharmaceutical companies in several massive criminal investigations on counterfeiting and cross-border trafficking of counterfeit medicines investigated by the National Police, State Border Service, under the supervision of Prosecutor General office. The investigations concerned dozens of global pharmaceutical companies, which products were counterfeited, and/or illegally trafficked in Ukraine
  • Novo Nordisk Ukraine on competition and regulatory aspects of implementation of a patient support program, aimed at assisting diabetes patients in Ukraine with access to novelty therapies
  • Advised 11 of top-20 global pharmaceutical companies on regulatory, compliance, commercial, tax and customs aspects of launch and conduct of multi-centre clinical trials in Ukraine, designed and drafted contractual framework (with CROs, study sites, scientific/educational institutions, investigators/study team members, laboratories, diagnostic centres, logistic service providers, insurance companies etc.) 
  • Represented a leading global research-based biopharmaceutical company in a dispute with the Ministry of Health of Ukraine, arisen due to violation of Client’s data exclusivity rights to one of its novel therapies in Ukraine, delivering legal advice and representing Client’s interests in Ukrainian administrative courts and in successful negotiations with the Ukrainian government in terms of investment dispute
  • Advised AstraZeneca on various legal aspects of conducting R&D activities in Ukraine
  • Advised Bayer on versatile regulatory, commercial, competition matters, as well as on available market access strategies
  • Advised Janssen, a pharmaceutical division of Johnson & Johnson, on multiple regulatory, compliance, commercial and competition matters, pricing and reimbursement, as well as available market access strategies
  • Advised Lilly on versatile regulatory, commercial, competition, compliance, corporate, employment, IP, tax and customs matters
  • Advised Roche on development of the Anti-Counterfeiting and Anti-Illicit Trade in Medicines Campaign, including conducting in-depth research, drawing up a comprehensive legal report on the current state of Ukrainian anti-counterfeiting and illicit trade legislation, practice of the regulatory and law enforcement agencies, recommending changes in the regulatory, criminal and criminal procedural legislation
  • Advised a global leading animal health company on various regulatory, commercial and competition matters in Ukraine
  • Advised a global leading Canadian medical cannabis company on regulatory requirements to import, registration and commercialising medical cannabis products in Ukraine
  • Advised and represented a top-20 global pharmaceutical company in the course of marketing authorisation in Ukraine of a biosimilar product in light of the then ongoing and later settled patent dispute between the client and the patent holder
  • Advised Shire (now Takeda) on Ukrainian components of US$2.4 billion oncology business sale to Servier S.A.S., specifically, on transfer of rights for pegaspargase – a treatment for acute lymphoblastic leukemia being marketed in Ukraine and procured through international organization contracted by the Ministry of Health of Ukraine
  • Acted for EBRD, as part of the international consortium of experts, on reviewing the pharmaceutical legislation, regulations and practices of regulatory authorities of Ukraine, drafting of new Law of Ukraine On Medicinal Products, and providing   recommendations on the Draft’s alignment with the EU legislation and practices

Memberships & Roles

2020-2023 – member of the Public Oversight Council at the National Health Service of Ukraine, providing oversight and expert legal advice on healthcare reform

Since 2021 – a legal advisor to the Animal Health Committees of the European Business Association (EBA) in Ukraine

2018 – present time - Member of the Ethics Committee of the Ukraine Network of Integrity and Compliance

Since 2012 – a legal advisor to the Health and the Association for Pharmaceutical Research and Development (APRaD), helping to guide the legislation in the pharmaceutical and medical device sector in line with the European Union standards

2009 – present time - Co-Chair of the Healthcare Committee, American Chamber of Commerce in Ukraine
2006 – Advocate (Attorney-at-Law) Certificate, Kyiv City Qualification Disciplinary Bar Commission, Ukraine

Education

2006 – Master's in Law Diploma (with Honours), National University of Kyiv-Mohyla Academy