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Borys Danevych

Partner
Life Sciences & Healthcare, CMS Cameron McKenna Nabarro Olswang

Portrait ofBorys Danevych

Borys Danevych

Partner
Life Sciences & Healthcare, CMS Cameron McKenna Nabarro Olswang

Contact
CMS Cameron McKenna Nabarro Olswang
6th Floor,
38 Volodymyrska Street,
01054 Kyiv
Ukraine
Languages English, Russian, Ukrainian

Borys Danevych is a Partner and Head of Life Sciences & Healthcare practices at CMS Cameron McKenna Nabarro Olswang Ukraine with 18-years of experience working with international pharmaceutical, biotech, animal health, medical devices 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 investor-state disputes, 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 a recommended lawyer for Health Care Law by Best Lawyers 2022 rankings and is recognised as a “leading individual” in the field of intellectual property by recent Legal 500. Borys is also “distinguished for his immense understanding of regulatory matters affecting clients in the healthcare and pharmaceutical industries” by Who’s Who Legal 2023 rankings.

Borys has been a Co-Chair of the Healthcare Committee of the American Chamber of Commerce since 2009, and since 2012 acting as a legal counsel for the Healthcare and Animal Health Committees of the European Business Association in Ukraine, and for Association of Pharmaceutical Research and Development (Epfia associate member in Ukraine). Since 2010 Borys has participated in numerous working groups under the Ministry of Health, Medicines Quality Inspectorate, and other regulatory and controlling bodies. Between 2020 and 2023, Borys had been a member of the Public Control Council of the National Health Service of Ukraine.

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Relevant experience

  • 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 original medicines in Ukraine, delivering legal advice and successfully representing Client’s interests in Ukrainian administrative courts and in 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 Takeda on versatile regulatory, commercial, competition matters, as well as on market access strategies.
  • Advised and represented 9 of top-20 global pharmaceutical companies in several massive medicines counterfeiting criminal investigation in Ukraine.
  • Represented a division of a top-5 global pharmaceutical company in a complex competition investigation focused on vertical agreements with domestic wholesalers.
  • Advised a global leading animal health company on regulatory, commercial and competition aspects of local operations in Ukraine.
  • Advised a global leading animal health company on regulatory, commercial and competition aspects of local operations in Ukraine.
  • Advised a global leading life sciences company on corporate, employment and regulatory matters following a global acquisition of an animal health division.
  • 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.
  • Successfully represented a top-10 global pharmaceutical company in a criminal investigation concerning allegedly illegal payments to HCPs associated with clinical trials, marketing authorisation procedures, promotion and public procurement of medicines.
  • Advised a global leading pharmaceutical company on the defence strategy, including domestic litigation and investor-state dispute in light of the expected unprecedented fine associated with the company’s business activities in Ukraine.
  • 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.
  • Advised 8 of top-20 global pharmaceutical companies on personal data protection restrictions and requirements, including personal data processing, use of databases, regulatory requirements to filings, local implementation of Efpia Disclosure Code, designing and drafting personal data legal framework for subsidiaries and repoffices of of global pharmaceutical companies in Ukraine.
  • Advised a leading niche cosmetics company on commercial and competition aspects of launching local sales of cosmetic products in 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.
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Memberships & Roles

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

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Publications

2023
May 2023 – Ukraine defines healthcare priorities for 2023-2025

2022
October 2022 – Ukraine adopts new legislation on medicines
August 2022 – Ukraine Health Ministry Calls for Relaxation of Cannabis Laws to Facilitate Medical Use
July 2022 – Ukraine to introduce outpatient reimbursement of medical devices from mid-2023
July 2022 – Ukraine Introduces Compassionate Use of Medicines
May 2022 – Wartime Flexibilities for the Life Sciences and Healthcare Sectors in Ukraine
January 2022 – Ukraine tightens regulations on tobacco industry
January 2022 – Ukraine aligns its legislation on veterinary medicine and products with EU law
January 2022 – Key healthcare and life sciences developments: Ukraine

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Education

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

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Expertise

12/05/2022
10 key aspects of the revised EU competition law in the field of distribution...
The new Vertical Block Exemption Regulation (VBER) and the new accompanying Vertical Guidelines (VGL) were published on 10 May 2022. The new VBER will enter into force on 1 June 2022 and apply for the next twelve years. The new VBER/VGL introduce sev
Law-Now Distribution and Franchising
12/10/2020
CMS strengthens global life sciences offering with four-strong lawyer hire...
International law firm CMS is pleased to announce that Borys Danevych will be joining the firm as a partner and Head of Life Sciences at CMS Cameron McKenna Nabarro Olswang in Kyiv from 1 November 2020...
News

Feed

27/03/2024
Cannabis law and legislation in Ukraine
Medical use Ukraine has recently adopted a new legal framework for medical cannabis, which will enhance patients’ access to cannabis-based treatment. It also notably eases regulations on the cultivation...
Expert Guide Life Sciences & Healthcare
23/01/2024
Ukrainian healthcare authority takes further steps to introduce eCTD standard
Through Order No. 1789 of 13 October 2023 (as further amended by the Order of the Ministry of Health of Ukraine No. 1924 of 8 November 2023), the Ministry of Health of Ukraine (MoH) inter alia introduced...
Law-Now Life Sciences & Healthcare
18/12/2023
Digital health apps and telemedicine in Ukraine
Digital Health Apps/Software 1. How is the software in the form of digital health apps classified in your jurisdiction, and what regulation(s) apply? 1.1 Is it considered a “medical device,” and...
Expert Guide TMC - Technology, Media & Communications
Comparable
20/10/2023
Through new law Ukraine adopts telemedicine in the face of war
On 4 September 2023, the President of Ukraine signed the Law of Ukraine On Amendments to Certain Legislative Acts of Ukraine on the Functioning of Telemedicine, which establishes a comprehensive and up-to-date...
Law-Now Life Sciences & Healthcare
06/10/2023
Ukrainian health ministry supports use of psy­che­del­ic-as­sisted therapy
The Ukrainian Ministry of Health (MoH) is supporting the future use of psy­che­del­ic-as­sisted therapy (PAT) in response to the mental disorders the nation is facing as a result of its prolonged war with...
Law-Now Life Sciences & Healthcare
26/05/2023
Ukraine launches updated electronic version of the Register of Medical...
In January 2023, the Ministry of Health of Ukraine (MoH) revised the Procedure for maintaining the register of persons responsible for placing medical devices, active implantable medical devices and IVDs...
Law-Now Life Sciences & Healthcare
02/05/2023
Ukraine defines healthcare priorities for 2023-2025
At the end of 2022, the Ministry of Health of Ukraine (MoH) approved the List of the Healthcare priorities for 2023-2025 (MoH Order #1832 dated 7 October 2022). Many priorities on the List match with...
Law-Now Life Sciences & Healthcare
17/04/2023
CEE Expert Guide on the reimbursement of orphan drugs in Ukraine
1. Is there a legal definition of orphan drugs under your law? Yes. There are two definitions of this term, which are quite similar. Under the “Procedure of Expert Evaluation of Materials for Medicinal...
Expert Guide
Comparable
15/03/2023
Rebuilding Ukraine
Ukraine’s National Recovery Plan envisions USD 750bn accumulated investment, and foreign governments and international financial institutions have pledged USD 1trn in support. Importantly, international support is targeting more than just rebuilding the destruction caused by the war; it is targeting Ukraine’s future economic recovery and growth. The private sector will play a vital role, and the government is rapidly implementing in­vestor-friendly reforms to enable the necessary scale of private investment, including EU mar­ket-in­teg­ra­tion agreements as it fast-tracks to EU candidacy. Ukraine’s reconstruction and recovery represents an unprecedented opportunity, both for Ukraine and for Europe. With lawyers qualified in Ukrainian and UK law operating in Kyiv since 2007, CMS can advise on:Business re­lo­ca­tion­Cloud-based op­er­a­tionsDoc­u­ment­ing and enforcing war dam­ageIn­sur­an­ceR­isk assessment and contingency planningMartial law and legal re­formsFin­an­cing, investing, and rebuilding and recovery opportunities. Get involved nowOur aim is to help companies participate meaningfully in the opportunities being created for Ukraine’s reconstruction and recovery. We offer specific services that can help your company. We have developed a short overview of Rebuilding Ukraine opportunities and latest updates, which is available for downloading. However, if  you would like to receive more information about “Rebuilding Ukraine” opportunities fill in the form below and we would reach out to you. 
Publication
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...
Event Webinar
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.
Publication
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...
Law-Now Coronavirus (COVID-19)
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