Ukrainian full-service law firm Arzinger houses the largest life sciences and healthcare team in Ukraine, which is proficient at servicing clients operating in industries like pharmaceutics, clinical trials, medical services, medical devices, cosmetics, special food products and biotechnologies. The firm is known for its wide-ranging regulatory expertise, as well as competition, compliance and IP, tax and customs, and transaction mandates. Arzinger’s team has developed a concept for the transfer of the procurement function from specialized procurement organizations (UNDP, UNICEF, Crown Agents) to the specialized state-owned enterprise Medical Procurement of Ukraine. Legal support to Stada on acquisition of a non-plasma pharmaceutical business from Biopharma (its first investment in pharmaceutical industry in the history of Ukraine) is among the most iconic projects of late; providing comprehensive advice to the European Business Association on legislative changes required to address the problem of engaging children in clinical trials who lack one of their biological parents, orphans, adopted children, children deprived of parental care. The firm regularly represents clients in investigations by the Antimonopoly Committee of Ukraine on the pharmaceutical market, and challenging its decisions in courts. Partner Lana Sinichkina heads the team and takes a leading role on many legislative initiatives involving clinical trials, registration and public procurement of pharmaceuticals. The senior team includes Mariya Baranovych, Yevgeniya Ocheretko, Volodymyr Svintsitskyi. Mykola Rekhlytskyi is known for his expertise in marketing and advertising.

Legal Alliance Company is an industry-focused firm with a wide spectrum of services, inter alia, regulatory, competition, intellectual property, employment. The regulatory workflow has shown a steady increase in the number of projects, rapidly developing due to changes in legislation in the field of healthcare and medical law. The main highlights were the collaboration with international organization within the framework of the USAID project on legal and advisory assistance in ensuring patients with quality and safe medications. Legal Alliance acts as a legal adviser to the project on providing technical assistance to the Government of Ukraine, the Ministry of Health and the Expert Committee on the selection and use of essential medicines, when about 30 regulatory legal acts and technical documentation were developed. The team successfully represented the interests of leading pharmaceutical companies in the AMCU in 2019; acted on several patent litigations and disputes related to the deregistration of medicines and import of medicines; proposed several basic models of organization of remuneration of medical workers. Among public clients are Berlin-Chemie, GSK, Boehringer Ingelheim, Takeda, Adamed, Yuria-Pharm, Acino, Orion Pharma, Meda, Clinic Lisod, etc. The regulatory practice is led by partner Dmytro Aleshko, who is known for his wealth of expertise in public procurement issues. Other partners are dedicated to clients’ queries from the sector: Andrii Gorbatenko (competition), Illya Kostin and Natalia Lavrenova  (IP, litigation), Oleksii Bezhevets (corporate).

In 2019, the ILF Law Firm’s healthcare practice team conducted projects centered on the transformation of community-based medical facilities in 18 regions of Ukraine. The transformation affected most of the internal processes of clinics, namely corporate and labor relations. These included reorganization, implementation of key performance indicators for the chief physician and medical staff, legalization of motivation systems, consultations during medical staff cuts and in the process of concluding financing contracts with a new specialized authority — the National Health Service of Ukraine. The team also led projects on the establishment of private medical practices with the purpose of private operators receiving funds from the state budget. The practice head, partner Olena Khytrova, has been handling cases on starting and expanding healthcare businesses for over seven years.

The Kyiv office of Baker McKenzie advises research-based multinational pharmaceutical and medical devices companies, as well as well-established Ukrainian industry majors. The practice group is mostly acclaimed for complex transactional, tax, IP, antitrust, investigations and compliance matters. Given its global reach and strategic focus on complex transactional work, the firm is approached to support large financial investments in the Ukrainian pharmaceutical industry. In 2019, the team advised shareholders of Biopharma, a leading Ukrainian manufacturer of pharmaceuticals and healthcare products on the carve-out of its non-plasma business, and its subsequent sale to Stada Arzneimittel AG, a global manufacturer of pharmaceuticals and consumer healthcare products. The team also conducts internal investigations, development and adaptation of business conduct standards, compliance and anti-corruption matters, competition, public procurement, regulatory, commercial and IP matters. Another area of constant presence is employment. The healthcare industry group is led by partner Olha Demianiuk, who has worked on every major healthcare transaction in Ukraine. The multidisciplinary team includes regulatory lawyer Olha Sviatenka, and partners and counsel of the office, inter alia, Oksana Simonova, Mariana Marchuk, Hennadiy Voytsitskyi, Oleksiy Stolyarenko.

Ukrainian law firm Asters customarily advises pharmaceutical/biotechnology and medical device manufacturers and suppliers on a large variety of Ukrainian law matters. The firm is approached for various antitrust issues, particularly in clearing mergers and horizontal arrangements, streamlining pricing, marketing, advertising and other commercial practices, unfair competition matters. The firm regularly represents pharmaceutical companies in investigations undertaken by the Ukrainian competition authority. In particular, the team represented Bayer LLC, Ukrainian subsidiary of Bayer AG, in the AMCU investigation on the market for distribution of pharmaceutical products, and Sanofi in its appeal against a fine levied by the AMCU. The firm continues to assist in corporate, compliance, regulatory, employment, patent protection. The team is also experienced in advising clinical trials of medicinal products in Ukraine. In July 2019, Asters team acted as a legal counsel to Dobrobut, a leading Ukrainian network of private medical centers, on its acquisition of Boris Medical Center, and rendered continuous pro bono legal support to Charity Fund Tabletochki in connection with various regulatory and advocacy initiatives in healthcare sector. Counsel Viktoriya Podvorchanska advises with a particular focus on regulatory matters. Recognized partners from other practices are involved in practice projects: Julia Semeniy focuses on IP, Vadym Samoilenko is active in M&A and corporate; Oleksandr Voznyuk runs competition law matters.

In 2019, AEQUO worked closely with the pharmaceutical industry on patent and trademark protection, transfer of IP rights, M&A, international trade and economic competition. Among the victories of the IP team is successfully protecting the interests of several pharmaceutical companies. For example, Alvogen, a global pharmaceutical company, in a patent dispute related to an invention protecting the process of manufacturing a pharmaceutical drug; protected Dr. Reddy’s product in a patent dispute against Genentech, Inc. The firm continued to advise its consistent client — pharmaceutical company Darnitsa on corporate and M&A, antitrust, litigation and IP. The team also represents Darnitsa in two trademark invalidation actions against one of its major competitors, whose disputed trademarks are confusingly similar to those of Darnitsa. AEQUO advises Renart on the development of a distribution scheme for Ukraine and drafting a distribution contract with Fresenius Medical Care Deutschland GmbH, a leading German medical equipment manufacturer. The client portfolio includes ELM-PLASTIC GmbH, Jeunesse Global, Lowenstein, Renart LLC, Sandoz, Synthon B.V. Oleksandr Mamunya, IP partner, is widely known for his extensive patent litigation track record.[1] Anna Babych runs the corporate and M&A practice, and Sergey Denisenko took on the antitrust and competition workload.

Ante Law Firm advises pharmaceutical producers and medical device distributors on various issues, including IP, media, labor, medicines and medical devices regulations, taxation, commercial and competition matters. The firm handles constant support to Sanofi-Aventis Ukraine on its marketing activities in Ukraine, involving the usage of their own and acquired objects of IP rights, and has represented Sanofi for several years in various cases initiated by several companies to recover more than EUR 1.6 million from it under a marketing services agreement. The team provides legal assistance to innovative medical software start-up company Altris AI, which is currently expanding its business internationally, and supports Zdravo LLC with its public procurement participation regarding the sale of large medical devices and in several court cases regarding the supply of medical equipment. The key team players are senior associates Roman Storonskiy and Kateryna Ishchenko. The practice is headed by Andriy Guck.

The Kyiv office of Dentons advises Ukrainian and international pharmaceutical companies (manufacturers and distributors), investors in the Ukrainian pharmaceutical industry, biotechnology companies, contract research organizations, manufacturers of medical devices, research centers, healthcare companies and private healthcare institutions. Among the core focuses of the practice are research and development, product placement, import and distribution, public procurement, advertising and promotion. The team has standout experience in regulatory issues relating to clinical trials in Ukraine and the CIS, and also assists with developing and implementing compliance programs. One of the most significant projects in 2019 was advising SMIS International Ltd on a complex corporate, competition and regulatory matter in Ukraine relating to the implementation of an e-health system in Ukraine. Counsel Igor Svitlyk is a key industry-focused practitioner. Volodymyr Monastyrskyy is lead partner.

Among the clients of DLA Piper Ukraine are multinational healthcare companies, global pharmaceutical companies, world leaders in the field of medical solutions for life, international companies specializing in life sciences. The team’s workload in 2019 encompassed advising on setting up commercial practices and distribution, patient assistance programs; regulatory advice, including clinical trials, conducting of legal due diligence of Ukrainian operations, public procurement processes, advice on the conducting of clinical trials, legal and tax review of set-up business in Ukraine, employment matters, transfer pricing and other queries. Key publishable client names are Pfizer, Sanofi, Egis Pharmaceuticals, Takeda. Anastasiya Bolkhovitinova, legal director, was active across recent projects, Galyna Zagorodniuk, partner, has an established portfolio of projects related to commercial practices and competition in the sector.

In 2019, EY was deeply involved in the reform of the country’s healthcare system. The team provided legal assistance to the Ministry of Health of Ukraine and National Health Service within the project related to a major healthcare financing reform. After a successful start to reform of healthcare financing at primary level, EY supported the pilot project on financing secondary health services in Poltava Region and the launch by the National Health Service of the updated drugs reimbursement program. The dedicated team was engaged in developing a completely new piece of legislation, from designing key definitions and to setting out framework rules on contractual arrangements for secondary healthcare. Other projects are closely related to tax issues, where EY traditionally has strong expertise. The key executive team includes ­Iryna Kovalenko and Olena Dreval, supervised by partner Albert Sych.

Ilyashev & Partners is known primarily for handling high-profile patent cases in the field of medicine and pharmaceuticals. The firm represents Omnifarma LLC, owner of registration certificate on the medicine enterosorbent carbon white in the course of protection of its IP rights on a well-known trademark in Ukraine; renders continuous legal support to Kalcex’s intellectual property rights on patents and trademarks. The routine part of work included analysis of the possibility of using warehouses for storing medical products, drafting contracts for the supply of medical products in Ukraine, surety contracts and customs law. The team also represents the interests of clients in such non-standard issues as protecting the interests of a pharmaceutical manufacturer in connection with the supply of low-quality electricity, which led to the failure of expensive equipment. In 2019 the practice was strengthened with new hires of counsel Oleksandr Padalka joined from Sayenko Kharenko, Dmytro Nikulesko from Doubinsky & Osharova, Alla Tsymanovska from Juscutum, and Olga Samoilenko from Law offices of OMP. The team is led by Mikhail Ilyashev, managing partner.

INTEGRITES is highly assigned by pharmaceutical players seeking advice on distribution and advertising of medical products, competition matters, protection of IP rights, corporate and tax, regulatory matters, including state registration of medicines, and disputes. The team’s recent engagements include representation of global pharmaceutical companies in probes initiated by the AMCU. Another highlight is representing WÖRWAG Pharma on developing a medicine distribution scheme in Ukraine. Serhiy Shershun, partner of antitrust and competition practice, heads the industrial team.

The Kyiv team of CMS Cameron McKenna Nabarro Olswang regularly advises clients on operational needs, providing support with advertisement and promotion of medicines, public sector procurement, pricing and reimbursement, patent enforcement and commercial and clinical trial agreements, as well as regulatory advice. This past year the firm focused on providing comprehensive competition advice, employment contracts, clinical trials. Olga Belyakova and Olexander Martinenko are the main contacts.

In 2019 KPMG Law provided sector clients with tax specific advisory. For example, the firm advised a few international pharmaceutical companies on tax implications and risks arising from different options of transfer pricing adjustment, CIT and VAT risks arising in connection with activities of Ukrainian branches and Anti-BEPS initiatives. Partner Oksana Olekhova is the main contact.

The Kyiv office of Peterka & Partners is approached by producers of medicines, medical devices and diet supplements, marketing authorization holders and wholesale distributors from the CEE region. In 2019 the firm supported Polpharma, the largest Polish manufacturer of pharmaceuticals, on the establishment of a subsidiary in Ukraine. Among other clients are international generic pharmaceutical company KRKA and Bioveta, a manufacturer of veterinary pharmaceutical products. The main practice contact is Taras Utiralov.

In 2019, Vdovychen & Partners demonstrated a series of projects related to developing the healthcare industry. In particular, the team rendered legal advice on investment in the opening of a medical center, covering all legal issues for investors. Another recent case is assistance in the procedure of debt write-off by a medical institution for the benefit of an employee. Managing partner Oleh Vdovychen is the main contact.

Danevych.Law, a local life sciences boutique, headed by Borys Danevych, is referred to during peers’ review as a well-established competitor.

[1]In September the IP practice team spun off and established Mamunya IP boutique firm.