Industry-focused Legal Alliance Company offers a comprehensive suite of services to the healthcare and pharmaceutical industries, serving international and national companies across antitrust and competition, corporate, IP, labor and employment and white-collar crime. The firm is exceptionally well-versed in handling regulatory work and policy making, advising on public procurement and state price regulation. Among the recent highlights of the firm are protecting the interests of a large European manufacturer of medical devices in connection with the decision of the conformity assessment body and restoration of its rights; current regulation of stem cell activity and necessary actions to comply with legal requirements; issues related to clinical trials of medicines in Ukraine; drug regulation and legal support of medicine registration. The firm is also referred for its strong competition practice, regularly representing the interests of leading pharmaceutical companies at the Antimonopoly Committee of Ukraine, assisting with promotion of products in pharmacies and retail chains, distribution and pricing. Clients include GSK, Boehringer Ingelheim, Boris medical clinic, ­Lisod clinic, Takeda, Adamed, Yuria-Pharm, Acino, Orion Pharma, ReFuture clinic and others. Dmytro Aleshko is a well-regarded figure acting across the full-circle of sector regulation. Andrii ­Gorbatenko is at the forefront of competition work; Oleksii ­Bezhevets handles corporate instructions; Illya Kostin takes in IP and labor workflow.

The Kyiv office of Baker McKenzie advises research-based multinational pharmaceutical and medical device companies on complex transactional, tax, antitrust, investigations and compliance, intellectual property rights protection and contractual matters. The firm is known for its strategic focus on transactional work, being the leader in supported M&A in the pharmaceutical and healthcare sector in Ukraine, and advising local pharmaceutical companies seeking outbound investments. Among the significant recent projects is advising the shareholders of Biopharma, a leading Ukrainian manufacturer of pharmaceuticals and healthcare products, on the carve-out of its non-plasma business and its further sale to Stada AG, which is one of the largest financial investments in the Ukrainian pharmaceutical industry; representing Bayer AG in connection with a merger control filing relating to the disposal of its Animal Health Business to Elanco, a world leader in developing products and services that enhance animal health. The firm acts as the official legal adviser to the Association of Pharmaceutical Research and Development (APRaD) to prepare legal analysis of reforms in the healthcare area. The healthcare industry group in the Kyiv office is led by partner Olha Demianiuk, an experienced transactional lawyer. The multidisciplinary team consists of experienced healthcare regulatory lawyer Olha Sviatenka, and leadership bench — Oksana Simonova, Mariana Marchuk, Ihor Siusel, Hennadiy Voytsitskyi, Oleksiy Stolyarenko and Olga Gavrylyuk.

CMS Cameron McKenna Nabarro Olswang has significantly strengthened its expert presence in the practice of life science and healthcare by integrating domestic firm Danevych.Law in November 2020. The firm is a port of choice for regulatory and compliance, IP, clinical trials, implementation of patients support programs in Ukraine. In 2020 the team advised clients specifically on clinical trials of investigational medicines for treatment of COVID-19 and vaccine candidates for preventing COVID-19; contributed to the urgent implementation of emergency legislation in the area of prevention of COVID-19. Recent projects include providing legal advice to Eli Lilly on the commercial terms and conditions of collaboration with local distributors, including advising on application of bonuses, rebates and compensations; advising a leading educational and research institution on the launch of clinical trials in Ukraine. The team is the exclusive legal advisor for several world-renowned pharmaceutical companies and deals with complex issues, such as investigation of cases of falsification of medicines in Ukraine, particularly the investigation of an unprecedented case of large-scale counterfeiting and illicit trade in medicines. Renowned expert ­Borys Danevych became a partner and head of life sciences in Kyiv. The team from Danevych.Law includes Anastasiya Filipiuk, ­Artem ­Grudinin, ­Anastasiya Maistruk.

With the launch of healthcare reform in Ukraine, ILF became a legal counsel for dozens of clinics, hospitals, medical institutions, consistently and methodically helping to implement new requirements in the operational activities of healthcare facilities. The firm is proficient in healthcare regulations, expanding its client profile with primary care centers and private healthcare operators. The daily work of the team includes, among other things, preparation of documents for obtaining a license to conduct economic activities in medical practice; audit of medical institutions; development and legalization of an individual model of staff motivation, development of internal documents for the implementation of a quality control system for the provision of medical services at enterprises; advising medical institutions and developing guidelines. The firm is enlisted for complex support for the opening of a private medical practice for provision of medical care, comprehensive legal support for the economic activities of a medical institution. Another recognized strength of the practice is GR. The head of the practice is Olena Khytrova, a well-known professional in the healthcare sector, noted as a good expert in the area of transformation of public healthcare institutions^[1].

Extensive industry specialization and a multi-practice offering has allowed Asters to retain an impressive bench of clients — manufacturers and suppliers of pharmaceutical/biotechnological products and medical equipment. The firm is equally well-versed to handle complex regulatory assignments, IP, competition, transactional support and litigation. The team’s experience encompassed advising pharmaceutical companies on the application of the new Bolar provision for Ukraine, advising on criminal issues related to the illegal sale of gray import medicine, tax risks associated with marketing programs, competition investigations. Asters continues its pro bono legal support to Tabletochki Charity Foundation in connection with various regulatory and advocacy initiatives in the healthcare sector. As a result, among other things, the ­Ministry of Health of Ukraine took a number of steps to improve the efficiency of public procurement of medicinal products for children with cancer. The team has extensive experience in obtaining permits for the acquisition of companies and portfolios of pharmaceuticals. For example, obtained clearance for the acquisition by Cheplapharm Arzneimittel GmbH from Sanofi, a portfolio of 12 cardiology brands. Alexpharm LLC, ­Association of ­Market ­Operators of Medical Devices (AMOMD), Becton Dickinson International, IGAR LLC, Tetapharm LLC are among disclosable clients. The practice is headed by Viktoriya Podvorchanska, counsel, which has strong regulatory expertise. The team is complemented by two partners — Julia Semeniy (IP) and Igor Svechkar (competition law).

With expertise across multiple practice areas, AEQUO’s team advises a range of domestic and multinational pharmaceutical companies. The offering spans M&A transactions, complex IP matters, competition, commercial, litigation. The firm advised Applied Molecular Transport Inc. on drafting contractual instruments, inter alia, related to the supply of medicine samples for conducting clinical trials in Ukraine. The team handles a number of projects for long-standing client and Ukrainian pharmaceutical company Darnitsa: successfully defended in the Supreme Court of Ukraine the company’s rights to shares in the ­Borshchahivskiy chemical-pharmaceutical plant; defended the IP rights to the Citramon trademark; supported in challenging the opponent’s attempts to obtain fame status for a generic mark on one of the key medicinal products developed in the USSR; represents Darnitsa against one of its competitors, Zdorovye, in a complex unfair competition case. The practitioners of the firm are involved in drafting legislation to combat patent trolling and “evergreening” patents. The life sciences and healthcare industry team is co-headed by Nataliya Dryuk and Tetiana Kudrytska.

Ante Law Firm advises a growing number of pharmaceutical companies and medical device distributors on IP, media, labor, medicines and medical devices regulations, taxation, commercial, antitrust and competition. The team successfully represented the interests of Sanofi-Aventis Ukraine in several projects: defended its interests in the Supreme Court in a marketing services case initiated by opponents; represented interests in a claim for compensation for damages resulting from illegal actions of the state executive service (bailiffs); advises in an unfair competition case involving the use of the Sanofi brand by another company. Zdravo also receives constant support from Ante on legal issues arising in connection with participation in public procurement, including claims proceedings at the AMCU, litigations and inquiries of law-enforcement bodies regarding the import of medical devices. The team also advises Perrigo Ukraine on the drafting of internal company policies regarding COVID-19. The team is led by Andriy Guck, who acts on regulatory issues, competition and litigation, with the significant contribution of Kateryna Ishchenko, focused on IP and pharma regulation.

In 2020 Dentons revealed its growing practice advising clients such as global pharmaceutical corporations and clinical trials companies on regulatory compliance and employment. The office’s recent caseload includes market entry which takes in regulatory and market authorization requirements; advertising and marketing; competition and trade, including commercial agreements; distribution, promotion, hospitality, sponsorship, limitations for healthcare professionals. The firm has unique experience in advising on clinical trials and operation of contract research organizations, biobanking and regulation of biobanks activities under Ukrainian law. Volodymyr Monastyrskyy manages the practice. Igor Svitlyk is singled out for his strong expertise in clinical trials.

The Kyiv office of DLA Piper^[2] is retained by global pharmaceutical companies and their representatives in Ukraine. The recent focus of the dedicated team was on areas of IP strategy and brand portfolio management, product liability, corporate, tax, regulatory and ­compliance, corporate reorganizations and antimonopoly matters. The firm regularly advises on commercial practices and distribution of pharmaceuticals in Ukraine and public procurement issues. In 2020, the cross-practice was particularly active in conducting proactive reviews of compliance systems and controls surrounding various aspects of pharmaceuticals companies’ operations. Key clients include Sanofi, Pfizer, IQVIA, Egis Pharmaceuticals, Takeda. The industry has two partners on board. Galyna ­Zagorodniuk advised pharma companies on competition compliance and commercial practices. Illya Sverdlov focuses on tax-related matters in pharmaceuticals.

In 2020 Ilyashev & Partners boosted its healthcare practice and retained a strong following among pharmaceuticals clients, seeking support in competition, IP and litigation. The firm represents patients and private healthcare providers in contentious issues and regulatory assignments, and has significant experience of clinical negligence and insurance. In particular, the team represents the interests of a client in a precedent case at the stage of pre-trial investigation on the confirmation of a medical error; represents the interests of a private person in the preparation of a claim for compensation for material damage by the organizers of a clinical trial of an experimental drug for multiple sclerosis, which led to the development of thyroid oncology. The firm conducted due diligence of the documentation of medical center Gravimed and specific patient regulation. This past year the firm successfully represented the interests of Biopharma, a leading Ukrainian pharmaceutical manufacturer in the Supreme Court in a dispute with the AMCU on the cancellation of the decision on violation of competition law; defended the interests of a client in disputes over the invalidation of patents for utility models and certificates for trademarks. The client roster includes Astellas Pharma Europe BV, Kalcex, MoviHealth, network of pharmacies Podorozhnyk, Ukrainian Red Cross Society and others. The sizeable team includes IP practitioners — Oleksandr Padalka and Dmytro Nikulesko, focused on pharma competition Olga Samoilenko. Alla Tsymanovska attained success in a number of high-profile medical cases.

INTEGRITES retains a significant client following among pharmaceutical companies, acting on operation issues, disputes, and comprehensive projects such as construction of complex medical facilities. The team represented the interests of one of the leading pharmaceutical companies in the EU in a dispute over national re-registration of a drug; advises Servier on the day-to-day corporate, employment and immigration matters of a Ukrainian subsidiary; acts on a project related to the design, construction and equipping of a hospital. Other recent work included taxation, corporate rights, employment. Partners Serhiy Shershun (antitrust and competition), Viktoriya Fomenko (tax), Illya Tkachuk (corporate, employment), Oleksandr Onishchenko (litigation) are involved in advising sector clients.

Renowned for its strong IP team, established in September 2020 boutique Mamunya IP now has life sciences among its core industrial focuses. Clients include major foreign and domestic innovative and generic pharmaceuticals manufacturers, patients’ organizations. The team provides for support with managing clients IP ­assets portfolio, patent and trademark enforcement, including litigation, anti-­counterfeiting, regulatory advice, protection against unfair competition, advertising regulation. Recent areas of growth include revocations of the permit for the sale of pharmaceuticals on the basis of IP violation, judicial review of additional certificates of protection. Contentious patent mandates make up the team’s standout expertise. In particular, the team represents the Synthon International Holding in a litigation case aimed at invalidating the opponent’s patent for method of treatment of disseminated sclerosis; successfully represented the CO 100% life in complex patent litigation aimed at increasing the accessibility of drugs. Another important highlight is ongoing representation of the client in a large-scale anti-counterfeiting matter handled by the Prosecutor-General’s Office of Ukraine against cross-border operations with fake medicines. Well-known IP specialist Oleksandr ­Mamunya, founding partner, is highly regarded as a patent litigator.

Doubinsky & Osharova is a leading IP boutique in Ukraine, with strong performance for clients from life science, pharmaceuticals and the chemical industry. The team advised on compulsory licensing and the application of standards in pharmaceuticals; acted as the IP representative of one of the world leaders in the pharmaceutical industry and revealed a series of third party trademarks that are confusingly similar to the famous brand of a client; protected IP rights AbbVie Inc. to inventions according to patents of Ukraine and also defended the IP rights of a number of other clients from the healthcare industry for an invention under patents of Ukraine. The unsurpassed Victoria ­Sopilnyak, partner, has many years of experience working with clients from the pharmaceutical and healthcare industry.

EVERLEGAL’s team has experience of the pharmaceutical market of Ukraine and abroad, acting as a legal partner for small, mid-size and growing businesses, as well as for global leaders. The team provides legal support in starting a business, ongoing activity and resolving disputes. The team advised one of the largest pharmaceutical companies in obtaining AMCU approval for a ­merger; represented the largest pharmaceutical company in Ukraine in a complex dispute regarding the ownership rights to a building in Kyiv. Yevheniy Deyneko, managing partner, is a key practice contact.

EY continues to assert its expertise in complex tax matters in the pharmaceutical and healthcare industries, and assists with general business issues. EY acted as Horizon Capital’s lead legal counsel and tax advisor on investing in Liki24, a Ukraine-based e-commerce platform for medicine delivery. In addition, in 2020 the team provided legal and tax advice regarding the choice of business presence in Ukraine for a leading Latvian manufacturer in the chemical and pharmaceutical sector, which is considering extending its activity in Ukraine. Albert Sych, Borys Lobovyk and Vladimir Kotenko are key practice contacts. Experts also highlight the work of Iryna Kovalenko, senior associate, for her strategic approach in advising authorities on the implementation of ongoing healthcare funding reform.

IP boutique Gorodissky & Partners is retained by sound clients from such sectors as chemicals, biotech, pharma, medicine. During 2020 lawyers and patent attorneys dealt with a number of pharmaceutical patent lawsuits and registration of assignment in patent rights. For example, on behalf of the patent holder, Allergan Sales LLC, the firm filed a suit with a court against the Ukrainian Patent Office’s decision to refuse to prolong a patent’s term of validity. The team was also enlisted in amendments to the claims of a patent, assists a pharmaceutical company in preparing for possible patent infringement litigation that might be initiated by an opponent in the near future. Oleg Zhukhevych and Maksym Bocharov are the main contacts.

Peterka & Partners provides legal services to producers of medicines, medical devices and diet supplements, marketing authorization holders and wholesale distributors across the CEE region. The Kyiv team often works at the intersection of different practices. For example, the office rendered legal advice to Bioveta Ukraine on various labor issues, and assisted international pharmaceutical company KRKA with salary indexation. Significant projects in 2020 include legal support to Polpharma, the largest Polish manufacturer of pharmaceuticals regarding the activities of its subsidiary in Ukraine, including numerous contractual matters. The main contact is Taras Utiralov, partner and director for Ukraine.

Vdovychen & Partners continues to advise clients on medical and healthcare matters, and accomplished a number of noteworthy projects this past year. In particular, the team’s work was focused on such issues as client protection in connection with the supply of low-quality equipment for medical procedures, support in alienation of corporate rights to a medical company, support of debt repayment by a medical institution, including tax-related aspects. The main practice contact is managing partner Oleh Vdovychen.

Market participants single out standout positions and the most diverse practice of Arzinger^[3] under the guidance of Lana ­Sinichkina, who is noted for her legislative drafting of reform of public procurement of pharmaceuticals. Yevgenia Ocheretko, counsel and practice co-head, has developed strong regulatory expertise in recent years.

^[1] In 2021 she left ILF.

^[2] Effective 14 June 2021, the Kyiv office of DLA Piper was acquired by Kinstellar.

^[3] The firm has not submitted information for the current research.