• Borys DANEVYCH | Marchenko Danevych

    The Ukrainian Life Sciences practice is now a combination of experts with different backgrounds, where regulatory and compliance, commercial, competition, IP and dispute resolution expertise is essential. Although the practice developed in the last 10 years, it per se differs a lot compared to the Western world, lacking a strong transactional wing.

    But we are now practicing in the most transformative and challenging period since the first life sciences practices appeared on the market back at the start of this century.

    What makes a difference these years is healthcare reform. Ukraine is in the midst of a dramatic transformation of the entire healthcare system. It raises a number of policy dialogues and development projects funded by international donors (World Bank, USAID, EBRD, WHO etc.) for the benefit of the Government and Health Ministry. Legal practitioners and law firms specializing in life sciences are more and more often enlisted into these projects as experts counselling on legislation development and practicalities of transformations from public health to clinical trials, from pricing and reimbursement to medical education.

    A notable growth in healthcare-related legal practice began in 2017, with a number of adopted laws aimed at changing the environment, healthcare institutions and the services that providers operate in.

    Competition remains one of the core sources of risks for pharmaceutical and medical devices companies, as the competition authority is being really tough in investigating these sectors. This adds a lot to cautiousness on the part of clients and generates commercial, contractual and competition work for the practice.

    We are facing remarkable grow in investigations of white-collar crimes affecting pharma, clinical trials, and supply of medical devices. The said investigations are far from usual ones, raising a number of complex industry specific questions, thus requiring life sciences legal professionals to be in, rather than solely criminal defence lawyers.

    The work commercial clients are hiring law firms for is becoming more complex and strategic. The trend for significant replacement of outside counsels doing routine legal work with in-house professionals remains, and will become even more visible in the coming year.

    We expect growth in reforms-related work and assignments, including development projects with establishment of the National Health Service, expected setting up of the Centralized Procurement Agency, extension of pricing regulation and Reimbursement programs changing the landscape.

    And let’s not forget about the future (which we’re actually experiencing today): Health tech (with eHealth, mHealth) and broadly speaking Future Health will bring new names, new stars, new specializations and new work to the market.

     

The dedicated practice team of Arzinger is widely recognized as a leader among full-service law firms in Ukraine, and commands diverse expertise in life sciences and healthcare, operating throughout pharmaceutics, clinical trials, medical services, medical devices, cosmetics, special food products, and biotechnologies industries. The firm’s client profile boosts of public and private international and local companies. Among disclosable names are the charity fund Patients of Ukraine, Covance, Dexcel Pharma, EBA, GlaxoSmithKline Pharmaceuticals, GlaxoSmithKline Consumer Healthcare, INC Research, Parexel, PSI, Sanofi, Servier, Teva. Its sizeable team advises on a broad range of regulatory matters, compliance, competition, and intellectual property law. The team works in synergy with the firm’s competition practice, representing clients in the course of antitrust investigations and litigations, unfair competition matters; expanded its advisory on public procurement. Other areas of activity include legal support of manufacturing, marketing and distribution, anti-corruption and compliance. Partner Lana Sinichkina is noted for her exceptional industry knowledge, and is constantly named as a proactive force in legislative improvements.

Marchenko Danevych has sizeable multifaceted expertise dedicated to life science, including the areas of clinical trials, pharmaceuticals, biotech and medical devices. It is regularly instructed by major global life sciences clients on complex and vital regulatory, compliance, competition, intellectual property, commercial matters. Marchenko Danevych advises AbbVie, Eli Lilly and Astra Zeneca and other biotech and pharmaceutical companies on various legal aspects of research and development projects in Ukraine, particularly, with regard to multi-center clinical trials of medicines; advises Eli Lilly on a number of simplified marketing authorization procedures recently introduced in Ukraine. The firm rapidly develops its profile of regulatory and investor-state disputes, as well as its established industry centered competition practice. Dedicated partner Borys Danevych is a prominent name in the sector. Other partners actively represent the interests of sector companies: Oleksandr Aleksyeyenko traditionally acts on pharmaceutical competition matters; Oleh Marchenko is at the forefront of disputes.

Baker McKenzie has well-established positions in life science globally, and its Kyiv healthcare industry group shows its focus on complex transactional, tax, intellectual property, antitrust, investigations and compliance matters. The firm is highly regarded for its transactions support and IP work for the largest multinational pharmaceutical companies and medical devices manufacturers. The multidisciplinary offering includes regulatory advice on pharmaceutical products, clinical trials, labeling and advertising, distribution agreements, contract manufacturing, import and export requirements, product liability. The firm’s traditionally strong IP practice handles patent defense, anti-counterfeiting and other intellectual property issues. Among disclosable clients are both multinational and local names like Abbott, Acino Pharma AG, APRaD, Baxter, Baxalta Incorporated, Eli Lilly, Takeda, Shire Pharmaceuticals. The dedicated group is led by transactional lawyer Olha Demianiuk,who is recognized by the market for her visibility in the sector. Among the key regulatory lawyers are Olha Sviatenka and Olena Serpukhovitina. Other practitioners Oksana Simonova, Mariana Marchuk, Ihor Siusel, Hennadiy Voytsitskyi and Yulia Kolchenko, act on assignments across their core areas of law practice.

Legal Alliance Company is a pharmaceutical and healthcare boutique which offers an industry-tailored offering. Along with ongoing legislative changes and development of the National Essential Medicines List, the firm has a robust workflow of regulatory assignments. The team supports applications on inclusion in the national checklist and legal assistance of public procurement of medicines and medical devices. The firm is enlisted for representations in antitrust investigations, concerted actions, unfair competition, and appealing against the results of public procurement. The firm’s partners handle projects along areas of focus through Dmytro Aleshko (regulatory), Andrii Gorbatenko (competition), Oleksii Bezhevets (corporate), Illya Kostin (IP and employment).

ILF Law Firm has unparalleled experience across the healthcare sector. Throughout the last couple of years the firm has acted as legal counsel for the state’s healthcare reform and advocates it at national and regional levels. In 2017 the practice team guided by Olena Khytrova, partner, carried out the first project in Eastern Ukraine on reforming finance of medical aid in the Chuguyiv District. The firm is a point of choice for healthcare providers, medical clinics and laboratories on a wide range of issues, including reorganizations, import of medical equipment, clinical trials and scientific research. Patient rights protection is another notable area of expertise. This past year ILF advised regional state administrations and international organizations on the autonomation of hospitals. Tetyana Gavrysh, managing partner, is praised for her in-depth knowledge of best international practices and contributes to the most strategic areas of reforms.

The solid client portfolio of life sciences and healthcare practiceat AEQUO law firm provides a growing offering, encompassing regulatory, trade and distribution, customs, data protection, corporate transactions, and is especially known for its strong patent litigation track record and flourishing antitrust and competition caseload. The firm’s IP team succeeded in representing Dr. Reddy’s Laboratories Limited in the first of a kind patent infringement case involving a biosimilar medicinal product registered in Ukraine and in a patent invalidation litigation matter. The competition team, as guided by counsel Sergey Denisenko, advised Cardinal Health, a global, integrated healthcare services and products company, on competition compliance issues of setting up a distribution system in Ukraine. Renowned IP partner Oleksandr Mamunya heads the practice. Senior associates Natalia Dryuk and Andrey Nikolayenko are involved in project work.

The Kyiv office of Dentons has a well-established reputation in the market with a strong international clientele on board. The practice is particularly noted for its substantial expertise in clinical trials and regulatory matters pertaining to the pharmaceutical sector, as well as historically strong compliance offering. The team is instructed on a consistent basis for commercial and distribution, corporate, tax, trademark protection, and competition matters. Volodymyr Monastyrskyy and Markian Silecky are lead partners. The name of Igor Svitlyk, associate, is known in the area of life science.

The Ukrainian outfit of DLA Piper has a diverse practice encompassing expertise in competition, IP, tax, regulatory, commercial and corporate. The firm consistently acts on global M&A in the sector, and most recently advised Takeda Pharmaceuticals in relation to acquisition of Unipharm Inc’s assets in the CIS. The team is known in the market for its notable strength in antitrust, competition and public procurement. Most recently the office advised British company Crown Agents on legal matters relating to agreements with the Ministry of Health of Ukraine to procure medicines under special state-financed programs. Other clients include Sanofi, Pfizer, Sandoz, GlaxoSmithKline, Pharma Start LLC. Partner Galyna Zagorodniuk is highly experienced in the pharmaceutical industry, being notably present in AMCU investigations and competition compliance. The firm’s broad industry practice integrates practitioners from different areas of law: Alla Kozachenko, Natalia Pakhomovska, Illya Sverdlov manage instructions across the core areas of their specialization.

EY runs a dedicated team providing services for the pharmaceutical industry. The scope includes complex legal and tax advice on the restructuring of operations in Ukraine to multinational pharmaceutical companies, regulatory requirements and taxation rules. Among large-scale landmark projects is providing legal assistance to the World Health Organization and the Ministry of Health of Ukraine within a project related to major reform of healthcare financing; and provision of legal advisory services in relation to ongoing establishment of the National Health Service of Ukraine. The team is led by partners Vladimir Kotenko and Albert Sych.

Ilyashev & Partners possesses recognized strength in trademark and patent litigation, acting for both domestic and multinational pharmaceutical companies. Other types of cases take in recognition of invalidity of the state registration of medicinal products. Among ongoing trademark litigations is representation of Feron in protection of IP rights to the “Viferon” trademark; acting for Omnipharm with regard to IP rights protection for a trademark that is well-known in Ukraine. The firm is instructed for supporting the general commercial activity of pharmaceutical companies, including issues of stocks for medical products, supply and distribution contracts, suretyship agreements and set-off, customs matters. The client roster includes Biopharma, Megainpharm GmbH, Astellas Pharma Europe, Johnson & Johnson, Celgene, Financiere Batteur SAS, etc. IP practitioner Irina Kirichenko is highly visible on the market.

Law Offices of OMP has a distinctive focus on advisingpharmaceutical companies and drug stores. The office delivered complex legal support to Crown Agents at all stages of preparation and signing of an agreement with Ministry of Health of Ukraine on purchasing of medicines and medical products; supported Pharm Media in the development and implementation of software to control the intake of medicines to STADA. The firm advised a wide range of reputable names (Boehringer Ingelheim, Grindex, Glenmark Pharmaceuticals, Ipsen, Unipharm, Mitek, Gledpharm, Universe Pharm, Coloplast Ukraine A/C) on analysis of advertising and promotional materials according to current Ukrainian legislation. The firm has experience in tax mediation and litigation, GR and legislative work. Recent growth areas take in corporate restructuring, competition, employment, commercial arrangements. Mykola Orlov and Igor Ogorodniychuk are the lead partners.

Asters offers a broad spectrum of legal support topharmaceutical/biotechnology and medical device manufacturers and suppliers. Among others, this includes commercial matters, distribution, regulatory compliance, intellectual property and antitrust. The firm is renowned for its top competition practice, and currently represents Bayer LLC in an AMCU sector investigation into the market for distribution of pharmaceutical products; and acts for Sanofi in a commercial court in connection with its appeal against the AMCU decision in this investigation. Igor Svechkar and Svitlana Chepurna are lead partners.

The full-service heavyweight Sayenko Kharenko has a dedicated multidisciplinary group for sector tailored solutions. The group’s focus is on trade and marketing matters, antitrust and competition, general corporate matters. The firm is noted for robust compliance practice and personal data protection. Anzhela Makhinova and Maksym Nazarenko are the key figures.

Ante Law Firm is acquiring a rapid reputation among clients of pharmaceutical and medical devices distributors, providing legal assistance on intellectual property, labor, medicines and medical devices regulations, taxation, commercial, antitrust and competition. The firm successfully represented Sanofi-Aventis Ukraine in a handful of litigations, and its attorneys also acted for Sanofi in one of the loudest example of pressure on business cases. Clients encompass Omega Pharma Ukraine (Perrigo group), Sandoz, Technomedex group, Zdravo, and others. Andriy Guck is the lead partner.

GOLAW is gaining a following of Ukrainian branches of global producers of medical products and pharmacy chains. Recent assignments include protection of business reputation from unfair competitors, support in tax matters and regulatory inspections, commercial matters. The firm advises Mercator Medical, a subsidiary of a leading global manufacturer of medical gloves, on certification of wholesale and retail prices for medical products. This past year the firm extended its expertise in PPP in healthcare. Partner Valentyn Gvozdiy is active across queries from clients.

INTEGRITES provides support to sectoral clients in sophisticated competition matters, tax, corporate and disputes.Farmak PJSC, a long-lasting client of the firm and one of the biggest Ukrainian pharmaceutical manufacturers instructed the team to represent it at the Antimonopoly Committee of Ukraine in a case against another pharmaceutical manufacturer. The firm’s clients include Ecopharm, representative office of Bosnalijek d.d., Zentiva International, EGIS Pharmaceuticals, Actavis International, Astellas. Vyacheslav Korchev, senior partner, and Serhiy  Shershun, counsel, are the key figures.

The Kyiv office of Peterka & Partners arranges advice to KRKA and Bioveta with regard to various legal issues, including advisory on labor and tax law matters. Tatiana Timchenko, partner, is the main contact.