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Dmytro ALESHKO|Legal Alliance COMPANY
When discussing the legal services market in the medical and pharmaceutical regulatory sectors, current trends should naturally be taken into account in connection with ongoing processes within the Ukrainian economy.
Constant positive economic trends and the stable national currency form a foundation for further development of the area within the framework of implementation of planned reforms. In addition, they are useful markers for foreign and domestic pharmaceutical manufacturers.
The Cabinet of Ministers of Ukraine has been implementing the program of reimbursement of medicines for specific categories of patients for two years now. The Ministry of Health provides simplified registration of medicines, which were registered previously following the centralized procedure in Europe, the USA, Japan, and Canada. Therefore, we can see intensified activities in the pharmaceutical market, which requires corresponding legal support.
Furthermore, for the last three years, the Antimonopoly Committee of Ukraine has become more active. The market participants witnessed several investigations in the pharmaceutical sector, which have resulted in a record number of fines. Decisions on impositions of the majority of penalties were appealed in court, and law firms working in the area were actively engaged in these trials. Ultimately, all participants are interested in competition being fair, especially in such a sensitive market as pharma.
The legal services market for pharma remains highly competitive and progressive. Clients for several years have carried tenders in the majority of projects, even those of insignificant complexity. As a rule, pharmaceutical companies sign agreements on legal support with several law firms.
At present we are more optimistic about the prospects for the development of the legal services market in our industry. Reform of the industry, which began in 2017, will impact increased demand for qualified legal assistance. Everything will depend on law firms themselves and whether they can offer clients exciting and necessary products and services.
Ukrainian law firm Arzinger has a stand-alone life sciences and healthcare practice team that takes in instructions for clients operating in pharmaceutics, clinical trials, medical services, medical devices, cosmetics, special food products and biotechnologies. The sizeable team is sought out by pharmaceutical companies for its expertise in antitrust investigations and sensitive competition matters, compliance and IP law, regulatory matters. The firm provided legal support to a number of leading Ukrainian and international pharmaceutical companies in public procurement procedures conducted by specialized international organizations (UNDP, Crown Agents and UNICEF). In 2018, the team’s work focused on protecting clients in complex investigations, unfair competition matters; developing patient support schemes, providing advice on possible response mechanisms to complaints from patients; personal data protection; distribution agreements. The acclaimed team is involved in the development of draft laws for the reform of legislation on life and health, antitrust law and competition. The practice is led by Lana Sinichkina, partner, pro-active practitioner with deep industry knowledge and recognized contribution to sector reform. Yevgeniya Ocheretko, associate, is mentioned in the poll for regulatory policy expertise.
Benefiting from its international network, the Kyiv office of Baker McKenzie has a strategic focus on high-value services such as complex transactions, tax, IP, antitrust, investigations and compliance matters. The office demonstrates a great track record in healthcare M&A, having been involved in major healthcare transactions in Ukraine. For example, this past year the team advised Invitro on the sale of its Ukrainian laboratory operations to Medicover; advised a French pharmaceutical company, Servier, on the Ukrainian aspects of its global acquisition of the oncology business of Shire. The office has an equally strong following among international and key local players, among others, Abbott, Acino Pharma AG, Baxter, Biofarma, Takeda. Throughout the research period the firm expanded a number of projects on structuring and financing investment in private healthcare hospitals. The Kyiv team acts as the official legal adviser of the Association of Pharmaceutical Research and Development (APRaD), and prepared changes to the legislation along with acting as a policy expert in interactions with various state authorities regarding reforms in the Ukrainian healthcare sector. The healthcare industry group is led by Olha Demianiuk, who was promoted to partner last year. The multidisciplinary team includes partners and counsels from different practice areas: Oksana Simonova (competition), Mariana Marchuk (employment), Ihor Siusel (litigation), Hennadiy Voytsitskyi (tax) and Oleksiy Stolyarenko (IP and data protection), and regulatory focused lawyer Olha Sviatenka.
For many years Legal Alliance Company has been keeping its core focus on pharmaceutical and healthcare sector. The firm is known as an industry boutique with its core strength in pharmaceutical regulatory and medical law, competition in pharma market, corporate structuring and compliance, IP and litigation. The regulatory projects overseen by Dmytro Aleshko include support of the submission of applications for the inclusion of drugs on the National List of Essential Medicines, as well as legal support in the field of the procurement of drugs and medical devices. The firm was chosen as a legal advisor to the SAFEMed project to provide technical assistance to the Government of Ukraine, the Ministry of Health and the Expert Committee on the selection and use of essential drugs. Among the major projects in 2018 was advising the UNDP on the development of legal acts in the field of public procurement of medicines and medical devices. The team accomplished the first private project in telemedicine in Ukraine. Another highlight was support of the Shans Clinic in its acquisition of a clinic. The competition related workflow as led by Andrii Gorbatenko, partner, took in representation in investigations of the Antimonopoly Committee on anti-competition concerted actions and unfair competition. The team worked out distribution contracts for an innovative Japanese pharmaceutical company; protected the interests of one of the leading private medical clinics in litigation about the recovery of material and moral damages. Oleksii Bezhevets is in charge of corporate instructions, while Illya Kostin runs litigation and employment practice areas.
Danevych.Law is a life sciences focused boutique firm, with the recognized brand name of its founding partner, Borys Danevych. The team is dedicated to providing legal advice to companies from the pharmaceutical, medical devices and clinical trials industries, and has close ties with major international law firms. It is notable that the firm contributes to healthcare reforms implemented by the Ministry of Health of Ukraine. Core services include compliance, regulatory, IP, competition, commercial, pricing, reimbursement and procurement. The team is noted for its exceptional expertise in clinical trials of medicines. Representing life sciences clients in white-collar criminal investigations (concerning registration of medicines, clinical trials, procurement of medicines and medical devices) is another area of recent growth. Danevych.Law advised AbbVie on regulatory, commercial and contractual aspects of supplying company’s innovative medicines procured through international organizations engaged by the Ukrainian Ministry of Health. The team, as part of an international consortium, is a strategic advisor to the Ministry (as the beneficiary in an EBRD-financed project) on development of medicines registration, clinical trials, pharmacovigilance and quality control systems of Ukraine. Among transactional highlights is advising Shire on Ukrainian components of a sale of an USD 2.4 billion oncology business to Servier S.A.S. The client list includes prestigious names, among others, AstraZeneca, Gilead, Janssen, Lilly, Baxter, Janssen. Having spent many years in the market, Borys Danevych, team leader, is one of the most recognizable individuals in this area.
As a result of long-lasting work on the regulatory acts for healthcare reform and its further advocacy in all regions of Ukraine, the dedicated portfolio of ILF Law Firm contains unique commercial projects from 18 regions related to changes in the system of healthcare organization. These projects include an audit of assets of hospitals in cities (communities) and existing business processes; development of models for new forms of healthcare organization; autonomy of certain hospitals with further reorganization into public utilities; the development of models for attracting investors to public-private partnership projects. The practice portfolio also includes projects on documentation of clinical trials, complex support of private clinics including business restructuring, equipment import, etc. The dispute resolution with clinics for the benefit of patients affected by medical errors is a recent engagement of the ILF’s dispute front. New clients include International Renaissance Foundation, the Department of Health Protection of the Lviv Regional State Administration and the Lviv Regional Organization of the Trade Union of Health Workers of Ukraine. Practice head associate partner Olena Khytrova is recognized for her contribution in transformation of the healthcare system. Tetyana Gavrysh, managing partner, is noted for her GR activity.
Following an industry-specific approach AEQUO has won consistent following of original and generic drugs producers in Ukraine. The team stands out especially for representing clients in enforcement of pharmaceutical patents, being involved in landmark litigations in this area. The most known cases are the protection products by Dr. Reddy’s Laboratories in several patent infringement disputes and in a patent invalidation dispute. AEQUO represents Darnitsa in a trademark infringement action regarding illegal use of its widely known trademark on copied packaging of pharmaceutical preparations by a competitor. Projects on the protection of IP rights in the pharmaceutical field are coordinated by partner and head of life sciences and healthcare Oleksandr Mamunya. He combines experience in IP with industry knowledge. The substantial industry specific competition expertise is demonstrated by Sergey Denisenko, counsel, and his subsequent team. The firm advises on competition compliance, distribution policy and agreements, unfair competition, merger clearance. In 2018, the corporate work also covered legal due diligence and advice on recent legislative novelties. Partner Anna Babych is in charge of these assignments. Among other disclosable names are Berlin Chemie, Pro-Pharma, Sandoz.
In 2018, Asters significantly strengthened its position of pharmaceutical and medical practice, being a point of choice by pharmaceutical/biotechnology and medical device manufacturers and suppliers. Last year’s combination with EPAP Ukraine added clientele and expertise in this area. The firm renders legal support in matters involving various antitrust issues, corporate and contractual, regulatory, intellectual property and data protection. With a market leading competition team, Asters is constantly approached for advising competition compliance and representation in investigations on the pharmaceutical market. In 2018 the team successfully defended the interests of Teva Pharmaceutical Industries in a dispute with the State Intellectual Property Service and Synthon B.V. on extension of a patent term for a medical product for additional 3 years over the standard 20 year term. The team arranges continuous pro bono legal support to Charity Fund Tabletochki. A select list of public clients includes Abbott Laboratories, AbbVie, Association of Market Operators of Medical Devices, Bayer, Dolphi-Ukraine (part of the MedPack Swiss Group), Tetafarm, Alexfarm, Merck Export GmbH. The team is led by partners Vadym Samoilenko and Igor Svechkar. Counsel Viktoriya Podvorchanska is noted for her regulatory knowledge. Taras Kyslyy, counsel of IP practice, has been active in a range of landmark cases in the pharmaceutical sector.
Among the clients of the Kyiv office of Dentons are leading national and global pharmaceutical companies, world health leaders, companies created to commercialize medical devices, global research organizations. Work in 2018 was focused on advising on competition law issues in connection with the activities of clinical trials in Ukraine, advising and revising agreements on cross-border distribution, debt collection on products supplied, trademark protection and employment matters. The firm is preferred by many industry players for its well-rounded compliance advice. The team advises global nonprofit organization Management Sciences for Health in developing the legal framework to implement a Health Technology Assessment, establishment a Centralized Procurement Body, and development of necessary amendments to the related legislation on labor issues. The practice is led by partner Volodymyr Monastyrskyy. Igor Svitlyk is noted for expertise in clinical trials and compliance.
Renowned for its strong industry focus DLA Piper is constantly preferred by major international pharmaceutical companies seeking advice on competition, compliance, taxation, employment, regulatory. The office is often involved in corporate and M&A projects in the sector. This past year was noted for instructions for competition compliance, regulatory aspects of conducting clinical trials, data protection and privacy. Its client list includes such well-known brand names as Pfizer, Sanofi-Aventis Ukraine, Egis Pharmaceuticals. The multidisciplinary team envisages involvement of partners and their teams from different practices: Margarita Karpenko (employment and benefits), Olga Vorozhbyt (litigation and regulatory), Illya Sverdlov, (tax), Natalia Pakhomovska (IP) and others. Partner Galyna Zagorodniuk, renowned competition and corporate law professional, is highly active advising subsequent clients.
EY is involved in ongoing reform of the national healthcare system, and in the course of the establishment of a new executive body — the National Health Service. The team continues providing legal assistance to the World Health Organization and the Ministry of Health of Ukraine within the project related to major reform of healthcare financing. Another focus of the legal team is the pharmaceutical industry, where the team regularly renders legal and tax advice on restructuring of operations in Ukraine to multinational pharmaceutical companies, and handles the compliance advisory. Iryna Kovalenko, senior associate, was named by peers for advisory work. Key partners are Albert Sych, Vladimir Kotenko and Iryna Kalyta.
The team of Ilyashev & Partners protects the interests of a number of large foreign pharmaceutical companies in litigations on the protection of IP rights on trademarks and patents, and recognition of invalid state registration of medicines. Exemplary projects in 2018 were the protection of Kalcex’s intellectual property rights on patents and trademarks; representing Megainpharm GmbH in a legal dispute against the Ministry of Health of Ukraine and others on the recognition of state registration of a medicinal product as being invalid; recognition and appeal to the execution on the territory of Ukraine of the Arbitration Court of Moscow Region on claims of NPO Petrovax Pharm (Russia) against company Immunogen-Ukraine for recovery of debt under supply contracts. The firm also renders general support of sectoral clients’ economic activities, advising on supply contracts, contracts of guarantee and offsetting homogeneous requirements, customs law, using warehouses for storage of medical products. The client roster includes Celgene, Biopharma, Omnifarm, Protech Solutions Ukraine, Chengdu Kanghong Biogechnology Co. (China), Erba Lachema (Czech), etc. The responsible partner of the practice is Mikhail Ilyashev. Irina Kirichenko, Stanislav Koptilin and Maryna Ryshtun are key team members.
Law Offices of OMP possesses an offering that is industry focused with the full range of tax and legal services. This long-standing firm has been instructed to handle a variety of corporate and commercial work in the sector, including establishment and liquidation of representations, structuring interaction with pharmacies chains, as well as competition law advice, personal data, tax mediation and litigation, GR. One of the recent areas of growth is support for promotion and marketing efforts in the pharma industry. In 2018, the OMP team provided complex support of signing agreements for the purchasing of medicine and medical products between Crown Agent and the Ministry of Healthcare of Ukraine. An impressive list of recent public clients contains such companies as Roche, Coloplast, Kreoma-Pharm, Boehringer Ingelheim, Innotech, MDM, Bionorica, Gedion Richter, Fitofarm, Biocon, Unipharm, Sandoz, Abbott, Glenmark, Alpen pharm, Woerwag Pharma, Recordati. The practice is led by two partners, Mykola Orlov and Igor Ogorodniychuk.
Ante Law Firm keeps track on advising pharmaceutical and healthcare clients covering issues of intellectual property, media, labor, medicines and medical devices regulations, taxation, commercial, competition, etc. The firm advised Sanofi-Aventis Ukraine on advertising of pharmaceuticals and successfully represented it in several litigations and AMCU investigations. Zdravo receives constant support with its public procurement participation regarding the sale of large medical devices. Other clients include Servier, Omega Pharma Ukraine (Perrigo group), and other pharmaceutical and medical devices distributors. Andriy Guck leads the practice.
In 2018 AVELLUM acted in a number of projects in the sector, being hired for corporate structuring and finance matters. The team acted as a special Ukrainian counsel to the EBRD and advised on drafting, negotiation with NPK Ekofarm on the issue of lending; advised an international clinical research organisation ClinTec International on employment issues related to structuring of employment relationships. Yuriy Nechayev, Glib Bondar and Mykola Stetsenko are the leading partners who coordinated the work of these projects.
The Kyiv team of CMS Reich-Rohrwig Hainz regularly advises clients on their day-to-day 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. Advice also includes consultations on corporate, tax, employment, IP issues. Maria Orlyk and Anna Pogrebna are the main contacts.
De-Jure Law Firm, which is based in Odesa, renders full legal support to one of the biggest private clinics in Ukraine and to dental clinics. Its unique offering includes a complete audit of medical business. House of Medicine, Clinic of Heriatric And Palliative Medicine House, Ukrprofzdravnitsa and Sirius-dent are among the firm’s representative clients. Attorney Alexander Gyn is head of the medical practice.
Attorneys’ Association Gestors acted as a legal adviser to Roche Ukraine for representing the client’s interests during the procedure on accreditation of medicines in the Expert Committee on the Selection and Use of Essential Medicines, Ministry of Health of Ukraine. Volodymyr Yemelyanov and partner Vitaliy Makhinchuk are the main contacts.
GOLAW’s work in the pharmaceutical industry is centered on litigation. In particular, cases concern appealing against the results of the audit of the Ministry of Health of clients, the contractual relations of clients with the Ministry, the appeal of decisions on the imposition of sanctions and penalties. In addition, the team regularly receives queries from clients for employment as top managers in Ukraine. Valentyn Gvozdiy, managing partner, is the key contact.
INTEGRITES has gained a following among leading domestic and major international pharmaceutical companies seeking legal advice in Ukraine. The team is focused on sophisticated competition cases in the sector, particularly unfair competition and abuse of dominant position; protection of intellectual property, corporate and tax structuring. The team defended the interests of its long-standing client Farmak, a leading pharmaceutical firm in Ukraine, in a case on the abuse of dominant position on the national market of medical substances used to produce completed pharmaceutical products; and represents a client on protection of its IP rights in an unfair competition case. The firm acts for the Central Bank of Iceland within Ukrainian civil litigation in respect of the shareholding in Ukrainian companies owning a pharmacy chain in Western Ukraine. The industry is led by Serhiy Shershun, counsel of the competition practice.
The Kyiv office of Peterka & Partners advises international pharmaceutical and healthcare companies (e.g., KRKA, Bioveta, AmerisourceBergen Corporation) with regard to various legal issues, including advisory on labor and tax law matters. Partner and director for Ukraine, Taras Utiralov, is the key contact.
Skliarenko, Sydorenko and Partners occupied niche expertise on the legal regulation of surrogacy and IVF in Ukraine. The firm advises a number of specialist private medical centers based in Ukraine relating to medical and contract law, citizenship and immigration law issues arising when providing medical services to non-residents. Associate partner Andriy Trigub is the main contact.
- Oleksii Bezhevets (Legal Alliance Company)
- Andrii Gorbatenko (Legal Alliance Company)
- Andriy Guck (Ante Law Firm)
- Irina Kirichenko (Ilyashev & Partners)
- Illya Kostin (Legal Alliance Company)
- Oleksandr Mamunya (AEQUO)
- Igor Ogorodniychuk (Law Offices of OMP)
- Mykola Orlov (Law Offices of OMP)
- Viktoriya Podvorchanska (Asters)
- Igor Svitlyk (Dentons)
- Galyna Zagorodniuk (DLA Piper Ukraine)