Pharmaceuticals / Medicine & Healthcare
The Ukrainian pharmaceutical market is predominantly an out-of-pocket or self-pay market and, therefore, it has been negatively affected by the unstable political and economic situation in Ukraine. In the last two years running the Ukrainian Hryvnia saw an unprecedented loss in value. Accordingly, although pharmaceutical sales have increased by value in Ukrainian national currency, they have dropped by volume and by value in US dollar equivalent. Most international pharmaceutical companies do not have manufacturing capabilities in Ukraine and, as a consequence, have to import the pharmaceutical products for local distribution. This situation has created additional competitive advantages for local pharmaceutical companies who, due to their lower exposure to foreign currency exchange risks, could maintain more competitive prices. As a result, the share of sales of domestic pharmaceutical products has increased by volume.
Once the situation in Ukraine stabilizes, this trend is expected to change and international pharmaceutical companies may explore local manufacturing capabilities in Ukraine through acquisitions, licensing transactions, etc. As foreign investors become cautiously optimistic about investing in Ukraine, the Ukrainian healthcare sector remains attractive for financial investors. For example, in 2015, an international financial institution invested in a pharmaceutical distributor, and a Swiss pharmaceutical company which is wholly-owned by private equity investors acquired a local pharmaceutical manufacturer.
As global M&A activity in pharma is on its rise, it will continue to have an indirect impact on the local market and generate work for local lawyers mainly in the areas of antitrust, compliance, tax, corporate and reorganizations. In terms of local M&A activity, the most active players are local pharmaceutical manufacturers which may consider acquisitions or mergers with their peers or entries into new markets, mainly EU ones. Due to the high fragmentation of the local retail market, further consolidation of pharmaceutical chains is expected.
The progress on the reforms in the Ukrainian healthcare sector will continue to have a significant impact on the Ukrainian pharmaceutical market. The only significant reform implemented today is the transfer of public procurement of pharmaceuticals to specialist organizations. Other significant changes are expected as the result of adoption of the new Act On Medicines, National Drug Policy, new Licensing Conditions On Manufacture, Sale and Import of Pharmaceuticals, Regulation on Medical Devices.
Arzinger is among the leading teams on the market advising a wide spectrum of industry players. In its clients roster are Servier, Sanofi, Baxter, BioMarin, Cowans, Dexcel Pharma, Parexel, Roche, Ranbaxy, Teva, Sandoz. As a sizeable practice with a sector-specific knowledge, the firm is regularly enlisted for advising on compliance and regulatory matters, advertising, distribution, competition and taxation. The practice team benefits from strong experience in corporate, competition, trade and customs, intellectual property, employment; at the same time, it possesses extended expertise in specific product regulation issues, clinical trials and product liability, licensing, data protection. Contributing to the drafting of sector specific legislation is another noteworthy feature of its team. The firm recently advised Sandoz on promotion of TM Linex in a video and AbbVie on logo in promo-materials. Highly active across various public and legislative initiatives partner Lana Sinichkina is admired by peers. Managing partner Timur Bondaryev, a renowned general practitioner, is highlighted as a high profile figure in the sector.
Legal Alliance Company retains its solid reputation as a long-standing and well-established niche domestic firm specializing in regulatory matters, corporate, employment, tax, competition, IP and litigation. Among the recent highlights of the firm are representations of Berlin-Chemie AG in a case on violation of economic competition and in a dispute on partial invalidation of the registration of a medicine similar to the “Espumizan” trademark. Some significant instructions also included matters regarding medicinal products turnover, supply and distribution, unfair advertising, promotion, clinical trials. The rich client portfolio included Adamed, Apotex, Astellas, Bayer, Berlin-Chemie AG, Boehringer Ingelheim, Boris, Contrad Swiss SA, Delta Medical, EU Pharmacia, Ever Neuro Pharma, Fitopharm, GlaxoSmithKline, Izotop, Jadran — Galenski Laboratorij d.d., Novartis Consumer, Orion Corporation, Stada, Takeda, etc. Throughout the past year the firm opened new practice of anti-corruption compliance and business ethics that is managed by partner Oleksii Bezhevets. Another significant development is a sharp focus on drafting sector-specific legislation under the guidance of Dmytro Aleshko. Partners Illya Kostin and Andrii Gorbatenko received strong market feedback.
Marchenko Danevych is widely quoted on the market for its robust life sciences/pharmaceuticals practice, branching out to the pharmaceuticals, healthcare, clinical trials and medical devices industries. This team is a point of choice for complex cases for leading global companies like AbbVie, Aspen, AstraZeneca, Lilly, GSK, Johnson & Johnson, Janssen and NovoNordisk, among others. The firm is also highly active across competition matters, IP, compliance, public procurement, sensitive regulatory matters. In a recent highlight the firm advised Aspen Pharma on various aspects of cooperation with wholesale distributors in Ukraine; Dr. Reddy’s and Johnson & Johnson on a safe and compliant approach to marketing arrangements with retailers in Ukraine. Founding partner Borys Danevych remains on to top of the sector due to strong market feedback on his strong industry expertise and has been constantly named an outstanding policy expert.
For many years Baker & McKenzie has been the adviser to some of the world’s largest pharmaceutical and healthcare companies. The Kiev office is the point of choice for high-value M&A, antitrust and IP matters, complicated tax, compliance and employment, and for advising research-based multinational pharmaceutical companies on their operations in Ukraine. The client list of the outfit contains Eli Lilly, Novo Nordisk, Novartis, Smith & Nephew, Berlin-Chemie AG, Johnson & Johnson, APRaD. In 2015 the team advised Acino Pharma AG in the acquisition of LLC Pharma Start, a top-ten Ukrainian pharmaceutical producer. The ranking newcomer — counsel Olha Demianiuk heads the healthcare industry group of the Kiev office, effective as of 1 July 2015, and expands her practice on regulatory, corporate, contract and other issues. Renowned expert Mariana Marchuk advises on pharma regulatory, compliance and employment issues. Partner Oksana Simonova is in charge of competition work.
Law Offices of OMP developed its comprehensive coverage of sectoral assignments particularly focused on corporate restructuring, M&A, production and supply operations. In the past year the firm boosted tax litigation in pharmapractice. The team is regularly instructed by multinational pharma producers and pharmacy chains, and continued complex support in the bankruptcy of Alba Ukraine, Public JSC. Impressive clientele, among others, number MSD, Boehringer Ingelheim, GSK, Valeant, Sandoz, Ipsen, Recordati, Ima Medical, Biocon, Biocad, Abbott, Grindeks, Indar, Omega Pharm, Herbs Trading, Hospico, Eupharmacia, Eximed, Aicore, Glenmar, Ranbaxy, Actavis, Egis, Ferring, Intervet, Vecops, Almeda, Sentiss Pharma, USP Ukraine, Woerwag Pharma, Sansky Trading, Unipharm, Universpharm, Medochemie, Novartis, Sperco, Belupo, Liktravy, Morion, Ewopharm, Medac. The 6-lawyer team is guided by Mykola Orlov and Igor Ogorodniychuk.
ILF (Inyurpolis Law Firm), with offices in Kiev and Kharkov, develops its pharma client base, which includes distributors, pharmaceutical companies and chains, and performs non-contentious and contentious instructions. ILF recently acted for a major national pharmacy chain in PPP project for lease of municipal pharmacies; and supported a local distributor of pharmaceuticals on its corporate structuring and arranging support into Ukraine. The dispute front, as led by partner Olena Khytrova, extends to debt/losses recovery, insolvency proceeding, regulatory and administrative disputes. Tetyana Gavrysh, managing partner, takes an active part in sectoral reforms and PPP projects.
The recent projects portfolio of Egorov Puginsky Afanasiev & Partners Ukraine included advising pharmaceutical companies on commercial and transactional issues; IP disputes involving generic and original medicines; various promotional and marketing activities; public procurement; as well as regulatory and compliance matters, competition, corporate, IP, tax and employment issues. Of late, the team advised two world’s leading pharmaceutical companies on structuring of their Ukrainian supply and marketing operations, including in terms of relationships with Ukrainian distributors and pharmacy chains. The IP team, as led by counsel Taras Kyslyy, represented a global pharmaceutical company in a successful appeal of refusal to grant a patent term extension for a medicinal product and represents generics pharma clients on several litigations against original pharma producers. The international arbitration team, headed by partner Markiyan Kliuchkovskyi, acted as a legal counsel in arbitration with a major Moldovan distributor of medicines. The practice is headed by Viktoriya Podvorchanska, who was promoted to a counsel, and singled out by the market for speedy performance. The projects are under the supervision of managing partner Serhii Sviriba.
DLA Piper’s expertise encompasses advice on M&A and corporate, public procurement, manufacturing localization, taxation and transfer pricing, IP protection and disputes. The office advised shareholders of Pharma Start LLC, a major Ukrainian pharmaceutical manufacturer, in connection with sale of a 100% stake in Pharma Start to Acino Pharma AG; and British company Crown Agentson a UAH 750 million agreement with the Ministry of Health of Ukraine to procure medicines under a special state-financed program. The multidisciplinary practice team is guided by a number of practitioners. Partner Svitlana Musienko focuses on tax-related matters; legal director Alla Kozachenko advises on a wide range of corporate and commercial matters. Galyna Zagorodniuk, legal director, has been dedicated to M&A work, and is acclaimed by market sources for her strong competition background in the sector.
IP rights protection matters are the mainstay of Ilyashev & Partners. Among the team’s recent highlights is representation of Feron in protection of its rights on “Viferon” trademark. Megainpharm GmbH, OmniPharm, Takeda, Pharmacy of Hormonal Drugs, Business Center Pharmacy can be found in the firm’s client portfolio. Irina Kirichenko is especially noted for her IP experience in the pharmaceuticals sector. Mikhail Ilyashev, managing partner, supervises the practice. Another important figure is Galina Melnik.
The dedicated practice of Asters spans across antitrust, regulatory, corporate and M&A, IP, tax and customs. The firm regularly performs with dedication to corporate assignments and M&A transactions involving the healthcare sector. The competition team is a point of choice for obtaining merger clearance in terms of global transactions and advice on anticompetitive concerted practices; among others, acquisition by Teva Pharmaceutical Industries Ltd of global generic pharmaceuticals business of Allergan plc; conditional transaction between GlaxoSmithKline plc and Novartis AG. The instructions are divided among the cross-practice team that is managed by three partners of Asters — Svitlana Chepurna, Igor Svechkar, Vadym Samoilenko.
The expertise of Dentons extends across regulatory and corporate advice, competition, IP, employment, trade and distribution matters, with a significant accent on compliance. The office benefits from its high-profile client base consisting of leading global pharmaceutical and healthcare companies, clinical trials organizations, wellness solution providers. Partners Volodymyr Monastyrskyy and Markian Silecky are in charge of the Kiev practice.
AEQUO has a well-rounded team dedicated to the firm’s core practice range. Renowned for its IP capabilities, the team guided by Oleksandr Mamunya, partner, represented pharma clients at the Ukrainian, Russian and Eurasian PTOs in patent and trademark prosecution, and portfolio management matters. In 2015 under the guidance of managing partner Denis Lysenko the firm acted on Ukrainian merger control issues and tax litigation, and represented Perrigo Company LLC (Ireland) at the Antimonopoly Committee of Ukraine in connection with the contemplated large hostile takeover by Mylan, a major US pharmaceutical company.
Sayenko Kharenko has strengthened its capacities in the sector over the past year, having advised on a number of regulatory, competition, corporate, international trade, IP and dispute resolution matters. This top antitrust team advises the world’s largest pharmaceutical companies (Actavis, Novartis, Solvay, Sanofi, Merck KGaA, AkzoNobel, Perrigo Company, Sigma-Aldrich Corporation, Israel Chemicals Limited, and Omega Pharma Invest) on various implications of competition law. Its key highlights included advice on the three-part inter-conditional transaction between GlaxoSmithKline and Novartis. The trade practice advised the Ukrainian distributor of medical devices regarding peculiarities of application of factoring scheme for trade finance. The white-collar crime team represented a leading global health care company and its Ukrainian subsidiary officials in criminal proceedings related to the alleged distribution of overpriced medical products and equipment on the territory of Ukraine. IP lawyers advised a French pharmaceutical companyon legal aspects trademarks registration in the pharmaceutical industry. Oleksandr Padalka, partner, and Anzhela Makhinova, counsel, are the core contacts in the area.
Avellum advises its clientele on a wide variety of issues including corporate advice and transactional issues, finance, competition, taxation, as well as sophisticated employment matters. Its portfolio includes significant domestic and international names. Another notable feature of the team is its enlistment in handling the Ukrainian parts of global transactions. In a recent highlight, the firm advised Novartis on the general structuring of the Ukrainian part of the transaction to establish a joint venture between Novartis and GlaxoSmithKline; and advised Bayer AG on the Ukrainian aspect of the carve-out of its chemical business Bayer Material Science AG into a separate company called Covestro AG. Well-known partners Mykola Stetsenko and Glib Bondar are the leading names to contact.
Redcliffe Partners (before 1 December 2015 — Clifford Chance) has been visible in handling cross-border transactions involving pharmaceutical sector clients. Many industry heavyweights are clients like Abbott Laboratories, Teva Pharmaceutical Industries Ltd, Liorco Investments. Recent highlights include representing Abbott Laboratories Inc. on the acquisition of Veropharm, including its subsidiaries in Ukraine; and the majority shareholders of a Ukrainian pharma business in connection with a buy-back of a minority stake from a private equity house. Dmytro Fedoruk and Zoryana Sozanska-Matviychuk act for Redcliffe’s pharmaceutical clients.
AstapovLawyers* maintains its traditional mainstay, inter alia, supporting clients oncorporate matters, acquisitions, IP protection, regulatory disputes. Significant clients of the group include Baxter, Bioton, Herbapol, International Group Zablotskogo Clinique. Oleh Malskyy, corporate and M&A partner, is the main practitioner. The firm delivered strategic consulting to International Group Zablotskyy Clinic on copyright management, franchising a contract for the project “Dental SPA”, “Clinic” in Ukraine and in EU countries. Ilarion Tomarov, senior associate and head of IP, leads subsequent queries.
Prominent Ukrainian IP boutique Doubinsky & Osharova is well positioned forconsiderable depth relating to IP in the sector, including full-scope issue of trademark and patent matters. Leading pharmaceutical manufacturers hire the firm for this type of advice. Victoria Sopilnyak is a recognized IP professional with sharp focus in the pharmaceutical area. Partner Yaroslav Ognevyuk is another important figure in the boutique as he has extensive presence in IP litigation.
In 2015 Vasil Kisil & Partners performed employment and IP projects for its pharma clients. The IP practice headed by Vladyslav Podolyak, counsel, handled patent clearance advice of products to be launched on the Ukrainian market and also represents a Ukrainian client in early termination of a trademark dispute with a major international pharmaceutical company.
Integrites’ pharma and healthcare practice has been significantly strengthened by the arrival of Danyil Fedorchuk from Gide Loyrette Nouel. He specializes predominantly on pharma and medical devices regulatory issues. The key highlights of 2015 include obtaining merger clearance for Farmak in connection with the acquisition of a Polish distributor and representing Farmak in unfair competition investigation. Some new arrivals for the practice in 2015 include Samsung Bioepis and Astellas Pharma. The team also advised EBRD on encumbrances over medical patents and trademarks and relevant contract and enforcement aspects. Another key partner is Oleksandr Aleksyeyenko, who focuses mostly on IP and antitrust work.
The active domestic firm FCLEX has a number of domestic pharmaceutical companies among its clients, inter alia, Arterium Corp., Kyivmedpraparat, NPO Farmatron, Halychpharm. The team arranges consistent legal support in the field of IP, corporate and tax. In the outgoing year the firm, as led by partner Oleg Malinevskiy represented NPO Farmatron in three IP disputes with the pharmaceutical company Darnitsa. Another highlight is advising long-standing client Arterium on intra-group transactions and tax.
The legal team of EY headed by Volodymyr Kotenko, partner, is dedicated to legal and tax advice for pharmaceutical companies, due diligence and structuring work. The team also assists the Ministry of Healthcare of Ukraine on drafting legislation needed for carrying out reform in the healthcare sector.
Shkrebets & Partners, one of the most vivid legal counsels in Kharkov, commands vast litigation experience. The firm, as guided by managing partner Eugene Shkrebets, represented the State institution Grigoriev Institute for medical Radiology of the National Academy of Medical Science of Ukraine in a number of debt collection disputes under procurement of medical equipment with state funds.
CMS Cameron McKenna is entrusted by global pharmaceutical, medical technology and services companies advising on various employment and competition-related matters. Jurimex Law Firm made primary input into drafting regulatory background. Olena Babich Law Office is noted for medical law advice, including surrogacy.