Field of Abuse
The year of 2009 turned out to be rich in events on the Ukrainian pharmaceuticals market. According to comments by the acting chairman of the Antimonopoly Committee (AMCU) Oleksander Melnychenko, the AMCU carried out a total of 259 inspections of large companies, pharmaceutical chains, and issued more than 1,700 orders to reduce the price of medicines of the “flu” group, which were fulfilled by practically all businesses of the pharmaceuticals market. A total of 108 cases were initiated, of which 94 cases have already resulted in decisions on punishment of pharmacy chains, including the imposition of fines coming to UAH 0.5 million. More than half of these fines have already been paid into the state budget. Investigations continue regarding wholesale suppliers of medicines, which control 70% of medicine turnover, and also national manufacturers of medications.
Gaining a long-stand reputation amongst its peers, Legal Alliance Company is known for working conscientiously for clients on the pharmaceutical sector. The group handled support of supply of a medical helicopter for a Ukrainian company; performed work on clinical trials on the territory of Ukraine and provided general advice on production of medicines in Ukraine. The poll showed that Illya Kostin and Dmytro Aleshko were widely recognized for their work in this area by peers.
Paritet Law Firm is named among the most experienced in high profile regulation of the sector. This is explained by extensive activity on providing legal analysis and the drafting new regulatory acts, including draft orders from the Ministry of Healthcare, draft acts, draft decrees of the Cabinet of Ministers in the field of healthcare and pharmaceuticals. The team carried out an impressive list of work for clients: advising various companies, including Pfizer and Bayer, on new regulations and legislation regarding packaging and labeling of medicinal products; advising the Association of Research and Development in Ukraine on Ukraine — EC Dialogue on the Intellectual Properties issues in the pharmaceuticals sector, including data protection, data exclusivity, TM protection, etc.; advising the American Chamber of Commerce in Ukraine membership on various legal matters relating to the healthcare system in Ukraine, as well as the pharmaceuticals industry; advising the pharmacy network on the Government’s anti-epidemic regulations. Notable expertise was accumulated in the area of clinical trial: legal, tax advice and drafting sets of clinical trial agreements for Bayer Healthcare/Bayer Schering Pharma; counseling one of the largest global biotech manufacturers in matters of conducting clinical trials, interaction with Ukrainian controlling and law-enforcement authorities, insurance of R&D activity in Ukraine, etc. Borys Danevych and Kateryna Halenko are the main practitioners with solid competence due to the above-mentioned list of workload in the past year.
Serving global pharmaceutical companies like GlaxoSmithKline, Sanofi Aventis and Novo Nordisk, DLA Piper in Ukraine has significant experience of the legal regulations pertaining to the pharmaceuticals sector. The team has unique experience of assisting clients to develop a sustainable trading business model for the Ukrainian wholesale pharmaceuticals market, taking into account restrictions imposed by Ukrainian pricing regulations and tax factors. Expertise encompasses advice on regulatory and tax matters as well as preparing a full contractual package.
The team recently advised a major Ukrainian group trading in the pharmaceuticals sector on restructuring of their Ukrainian and foreign presence and advising a large Ukrainian pharmaceuticals company in relation to its preparation for sale to a major global pharmaceuticals company. The team conducted due diligence of more than 20 member companies of a major Ukrainian chemicals and medicines producer, advising on corporatization of certain assets kept by a client intending to go ahead with an IPO. Another domain of the recent work for sectoral clients included representation one of its clients of the pharmaceuticals sector in the process of being investigated by the AMCU. Arthur Kotenko and Svitlana Musienko handled the projects for the office’s clients in this area.
Vasil Kisil & Partners has considerable experience of a broad range of legal aspects in developing, manufacturing and marketing medical products, and related regulatory and intellectual property issues in this field. Employing a multidisciplinary approach, the team of attorneys also successfully assisted clients in finance, M&A, competition, product liability and litigation matters in the pharmaceuticals sector. In 2009 the firm provided legal support to world-known pharmaceutical and biotechnology companies, healthcare companies and investors in this industry. The firm’s team actively supported the EBA Health Care Committee by legal advisory and lobbying efforts. Mariya Nizhnik, counselor, is highly respected for her expertise on pharmaceuticals matters. Oleksiy Filatov, partner, and Olexandr Mamunya, senior associate, are known for their in-depth approach to IP and regulatory issues faced by industry players, as well as extensive dispute resolution experience in this field. Vadym Belyanevych, senior counselor, is also acknowledged for his successful litigation practice involving pharmaceutical companies.
Medicine and healthcare is present in the IP practice area of Baker & McKenzie. Being a central element of its practice, IP litigation in 2009 included acting on behalf of a leading international pharmaceuticals company in a patent infringement suit against a local competing pharmaceutical generic company with respect to cancer treatment medication and representation of an international pharmaceuticals company in a trade dress and trademark infringement case against a competitor with regard to an anti-allergy medicine. Yuliya Kolchenko and Ruslan Drobyazko provide expert advice on IP-related issues.
Gvozdiy & Oberkovych law firm represented a number of pharmaceutical and healthcare companies in dispute resolution issues and administrative disputes with state and municipal authorities. In particular, in 2009 the group of lawyers, as led by Valentyn Gvozdiy, advised a large Ukrainian supplier of medical goods called Medcom Ukraine in a USD 1.5 million dispute related to application of financial sanctions by the Ukrainian tax authorities.
Asters has developed its pharmaceutical practice with a team composed of corporate practitioners focused on the life science industry. In 2009 the team headed by partner Oleksandr Padalka advised Ansell Healthcare on legal requirements of registration and labeling of medical products in Ukraine; Sopharma AD in connection with passing by its Ukrainian medical products factory (OJSC Vitaminy) of an evaluation on meeting GMP requirements and provided consultations on various issues of Ukrainian licensing requirements to production of medical products; Biologische Heilmittel Heel GmbH on various issues of Ukrainian law connected with distribution of medical products in Ukraine; GlaxoSmithKline on various regulatory and commercial issues under Ukrainian law. Asters partners Igor Svechkar and Armen Khachaturyan provide advice to clients of this industry related to their practice areas.
The tax and legal of Deloitte in Kiev has shown growing focus on regulatory advice that included providing legal advice on compliance of pharmaceutical products entering the Ukrainian market (including certification and registration issues) and advertising materials with Ukrainian legislation; advice on mark-up regulations applicable to medicines. Corporate practitioners handled work on transferring activities from a representative office to a legal entity.
In 2009 INTEGRITES significantly broadened its experience in medical and pharmaceutical law. The firm’s expertise includes advising clients on commercial activity of pharmaceutical companies and representative offices, manufacturing, import and export of pharmaceuticals, conducting of clinical trials in Ukraine, registration of pharmaceuticals with Ukrainian state authorities and legal aspects of pharmaceuticals advertising. Bayer, Astellas Pharma, Merck Sharp & Dohme Idea and Egis Pharmaceuticals are all among key clients. The firm has strengthened its practice with the admission of new partner Oleksandr Aleksyeyenko.
The Kiev office of Chadbourne & Parke has focused its current advice on pharmaceutical regulations. The lawyers handle representation of a US nutritional products manufacturer in connection with obtaining government approval for the sale of products in Ukraine and a US drug manufacturer in connection with registration and distribution of a wide range of pharmaceuticals in Ukraine. Jaroslawa Johnson and Oksana Firsova work on the corresponding projects.
The Kiev office of Peterka & Partners has experience of regulatory practice in the healthcare industry. In 2009 it handled advisory work to Novo Nordisk A/S, a Danish company and worldwide leader in the pharmaceuticals industry, as regards the conclusion of a clinical trial agreement in Ukraine.
Alexander Poels is a key contact.
Volkov Koziakov & Partners has successfully assisted the State Pharmacological Centre in connection with litigation against a large international pharmaceuticals company.
The team of lawyers included Mykola Podpalov and Yevgen Blok.
CMS Cameron McKenna advised a multinational pharmaceuticals corporation on insurance issues related to clinical trials in Ukraine. Gide Loyrette Nouel focused on IP practice, namely anti-counterfeiting litigation representing a pharmaceuticals company. Jurline law firm provided legal support to the operations of private hospitals.