Healthcare & Pharma
Musat & Asociatii is recognized as one of the country’s most knowledgeable law firms in the Healthcare & Pharma sectors, having advised an impressive portfolio of international clients over the years, including 9 of the top 12 medicine producers worldwide. In a unique position to provide expert advice in all legal matters concerning these highly regulated sectors, the firm has achieved constant success due to the strength and depth of its legal team, which encompasses corporate, antitrust, intellectual property, regulatory attorneys, as well as extensive litigation resources. This array of talent enables the firm to consolidate its undisputed top-tier position while developing further expertise in the most sensitive issues and conducting landmark cases.
We are recognized as highly active in representing major players on the Healthcare & Pharma markets in a wide range of transactions, including mergers and acquisitions, restructurings and reorganizations, regulatory, competition and compliance related advisory work, etc. We have been at the heart of developments in these sectors, advising on the highest profile transactions and providing our clients with legal advice suitable to the commercial reality of their business. We base our services on understanding our clients’ business and market at a local level, and providing expertise and resources required to help them achieve their business goals.
On numerous occasions, the firm has served as counsel to industry leaders in all types of antitrust matters, such as merger control, restrictive practices, dominance, cartel investigations, dawn-raids and sector inquiries, and has represented clients both before the European Commission and the Romanian Competition Council. Moreover, market-leading IP expertise enables us to provide effective intellectual property rights protection in all stages of the product’s lifecycle, including patent prosecution, validity and opposition work, as well as patent portfolio management and strategizing/enforcement advice.
Our recent instructions in the area include:
- Advising ARPIM (the Romanian Association of International Medicines Manufacturers) on various enactments concerning social health insurance and national programs, the framework medical assistance agreement, pricing on the same, including dispute resolution legal work related to the constitutionality and legality of the claw-back system and pricing enactments. Our work also included anticompetitive issues related to the claw-back system and the reimbursement of the therapeutic reference price.
- Assisting ARPIM, Abbott Laboratories, Servier, Roche, Eli Lilly with respect to the Competition Council’s ongoing sector inquiry on the wholesale pharmaceuticals distribution market in Romania, including training programs, designing and implementing specific compliance programs and representation before the Competition Council.
- Advice on the full range of legal matters in connection with pharmaceutical activities in Romania for GlaxoSmithKline, one of the world's leading pharmaceutical and healthcare companies in relation to the spin-off of its pharmacy chain, as well as in connection with the sale of its shares to Sensiblu S.R.L., the largest pharmacy chain in Romania. We were also retained in connection with multi-million public acquisition disputes, as well as with one of the first pharmaceutical patent-related infringement proceedings in Romania.
- Legal assistance provided to GlaxoSmithKline and Hoffman La Roche during the investigations initiated by the Competition Council on the dialysis and oncology market, as well as in relation to their alleged abuse of dominant position in the beginning of the European Commission practice and jurisprudence of the European Court of Justice.
- Advising Roche Diagnostics International Ltd. in connection with the EUR 17,500,000 successful acquisition of several assets of Top Diagnostics S.R.L., one of the most important companies on the Romanian diagnostics and diabetes care market.
- Retained as legal counsel by Roche Romania in a wide range of legal issues, such as the Protocol with the National Insurance House, claw-back-related matters, competition and IP issues; our work also included legal assistance pertaining to mergers & acquisitions matters.
- Advising Eli Lilly on a daily basis in relation to various legal matters, such as regulatory, pricing, data protection and IP issues, including on the reimbursement system of the Romanian market and the implementation of a complex therapeutic education program for nurses. We have also been retained for the investigation launched by the Competition Council on the insulin marketand represented the client in court proceedings concerning the same.
- Retained as legal counsel by Roche Romania in a wide range of legal issues, such as the Protocol with the National Insurance House, claw-back-related matters, competition and IP issues.
- Advising Novartis on a daily basis in relation to a wide range of legal issues, such as regulatory, pricing, data protection, competition, IP, Reports of the European Commission on the pharmaceutical market and Protocols with the National Insurance House.
- Advised Sanofi-Aventis, the leading French pharmaceutical group, on the mandatory public tender offer on Zentiva Romania for a total offer value amounting to approximately EUR 17,400,000.
- Advising H Lundbeck A/S, one of the world’s leading producers of innovative medicines used in the treatment of psychiatrical diseases, in connection with the whole range of IP-related matters, including protection of its IP rights over innovative drugs and the enforcement of its patent rights in Romania.
- Advising Pfizer in the procedures conducted in view of obtaining the requisite antitrust and merger control clearances arisen from the worldwide acquisition of Pharmacia Corporation USA by Pfizer Inc. USA.
- Advising Merz Pharmaceuticals and Biogenerix AG in connection with the legal protection of certain innovative medicinal products in Romania and other IP-related matters.
- Assisting Ipsen Pharma in connection with day-to-day legal assistance on healthcare, regulatory, corporate and commercial-related matters and various competition aspects regarding distribution operations performed in Romania. Further legal work included assistance in connection with the parallel import of certain pharmaceutical products.
- Retained by Servier Pharma, a leading pharmaceutical company, in connection with regulatory matters pertaining to the price of medicines on the Romanian market and performing an extensive analysis of the secondary Romanian legislation, as well as of the European legislation and case-law relevant to the project.
- Advising AstraZeneca, one of the world's leading pharmaceutical companies, in relation to the regulatory aspects raised by the implementation of the Directly-to-Pharmacies distribution system in Romania.
- Legal assistance provided to Richter Gideon in connection with its investment in two Romanian pharmaceutical companies (production and distribution companies).
- Assisting and representing New Life Drugstore, a Romanian pharmacy chain, with respect to an insolvency procedure undertaken against the company by several creditors.
- Assisting Synthelabo in connection with various legal aspects, including drafting and negotiating several distribution, leasing and sale-purchase agreements.
- Retained by Astellas Pharma, one of the biggest global pharmaceutical companies, with respect to various sponsorship, consulting services, speaker services and advisory board agreements, as well as on relevant data protection matters.
- Advising Rhea Medical in connection with the development of its new medical center in Bucharest.
- Assisting Anwaltskanzlei Straeter, specialists in the health legislation of the Federal Republic of Germany and the European Union, in order to initiate legal procedures for gathering relevant information regarding generic drugs containing the substance Glatiramer, with a view to protecting its IP rights against infringing third parties.
- Retained by B Braun, one of the largest European providers of dialysis medical services and equipment, for day-to-day legal assistance on regulatory, competition, mergers & acquisitions, corporate and commercial-related matters.
- Assisting Clinicco, a leading privately-owned hospital located in Brasov, in connection with the full spectrum of authorizations related to opening a new clinic specializing in cardiovascular diseases.
- Assisting Targoviste Emergency Hospital in connection with the full range of legal work, including advice on restructuring its activities, refinancing schemes, complex employment issues, as well as regulatory, data protection and compliance matters.
