Overview & Experience

Mușat & Asociații is recognized as one of the country’s most knowledgeable law firms in the Healthcare and Pharmaceuticals 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 and Pharmaceuticals 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.

PAUL GEORGE BUTA
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9V8A4623 Paul Buta

Partner

Areas of practice: Competition & State Aid, Mergers & Acquisitions / Privatisation, Healthcare / Pharma & Intellectual Property, Litigation & Arbitration

Phone: +40 21 202 59 09

Fax: +40 21 223 04 95

E-Mail: paul.buta@musat.ro

Address: 43 Aviatorilor Boulevard, 1st District, Code 011853, Bucharest, Romania

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A selection of our recent instructions includes advising:

 

  • The Romanian Association of International Medicines Manufacturers on various enactments and initiatives concerning the social health insurance system and the national health programs, the pricing and reimbursement of medicinal products, including dispute resolution legal work related to the constitutionality and the legality of the claw back system implemented in Romania.
  • The leading American global pharmaceutical company in relation to various regulatory, commercial and contractual matters, such as the pricing, distribution and reimbursement of medicines and medical devices, the promotion of medicinal products, clinical trials, the implementation of complex education programs for healthcare professionals, the sponsorship of scientific events, the claw back tax applicable to medicinal products traded in Romania, employment matters, as well as numerous registrations of its operations with the Romanian data protection authority.
  • A global research-based pharmaceutical company in connection with numerous pharma regulatory matters, including without limitation the issuance of the marketing authorization for medicinal products, the approval of the medicines’ prices, the inclusion of medicinal products in the lists of reimbursed medicines approved by the healthcare authorities, the supply of medicines under public procurement proceedings, clinical trials, the conclusion of numerous agreements with healthcare professionals and various services providers and business partners.
  • The leading French independent pharmaceutical company on a daily basis in connection with numerous legal matters, such as market access, health technology assessment, the inclusion of medicines in the reimbursement list, the pricing, the trade and the distribution of medicinal products, the implementation of educational and of promotional programs, the donation of medicines, the drafting and conclusion of logistic services agreements, services and supply agreements, as well as numerous other agreements with healthcare professionals and healthcare organizations, the sponsorship of healthcare professionals, medical institutions and of scientific events. We successfully represented the Romanian subsidiary of the Client before the courts in numerous litigations having as object the challenging of claw back notifications for various quarters.
  • The leading Swiss multinational pharmaceutical company in relation to a wide range of legal issues, including without limitation to market access, health technology assessment, the pricing and the reimbursement of medicinal products, the supply of samples and the donation of medicines, the implementation of complex programs for supporting the access of patients to the prescribed treatment, the drafting and conclusion of protocols with the healthcare authorities, the claw back tax.
  • One of the world’s leaders in the pharmaceutical and diagnostic industries in connection with numerous regulatory and commercial legal matters, such as the distribution and trade of medicinal products and of medical devices, the claw back tax, the conclusion of various agreements and protocols with healthcare authorities, public institutions, healthcare professionals and healthcare associations, the supply of medicines under public procurement procedures.
  • The leading Danish multinational pharmaceutical company in connection with numerous pharma regulatory matters, including without limitation to the conclusion of wholesale distribution agreements, the donation of medicinal products and medical devices, the implementation of educational programs for healthcare professionals; our mandates included the representation of the Client before the competent courts in the clawback litigations, where we successfully challenged numerous clawback notifications issued by the healthcare authorities.
  • A leading global pharmaceutical company with respect to the distribution of medicinal products, the drafting and conclusion of various sponsorship, consulting services, speaker services and advisory board agreements, as well as on relevant data protection matters.
  • One of the world’s leading pharmaceutical and healthcare company 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.
  • An international research-based pharmaceutical company in relation to the pricing and reimbursement of medicinal products, the conclusion of various protocols with the healthcare authorities, the claw back tax, and the donation of medicinal products to Romanian hospitals.
  • An international biotechnology company in relation to the distribution of its medicinal products in Romania, the payment of the claw back tax and the conclusion of wholesale distribution agreements with Romanian business partners.
  • The leading multinational pharmaceutical and biologics company in relation to the regulatory, competition and commercial aspects related to the change of their distribution system in Romania.
  • The Romanian Association of International Medicines Manufacturers and various leading pharmaceutical companies with respect to the national competition authority’s 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.
  • The world’s leading pharmaceuticals and healthcare companies during the investigations initiated by the national competition authority 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.
  • Various pharma companies in connection with the distribution system implemented in Romania for medicinal products and potential changes to such systems, such as the direct-to-pharmacy distribution and the setting up emergency supply systems, in such a manner as to comply with the competition law requirements.
  • A leading Croatian pharmaceuticals producer in respect of an investigation conducted by the national competition authority related to an alleged infringement of competition rules at both national and EU level, via the impairment of parallel trade.
  • One of the world’s leaders in the pharmaceuticals and diagnostic industries in relation to the first investigation in Romania dealing with an alleged abuse of dominance in the pharma industry, as well as in relation to the sector inquiry launched by the national competition authority with respect to the pharma sector, and also in connection with various other competition, corporate, commercial and IP matters.
  • A global research-based pharmaceutical company in connection with numerous IP matters, including without limitation to the protection of its patents in the context of the threats concerning the launch in Romania of a generic version of Client’s top selling medicines, more than 5 years before the expiry of the patent protection thereof.
  • A leading Swiss multinational pharmaceutical company in connection with numerous IP matters, including the protection of the company’s interests against the launching of certain generic medicinal products before the expiry of the patents held by the Client.
  • One of the world’s leading producers of innovative medicines used in the treatment of  mental illness 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.
  • The world’s leading pharmaceutical and healthcare companies in connection with one of the first pharmaceutical patent-related infringement proceedings in Romania.
  • A leading pharmaceutical and healthcare company in connection with the IP and regulatory matters related to the parallel import of certain pharmaceutical products.
  • Two international pharmaceutical companies in connection with the legal protection of certain innovative medicinal products in Romania and other IP-related matters.
  • A company specializing 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 certain generic medicines, with a view to protecting its IP rights against infringing third parties.
  • An American pharmaceuticals and healthcare company in connection with the structuring and implementation of the separation of its operations in Romania into two different companies: one acting in the research based pharmaceutical area, and another one acting in the diversified medicinal products field, as well as in connection with the spin-off of the generic medicines business operations to a joint-venture vehicle.
  • The leading American global pharmaceutical company in connection with structuring and implementation of the transfer of the business related to the supply of medicinal products for veterinary use in Romania, between two of its Romanian subsidiaries, and also in connection with various other corporate matters.
  • World’s leading pharmaceutical and healthcare company on the full range of legal matters in connection with the spin-off of its pharmacy chain, as well as in connection with the sale of its shares to the largest pharmacy chain in Romania.
  • The diagnostic division of a global leader in healthcare in connection with the EUR 17,500,000 successful acquisition of several assets of one of the most important companies on the Romanian diagnostics and diabetes care market.
  • The leading French pharmaceutical group on the mandatory public tender offer on a Romanian player in the field for a total offer value amounting to approximately EUR 17,400,000.
  • An American multinational pharmaceutical corporation 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.
  • The largest biotechnology and pharmaceutical company, based in Hungary, in connection with its investment in two Romanian pharmaceutical companies (production and distribution companies).
  • A Romanian pharmacy chain with respect to an insolvency procedure undertaken against the company by several creditors.
  • 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.
  • A leading privately-owned hospital located in Romania in connection with the full spectrum of authorizations related to opening a new clinic specializing in cardiovascular diseases.
  • An American chain of hospitals in connection with the development of a new medical center in Bucharest.
  • A Romanian 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.

Accolades 
The prestigious British legal publishers IFLR 1000, Legal 500 and Chambers & Partners rank Muşat & Asociaţii as leading / highly recommended law firm in Corporate/M&A, Privatization & PPP, Dispute Resolution, Banking, Project Finance, Energy, Real Estate, IT, Telecoms and Media, Employment, Environment, Capital Markets, Restructuring & Insolvency, Competition / Antitrust, Tax, Private Equity.

“Clients about our firm: “Muşat & Asociaţii exceeded our expectations every time we requested their advice. They are one of the few full service law firms in Romania, thus having the capability and knowledge to provide integrated legal advice.” Source: IFLR 1000

“Clients of Muşat & Asociaţii appreciate the firm’s ‘ability to provide efficient legal services but also proactively meet the client’s needs”. Source: Legal 500

Muşat & Asociaţii: “a firm with international standards and an important local player”. Source: Chambers & Partners

Clients appreciate the firm's “competence and timely manner”, acknowledging that the “service they provide is excellent and we always feel confident that what we ask from them will be delivered”. Source: Legal 500

Muşat & Asociaţii has “a dominant share of the country's business” and “garners much respect from its competitors and clients”. Source: IFLR 1000

“Muşat & Asociaţii delivers great service in a very tough environment.” Source: Chambers & Partners

“Interviewees say they are drawn to the firm for its “responsiveness and client-focused approach”. Source: Chambers & Partners

“This firm is involved in some of the biggest cases, which are often the first of their kind” say peers. Source: Chambers & Partners

Muşat & Asociaţii: “a firm with international standards and an important local player”. Source: Chambers & Partners

Clients applaud the team's “innovative preparation of the legal strategy,” asserting that “they take the time to consider all possible courses of action”. Also noted was the lawyers’ “timely and responsive” style, with interviewees reporting that “they answer all enquiries promptly and concisely”. Source: Chambers & Partners

“Clients about our firm: “Muşat & Asociaţii exceeded our expectations every time we requested their advice. They are one of the few full service law firms in Romania, thus having the capability and knowledge to provide integrated legal advice.” Source: IFLR 1000

Clients appreciate the firm's “competence and timely manner”, acknowledging that the “service they provide is excellent and we always feel confident that what we ask from them will be delivered”. Source: Legal 500
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