Overview & Experience

Muşat & Asociaţii 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, to further deepen its expertise in the most sensitive issues and to continue its prosecution of landmark, precedent-creating 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. We have been at the heart of all major 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 markets at both local and global level, and on providing the 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 before both 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

Deputy Managing 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 experience includes advising:

  • The Romanian Association of International Medicines Manufacturers on numerous enactments and initiatives concerning the social health insurance system, the national health programs, the pricing and the reimbursement of medicinal products.
  • A top pharmaceutical research-driven company, in relation to the marketing authorization for medicinal products, the approval of the medicines’ prices, the inclusion in the national list of reimbursed medicines, the supply of medicines under public procurement proceedings.
  • A major US pharmaceutical company, in relation to the pricing, distribution and reimbursement of medicines and medical devices, the promotion of medicinal products, the implementation of complex education programs for healthcare professionals.  
  • One of the world’s biggest biopharma company, in connection with the conclusion of cost-volume agreements, protocols and other agreements with the healthcare authorities, public institutions, healthcare professionals and associations.
  • A major French pharma company, in connection with the pricing, import and distribution of medicinal products, the drafting and conclusion of logistic services agreements, services and supply agreements.
  • A global healthcare company specialized in diabetes care, in connection with numerous pharma regulatory matters, including the conclusion of wholesale distribution agreements, the donation of medicinal products and medical devices.
  • A global healthcare company, in relation to market access, health technology assessment, the pricing and the reimbursement of medicines, the implementation of complex programs for supporting the access of patients to the prescribed treatment.
  • A major global healthcare company, for the drafting and implementation of complex compliance policies, the drafting and conclusion of various agreements with HCPs, professional associations and other business partners.
  • An innovative pharma company, with respect to the drafting and conclusion of various sponsorship, consulting services, speaker services and advisory board agreements, as well as on relevant data protection matters.
  • Three leading biopharmaceutical companies, in connection with the transfer of the marketing authorizations for the medicines traded in Romania, the pharmacovigilance system and other regulatory matters.
  • Over 20 international marketing authorization holders, in connection with the computation, declaration and payment of the clawback tax, the registration with the National Health Insurance House and with the tax authorities, the tax audits, successfully challenging the clawback notifications and consumption data before the competent courts. 
  • A major biologics manufacturer, in relation to the distribution of its medicinal products in Romania, the conclusion of wholesale distribution agreements with Romanian business partners and the changes to the pharmacovigilance system.
  • An innovative, research-driven biopharma company, on the implementation of complex projects designed for improving the medical education of healthcare professionals, as well as on promotional related aspects.
  • A global pharma group based in France, in connection with regulatory, corporate and commercial-related matters and various competition aspects regarding the distribution operations. 
  • One of the world’s largest human protein manufacturers, in connection with regulatory, contractual and compliance aspects related to the supply of medicines on the Romanian market.
  • One of the biggest pharmacy chains in Central Europe, on the regulatory and contractual aspects pertaining to the successful acquisition of the largest wholesale distributor of medicines in Romania and a pharmacy chain of +600 pharmacies, including on the distribution and reimbursement of medicines, and the supply of medical devices, cosmetics and food supplements.
  • Numerous leading companies acting in the clinical trials field, on the regulatory, contractual and compliance aspects related to the performance of clinical trials in Romania.
  • The Romanian Association of International Medicines Manufacturers and several of its members, during the Competition Council’s sector inquiry on the wholesale pharmaceuticals distribution market in Romania, including training programs, implementing specific compliance programs and representation before the Competition Council.
  • Numerous 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, to comply with the competition law requirements.
  • A major Croatian pharma company, in respect of an investigation conducted by the Romanian Competition Council related to an alleged infringement of competition rules at both national and EU level, via the impairment of parallel trade of products.
  • A global healthcare company, in connection with a landmark investigation in Romania dealing with an alleged abuse of dominance in the pharma industry and also in connection with various other competition, corporate, commercial and IP matters.
  • A leading pharma company, in connection with numerous IP matters, including the protection of its patents in the context of the threats concerning the launch in Romania of a generic version of its top selling medicines.
  • A major Germany-based pharma company, during a dispute resolution procedure concerning the protection of intellectual property rights, in the context of promoting certain of its products.
  • A major biopharma company, in connection with the protection of its IP rights in the context of the requests for compulsory patent licenses submitted by third parties in relation to its best-selling drug.
  • A Danish pharma company, 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.
  • A Japanese pharma company, in connection with the protection of its IP rights over innovative drugs, the assignment and the enforcement of its patent rights in Romania.
  • A French pharma group, in connection with IP protection and regulatory matters related to the parallel import of certain pharmaceutical products.
  • A global 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 the other, acting in the medical devices field.
  • Two major drug manufacturers, in connection with the spin-off of one of its businesses, including the corporate, employment, tax and regulatory aspects related to the transfer of the new business between two of their Romanian affiliates.
  • A US pharma 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 affiliates.
  • A leading American medicine manufacturer, in connection with the procedures conducted in view of obtaining the requisite antitrust and merger control clearances arisen from the worldwide acquisition of another medicine manufacturer. 
  • One of the world’s leading suppliers of medicinal gases, on the regulatory and contractual matters pertaining to the transfer of its medical division in Romania, including on the transfer of the reimbursement agreements concluded with 42 health insurance houses across Romania.
  • Germany’s largest provider of homecare services, in connection with the regulatory and employment matters related to the implementation of an educational program for nurses in Romania.
  • Several pharmaceutical companies with respect to the debt recovery proceedings, the insolvency procedures and other actions undertaken for the recovery of significant receivables.
  • One of the world leaders in healthcare services, for day-to-day legal assistance on regulatory, competition, mergers & acquisitions, corporate and commercial-related matters.
  • A clinical research centre, for obtaining the required authorizations for performing medical activities and clinical trials in their 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.
  • One of the largest Romanian private hospitals, in connection with organizing training programs for the employees on different areas of interest, including compliance related aspects, competition, malpractice, as well as other regulatory aspects, and day-to-day legal assistance in connection with the performance of medical activities.

 

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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