Healthcare & Pharma

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.

Practice Highlights.

A selection of our deal highlights includes advising:

A private investment firm and a pharmacy chain, 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 of medicines, medical devices, cosmetics, and food supplements.
A global healthcare company, on 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 in the medical devices field, as well as in connection with the spinoff of the generic medicines business operations to a joint-venture vehicle established together with another global pharmaceutical company.
A diagnostics and pharmaceutical company, in connection with the successful acquisition of several assets of a major company in the Romanian diagnostics and diabetes care market, valued at EUR 17.5 million.
Three major healthcare companies, on the transfer of the marketing authorizations for the medicines traded in Romania and the related changes to the pharmacovigilance system and to the regulatory activities.
A multinational pharmaceutical company, on the implementation of complex programs for supporting the access of patients to the prescribed treatment, and the conclusion of cost-volume agreements and protocols with the healthcare authorities.
A global pharmaceutical company, in relation to the price, distribution, and reimbursement of medicines and medical devices, the promotion of medicinal products, and the performance of clinical trials on innovative products.
A biopharmaceutical 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 the company’s best-selling drug.

A pharmaceutical company from the United Kingdom, during the investigations initiated by the Competition Council on the dialysis and oncology products’ 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.
An 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 clawback system implemented in Romania.
A pharmaceutical company from France, in connection with various matters including market access, health technology assessment, the inclusion of medicines in the reimbursement list, pricing, the trade and distribution of medicinal products, the implementation of educational and 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 physicians, medical institutions and scientific events. We have successfully represented the Romanian subsidiary of this company before the courts in numerous litigations having as object the challenging of clawback notifications for various quarters.
A pharmaceutical company from Switzerland, on numerous regulatory and commercial legal matters, such as the distribution and trade of medicinal products and of medical devices, the clawback tax, the conclusion of cost-volume agreements, protocols and other agreements with the healthcare authorities, public institutions, healthcare professionals and healthcare associations, the supply of medicines under public procurement procedures.
A pharmaceutical company from the United States, in connection with price authorization procedures, health technology assessment and the reimbursement of certain medicines.

Other representative mandates.

A selection of mandates of our Healthcare & Pharma practice includes advising:

A pharmaceutical company from the United States, on numerous pharmaceutical regulatory matters, including without limitation to the issuance of the marketing authorization for medicinal products, the approval of the medicines’ prices, the inclusion of medicinal products in the national list of reimbursed medicines, 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.
A pharmaceutical company from the United States, in relation to the implementation of complex education programs for healthcare professionals, the conclusion of protocols with the authorities, the sponsorship of scientific events, the clawback tax applicable to medicinal products traded in Romania, employment matters, as well as numerous data protection matters.
A multinational pharmaceutical company from Denmark, on numerous pharma regulatory matters, including the conclusion of wholesale distribution agreements, the donation of medicinal products and medical devices, the implementation of educational programs for physicians and data protection matters; representation of the company before the competent courts in the clawback litigations, successfully challenging numerous clawback notifications issued by the healthcare authorities.
A pharmaceutical company from Switzerland, in relation to a wide range of matters, including market access, health technology assessment, the pricing and reimbursement of medicines, the supply of samples and the donation of medicines.
A healthcare company from the United States, for the drafting and implementation of complex compliance policies, the drafting and conclusion of various agreements with healthcare professionals, professional associations, and other business partners.
A pharmaceutical company from Japan, with respect to the distribution and establishing the price of medicines, the pricing of medicines, the drafting and conclusion of various sponsorship, consulting services, speaker services and advisory board agreements, as well as on relevant data protection matters.
A pharmaceutical company from Germany, in relation to the distribution of its medicinal products in Romania, the payment of the clawback tax and the conclusion of wholesale distribution agreements with Romanian business partners.
A pharmaceutical company from Switzerland, on the implementation of complex projects designed for improving the medical education of healthcare professionals, as well as on promotional related aspects.
A pharmaceutical company from Greece, in relation to the pricing and reimbursement of medicinal products, the conclusion of various agreements and protocols with healthcare professionals, healthcare organizations and regulatory authorities, the clawback tax and the donation of medicines to hospitals.
A top pharmaceutical company from France, 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.
A pharmaceutical company from the United States (part of a larger healthcare conglomerate), in connection with the marketing authorization, pricing, distribution, supply, and donation of medicinal products in Romania and on specific authorization procedures.
A top pharmaceutical company from Italy, in connection with the pricing and reimbursement of the medicinal products traded in Romania, including in the litigations concerning the clawback tax.
A pharmaceutical company from the United Kingdom, in connection with the health technology assessment, reimbursement, pricing and distribution of the medicines placed on the Romanian market, and various other regulatory matters.
A pharmaceutical company from Switzerland, in connection with regulatory, contractual, and compliance aspects related to the supply of medicines on the Romanian market, including on aspects regarding price establishment, reimbursement, and promotion of medicines.
Several contract research organizations from the United States and the United Kingdom, on the regulatory, contractual, and compliance aspects related to the performance of clinical trials in Romania.
A pharmaceutical company from the United States, on the health technology assessment, pricing, reimbursement, and other regulatory matters related to the supply of certain innovative medicines for patients in Romania.
An association of international medicines manufacturers, a healthcare company from the United States, a pharmaceutical company from France, a pharmaceutical company from Switzerland, and a pharmaceutical company from the United States, with respect to the Competition Council’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.
A pharmaceutical company from Switzerland, a pharmaceutical company from the United States, a pharmaceutical company from France, and a pharmaceutical company from Japan, 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 of emergency supply systems, to comply with competition law requirements.

A pharmaceutical and cosmetics company from Croatia, in respect of an investigation conducted by the Romanian Competition Council related to an alleged infringement of competition rules at both national and EU levels, via the impairment of parallel trade of products.
A top pharmaceutical company from Switzerland, in connection with 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 Romanian Competition Council with respect to the pharma sector, and also in connection with various other competition, corporate, commercial, and IP matters.
A multinational pharmaceutical company from the United States, 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 the company’s top-selling medicines, more than 5 years before the expiry of the patent protection thereof.
A pharmaceutical company from Germany, during a dispute resolution procedure concerning the protection of intellectual property rights, in the context of promoting certain products.
A pharmaceutical company from the United States, in connection with the protection of its industrial property rights against the launching of certain generic medicines before patent expiry.
A pharmaceutical company from Denmark, in connection with the whole range of IP-related matters, including the protection of its IP rights over innovative drugs and the enforcement of its patent rights in Romania.
A multinational pharmaceutical company from Japan, in connection with the protection of its IP rights over innovative drugs, the assignment, and the enforcement of its patent rights in Romania.
A leading pharmaceutical company from the United Kingdom, in connection with one of the first pharmaceutical patent-related infringement proceedings in Romania.
A top pharmaceutical company from France, in connection with IP protection and regulatory matters related to the parallel import of certain pharmaceutical products.
Two pharmaceutical companies from Germany, in connection with the legal protection of certain innovative medicinal products in Romania and other IP-related matters.
Two healthcare companies from the United States, in connection with the spin-off of the BioScience business, including the corporate, employment, tax, and regulatory aspects related to the transfer of the BioScience business between two of their Romanian affiliates.
A pharmaceutical company from the United States, on the 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 affiliates, and also in connection with various other corporate matters.
A pharmaceutical company from the United States, in connection with the procedures conducted to obtain the requisite antitrust and merger control clearances arising from the worldwide acquisition of Pharmacia Corporation USA by the company.
A pharmaceutical company from France, on the mandatory public tender offer on Zentiva Romania for a total offer value of approximately EUR 17.4 million.
A medical company from Germany, on the regulatory and contractual matters pertaining to the transfer of its medical division in Romania, including the transfer of the reimbursement agreements concluded with 42 health insurance houses across Romania.
A healthcare company from Germany, in connection with the regulatory and employment matters related to the implementation of an educational program for nurses in Romania.
A Romanian pharmacy chain, with respect to an insolvency procedure undertaken against the company by several of its creditors.
A healthcare company from Germany, for day-to-day legal assistance on regulatory, competition, mergers & acquisitions, corporate, and commercial-related matters.
A leading privately-owned hospital located in Brasov, Romania, in connection with the full spectrum of authorizations related to opening a new clinic specializing in cardiovascular diseases.
A medical company from Romania, in connection with the development of a new medical center in Bucharest.
A medical research organization, 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.
A private hospital in Romania, in connection with organizing training programs for physicians and other 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.

Muşat & Asociaţii: “A firm with international standards and an important local player.”

Chambers & Partners

“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.”

IFLR 1000

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

Legal 500

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”.

Legal 500

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

IFLR 1000

“Muşat & Asociaţii delivers great service in a very tough environment.”

Chambers & Partners

“Interviewees say they are drawn to the firm for its “responsiveness and client-focused approach”.

Chambers & Partners

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

Chambers & Partners

Muşat & Asociaţii`s “highly competent, serious and reliable” lawyers provide “client-oriented advice and have extensive experience”.

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.” Interviewees report that “they answer all enquiries promptly and concisely”.

Chambers & Partners

Muşat & Asociaţii’s “engaged and thoughtful” team “understands” and “accommodates” the client’s needs “whenever possible”.

Legal 500

Muşat & Asociaţii has a “strong local presence in Romania” coupled with “an impressive ability to coordinate a cross-border deal”.

Legal 500

Mușat & Asociații has been described as a “one stop shop law firm with the ability to provide us with all the services we need” by one client.

Chambers & Partners

Sources say: “We choose Mușat & Asociații because of its impeccable service. Prompt, innovative and practical, it always suggests several solutions to fit our business strategy.”

IFLR 1000

Clients about Mușat & Asociații’ lawyers: “High level of professionalism and involvement, innovative spirit and original solutions.”

IFLR 1000

Clients believe the firm to be “professional, with a great team of lawyers displaying depth of knowledge”.

IFLR 1000

Clients appreciate the firm's comprehensive support, with one highlighting that the lawyers “consistently work extremely well”.

Chambers & Partners

“Easily compete with any international firm in terms of presence, expertise and vision.”

Chambers & Partners