Bucharest, 5 June 2024
Mușat & Asociații represented a multinational pharmaceutical company in a complex dispute with the National Health Insurance House (CNAS) regarding the clawback tax for medicines, in the context of the concurrent application of two special regulations with contradictory provisions, namely GEO No. 31/2020 and Law No. 53/2020.
The case was settled by a recent decision of the High Court of Cassation and Justice in favour of the company represented in court by Mușat & Asociații.
The Court has definitively clarified the applicable law in determining the clawback tax due for the first quarter of 2020, given that, under the influence of the pandemic situation, the Romanian Parliament and Government have regulated differently the calculation formula and the rules corresponding to that quarter.
The decision is a landmark one as it held that the legislative changes introduced by Law No. 53/2020, just a few days before the deadline for the enforcement of the payment obligation for the first quarter of 2020 (i.e. 25 May 2020), were of immediate applicability in the context where the tax legal relationship was still ongoing. Thus, the new rules established by Law No. 53/2020 had to be applied for the review and readjustment of the fiscal conduct, even if on the date of their entry into force CNAS had issued the clawback notifications, administrative acts with fiscal validity.
The Supreme Court finally ruled that, given the specific nature of tax matters in which there is the possibility of legislative changes occurring between the date of commencement of the legal tax relationship (the reporting period of the tax obligation) and the date of its finalisation (the due date of the obligation), the CNAS had to recognise the immediate effects of Law No. 53/2020, in the context that the new law refers to a legal situation which arose under the old law, but which was not finalised at the time of the intervention of the new law.
The Mușat & Asociații team, made up of experienced litigators and lawyers specialized in pharmaceutical law - Paul Buta - Managing Partner, Dan Minoiu - Deputy Managing Partner, Angela Porumb - Partner, Mateea Codreanu - Partner, Ana Maria Burada - Senior Associate, Georgiana Negulescu and Iuliana Negură - Associates - obtained the final annulment of the initial notifications issued by CNAS for the first quarter of 2020, the amount of the fee being subject to adjustment by significantly reducing the payment obligation.
“The favourable solution obtained for our client in the pharmaceutical sector is the result of the work of an interdisciplinary team and reconfirms Mușat & Asociații’s ability to handle complex disputes in over-regulated industries, with rules that often create actual difficulties in interpretation and application, even for public authorities. Such mandates underline the unique advantage we have as a full-service law firm to provide advice and representation in all legal and tax matters, through interdisciplinary collaboration within a team of lawyers specialised in the most diverse areas”, said Angela Porumb, Partner, coordinator of the project in court.
In fact, Mușat & Asociații’s extensive expertise and outstanding results in the field of medical and pharmaceutical law were most recently recognised at the LMG Life Sciences Awards EMEA, held in London in May 2024, where Mușat & Asociații was awarded Romania Firm of the Year. These results are due to a strong and diverse team of lawyers specialising in regulatory, corporate, competition law, medical & pharmaceutical law, intellectual property, employment law and tax advice, as well as highly experienced litigators.
LMG Life Sciences is one of the most prestigious legal guides that centralizes the leading law firms and lawyers working in the life sciences (biotech, pharmaceuticals, medical devices, dietary supplements, food, cosmetics, etc.). Each year, LMG Life Sciences grants awards to the law firms and lawyers behind the most innovative and challenging legal projects in EMEA, the US and Canada, along with its sister companies International Financial Law Review (IFLR), Benchmark Litigation, Managing IP, Expert Guides and ITR.
In 2022 and 2023, Mușat & Asociații was awarded Eastern Europe Firm of the Year at the LMG Life Sciences Awards EMEA gala.