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The Romanian pharmaceutical sector has been constantly subject to legislative amendments and also scrutiny by numerous (tax, competition, criminal, regulatory) authorities. The base law on the healthcare system alone was modified more than 170 times in 16 years. While each authority has dealt with its own matters when regulating this sector, one of the main shortcomings is the lack of an integrated approach that, to the benefit of Romanian patients, looks holistically at aspects from clinical trials to pricing and reimbursement and claw-back tax.

The electronization of healthcare (eHealth) streamlines processes in healthcare and improves the quality and availability of medical care. Some elements of eHealth already existed in Czech law, but the legislation was fragmented. To set the general framework, basic rules, and standards for the functioning of eHealth, a new Act No 325/2021 Coll., on electronization of healthcare (Act) was adopted, with effect from January 1, 2022.

There is a growing concern, across CEE, about a potential wave of insolvency and restructuring proceedings. Given the economic aftermath of COVID-19, coupled with the ramifications of rising inflation and interest rates, energy crisis concerns, and the war in Ukraine – the road ahead seems bumpy at best.

The Hungarian Parliament recently adopted a rather significant update to Act LVII of 1996 on the prohibition of unfair market practices and the restriction of competition (“Hungarian Competition Act”). The updates are, at a number of points, based on recommendations made by the Hungarian Competition Association (with DLA Piper’s antitrust group providing significant input). The amendments will generally enter into force on 1 January 2023 (with some exceptions for 1 February 2023). Below, we have collected some of the key changes for Hungarian and international businesses.

DLA Piper at a Glance

DLA Piper is a global law firm with lawyers located in more than 40 countries throughout the Americas, Europe, the Middle East, Africa and Asia Pacific, helping clients with their legal needs around the world. We strive to be the leading global full-service law firm by delivering quality and value to our clients. With practical and innovative legal solutions, we help our clients succeed.

In Central and Eastern Europe (CEE), DLA Piper continues to grow and now employs more than 320 lawyers, including 46 partners across its six offices in Austria, the Czech Republic, Hungary, Poland, Romania and Slovakia. With our global set-up and established relationship firms across all other CEE jurisdictions, we are among the largest and most experienced international law firms in the region. Through our experience gained advising on a variety of high-profile projects and the long-term relationships we have established with our clients, we have built a reputation as a leading business law firm across CEE.

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