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A sector under the spotlight: what recent cases in Romania and at the EU level signal for pharma compliance
Competition and regulatory authorities across Europe are showing renewed vigilance toward the pharmaceutical sector—a field shaped by the intersection of competition law, regulatory frameworks, consumer protection, and IP. Recent cases illustrate that investigations in this area are increasingly complex and precedent driven, offering valuable guidance on how authorities assess commercial behaviour. Sun Wave Pharma case – the Romanian Competition Council unveils unfair competition practices In May 2025, the Romanian Competition Council (“RCC”) announced the conclusion of its investigation into Sun Wave Pharma S.R.L., a major player in the food supplements market in Romania. The inquiry focused on allegations
Kinstellar advises Integral Capital Group on the acquisition of a majority stake in IVF clinic Calla, via its subsidiary Embryos
Kinstellar has advised Integral Capital Group, a leading private equity firm in Central and Eastern Europe, on the acquisition of a majority stake in Calla Clinic, an in vitro fertilization (IVF) clinic in Oradea, Romania, through its subsidiary Embryos. The acquisition is part of Embryos’ regional expansion strategy, which includes the opening of a satellite clinic in Buzau and the acquisition of Adella Clinic in Sofia, Bulgaria earlier this year. Integral Capital Group acquired a majority stake in Embryos in February 2025, enhancing the group’s position in the rapidly growing fertility services market in Romania and Southeast Europe. Calla Clinic has been operating in Oradea for over 13 years, offering a
Croatia introduces Draft Foreign Direct Investment Screening Act
The Croatian Government has introduced the Draft Act on the Screening of Foreign Investments, which is currently undergoing public consultations. The Draft Act seeks to establish a foreign direct investment (FDI) screening mechanism in line with Regulation (EU) 2019/452 and OECD investment standards. Its aim is to create a national framework for reviewing FDIs that may pose risks to national security or public order. The Draft Act is open to public comments (via https://esavjetovanja.gov.hr/) until 3 October 2025. Scope of application The screening mechanism will apply to: Foreign investors – natural or legal persons from third countries, and EU entities that are under direct or
Kinstellar advises GTCR on its acquisition of Zentiva
Kinstellar has successfully advised GTCR, a leading US-based private equity firm, on its agreement to acquire Zentiva, a prominent European generics pharmaceutical company, from global private equity investor Advent International. The transaction marks one of the most significant healthcare buyouts in Europe this year and is expected to close in early 2026, subject to customary regulatory approvals. Kinstellar acted as local counsel to GTCR, providing full-scope legal support across Central and Eastern Europe, including corporate, regulatory, and transactional matters. The firm collaborated closely with Kirkland & Ellis, GTCR’s lead legal advisor, on this high-profile cross-border deal. Under Advent’s ownership
Updates on NIS2 in Romania
Following up on our initial article regarding the transposition of the NIS2 Directive (EU) 2022/2555 (“NIS2”) in Romania via Government Emergency Ordinance no. 155/30.12.2024 (“GEO 155”), we would like to inform you of the following relevant evolutions in this area as of today, 20 August 2025: The Romanian National Directorate for Cybersecurity ("DNSC”) has issued the long awaited application norms for registering with DNSC as important or essential entity. DNSC Order no. 1/2025 was published in the Official Gazette of Romania on 20 August 2025. As of publication, in-scope entities have 30 days at their disposal to register with DNSC. Registration should primarily be done using the online
Navigating NIS 2: How businesses can achieve cybersecurity compliance across the EU
The NIS 2 Directive is the European Union’s cybersecurity framework that requires considerable efforts by companies in sectors like energy, transportation, life sciences and digital infrastructure to establish the required compliance. The directive mandates that the companies within the scope of NIS 2 implement a large number of technical and organizational measures to manage cybersecurity risks and puts cybersecurity as a top management responsibility. EU Member States must transpose the NIS 2 Directive into their national acts of law. Although a number Member States are delayed in this legislative process, other jurisdictions are already well past requiring registration and implementation of cybersecurity risk management.
Kinstellar, together with Addleshaw Goddard as lead counsel, advises Phoenix Equity Partners Limited on the acquisition of FutureMeds in Bulgaria and Ukraine
Kinstellar, together with Addleshaw Goddard as lead counsel, has advised Phoenix Equity Partners Limited, a leading UK-based private equity investor, in connection with the acquisition by Phoenix of FutureMeds, a fast-growing clinical trial site network operating across Europe, including subsidiaries in Bulgaria and Ukraine. The transaction marks a significant step in Phoenix’s investment in the healthcare and life sciences sector and supports FutureMeds’ ambition to accelerate access to clinical trials across Europe and beyond. FutureMeds is Europe’s first dedicated independent site management organisation (SMO), providing access to state-of-the-art clinical research infrastructure across multiple countries.
Kinstellar advises on the financial close of Central Asia’s largest healthcare PPP project in Kazakhstan
Kinstellar is delighted to announce the successful financial close of a landmark public-private partnership (PPP) healthcare initiative in Kokshetau, Kazakhstan. This transformative project, which marks a first for the region in healthcare PPPs, has secured a EUR 365 million financing package, spearheaded by the European Bank for Reconstruction and Development (EBRD) and the Asian Infrastructure Investment Bank (AIIB), alongside key contributors Proparco, ICD, DEG, and the Development Bank of Kazakhstan (DBK). After months of legal structuring, negotiations, and due diligence, the project has officially reached financial close. This milestone unlocks the next phase - the commencement of construction on the 630-bed medical
Category Management Agreements: Belgian Competition Authority issues landmark decision in cartel case involving anti-competitive arrangements for the placement of OTC medicines in pharmacies
On 24 April 2025, the Belgian Competition Authority (“BCA”) announced that it had imposed fines totalling EUR 11.2 million on pharmaceutical companies Johnson & Johnson, Boehringer Ingelheim, and Haleon. The sanctions were issued following a settlement in a case concerning anti-competitive practices linked to category management agreements for over-the-counter (“OTC”) medicines. According to the European Commission Guidelines on Vertical Restraints, category management agreements are agreements whereby a distributor delegates to a supplier (the so-called “category captain”) the responsibility for marketing an entire category of products. While such agreements are generally considered unproblematic, the Guidelines
Kinstellar advises Blue Sea Capital on the sale of MediGroup Serbia to Mehiläinen Group
Kinstellar is pleased to announce that it has advised Blue Sea Capital on the sale of MediGroup, Serbia’s largest private healthcare provider, to Mehiläinen Group, Finland’s largest private healthcare provider. The transaction forms part of a broader regional deal involving the Regina Maria Group, MidEuropa’s healthcare services platform in Central and Eastern Europe. Blue Sea Capital is an independent private equity firm with offices in Belgrade and Zagreb, focusing on small and medium-sized enterprises in the region. MediGroup is the largest private healthcare provider in Serbia, offering a wide range of services, including inpatient and outpatient care, laboratory diagnostics, IVF, maternity, and ophthalmology.
Kinstellar advises Macopharma Group – GMPi on its acquisition of Lmb Technologie
We are delighted to announce that the Kinstellar Belgrade team, in collaboration with international advisor Forvis Mazars Germany, has successfully advised Macopharma Group – GMPi, a global leader in the healthcare industry, on its acquisition of Lmb Technologie. Macopharma has been a leader in the blood industry for over 45 years, and this acquisition is a key element of its five-year strategic plan to expand its product range and further strengthen its position in the European, American, and Middle Eastern markets. As part of the expansion in Serbia, Lmb plans to extend its factory in Niš, by 2,500 square meters, creating 30 new jobs in addition to the existing 120 employees. A heartfelt thank you to
Hartwig Kienast, a leading Austrian M&A lawyer, joins Kinstellar as Partner in Vienna
Kinstellar is delighted to announce that Hartwig Kienast, a highly regarded M&A lawyer, has joined our newly launched Vienna office as a Partner. His arrival further strengthens our M&A and private equity capabilities in Austria and across the wider CEE region, reaffirming our commitment to delivering top-tier legal advice in this key market. Hartwig Kienast specialises in mergers & acquisitions, private equity, and venture capital transactions, as well as corporate reorganisations. He has been actively involved in large cross-border M&A transactions and restructurings, advising both international corporations and investors. His experience spans a wide range of sectors, including: infrastructure & energy