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Regional Competition Law Update – Q3 2025
Kinstellar’s Competition & FDI team is pleased to present the Q3 2025 update to our Regional Competition Review. This latest edition provides a snapshot of recent enforcement activity, legislative changes, and emerging trends across Austria, Bulgaria, Croatia, Czech Republic, Romania, Turkey and Ukraine. Key highlights include the introduction of new “call-in” powers in Bulgaria, as well as proposed and newly implemented FDI regimes in Croatia and Ukraine, alongside a range of developments that are reshaping competition and FDI control across the region, such as: Austria – Enforcement and energy market focus Czech Republic – Merger remedies, sector inquiries, and cartel fines Romania
Kinstellar’s Regional Competition Law Update: Mid-Year Insights 2025
We are pleased to share this mid-year update to Kinstellar’s Regional 2025 Competition Review and 2026 Outlook. This document provides a snapshot of the latest competition law developments in Austria, Bulgaria, Romania, Serbia, and Turkey, covering key enforcement actions, legislative updates, and regulatory trends observed in the first half of 2025.As always, our aim is to keep clients and partners informed and equipped to respond to ongoing changes in the regulatory landscape.We hope you find this update useful and welcome the opportunity to discuss its implications for your business. Read more in our brochure below: DO WNLOAD BROCHURE
Kinstellar's Regional 2024 Competition Review and 2025 Outlook: Key insights and trends
We are excited to release the first edition of Kinstellar's Regional 2024 Competition Review and 2025 Outlook: Key insights and trends. This report provides an overview of the latest developments in competition law across our jurisdictions, highlighting key regulatory updates, enforcement trends, major fines, merger control decisions, foreign direct investment (FDI) screening developments, and upcoming legislative changes, among others. Competition authorities across the region—Bulgaria, Croatia, Czech Republic, Hungary, Kazakhstan, Romania, Serbia, Slovakia, Turkey, Ukraine, and Uzbekistan—are intensifying their scrutiny of anti-competitive practices, strengthening enforcement efforts, and refining national competition
Competition Law in the CEE Region: "Cross-Sector Perspectives" Conference
We are pleased to announce Kinstellar’s Competition Law Conference: Cross-Sector Perspectives, taking place on 15 November 2024 at the Hilton Hotel in Belgrade, Serbia. This exclusive event will bring together leading experts to explore the latest developments and challenges in competition law, providing valuable insights across various sectors. T he agenda includes: Fast Forward: Competition and the Current Trends in FMCG, moderated by Olga Šipka, Special Counsel, Co-head Competition & State Aid, Kinstellar, Belgrade Speakers: Stefan Dobrić (Bambi), Vukašin Petković (Nectar Group), Vitaly Pruzhansky (RBB Economics), Branislav Žeravić (Delhaize), Geoffroy van
Kinstellar has successfully advised Edwards Lifesciences in the area of data protection
Kinstellar has recently provided expert legal advice to Edwards Lifesciences, a global leader in medical innovations for heart disease, as well as critical care and surgical monitoring, through a secondment arrangement, focusing on data protection. This collaboration ensured that Edwards Lifesciences navigated complex data protection regulations effectively, safeguarding their business interests and maintaining compliance with applicable laws. The expert legal advice was provided by Simona Semanová, with further support from our Kinstellar team in Prague led by Tomáš Čihula and Petr Bratský.
Amendment adopted to Czech Pharmaceuticals Act to address drug shortages
An amendment to the Pharmaceuticals Act has been adopted by the Czech parliament and officially published. As already reported in our previous newsletter, the aim of the amendment is to improve the availability of medicines on the market and to mitigate the potential negative impacts of recent and ongoing medicine supply shortages. The amendment creates new obligations for operators in the medicines market, in particular (i) additional obligations following the interruption or discontinuation of the supply of a given medicinal product; and (ii) a mandatory system of reserve stocks. Following a number of additional changes made by Czech legislators, the national pharma regulator, the State Institute for Drug Control
Cannabis use: CEE regulatory update
Significant changes in the regulation of cannabis use have occurred in some countries in Central and Eastern Europe since our last report. In addition to a number of countries gradually legalising the use of cannabis for medical purposes, increasing efforts by some countries are being seen to also legalise the use of cannabis for recreational use, as well as the use of other products containing various cannabinoids, most importantly cannabidiol (CBD). Click here to read a summary of recent changes related to the national regulation of this rapidly growing sector across Central and Eastern Europe. For any other details or information, please contact Tomáš Čihula, Partner. Contributors:
New regulation of telemedicine in the Czech Republic
The Czech Republic should soon have its own legal regulation for telemedicine. A government proposal is on its way to the Parliament to introduce a basic definition of telemedicine. Until now, there has been no legal definition, which in practice has led to many uncertainties and questions, including the possibility and conditions of provision by healthcare providers, but also, for example, the admissibility of reimbursement by health insurance companies. The proposed amendment to the Health Services Act should remove this uncertainty and will explicitly state that telemedicine is a legally permitted way of providing health services and will set out the framework conditions. Telemedicine services are defined
Czech amendment to the Medicines Act seeks to address drug shortages
On 14 June 2023, the Czech government approved a draft amendment to the Medicines Act. The aim is to improve the availability of medicines on the market and to mitigate the potential negative impacts of recent and ongoing medicines supply shortages. To this end, the proposed amendment creates new obligations for operators in the medicines market, in particular (i) additional obligations following the interruption or discontinuation of the supply of a given medicinal product; and (ii) a mandatory system of reserve stocks. The specific proposed form of these obligations is as follows: (i) Obligations after a supply interruption or termination Under the proposed plan, marketing authorisation
Current eHealth trends in CEE and Turkey
The healthcare industry in Central and Eastern Europe and Turkey is undergoing a digital transformation, with telemedicine at the forefront. Governments and healthcare providers are adopting digital solutions to improve medical services and support healthcare system digitization, which can increase efficiency, reduce costs, and improve access to healthcare. Click on this link or the image below to read the overview put together by a team of our experts led by Partner Tomáš Čihula.
Czech Competition Authority's sector inquiry ends with recommendations for pharmaceutical industry
The Czech Competition Authority has concluded its sector inquiry into the distribution of pharmaceuticals in the Czech Republic, with a focus on the impact of direct distribution systems on competition. The inquiry found that the direct-to-pharmacy/direct-to-h ospital (DTP/DTH) systems in the country only cover a limited range of medicinal products, accounting for roughly 9% in quantity and 27-30% in financial terms. The Authority determined that the priority of ensuring the availability of medicines for patients outweighs any potential negative effects these systems might have on competition. The primary purpose of these systems should be to ensure the supply of medicinal products to patients.The sector inquiry found
Decentralized clinical trials: Current developments in CEE and Turkey
The rapid development of technologies and solutions in the healthcare sector is contributing to the proliferation of decentralised clinical trials (“DCTs”). The aim of DCTs is for clinical trials to be conducted more effectively and conveniently – for patients, sponsors and investigators – through the use of digital technologies. In addition, with hospital visits temporarily limited and staff capacities overwhelmed, the challenges associated with the Covid-19 pandemic have significantly underscored the necessity of performing certain elements of clinical trials remotely. Download in English: