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News June 2022

Kinstellar promotes Mert Elçin to Counsel in Istanbul

Kinstellar is delighted to announce the promotion of Mert Elçin to Counsel in our Istanbul office. Mert has more than 10 years of experience in corporate, M&A and banking and finance transactions as well as regulatory matters and has represented clients from a wide range of sectors, in particular banks, brokers, insurers, asset managers, investment funds and other market participants from the financial services industry, venture capital firms, founders, angel and private equity investors, and companies focusing on life sciences and healthcare, technology, media and telecommunications, retail and manufacturing. He is also experienced handling international arbitration. Mert joined Kinstellar in 2019 as

News June 2022

Kinstellar hosts webinar on current developments in the CEE life sciences & healthcare sector

On 14 June 2022, Kinstellar hosted a webinar centred on current developments in the life sciences & healthcare sector across Central and Eastern Europe. We covered some of the most relevant and pressing topics currently impacting the life sciences & healthcare landscape, including (i) sector inquiries by local competition authorities in the area of life sciences; (ii) price reduction announcements and their relevance for the CEE pharma sector; and (iii) legal challenges on the use of artificial intelligence across the life sciences industry. Presentations were made by Tomáš Čihula, Eszter Takácsi-Nagy, Péter Vörös and Petr Bratský. Below we provide a brief summary: Sector inquiries

Insights February 2022

Update of current eHealth trends in CEE and Turkey

As previously reported, eHealth (including telemedicine) has been one of the fastest growing areas within the healthcare sector over the last two years. Governments as well as healthcare sector operators across Central and Eastern Europe and Turkey continue to implement new solutions with a view to improving the provision of healthcare services and to enhance the digitalization of healthcare systems. Private healthcare providers and the various newly created eHealth providers and start-ups are crucial in pushing development in this highly dynamic area. Innovative solutions include online consultations and health examinations, the possibility of remote patient health data monitoring as well as electronic drug prescriptions.

News November 2021

Peter Kováč leads expert medical congress co-sponsored by Kinstellar

Peter Kováč, Of Counsel and head of the Life Sciences & Healthcare sector at Kinstellar’s Bratislava office, served as lead organiser for the expert medical congress “Legal, Forensic and Economic Aspects of the Medical Profession”, which took place online on 18 November 2021. The event, co-sponsored by medical education specialists SOLEN, forensic.sk and Kinstellar, is organised for medical doctors, managers and other healthcare professionals in Slovakia and is officially recognised by the Slovak Health Care Surveillance Authority as an expert event.  Renáta Bláhova, Chairman of the Slovak Health Care Surveillance Authority, gave the opening speech at the congress, while Zuzana Baťová, Director of

Insights October 2021

New rules for the cultivation and export of medical cannabis and increased limits for THC concentrations in industrial hemp in the Czech Republic

On 8 October 2021, an amendment to the Act on Addictive Substances (the “Amendment”) was published. The Amendment is designed to expand the possibilities for cultivating medical use cannabis to a broader range of subjects, including natural person entrepreneurs, thus increasing its availability to Czech patients. It is expected that increased production will lead to a fall in the price of cannabis for medical use. A new licensing system is being created under the Amendment, enabling entities or natural person entrepreneurs to cultivate plant-based cannabis for medical use, provided that they obtain: a licence to cultivate cannabis for medical use issued by the State Institute for Drug Control (the “Institute”)

Insights June 2021

Romania sets out new rules on medical devices

On 11 June 2021, the Government Emergency Ordinance no. 46/2021 (“GEO no. 46/2021”), which establishes the institutional framework and measures for the implementation of Regulation (EU) 2017/745, entered into force. The aim of GEO no. 46/2021 is to ensure the proper functioning of the placing and making available on the market of medical devices for human use and the accessories for such devices. Below is a summary of the key changes introduced by GEO no. 46/2021: The information provided by the manufacturer together with the medical device must be in the Romanian language, without excluding the presentation of such information in other official languages of the European Union. Instructions of use for

Insights May 2021

Current telemedicine trends in CEE and Turkey

Telemedicine has been one of the fastest growing areas within the healthcare sector during the current coronavirus pandemic. But even in 2018, well before the COVID-19 outbreak, the European Commission predicted in its Market study on telemedicine that by 2021 the global telemedicine market would be worth around EUR 37 billion, with an annual growth rate of 14 percent. It is now evident that the pandemic has led to a massive growth of this market. The term “telemedicine” or “telehealth” is used in numerous ways. For the purposes of this newsletter, we use the following definition: telemedicine includes healthcare services that are provided remotely, and where healthcare professionals communicate, diagnose and treat

Insights April 2021

Liberalisation of regulations on the use of cannabis-based medical products in Ukraine

Ukraine has taken a step towards liberalising regulations on the use of cannabis-based medicines. In particular, the Cabinet of Ministers has legalized: Nabilone (a synthetic cannabinoid, mimicking the effect of THC); and Nabiximols (a specific cannabis extract with the same content of THC and cannabidiol). The psychotropic substances Dronabinol, Nabilon and Nabiximols are allowed only in the form of medicines (on prescription) or in the form of substances intended for the production and manufacture of such medicines. To recap, medical use of cannabis is currently prohibited in Ukraine. Subject to obtaining of a relevant license, cannabis is permitted for (i) forensic examination; (ii)

Deals March 2021

Kinstellar advises on the sale of the largest Czech eye-care services provider

Kinstellar has successfully advised Eight Roads on its sale of Optegra International Limited (“Optegra”) to H2 Equity Partners. Optegra is a leading pan-European ophthalmology group with 23 eye hospitals and clinics across the United Kingdom, the Czech Republic and Poland. The company provides a range of critical eye-care services including cataract surgeries and AMD, as well as leading innovative vision correction procedures. Kinstellar was part of a multijurisdictional team led by McDermott Will & Emery and advised mainly on legal matters related to Lexum, the Czech subsidiary of Optegra. Lexum is an established eye-care services provider that has been active on the market for more than 25 years. The company has

Insights March 2021

Peter Kováč contributes to a publication entitled "Urgent Medical Care – Prehospital and Hospital – for Adults and Children"

Peter Kováč, Of Counsel in Kinstellar's Bratislava office, has contributed to a publication entitled "Urgent Medical Care – Prehospital and Hospital – for Adults and Children". The team of authors was led by Viliam Dobiáš, President of the Slovak Red Cross, and consisted mainly of general practitioners and other healthcare professionals in Slovakia providing urgent medical care on a daily basis and with extensive experience handling various healthcare-related personnel, material and organisational circumstances. The ambition of the publication is to provide information on the most frequent diagnoses of adults and children in order to prevent the concentration of emergency cases at specialised and paediatric healthcare

Insights March 2021

Czech Republic: New rules adopted for medical devices

The Czech parliament has adopted local rules to implement the anticipated entry into force of a new EU Regulation on Medical Devices. The main purpose of the new rules is to increase the safety of medical devices. Additional legislation will also address the advertising of medical devices. 1. New Act on Medical Devices Regulations concerning medical devices will undergo a significant overhaul in the months ahead. At the EU level, on 26 May 2021, Regulation No. 2017/745 on Medical Devices (“MDR”) will enter into force. The MDR was adopted to increase both the safety of medical devices and the confidence of healthcare providers and patients in the effectiveness, functionality and safety of medical devices. The

Insights March 2021

Peter Kováč contributes to a study on the EU Member States’ rules on health data in the light of GDPR

Peter Kováč, Of Counsel in the Bratislava office, has contributed to a study on the EU Member States’ rules on health data in the light of GDPR. A series of workshops was held in the first half of 2020 with the participation of representatives from Ministries of Health, Data Protection Authorities, stakeholders’ representatives and independent experts, and complemented by legal analysis carried out by national legal experts, as well as online consultations to wider stakeholder audiences. The European Commission, DG Health and Food Safety, has recently published the results of this study. Please, click on the picture below to read more.       For more information, please contact