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Ukraine leaps forward in its cannabis policy
A cannabis law passed by the Ukrainian parliament back in December of last year, will come into force on 16 August 2024. Developed in compliance with EU regulations, the law represents a significant overhaul of cannabis regulations in Ukraine. Secondary cannabis-related legislation is expected to be drafted by the Ukrainian government by the end of May 2024. Click on one of the images below or click on the following links to read the overview in English or in Ukrainian. Down load in English: Download in Ukrainian:
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.
Kinstellar advises on an IFI-financed pharma sector acquisition in Uzbekistan
Kinstellar is delighted to announce that it has advised a holding company of a leading Ukrainian pharmaceutical company, YURiA PHARM, on the two-stage acquisition of a pharmaceutical company in Uzbekistan. The acquisition, which was supported by financing from an international financial institution, will enable Yuria Pharm to maintain exports despite the war, localise and increase production in Uzbekistan as well as allocate more critical medicine to the market in Ukraine. Our team undertook comprehensive due diligence and advised on transactional, corporate governance, regulatory, anti-trust as well as financing-related and other matters. Kinstellar’s team was led by Sherzod Yunusov, Partner, with the support
Slovak court orders public health insurance provider to pay EUR 2 million for the medicinal product Zolgensma, citing discrimination
Zolgensma[i] is an orphan medicinal product designated by the European Medicines Agency for the treatment of spinal muscular atrophy (“SMA”), a long-term debilitating and life-threatening disease that causes breathing difficulties and paralysis that worsens over time. Zolgensma, which has been authorised in the EU since 18 May 2020, was developed by AveXis EU, Ltd. and later acquired by Novartis. On 13 March 2023, the Bratislava V District Court issued an injunction against public health insurance provider Všeobecná zdravotná poisťovňa (General Health Insurance, "VsZP"), ordering it to pay for Zolgensma, which is not reimbursed by the Slovak public health insurance system. This is the first court decision ordering
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:
Žurić i Partneri Kinstellar advises OTP banka d.d. on the financing for the acquisition of Fiziodent Polyclinic
Our team in Croatia has once again advised OTP banka d.d., this time on the financing for the acquisition of Fiziodent Polyclinic through the sale of a majority ownership stake to Adria Dental Group. Fiziodent operates two polyclinics in the Croatian capital, Zagreb, and employs a total of 40 employees. It was founded in 2003 and is the leading clinic in the field of transparent and mobile braces in the region. OTP banka d.d. continues to support the growth of Adria Dental Group. As the largest dental group in Croatia and the wider region, Adria Dental Group now has more than 450 employees and 180 dental specialists and includes seven clinics and five laboratories in the cities of Zagreb, Solin, Rijeka and Poreč.
Žurić i Partneri (ŽIP) Kinstellar advises OTP Banka d.d. on the financing for the acquisition of Dentum Dental Clinic
Our team in Croatia has advised OTP Banka d.d. on the financing for the acquisition of Dentum Dental Clinic via the sale of a majority ownership stake to Adria Dental Group. With this transaction, OTP Banka d.d. continues to support the expansion of Adria Dental Group, which has now positioned itself as the largest dental group in Croatia and the wider region. The group has more than 420 employees, more than 70 practices and over 160 dental specialists, with annual revenues above 30 million euros. The group includes five clinics and five laboratories (Zagreb, Solin, Rijeka and Poreč) with a plan to further expand to the domestic and regional markets. The Kinstellar team in Zagreb was led by Mihovil Granić (Partner)