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
This article refers to situations where a director of a Slovak company (i.e., a person appointed to be the statutory representative) is in parallel engaged as an employee, occupying a senior management position such as CEO, CFO, COO, etc., in the same company. These situations are relatively common in Slovakia, but they bring more practical and legal challenges than the company might expect. Employee Employment relationships are regulated by the Slovak Labour Code. In an employment relationship, the employee performs for the employer (the company) so-called dependent work characterised by the employer´s authority and the employee´s subordination. Empl oyment has the
On 21 February 2023, the Ministry of Economy of the Slovak Republic (“the Ministry”) published a call for the submission of applications for a subsidy to cover additional costs due to the increase in gas and electricity prices (“the Call”). The aim of the Call is to compensate qualifying companies and natural persons (entrepreneurs) for excessive energy prices from January to March 2023. In this article, we present an overview of the key information. Basis The Call was published in accordance with the state aid scheme approved by the European Commission under No. SA. 104846 under the State aid Temporary Crisis Framework (“the Scheme”). The Ministry has allocated a total amount of EUR 279,820,623
The European Commission and European Intellectual Property Office (“EUIPO”) have launched a small and medium sized business fund (SME Fund) to provide reimbursement for trademark and design application fees and pre diagnostic services. The grant scheme, designed to encourage SMEs to expand their IP portfolios, has a budget of EUR 25 million, available on a first come, first serve basis. The submission period for applications runs from 23 January to 8 December 2023. Read more in the brochure below: Download in English: In case of any questions with respect to the above, our specialists
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:
Last week, the European Parliament (“EP”) adopted a resolution on online video games (the “Resolution”) . In essence, the Resolution calls for strong enforcement of consumer protection rules in the video game industry, requires stricter regulation of loot boxes and emphasizes the enormous potential of the gaming sector. Download in English: In case of any questions with respect to the above, our specialists are standing by to offer guidance and counsel.
Act No. 497/2022 Coll. on Screening of Foreign Direct Investments (the “FDI Act”), published on 23 December 2022, will have a significant impact on foreign investments in Slovakia, at least in terms of the time needed to complete transactions. The FDI Act takes effect on 1 March 2023. The new rules do not apply to investments completed prior to such date. Our specialists have put together a summary of the key measures the FDI Screening Act introduces: Download in English: In case of any questions with respect to the above, our specialists are ready to offer guidance and counsel.
On 27 December 2022, the Directive on “measures for a high common level of cybersecurity across the Union”, repealing Directive (EU) 2016/1148 (the “NIS 2 Directive”), was published in the Official Journal of the European Union. The NIS 2 Directive builds on a previous NIS Directive adopted in 2016 expanding its scope to other entities. Due to a rising number of cybersecurity incidents as well as ongoing increased digitalization, the aim of the NIS 2 Directive is to cover more economic sectors and to introduce additional security and reporting requirements across all EU Member States. Member States will have until 17 October 2024 to transpose the NIS 2 Directive into their national laws. Our specialists
As of 2020, European Union (“EU”) Member States are obliged to make details of ultimate beneficial owners (“UBOs”) of corporate and other legal entities available to the general public. However, in light of the recent decision of the Court of Justice of European Union (“the ECJ”), it is now questionable whether this obligation will remain. The requirement to make details of UBOs publicly available was introduced by Article 30 (5) of Directive (EU) 2015/849 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing (“the AML Directive”). The Member States are entitled to restrict public availability of details on UBOs under the AML Directive in the
On 1 December 2022, the Ministry of Economy of the Slovak Republic (“the Ministry”) published a call for the submission of applications for the provision of a subsidy to cover additional costs due to the increase in gas and electricity prices (“the Call”). The aim of the Call is to compensate qualifying companies and natural persons (entrepreneurs) for excessive energy prices in August and September 2022. In this article, we present an overview of the related key information. 1 Basis The Call was published in accordance with the state aid scheme approved by the European Commission under No. SA. 104846 under the State aid Temporary Crisis Framework (“the Scheme”). The Ministry
Kinstellar is pleased to announce that it has been named “2022 Law Firm of the Year: Central Europe” by the leading UK and European legal publication The Lawyer at its annual European Awards ceremony. Each year the awards celebrate excellence across the European legal market and recognise firms that have demonstrated outstanding achievements through their mandates, performance, impressive strategic growth and excellence in client service. Winners are chosen from among over 120 independent law firms headquartered in Europe and global firms across the continent. Kinstellar is also proud to have been shortlisted for the “Law Firm of the Year: South Eastern Europe” and ‘’Law Firm of the Year: Ukraine’’
Kinstellar supports professional growth by offering a broad range of career development opportunities for our team including Sector/Service line head or co-head roles. We provide growth opportunities to all of our talented lawyers with relevant experience and who have an outstanding track record. We believe in an inclusive recruitment process where we create an equitable application, interview and selection process. We are delighted to announce the appointments of the following sector and service line heads: Müfit Arapoğlu, a Partner in the Istanbul office, is the firm-wide Financial Institutions (non-transactional) Sector Co-Head and the firm-wide Head of Banking, Finance & Capital Markets (service line).