Publication date: November 13, 2024
The European Union, issuing Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ EU. L. of 2016, No. 119, p. 1, as amended), commonly known as the GDPR Regulation, had to face the threats resulting from the effects of globalism. It could not limit the processing of personal data only to the borders of Europe, where the GDPR guaranteed strong protection. It had to create a system that could also provide this protection in third countries outside the old continent.
It did so in Chapter V of the regulation, where a number of solutions were found to facilitate the processing of data in third countries and, on the other hand, ensure a high level of protection. The essence of this solution is the institution of “adequate countries”, i.e. those in which the European Commission has found an adequate level of personal data protection. However, the regulation also contains other solutions for situations when we will not be dealing with an adequate country.
European Data Protection Board
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Publication date: November 13, 2024
by Łukasz Ruman, KIELTYKA GLADKOWSKI KG LEGAL
Electronic money institution, Payment institution, Small payment institution, Payment services office
In today’s world, conducting financial activities electronically is becoming increasingly popular. Banks are focusing on conducting their activities via the Internet and electronic payments. Companies that conduct their accounting remotely and freely make payments using intangible money do the same.
Technical and IT support for such a large financial industry requires specialized entities. For this purpose, numerous companies have been established that are called “fintech”. The abbreviation comes from the English phrase financial technology. It is used to collectively name programs used to handle finances electronically, but also companies involved in the production and maintenance of such programs.
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Publication date: November 13, 2024
We are pleased to announce that we have the honour of being invited to personally participate in the upcoming inaugural event of the World Justice Project EUROVOICES, which will take place on Tuesday, 26 November 2024 at 15:00 CET in Brussels. The event will present the results of over 72,000 surveys conducted with both legal experts and the general public, providing valuable data to guide evidence-based policies at national and regional levels. Speakers will delve into key observations on the rule of law, governance and justice across the EU, helping to identify strengths and areas for improvement.
World Justice Project is an American legal organisation. One of its activities was a campaign to assess the actual perception of the rule of law around the world. The programme was organised in cooperation with an institution of the European Union, therefore the final of the rule of law survey will take place in Brussels.
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Publication date: November 08, 2024
In KIELTYKA GLADKOWSKI each court case is handled by a team that combines the experience of a senior statesperson with the fresh energy of a new generation of lawyers, and this combination of live human power accelerates the potential of winning a case in court.
KIELTYKA GLADKOWSKI notes the achievement of our team, which includes the lawyer admitted to practice in 1982 (42 years of experience before common courts). The Polish Supreme Court verifies cases very rarely. Despite the fact that the Polish Supreme Court does not have to accept a given case for consideration, in one of our recent cases we convinced the Polish Supreme Court to review the case and verify the final unfavourable decision of our Client’s case, with which the Client approached our firm at the last stage.
KIELTYKA GLADKOWSKI’s litigation practice lawyers are authorized to represent their clients in commercial cases, also of a cross-border profile, before all courts, including the Supreme Court.
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Publication date: November 07, 2024
EU AND POLISH PERSPECTIVE
The role of Polish Agency for Health Technology Assessment and related reimbursement of medicinal products
1. Introduction
In December 2021, Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (OJ EU L 458, 2021, p. 1; hereinafter referred to as the Joint Clinical Assessment Regulation or the Regulation) was adopted. In turn, less than half a year ago, Commission Implementing Regulation (EU) 2024/1381 of 23 May 2024 was adopted, establishing, in accordance with Regulation (EU) 2021/2282 on health technology assessment, procedural rules on interactions during the preparation and updating of joint clinical assessments, the exchange of information on the preparation and updating of joint clinical assessments and the participation in the preparation and updating at Union level of joint clinical assessments for medicinal products for human use, and establishing document templates for those joint clinical assessments (OJ EU L 2024; hereinafter referred to as the Implementing Regulation).
Both of these regulations will soon become legally binding, which will lead to fundamental changes in the pharmaceutical market of the European Union Member States, including Poland. A joint clinical assessment will be introduced, as a result of which the clinical assessment of medicines and medical devices introduced to the Polish market will no longer be carried out at the national administration level by the Agency for Health Technology Assessment and Tariff System.
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