Analytical notes
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Abstract. Shaping a reliable and effective legal framework that would not hinder innovation and quick access of consumers to innovative devices and at the same time guarantee the safety of these devices and their benefits for patients, users or third parties at an equally high level is an important element of the legislative regulation of the procedure for admission of medical devices to the market and implementation of control over their circulation. Analysis of EU legislation in terms of regulations aimed at ensuring the safety and effectiveness of medical devices and facilitating patient access to them, as well as the experience of EU member states which have established control over safety, quality, use, introduction into market, supply, compliance assessment, clinical trials and studies of the effectiveness of medical devices in accordance with the legislation are of significant interest to Ukraine. The analysis covered Ukrainian legislation in the field of medical devices circulation, in particular, state guarantees in the field of healthcare and ensuring high level safety for medical devices consumers, as well as the legislation of the European Union, Austria, Estonia, Latvia, Lithuania, Germany, Poland and Czech Republic.
Key words: medical devices, circulation of medical devices, ensuring the safety of consumers of medical devices, Regulation (EU) 2017/745, EUDAMED database of the European Union on medical devices.
05/2023
Abstract. Models of legal regulation of professional self-governance in the field of healthcare in Canada, Latvia, Poland and the USA have been studied. Attention was focused on the activities of professional self-governance institutions of doctors and other specialists in the field of healthcare. Problematic issues related to introduction of professional medical self-governance in the aforementioned countries have been analyzed. The research highlights the recommendations of scholars and specialists in the field of healthcare, including those of foreign countries.
Key words: healthcare, professional self-governance in the field of healthcare, medical professions, professional responsibility.
05/2023
Abstract. The analytical note describes the experience of foreign countries that have defined the requirements for the circulation of dietary supplements (labeling, procedure of introduction into market, import and export, types of violations in this area) in their laws and regulations. Particular attention was paid to the efforts of the member states of the European Union to find a universal approach to regulating circulation of dietary supplements, which contain active pharmaceutical ingredients.
Key words: dietary supplement, medicinal plant, labeling, circulation, health care, consumer.
05/2023
Abstract. The results of the analysis of the Draft Law “On Amendments to Certain Legislative Acts of Ukraine on Simplifying the Deployment of High-Speed Electronic Communications Networks in the Reconstruction of Settlements and Adapting the Legislation to the Requirements of EU Directive 2014/61” regarding its compliance with EU legislation in the specified area are presented.
Key words: high-speed Internet, Digital Single Market, electronic communications, generation of mobile networks (4G, 5G), broadband access to the Internet.
05/2023
Abstract. The note presents the results of the analysis of Ukraine’s legislative acts and registered in the Parliament legislative initiatives related to the legal support for the digital reforms implementation aimed at promotion of key areas of the digital economy in the society. The analysis deals with the compliance of such acts and initiatives with the legislation of the European Union in terms of the implementation of EU programs “Digital Single Market”, “Europe’s Digital Decade” and other digital cooperation programs. The regulatory legal acts of the EU institutions related to the creation of the EU Digital Single Market and digital economy, including those developed within the framework of EU4Digital, European Union’s Eastern Partnership initiative, which unites priority actions and programs at regional levels, have been analyzed.
Key words: digital single market, digital Europe, digital economy, digitalization.
04/2023
Abstract. Norms providing for measures to ensure the health of food (dietary) supplement consumers constitute an important element of the legislative regulation of the procedure for admission of such products to the market and control of their circulation. The analytical note focuses on the foreign experience of regulating measures to control compliance with the requirements of the legislation on food (dietary) supplements safety.
Key words: food (dietary) supplement, food product, labeling, circulation, control, healthcare, consumer.
04/2023
Abstract. The experience of the EU member states, the USA, and Japan on production, transportation and distribution of hydrogen, including the implementation of pilot projects for the development of hydrogen energy sector, was studied. EU legal acts and legislation of the EU member states in the field of legal regulation of hydrogen utilization were analized, and the priorities for production "green" hydrogen with the help of renewable energy sources (wind, solar) were defined. The proposals for the development prospects of hydrogen energy in Ukraine based on the analysis were formulated in the note.
Key words: hydrogen energy, hydrogen, «green hydrogen», alternative fuels, renewable energy sources.
03/2023
Abstract. A comparative analysis and generalization of the legislation of foreign countries on combating bullying and mobbing was carried out in the following areas:
- the model of legal regulation of bullying and mobbing;
- types of legal liability and sanctions (measures of influence) applied for acts related to bullying and mobbing;
- measures to prevent, respond to and counteract bullying and mobbing.
Legislation of the USA, Canada, France, Germany, Sweden, Norway, Poland, Estonia, Great Britain, the Netherlands, and Spain was analyzed. It was established that the model of legal regulation of bullying and mobbing provides for the determination of preventive and sanctioning provisions in legislation for actions related to persecution the victims in legal relations in the fields of education and labor. It was noted that there are no unified approaches to the definition of the terms "bullying" and "mobbing" in the legislation of foreign states, and legal liability for such actions, as a rule, is disciplinary, material, civil and criminal.
Key words: bullying, mobbing, persecution, victim, offender.
02/2023
Abstract. Legal regulation and operating of the nuclear regulators in the EU member-states (France, Poland), Great Britain, and the USA were studied, in particular, the nuclear regulators’ legal status, powers, guarantess of independence, appointment of management staff (commissioners), decision-making process, functions of the mashinery of state regulation of nuclear safety. Foreign legislation on nuclear safety, and requirements for the nuclear regulators were analyzed.
Key words: nuclear safety; nuclear regulator; reactor; commission; a collective governing body.
02/2023
Abstract. Implementation of systems and guarantees of origin of energy resources in the EU member states and the experience of their functioning was studied in the analytical note. The practice of providing guarantees of origin in several leading EU countries was analized.
The results of the analysis are presented in the table below for the purposes of comparison.
Key words: guarantee of origin; certificate; renewable energy sources; electricity generation; state regulator; electronic system.
02/2023