Review of European and Comparative Law, 2024, Vol. 57, No. 2

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https://hdl.handle.net/20.500.12153/7547

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Now showing 1 - 5 of 12
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    The Evolution of One Health concept – A European perspective
    (Wydawnictwo KUL, 2024) Mełgieś, Katarzyna Małgorzata
    Over the past years, the European Union has been engaged in activities aimed at finding solutions to protect health in accordance with interdisciplinary and transdisciplinary thinking in line with the One Health approach. The experiences related to the Covid-19 pandemic, clearly demonstrated the close connection between humans, animals, and the shared environment and increased interest for this approach to be applied and translated into action. This paper seeks to present the readiness of the European Union and its institutions for the challenges related to the political and legal approach and implementation of One Health concept.
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    Social Enterprises and Health Care Services within the European Legal Framework
    (Wydawnictwo KUL, 2024) Santuari, Alceste
    Social enterprises (SEs) are organizations that pursue a purpose of general interest through the carrying out of economic activities on a steady and permanent basis. Despite the legal, economic and social differences among the Member States (MSs) of the European Union, SEs display at least two similar characteristics. Firstly, SEs are capable of combining entrepreneurial activities together with the pursuit of a social mission. Secondly, SEs largely deliver health care services both independently and in close partnership with public authorities, either through public procurement or by means of direct co-operation agreements. In this perspective, modern welfare systems rely heavily on a significant proportion of health care services and benefits provided by SEs. In addition, in some MSs, such as Italy, SEs are supported by enabling legal frameworks, which also include some important tax benefits. Against this background, the article aims to shed light on the legal aspects and the role of SEs in the delivery of health care services as well as their contribution to ensuring citizens/patients their fundamental right to health.
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    Normative Approach to Workers’ Mental Well-Being in the Digital Era
    (Wydawnictwo KUL, 2024) Stojković Zlatanović, Sanja; Sjeničić, Marta
    The paper aims to provide theoretical insights and explore the comparative legal practice of approaching mental health and well-being at the workplace by applying legal normative and comparative methods in a digitalized world of work. In this regard, subordination vs autonomy needs to be considered as a starting theoretical point accompanied by an overview of comparative legal approaches that have recently introduced some novel legal mechanisms, such as the right to disconnect to deal better with the exercise of fundamental labor rights. Additionally, introducing a psychosocial risk management model in occupational health and safety could significantly improve workers’ mental health and well-being in the digital age. Therefore, the proactive, holistic, and integrated approach to workers’ rights and status in the digital environment must be analyzed by exploring the bounding point between organizational management views on the subject and labor law standpoints.
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    Biomedical Research on Vulnerable Subjects in Bosnia and Herzegovina
    (Wydawnictwo KUL, 2024) Milinkovic, Igor
    Medical research involving human subjects can enhance the well-being of individual patients and provide enormous social benefits. It enables the acquisition of new scientific knowledge and the development of novel therapeutic and diagnostic procedures but also raises significant ethical and legal issues. This kind of medical research is controversial and implies a clash of values that are not always easy to balance. Particularly contentious is research on subjects who are incapable of giving consent or are in a position of subordination and more susceptible to manipulation and mistreatment. Such subjects are considered vulnerable and under special protection. The paper deals with the legal framework of medical research on vulnerable subjects in Bosnia and Herzegovina (its entities: the Republic of Srpska and the Federation of Bosnia and Herzegovina). In the first part of the paper, the notion and basic forms of medical research will be explored, as well as the concept of vulnerability. Reference will be made to relevant international documents defining the standards of medical research on vulnerable subjects. The paper will also provide a comparative overview of provisions governing vulnerable subjects research adopted in different national legislations. In the second part of the paper, the legal framework of medical research on vulnerable subjects in Bosnia and Herzegovina will be analyzed, and suggestions for possible changes will be made.
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    Informed Consent in Clinical Studies in the Republic of Srpska
    (Wydawnictwo KUL, 2024) Pantović, Snežana; Zrnić, Dijana
    As human medicine is developing at a galloping pace, continuously offering new medical products, diagnostic methods and preventive programmes, there is almost no time gap between their creation and application in medical practice. All these biomedical achievements are primarily intended to improve public health and the patient’s quality of life and health. Hence, it is important to define potential risks, side effects, and unwanted outcomes when applying a medical product/treatment before integrating it into healthcare. Unlike any other product/treatment intended for human use, medical products/treatments require prior clinical testing on human subjects (sick or sound). The authors of this paper have restricted their scientific interest to the participant (human subject) of a clinical study as one of the core elements of a clinical investigation, representing at the same time its means and its aim. By analyzing relevant international as well as national legal rules and ethical principles of the Republic of Srpska related to the participation of humans in clinical studies, it will be concluded that the participants’ safety and right to self-determination, integrity, and autonomy manifested through their independent right to either consent or refuse to participate in a clinical study supersedes the interests of science or society. However, clinical trial-related statistical data obtained from randomly chosen healthcare institutions in the Republic of Srpska will show certain derogations from prescribed ethical policies. Considering this fact, the authors have paid special attention to thematising the ethicality of recruiting participants for a clinical study based on partial or no information related to the purpose, methods, potential risks and side effects of the investigation in the name of the greater good for humanity. Such practice has accentuated the discretionary powers of ethical review committees on the one side and the uncertainty of the right to informed consent on the other.