Review of European and Comparative Law

The Evolution of One Health concept – A European perspective

Katarzyna Małgorzata Mełgieś — 2024-06-28

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.

Social Enterprises and Health Care Services within the European Legal Framework

Alceste Santuari — 2024-06-28

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.

Normative Approach to Workers’ Mental Well-Being in the Digital Era

Sanja Stojković Zlatanović — 2024-06-28

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.

Biomedical Research on Vulnerable Subjects in Bosnia and Herzegovina

Igor Milinkovic — 2024-06-28

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.

Informed Consent in Clinical Studies in the Republic of Srpska

Snežana Pantović — 2024-06-28

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.

Informed Consent for the Use of AI in the Process of Providing Medical Services

Katarzyna Wałdoch — 2024-06-28

It has been for several years now that physicians use medical devices based on artificial intelligence (AI) in their professional practice. The use of these tools makes health services more personalized, tailored to the individual characteristics and needs of the patient. There is also a technological possibility for AI systems to provide patients with information regarding their health condition and treatment methods. The use of medical devices equipped with AI creates new types of risk, including the risk of algorithmic error, the risk of cyber-attack, and the risk of algorithmic mismatch (false-positive or false-negative results). Most patients do not know these tools, so not everyone will trust them. Obtaining informed consent from the patient is a necessary condition for any medical intervention. This study attempts to answer the following questions: (1) Is there a legal possibility to provide AI with the ability to inform the patient about their health condition and proposed treatment methods?; (2) Does the unpredictability and opacity of AI behavior affect the scope of information that should be provided to the patient before medical intervention?; (3) What information should the physician provide to the patient for this consent to be considered informed?; (4) Should the patient always be informed that AI was involved in the diagnosis or therapeutic process? The presented study uses comparative law methodology. American, Belgian and German law are analysed.

Is there a legal possibility to provide AI with the ability to inform the patient about his health condition and proposed treatment methods?
Does the unpredictability and opacity of AI behavior, affect the scope of information that should be provided to the patient before medical intervention?
What information should the physician provide to the patient for this consent to be considered
informed?
Should the patient always be informed that an AI was involved in the diagnosis or therapeutic process?

The comparative law methodology was used in this study. American, Belgian and German law were analyzed.

Fault–Based Liability for Medical Malpractice in the Age of Artificial Intelligence: Α Comparative Analysis of German and Greek Medical Liability Law in View of the Challenges Posed by AI Systems

Vasileios P. Maroudas — 2024-06-28

The rapid developments in the field of AI pose intractable problems for the law of civil liability. The main question that arises in this context is whether a fault-based liability regime can provide sufficient protection to victims of harm caused by the use of ΑΙ. This article addresses this question specifically in relation to medical malpractice liability. Its main purpose is to outline the problems that autonomous systems pose for medical liability law, but more importantly, to determine whether and to what extent a fault-based system of medical liability can adequately address them. In order to approach this issue, a comparative examination of German and Greek law will be undertaken. These two systems, while similar in substantive terms, differ significantly at the level of the burden of proof. In this sense, their comparison serves as a good example to “test” the adequacy of the fault principle in relation to AI systems in the field of medicine, but also to illustrate the practical importance that rules on the allocation of the burden of proof can have in cases of damage caused by the use of AI. As will eventually become apparent, the main problem appears to lie not in the fault principle itself, which, for the time being, at least in the form of objectified negligence, seems to protect the patient adequately, but mainly in the general rule for the allocation of the burden of proof, which is precisely why the fault principle ends up working to the detriment of the patient.

The American and Polish Legal Perspectives on Cases of Neurological Perinatal Damage – Selected Issues

Urszula Dorota Drozdowska — 2024-06-28

The purpose of the article is to present and analyze the method of compensation for a special type of medical damage – neurological perinatal damage – which arises in connection with childbirth and is neuropathological in nature. This damage is irreversible and the cost of medical care, which sometimes continues throughout the child’s entire life, is very high. Claims involving this type of damage generate the highest compensation amounts, which means, from the liability insurance point of view, that it is a “hard-to-insure” injury. This is true for both the Polish and US liability systems, even though they are legal orders apart. What we are dealing here is, on the one hand, the need to support the family of the injured child, so that, thanks to the money obtained, they can begin their treatment and rehabilitation as soon as possible, and on the other hand, the need to take into account the interests of gynecologists and obstetricians, so that their occupations do not become deficit occupations. The idea is to increase the sense of legal security for these socially important medical professions. Given the above, attempts to seek an alternative to the judicial model of liability as a means of compensating this type of medical damage should come as no surprise. An example of an alternative liability model is the legislation enacted in two US states: Virginia and Florida (so-called “slice” no-fault liability models). These models, in effect for more than 35 years, are described in the first part of the article. In the second part, the author compares them with the main principles of the Polish judicial model of liability and the extrajudicial model, which, due to recent amendments to the law have undergone a major transformation. Then (due to the comprehensiveness of the subject matter), using the example of selected representative court cases, the author analyses the types of compensation claims and the amounts of benefits awarded in cases of perinatal neurological damage. The discussion ends with conclusions comparing the US and Polish models.

Portuguese Health System – Challenges in Times of Genomics

André Gonçalo Dias Pereira — 2024-06-28

This article presents the Portuguese health care system that combines the National Health Service, health subsystems and private health insurance. Genomic medicine is expanding the scope of its activity, and its main challenges in pre-natal medicine and post-natal healthcare will be presented here and it will be discussed whether a private health insurance system can provide genomic medicine. As the Four “Ps” concept of Medicine is increasingly relevant, it is important to check if the private system can accommodate this evolution.

Legal Regulation of Surrogacy in Poland and Ukraine – a Comparative Analysis

Emilia Sarnacka — 2024-06-28

The paper focuses on surrogacy regulation, which is diverse across European countries. Four categories of rules can be identified, namely: absence of regulation, regulations allowing surrogacy , regulations that do not allow it with ongoing discussion about allowing it, and regulations under which surrogacy is strictly forbidden. Poland and Ukraine are neighboring countries with radically different regulations on surrogacy. There is no direct regulation on surrogacy in Poland and it can be stated that surrogacy agreements are not valid. IVF procedure is strictly forbidden for surrogacy. Ukraine is an example of the most liberal country when it comes to surrogacy regulation. Surrogacy agreements are regulated and requirements are formulated for surrogate mothers. Ukrainian regulation allows remuneration for surrogate mothers. After the Russian invasion, Ukrainian surrogate mothers came to Poland looking for safety. The Polish state provided extensive support for the Ukrainian people, including specific legal regulation on the right to access health care and employment opportunities. Yet, the Ukrainian surrogacy agreements are not valid in Poland, and the surrogate mothers will be approved as legal mothers.

EU Medical Device Regulation – The Level of Convergence and Impact on Regulatory Complexity

Nika Gavrilović Jankovič — 2024-06-28

Medical Device Regulation (MDR) entered into force in 2017 and became applicable in 2021. In the context of Europeanization and the European Union (EU) multilevel governance system, regulations are used as a means of unification. EU has gradually increased the degree of convergence in medical devices, even though medical devices pertain to the health sector, which is within the Member States’ competence. Despite MDR being a regulation, its preamble states that its aim is to harmonize rules for the placing on the market and use of medical devices on the EU market. This article analyzes the level of convergence introduced by the MDR and its impact on regulatory complexity. Our findings demonstrate that many relevant elements, such as mandatory CE marking, reached the level of unification, whereas some that are still to become legally effective, such as the European database on medical devices (EUDAMED), went further and reached the highest level – supranational and integral joint administrative capacities. Unlike the expected inverse correlation between EU convergence and regulatory complexity, our findings revealed that due to delays in bringing into effect certain unifying elements, de facto, MDR introduced additional constraints compared to the previous Medical Device Directive (MDD) framework. This leads to the main finding of this research, which is that the MDR convergence increase has led to a conflicting outcome – an increase in regulatory complexity.

Rethinking Conscientious Objection to Mandatory Vaccination

Ivana Tucak — 2024-06-28

Among the member states of the Council of Europe, there is a consensus on the importance of vaccination as a successful and effective preventive health intervention. Every state aims to achieve herd immunity, i.e., a high vaccination rate of the population that will prevent the circulation of contagious diseases in the population and thus protect those who cannot be vaccinated due to age or poor health. However, despite the general recognition of the importance of vaccination, there is no consensus on a “single model” of how best to achieve the goals of mass immunization. Countries have different public health policies, so while the vaccination policy of some members of the Council of Europe is limited to a recommendation, others have made vaccination compulsory. Today, there are many opponents of vaccination and those who are hesitant. This paper will focus on those who refuse to be vaccinated based on a moral understanding of how to act in certain circumstances. The paper will explore whether countries imposing mandatory vaccination, with financial or other sanctions imposed in the case of non-compliance, should recognize the right to conscientious objection. This includes the right of adults to refuse vaccination, and respecting the religious and philosophical beliefs of parents who refuse to vaccinate their children. The article consists of two main parts. The first part will explore the legal-theoretical and legal-philosophical dimensions of the relationship between justice and conscience, with special emphasis on the interpretation of this relationship provided by the American political philosopher John Rawls. The second part of the paper will examine the issue of compulsory vaccination and conscientious objection through the prism of the rights provided for in the Convention for the Protection of Human Rights and Fundamental Freedoms.