Białostockie Studia Prawnicze są kwartalnikiem wydawanym przez Wydział Prawa Uniwersytetu w Białymstoku ukazującym się od 2006 r. Poszczególne zeszyty mają charakter tematyczny i obejmują publikacje z różnych dziedzin prawa skupione wokół zagadnienia głównego. Poruszane są w nich aktualne problemy z zakresu prawa. Autorami publikacji są zarówno teoretycy jak też praktycy z kraju i z zagranicy. Wszystkie teksty publikowane w BSP są recenzowane. W czasopiśmie publikowane są artykuły naukowe, recenzje monografii naukowych i glosy. Artykuły są publikowane w języku polskim i angielskim. BSP ukazuje się w wolnym dostępie (open access). Oznacza to, że cała zawartość czasopisma jest dostępna nieodpłatnie dla użytkowników, w tym instytucji. Białostockie Studia Prawnicze zostały ujęte w Wykazie czasopism naukowych i recenzowanych materiałów z konferencji międzynarodowych opublikowanym przez Ministerstwo Edukacji i Nauki. Czasopismo otrzymało w wykazie 140 pkt.
Wydział Prawa Uniwersytetu w Białymstoku
Umowy o dostarczanie treści cyfrowej lub usługi cyfrowej – uwagi dotyczące charakteru prawnego
Chapter 5b of the Consumer Rights Act covers the regulation of contracts for the supply of digital content or a digital service, which is the result of the implementation into the Polish legal order of Directive (EU) 2019/770 of the European Parliament and of the Council of 20 May 2019 on Certain Aspects of Contracts for the Supply of Digital Content and Digital Services. This regulation brings up a number of legal issues, some of which are considered in this study. First and foremost is the question of whether a separate type of contract (in addition to, for example, a sale, exchange or donation contract) has been identifi ed in this way. In view of the conclusion that we are only dealing with a certain class of contracts in this case, the question of what criteria determine inclusion in this category will be analysed, as well as the question of how to distinguish a contract for the supply of digital content from a contract for the supply of digital services. The study also includes a consideration of what type of named or unnamed contracts fall into this category.
Prawa autorskie (c) 2025 Białostockie Studia Prawnicze
Can a National Financial Supervisor Support the Development of the Fintech Sector? Innovation Hubs as a Tool for Supporting Innovation: The Examples of Poland, Estonia, and Italy
This article aims to examine one of the primary tools utilized by national financial supervisors to support innovative projects in the fintech sector. The analysis focuses primarily on the Innovation Hub established by the Polish Financial Supervision Authority (KNF), with additional insights provided from similar initiatives in two other European countries, Estonia (Finantsinspektsioon) and Italy (Bank of Italy). The article is further enriched by examples from other European Economic Area supervisors. The study seeks to address the question of whether national fi nancial supervisors can eff ectively support innovative projects through instruments such as innovation hubs.
Administracja publiczna rynku finansowego wobec innowacji. Centrum innowacji (innovation hub), piaskownica regulacyjna (regulatory sanbox) i inne specjalne instytucje regulacyjne innowacji
The digitalization of products and services on the financial market creates new challenges for public authorities administering this area. Th e Polish Financial Supervision Authority (PFSA) has been legally obliged to take care of the security of the market and at the same time support the innovation of it. Currently, innovation is strongly related to digitalization. Th is means that the PFSA has had to fi nd legal and organizational solutions to fulfi l these obligations. Th is article presents an argument indicating the contradiction between security and innovation. It then discusses solutions that allow the maximization of both security and innovation in the fi nancial market. Th ese solutions were developed in the administrations of highly developed fi nancial markets and have already been transferred or can be transferred to the practice of the PFSA. On the basis of the British solutions, the article gives the examples of and discusses the most important solutions, collectively referred to as special regulatory institutions for innovation, i.e. innovation hubs, regulatory and digital sandboxes and innovation pathways.
Koncepcja i podstawy prawne dla nowego ujęcia rejestru – „Rejestr 3.0”
This article introduces the authors’ original concept of ‘Register 3.0’, a modernized model of public registers designed to meet the demands of the evolving European digital economy and the increasing algorithmization of law. In the context of signifi cant regulatory developments in the European Union, particularly the adoption of the eIDAS2 Regulation, the authors emphasize the urgent need to reformulate the architecture and function of public registers. Register 3.0 is envisioned as an interoperable, automated, and highly secure data system, built upon cutting-edge technologies. A central component of this concept is datafi cation, understood as the real-time and automatic acquisition of data from reference sources without the need for manual processing. Th e article presents a comparative analysis of three generations of registers: traditional data repositories (Register 1.0), interoperable systems with partial automation (Register 2.0), and advanced registers integrated with algorithmic legal frameworks (Register 3.0), capable of issuing legal decisions and initiating cascading legal consequences autonomously. Th e authors discuss the possibility of embedding legal rules within algorithmic architecture – a process referred to as ‘crypto-law’ – where traditional legal norms are encoded directly into secure digital environments, thus enabling fully automated legal and administrative processes. Furthermore, the article explores practical applications of this concept, such as the Unified Business Registry system in Dubai, as proof of the feasibility and eff ectiveness of Register 3.0 in real-world scenarios. By examining the legal, technological, and institutional prerequisites for implementation, the authors argue that Register 3.0 not only supports the automation of state functions and judicial systems but also serves as a foundation for next-generation legaltech solutions. Th e study opens the door to further interdisciplinary research on adapting European legal frameworks to accommodate these innovations, positioning Register 3.0 as a cornerstone of future digital governance.
Generative AI in International Trade Law: Navigating Opportunities and Challenges
The subject of this article is an analysis of the impact of generative AI (GenAI) on international trade law, from the perspective of both the threats and the opportunities of integrating GenAI into international trade. It addresses topics including intellectual property law, international trade law principles, information security, trade negotiations, contracts, competition, liability and AI ethics. The authors employ a holistic approach, examining numerous applications of GenAI in international trade. They conclude with how the international legal framework for GenAI may help people navigate challenges and seize opportunities to benefi t international trade.
AI in the Banking Sector: Lessons from the Schufa Case
The advent of Artificial Intelligence (AI) has opened many opportunities and, equally, has brought many challenges. Th is is also true for the banking sector, as the Schufa case attests. Th e purpose of this paper is to examine the CJEU’s decision in the Schufa case regarding AI use within the banking sector and its legal implications. Th is case questions recent practices concerning credit scoring and demands more robust protection of individual rights and a more accountable use of AI in the fi nancial sector. Th e ongoing dependence of banks on automated decision-making to assess the creditworthiness of their clients raises important questions about transparency and fairness regarding the outcomes of such assessments. Th e paper offers an analysis of the GDPR, namely Article 22(1), and the criteria for automated decision-making clarified in the Schufa case, particularly in situations that fall outside the scope of the GDPR.
Digital Currency in the Context of the Czech Financial System: Legal and Regulatory Challenges for a Two-Tier Banking System
Central bank digital currencies are a topic that is currently receiving increasing attention. It is a type of money that brings signifi cant innovations to the fi nancial system. Because of the development of cryptoassets and their alternatives, states are also considering the possible introduction of digital currencies into their legal systems. However, the very defi nition of digital currency by central banks and the variety of diff erent types of currency are challenges to its introduction. In addition, many jurisdictions do not currently allow for the introduction of these digital currencies and require some revision. Th is article aims to assess the Czech legal framework around the possibility of introducing central bank digital currencies in the Czech Republic. Th e authors also address the legislative challenges associated with implementing central bank digital currencies in general and specifi cally concerning the Czech Republic. The stated objective is achieved through scholarly methods of primary and secondary data analysis, followed by a comparison of starting points in diff erent countries.
Nadzór AML nad kryptoaktywami od 30.12.2024 r. – zmiany w Dyrektywie 2015/849 wprowadzone rozporządzeniem 2023/1113
Th e aim of this article is to take a closer look at the most important changes to EU AML supervision of cryptoassets introduced to EU Directive 2015/849 by EU Regulation 2023/1113. Th e analysis leads to the thesis that as of 30 December 2024, this supervisory landscape has been signifi cantly remodelled. Th ere have been changes to the subject of supervision, the scope of supervised activity, entity modifi cations and licensing requirements. Th ese changes are aimed at tightening AML supervision over cryptoassets. The considerations made also allow us to state that the EU legislation perceives the MiCA regulation as a legal act of a systemic nature for a new class of assets, i.e. cryptoasset
Stosowanie Rozporządzenia DLT Pilot Regime w polskim i francuskim porządku prawnym – analiza prawnoporównawcza
Th is article addresses the issue of applying the DLT Pilot Regime Regulation in the realities of national legal orders. Th e Polish and French legislation is analysed, using the dogmatic and comparative legal methods. Th e main objective of the article is to attempt to answer two questions: fi rstly, whether the scope of application of the DLT Pilot Regime Regulation allows the use of the potential of blockchain technology on the EU fi nancial instruments markets, and secondly, to what extent it is possible to apply the solutions provided for in the DLT Pilot Regime Regulation in the realities of national legal orders. Th e following theses are put forward in the study: fi rstly, the scope of application of the Regulation has been excessively limited and does not allow the use of the full potential of distributed ledger technology on fi nancial markets. Secondly, in the case of the Polish legal system, even the amendments to the legal provisions introduced in connection with the entry into force of the Regulation do not allow the full application of the solutions provided for therein. Solutions that guarantee the possibility of a wider use of tools available on the basis of the DLT Pilot Regime Regulation are provided for in the French legal system. The study shows that these are solutions that could be considered by the Polish legislature.
Model i środki bezpośredniej ochrony praw podmiotowych nabywców i posiadaczy kryptoaktywów w prawie polskim
Th e legal basis for investigations into the model and means of direct protection of the subjective rights of buyers and holders of cryptoassets in Polish law is the provisions of the MiCA Regulation and the provisions of the Polish Act on Cryptoassets, assuming that the draft law will be adopted in the form known on 31 December 2024. Summarizing the normative solutions already in force and planned in Polish law which are devoted to the means of direct protection for the subjective rights of purchasers and holders of cryptographic assets is a source of limited optimism. In the current legal situation, the model of protecting the subjective rights of buyers and holders of cryptographic assets is not eff ective, and the means of direct protection of these subjective rights are not suffi cient or fully eff ective.
Prawo do jednostki kryptowaluty – uwagi de lege lata, prawnoporównawcze i de lege ferenda
Despite the fact that cryptocurrency trading has been taking place in Poland for a dozen or so years, the issue of the existence and nature of the right to cryptocurrency units has not been resolved in civil law doctrine and case law. Th e legislature has also not taken any action in this regard, including in the draft act on the cryptoasset market currently in process. Meanwhile, this issue is of signifi cant theoretical and practical importance. Th is article therefore examines the currently presented views together with their indicated consequences, and then supplements the ongoing discussion with comparative legal remarks usually omitted in Polish literature. In this respect, solutions proposed or in force in European Union, German, British and Chinese law are taken into account. Th is provides an opportunity to comment on existing concepts, in particular the rejection of the proposal to adopt in Polish law de lege lata the right to a unit of cryptocurrency, eff ective erga omnes (although with the submission of a de lege ferenda application), and the view that there is no substantive right in this respect. In conclusion, it is considered that currently in Poland, the right to a unit of cryptocurrency is of a relative nature.
Cyfrowe pole bitwy: strona internetowa spółki jako miejsce publikacji ogłoszeń a spory domenowe i korporacyjne
In Article 5 § 5 of the Commercial Companies Code, the legislature imposes on joint-stock companies and limited joint-stock partnerships the obligation to maintain their own websites and to publish on them announcements required by law and the statutes of the companies. However, a number of detailed issues related to the determination of the address of such a website and its functioning have not been regulated, including such a fundamental issue as the method to determine what is or is not a company’s website within the meaning of the above-mentioned provision. In practice, shareholders generally assume that the website will be the one located at the address appearing in the National Court Register. Although such a conclusion seems logical, it does not clearly result from the applicable legal regulations. However, this circumstance takes on particular signifi cance in cases where a corporate dispute overlaps with a dispute over the company’s internet domain. Such cases provoke questions such as what requirements (e.g. in terms of hosting, domain registration, actual control, etc.) must be met for a website to be considered the company’s ‘own’ within the meaning of Article 5 § 5 ; whether a company can maintain (and alternatively use) more than one website for the publication of advertisements; from when a change of a company’s website address is eff ective; and what the corporate consequences are of a company losing control over the content of its website. Th e subject of this article is analysis of the above issues and an attempt to provide answers to the questions presented. The entire discussion is crowned with conclusions de lege ferenda.
Problem adekwatności rozwiązań prawnych przyjętych przez polskiego ustawodawcę dla zgromadzeń online wspólników spółek kapitałowych – ze szczególnym uwzględnieniem regulacji dotyczących prostej spółki akcyjnej
The aim of this article is to discuss the use of digital technologies to conduct online shareholder meetings in limited liability companies, joint-stock companies, and simple joint-stock companies under Polish law. Th e authors rely on a dogmatic analysis of amendments in this area introduced in the Polish Commercial Companies Code before and aft er the COVID-19 pandemic, supported by a comparative method with German and Austrian law. It is argued that the regulation of simple joint-stock companies is not compatible with the regulation of limited liability companies and joint-stock companies, and therefore three de lege ferenda postulates have been formulated: (1) online shareholder meetings in a simple joint-stock company should be foreseen by default as ex lege, not as up-to-date ex contractu, which will constitute a unifi cation with the ex lege model already existing in limited liability companies and jointstock companies, (2) the prerequisite of secrecy in voting should also be maintained in a simple joint-stock company, (3) more generally, due to the rapid changes in technology and the development of artifi cial intelligence systems, the regulation of online shareholder meetings in all types of companies should be regularly revised at certain time intervals, and these revisions should be programmed by law.
Charakter prawny umowy o prowadzenie rejestru akcjonariuszy oraz obowiązek zapewnienia bezpieczeństwa i integralności danych zawartych w rejestrze
Th e content of the obligation to ensure the security of data contained in the register of shareholders, emphasized by the legislature, the implementation of which rests with the entity maintaining the register, has not been developed in the provisions of the Commercial Companies Code. In the context of the potential liability of this entity for improper performance of the agreement to maintain the shareholder register, it is therefore necessary to determine the features that are important for this issue and the legal nature of such an agreement, as well as which sources of normative law specify orders or prohibitions of specifi c conduct, so as to ensure the security of digital data contained in the shareholder register.
The Admissibility of Blockchain-Based Solutions for Share Trading and Maintaining Shareholders’ Register in the Context of the Dematerialisation of Shares
The mandatory dematerialisation of shares, which involves converting physical share certificates to electronic records, has unifi ed the trading framework for registered and bearer shares. This paper examines the impact of mandatory dematerialisation on the regulations governing the trading and registration of shares in non-listed joint-stock companies, where shares are registered in the shareholders’ register. Th e analysis is conducted in the context of modern technologies, such as smart contracts, distributed ledger technology and tokenisation, and their role in these processes. Th e authors refer to the possibility of concluding a share transfer agreement using smart contract technology and argue that, although maintaining a shareholders’ register in the form of a distributed and decentralised database is permitted, the provisions currently in force do not allow or fully enable the exploitation of the benefi ts available through blockchain technology, particularly the tokenisation of shares.
The Definitive Primacy of Patient Autonomy over the Right to Life? Commentary on the Judgment of the European Court of Human Rights of 4 September 2022 on the Case of Mortier v. Belgium (appl. no. 78017/17)
This Commentary is an in-depth critical study of the European Court of Human Rights ruling in Mortier v. Belgium. The authors present the facts and the tribunal’s decision against the background of the ECtHR’s previous case law on terminally ill patients. Unlike Polish law, euthanasia and assisted suicide are permissible under Belgian law; thus, for the first time in its existence, the tribunal addressed not so much the permissibility of euthanasia as it examined the circumstances of its use. In this regard, it was critical for the authors to look at the ECtHR reasoning on the interplay between Articles 2 and 8 of the European Convention on Human Rights in order to answer the question of whether there has been an evolution or a revolution in the interpretation of the two laws. In the case of the rights of terminally ill patients, the issue is the right to make end-of-life decisions in accordance with the patient’s wishes, and whether the paradigm of patient autonomy has become the highest value in the doctor–patient relationship; this hich could also be indicated by recent changes to the International Code of Medical Ethics and the international text of the Hippocratic Oath (the Declaration of Geneva). In this context, it also becomes valuable to analyse the changes made to the Polish Code of Medical Ethics, which came into effect on 1 January 2025.
Prawne aspekty żywności funkcjonalnej w kontekście rozwoju rynku spożywczego w Polsce
Scientific research on functional foods has been conducted in Poland only by scientists specializing in food and nutrition, economics, biology and medicine. Therefore there is a real market demand for research on the legal aspects of functional foods. The aim of this article is to critically analyse current legal regulations that may apply to functional foods; the author assumes that they do not support the development of the market in functional foods, including consumer awareness of the health properties of food products. For this purpose, the paper presents the history of functional foods, its non-legal definitions and types. It is also necessary to define a catalogue of legal acts and soft law documents that may apply to functional foods, and to locate this type of food in the terminology of legal language. The author concludes that the lack of a concept of functional foods in legislation and overly complicated and strict regulations in the field of nutritional and health claims are not conducive to the development of the market in functional foods.
The Participation of Private Clinics in the Italian National Health System
In the Italian healthcare system, private facilities can supplement public ones in delivering services within the framework of the Italian National Health System, provided they meet specific conditions and obtain the necessary authorisations. This set of requirements is known as the ‘four As’ system, comprising authorisation for the construction of the facility, authorisation to provide healthcare services, accreditation, and contractual agreements. A crucial element in this regulatory framework is the system of tariffs for the remuneration of healthcare services, which are periodically established by the Ministry of Health through a complex procedure. This model of ‘administered competition’ aims to protect both citizens’ health and fair competition among healthcare providers. Proper integration of private facilities into the National Health System is intended to enhance the efficiency of service delivery. The purpose of this paper is to examine the current regulatory framework governing the participation of private clinics in the Italian National Health System and to identify any critical issues.
On the Need to Change the Model of Supervision over Substances of Human Origin from the Perspective of Regulation (EU) 2024/1938: Polish and Serbian Examples
Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on Standards of Quality and Safety for Substances of Human Origin Intended for Human Application and Repealing Directives 2002/98/EC and 2004/23/EC provides a new legal framework, after almost 20 years, in which issues concerning the quality and safety of substances of human origin (SoHOs) as well as the safety of SoHO donors will be settled. One of these is the way the institutions supervising the implementation of the provisions of the Regulation are shaped. New requirements addressed to the SoHO competent authority must be met by August 2027. Hence the particular challenge facing EU Member States is adapting their own organizational solutions regarding the transplant system in a way that meets the requirements of the Regulation. Using the examples of legal and organizational solutions adopted in Poland and Serbia, the authors try to assess their performance from the perspective of the expectations of the EU legislation.
Podejmowanie czynności leczniczych wobec osób cierpiących na zaburzenia odżywiania (anorexia nervosa)
The aim of this study is to answer the question of whether the law allows for the coerced hospitalization and treatment of adult and non-incapacitated patients suffering from eating disorders. The analysis concerns anorexia nervosa as one of the most serious and dangerous of these disorders due to its high mortality. The considerations include two groups of provisions: Articles 30 and 33 of the Act on the Professions of Doctor and Dentist (Sejm of the Republic of Poland, 1996) and Articles 23–24 of the Act on Mental Health Protection (Sejm of the Republic of Poland, 1994). The author concludes that under the later Act, anorexic patients cannot be admitted to hospital against their will because they are not mentally ill; according to the view of most doctors, anorexia is not an illness but a disorder. The study ends with conclusions and de lege ferenda remarks (proposals for changes to the Act on Mental Health Protection).
Aspekty prawne oceny jakości życia pacjentów w schyłkowym okresie choroby – analiza porównawcza Polski i Ukrainy
Palliative care is intended to provide patients with the highest possible level of quality of life in the final phase of a disease. The aim of this work is to present the issue of quality assessment in palliative medicine, necessary due to the specificity of services and their short duration due to the exceptional fragility of patients. Polish regulations are compared with the actual conditions in Ukraine, and the current problem of palliative care in terms of the quality of services provided in Ukraine is outlined. The article presents the concept of the patient’s quality of life in the light of the law introduced in Poland in 2023. As a result of the narrative review, the issues of quality of life in palliative care and methods for its measurement and assessment are discussed and compared. The analysis shows that although quality-of-life studies in palliative care are the basis for a subjective, not an objective, assessment of the patient’s condition, they allow for obtaining information on both the symptoms of the disease and the assessment of treatment, and additionally, and extremely importantly, for the assessment of the psychological, social and spiritual dimensions of patients receiving palliative care.
Informing the Patient about Palliative Care: Legal Considerations
The obligation of a doctor to provide information about a patient’s health is a frequently discussed topic in Polish literature on medical law. To date, publications have focused on the topics of providing information about the diagnosis or about possible treatment options and discussing test results, and rarely discuss the termination of causal treatment, giving information instead on specialized symptomatic management and palliative care for patients with a chronic disease or a disease with an unfavourable prognosis. Providing honest and reliable information in this area increases patients’ awareness of their current health status, and thus allows them to make appropriate decisions related to the abandonment of futile therapy, and also reduces the distress associated with a fear of a lack of specialized medical care and physical, social and spiritual suffering. This article presents legal considerations for informing patients about specialist palliative care.
Zaniechanie uporczywej terapii w świetle regulacji prawnokarnych i ich ratio legis a zasadność penalizacji eutanazji
This article examines the issue of specifying the sematic ranges of the concepts of discontinuing futile therapy and euthanasia and determining their relationship, which translates into resolving the question of the legal (and moral) assessment of the behaviour in question and whether it is or can be identical in both cases. It is frequently said that futile therapy is prolonged dying and euthanasia is the shortening of life. The possibility of discontinuing a futile therapy, or even an order to do so, means that assessment of the legal nature of ceasing futile therapy takes on particular importance – an indication of the normative basis for a physician’s impunity, the prerequisites of that impunity and its ratio legis, and a comparison of the findings with the prerequisites and ratio legis of the crime of euthanasia. It seems that the arguments for the possibility of discontinuing futile therapy are arguments for the admissibility of (active and passive) euthanasia. This means that the postulate of the statutory regulation of the prerequisites for discontinuing futile therapy must be linked to the postulate of making these provisions consistent with criminal law regulations, inter alia, in the area of euthanasia.
Amputacja ze względu na dysforię związaną z integralnością ciała a prawo karne
One of the issues related to the legality of medical procedures is the response to the question of the legality of deep interventions in the human body resulting from a patient’s medical conditions. This includes the issue of amputating a healthy limb, which can lead to an improvement in the mental quality of life for a patient suffering from body integrity dysphoria. From a medical standpoint, non-invasive treatment methods do not lead to significant improvements in the patient’s mental condition; in contrast, amputation serves as an effective therapeutic method. However, from the perspective of criminal law, such an amputation constitutes a severe impairment of human health. Nevertheless, since it has a medical justification, it is legally permissible under criminal law. A physician’s actions for therapeutic purposes, conducted in accordance with the principles of medical practice, do not violate the rules governing the treatment of legal goods in the form of health. However, it is not possible to justify amputation solely based on the patient’s consent to such a procedure (consent of the possessor of the legal good); an individual does not have the right to freely dispose of all their legal goods, and they cannot give legally valid consent to a severe impairment of their health.
Odpowiedzialność karna za prowadzenie badania klinicznego bez świadomej zgody uczestnika lub jego przedstawiciela ustawowego
On 14 April 2023, the Act of 9 March 2023 on clinical trials of medicinal products for human use entered into force, with certain exceptions. The criminal provisions of this Act include Article 77 point 1, which provides the offence of conducting a clinical trial without the informed consent of the participant in such a trial or his/her legal representative, which is carried out contrary to the provisions of Article 28 paragraph 1 letters b and c, paragraphs 2 and 3, Articles 29–32 or Article 35 of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC. This criminal regulation is analysed in this paper. Among other things, attention was drawn to the blanket nature of the analyzed criminal provision, and findings were made regarding its subject, the subject of protection, and the manner of capturing the causative act of the offense regulated in this provision. The concept of informed consent to a clinical trial was also analyzed, establishing that not every failure to comply with the information obligations under Article 29 paragraphs 2–6 of Regulation (EU) No 536/2014 should be treated as an offence.
Granice ochrony karnej prawa do samostanowienia uczestnika badania klinicznego produktu leczniczego
This article addresses the issue of criminal law protection of the right to self-determination in clinical trials of medicinal products. It focuses on establishing the scope of the criminalisation of behaviours violating the right in question under Article 77 points 1–3 of the Act of 9 March 2023 on Clinical Trials of Medicinal Products for Human Use. The method of referring to the EU law applied in statutory features of these offences is, however, affected by obvious legislative deficiencies, seriously hampering the process of interpretation and casting doubt on the rationality of the decision about criminalisation. What can be concluded with certainty is that criminalisation covers the conduct of a clinical trial both when the subject did not express any statement approving their participation in it, and when such a statement lacked the essential features of informed consent. Furthermore, criminal law protection of the right to self-determination does not include minors or incapacitated persons, even to the extent that clinical trial provisions require it to be respected.
Eksperyment medyczny w świetle art. 39 Konstytucji RP
This article focuses on the subject matter of Article 39 of the Constitution of the Republic of Poland. This provision states that no one shall be subjected to scientific experimentation, including medical experimentation, without his or her voluntary consent. There are conflicting views expressed in the literature regarding the meaning of a medical experiment. It is necessary to decide whether the Constitution applies to both therapeutic and research experiments or research experiments only. The meaning of the term ‘medical experiment’ is examined against a wide background, and methods of linguistic, teleological and systemic interpretation are used. To the extent necessary, relevant international law is cited. As a result of the analysis, the conclusion is drawn that Article 39 of the Constitution does not apply to therapeutic experiments. The provision is interpreted inconsistently and creates problems in application. The conclusion is that it is necessary to consider amending the Constitution where medical experiments are concerned.
Udzielanie świadczeń zdrowotnych bez uprawnień – kto (nie)może diagnozować i leczyć pacjentów w Polsce
This article discusses the issue of providing health services without entitlement. Prohibited acts related to this are typified in the Law on the Profession of a Medical Doctor and Dentist. The seemingly clear typification of a misdemeanour and an offence, contained respectively in Article 58(1) and (2) of this law, proves in judicial practice to be quite problematic. Accordingly, the article attempts to examine the acts in question in terms of their sufficient clarity and the possibility of correctly interpreting the elements that constitute them. The results of this attempt indicate that in the Polish legal system, the possibility of determining precisely which health services are reserved exclusively for performance by doctors is particularly complicated. In addition, most allied health professions and related activities are not legally regulated. Such a situation requires legislative action so that Article 58(1) and (2) of the abovementioned law can be applied in practice and meet the requirements of the principle of nullum crimen sine lege certa.
Mediacja w sprawach cywilnych z udziałem pacjentów
The development of legal awareness among patients results in an increase in the number of cases heard by courts. However, mediation in civil cases involving patients is becoming an increasingly popular alternative to traditional court proceedings. This article discusses the specificity of mediation in civil disputes related to healthcare, considering the relationship between the patient, medical staff and healthcare institutions. The authors analyse the benefits and potential risks associated with mediation and also point out the challenges associated with it. Legal regulations and the practical aspects of implementing mediation in so-called medical disputes in Poland, as well as the issue of the costs of these proceedings, are discussed. The authors point out that mediation can be an effective tool in resolving medical disputes, minimizing the duration and costs of disputes, as well as improving relations between the parties.
O potrzebie nowelizacji definicji świadczenia zdrowotnego
Aesthetic medicine and aesthetic medicine services are not legally defined concepts. Social changes related to increasing attention to one’s appearance result in a wider use of not only cosmetic services, but also medical services of a non-therapeutic nature from the area of aesthetic medicine. Despite the lack of comprehensive legal regulations, the scope of such services is increasing, and the number of their beneficiaries is growing year by year. The legal system should guarantee the clarity of appropriate regulations for unaware decision-makers who want to improve their appearance. There is an absolute necessity to amend art. 2 sec. 1 point 10 of the Act on Medical Treatment in order to properly arrange the provision of services in the field of aesthetic medicine and to protect its beneficiaries.