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Kwestia dostępu do terapii eksperymentalnej w orzecznictwie Europejskiego Trybunału Praw Człowieka

Kwestia dostępu do terapii eksperymentalnej w orzecznictwie Europejskiego Trybunału Praw Człowieka

Author(s): Wojciech Ciszewski / Language(s): Polish Issue: 81/2024

The article focuses on the issue of access to experimental therapy under the Convention for the Protection of Human Rights and Fundamental Freedoms, and more specifically in the case law of the European Court of Human Rights. To date, this issue has been the subject of three cases decided by the Court. In none of these cases the Court has recognized a right to experimental therapy. The article has two main research objectives. The first is to reconstruct the arguments for the validity of the right to experimental therapy provided by the applicants in the cases considered by the Court. The second objective is to assess these arguments, as well as their criticism that might be found in Court’s decisions.

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Off-label – praktyczne konsekwencje niejasnego prawa

Off-label – praktyczne konsekwencje niejasnego prawa

Author(s): Maria Gutowska- Ibbs / Language(s): Polish Issue: 81/2024

The article discusses off-label use of medicinal products and problems in separating situations in which this form of treatment constitutes innovative therapy from normal medical practice. It highlights the important risk of qualifying routine therapy as a medical experiment and the relationship between the notion of “current medical knowledge” and the Summary of Product Characteristics. The effectiveness in determining whether the proposed method of treatment is a new or used method is discussed, and the postulate of the medical activity of the scientific society in this regard is given. Finally, the implications of considering off-label treatment as a therapeutic experiment, including the need to obtain the opinion of a bioethics committee and to subscribe for the third party liability insurance, as well as their impact on patient safety, legal security of the doctor and overall accessibility of medical treatment are presented.

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Udzielanie i finansowanie terapii spoza katalogu świadczeń gwarantowanych w niemieckim ubezpieczeniu zdrowotnym

Udzielanie i finansowanie terapii spoza katalogu świadczeń gwarantowanych w niemieckim ubezpieczeniu zdrowotnym

Author(s): Daniel Eryk Lach / Language(s): Polish Issue: 81/2024

The subject of the study is to discuss the admissibility of providing and financing therapies outside the catalog of benefits guaranteed in the German health insurance. The starting point is the analysis of the so-called St. Nicholas' Day resolution of the German Federal Constitutional Court (BVerfG) and the judgments of the Federal Social Court (BSG) specifying the guidelines contained therein. Then, against this background, will be presented the regulation of § 2 sec. 1a of Book Five of the German Social Code (SGB V), stipulating – on an exceptional basis – the right of insured persons to health care services not covered by the system guarantee.

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Art. 25a Ustawy o zawodach lekarza i lekarza dentysty – komentarz etyka

Art. 25a Ustawy o zawodach lekarza i lekarza dentysty – komentarz etyka

Author(s): Olga Dryla / Language(s): Polish Issue: 81/2024

The following text is a voice in the discussion around normative problems of innovative therapies. It refers to problems related to the amendment to the Polish Act on the Professions of Physician and Dentist, particularly to therapeutic experiment category, also discussed in this issue in the article by Maria Gutowska-Ibbs: “Off-label - practical consequences of unclear legislation.”

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Eksperyment leczniczy a cel badawczy

Eksperyment leczniczy a cel badawczy

Author(s): Maria Gutowska- Ibbs / Language(s): Polish Issue: 81/2024

The following text is a voice in the discussion around normative problems of innovative therapies. It particularly refers to the problem of the relationship between therapeutic experiment and the research purpose of a physician's action, also discussed in this issue in the article by Rafał Kubiak "A few comments on the background of the article »Off label - practical consequences of unclear legislation«.”

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The European Union’s Investment Policy – The Effects of the Achmea Case and the 2020 Termination Agreement of Intra-EU BITs1

The European Union’s Investment Policy – The Effects of the Achmea Case and the 2020 Termination Agreement of Intra-EU BITs1

Author(s): Erika Bihari,Veronika SZIKORA / Language(s): English Issue: 1/2023

The increasing involvement of the European Union (EU) in the field of investment protection has been a source of several conflicts in the recent years. Also, this phenomenon has led to significant changes in international and EU investment protection regulations and related dispute settlement or even arbitration procedures. In this article, we briefly present what investment protection usually means and how investment protection law has developed. Later on, we cover the investment protection policy of the EU, including its regulations and reform efforts related to investment protection. Last but not least, we highlight the problems of investment protection litigation in the EU, based on a judgment of the CJEU and a multilateral agreement between Member States (Termination Agreement).

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A Sketch of the Anglo-Saxon Roots of Constitutional Identity

A Sketch of the Anglo-Saxon Roots of Constitutional Identity

Author(s): Luca BOROS / Language(s): English Issue: 1/2023

Constitutional identity has become a focal point of Hungarian political and public discourse in recent years and is increasingly being discussed also in the European dialogue. More and more people are familiar with the meaning and value of the concept in Hungarian public law, but perhaps fewer are aware of the Anglo-Saxon roots of the concept of constitutional identity. My paper aims to summarize the latter (only sketchily, given that the subject matter of the paragraphs of this paper could fill books), providing a starting point for contemporary arguments and reasoning.

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Preliminary Chamber According to the Latest Amendments to the Criminal Procedure Code

Preliminary Chamber According to the Latest Amendments to the Criminal Procedure Code

Author(s): Eugen Gheorghe Crişan / Language(s): English Issue: 1/2023

The author examines the Romanian procedure before the preliminary chamber during the penal (criminal) procedure as regulated by current legal norms. The basis of the examination is formed by the requirements for a fair trial in the course of penal justice, especially from the perspective of the specific objections which may only be raised in the preliminary phase of the procedure. The author concludes that the preliminary chamber procedure may be optimized under several aspects in order to ensure a better, more efficient approach to the criminal trial.

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Protection of Children’s Personal Data and Risks Posed by Smart Toys

Protection of Children’s Personal Data and Risks Posed by Smart Toys

Author(s): Zsolt Hajnal,Fanni TÓTH / Language(s): English Issue: 1/2023

Data protection and consumer protection organizations have identified a number of data protection risks in connection with smart children’s toys that use online services. This study presents the EU legislation that serves to protect the personal data of children using smart toys, with particular regard to the special provisions for children, and it also points out the extent to which these laws oblige the relevant economic actors to establish adequate protection. Examining all of this shows that the current legal framework is only able to manage the risks to a limited extent.

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Constitutional Position of the Head of State in Czechoslovakia, Yugoslavia, and Poland in the Period between 1918 and 1990

Constitutional Position of the Head of State in Czechoslovakia, Yugoslavia, and Poland in the Period between 1918 and 1990

Author(s): Ivan Jokanović,Zsófia Nagy,Ádám Pál,Kaja HOPEJ / Language(s): English Issue: 1/2023

The constitutional development in Czechoslovakia, Yugoslavia, and Poland was turbulent from their birth in 1918 until the fall of the communist regime. It can be said that during this period of time a significant number of acts of constitutional nature have been adopted in the mentioned countries and that Yugoslavia certainly had the most dynamic constitutional development adopting one constitutional act in each decade. All these acts of constitutional character inevitably regulated the position of the head of state introducing certain particular legal solutions such as the election of the head of state with the participation of the Council of Electors and the outgoing President in Poland or the existence of the collective and individual head of state at the same time with certain overlapping prerogatives in Yugoslavia. The aim of this article is to examine the position of the head of state, taking into consideration every act of constitutional nature adopted in the above mentioned countries and particularly dealing with issues such as the election, term of office, termination of office, prerogatives, and accountability of the head of state with the intent to determine the specificities, similarities, and, above all, differences in this regard.

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Posiedzenia zdalne w sprawach cywilnych jako odpowiedź na sytuację kryzysową wywołaną przez COVID-19

Posiedzenia zdalne w sprawach cywilnych jako odpowiedź na sytuację kryzysową wywołaną przez COVID-19

Author(s): Ewa Posłowska / Language(s): Polish Issue: 2/2024

Sytuacja kryzysowa wywołana pandemią spowodowaną przez koronawirusa SARS-CoV-2 wpłynęła na sposób procedowania w sprawach cywilnych w zakresie organizacji rozpraw i posiedzeń jawnych. Niewątpliwie możliwość przeprowadzania posiedzeń zdalnych, wprowadzona ustawą o szczególnych rozwiązaniach związanych z zapobieganiem, przeciwdziałaniem i zwalczaniem COVID-19, innych chorób zakaźnych oraz wywołanych nimi sytuacji kryzysowych, stanowiła swoiste novum względem dotychczas obowiązujących przepisów Kodeksu postępowania cywilnego. Głównym zamierzeniem badawczym artykułu była ocena wpływu regulacji wywołanej sytuacją kryzysową na aktualne brzmienie przepisów procedury cywilnej. Po nowelizacji Kodeksu postępowania cywilnego z dnia 7 lipca 2023 r. doszło do swoistej implementacji przepisów ustawy covidowej w omawianym zakresie do Kodeksu postępowania cywilnego. W artykule skoncentrowano się na ocenie wpływu procedowania w sprawach cywilnych z zastosowaniem rozpraw zdalnych na realizację zasad rzetelnego procesu, w szczególności zasady jawności postępowania. Wskazane zostały także zagrożenia związane z wykorzystaniem rozpraw zdalnych, jakie pojawiły się w praktyce, i sposoby ich uniknięcia.

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10.17951/g.2024.71.2.91-108

10.17951/g.2024.71.2.91-108

Author(s): Kamil Sikora / Language(s): Polish Issue: 2/2024

Ustrój gospodarczy Rzeczypospolitej Polskiej opiera się na społecznej gospodarce rynkowej, której jednym z filarów jest wolność działalności gospodarczej. Każdemu zatem dozwolone jest podjęcie, prowadzenie i zakończenie działalności gospodarczej. Szczególną kategorią pośród pracowników są pracownicy samorządowi, od których oczekuje się profesjonalizmu, rzetelności, sumiennego i starannego wykonywania pracy. To także obowiązek bezstronnego działania oraz dbania o interes publiczny w pierwszej kolejności. Pracownicy samorządowi obowiązani są do powstrzymania się od działań, które mogą ich narazić na zarzut działania interesownego i stronniczego oraz muszą zgłaszać swoją dodatkową działalność przełożonym. Wykonywanie poza zatrudnieniem w urzędach i jednostkach samorządowych dodatkowego zatrudnienia czy też prowadzenie działalności gospodarczej może narazić pracownika samorządowego na zarzuty, że w swojej działalności nie kieruje się interesem publicznym i słusznym interesem obywateli. Z tego względu doznają oni szeregu ograniczeń w zakresie prowadzenia różnego rodzaju działalności, także zarobkowej, w tym działalności gospodarczej, poza pracą w urzędach lub innych jednostkach samorządowych.

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Ochrona informacyjna konsumenta w umowach ubezpieczenia

Ochrona informacyjna konsumenta w umowach ubezpieczenia

Author(s): Alicja Szybalska / Language(s): Polish Issue: 2/2024

W artykule omówiono problematykę związaną z ochroną informacyjną konsumenta w umowach ubezpieczenia. Wyjaśniono, na czym polega prawo konsumenta do informacji oraz przedstawiono, z czego wynika charakter prawny obowiązku informacyjnego ubezpieczyciela. W wyniku przeanalizowania obowiązków informacyjnych stanowiących podstawowy instrument ochrony konsumenta wysunięto odpowiednie wnioski dotyczące realizacji tych obowiązków. Zdaniem autorki system ochrony informacyjnej konsumenta jest realizowany połowicznie, ponieważ praktyka pokazała uchybienia w jego realizacji. Należy się jednak zgodzić, że idea ochrony przez informację jest założeniem właściwym. Niewątpliwie słuszny jest kierunek zwiększający poziom ochrony informacyjnej konsumenta poprzez doprecyzowanie przepisów i takie działania edukacyjno-informacyjne jak rekomendacje wydawane przez wyznaczone do tego organy.

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Procedimento come principio inespresso. Proceeding as an Unexpressed Principle

Procedimento come principio inespresso. Proceeding as an Unexpressed Principle

Author(s): Przemysław Michowicz / Language(s): Italian Issue: 2/2024

This paper discusses the possibility pertaining to the field of a new principle of law theorised, according to the communion ecclesiology issued by the Second Vatican Council. By considering the accurate proceeding disposition, the author accepts that a new principle constitutes necessary rules for the correct functioning of the canon law system and, as such, are inducted from the legal reasoning of those entitled to take legal decisions in the process of applying the law, especially the judiciary. Furthermore, it could constitute an integrative tool of the entire legal system. Such a new principle is understood to be of great value, because of the significant role assigned to principles in the theory of law in general. In every case, a new principle evokes by, and alludes to, values that govern the entire canon law science.

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The Institution of the Prime Minister in the Republic of Serbia: Its Systemic Evolution and Constitutional Practice

The Institution of the Prime Minister in the Republic of Serbia: Its Systemic Evolution and Constitutional Practice

Author(s): Jacek Wojnicki / Language(s): English Issue: 3/2024

The article examines the evolution of the political position of the head of government institution in the Serbian state. The analysis covers the different models of government that have developed in Serbia over the last 180 years. During the monarchical period, the prime minister’s position was a function of his relationship with the king and the political alignment in parliament. In turn, during the period of popular democracy and socialism, the prime minister’s position depended on the political alignment at the top of the communist elite. It is also an interesting exercise to analyse the evolution of the post-1990 position of the head of government, especially in the context of the new constitutional order and the rather turbulent changes on Serbia’s political scene.

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Protection of Workers’ Rights in Bankruptcy Proceeding in Serbian and Western Balkans Legislation

Protection of Workers’ Rights in Bankruptcy Proceeding in Serbian and Western Balkans Legislation

Author(s): Marija Mijatović,Zoran Vavan,Tamara Gajinov / Language(s): English Issue: 3/2024

The protection of workers’ rights in bankruptcy proceedings is a matter of supreme importance in every country. Comparing national laws, one could conclude that the predominant solution is to grant workers the position of privileged creditors. In Serbia, workers are protected by means of two laws: the Labour Law, which is the lex generalis for this area, and the Bankruptcy Law, which has the role of lex specialis. In addition to protection during bankruptcy proceedings before commercial courts, workers can appeal to the state’s national guarantee institution, namely, the Solidarity Fund. Serbia is, therefore, among the countries which employ a mixed – protectionist system. By analysing the legal solutions related to these issues, the authors want to determine the correlation between national legal solutions and those at the European Union level, and to consider the problems in bringing these claims in legal practice. They have also reviewed the current legislation in some Western Balkans countries including Croatia as a member of the EU, and Bosnia and Herzegovina, which has candidate status akin to Serbia. The authors conclude that Serbian law has a modern, hybrid approach in securing the rights of workers in bankruptcy proceedings, but that there is room for improving regulations in this area. This could be achieved by, inter alia, increasing the volume of claims guaranteed to workers, restricting the reasons for initiating bankruptcy proceedings, making preliminary payments to workers in the initial stages of the proceedings, and keeping court records on the percentage of workers’ claims being realised in bankruptcy proceedings.

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Dopuszczalność wykorzystania informacji z internetowej encyklopedii Wikipedia w rozstrzygnięciu oraz uzasadnieniu prawnym wyroku sądu administracyjnego.

Dopuszczalność wykorzystania informacji z internetowej encyklopedii Wikipedia w rozstrzygnięciu oraz uzasadnieniu prawnym wyroku sądu administracyjnego.

Author(s): Jan Chmielewski / Language(s): Polish Issue: 3/2024

W wyroku z 14 grudnia 2022 r., II SA/Gl 1201/22, Wojewódzki Sąd Administracyjny w Gliwicach stwierdził, że ogólne zasady wykładni prawa, w przypadku braku definicji legalnej, nakazują sięgnięcie do językowego znaczenia określonego pojęcia, w tym także do definicji zawartej w Wikipedii. Zdaniem Sądu należy mieć jednak świadomość, że Wikipedia nie jest słownikiem ani encyklopedią tworzoną przez specjalistów, wedle określonych reguł, może zatem zawierać nieścisłości lub przekłamania. Centralnym problemem prawnym glosowanego wyroku jest zakres wykorzystania Wikipedii w operatywnej wykładni prawa. Sformułowana teza orzecznicza dotyka interesującego zagadnienia ogólnej użyteczności Wikipedii jako źródła wiedzy, przede wszystkim oceny dopuszczalności jej stosowania w konstruowaniu wypowiedzi wartościujących oraz argumentacyjnych. Wedle glosatora prezentowany pogląd zasługuje na pełną aprobatę, gdyż dostrzegając zalety Wikipedii,skład orzekający postuluje ostrożne podejście do zawartych w niej informacji. W niniejszym opracowaniu starano się wzmocnić to stanowisko, argumentując, że korzystanie z internetowej encyklopedii niesie za sobą potencjalnie duże ryzyko i dlatego też powoływanie się na nią w treści rozstrzygnięcia sądowego nie może odbywać się w sposób bezrefleksyjny.

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Analysis of the New Road Safety and Transportation Measures Enforced in India

Analysis of the New Road Safety and Transportation Measures Enforced in India

Author(s): SONY KULSHRESTHA / Language(s): English Issue: 3/2024

Over the past few decades, there has been an increased number of deaths in road accidents. The joint efforts to lower the rate of accidents and deaths are visible in the latest analysis reports of Motor Vehicles Act amended in 2019 over the thirty years of applicability of the Motor Vehicles Act of 1988. In the current research projects, the researcher examined the implications of the new road safety measu-rements included in the provisions of the 2019 Amendment Act and investigated the effectiveness of new safety parameters by comparing the percentage of accidents before and after the enforcement of the Act. The researcher has analysed a codified and narrative text to examine the provisions of this Amendment Act of 2019 through the reports of National Crime Records Bureau, Ministry of Home Affairs, and Mini-stry of Road Transport and Highways (MORTH). The analysis of the data gathered shows that the provisions of the Act are meant to give effective tools to improve road safety measures.

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Nowela z 13 lipca 2023 r. ustawy Prawo farmaceutyczne

Nowela z 13 lipca 2023 r. ustawy Prawo farmaceutyczne

Author(s): Maciej Rogalski / Language(s): Polish Issue: 3/2024

Artykuł dotyczy najnowszej noweli ustawy Prawo farmaceutyczne z dnia 13 lipca 2023 r., która związana jest z ograniczeniami o charakterze antykoncentracyjnym w zakresie wydawania zezwoleń na prowadzenie apteki ogólnodostępnej. W dniu 4 października 2023 r. Prezydent RP, na podstawie art. 191 ust. 1 pkt 1 Konstytucji RP, złożył wniosek o zbadanie zgodności z Konstytucją tej noweli. We wniosku Prezydent stwierdził, że nowela wprowadza nowy zakaz koncentracji na rynku aptek (art. 99 ust. 3aa prawa farmaceutycznego), który został wprowadzony z naruszeniem zasady ochrony praw nabytych i bez odpowiedniej długości vacatio legis. W związku z wnioskiem Prezydenta przedmiotem artykułu jest analiza postanowień noweli w zakresie zmian polegających na dodaniu w art. 99 ust. 3aa i 3ab oraz w art. 103 ust. 2a–2d prawa farmaceutycznego, w celu ustalenia ich prawnego charakteru, przestrzegania zasady ochrony praw nabytych, a także ustalenia, czy przyjęty okres vacatio legis jest odpowiedni.

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The 13 July 2023 Amendment to the Pharmaceutical Law Act

The 13 July 2023 Amendment to the Pharmaceutical Law Act

Author(s): Maciej Rogalski / Language(s): English Issue: 3/2024

The article deals with the latest amendment to the Pharmaceutical Law Act, dated 13 July 2023, which is related to anticoncentration restrictions on the issuance of licenses to run generally accessible pharmacies. On 4 October 2023, the President of the Republic of Poland, pursuant to Article 191 section 1 item 1 of the Constitution of the Republic of Poland, filed a motion to examine the constitutionality of this amendment. In the motion, the President argued that the amendment intro-duces a new ban on pharmacy market concentration (Article 99 section 3aa of the Pharmaceutical Law), which was introduced in violation of the principle of protec-tion of acquired rights and without adequate vacatio legis. In light of the President’s motion, the subject of this article is an analysis of the provisions of the amendment with regard to the changes involving the addition of sections 3aa and 3ab under Article 99 and sections 2a-2d under Article 103 of the Pharmaceutical Law in order to determine their legal nature, comply with the principle of protection of acquired rights, and to decide whether the adopted vacatio legis period is appropriate.

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