{"title":"Informed Consent in Clinical Studies in the Republic of Srpska","authors":"Snežana Pantović, Dijana Zrnić","doi":"10.31743/recl.17188","DOIUrl":"https://doi.org/10.31743/recl.17188","url":null,"abstract":"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.","PeriodicalId":337306,"journal":{"name":"Review of European and Comparative Law","volume":"144 7‐8","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141007254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"EAW: Next Steps, Will Pandora’s Box Be Opened?","authors":"Vincent Glerum, Hans Kijlstra","doi":"10.31743/recl.16169","DOIUrl":"https://doi.org/10.31743/recl.16169","url":null,"abstract":"The authors advocate operational improvement of the European Arrest Warrant system. When applying the judicial cooperation instruments concerning criminal matters, more attention should be devoted to the requirements of proportionality, effective judicial protection, and coherence. The power to issue an EAW should be more circumscribed whereas executing authorities should be allowed more flexibility in the decision making process as far as the execution of an EAW is concerned. The authors conclude by sketching amendments to the legal and practical framework and the efforts required to implement them as well as by addressing the issue of political feasibility.","PeriodicalId":337306,"journal":{"name":"Review of European and Comparative Law","volume":"39 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135084550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Mediation as Means of Communication for Public Administration in Settling Administrative Disputes","authors":"Katarzyna Kułak-Krzysiak, Paweł Śwital","doi":"10.31743/recl.16226","DOIUrl":"https://doi.org/10.31743/recl.16226","url":null,"abstract":"Nowadays solutions are sought for public administration to involve citisens in decision-making as one of the ways of promoting the development of civil society and thus to foster democratic forms of government. Public administration is looking for efficient methods of resolving administrative disputes. Administrative mediation serving the purpose of ensuring proper communication between the parties to administrative proceedings is one of such methods. Mediation in public administration hinges upon the definition of communication rules. The aim of this paper is to define communication from the perspective of legal science and discuss its application in the administrative mediation proceedings. In this article, we discuss the essence, the subject matter and the object of mediation as well as the legal regulations governing the mediation procedure and consider the possibility of applying mediation to the administrative procedure, as exemplified by the related case law. The study has been conducted by means of the legal research methods, in particular the legal-dogmatic approach and the legal functionalism approach.","PeriodicalId":337306,"journal":{"name":"Review of European and Comparative Law","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135084684","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Obtaining Evidence Protected by Banking Secrecy through European Investigation Order in Preparatory Proceedings. Remarks from the Polish Perspective","authors":"Marek Ryszard Smarzewski","doi":"10.31743/recl.16210","DOIUrl":"https://doi.org/10.31743/recl.16210","url":null,"abstract":"The subject matter of considerations undertaken in the paper is the issue of obtaining evidence entailing banking secrecy under the European Investigation Order at the stage of the preparatory proceedings from the Polish perspective. The examination of the described evidence activity is often necessary to make key findings, for example, in the field of the data on bank accounts or bank transactions. Actions taken in this regard may concern the monitoring of banking operations and may also be used for establishing financial links between entities operating in different European Union Member States. The procedure for applying the European Investigation Order generates many problems in the analysed scope, in particular at the stage of the preparatory proceedings, starting from determining the authority competent to issue the European Investigation Order, to the need to consider legitimacy of obtaining the consent by the prosecutor to exempt from banking secrecy in order to further request for the required information. Against the background of the issues presented in the article, an attempt was made to analyse the normative institution of the European Investigation Order, used for obtaining evidence covered by banking secrecy, and to show the model that determines its optimal functioning in the face of existing problems in the application challenges related to the European cooperation in this area.","PeriodicalId":337306,"journal":{"name":"Review of European and Comparative Law","volume":"59 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135084553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A Bottom-up Look at Mutual Trust and the Legal Practice of the Aranyosi Test","authors":"Christina Peristeridou","doi":"10.31743/recl.16203","DOIUrl":"https://doi.org/10.31743/recl.16203","url":null,"abstract":"This contribution offers an insight into the legal practice of the Aranyosi test during the EAW proceedings in seven Member States, an outcome of the research conducted during the ImprovEAW Project. Only the executing judicial authorities of some Member States do trigger the test. Member States are roughly differentiated between those having facilities with usually bad or usually good detention conditions, promoting antagonistic relationships instead of equal partnership. The lack of streamlining of the communication when supplementary information is requested, the lack of common standards and approach towards guarantees lead to further misunderstandings and frustration. The findings of this research have revealed the importance of departing from a pure legal understanding of mutual trust and follow a more empirical, experiential or bottom-up concept. Mutual trust is not only a legal concept, but it underpins the legal culture of the cooperation and collegial attitudes of authorities towards one another. This expression of mutual trust remains quite undiscovered: how is miscommunication affecting mutual trust? Do judicial authorities of legal systems express collegiality to one another? How do cultural aspects and preconceived ideas regarding the quality of other legal systems influence mutual trust? Accordingly, some suggestions have been made to improve the cooperation and the establishment of rapport when supplementary information is requested. Finally, I advocate for a more neutral view towards the Aranyosi test. As opposed to considering it as a supervisory mechanism, I have explored the idea of approaching it as a risk management tool: it tackles risks created by mutual trust. Such approach helps both sides to take responsibility to avert ad hoc risks, instead of experiencing Aranyosi as a testing moment. Such approach centres the real problem, i.e. the risks created by mutual trust for individuals and it can stimulate more proactive policy-making in this regard.","PeriodicalId":337306,"journal":{"name":"Review of European and Comparative Law","volume":"25 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135084584","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A Double-Edged-Sword Approach to Fighting Pandemics: Patent Waivers and Incentives to Innovate","authors":"Katarzyna Kostka, Mitja Kovač","doi":"10.31743/recl.15503","DOIUrl":"https://doi.org/10.31743/recl.15503","url":null,"abstract":"Although continents recently experienced an apocalyptic pandemic that posed a mortal danger to millions of people, a new, even deadlier pandemic could soon emerge… The paper seeks to address the role played by patent waivers and current contractual arrangements in the pharmaceutical industry in addressing the dangers caused by the current and future pandemics. The process of waiving patents is explored where it is argued that it sadly cannot amount to the knight in shining armour that everyone has been expecting. Due to the lack of coordination, the tremendously long process, and the potential block in innovation arising from pharmaceutical companies having smaller incentives, more attention must be paid to other alternative institutional solutions. Drawing from the economics literature on innovation in the pharmaceutical sector, a conceptual framework is proposed for improved legal intervention in the case of patent waivers in international intellectual property law instruments. In addition, the paper provides a comparative law and economics treatment of current patent waivers in US, EU, and international law instruments.","PeriodicalId":337306,"journal":{"name":"Review of European and Comparative Law","volume":"45 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135084585","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Translating and Interpreting the Letter of Rights","authors":"André Klip","doi":"10.31743/recl.16236","DOIUrl":"https://doi.org/10.31743/recl.16236","url":null,"abstract":"This article focuses on the implementation of Directive 2012/13 on the Right to Information with reference to foreigners arrested in the Member State of the EU. In particular, the Author analyses whether foreigners provided with a Letter of Rights receive the same information despite their handicap of not understanding the language. Special attention is given to how the Netherlands and Poland deal with the Letter of Rights for foreigners. The picture that emerges concerning foreigners is that providing them with a Letter of Rights in their language is seriously handicapped in almost all aspects: the timing (availability), the linguistic quality, the accessibility and simplicity. This situation creates severe risks concerning the right to a fair trial for foreigners. They may not invoke rights because they do not know them. They may not come to their own trial because they did not understand.","PeriodicalId":337306,"journal":{"name":"Review of European and Comparative Law","volume":"49 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135084555","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Erosion of the Principle of Mutual Recognition. European Arrest Warrant and the Principle of Mutual Recognition in the Light of the Recent CJEU Rulings","authors":"Andrzej Sakowicz","doi":"10.31743/recl.16209","DOIUrl":"https://doi.org/10.31743/recl.16209","url":null,"abstract":"An effective implementation of mutual recognition in the Area of Freedom, Security, and Justice requires mutual trust between the Member State. Mutual trust has been eroded in some Member States due to the rule of law crisis. However, it is not only the rule of law crisis, but also the departure of the Member States from the shared values of respect for fundamental rights, as well as the differences in the prosecutorial systems of individual Member States, that have caused changes in the perception of the principle of mutual recognition. This paper will examine the evolving approach to the principle of mutual recognition based on the recent Court of Justice of the European Union rulings on the European arrest warrant. The analysis concludes that the CJEU attaches more importance to the protection of the principle of mutual recognition, the prosecution of perpetrators of crime, and the unwavering presumption of respect for fundamental rights by the Member states than to the effective protection of fundamental rights.","PeriodicalId":337306,"journal":{"name":"Review of European and Comparative Law","volume":"25 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135084583","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Obligation to Report Cases of Child Sexual Abuse – Comparison of Legal Regulations in Poland, Austria, and the Federal Republic of Germany","authors":"Iwona Magdalena Bień-Węgłowska, Ewa Tuora-Schwierskott","doi":"10.31743/recl.16233","DOIUrl":"https://doi.org/10.31743/recl.16233","url":null,"abstract":"Przedmiotem opracowania jest porównanie regulacji prawnych w zakresie obowiązku zgłoszenia przypadków wykorzystania seksualnego dzieci w Polsce, Austrii i Republice Federalnej Niemiec. Autorki skupiły się na analizie sposobu realizacji zgłoszenia przestępstwa pedofilii, konsekwencji prawnych i społecznych niezawiadomienia oraz na różnicach w podejmowanych działaniach ustawodawczych, administracyjnych, społecznych i wychowawczych służących ochronie dobra dziecka.","PeriodicalId":337306,"journal":{"name":"Review of European and Comparative Law","volume":"71 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135084685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Gloss on the Judgement of the Polish Supreme Court of 2 June 2022, I KZP 17/21","authors":"Jakub Kosowski","doi":"10.31743/recl.16549","DOIUrl":"https://doi.org/10.31743/recl.16549","url":null,"abstract":"The article discusses the decision of the Polish Supreme Court of 2 June 2022, I KZP 17/21. The ruling of the Supreme Court was issued based on a legal question submitted by a common court in relation to the European Investigation Order (EIO). The Author refers to the ruling by discussing broadly both the issues of the legal question and the authority issuing the European Investigation Order within the framework of pre-trial proceedings. Of paramount importance are the characteristics of the subjective sphere, i.e. the authority empowered to issue a European Investigation Order from the point of view of legally protected confidential information, in particular bank secrecy constituting the subject matter that served the basis for the ruling of the Supreme Court being commented herein.","PeriodicalId":337306,"journal":{"name":"Review of European and Comparative Law","volume":"32 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135084552","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}