An EU comparative analysis of the regulation of clinical trials supervisory bodies in the aftermath of Regulation 536/2014

The new EU regulation on clinical trials is intended to promote a greater level of harmonization of European Union rules in this area. However, it does not elaborate a common normative framework regarding the functioning of research ethics committees, leaving this responsibility to the Member States. This article offers a comparative analysis of the resulting regulatory situation. It demonstrates that this scenario is defined by considerable variability in the regulation of ethics monitoring between the EU Member States. We argue that this disparity should not necessarily be a negative factor for the optimization of the trial supervision regime in the EU. Moreover, we consider that it may be a stimulus for the achievement of excellence in the performance of this monitoring task. On the other hand, we also highlight risks for the rights of participants if an adequate monitoring framework is not ensured. Under these circumstances, we observe how the EU faces a dilemma. On the one hand, it may promote a rigid uniformity between the regulation of ethics committees between Member States, but this might diminish the quality of their performance. On the other hand, it may opt for maintaining the current situation, but this might increase differences in the performance of the ethics committees between Member States, including the number trials performed by country. A third option would be to allow the competitive framework to remain for a set period of time, in order to learn from the best practices reached in individual Member States before finally harmonizing national legislative provisions on this basis.This work was supported by Eusko Jaurlaritza [grant number Ayudas a grupos de investigación IT-1066-16]; H2020 Science with and for Society [grant number GRANT AGREEMENT NUMBER — 788039 — PANELFIT]

The role of medical ethics as a source of law : a comparative analysis

L'objet de la thèse, préparée dans le cadre de la convention de co-tutelle entre l’Université de Trento en Italie et l’Université Paris Ouest Nanterre la Défense en France, consiste dans une analyse comparée du rôle de la déontologie médicale dans les sources du droit en Italie, France et Allemagne. Le spectre d’analyse adopté est double. On cherche d’abord à rendre compte des aspects architecturaux des rapports entre droit et déontologie médicale ; ce faisant, on concentre l’analyse sur les modalités de la codification de l’éthique professionnelle en France, en Allemagne et en Italie, sur le pouvoir normatif des ordres professionnels, et sur la valeur juridique des codes de déontologie médicale et leur intégration dans le système des sources du droit. En second lieu, on cherche, dans une perspective plus substantielle, à comprendre les relations entre droit et déontologie, et notamment le rôle de la déontologie médicale dans le domaine du biodroit. Ce spectre d’analyse est en outre élargi à la procédure disciplinaire et à la perspective européenne. La première partie de la thèse est dédiée à certaines remarques préliminaires et notamment à un effort de définition de la déontologie médicale, à certaines « questions ouvertes » de son rapport avec le droit et à la relation, en perspective comparée, entre langue et droit dans la signification du mot « déontologie ». La seconde partie est dédiée à la codification de l’éthique professionnelle, alors que le rôle de la déontologie médicale dans le biodroit est l’objet de la troisième partie. La quatrième partie concerne la procédure disciplinaire et, finalement, la cinquième partie est dédiée à la reconstruction et l’analyse critique des résultats de la comparaison, à la perspective européenne et à la proposition d’un nouveau modèle italien des rapports entre le droit et la déontologie médicale.The thesis aims at analysing, from a comparative perspective, the role of medical ethics in Italy, France and Germany. The survey focuses on both the formal and substantive aspects of the relationships between law and medical ethics. As to the first issue, the thesis analyses the codification of medical ethics, the normative function of the medical councils, the binding value of the codes of medical ethics and their position in the hierarchy of norms. With regard to the second aspect, the role of medical ethics is studied from a more substantial perspective, analysing the concrete interrelations between law and medical ethics in the field of biolaw. The survey is then extended to the disciplinary procedure and to the European level. In the first part, the relationships between law and medical ethics are analysed from a linguistic perspective, aiming at underlining some specific features of the concepts referred to as “déontologie”, “deontologia” or “Standesrecht” and “Berufsordnung” in France, Italy and Germany. This part also deals with some “open questions” characterising the relationships between medical ethics and the law. The second part concerns the codification of medical ethics, while its role in the field of biolaw is analysed in the third part. The fourth part deals with deontological liability and disciplinary procedures. Lastly, the fifth part aims at elaborating a theoretical reconstruction of the results of the comparative analysis, at highlighting the main roles of medical ethics at the European level and at suggesting a different model for the relationships between law and medical ethics in the Italian system.L’obiettivo della tesi è un’analisi comparata del ruolo della deontologia medica nel sistema delle fonti del diritto in Italia, Francia e Germania. Per tenere conto della complessità del rapporto tra diritto e deontologia, sono stati analizzati sia gli aspetti formali di tale rapporto, sia i profili sostanziali del ruolo della deontologia medica nel biodiritto. Nella prima parte alcune considerazioni preliminari e l’analisi linguistica hanno permesso di definire l’ambito di indagine e i profili di maggiore complessità del rapporto tra dimensione deontologica e dimensione giuridica sui quali nelle parti successive si è concentrata l’indagine. La seconda parte, dedicata alla codificazione dell’etica medica, ha messo in luce la varietà di soluzioni e di modalità di ingresso della norma deontologica nell’ordinamento giuridico. Nella terza parte sono stati analizzati il ruolo della deontologia medica nell’ambito del biodiritto e l’influenza di alcuni fattori particolarmente rilevanti sull’evoluzione dei contenuti concreti dei codici deontologici e sulla loro portata pratica. La quarta parte è dedicata alla violazione della deontologia e ai procedimenti disciplinari. Infine la parte conclusiva contiene una ricostruzione teorica dei risultati emersi dall’analisi comparata, lo studio di alcuni profili legati alla dimensione europea della deontologia e la proposta di alcune ipotesi di riforma per un modello italiano più coerente, flessibile ed efficace dei rapporti tra diritto e deontologia

Il ruolo della deontologia medica nel sistema delle fonti del diritto: un'analisi comparata. Le rôle de la déontologie médicale dans les sources du droit :analyse comparée.

L’obiettivo della presente tesi è un’analisi comparata del ruolo della deontologia medica nel sistema delle fonti del diritto in Italia, Francia e Germania. Nella prima Parte alcune considerazioni preliminari e l’analisi linguistica hanno permesso di definire l’ambito di indagine e i profili di maggiore complessità del rapporto tra dimensione deontologica e dimensione giuridica sui quali nelle Parti successive si è concentrata l’indagine. La seconda Parte, dedicata alla codificazione dell’etica medica, ha messo in luce la varietà di soluzioni e di modalità di ingresso della norma deontologica nell’ordinamento giuridico. Dal punto di vista comparato, possono distinguersi almeno due modelli principali. In alcuni ordinamenti, infatti, il codice deontologico assume la forma di una fonte del diritto e viene collocato così in maniera “non mediata” nel sistema delle fonti dell’ordinamento statale. Nel modello di ingresso “mediato”, invece, la norma deontologica acquisisce rilevanza sul piano giuridico attraverso il rinvio che ad essa fanno altri principi, norme e clausole generali dell’ordinamento. Il codice di deontologia medica italiano rientra in questo secondo modello, poiché, nonostante assuma significativa rilevanza sul piano giuridico, dal punto di vista strettamente formale rimane ancora un regolamento interno alla categoria professionale. Del modello “non mediato” fanno invece parte il codice deontologico francese (e, più in generale, la categoria di déontologies étatiques, a cui esso appartiene) e le Berufsordnungen del Länder tedeschi. Ciò nonostante, le due esperienze presentano diversità sostanziali nella struttura dei rapporti tra diritto e deontologia. Nell’ordinamento francese il codice di deontologia medica diventa infatti una fonte dello Stato poiché viene pubblicato sul Journal Officiel come decreto del Primo Ministro, nello specifico come décret en Conseil d’Etat, ossia un decreto per il quale è obbligatorio il parere del Consiglio di Stato francese ed è stato infine integrato in un codice statale, il Code de la santé publique. In Germania, invece, i codici deontologici vengono emanati dagli ordini professionali con la forma di Satzungen, fonti sublegislative (untergesetzlich) che rimangono però espressione dell’autonomia amministrativa riconosciuta agli ordini professionali in qualità di Körperschaft des öffentlichen Rechts. Rispetto a questi due modelli, in Italia la collocazione del codice deontologico tra le fonti del diritto risulta quindi più complesso e la definizione della sua natura giuridica rimane ancora controversa. Nella terza Parte è stato analizzato il ruolo della deontologia medica nell’ambito del biodiritto, sottolineando innanzitutto l’esistenza di un nucleo di principi comuni ai codici deontologici, i quali si sono progressivamente aperti ad una sostanziale tutela dei diritti fondamentali della persona assistita, in sintonia con i principi elaborati a livello costituzionale, nazionale e internazionale. L’analisi comparata dei rapporti tra deontologia e diritto in alcuni ambiti specifici ha però evidenziato come, al di là di tale nucleo comune, l’evoluzione di contenuti concreti dei codici e l’ampiezza di determinate discipline dipenda da quattro fattori principali: le caratteristiche dell’oggetto da disciplinare; le scelte di intervento dell’ordinamento giuridico nell’ambito del biodiritto; il modello dei rapporti tra diritto e deontologia medica e la capacità della categoria professionale di farsi carico delle nuove esigenze di tutela dei diritti fondamentali. La combinazione tra questi fattori può variare in maniera significativa nei singoli ordinamenti, dando vita ad esiti anche molto diversi sul piano normativo. Lo studio di alcuni specifici ambiti del biodiritto ha messo inoltre in luce le peculiarità del ruolo della deontologia medica, la quale svolge una funzione essenziale nella definizione del caso concreto, ma può anche costituire fonte di disciplina specifica del biodiritto, in ragione di un’inerzia o di una specifica delega del legislatore. La quarta Parte è dedicata alla violazione della deontologia e ai procedimenti disciplinari, che sono stati valutati in relazione alla loro idoneità ad emancipare l’accertamento della responsabilità deontologica dalla dimensione meramente corporativistica. Infine nella Parte conclusiva sono stati analizzati alcuni profili legati alla dimensione europea della deontologia e, alla luce di quanto emerso dall’analisi comparata, sono state proposte alcune ipotesi di riforma per un modello italiano più coerente, flessibile ed efficace dei rapporti tra diritto e deontologia

Towards a European code of medical ethics. Ethical and legal issues

The feasibility of a common European code of medical ethics is discussed, with consideration and evaluation of the difficulties such a project is going to face, from both the legal and ethical points of view. On the one hand, the analysis will underline the limits of a common European code of medical ethics as an instrument for harmonising national professional rules in the European context; on the other hand, we will highlight some of the potentials of this project, which could be increased and strengthened through a proper rulemaking process and through adequate and careful choice of content. We will also stress specific elements and devices that should be taken into consideration during the establishment of the code, from both procedural and content perspectives. Regarding methodological issues, the limits and potentialities of a common European code of medical ethics will be analysed from an ethical point of view and then from a legal perspective. The aim of this paper is to clarify the framework for the potential but controversial role of the code in the European context, showing the difficulties in enforcing and harmonising national ethical rules into a European code of medical ethics

Palliative Care against Medically Assisted Death? Misunderstanding and Instrumental Objections

Context: Palliative Care (PC) and Medically Assisted Death (MAD), specifically assisted suicide and euthanasia, are distinct practices characterized by differing objectives, methods, implementation and outcomes. Representatives of PC, including scientific societies or physicians, may, in certain cases, adopt a critical stance towards MAD. Objectives: The study aims to explore the underlying reasons for such opposition. Methods: To this end, the philosophical underpinnings and legal conditions of PC and MAD will be analyzed. Results: The ethical and philosophical landscape of PC and MAD leads us to identify, on one hand, the Hippocratic paradigm and, on the other hand, what we call Socratic medicine. From a legal analysis perspective, the presence of intolerable suffering serves as a common ground between the two practices, albeit risking being the subject of misunderstandings and instrumental objections. Conclusion: Preventing an instrumental use of PC in relation to MAD is crucial to enable the respect and the coexistence of the two practices

CASE STUDY (II) ON FREEDOM OF EXPRESSION IN THE CONTEXT OF THE MEDIA (Deliverable 7.4)

The objective of WP7 is to study, from the perspective of EU citizenship, specific problems EU citizens face in exercising civil rights and liberties in areas which fall within the scope of EU law, but also in areas beyond the scope of EU law. In the EU legal context, fundamental rights, including civil rights, have gained not only visibility but also, arguably, significance, now that the Lisbon Treaty has made the Charter of Fundamental Rights legally binding. Media freedom and policy in the EU in general has been widely researched and studied, focusing largely on the areas less directly relevant for citizens, i.e. television and radio broadcasting, media regulators, etc. This case study therefore focuses on tackling barriers in an area more relevant for individual citizens’ freedom of expression, referred to as citizens’ journalism. This is a new field of practice and research, where conceptual clarifications are needed and which calls for further research into the application and evolution of legal and procedural frameworks, in line with changing journalism landscape (blogs, online comments, etc). The Council of the European Union adopted Guidelines on freedom of expression online and offline for its external policy, while it does not have such guidelines internally, for its member states. Internally, freedom of expression is not strongly under the radar. There has been a discussion whether the mutual recognition of judgments in civil and commercial matters should not apply to defamation cases, since there is so much divergence. At the end, this has not become the case, therefore the strong substantive divergences remain, and need to be mutually recognized, with all resulting problems with forum shopping, and a potential race to the bottom. This report’s initial understanding of citizen journalist has deliberately been an uncircumscribed one, in order not to impose an arbitrary, potentially too narrow concept on the different legal orders examined in this task. Therefore, the questionnaire was drafted to screen all possible forms of citizen journalism, such as blogs, social media, comments, wiki contributions, and had asked specific questions about their status, responsibility, sanctions on their own, and in comparison to a generally perceived category of journalism if there is one in the given legal system. Citizen journalism is generally seen to provide an important avenue for political participation, the political engagement of citizens between elections, and the reinvigoration of a sense of authenticity or belonging. In an era of mistrust in both domestic and EU political institutions, republicanism is gaining appeal: scholarship has already recognized the need with regard to citizen journalism specifically, Ian Cram wrote a whole book on citizen journalism from the republican perspective. If there is any chance that the internet creates a truly republican "digital commons" so many hope for, it would certainly not be possible without citizen journalists. Equally, any prospect that EU citizens develop or further develop a transnational political discourse or an European public opinion or political public as Habermas would argue, presupposes citizen journalists writing on it. In this sense, citizen journalists writing on EU issues appear to be a necessary (though naturally insufficient) condition for more political, social, or in any sense thicker (post/or beyond-market) version of EU citizenship, both in practice and conceptually. The so conceived ideal of citizen journalism would promote these more ambitious ideals of European citizenship and democracy. This is not to deny that activities looking like citizen journalism might of course harm others or might go beyond the scope of freedom of expression, and violate privacy rights or spread hate messages, and so on. There is some literature observing that citizen journalism might run the risks of bad journalism (hate speech, misinformation, etc.) to a larger extent than professional journalism. The initial understanding of this paper however was not to form any view on that. The risks generally do not seem to outweigh the massive legitimacy and other political-moral gains a more engaged transnational citizenry would bring to the European project. Furthermore, there was no indication that courts would be less willing to grant protection against violations of privacy, equality or dignity if caused by citizen journalists. This deliverable undertakes to check what the legal conditions are under which they operate, and whether there is convergence or divergence between different EU countries’ legal orders in this regard