Scopo di questa ricerca è illustrare la complessità e la frammentazione delle fonti della legislazione sanitaria. Il corpus normativo che regola la tutela della salute si presenta disorganico e stratificato. Il filo rosso seguito per orientarsi nella regolazione del settore è quello delle forti conflittualità tra ragioni giuridiche, sociali, culturali ed economiche nell’ambito delle quali si produce la regolazione in materia. Il diritto sanitario non sarebbe una disciplina autonoma, ma appunto una legislazione speciale che riunisce il diritto prodotto intorno ad un oggetto politico come la tutela della salute. In subordine, visto il modo di produzione dello stesso, è possibile pervenire ad un’altra importante conclusione: che il settore sanitario, molto sensibile ai cambiamenti culturali e sociali, anzi da questi determinato, sarebbe la punta avanzata del fenomeno di frammentazione delle fonti del diritto per cui il modo tradizionale di descrivere e ordinare le stesse non sarebbe più in grado di contenere l’esuberanza dei modi specifici di regolazione del settore. Una ricerca che voglia descrivere questo assetto normativo non potrà che essere trasversale e multidisciplinare, pronta a recepire problematiche e ad usare categorie proprie di scienze non giuridiche. / The aim of this research is to explain the complexity and the fragmentation of the health legislation sources. The perspective corpus that rules healthcare appears unorganized and stratified. The red thread followed to understand the way this sector operates is that of the strong conflict between legal, social, cultural and economic reasons that regulate this field. The healthcare law isn't an autonomous discipline, but a special legislation that unifies the rights around a political issue such as healthcare. Therefore, considering how the law is brought forward, it's possible to reach another important conclusion: the healthcare sector, sensitive to cultural and social changes, indeed has led from these, would be the advanced point of the fragmentation phenomenon of the law sources thus the traditional terms to describe and order them would not be able to contain the exuberance of the specific ways of sector regulation. A research that wants to describe this normative structure can't be but indirect and multidisciplinary, ready to acknowledge difficulties and use categories not proper of juridical sciences.

La tesi analizza il quadro normativo relativo alla partecipazione del pubblico nei procedimenti amministrativi applicativi del principio di precauzione. Il lavoro si sviluppa in tre Capitoli: il primo inquadra il tema della partecipazione in materia ambientale nel quadro più generale dei modelli di partecipazione all’attività amministrativa generale presenti in altri settori, come quello dell’urbanistica e della regolazione condizionale dell’attività economica. In questo si precisa, inoltre, la ratio e il contenuto del principio di precauzione e si illustrano i relativi nessi con quello di partecipazione. Il secondo Capitolo affronta l’analisi della disciplina europea ed internazionale in materia di partecipazione ambientale laddove la qualità delle forme partecipative è molto più sofisticata e incisiva rispetto alla disciplina domestica; in esso è analizzato anche il procedimento di autorizzazione per l’immissione in commercio di cibi contenenti OGM. Il terzo ed ultimo Capitolo analizza le procedure di valutazione di impatto ambientale e il ruolo significativo rivestito, in esse, dai modelli di partecipazione. Nella fase conclusiva si mettono in luce gli aspetti critici, sotto il profilo procedurale, dei modelli di partecipazione analizzati e si offrono alcuni suggerimenti diretti al loro superamento. / The thesis analyzes the legal framework provided for the public participation in administrative proceedings connected to environmental matters, especially when the precautionary principle is applied. The work consists of three chapters: the first situates participation in in the Italian general framework for public participation, especially regarding planning and regulatory proceedings. The meaning of precautionary principle and its connections with the public participation are also analyzed. The second chapter analyses the main features of participation in the international and European legal systems and their influence on the national regulations. This chapter deals in particular with the regulation provided by the EU law for the authorization of GM food. The last chapter discuss the role of public participation in the environmental impact assessments. Finally, the thesis highlights the weak points of environmental participation and propose some measures to improve its legal regulation.

Giving real substance to the value of "legal certainty" is a common goal of contemporary democratic legal systems. This is the genesis of research. The nomophylactic function has the primary objective of guaranteeing a coherent and constant interpretation of the law and a general uniformity of jurisprudence, so as to ensure the unity of the law within the legal system. This objective clashes with the instability of the sources of law, an expression of a wider phenomenon of a general nature - the so-called "crisis of legality" - which has led to a new centrality for the work of the judge of last instance and imposed a strengthening of the implementation methods of the nomophylactic function. The strengthened role assumed by the nomophylachia guarantees the uniformity of the law within the jurisdictional orders but, in the absence of appropriate instruments of institutional connection, it calls into question the overall capacity of the system to guarantee the functional unity of the jurisdiction. Therefore, the research moves from the identification of the institutional mechanisms which aim at coordinating the apical jurisdictions, the existing criticalities and the prospects. First of all, the existing correlations between the structure of the jurisdictional function and the nomophylactic function have been studied in depth, paying attention on the peculiar characteristics of this relationship within the national system. Eventually the exercise of the nomophylactic function was analyzed, looking at the recent legislative reforms, with reference to the three superior jurisdictions. The mechanisms through which the national legal system tends to ensure the connection between the apical judge have also been outlined. Specifically, two different problems emerged, which the system does not provide effective solutions for: conflicts in terms of jurisdictional distribution and the consolidation of interpretative contrasts between the apical judges. Considering these findings, a comparative analysis was carried out in order to verify - with reference to other jurisdictions - the existence or not of similar critical issues and resolution tools, so as to better interpret the systematic nature of national problems. Finally, specific assumptions have been proposed to guarantee the functional unity of the jurisdiction. Those proposals led to the achievement of an effective coordination within jurisdictions; it also means that every legal system, although devoted to a structural pluralism of the jurisdiction, can only know one way to do justice. / Dare contenuto effettivo al valore della «certezza del diritto» è un fine comune agli ordinamenti giuridici contemporanei di impronta democratica. Questa la genesi della ricerca. La funzione nomofilattica, principale strumento con il quale viene perseguito tale proposito, ha l’obiettivo primario di garantire una coerente e costante interpretazione della legge ed una generale uniformità degli indirizzi giurisprudenziali, così da assicurare una complessiva unità del diritto all’interno dell’ordinamento giuridico. Il fine, tuttavia, si scontra con l’instabilità delle fonti di produzione del diritto, espressione di un più ampio fenomeno di carattere generale - la c.d. «crisi della legalità» - che ha comportato una nuova centralità per l’operato del giudice di ultima istanza ed imposto un rafforzamento delle modalità attuative della funzione nomofilattica. Il rafforzato ruolo assunto dalla nomofilachìa garantisce l’uniformità del diritto all’interno di ciascun plesso giurisdizionale, ma, in assenza di opportuni strumenti di raccordo istituzionale, mette in discussione la complessiva capacità dell’ordinamento di garantire l’unità funzionale della giurisdizione. Ricostruito il fomento la ricerca si è snodata, con una pentapartizione, nell’individuazione dei meccanismi istituzionali tesi a garantire il coordinamento fra le giurisdizioni apicali, le criticità esistenti, le prospettive. Innanzitutto sono state approfondite le correlazioni esistenti fra l’assetto della funzione giurisdizionale e l’estrinsecarsi della funzione nomofilattica, concentrando l’attenzione sui caratteri peculiari di tale rapporto all’interno dell’ordinamento nazionale. Poi si è analizzato l’esercizio della funzione nomofilattica, anche alla luce dei recenti interventi di riforma legislativa, in riferimento alle tre giurisdizioni superiori. Sono stati altresì delineati i meccanismi attraverso cui l’Ordinamento tende ad assicurare il raccordo tra i diversi giudici della nomofilachìa. Nello specifico, sono emersi due diversi ordini di problemi, rispetto ai quali l’Ordinamento non appronta soluzioni efficaci: i conflitti in tema di riparto giurisdizionale ed il consolidarsi di contrasti interpretativi tra i giudici apicali. In considerazione di tali rilievi nella quarta parte si è proceduto all’analisi comparata, al fine di verificare - in riferimento ad altri Ordinamenti - l’esistenza o meno di analoghe criticità e strumenti di risoluzione, così da meglio interpretare la sistematica delle problematiche nazionali. Nella parte conclusiva sono stati ripresi gli esiti dell’analisi svolta, meglio definiti i profili critici emersi ed enucleate ipotesi specifiche che possano garantire l’unità funzionale della giurisdizione. Il convincimento trattone è che il raggiungimento di un effettivo coordinamento interno alla funzione giurisdizionale può realizzare l’assunto per cui ogni Ordinamento giuridico, sebbene votato ad un pluralismo strutturale della giurisdizione, non può che conoscere un unico modo di rendere giustizia.

Neste trabalho buscou-se revisitar os pressupostos do conhecimento da ilicitude pela doutrina, inserindo-os no contexto da teoria do delito, especialmente no que tange à problemática da expansão do direito penal, tendo-se em conta a existência de bens jurídicos difusos, a inflação do direito penal, questões relativas às normas penais em branco e a elementos normativos do tipo, além de questões envolvendo o Direito Penal e o Administrativo Sancionador. Pretendeu-se, ainda, relacionar o conhecimento da ilicitude com o erro de proibição, ilustrando como a jurisprudência pátria aborda o tema. / Il presente documento si propone di rivisitare i presupposti di conoscenza dell\'antigiuridicità del fatto dalla dottrina, collocandolo nel contesto della teoria del reato, soprattutto per quanto riguarda il problema della espansione del diritto penale, tenendo conto in particolare l\'esistenza di beni giuridici diffondere l\'inflazione del diritto penale, le questioni di diritto penale in materia di elementi bianchi e normativa del tipo. L\'intenzione era anche di mettere in relazione la conoscenza dell\'antigiuridicità del fatto con l\'errore di divieto, che illustra come i tribunalli brasiliani affronta il caso soggetto.

La ricerca è tesa a verificare se e in quale misura le sanzioni amministrative attualmente vigenti risultino strumenti idonei ad assicurare il rispetto delle norme in materia di lavoro. A tale scopo, esaminate, al capitolo primo, le principali teorie elaborate in materia di effettività (principio idoneo a disvelare i rapporti tra fatto e diritto), la ricerca analizza le cause della depenalizzazione degli illeciti in materia di lavoro ed i principi generali in materia di illecito amministrativo dettati dalla legge numero 689/81 (capitolo II). Al terzo capitolo è una sintetica ricognizione dei principali illeciti amministrativi in materia di lavoro; particolare attenzione è riservata agli illeciti in materia di orario di lavoro e di lavoro sommerso, attesa la centralità dei beni giuridici che vengono in considerazione e dei molteplici, recenti, interventi legislativi succedutisi in materia. Il quarto capitolo è, infine, dedicato all’esame della disciplina (primaria e secondaria) in materia di vigilanza del lavoro atteso il rilievo che la vigilanza (momento che precede, cronologicamente e logicamente, l’applicazione della sanzione) assume nella prospettiva dell’effettività della norma. / The present study is directed to verify if administrative sanctions in force are fit instruments to ensure that labour rules are observed. After examining, in chapter I, the main theories about effectiveness (principle revealing relationships between facts and law), the study analyses the cause of decriminalization of labour crimes and the general principles of administrative crimes as regulated by legge n. 689/81. In chapter III is a short pass of the main administrative labour crimes. Particular attention is given to administrative time work and undeclared work crimes because of the importance of values concerned and the numerous laws recently occurred. In chapter IV labour vigilance is examined considering the importance that controls have to ensure laws’ respect.

This Doctoral Thesis develops the illegal procedure delays in Spain, making a comparison with Italian system, which is more advanced in this matter and recently issued the Law 69 of 2009 on the damage delay. The illegal delays can be defined as a: “Postpone incurred by the Spanish Public Administration exceeding the term provided to decide, causing damages to the associates”. Currently at Spain, despite of the obligation of solving established in Article 42 of Law 30 of 1992, does not exist a truly liability when public authorities non fulfillment the term to provide and the citizens are defenseless against Administration’s inactivity.

Though causing water and soil contamination and serious threats to the natural environment and human well-being, waste crime has not been considered a serious crime in any society. Moreover, while the problem of waste crime has often been portrayed as the result of organized crime’s involvement in the legitimate economy, scant attention has been given to the role of legitimate economic operators in illegal waste diversion activities. Seeking profitability and cost reduction, respected companies rationally opt for managing waste illegally in the course of everyday business activities when faced with crime opportunities. Existing research has suggested that legislative loopholes or complex and ambiguous law rules can provide crime opportunities, which profit-driven market players may choose to exploit at the expense of the environment. These studies so far have been hampered by the lack of an empirical analysis of whether existing laws may facilitate or encourage illegal waste diversion activities. The present dissertation sought to examine the problem, which is mainly legal in nature, from a criminological perspective. It examined waste crime committed by legitimate economic operators, focusing specifically on the crime prosecuted in Italy under the heading of illegal traffic of waste. The purpose of such crime-specific focus was to qualitatively explore how this specific type of waste crime is committed and further identify crime opportunities provided by the legal environment in which waste management activities regularly take place. More specifically, the research attempted to determine whether legislative shortcomings within the legislation that regulates the waste management sector may bestow opportunities to lawbreaking. The analysis of the data sources in the study provided reliable evidence about the involvement of legitimate market players in illegal waste diversion activities. The research not only revealed the process through which illegal waste traffic is perpetrated by legitimate market players, but also uncovered potential crime opportunities provided by the legislation that governs the waste management sector. Furthermore, the findings indicated that shortcomings within administrative controls play a substantial role in facilitating and encouraging illegal waste diversion activities. The results form the basis for inductive inferences about the existence of a relationship between crime opportunities provided by the law and administrative controls, and economic operators’ involvement in waste crime.

"Funzione" è un termine di per sé neutro che si carica di significati diversi a seconda dei sistemi in cui è immerso. Nel diritto è un termine ricco di insidie perchè porta alle matrici stesse dell'ordinamento giuridico. Nel testo si analizza il concetto di funzione da un punto di vista storico-ricostruttivo per giungere alla definizione della funzione in senso obiettivo. Sulla base di tali premesse si spiegano gli istituti del diritto pubblico e le loro trasformazioni con particolare riguardo al mondo dell'amministrazione e alla diversità dei soggetti che oggi lo compongono. / This thesis analyzes the concept of public function with particular regard to administrative world. It starts by an historical point of view and arrives to a definition of function in an objective sense. This concept is used to explain the transformation of contemporary administration.

Life is full of uncertainties. Legal rules should have a clear intention, motivation and purpose in order to diminish daily uncertainties. However, practice shows that their consequences are complex and hard to predict. For instance, tort law has the general objectives of deterring future negligent behavior and compensating the victims of someone else's negligence. Achieving these goals are particularly difficult in medical malpractice cases. To start with, when patients search for medical care they are typically sick in the first place. In case harm materializes during the treatment, it might be very hard to assess if it was due to substandard medical care or to the patient's poor health conditions. Moreover, the practice of medicine has a positive externality on the society, meaning that the design of legal rules is crucial: for instance, it should not result in physicians avoiding practicing their activity just because they are afraid of being sued even when they acted according to the standard level of care. The empirical literature on medical malpractice has been developing substantially in the past two decades, with the American case being the most studied one. Evidence from civil law tradition countries is more difficult to find. The aim of this thesis is to contribute to the empirical literature on medical malpractice, using two civil law countries as a case-study: Spain and Italy. The goal of this thesis is to investigate, in the first place, some of the consequences of having two separate sub-systems (administrative and civil) coexisting within the same legal system, which is common in civil law tradition countries with a public national health system (such as Spain, France and Portugal). When this holds, different procedures might apply depending on the type of hospital where the injury took place (essentially whether it is a public hospital or a private hospital). Therefore, a patient injured in a public hospital should file a claim in administrative courts while a patient suffering an identical medical accident should file a claim in civil courts. A natural question that the reader might pose is why should both administrative and civil courts decide medical malpractice cases? Moreover, can this specialization of courts influence how judges decide medical malpractice cases? In the past few years, there was a general concern with patient safety, which is currently on the agenda of several national governments. Some initiatives have been taken at the international level, with the aim of preventing harm to patients during treatment and care. A negligently injured patient might present a claim against the health care provider with the aim of being compensated for the economic loss and for pain and suffering. In several European countries, health care is mainly provided by a public national health system, which means that if a patient harmed in a public hospital succeeds in a claim against the hospital, public expenditures increase because the State takes part in the litigation process. This poses a problem in a context of increasing national health expenditures and public debt. In Italy, with the aim of increasing patient safety, some regions implemented a monitoring system on medical malpractice claims. However, if properly implemented, this reform shall also allow for a reduction in medical malpractice insurance costs. This thesis is organized as follows. Chapter 1 provides a review of the empirical literature on medical malpractice, where studies on outcomes and merit of claims, costs and defensive medicine are presented. Chapter 2 presents an empirical analysis of medical malpractice claims arriving to the Spanish Supreme Court. The focus is on reversal rates for civil and administrative decisions. Administrative decisions appealed by the plaintiff have the highest reversal rates. The results show a bias in lower administrative courts, which tend to focus on the State side. We provide a detailed explanation for these results, which can rely on the organization of administrative judges career. Chapter 3 assesses predictors of compensation in medical malpractice cases appealed to the Spanish Supreme Court and investigates the amount of damages attributed to patients. The results show horizontal equity between administrative and civil decisions (controlling for observable case characteristics) and vertical inequity (patients suffering more severe injuries tend to receive higher payouts). In order to execute these analyses, a database of medical malpractice decisions appealed to the Administrative and Civil Chambers of the Spanish Supreme Court from 2006 until 2009 (designated by the Spanish Supreme Court Medical Malpractice Dataset (SSCMMD)) has been created. A description of how the SSCMMD was built and of the Spanish legal system is presented as well. Chapter 4 includes an empirical investigation of the effect of a monitoring system for medical malpractice claims on insurance premiums. In Italy, some regions adopted this policy in different years, while others did not. The study uses data on insurance premiums from Italian public hospitals for the years 2001-2008. This is a significant difference as most of the studies use the insurance company as unit of analysis. Although insurance premiums have risen from 2001 to 2008, the increase was lower for regions adopting a monitoring system for medical claims. Possible implications of this system are also provided. Finally, Chapter 5 discusses the main findings, describes possible future research and concludes.

This doctoral thesis focuses on certain private actors that operate transnationally in fields relevant to administrative law, such as food security, environmental protection, pharmaceuticals and medical device regulation. We are only interested in some of the activities carried out by these private actors, concretely those which have an effect that we have termed “regulatory impact”. In this work, we use the term “regulatory” as a meta-juridical concept, in order to understand the capacity that characterizes the activities of our transnational private actors to influence the final recipients in the respective fields. These activities do not result in the coercive imposition of a certain behaviour or an obligation on recipients (whether public or private subjects). Instead, they materialise through a series of varied acts with a flexible nature and a non-binding nature (e.g. technical norms or private standards, guidelines, recommendations or other instruments). However, these activities have considerable multiplier effects on the analysed fields as a consequence of their possible impact (in particular, on the protection of certain fundamental rights recognised at an European level). This makes their study from a legal-administrative perspective all the more relevant. In our view, the branch of administrative law is perhaps the most experienced in this matter. In particular, administrative doctrine has shown the greatest interest in understanding how far certain private actors may intervene in the regulatory chain in a way that is analogous or parallel –and not substitutive– to that of the Public Administration itself in these or other comparable fields. Depending on the case studies, administrative law can be a tool for finding out and understanding how our private legal actors operate transnationally and how they carry out their activities. Likewise, many of the internal rules and codes of conduct that make up the internal policy of our private actors contain procedural criteria or practices. These rules include some of the cultural values of administrative law, particularly participation and transparency. These criteria or practices have a certain similarity to those typically procedural principles of a legal-administrative nature that govern the activity of the Public Administration. The participation and transparency function as “strategies” which, in certain cases, set out to substantiate said activities of some private actors, in order to put in place harmonized and more efficient instruments in the various sectors in which they operate. On the one hand, with the incorporation of the practice of participation, some private actors recognize multiple subjects and stakeholders the opportunity to take part in the regulatory task, in order to give voice to their claims and deliberate collectively. On the other, sometimes the practice of transparency allows the global community to know and understand how these private actors carry out their activities. As a basis, we rely on extant studies in administrative doctrine pertaining to associated matters and fields. We intend to address, in this context and from a subjective viewpoint, the meaning of such practices and criteria and how they operate within the structural framework of transnational private actors. / Nuestra tesis doctoral toma en consideración algunos actores privados que operan a nivel transnacional en sectores de relevancia para el Derecho administrativo, tales como la seguridad alimentaria, la protección ambiental, la regulación farmacéutica y de los dispositivos sanitarios. De esos actores privados nos interesan sólo algunas de las actividades que prestan y que aquí denominamos de “impacto regulador”. Ese “impacto regulador” se presenta en nuestro trabajo como un concepto meta-jurídico que empleamos de manera amplia para comprender la capacidad que caracteriza las actividades que prestan nuestros actores privados transnacionales para influir sobre los destinatarios finales en los respectivos sectores. Conviene indicar que esas actividades no se traducen en la imposición coactiva de un determinado comportamiento o una obligación a sus destinatarios (ya sean sujetos públicos como privados), pues se materializan a través de una serie de actos de diversa índole –tales como normas técnicas o estándares privados, directrices, recomendaciones u otros instrumentos– de naturaleza flexible y de carácter no vinculante. No obstante, y como se verá, son considerables los efectos multiplicadores que tales actividades despliegan sobre los sectores objeto de análisis, como consecuencia del impacto que pudieran generar –en particular sobre la protección de determinados derechos fundamentales reconocidos a nivel europeo– y de ahí su relevancia para ser estudiado desde la perspectiva jurídico-administrativa. Y es que consideramos que la rama del Derecho administrativo es, quizás, la más experimentada en este campo, máxime cuando es la doctrina administrativista la que mayor interés ha demostrado en comprender en qué medida ciertos actores privados pueden llegar a intervenir en la cadena regulatoria de forma análoga o paralela –que no sustitutiva– a como lo ha podido venir haciendo hasta ahora la propia Administración en esos u otros ámbitos análogos. En función de los casos de estudio, el Derecho administrativo podría interesarse por conocer y comprender cómo nuestros actores de naturaleza jurídica privada operan a nivel transnacional y llevan a cabo sus actividades de impacto regulador. Observamos, además, que buena parte de los reglamentos internos y códigos de conducta que conforman la política interna de nuestros actores privados contienen criterios o prácticas de procedimiento que guardan una cierta similitud con aquellas normas típicamente procedimentales de naturaleza jurídico-administrativa que rigen la actividad de la Administración. Estas representan, por analogía y de manera abstracta, algunos de los valores de la cultura del Derecho administrativo como son, en particular, la participación y la transparencia. En algunos casos, tales criterios o prácticas permiten a determinadas realidades privadas –especialmente aquellas donde han adquirido carta de naturaleza– poner en marcha instrumentos armonizados y más eficientes en los diversos sectores en los que estos se proyectan. Por un lado, con la incorporación de la práctica de la participación, algunos actores privados reconocen a múltiples sujetos e intereses especialmente relevantes la oportunidad de intervenir en la tarea regulatoria, a fin de dar voz a sus pretensiones, deliberar y decidir de manera compartida. Por otro lado, la práctica de la transparencia permite a la comunidad global, si cabe, conocer y comprender cómo llevan a cabo sus actividades. En este orden de cosas, y desde el plano subjetivo, con nuestro trabajo pretendemos indagar –apoyándonos en los estudios ya realizados por parte de la doctrina administrativista en materias y sectores concomitantes– sobre el verdadero sentido de tales criterios o prácticas y de qué manera operan dentro de este marco estructural de actores privados transnacionales.