853 resultados para drug law enforcement


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This thesis is a collection of essays about the instrumental use of commitment decisions to facilitate the completion of the European internal electricity market. European policy can shape markets in many ways, two most evident being regulation and competition enforcement. The interplay between these two instruments attracts a lot of scholarly attention. One of the major concerns in the competition vs. regulation debate is the instrumental use of competition rules. It has been observed that competition enforcement is triggered not only as a response to an anticompetitive harm occurring in the market, but that it sometimes becomes a powerful tool in the European Commission’s hands to pursue regulatory goals. This thesis looks for examples of such instrumentalisation in the context of electricity markets and finds that the Commission is very pragmatic in using all the possible instruments it has at hand to push forward its project of creating the internal electricity market. This includes regulation, competition enforcement and all sorts of political pressure. To the extent that commitment decisions accelerate sector-specific regulation and overcome political deadlocks, they contribute to the Commission’s energy policy goals. However, instrumentalisation of competition rules comes at a certain cost to competition policy, energy policy and, most importantly, to electricity markets themselves. Markets might be negatively affected either indirectly, by application of sector-specific regulation or competition policy building on previous commitment decisions, or directly, through the implementation of inadequate commitments in individual cases. Concluding, commitment decisions generally contributed to achieving the policy objectives of the internal electricity market, but their use for that purpose does not come without cost. Given that this cost is ultimately borne by the internal electricity market, the Commission should take a more balanced approach to the instrumental use of commitment decisions so that it does not do more harm than good.

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Le profonde trasformazioni che hanno interessato l’industria alimentare, unitamente alle accresciute capacità delle scienze mediche ed epidemiologiche di individuare nessi causali tra il consumo di determinate sostanze e l’insorgere di patologie, hanno imposto al legislatore di intervenire nella materia della c.d. sicurezza alimentare mettendo in atto sistemi articolati e complessi tesi a tutelare la salute dei consociati. Quest’ultimo obiettivo viene perseguito, da un lato, mediante disposizioni di natura pubblicistica e di carattere preventivo e, dall’altro lato, dallo strumento della responsabilità civile. Le due prospettive di tutela della salute delle persone costituiscono parti distinte ma al tempo stesso fortemente integrate in una logica unitaria. Questa prospettiva emerge chiaramente nel sistema statunitense: in quel ordinamento la disciplina pubblicistica della sicurezza degli alimenti – definita dalla Food and Drug Administration – costituisce un punto di riferimento imprescindibile anche quando si tratta di stabilire se un prodotto alimentare è difettoso e se, di conseguenza, il produttore è chiamato a risarcire i danni che scaturiscono dal suo utilizzo. L’efficace sinergia che si instaura tra la dimensione pubblicistica del c.d. Public Enforcement e quella risarcitoria (Private Enforcement) viene ulteriormente valorizzata dalla presenza di efficaci strumenti di tutela collettiva tra i quali la class action assume una importanza fondamentale. Proprio muovendo dall’analisi del sistema statunitense, l’indagine si appunta in un primo momento sull’individuazione delle lacune e delle criticità che caratterizzano il sistema nazionale e, più in generale quello comunitario. In un secondo momento l’attenzione si focalizza sull’individuazione di soluzioni interpretative e de iure condendo che, anche ispirandosi agli strumenti di tutela propri del diritto statunitense, contribuiscano a rendere maggiormente efficace la sinergia tra regole preventive sulla sicurezza alimentare e regole risarcitorie in materia di responsabilità del produttore.

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The recent financial crisis triggered an increasing demand for financial regulation to counteract the potential negative economic effects of the evermore complex operations and instruments available on financial markets. As a result, insider trading regulation counts amongst the relatively recent but particularly active regulation battles in Europe and overseas. Claims for more transparency and equitable securities markets proliferate, ranging from concerns about investor protection to global market stability. The internationalization of the world’s securities market has challenged traditional notions of regulation and enforcement. Considering that insider trading is currently forbidden all over Europe, this study follows a law and economics approach in identifying how this prohibition should be enforced. More precisely, the study investigates first whether criminal law is necessary under all circumstances to enforce insider trading; second, if it should be introduced at EU level. This study provides evidence of law and economics theoretical logic underlying the legal mechanisms that guide sanctioning and public enforcement of the insider trading prohibition by identifying optimal forms, natures and types of sanctions that effectively induce insider trading deterrence. The analysis further aims to reveal the economic rationality that drives the potential need for harmonization of criminal enforcement of insider trading laws within the European environment by proceeding to a comparative analysis of the current legislations of height selected Member States. This work also assesses the European Union’s most recent initiative through a critical analysis of the proposal for a Directive on criminal sanctions for Market Abuse. Based on the conclusions drawn from its close analysis, the study takes on the challenge of analyzing whether or not the actual European public enforcement of the laws prohibiting insider trading is coherent with the theoretical law and economics recommendations, and how these enforcement practices could be improved.

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This work provides several policy proposals capable to strengthen the private enforcement of EU competition law in arbitration. It focuses on the procedural law aspects that are permeated by legal uncertainty and that have not yet fallen under the scrutiny of the law and economics debate. The policy proposals described herein are based on the functional approach to law and economics and aim to promote a more qualified decision making process by: adjudicators, private parties and lawmakers. The resulting framework of procedural rules would be a cost-effective policy tool that could sustain the European Commission’s effort to guarantee a workable level of competition in the EU internal market. This project aims to answer the following broad research question: which procedural rules can improve the efficiency of antitrust arbitration by decreasing litigation costs for private parties on the one hand, and by increasing private parties’ compliance with competition law on the other hand?Throughout this research project, such broad question has been developed into research sub-questions revolving around several key legal issues. The chosen sub-research questions result from a vacuum in the European enforcement system that leaves several key legal issues in antitrust arbitration unresolved. The legal framework proposed in this research project could prevent such a blurry scenario from impairing the EU private enforcement of competition law in arbitration. Therefore, our attention was triggered by those legal issues whose proposed solutions lead to relevant uncertainties and that are most suitable for a law and economics analysis.

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This dissertation has studied how legal and non-legal mechanisms affect the levels of trust and trustworthiness in an economy, and whether and when subtle psychological factors are crucial for establishing trust and even for recovering trust from a breach of contract. The first Chapter has addressed the question of whether formal legal enforcement crowds out or crowds in the amount of trust in a society. We find that formal legal mechanisms, especially formal contracts backed by a powerful authority, normally undermine trust except when they are perceived as legitimate, or when there are no strong social norms of fairness (i.e. the population in a society is considerably heterogeneous), or when the environment in which repeated commercial relationships take place becomes highly uncertain. The second Chapter has examined whether the endogenous adoption of a collective punishment institution can help a society coordinate on an efficient outcome, characterized by high levels of trust and trustworthiness. The experimental results show that the endogenous introduction of collective punishment by means of a majority-voting rule does not significantly improve coordination on the efficient equilibrium. Not all subjects seem to be able to anticipate the change in behavior induced by the introduction of the mechanism, and a majority of them vote against it. The third Chapter has explored whether high-trustors adapt their behavior in response to others’ trustworthiness or untrustworthiness more quickly, which in turn supports them to maintain higher default expectations of others’ trustworthiness relative to low-trustors. Our experimental results reveal that high-trustors are better than low-trustors at predicting others’ trustworthiness because they are less susceptible to the anticipated aversive emotions aroused by the potential betrayal and thereby have a higher willingness to acquire the valuable information about their partner’s actions.

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The inter-American human rights system has been conceived following the example of the European system under the European Convention on Human Rights (ECHR) before it was modified by Protocol No 11. However, two important differences exist. First, the authority of the European Court of Human Rights (ECtHR) to order reparation has been strictly limited by the principle of subsidiarity. Thus, the ECtHR's main function is to determine whether the ECHR has been violated. Beyond the declaratory effect of its judgments, according to Article 41 ECHR, it may only "afford just satisfaction to the injured party". The powers of the Inter-American Court of Human Rights (IACtHR) were conceived in a much broader fashion in Article 63 of the American Convention on Human Rights (ACHR), giving the Court the authority to order a variety of individual and general measures aimed at obtaining restitutio in integrum. The first main part of this thesis shows how both Courts have developed their reparation practice and examines the advantages and disadvantages of each approach. Secondly, the ECtHR's rather limited reparation powers have, interestingly, been combined with an elaborate implementation system that includes several of the Council of Europe's organs, principally the Committee of Ministers. In the Inter-American System, no dedicated mechanism was implemented to oversee compliance with the IACtHR's judgments. The ACHR limits itself to inviting the Court to point out in its annual reports the cases that have not been complied with and to propose measures to be adopted by the General Assembly of the Organization of American States. The General Assembly, however, hardly ever took action. The IACtHR has therefore filled this gap by developing a proper procedure to oversee compliance with its judgments. Both the European and the American solutions to ensure compliance are presented and compared in the second main part of this thesis. Finally, based on the results of both main parts, a comparative analysis of the reparation practice and the execution results in both human rights systems is being provided, aimed at developing proposals for the improvement of the functioning of either human rights protection system.

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GPL enforcement is successful in Europe. In several court decisions and out of court settlements the license conditions of the GPL have been successfully enforced. In particular, embedded systems are the main focus of such compliance activities. The article describes the practice of enforcement activities and the legal prerequisites under the application of German law.

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Enforcement of copyright online and fighting online “piracy” is a high priority on the EU agenda. Private international law questions have recently become some of the most challenging issues in this area. Internet service providers are still uncertain how the Brussels I Regulation (Recast) provisions would apply in EU-wide copyright infringement cases and in which country they can be sued for copyright violations. Meanwhile, because of the territorial approach that still underlies EU copyright law, right holders are unable to acquire EU-wide relief for copyright infringements online. This article first discusses the recent CJEU rulings in the Pinckney and Hejduk cases and argues that the “access approach” that the Court adopted for solving jurisdiction questions could be quite reasonable if it is applied with additional legal measures at the level of substantive law, such as the targeting doctrine. Secondly, the article explores the alternatives to the currently established lex loci protectionis rule that would enable right holders to get EU-wide remedies under a single applicable law. In particular, the analysis focuses on the special applicable law rule for ubiquitous copyright infringements, as suggested by the CLIP Group, and other international proposals.

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Arzneimittel für seltene Krankheiten (orphan drugs) lassen sich unter normalen Marktbedingungen kaum kostendeckend erforschen, entwickeln und vermarkten, was zu einem Mangel an geeigneten Therapien und zugelassenen Arzneimitteln für seltene Krankheiten führt. Um den fortdauernden Ausschluss von betroffenen Patienten vom medizinischen Fortschritt zu verhindern und die Defizite in der Erforschung und Entwicklung von orphan drugs zu beseitigen, schuf die Europäische Union – nach US-amerikanischem Vorbild – ein Anreizsystem. Der vorliegende Beitrag erläutert die regulatorischen Rahmenbedingungen für orphan drugs in der EU und zeigt auf, dass die Schweiz in der Schaffung günstiger Rahmenbedingungen für Patientinnen und Patienten, die an einer seltenen Krankheit leiden, anderen Ländern um Jahre hinter her hinkt, sich aber allmählich etwas tut.

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This chapter examines the economics of property rights and property law. Property law is a fundamental part of social organization and is also fundamental to the operation of the economy because it defines and protects the bundle of rights that constitute property. Property law thereby creates incentives to protect and invest in assets and establishes a legal framework within which market exchange of assets can take place. The purpose of this chapter is to show how the economics of property rights can be used to understand fundamental features of property law and related extra-legal institutions. The chapter will both examine the rationale for legal doctrine and the effects of legal doctrine regarding the exercise, enforcement, and transfer of rights. It will also examine various property rights regimes including open access, private ownership, common property and state property. The guiding questions are: How are property rights established? What explains the variation in the types of property rights? What governs the use and transfer of rights? And, how are property rights enforced?

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It is widely recognized that trade credit is an important financial mechanism, particularly in developing economies and transition economies where institutions are weak. This paper documents theoretical analysis and empirical accounts on what facilitates an effective supply of trade credit based on original surveys conducted in P.R. of China. Our theory predicts that trade volume and trade credit are increasing function of cash held by the buyer and enforcement technology of the seller. Furthermore, if the state sector’s enforcement technology is high, it has positive external effect to expand the volumes of trade credit and trades in the whole economy. From the data, we found that government made active commitment in enforcement of trade credit contract and the government owned firms are main supplier and receivers of trade credit, which suggest that enforcement by government and state sector were effective against presumptions in the previous literatures.

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This report examines recent updates to the regulation and enforcement of intellectual property (IP) rights in Korea and China, in particular patent rights including invention, utility, and design rights. This paper also discusses some features and issues of the actual IP enforcement situation in those countries in comparison with Japan.

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The idea of a conservation easement – restrictions on the development and use of land designed to protect the land’s conservation or historic values – can be relatively easily understood. More significant and more challenging is the complex body of state and federal laws that shapes the creation, funding, tax treatment, enforcement, modification, and termination of conservation easements. The explosion in the number of conservation easements over the past four decades has made them one of the most popular land protection mechanisms in the United States. The National Conservation Easement Database estimates that the total number of acres encumbered by conservation easements exceeds 40 million.Because conservation easements are both novel and ubiquitous, understanding how they actual work is essential for practicing lawyers, policymakers, land trust professionals, and students of conservation. This article provides a “quick tour” through some of the most important aspects of the developing mosaic of conservation easement law. It gives the reader a sense of the complex inter-jurisdictional dynamics that shape conservation transactions and disputes about conservation easements. Professors of property law, environmental law, tax law, and environmental studies who wish to cover conservation easements in the context of a more general course can use the article to provide their students with a broad but comprehensive overview of the relevant legal and policy issues.

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Introduction. On June 2005, after a five year investigation, the Commission imposed a 60 millions euros fine on AstraZeneca (hereinafter AZ) for having abused its dominant position in several Member States in the market for proton-pump inhibitors (PPI)2. It was alleged that AZ misused the patent system and procedures for marketing pharmaceuticals to block or delay the entry of generic competitors and parallel traders to its ulcer drug Losec3. This decision is a seminal one. The political and legal importance of the CFI judgment that will review the case (and the ECJ appeal that is likely to follow) cannot be understated. On the one hand the incentive to innovate and to undertake R&D is at stake, on the other, the uncertain boundaries between competition and intellectual property law should once again be explored. In contrast to the US, where many cases concerning the abuse of regulatory and governmental procedures have already been dealt with competition authorities and courts, it is the first time in Europe that such conduct is subject to scrutiny through an anti-trust lens. Moreover, following the appeal brought by AZ against the Commission decision, the CFI will be confronted for the first time with an abuse of a dominant position in the pharmaceutical sector, which explains why this judgment is eagerly anticipated4.