The importance of national laws in the implementation of European legislation of biomedical research

The industrialization and internationalization of biomedical research is not without consequences on the regulation of research or, at least, on the interpretation of that regulation. As more research is done at the international level, the pharmaceutical industry and the research community are calling for a harmonized regulation to limit the administrative burden of controlling clinical trials and to fasten the R&D process. The purpose of this paper is to analyse briefly the role of the national laws in that process. Part I will outline the structure and the nature of the international regulation of research in a European perspective. Using the examples of research ethics committees (RECs), informed consent and the question of liability and liability insurance, Part II will analyze the importance of the national laws in the implementation of this international regulation.     

The power of legislative hot air: Informal rules and the enlargement debate in the European parliament

Integration theorists disagree over the extent to which the European Parliament can substantially influence policy‐making processes in the absence of formal agenda‐setting power. This article discusses the impact the European Parliament had on the current enlargement negotiations. Although the legislature does not yet possess the means to alter the stance of the European Council, it has tried to reverse the status quo through the use of its informal bargaining power. We argue based on a principal‐agent framework of analysis that the effectiveness of this strategy is largely a consequence of the ability to speak with one voice. The article evaluates various mechanisms to help the European Parliament build a unified position. It refutes socialisation and specialisation theories, showing that party group pressure towards a unified position overrode national concerns and constituted a necessary precondition in the development of an integrationist attitude. A statistical analysis of the pre‐bargaining positions inside the Foreign Affairs and Security Committee largely confirms the insights from qualitative interviews with participants and observers.     

The role of private and public regulation in the case study of crypto-assets: The Italian move towards participatory regulation

With the Digital Financial package (MiCA, DLT Pilot, and DORA, later on complemented by the DAC8 proposal) the European Union seeks to establish an appropriate legal framework for crypto-assets showing a financial nature. The package represents a first attempt to regulate a complex and emerging phenomenon, characterised by significant trade-offs. Unsurprisingly, in this early stage of the law-making process several relevant aspects of the crypto environment remain unaddressed, such as pure DeFI models, DAOs, and NFTs. Such regulatory gap is to a large extent attributable to the difficulty of addressing technologically complex issues through command-and-control top-down legislation. The improvements delivered by the Better Regulation Agenda are not enough to solve this conundrum. In this context, the Communication by the Bank of Italy on Decentralised Technology in Finance and Crypto-assets and its first move, the smart-contract MoU, provide an interesting case study to discuss the potential of ‘participatory regulation.’ This experimental form of regulation tries to get the most out of co-regulation, self-regulation, and command-and-control, combining their characters with the view of reconciling the technology neutrality principle with technology-based regulation. Participatory regulation aims to bridge the public and private sector in order to strike a right balance between flexibility and legal certainty, without stifling innovation.     

The role of competition in health care: a Western European perspective

The Federal Trade Commission and Department of Justice 2004 report Improving Health Care: A Dose of Competition expresses a clear allegiance to competition as the organizing principle for health care. In Europe, by contrast, the key organizing principle of health care systems is solidarity. Solidarity means that all have access to health care based on medical needs, regardless of ability to pay. This is not to say that competition is not important in Europe, but competition must take place within the context of solidarity. This article critiques the report from a European perspective, describes the role of competition in Europe (focusing in particular on European Union law), and suggests that the United States could learn from the European perspective.     

The role of moral disengagement in the execution process

The present study tested the proposition that disengagement of moral self-sanctions enables prison personnel to carry out the death penalty. Three subgroups of personnel in penitentiaries located in three Southern states were assessed in terms of eight mechanisms of moral disengagement. The personnel included the execution teams that carry out the executions; the support teams that provide solace and emotional support to the families of the victims and the condemned inmate; and prison guards who have no involvement in the execution process. The executioners exhibited the highest level of moral, social, and economic justifications, disavowal of personal responsibility, and dehumanization. The support teams that provide the more humane services disavowed moral disengagement, as did the noninvolved guards but to a lesser degree than the support teams.     

我国发展循环经济面临的问题及对策

要实现经济的可持续发展,关键在于经济发展方式的转变。而循环经济可以为优化人类经济系统各个组成部分之间关系提供整体性的思路。本文重点探讨了目前我国发展循环经济面临的主要问题及解决的对策。     

Marginally discriminated: the role of outcome tests in European jurisdiction

For decades, racial profiling has been subject of intense debate in US jurisdiction. Recently, outcome tests based on economic models have contributed to the legal discourse. However, it is not readily obvious if and to what extent they also pertain to European jurisdiction, where racial profiling has only as of late stirred up controversy. In a comprehensive examination of their basic building blocks, this paper illustrates why the these tests are not particularly suited for the European case. The models are tailored to identify racial prejudice but are unfit to provide evidence of statistical discrimination, reflecting their adaption to the current US legal approach. A simple alternative test remedies this shortcoming and manages to inform the European jurisdiction.     

The role of stretching in the process of fracture formation

The author analyses various kinds of bone deformations. The stretching development and its influence on fracture formation are described in the article. Morphological signs confirming presence of stretching as a destroy moment are represented.     

Buy baby: the European Union and regulation of human reproduction

In its decision in ex parte Blood the Court of Appeal relied on European Community (EC) law to hold that the Human Fertilization and Embryology Authority had acted unlawfully in taking its decision to prevent Mrs Blood from exporting sperm taken from her dying husband without his written consent. The Blood case raises the issue of the extent to which EC law may affect the regulation of human reproduction in the Member States. Responding to fears that such national regulation might be 'swept away' by the commodifying nature of EC law, this article considers the scope of the potential application of EC law to regulation of human reproduction. The cautious conclusion is that, while there may be some increase in deregulatory pressures, the 'vertical relationship' of supreme EC law to national law may turn out to be less significant than 'horizontal relationships' between policy-makers within and between the EU and its Member States.     

The conference of European affairs committees: A collective voice for national parliaments in the European union

The role of national parliaments in the European Union has been the subject of intense debate in the last decade. The Maastricht and Amsterdam Treaties contained significant texts aimed at enhancing the role of national parliaments. Several major political figures in Europe have recently discussed the case for making the collective voice of national parliaments better heard and this issue is firmly on the ‘post‐Nice’ agenda.’ In parallel, an important debate has been running between the parliaments themselves about a collective role for national parliaments. Since 1989, a little‐known body has provided a forum for these debates. This article aims to set out the history of that body, and to highlight some of the issues surrounding an enhanced role for national parliaments.     

Keeping national parliaments informed: The problem of European legislation

Since Maastricht there has been a growing realisation in the institutions of the European Union, that the unfettered flow of information is vital to the health of the whole European project. Some moves have been made towards more transparent decision‐making, but progress has been slow and is limited by a culture which values confidentiality, particularly in intergovernmental negotiations. The free flow of information is especially important to national parliaments if they are to exercise any influence in the EU. The House of Commons Select Committee on European Legislation has recently pronounced the scrutiny system to be ‘in deep crisis’ because of chaotic decision‐making and a disregard for the rights of national parliaments. Many Westminster MPs feel frustrated by the difficulty of keeping track of EU legislation. The paper suggests that the ingredients of an improved information system already exist. A wealth of current information can be derived from EU‐related electronic databases and through direct links between the European Parliament and national parliaments. It proposes that a new current awareness service for the House of Commons, distributed via the parliamentary network and as hard copy, could focus information for MPs in a much more accessible way.     

The Evolving Judicial Politics of European Integration: The European Court of Justice and national courts revisited

This article analyzes how the judicial politics sparked by the European Union's (EU) legal development have evolved over time. Existing studies have traced how lower national courts began cooperating with the European Court of Justice (ECJ) to apply EU law because this empowered them to challenge government policies and the decisions of their domestic judicial superiors. We argue that the institutional dynamics identified by this ‘judicial empowerment thesis’ proved self‐eroding over time, incentivizing domestic high courts to reassert control over national judicial hierarchies and to influence the development EU law in ways that were also encouraged by the ECJ. We support our argument by combining an analysis of a dataset of cases referred to the ECJ with comparative case study and interview evidence. We conclude that while these evolving judicial politics signal the institutional maturation of the EU legal order, they also risk weakening the decentralized enforcement of European law.     

The evolution of security industry regulation in the European Union

ABSTRACT

The European private security sector has grown from a handful of small companies at the end of the Second World War into a multibillion Euro industry with thousands of firms and millions of security staff. In Europe, the demands for security is not just expressed notionally but also officially in The European Agenda on Security stating the European Union (EU) aims to ensure that people live in an area of freedom, security, and justice. This article will begin by exploring the role of private security in society. It will then move on to consider the main phases in the development of private security regulation in Europe. Following on from this, some of the main areas of policy development will be considered, such as European bodies, initiatives, and standards. Finally, the article will explore some of the potential options for the future in better regulating the European private security sector. From a historical perspective, the evolution of private security regulation can be divided into three phases: the laissez-faire, the centrifugal, and the centripetal era – each with its own distinct characteristics and impact on the concurrent industry. In the EU where there is the legal framework for the development of a single market in services, the key social partners have been at the forefront of developing a series of standards and guidance documents which promote standards across borders at the European level. However, the institutions of the EU have been reluctant to intervene at a European level in setting minimum standards of private security regulation. Thus, the changing terrain of the EU relating to security, regulation, and the private security industry means the current trajectory may be in need of an injection of more radical thought and consideration.     

The development of air transport law within the European Community

I would like to acknowledge the funds provided by the ESRC and the help and advice of Professor John Usher.     

The attack on national regulation: why we need a global framework for domestic regulation

The first 150 words of the full text of this article appear below. Key points

• In regulating cross-border capital markets transactions,regulators are employing either an exemptive approach, or aunilateral or mutual recognition approach. The exemptive approachallows market participants wherever located to transact businessin the host countries without complying with local requirements.The recognition approach is limited to a particular market,but is more expansive in terms of access to host country investors.In regulating cross-border transactions, the SEC has traditionallyrelied on the exemptive approach, and has restricted participationto only the largest, most sophisticated US investors. Recently,it has moved to a mutual recognition approach with its agreementwith Australia, which allows a broader range of US investorsto conduct cross-border transactions with Australian exchangesand broker–dealers relying almost entirely on the adequacyof the Australian regulatory system. However, both its exemptiveapproach and mutual recognition approach deal only with secondarymarket transactions, not participation in offerings.
• While. . . [Full Text of this Article]