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Directive

About: Directive is a research topic. Over the lifetime, 5695 publications have been published within this topic receiving 56084 citations.


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Journal ArticleDOI
TL;DR: This commentary discusses the likely requirements of the EU directives for air quality in tissue-processing laboratories and draws attention to the concept of validation, which becomes essential to justify all processes.
Abstract: Assisted conception is among many tissue-processing disciplines encompassed by new European legislation on the quality and safety of tissues and cells used therapeutically. These directives have highlighted interdisciplinary differences in some current practices, such as variations in laboratory air quality. This commentary discusses the likely requirements of the EU directives for air quality in tissue-processing laboratories. It also draws attention to the concept of validation. Validation becomes essential to justify all processes, and would be an essential tool to support any deviations from normal 'Good Manufacturing Practices', such as adopting a lesser grade of laboratory air quality.

15 citations

Journal ArticleDOI
TL;DR: In this paper, the potential impact of the Court of Justice's decision in Case C-168/09 Flos v Semararo on the harmonization of European law on the design copyright interface is examined.
Abstract: The paper examines the potential impact of the Court of Justice’s decision in Case C-168/09 Flos v Semararo on the harmonization of European law on the design copyright interface. The paper reviews the travaux of three Directives on Copyright Term, Designs and the Information Society to demonstrate that the legislative organs of the European Union intended to leave the question of the circumstances in which copyright would protect designs, the term of protection, and exceptions to such protection to the laws of Member states. In holding that Member states must protect original designs by copyright under the Information Society Directive, the Court in Flos has contradicted what was agreed by Member states with potentially significant implications. Already, the UK has responded by proposing to remove section 52 of the CDPA, even though when the Designs Directive was adopted, the Patent Office negotiated in Europe successfully explicitly to retain the provision. But the implications of Flos may be much more radical than UK IPO has acknowledged, and in some respects might be said to represent ‘the return of industrial copyright.’ The article concludes by arguing that it would have been preferable for the IPO to wait before proposing amendments to section 52 (in the Enterprise and Regulatory Reform Bill), and instead to approach the Commission with a view to clarifying legislation or simply to wait for further decisions of the CJEU, ensuring (through UK observations) that the legislative history was placed fully before the Court.

15 citations

Journal ArticleDOI
20 May 2021
TL;DR: In this paper, the authors describe the essential points of Italian and European legislation governing the use of animals in biomedical experimentation and discuss cases of inadequate and insufficient implementation of the requirements laid down by Directive 2010/63/EU.
Abstract: The aim of this paper is to describe the essential points of Italian and European legislation governing the use of animals in biomedical experimentation. A close look will be taken at the principles of the 3Rs, which represent the mainstay of the legal architecture based on which a correct interpretation may be drawn of the legislative documents on animal experimentation. Furthermore, this paper will address the ways in which Directive 2010/63/EU is implemented in Italian legislation on the welfare of laboratory animals. In addition to an assessment of legal issues (such as the scope of jurisdiction of supervisory authorities tasked with issuing authorizations), it will include a discussion of cases of inadequate and insufficient implementation of the requirements laid down by Directive 2010/63/EU. Both the consistency of the interpretation of national legislation with the Directive and the direct effectiveness of the Directive in national law, in which animal testing has been and still is the subject of heated debate between supporters and opponents, will be examined.

15 citations

Journal ArticleDOI
TL;DR: In this article, the authors introduce a series of papers in the ECFR discussing the new European Takeover Directive and look back on the long and winding road to the final version, marked by trading posts where Member States haggled over their support.
Abstract: The following article introduces a series of papers in the ECFR discussing the new European Takeover Directive. It looks back on the long and winding road to the final version, marked by trading posts where Member States haggled over their support, and questions whether the remaining weaknesses really justify a pessimistic view of its future role.

15 citations

Journal ArticleDOI
TL;DR: In this article, the authors argue that the success and failure of the European Union's Takeover Directive can, in large part, be measured by the number of Member States that have opted-in, or out of the neutrality principle, or have opt-in subject to the reciprocity option.
Abstract: Whether the European Union's Takeover Directive should have adopted a mandatory neutrality rule has been the subject of much debate. As the European Commission commences its review of the Directive this debate is being reignited. A view is crystallising that the success and failure of the Directive can, in large part, be measured by the number of Member States that have opted-in, or out of the neutrality principle, or have opted-in subject to the reciprocity option. The contestability of European corporations is viewed through this lens as a function of the extent to which EU Member States have adopted an unqualified neutrality rule. This article takes issue with this viewpoint. It argues that the pre-Directive debate and the post-Directive assessment have failed to consider the core lesson of takeover defences in the United States, namely that the construction of defences and their potency are a function of basic corporate law rules. If corporate law rules do not enable the construction of takeover defences, or undermine the extent to which they can be potently deployed, then the adoption or rejection of the neutrality principle in Member States is of trivial significance. This article explores the triviality hypothesis in three central EU jurisdictions: the United Kingdom, Germany, and Italy. It concludes that, although there is variable scope to construct and deploy takeover defences in these jurisdictions, the triviality thesis is well founded.

15 citations


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Performance
Metrics
No. of papers in the topic in previous years
YearPapers
2023836
20221,824
2021129
2020188
2019245
2018280