scholarly journals From the EU Legislation to the Application of the Single European Code: Support to the Implementation

2017 ◽  
Vol 44 (6) ◽  
pp. 391-394
Author(s):  
Valentina Caramia ◽  
Angelo Ghirardini ◽  
Paola Di Ciaccio ◽  
Francesca Vespasiano ◽  
Maura Mareri ◽  
...  
Keyword(s):  
Eu Legislation ◽  
European Code ◽  
Single European Code ◽  
The Eu

scholarly journals Coding in medically assisted reproduction: the status of the implementation of the Single European Code for reproductive cells and tissues†

2020 ◽  
Vol 2020 (3) ◽  
Author(s):  
Alessandra, Alteri ◽  
Nathalie Vermeulen ◽  
Ioana Adina Rugescu ◽  
Daniela Nogueira ◽  
Zdravka Veleva ◽  
...  
Keyword(s):  
Assisted Reproduction ◽  
Online Survey ◽  
Added Value ◽  
The European Union ◽  
European Continent ◽  
Medically Assisted Reproduction ◽  
European Code ◽  
Single European Code ◽  
Insight Into ◽  
The Eu

Abstract STUDY QUESTION To evaluate the implementation of the coding systems in medically assisted reproduction (MAR) centres in the European Union (EU). SUMMARY ANSWER Our data show that a significant number of MAR centres use the Single European Code (SEC), but it also shows certain limitations to the coding. WHAT IS KNOWN ALREADY Traceability and identification of tissue and cells used for clinical application are extremely important as it is one of the key aspects of quality and safety both for the donors and the recipients. Patients as well as tissues and cells move across the European continent and far beyond, hence a uniform coding system was very much needed. The coding of tissues and cells from human origin was already embedded in the EU directives 2004/23/EC. The use of the Single European Code (SEC) on tissues and cells was enforced in 2017 for tissues and cells distributed within the EU or exported from the EU. The SEC ensures standardization within the EU, allowing the integration of the two existing codes (ISBT-128 and Eurocode) within the SEC structure. Likewise, in the MAR field, the SEC was launched in order to ensure the traceability of reproductive tissues and cells. Gametes and embryos from partner donation as well as reproductive cells and tissues of allogeneic donation were excluded from the SEC as long as they remain in the centre of origin. STUDY DESIGN, SIZE, DURATION A cross-sectional survey aimed to gain insight into the use of SEC by MAR centres was conducted between 5 November and 15 December 2018. PARTICIPANTS/MATERIALS, SETTING, METHODS The online survey was distributed among the ESHRE members. MAIN RESULTS AND THE ROLE OF CHANCE The survey results highlight the strengths and weaknesses in the practical use of the SEC. The data from the survey showed that the SEC code is something that is known in the MAR field. Our data showed that over half of the respondents were using the SEC in their centre. On the other hand, there is also criticism about the use of SEC in MAR, especially that the added value for traceability and identification in ART is found to be rather limited. LIMITATIONS, REASONS FOR CAUTION The survey response rate was rather low (4.84%). The view of the use of SEC discussed in this paper still provides insight into the use of the SEC in several MAR centres. WIDER IMPLICATIONS OF THE FINDINGS The survey highlights some knowledge gaps concerning coding. This information can be used to develop tools to increase knowledge of the SEC. STUDY FUNDING/COMPETING INTEREST(S) There was no external funding for this study. The authors declare that they have no conflict of interest. TRIAL REGISTRATION NUMBER N/A.

The Interaction of Judicial and Legislative Policymaking

2018 ◽  
Author(s):  
Susanne K. Schmidt
Keyword(s):  
Mutual Recognition ◽  
Case Law ◽  
Legislative Process ◽  
European Legislation ◽  
Eu Legislation ◽  
Political Preferences ◽  
General Rules ◽  
Judicial Policymaking ◽  
The Impact ◽  
The Eu

Chapter 4 systematizes the different ways that judicial policymaking can have an impact on European legislation. Identifying the codification of case-law principles in secondary law contributes to research on the EU in two important ways: it shows how EU legislation is embedded in case-law development, and that the impact of case law cannot be reduced to the question of compliance with single rulings. A differentiation is made between several types of judicial ‘shadow’ over the legislative process. Then the Services Directive and the regulation on the mutual recognition of goods are analysed. The principles of case law that were motivated by the specific circumstances of individual cases constrain the design of general rules. Secondary law cannot modify constitutional principles. At best, the legislature can hope to signal its political preferences to the Court.

scholarly journals Artificial Intelligence in Biomedicine: A Legal Insight

BioTech ◽  
2021 ◽  
Vol 10 (3) ◽  
pp. 15
Author(s):  
Takis Vidalis
Keyword(s):  
Artificial Intelligence ◽  
Personal Data ◽  
Health Data ◽  
The Self ◽  
Data Handling ◽  
Direct Control ◽  
Eu Legislation ◽  
Attending Physicians ◽  
Self Learning ◽  
The Eu

The involvement of artificial intelligence in biomedicine promises better support for decision-making both in conventional and research medical practice. Yet two important issues emerge in relation to personal data handling, and the influence of AI on patient/doctor relationships. The development of AI algorithms presupposes extensive processing of big data in biobanks, for which procedures of compliance with data protection need to be ensured. This article addresses this problem in the framework of the EU legislation (GDPR) and explains the legal prerequisites pertinent to various categories of health data. Furthermore, the self-learning systems of AI may affect the fulfillment of medical duties, particularly if the attending physicians rely on unsupervised applications operating beyond their direct control. The article argues that the patient informed consent prerequisite plays a key role here, not only in conventional medical acts but also in clinical research procedures.

scholarly journals Company Changing Status and Its Linking to Competitiveness

2015 ◽  
Vol 53 (1) ◽  
pp. 1-17
Author(s):  
Dragana Radenković-Jocić ◽  
Ivan Barun
Keyword(s):  
Mergers And Acquisitions ◽  
Legal Framework ◽  
Decision Makers ◽  
Economic Activities ◽  
Economic Interests ◽  
Eu Legislation ◽  
The Republic ◽  
The Right ◽  
A Company ◽  
The Eu

Abstract The authors present the issues and challenges related to the changes in status of a company and its impact on competitiveness. Status changes of companies, mostly mergers and acquisitions of companies, are one of the ways in which capital owners and management direct economic activities with the aim of maximizing profits. In order to make the right and justified decision, in terms of achieving the economic interests of the company, it is essential to know the laws and regulations in this area. This paper should provide answers on various questions which will be presented to decision makers in every company, considering status changes. Bearing in mind that the question of status changes often associated with an international element, the authors will pay special attention on the EU legislation and current legal framework in the Republic of Serbia.

scholarly journals Has the Action for Failure to Act in the European Union Lost its Purpose?

2014 ◽  
Vol 7 (2) ◽  
pp. 209-226 ◽  
Author(s):  
Inga Daukšienė ◽  
Arvydas Budnikas
Keyword(s):  
European Union ◽  
Judicial Review ◽  
Scientific Literature ◽  
Case Law ◽  
The European Union ◽  
Eu Legislation ◽  
Court Of Justice ◽  
Legal Remedy ◽  
The Eu

ABSTRACT This article analyzes the purpose of the action for failure to act under article 265 of the Treaty on the Functioning of the European Union (TFEU). The statements are derived from the analysis of scientific literature, relevant legislation, practice of the European Union Court of Justice (CJEU) and the European Union General Court (EUGC). Useful information has also been obtained from the opinions of general advocates of the CJEU. The article of TFEU 265, which governs the action for failure to act, is very abstract. For this reason, a whole procedure under the article 265 TFEU was developed by the EU courts. The original purpose of the action for failure to act was to constitute whether European Union (EU) institution properly fulfilled its obligations under the EU legislation. However, in the course of case-law, a mere EU institution’s express refusal to fulfill its duties became sufficient to constitute that the EU institution acted and therefore action for failure to act became devoid of purpose. This article analyzes whether the action for failure to act has lost its purpose and become an ineffective legal remedy in the system of judicial review in the EU. Additionally, the action for failure to act is compared to similar national actions.

scholarly journals Cybersecurity in the EU and Member States: Genesis and Issues of its Enhancing

2019 ◽  
pp. 57-69
Author(s):  
Viktor Boiko ◽  
Mykola Vasylenko ◽  
Serhii Kukharenko
Keyword(s):  
Systematic Approach ◽  
New Technologies ◽  
Member States ◽  
Eu Member States ◽  
Eu Legislation ◽  
Regulatory Instruments ◽  
New Challenges ◽  
Ict Development ◽  
The Impact ◽  
The Eu

The article deals with the issues of establishing cybersecurity in the EU and its member-states at the legislative level as viewed from the point of a systematic approach. The authors identified problematic aspects of improving cybersecurity quality and conditions. They analyzed the impact of the EU member states legislation on cy-bersecurity. The article as well considers the process of ICT development and pre-sents the ways of creating new challenges by means of new technologies. Key words: cybersecurity, cyber resilience, regulatory instruments, EU legislation, innovations.

JUDICIAL AND NON-JUDICIAL PROTECTION IN THE CONTEXT OF THE MULTI-LEVEL ADMINISTRATIVE SPACE OF THE EUROPEAN UNION

2021 ◽  
pp. 69-80
Author(s):  
A.V. Chetvernina
Keyword(s):  
Mutual Recognition ◽  
German Law ◽  
The European Union ◽  
Special Issue ◽  
Eu Legislation ◽  
Recognition Systems ◽  
Multi Level ◽  
Judicial Protection ◽  
Regulatory Models ◽  
The Eu

The review is based on the publications of a series of articles in a special issue of the German Law Journal (German law journal. 2021. Vol. 22, N 3). It examines the complex of judicial and non-judicial problems that arise in the complex multi-level administrative structure of the EU. The main focus is on mechanisms of horizontal and vertical administrative cooperation, as well as new regulatory models that «generate» transnational administrative acts and mutual recognition systems, as well as multi-level inspection activities carried out to ensure compliance with EU legislation.

10. EU Legislation

2018 ◽  
Author(s):  
Ed Beale ◽  
Libby Kurien ◽  
Eve Samson
Keyword(s):  
Direct Access ◽  
Legislative Process ◽  
House Of Commons ◽  
National Parliaments ◽  
Eu Legislation ◽  
House Of Lords ◽  
The Government ◽  
The Uk ◽  
The Eu

This chapter examines the ways in which the UK Parliament formally constrains the government and engages with European Union (EU) institutions. The House of Lords and the House of Commons both have processes to ensure that legislation proposed at the EU level has been properly reviewed before it takes effect in UK law. The ‘scrutiny reserve’, which stipulates that ministers should not agree to proposals under scrutiny, is used to elicit information about the government's negotiating position. Parliament also has a role in examining EU legislation and providing direct access to European institutions. The chapter first provides an overview of the EU legislative process, focusing on three principal EU institutions: member states, the European Parliament (EP), and the European Commission. It also considers the formal role of national parliaments in the EU legislative process, the UK Parliament's scrutiny of the EU legislation and its effectiveness, and parliamentary scrutiny after Brexit.

6. Legislation and Decision-Making

EU Law ◽  
2020 ◽  
pp. 155-193
Author(s):  
Paul Craig ◽  
Gráinne de Búrca
Keyword(s):  
Decision Making ◽  
Legislative Process ◽  
Eu Legislation ◽  
Legislative Procedure ◽  
Ordinary Legislative Procedure ◽  
The Uk ◽  
The Eu ◽  
Academic Debate

All books in this flagship series contain carefully selected substantial extracts from key cases, legislation, and academic debate, providing students with a stand-alone resource. This chapter, which discusses the process by which the EU enacts legislation and makes decisions, begins by considering the making of legislative acts. This includes the Treaty rules and practice concerning the initiation of the legislative process, and how the ordinary legislative procedure, in which the Council and EP act as co-legislators, has come to occupy centre stage. The focus then shifts to the making of delegated acts followed by an analysis of how implementing acts are made. The chapter concludes with discussion of democracy in the EU, and evaluates the extent to which the EU might be said to have a democracy deficit. The UK version contains a further section analysing issues concerning EU legislation and decision-making in relation to the UK post-Brexit.

Digital Economy

2019 ◽  
pp. 131-170
Author(s):  
Anu Bradford
Keyword(s):  
Data Protection ◽  
Hate Speech ◽  
Digital Economy ◽  
The Internet ◽  
Eu Legislation ◽  
The World ◽  
The Eu

Chapter 5 focuses on two areas of regulation that have been central to the EU’s efforts to regulate the digital economy: data protection and the regulation of hate speech online. The chapter first reviews the EU legislation governing data protection and explains the economic and political drivers behind it. It then discusses some examples of both the de facto and de jure Brussels Effect on data protection. Then, the focus turns to online hate speech, again reviewing the regulation, the underlying economic and political motivations, as well as examples of how the EU has drawn the line between acceptable and unacceptable speech in the internet era—not just in Europe but around the world.

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