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Information Exchange Between Competitors in EU Competition Law Martin Gassler Competing firms often exchange information in order to make more informed market decisions which can help to overcome market inefficiencies. However, an abundance of legal and economic research as well as case law has shown that information exchange may also enable firms to engage in collusion more readily and sustain it longer. This book is the first to concentrate on this challenging topic of EU competition law in such depth. It focuses on ‘pure’ information exchanges – exchanges that are not ancillary to a wider pro-competitive or anticompetitive conduct – and thoroughly explains the characteristics of such information exchanges, their pro-competitive and anticompetitive effects and discusses all the relevant legal aspects for their assessment. The author provides a robust analytical framework for assessing information exchanges under Article 101 TFEU, focusing on the risk of collusive outcomes and what types of information exchange are particularly harmful. With detailed attention to the leading cases on information exchange, the analysis examines the most important aspects for assessing information exchange between competitors, in particular: the concept of a concerted practice; the concepts of a restriction by object and effect, including their similarities and differences; the importance of evidentiary issues; the issue of signalling via advance public announcements; factors that facilitate collusion; efficiencies of information exchange, including market transparency; the legal challenges of tackling mere parallel conduct; facilitative practices in the Commission Guidelines, including the Horizontal Cooperation Guidelines; and safe harbours for certain types of information exchange. The book offers clear guidance on how to identify and thus distinguish information exchange that restricts competition by its object and information exchange that restricts competition (only) by its effects. It offers practical solutions to some of the perceived issues when assessing information exchanges. With its wealth of analysis not available from other sources, this concise yet comprehensive review of a much-debated topic in competition law offers clear guidance for practitioners in assessing the issues surrounding information exchange. The book will also be welcomed by competition law academics, competition lawyers and competition authority officials throughout Europe.
This book draws a unique perspective on the regulation of access to clinical trial data as a case on research and knowledge externalities. Notwithstanding numerous potential benefits for medical research and public health, many jurisdictions have struggled to ensure access to clinical trial data, even at the level of the trial results. Pro-access policy initiatives have been strongly opposed by research-based drug companies arguing that mandatory data disclosure impedes their innovation incentives. Conventionally, access to test data has been approached from the perspective of transparency and research ethics. The book offers a complementary view and considers access to individual patient-level trial data for exploratory analysis as a matter of research and innovation policy. Such approach appears to be especially relevant in the data-driven economy where digital data constitutes a valuable economic resource. The study seeks to define how the rules of access to clinical trial data should be designed to reconcile the policy objectives of leveraging the research potential of data through secondary analysis, on the one hand, and protecting economic incentives of research-based drug companies, on the other hand. Overall, it is argued that the mainstream innovation-based justification for exclusive control over the outcomes of research and development can hardly rationalise trial sponsors’ control over primary data from trials. Instead, access to such data and its robust analysis should be prioritised.
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
The rapid development of information technology has exacerbated the need for robust personal data protection, the right to which is safeguarded by both European Union (EU) and Council of Europe (CoE) instruments. Safeguarding this important right entails new and significant challenges as technological advances expand the frontiers of areas such as surveillance, communication interception and data storage. This handbook is designed to familiarise legal practitioners not specialised in data protection with this emerging area of the law. It provides an overview of the EU’s and the CoE’s applicable legal frameworks. It also explains key case law, summarising major rulings of both the Court of Justice of the European Union and the European Court of Human Rights. In addition, it presents hypothetical scenarios that serve as practical illustrations of the diverse issues encountered in this ever-evolving field.
This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.
Offering a comprehensive exploration of EU taxation law, this engaging Research Handbook investigates the associated legal principles in the context of both direct and indirect taxation. The important issues and debates arising from these general principles are expertly unpicked, with leading scholars examining the status quo as well as setting out a clear agenda for future research.
Bringing together leading European scholars, this thought-provoking Research Handbook provides a state-of-the-art overview of the scope of research and current thinking in the area of European data protection. Offering critical insights on prominent strands of research, it examines key challenges and potential solutions in the field. Chapters explore the fundamental right to personal data protection, government-to-business data sharing, data protection as performance-based regulation, privacy and marketing in data-driven business models, data protection and judicial automation, and the role of consent in an algorithmic society.
For many observers, the European Union is mired in a deep crisis. Between sluggish growth; political turmoil following a decade of austerity politics; Brexit; and the rise of Asian influence, the EU is seen as a declining power on the world stage. Columbia Law professor Anu Bradford argues the opposite in her important new book The Brussels Effect: the EU remains an influential superpower that shapes the world in its image. By promulgating regulations that shape the international business environment, elevating standards worldwide, and leading to a notable Europeanization of many important aspects of global commerce, the EU has managed to shape policy in areas such as data privacy, consumer health and safety, environmental protection, antitrust, and online hate speech. And in contrast to how superpowers wield their global influence, the Brussels Effect - a phrase first coined by Bradford in 2012- absolves the EU from playing a direct role in imposing standards, as market forces alone are often sufficient as multinational companies voluntarily extend the EU rule to govern their global operations. The Brussels Effect shows how the EU has acquired such power, why multinational companies use EU standards as global standards, and why the EU's role as the world's regulator is likely to outlive its gradual economic decline, extending the EU's influence long into the future.
Key chapters, written by leading experts across the field, engage with important ongoing debates in the field of EU administrative law, focusing on areas of topical interest such as financial markets, the growing security state and problematic common asylum procedures. In doing so, they provide a summary of what we know, don’t know and ought to know about EU administrative law. Examining the control functions of administrative law and the machinery for accountability, this Research Handbook eloquently challenges areas of authoritarian governance, such as the Eurozone and security state, where control and accountability are weak and tackles the seemingly insoluble question of citizen ‘voice’ and access to policy-making.
Offering a wealth of thought-provoking insights, this topical Research Handbook analyses the interplay between the law and politics of the EU and examines the role of law and legal actors in European integration.