Download or read book The Challenges of the New EU Pharmaceutical Legislation written by José Luis Valverde and published by IOS Press. This book was released on 2005 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the domain of public policy on pharmaceuticals, protecting public health requires a dual strategy: robust regulation on the one hand and stimulation of competitiveness and innovation on the other. Regulation must be robust to ensure that only medicines meeting exact standards of safety, quality and efficacy are authorised for human and animal use. At the same time competitiveness and innovation must be stimulated. Without innovation in pharmaceuticals, the incurable diseases of today will remain incurable. Competitiveness drives innovation and innovation saves lives. Increased competitiveness of the pharmaceutical sector will not only better protect public health, but will also create high quality jobs and create growth. In this context the implementation of the G10 recommendations, particularly regarding the pricing and reimbursement of medicines by Member States, remains a considerable challenge.
Download or read book EU Pharmaceutical Regulation written by Govin Permanand and published by Manchester University Press. This book was released on 2006-09-05 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an analysis of European Union pharmaceutical regulation from a policy-making perspective. The focus is on how the often conflicting agendas of the pharmaceutical industry, the EU member states, the European Commission, and consumer interests are reconciled within the context of regulatory outcomes having to serve public health, healthcare and industrial policy needs within the single market. In providing a unique perspective on how and why EU pharmaceutical policy is made, the book will be of interest to academics, students and policy-practitioners interested in EU policy-making, regulation and public policy analysis.
Download or read book The Interplay of Global Standards and EU Pharmaceutical Regulation written by Sabrina Röttger-Wirtz and published by Bloomsbury Publishing. This book was released on 2021-09-23 with total page 251 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.
Download or read book Key Issues in Pharmaceuticals Law written by José Luis Valverde and published by IOS Press. This book was released on 2007 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The focus of Key Issues in Pharmaceuticals Law is on the ongoing achievement of an authentic world code for medicinal products - a so-called "Pharmacopoeia"--Through scientific technical harmonization. The legal dimension of medicinal products conditions the whole sector and it acquires a global dimension through the demand to protect people's health. Hence it is necessary to go forward to total harmonization of all its aspects. A global legal statute for medicinal products is justified by the very nature of the product, by its social control and the need for it to circulate freely, although limitations can be accepted, for reasons of solidarity with less favored populations. Awareness must arise that the challenge for healthcare is not going to find an adequate answer at the world level without a qualitative change in the world organization of the UN. The globalized world we live in demands reinforced continental solidarity, if we are to confront the common problems and bring about international order. A scientific technical code on the quality of medicinal products is essential for a statute on medicines. That code is the Pharmacopoeia."--Publisher.
Download or read book Guide to Eu Pharmaceutical Regulatory Law written by Sally Shorthose and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fully revised and updated, this practical book contains information on the processes, legislation, cases and customs that apply to the introduction, marketing and sale of a medicinal product (or medicinal device) in Europe. 00Pharmaceutical regulatory law is becoming ever more complicated, with the need to balance the constitutional requirements of the EU and its constituent Member States. This work, written by and for lawyers, will help you advise your clients on this constantly changing area. 00The new edition provides you with information on the changes to clinical trials, pharmacovigilance and competition law, helping you stay abreast of new legislation. 00Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, providing you with comprehensive and unambiguous guidance at every stage. 00Comprising three main sections, you’ll find the mainstream medicinal products from cradle to grave; specific regimes which do not fall into those categories; and three standalone chapters, dealing with an overview of what a medical device is, parallel trade, and competition law. 00Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of 15 incisive chapters examines a particular process or subject.
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Download or read book Health Governance in Europe written by Monika Steffen and published by Routledge. This book was released on 2005-11-28 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Health constitutes a core element of welfare states and a vital nerve in the trust relation between citizen and their governments. Focusing on the health sector, this book analyzes the closely interwoven relationship between the European Union and Member States. The authors explore the dynamic and multi-fold process of de-nationalizing health policies and illustrate how European policies develop in a sector that still appears to be under exclusively national competence. They describe the multiple forms and ways the Europeanization process takes, driven by market integration, public health crises and politics of consumer protection. The authors also provide a detailed analysis of key topics: the pharmaceutical sector, market regulation of medical goods and devices, food safety, the blood provision and plasma industry, European politics on bioethics, and risk reduction in the field of drug abuse. Providing a comprehensive and informed assessment of the Europeanization process in the field of health policies, this book will be of interest to students and scholars of health, European integration and policy-making.
Download or read book European Law and New Health Technologies written by Mark L Flear and published by OUP Oxford. This book was released on 2013-03-14 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: Health is a matter of fundamental importance in European societies, both as a human right in itself, and as a factor in a productive workforce and therefore a healthy economy. New health technologies promise improved quality of life for patients suffering from a range of diseases, and the potential for the prevention of incidence of disease in the future. At the same time, new health technologies pose significant challenges for governments, particularly in relation to ensuring the technologies are safe, effective, and provide appropriate value for (public) money. To guard against the possible dangers arising from new health technologies, and to maximize the benefits, all European governments regulate their development, marketing, and public financing. In addition, several international institutions operating at European level, in particular the European Union, the Council of Europe, and the European Patent Office, have become involved in the regulation of new health technologies. They have done so both through traditional 'command and control' legal measures, and through other regulatory mechanisms, including guidelines, soft law, 'steering' through redistribution of resources, and private or quasi-private regulation. This collection analyses European law and its relationships with new health technologies. It uses interdisciplinary insights, particularly from law but also drawing on regulation theory, and science and technology studies, to shed new light on some of the key defining features of the relationships and especially the roles of risk, rights, ethics, and markets. The collection explores the way in which European law's engagement with new health technologies is to be legitimized, and discusses the implications for biological or biomedical citizenship.
Download or read book EU Law of Competition and Trade in the Pharmaceutical Sector written by Pablo Figueroa and published by Edward Elgar Publishing. This book was released on 2019 with total page 758 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry. The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.
Download or read book Medical Devices and the Public s Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Download or read book Improving Healthcare Quality in Europe Characteristics Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.
Download or read book Public Health Effectiveness of the FDA 510 k Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Download or read book Private Law in the External Relations of the EU written by Marise Cremona and published by Oxford University Press. This book was released on 2016-03-17 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: Private Law in the External Relations of the EU is an innovative study of the interactions between EU external relations law and private law, two unrelated fields of law, inverted if private law is understood as regulatory private law - the space where regulatory law intersects with private economic activity. Here the link between the Internal Market and the global market - and thereby international law - is much more prominent. In this book, key questions about the relationship between EU external relations law and private law are answered, including: in what ways might European private law act as a tool to achieve EU external policy objectives, particularly in regulatory fields? How might the quickly developing EU external competence over the procedural dimensions of private law, including private international law, impact on substantive law, both externally and internally? And how is the legal position of private parties affected by EU external relations? In asking these questions, this edited collection opens up a field of enquiry into the so far underexplored relationship between these two fields of law. In doing so, it addresses three different aspects of the relationship: (i) the evolution of the EU competence, (ii) the ways in which EU private law extends its reach beyond the boundaries of the internal market, and (iii) the ways in which the EU contributes to the formation of private regulation at the international level.
Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Download or read book Civil Society and Health written by Scott L. Greer and published by World Health Organization. This book was released on 2017-11-20 with total page 191 pages. Available in PDF, EPUB and Kindle. Book excerpt: Civil Society Organizations (CSOs) can make a vital contribution to public health and health systems but harnessing their potential is complex in a Europe where government-CSO relations vary so profoundly. This study is intended to outline some of the challenges and assist policy-makers in furthering their understanding of the part CSOs can play in tandem and alongside government. To this end it analyses existing evidence and draws on a set of seven thematic chapters and six mini case studies. They examine experiences from Austria Bosnia-Herzegovina Belgium Cyprus Finland Germany Malta the Netherlands Poland the Russian Federation Slovenia Turkey and the European Union and make use of a single assessment framework to understand the diverse contexts in which CSOs operate. The evidence shows that CSOs are ubiquitous varied and beneficial and the topics covered in this study reflect such diversity of aims and means: anti-tobacco advocacy food banks refugee health HIV/AIDS prevention and cure and social partnership. CSOs make a substantial contribution to public health and health systems with regards to policy development service delivery and governance. This includes evidence provision advocacy mobilization consensus building provision of medical services and of services related to the social determinants of health standard setting self-regulation and fostering social partnership. However in order to engage successfully with CSOs governments do need to make use of adequate tools and create contexts conducive to collaboration. To guide policy-makers working with CSOs through such complications and help avoid some potential pitfalls the book outlines a practical framework for such collaboration. This suggests identifying key CSOs in a given area; clarifying why there should be engagement with civil society; being realistic as to what CSOs can or will achieve; and an understanding of how CSOs can be helped to deliver.
Download or read book Health Policy and European Union Enlargement written by Mckee and published by McGraw-Hill Education (UK). This book was released on 2004-04-01 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: While there may be consensus on the broader issues of the core objectives of the health care system, expectations differ between EU countries, and European national policy-makers. This book seeks firstly to assess the impact of the enlargement process and then to analyse the challenges that lie ahead in the field of health and health policy.
Download or read book Responsibilities in the Efficient Use of Medicinal Products written by José Luis Valverde and published by IOS Press. This book was released on 2006 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: The emphasis of this book is on the problem of the efficient use of medicinal products. It is known that this is a subject that is neither new nor unknown. Hundreds of articles have been, and will continue to be written about it. Yet it has not been resolved. The lines of consensus to tackle it have not even been defined, and there are many opinions about different aspects. What is needed is overall consideration and then to try to act on common agreed bases. But first the problem must be analysed, and so the book raises the problem in the form of a Forum. The different actors have to be heard, and the governments, too, of course, which express themselves through the legal system. We are far from providing an adequate response in any national legal system. The debate is still open, but society is waiting for replies from those who have responsibilities. There is no one right answer. Many actors are jointly responsible in this situation...
