The Challenges of the New EU Pharmaceutical Legislation PDF Download

Author: José Luis Valverde
Publisher: IOS Press
ISBN: 9781586035211
Category : Business & Economics
Languages : en
Pages : 154

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Book Description
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.

Author: Govin Permanand
Publisher: Manchester University Press
ISBN: 9780719072727
Category : Medical
Languages : en
Pages : 272

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Book Description
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.

Author: Sabrina Röttger-Wirtz
Publisher: Bloomsbury Publishing
ISBN: 1509942998
Category : Law
Languages : en
Pages : 251

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Book Description
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.

Author: José Luis Valverde
Publisher: IOS Press
ISBN: 9781586038403
Category : Law
Languages : en
Pages : 176

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Book Description
"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.

Author: Sally Shorthose
Publisher:
ISBN: 9789041166388
Category : Drugs
Languages : en
Pages : 0

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Book Description
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.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212456
Category : Medical
Languages : en
Pages : 318

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Book Description
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.

Author: Monika Steffen
Publisher: Routledge
ISBN: 1134219555
Category : Political Science
Languages : en
Pages : 232

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Book Description
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.

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309498635
Category : Medical
Languages : en
Pages : 169

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Book Description
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.

Author: Pablo Figueroa
Publisher: Edward Elgar Publishing
ISBN: 1785362615
Category : Business & Economics
Languages : en
Pages : 758

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Book Description
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.

Author: David Sir Cooksey
Publisher: The Stationery Office
ISBN: 0118404881
Category : Medical
Languages : en
Pages : 132

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Book Description
This Review sets out to propose a structure for the funding arrangements for the whole spectrum of health research, with the objective of obtaining the maximum benefit from research success and, where possible, eliminating duplication of effort. The Review found, however, that the UK is at risk of failing to reap the full economic, health and social benefits that the UK's public investment in health research should generate. There is no overarching UK health research strategy to ensure UK health priorities are considered through all types of research and there are two key gaps in the translation of health research: (i) translating ideas from basic and clinical research into the development of new products and approaches to treatment of disease and illness; (ii) implementing those new products and approaches into clinical practice.The Review also found that the wider funding arrangements for supporting translation of ideas from conception to practice could be more coherent or comprehensive and, where arrangements exist, they do not function well. The Review identified cultural, institutional and financial barriers to translating research into practice in the publicly funded research arena. But it also found that, in the private sector, the pharmaceuticals industry is facing increasing challenges in translating research into health and economic benefit. The Review has sought to make recommendations that will increase the translation of R&D into health and economic benefit for the UK, both in the public and private sectors. The Review recommends that the Government should seek to achieve better coordination of health research and more coherent funding arrangements to support translation by establishing an Office for Strategic Coordination of Health Research (OSCHR).