The Law and Regulation of Medicines and Medical Devices

The Law and Regulation of Medicines and Medical Devices
Author: Peter Feldschreiber
Publisher:
Total Pages: 512
Release: 2021-10-04
Genre:
ISBN: 9780192847546

A practical guide for legal, medical, and pharmaceutical professionals, offering an authoritative and comprehensive source of expertise on the legislation and case law governing regulation of medicines and medical devices, and their liability under consumer protection law in the UK and EU.

Law and the Regulation of Medicines

Law and the Regulation of Medicines
Author: Emily Jackson
Publisher: Bloomsbury Publishing
Total Pages: 339
Release: 2012-03-01
Genre: Law
ISBN: 1847319092

The principal purpose of this book is to tell the story of a medicine's journey through the regulatory system in the UK, from defining what counts as a medicine, through clinical trials, licensing, pharmacovigilance, marketing and funding. The question of global access to medicines is addressed because of its political importance, and because it offers a particularly stark illustration of the consequences of classifying medicines as a private rather than a public good. Two further specific challenges to the future of medicine's regulation are examined separately: first, pharmacogenetics, or the genetic targeting of medicines to subgroups of patients, and second, the possibility of using medicines to enhance well-being or performance, rather than treat disease. Throughout, the emphasis is on the role of regulation in shaping and influencing the operation of the medicines industry, an issue that is of central importance to the promotion of public health and the fair and equitable distribution of healthcare resources.

Regulating Medicines in a Globalized World

Regulating Medicines in a Globalized World
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 169
Release: 2020-04-25
Genre: Medical
ISBN: 0309498635

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.

The Law and Ethics of the Pharmaceutical Industry

The Law and Ethics of the Pharmaceutical Industry
Author: M.N.G. Dukes
Publisher: Elsevier
Total Pages: 429
Release: 2005-11-04
Genre: Medical
ISBN: 0080459366

As one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and criminal - succeeds in guiding (and where neccessary contraining) it. The rules of behavior that may be considered to apply to today's pharmaceutical industry have emerged over a very long period and the process goes on. Even the immensely detailed standards for quality, safety and efficacy laid down in drug law and regulation during the second half of the twentieth century have their limitations as tools for ensuring that the public interest is well served. In particular, national and regional regulatory agencies are heavily dependent on industrial data for their decision-making, their standards and competence vary, and even the existing network of agencies does not cover the entire world. What is more there are many areas of law and regulation affecting the industry, concerning for example the pricing of medicines, the conduct of clinical studies, the health protection of workers and concern for the environment. In some fields it is indeed hardly possible to maintain standards through regulation.Professor N.M. Graham Dukes, a physician and lawyer with long term experience in industrial research management, academic study and international drug policy, provides here a powerfully documented analysis into the way this industry thinks, acts, and is viewed, and examines the current trends pointing to change.*Provides a balanced picture of the current role of the pharmaceutical industry in society*Includes indices of conventions, laws, and regulations; as well as judicial and disciplinary cases*This is the only book addressing the legal implications of big pharma activities and ethical standards

Pharmaceutical Medicine

Pharmaceutical Medicine
Author: Adrian Kilcoyne
Publisher: OUP Oxford
Total Pages: 473
Release: 2013-05-23
Genre: Medical
ISBN: 0191510394

The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas of pharmaceutical medicine adjacent to your current role. For healthcare professionals already working in the field, this book offers a guiding hand in difficult situations as well as supplying rapid access to the latest recommendations and guidelines. Written by authors with experience in the industry and drug regulation, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.

Countering the Problem of Falsified and Substandard Drugs

Countering the Problem of Falsified and Substandard Drugs
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 377
Release: 2013-06-20
Genre: Medical
ISBN: 0309269393

The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

Law and the Regulation of Medicines

Law and the Regulation of Medicines
Author: Emily Jackson
Publisher: Bloomsbury Publishing
Total Pages: 308
Release: 2012-03-01
Genre: Law
ISBN: 1847319084

The principal purpose of this book is to tell the story of a medicine's journey through the regulatory system in the UK, from defining what counts as a medicine, through clinical trials, licensing, pharmacovigilance, marketing and funding. The question of global access to medicines is addressed because of its political importance, and because it offers a particularly stark illustration of the consequences of classifying medicines as a private rather than a public good. Two further specific challenges to the future of medicine's regulation are examined separately: first, pharmacogenetics, or the genetic targeting of medicines to subgroups of patients, and second, the possibility of using medicines to enhance well-being or performance, rather than treat disease. Throughout, the emphasis is on the role of regulation in shaping and influencing the operation of the medicines industry, an issue that is of central importance to the promotion of public health and the fair and equitable distribution of healthcare resources.

The Changing Economics of Medical Technology

The Changing Economics of Medical Technology
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 225
Release: 1991-02-01
Genre: Medical
ISBN: 030904491X

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.

Radiation in Medicine

Radiation in Medicine
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 321
Release: 1996-03-25
Genre: Medical
ISBN: 0309175674

Does radiation medicine need more regulation or simply better-coordinated regulation? This book addresses this and other questions of critical importance to public health and safety. The issues involved are high on the nation's agenda: the impact of radiation on public safety, the balance between federal and state authority, and the cost-benefit ratio of regulation. Although incidents of misadministration are rare, a case in Pennsylvania resulting in the death of a patient and the inadvertent exposure of others to a high dose of radiation drew attention to issues concerning the regulation of ionizing radiation in medicine and the need to examine current regulatory practices. Written at the request from the Nuclear Regulatory Commission (NRC), Radiation in Medicine reviews the regulation of ionizing radiation in medicine, focusing on the NRC's Medical Use Program, which governs the use of reactor-generated byproduct materials. The committee recommends immediate action on enforcement and provides longer term proposals for reform of the regulatory system. The volume covers: Sources of radiation and their use in medicine. Levels of risk to patients, workers, and the public. Current roles of the Nuclear Regulatory Commission, other federal agencies, and states. Criticisms from the regulated community. The committee explores alternative regulatory structures for radiation medicine and explains the rationale for the option it recommends in this volume. Based on extensive research, input from the regulated community, and the collaborative efforts of experts from a range of disciplines, Radiation in Medicine will be an important resource for federal and state policymakers and regulators, health professionals involved in radiation treatment, developers and producers of radiation equipment, insurance providers, and concerned laypersons.