Regulating European Drug Problems


Book Description

Throughout Europe - from town halls and regional governments, through national Parliaments and ministries, to the high institutions of the European Union - there runs a vigorous debate on organised crime, municipal safety and private conduct. Drug problems and what to do about them often occupy center-stage at these debates. Throughout the 1990s the focus of legal attention has been primarily on the criminal law. New criminal offenses have been created, partly in response to influences `from above' (from international and European agreements) and partly in response to pressure `from below' (concerns of citizens at national and sub-national levels). But although criminal law certainly is important as far as the development of drug controls is concerned, it is by no means the whole story. There is a parallel history, a regulatory one, consisting of the increasing use of administrative measures, some of which are directly concerned with drugs while others are more general but equally applicable. These responses, together with civil law, variously function as adjuncts to criminal law or as alternatives to it, in relation to drug trafficking at European and national levels, drug-related public nuisance as it concerns citizens at municipal level, and drug users. After charting existing measures in the legal orders of Member states and of the Community, Regulating European Drug Problems looks at prospects for administrative drug controls after Amsterdam - in the context of the development of the Single Market, cooperation against crime and insecurity, subsidiarity, and human rights. At a practical level, the study offers provocative ideas to policy-makers and administrators working at the intersection of city-level, national, and European responses to drugs. For scholars and students, the book offers comparative legal research and European synthesis, and forges new links between fields of law, suppresion of organised crime, and economic and social regulation.




Treating Drug Problems:


Book Description

Treating Drug Problems, Volume 2 presents a wealth of incisive and accessible information on the issue of drug abuse and treatment in America. Several papers lay bare the relationship between drug treatment and other aspects of drug policy, including a powerful overview of twentieth century narcotics use in America and a unique account of how the federal government has built and managed the drug treatment system from the 1960s to the present. Two papers focus on the criminal justice system. The remaining papers focus on Employer policies and practices toward illegal drugs. Patterns and cycles of cocaine use in subcultures and the popular culture. Drug treatment from a marketing, supply-and-demand perspective, including an analysis of policy options. Treating Drug Problems, Volume 2 provides important information to policy makers and administrators, drug treatment specialists, and researchers.




Pain Management and the Opioid Epidemic


Book Description

Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.




Cannabis Legislation in Europe


Book Description

"At a time of increased debate on the laws controlling the use of cannabis in the European Union, this report answers some of the questions most often asked about cannabis legislation. Using a question and answer format, basic definitions and the obligations of countries under international law are set out in a section on ‘What is cannabis and what are countries’ obligations to control it?‘ Two following sections examine the links and disparities between the content of the laws and their guidelines on the one hand and the actual implementation of the laws on the other. The final question and answer section considers whether changes in law have affected cannabis use and how much public support for legal change exists, as it looks at the future direction of cannabis legislation in Europe." -- Provided by publisher.




Medical Devices and the Public's Health


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.




Pathways of Addiction


Book Description

Drug abuse persists as one of the most costly and contentious problems on the nation's agenda. Pathways of Addiction meets the need for a clear and thoughtful national research agenda that will yield the greatest benefit from today's limited resources. The committee makes its recommendations within the public health framework and incorporates diverse fields of inquiry and a range of policy positions. It examines both the demand and supply aspects of drug abuse. Pathways of Addiction offers a fact-filled, highly readable examination of drug abuse issues in the United States, describing findings and outlining research needs in the areas of behavioral and neurobiological foundations of drug abuse. The book covers the epidemiology and etiology of drug abuse and discusses several of its most troubling health and social consequences, including HIV, violence, and harm to children. Pathways of Addiction looks at the efficacy of different prevention interventions and the many advances that have been made in treatment research in the past 20 years. The book also examines drug treatment in the criminal justice setting and the effectiveness of drug treatment under managed care. The committee advocates systematic study of the laws by which the nation attempts to control drug use and identifies the research questions most germane to public policy. Pathways of Addiction provides a strategic outline for wise investment of the nation's research resources in drug abuse. This comprehensive and accessible volume will have widespread relevanceâ€"to policymakers, researchers, research administrators, foundation decisionmakers, healthcare professionals, faculty and students, and concerned individuals.




Regulating Medicines in a Globalized World


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.




Regulating Europe


Book Description

Regulating Europe explains why economic and social regulation is rapidly becoming the new frontier of public policy and public administration in Europe, both at the national and EU levels. Statutory regulation, implemented by independent regulatory bodies, is replacing not only older forms of state intervention but also, to some extent, the redistributive policies of the welfare state. Thus Regulating Europe is an examiniation of the emergence of the regulatory state as the successor of the Keynesian welfare state of the past. Contributions emphasize the parallelism of policy developments at the national and European levels. Part one provides the necessary theoretical background, including a new model of demand and supply of Community regulation. The second part presents a series of case studies of particular regulatory policies and institutions in the UK, Germany, France, Spain and the EU. Part three evaluates current policy and institutional developments, pointing out how the lack of a tradition of statutory regulation in Europe affects the design of the new institutions. Special attention is devoted to the issue of the democratic accountability of expert, politically independent agencies - a problem which, contrary to widespread opinion, is as severe at the national level as it is in Brussels. It is suggested that the requirements of democratic accountability, and of subsidiarity, cannot be met by re-nationalizing European policies, much less by increasing the current level of centralization. A more promising solution is the development of regulatory networks closely integrating national and supranational regulators.




Clinical Pharmacology: Current Topics and Case Studies


Book Description

Today we witness an eventful time in which the powerful new forces of genomics, information technology and economics are rapidly changing the science and art of medicine. This will require more specialization than ever before. However, there is also an increasing demand for an integrated approach, which is provided by the discipline of Clinical Pharmacology (CP). CP pursues a scientific goal by studying drug action in patients and volunteers, a clinical goal by administering appropriate drug therapy and a regulatory goal by assessing the risk/benefit ratio of drug candidates in drug development and reimbursement. This introduction to current topics of CP covers traditional topics of clinical drug research and trial methodology but also provides insight in current topics like genomics, imaging technology and issues in drug reimbursement. A number of concrete case studies in clinical drug research and development help to give a better understanding of the general principles of CP.




A review of UK health research funding


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).