Standards are a feature of virtually all areas of trade in products and services. Yet, although standards may achieve an efficient economic exchange, they have discriminatory consequences for trading partners when governments formulate or apply them in such a way as to cause obstacles to trade, thus enrolling standards among the increasingly significant 'non-tariff barriers' regulated by the WTO. This unique and original study analyses the functions that standards fulfil in the market, their effect on trade, and the legal regime based on harmonization, equivalence and mutual recognition developed by the WTO to deal with standards. The author investigates the way in which both the WTO Technical Barriers to Trade (TBT) and the Sanitary and Phytosanitary (SPS) Measures Agreements regulate these three tools, and discusses key topics including: The definition of the concept 'International Standard' in the TBT Agreement. Guidelines on equivalence issued by organizations such as the Codex Alimentarius Commission, the World Organization for Animal Health and the International Plant Protection Convention. Parallels between the EC mutual recognition regime and the WTO system. This is the first work on its subject. With its detailed and practical analysis of WTO law on standards, the book is a fundamental reference for practitioners, academics and policy makers in international trade law.

Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en

Mutual Recognition (MR) implies that each Member State is free to use the standards for production it prefers but cannot inhibit the import from other Member States lawfully using other standards, unless justified by emergency reasons. The home country rule then prevails on the host country. Barriers to entry diminish, competition rises in the internal market. This volume looks at a number of aspects of MR, including why its importance cannot be understood outside the general practice of free movement and how some elements of MR already emerge in the skilled labour market of professionals.

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.

In view of the alleged democratic deficit at the European level, it is all the more important that the administration of European law suffers neither from an application or enforcement deficit nor from a judicial deficit. This concern is particularly acute when the Member States depend on each other for the effective implementation of European law. Since the Treaty leaves the administration of European law primarily in the hands of the Member States, without offering a legal basis for the harmonization of procedural administrative law, each area of law has its own administrative procedural rules. It is evaluated in the context of Community product regulation whether the available European rules are adequate to enable the administration to achieve the aims of the legislation (the free movement of authorized products on the internal market and a high level of protection for the environment or public health) and guarantee respect for the right to be heard and the right to judicial protection as well. This book demonstrates that many lessons could be learned from the regulation of products in order to improve the drafting of European legislation that produces European administrative decisions. Then, it is no longer necessary to reinvent the wheel each time effective implementation requires administrative cooperation between the Member States and the Community institutions and bodies. The main result of administrative cooperation between the Member States, with the aid of the Community institutions and bodies, is the creation of administrative decisions with EU-wide effect. This occurs for instance through mutual recognition of administrative decisions. The exchange of information and mutual assistance should give enforcement EU-wide effect as well, but this is still in its infancy in the area of EC product regulation. The development of rules, which ensure respect for the right to be heard and to judicial protection, is also lagging behind. This leads to gaps in the legal protection of individuals.

This book is a comprehensive, detailed, and highly systematic treatment which both describes and critically analyses the administrative law and policy of the European Union.