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Lawyers and academics reassess the impact of European law on health care and pharmaceutical law.
Pharmaceuticals Biotechnology and the Law is the definitive guide to the law in Europe relating to pharmaceuticals, biotechnology and their related areas such as medical devices.Written by leading patent and regulatory lawyer (Trevor Cook, WilmerHale), this is the only text which comprehensively covers the wide variety of legal and regulatory issues which surround these industry sectors.The new edition examines the background to, and the impact of, the law affecting this area. The text is primarily written from the perspective of European Community law, although in those relatively few areas where this is not harmonised it is written from the perspective of English law.
The book is written to help lawyers faced with the challenge of identifying the legal issues and processes that must be faced by their clients in building, marketing, and protecting a biotech business. The contributors are experts in this specialized area and provide thorough, yet accessible, overviews of biotech subspecialties with an eye to practical application. A biotech legal practice involves specialized subject matter and regulatory schemes that, generally, are not part of the business lawyer's repertoire and which can present many hazards for the uninitiated. Because of the expansion in biotech practice beyond the traditional organizations and their representatives, this guide was written to help lawyers find their way through the biotech maze.
Pharmaceuticals Biotechnology and the Law is the definitive guide to the law in Europe relating to pharmaceuticals, biotechnology and their related areas such as medical devices.Written by one of the country's leading patent and regulatory lawyers (Trevor Cook, Bird & Bird), this is the only text which comprehensively covers the wide variety of legal and regulatory issues which surround these industry sectors.The book examines the background to, and the impact of, the law affecting this area. The text is primarily written from the perspective of European Community law, although in those relatively few areas where this is not harmonised it is written from the perspective of English law.The book has been comprehensively updated if not re-written to take account of the enormous amount of development in the field since publication of the first edition in 1991.Virtually every single regulatory framework addressed is completely new or radically updated since then and, for example, only two of the materials in the appendix date back to the first edition (e.g., pricing transparency and contained use).Entire areas of law have developed since then, such as regulatory data, which is accorded three chapters of coverage within the book. The field has also seen the introduction of the EPC 2000, the Biotechnology Directive and the maturing of biotechnology patenting, which was in its infancy at the time of the first edition. From these developments has come a raft of case law which is cross-referred to throughout.
"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.
The main problem in the use of medicinal plants, discussed in this book, is that citizens are being persuaded that herbal medicine is based on its low or even absent toxicology. A good efficacy is assumed as self-evident, and therapeutic benefit without risks is expected. Many users prefer natural medicine instead of synthetic remedies. However, the number of reports on unwanted side effects of phytomedicines increased in the last years. In some instances, a lack of pharmaceutical quality was found. The unqualified recommendation of herbal medicines may represent a considerable risk to the user. The use of a herbal remedy with unproven efficacy can represent a risk for the user when a more effective and necessary treatment will therefore be stopped or omitted. These circumstances must be taken into account by the governments, inspection services, the doctors and the judges. The present approach to herbal medicines and fraud with these products do not receive the necessary punishment because it is believed that if the product does not have any therapeutic property, it cannot entail any harm either.
The pharmaceutical industry and patent legislation are inextricably linked. Pharmaceutical companies could not exist without some guarantee that they can recoup the cost of developing a new product. European patent law offers this opportunity, as it allows companies to exclude competition for a specific product for a fixed time scale. In Pharmaceutical Patents in Europe the current legal patent situation is examined by a detailed analysis of case law from the European Patent Office (EPO), the international body created with the signing of the European Patent Convention (EPC). Aspects of European patent law not primarily regulated in the EPC, for example Supplementary Protection Certificates and infringement matters, are examined in the setting provided by EC law and domestic laws of European states. This book is written for the reader who understands the main characteristics of patent law and is looking for a practitioner's text on the European pharmaceutical patent law scene. Moreover, the author's remarks can help all readers to look at the field with fresh eyes.
A comprehensive analysis of European competition law and intellectual property law issues affecting the pharmaceutical and biotechnology sectors, offering both theoretical and practical perspectives.
In this thoroughly updated second edition, Matthias Herdegen provides a comprehensive and contemporary assessment of the regulation of biotechnology processes and products from an international and comparative perspective, complete with analysis of intricate legal and ethical debates.