The Challenges Of The New Eu Pharmaceutical Legislation

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.

Private Law in the External Relations of the EU is an innovative study of the interactions between EU external relations law and private law, two unrelated fields of law, inverted if private law is understood as regulatory private law - the space where regulatory law intersects with private economic activity. Here the link between the Internal Market and the global market - and thereby international law - is much more prominent. In this book, key questions about the relationship between EU external relations law and private law are answered, including: in what ways might European private law act as a tool to achieve EU external policy objectives, particularly in regulatory fields? How might the quickly developing EU external competence over the procedural dimensions of private law, including private international law, impact on substantive law, both externally and internally? And how is the legal position of private parties affected by EU external relations? In asking these questions, this edited collection opens up a field of enquiry into the so far underexplored relationship between these two fields of law. In doing so, it addresses three different aspects of the relationship: (i) the evolution of the EU competence, (ii) the ways in which EU private law extends its reach beyond the boundaries of the internal market, and (iii) the ways in which the EU contributes to the formation of private regulation at the international level.

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.

"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 emphasis of this book is on the problem of the efficient use of medicinal products. It is known that this is a subject that is neither new nor unknown. Hundreds of articles have been, and will continue to be written about it. Yet it has not been resolved. The lines of consensus to tackle it have not even been defined, and there are many opinions about different aspects. What is needed is overall consideration and then to try to act on common agreed bases. But first the problem must be analysed, and so the book raises the problem in the form of a Forum. The different actors have to be heard, and the governments, too, of course, which express themselves through the legal system. We are far from providing an adequate response in any national legal system. The debate is still open, but society is waiting for replies from those who have responsibilities. There is no one right answer. Many actors are jointly responsible in this situation...

This monograph brings together a number of important papers dealing with the medical, societal and demographic ramifications of fertility and is a very valuable contribution to the European debate on fertility. The very low fertility levels in several EU Member States are a matter of public concern. An increase in fertility will not by itself stop demographic ageing but can contribute to decelerating current demographic trends. It is therefore essential to understand better the reasons behind Europe's low fertility rates. The difficulty of reconciling private life with a professional career far too often compel women to postpone having a family or to have fewer children than they would desire. It follows that more and more couples reach an age where fertility problems become prevalent. Involuntary infertility is a serious medical condition with strong negative consequences on the wellbeing of the couples concerned and has a negative impact on demographic trends.

Labile blood products and plasma-derived products are very sensitive form a social viewpoint. Along with the challenges faced by all medicinal products there is an added challenge due to the lack of raw material and the social problems with regards to their acquisition. Obtaining them depends on blood and plasma donations, which are insufficient. Europeans as a whole fail to even cover 40 % of their needs in plasma for fractionation. The aspiration that all donations shall be voluntary, free and unpaid, is an altruistic objective, which reality, unfortunately, contradicts every day. Governments and all social Agencies should promote to the maximum its actions in order to achieve the greatest number of donation each day. Even from a humanitarian or ethical viewpoint nobody can deny a possible donor accepting incentives. This incentive discussion, plus the concept of self-sufficiency of countries and more are discussed in this volume.

In the European Union (EU) and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting 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, offering comprehensive and unambiguous guidance at every stage. A brief overview of how the proposed exit from the EU by the UK will affect the regulatory regime is also included. Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of fifteen incisive chapters examines a particular process or subject. Among the many topics and issues covered are the following: - obtaining a marketing authorisation; - stages and standards for creating a product dossier; - clinical trials; - how and when an abridged procedure can be used; - criteria for conditional marketing authorisations; - generic products and ‘essential similarity’; - paediatric use and the requisite additional trials; - biologicals and ‘biosimilars’; - homeopathic and herbal medicines; - reporting procedures; - pharmacovigilance; - parallel trade; - relevant competition law and intellectual property rights; and - advertising. In addition, national variation charts in many of the chapters illustrate eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK). Sample forms and URLs for the most important Directives are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.