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This timely book discusses the application of the EU competition rules to pharmaceuticals, covering the prohibitions on anticompetitive agreements and abuse of dominance, and merger control. It carefully considers the balance between competition and innovation, as well as between competition and regulation, and concludes that competition and regulation are not alternatives, but complementary, and that novel ways of taking into account risk and real innovation through competition assessments have been developed.

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Monograph Book

Written by an experienced European Patent Attorney and scholar, this book sets out in detail the framework for protection of pharmaceutical innovation under the SPC Regulation. With a focus on both biotechnological innovation and secondary innovation, and through extensive reference to the case law, Ulla Klinge surveys the court’s evolving interpretation of legal and technical eligibility for this extended term of protection. This book provides clear and pragmatic tools to reflect and guide future practice, while offering key explanations and insights as to why and how technological developments challenge the legal SPC framework.

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Monograph Book
Eligibility, Ethics and Public Interest
Edited by Naomi Hawkins

This book examines patent law and policy in biotechnology across the full lifecycle of the patent, focusing on the patent bargain and the public interest. It considers the central issues of how to strike an effective balance of rights, and whether public interest is adequately safeguarded - two issues that are particularly important in areas of rapidly emerging technology.

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Monograph Book
Reclaiming the Right to Health in Latin America

This forward-looking book provides an in-depth analysis of the major transformations of the right to health in Latin America over the past decades, marked by the turn towards the pharmaceuticalisation of health care. Everaldo Lamprea-Montealegre investigates how health-based litigation has deepened inequalities in the global South, exploring the practices of key actors that are reclaiming the right to health in the region.

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Monograph Book
An Evolving Relationship
This timely book emphasizes the importance of regulation in enabling and channelling innovation at a time when technology is increasingly embedded in healthcare. It considers the adequacy of current regulatory approaches, identifying apparent gaps, risks and liabilities, and discusses how these might be collectively addressed. The authors present possible solutions that balance the protection and promotion of public trust in healthcare against enabling technological progress and disruptive innovation.
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Monograph Book
Presenting detailed analysis of the industrialization of pharmaceutical patents in China, this timely book explores a range of related topics including a comparison of the ideal and existing state of the pharmaceutical market and patent industrialization. It argues that the core purpose of the industrialization of pharmaceutical patents is to promote the development of the local pharmaceutical industry whilst also protecting society’s right to safe and effective medication.
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Monograph Book
Law and Regulation
This comprehensive book provides a detailed survey and practical examination of a wide range of legal and regulatory topics in HealthTech. Key features include: • Analysis of the impact of emerging innovations on the accessibility, efficiency and quality of healthcare and its effects on healthcare providers • Examination of artificial intelligence, blockchain and digital identity applications in healthcare, alongside associated regulatory challenges • Guidance on the financial requirements of healthcare start-ups at different stages of growth and various collaboration and partnership models in the HealthTech market • Discussion of the major regulatory questions affecting the HealthTech industry, from data protection, public procurement and product liability, to the regulation of medical devices, intellectual property and advertising.
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Monograph Book
A Global Analysis
Informed consent is the legal instrument that purports to protect an individual’s autonomy and defends against medical arbitrariness. This illuminating book investigates our evolving understanding of informed consent from a range of comparative and international perspectives, demonstrating the diversity of its interpretations around the world. Chapters offer a nuanced analysis of the problems that impede the understanding and implementation of the concept of informed consent and explore the contemporary challenges that continue to hinder both the patient and the medical community.
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Monograph Book
Legal, Ethical, and Scientific Challenges in International Biobanking
With interdisciplinary chapters written by lawyers, sociologists, doctors and biobank practitioners, Global Genes, Local Concerns identifies and discusses the most pressing issues in contemporary biobanking. Addressing pressing questions such as how do national biobanks best contribute to translational research and how could academic and industrial exploitation, ownership and IPR issues be addressed and facilitated, this book contributes to the continued development of international biobanking by highlighting and analysing the complexities in this important area of research.
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Monograph Book
Human Rights, Trade, Patents, Health and the Environment
Biotechnology is a field that inspires complex legal and ethical debates on an international scale. Taking a fresh approach to the subject, Matthias Herdegen provides a comprehensive assessment of the regulation of biotechnology processes and products from an international and comparative perspective.
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Monograph Book