Download or read book A User s Guide to Intellectual Property in Life Sciences written by Paul England and published by Bloomsbury Publishing. This book was released on 2021-03-26 with total page 922 pages. Available in PDF, EPUB and Kindle. Book excerpt: Life Sciences is one of the most innovative and complex areas of law. It is currently undergoing a period of intense transformation, with companies facing an ever-increasing level of regulation as well as strict cost management in order to remain competitive and profitable. The latest in "A User's Guide to..." series it covers life sciences in relation to: - patents - copyright - trade marks; and - data protection The book covers UK law with references to significant EPO cases. A key part of the book is the coverage of case law. Case studies and detailed analysis of the key cases, eg the Kymab mouse case, the human genome sciences case, and the pregabalin case feature heavily helping to put this often complex area of law into context. Where appropriate and for comparison purposes, approaches of key foreign jurisdictions are summarised and for ease of use there are clearly signposted. A key text for practitioners specialising in life sciences and intellectual property in general and patents officers dealing with life sciences applications.

Download or read book Medicine patients and the law written by Emma Cave and published by Manchester University Press. This book was released on 2023-06-06 with total page 729 pages. Available in PDF, EPUB and Kindle. Book excerpt: Embryo research, cloning, assisted conception, neonatal care, pandemic vaccine development, saviour siblings, organ transplants, drug trials – modern developments have transformed the field of medicine almost beyond recognition in recent decades and the law struggles to keep up. In this highly acclaimed and very accessible book Margaret Brazier, Emma Cave and Rob Heywood provide an incisive survey of the legal situation in areas as diverse as fertility treatment, patient consent, assisted dying, malpractice and medical privacy. The seventh edition of this book has been fully revised and updated to cover the latest cases, Brexit-related regulatory reform and COVID-19 pandemic measures. Essential reading for healthcare professionals, lecturers, medical and law students, this book is of relevance to all whose perusal of the daily news causes wonder, hope and consternation at the advances and limitations of medicine, patients and the law.

Download or read book Guide to EU and UK Pharmaceutical Regulatory Law written by Sally Shorthose and published by Kluwer Law International B.V.. This book was released on 2023-01-10 with total page 840 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but also 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. Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of the following twenty-one incisive chapters examines a particular process or subject. Among the many topics and issues covered from both an EU and UK perspective are the following: clinical trials; stages and standards for creating a product dossier; obtaining a marketing authorisation; how and when an abridged marketing authorisation procedure can be used; criteria for conditional marketing authorisations; generic products and ‘essential similarity’; paediatric use and the requisite additional trials; orphan medicinal products; biologicals and ‘biosimilars’; homeopathic, herbal and similar medicines; medical devices; pandemics, epidemics and vaccines; pharmacovigilance; parallel trade; advertising; and relevant competition law, intellectual property rights and data protection regulation. In addition, sample forms and URLs for the most important reference materials 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.

Download or read book Clinical Negligence written by Dr Michael Powers KC and published by Bloomsbury Publishing. This book was released on 2023-08-04 with total page 1444 pages. Available in PDF, EPUB and Kindle. Book excerpt: "I would highly recommend this book...It is high quality, clear and comprehensive and will no doubt prove an invaluable source of reference. Five stars on all counts." Tim Kevan, co-editor, PIBULJ.COM This book remains the only text of its kind to cover both the medical and legal aspects of medical negligence. Written by a team of more than 60 experts, it continues to provide the most comprehensive and authoritative guidance on all aspects of clinical negligence claims, from bringing an action for damages to presenting expert evidence in court. It also includes detailed consideration of funding and cost implications. Those needing clear guidance to make the best possible preparations for an action will find all they need here. The new 6th edition has been fully revised and restructured, including new chapters on the future of clinical negligence litigation, cardiology, gynaecology, obstetrics, haematology , and also includes coverage and analysis of recent key cases such as: - Williams v Bermuda Hospitals [2016] UKPC 4 (causation) - R (on the application of Maughan) v HM Senior Coroner for Oxfordshire [2020] UKSC 46 (suicide in inquests) - Darnley v Croydon Health Authority [2018] UKSC 50 (duty of care owed by receptionist) - ABC v St George's Hosp [2020] EWHC 455 (Huntington's chorea confidentiality) - Swift v Carpenter [2020] EWCA Civ 1295 (future accommodation costs) - Whittington Hospital NHS Trust v XX [2020] UKSC 14 (damages for surrogacy) - Khan v Meadows [2021] UKSC 21 (scope of duty of care) - Nguyen v HM Assistant Coroner for Inner West London [2021] EWHC 3354 (sufficiency of inquiry) Easy-to-access structure The new edition maintains its easy-to-access, two-part structure. The first part, set out in 16 chapters, deals with legal aspects of medical malpractice, including complaints procedures, poor performance and medical professional governance, preparation of medical evidence, settlements and trial. There are also chapters on product liability, and coronial law. The final 27 chapters in the second part cover the risks associated with particular areas of specialist medical practice. This title is included in Bloomsbury Professional's Clinical Negligence online service.

Download or read book Pharmaceutical Test Data Exclusivity written by John C. Todaro and published by Kluwer Law International B.V.. This book was released on 2022-08-12 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data exclusivity gives pharmaceutical companies a limited period of time in which clinical test data are exclusive to the innovator. Internationally, however, aside from prohibition against unfair commercial use, there are no specifics as to how these data are protected; exclusivity is available on a jurisdiction-by-jurisdiction basis. This book, the only one of its kind, provides expert guidance, chapter by chapter, on test data exclusivity rights for pharmaceutical products in twenty-two major markets worldwide. For each jurisdiction, in addition to explaining the available regulatory data protection – including both substantive and formal requirements for approvals and testing, protection of undisclosed data, confidentiality, and enforcement in practice – local experts provide detailed information and guidance on the degree to which test data exclusivity may be achieved in such areas of pharmaceutical research as the following: infectious disease products; paediatrics products; chemical and biological products; agricultural products; animal health products; orphan drugs; and new chemical entities. This book originated from a project conducted by the Pharma Committee of the International Association for the Protection of Intellectual Property (AIPPI), the world’s leading non-profit association dedicated to the development, expansion, and improvement of international and regional treaties and agreements and national laws relating to intellectual property. Many committee members and observers are authors of chapters in this book. An unmatched starting point for innovator pharmaceutical companies and their advisers to evaluate data exclusivity rules and opportunities around the world, this book will be an invaluable resource for IP professionals, governments, non-governmental organizations, and international organizations to promote and share IP laws and practices.

Download or read book A Practitioner s Guide to European Patent Law written by Paul England and published by Bloomsbury Publishing. This book was released on 2022-09-08 with total page 659 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition is a comprehensive and practical guide to European patent law – a 'ius commune'. The book highlights the areas of consistency and difference between the most influential European patent law jurisdictions: the European Patent Office, England and Wales, France, Germany, and the Netherlands. The book also draws insights from further afield, with contributions from other, very active, patent jurisdictions, including Italy, Sweden, Denmark, and Switzerland. Uniquely, the book addresses European patent law by subject matter area, assessing the key national and EPO approaches together rather than nation by nation. Each chapter outlines the common ground between the national approaches and provides a guide for the possible application of European patent law in national courts and the UPC in the future. In addition to featuring content on new countries, the second edition includes new chapters dedicated to the substantive aspects of FRAND, declarations, and evidence. There is also an expanded commentary on construction, including common terms used in patent claims. A must-read for anyone working in the field of European patent law.

Download or read book Cases and Materials on Constitutional and Administrative Law written by Brian Thompson and published by Oxford University Press. This book was released on 2021-10-14 with total page 737 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cases and Materials on Constitutional and Administrative Law provides an essential collection of key primary and secondary materials with incisive commentary from the authors.

Download or read book Product Liability written by Duncan Fairgrieve and published by Oxford University Press. This book was released on 2020-05-20 with total page 1329 pages. Available in PDF, EPUB and Kindle. Book excerpt: Product Liability is a recognised authority in the field and covers the product liability laws through which manufacturers, retailers, and others may be held liable to compensate persons who are injured, or who incur financial loss, when the products which they manufacture or sell are defective or not fit for their purpose. Product defects may originate in the production process, be one of design, or be grounded in a failure to issue an adequate warning or directions for safe use and practitioners advising business clients or claimants will find this book provides all the necessary information for practitioners to manage a product liability claim. This new edition has been fully updated to take account of 10 years of development in case law and regulation, and the increasing impact of cross-border and transnational sale of goods. The Court of Justice of the European Union handed down major rulings concerning the Product Liability Directive which affect the application of the Directive and national arrangements and Fairgrieve and Goldberg examines this in detail. For any legal practitioner operating in areas which require knowledge of European product liability law, an understanding of the impact of recent developments is essential and this work is an essential resource for practitioners working on product liability, sale of goods, personal injury and negligence. The work provides comprehensive coverage of the law of negligence as it applies to product liability, of the strict liability provisions of the Consumer Protection Act 1987, and of the EU's Product Liability Directive on which the Act is based. Although the majority of cases involve pharmaceuticals and medical devices, in recent English cases the allegedly defective products have been as diverse as a child's buggy, an All Terrain Vehicle, and even a coffee cup. Many cases are brought as group actions, and the book examines the rights of those who are injured by defective products. As well as considering the perspective of the law as it has developed in the UK, this edition contains detailed discussion of case law from other jurisdictions including the USA, Australia, New Zealand, Canada, France and Germany. The coverage in the work is complemented by a full analysis of issues which arise in transnational litigation involving problems of jurisdiction and the choice of laws.

Download or read book Intellectual Property Free Trade Agreements and the United Kingdom written by Johnson, Phillip and published by Edward Elgar Publishing. This book was released on 2021-10-12 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining how trade agreements are interpreted both in trade tribunals and in the United Kingdom, this innovative book provides a well-rounded exploration of the numerous UK free trade agreements, including the UK–EU Trade and Cooperation Agreement, and their legal and policy implications for intellectual property.

Download or read book Not What The Bus Promised written by Tamara Hervey and published by Bloomsbury Publishing. This book was released on 2023-10-05 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: What does the UK's exit from the EU mean for health and the NHS? This book explains the legal and practical implications of Brexit on the NHS: its staffing; especially on the island of Ireland; medicines, medical devices and equipment; and biomedical research. It considers the UK's post-Brexit trade agreements and what they mean for health, and discusses the effects of the COVID-19 pandemic on post-Brexit health law. To put the legal analysis in context, the book draws on over 400 conversations the authors had with people in the north of England and Northern Ireland, interviews with over 40 health policy stakeholders, details of a film about their research made with ShoutOut UK, the authors' work with Parliaments and governments across the UK, and their collaborations with key actors like the NHS Confederation, the British Medical Association, and Cancer Research UK. The book shows that the language people use to talk about hoped-for legitimate post-Brexit health governance suggests a great deal of faith in law and legal process among 'ordinary people', but the opposite from 'insider elites'. Not What The Bus Promised puts the authors' knowledge and experiences centre frame, rather than claiming to express 'objective reality'. It will be of interest to any reader who cares about the NHS and wants to understand its present and future.

Download or read book The Law of Off label Uses of Medicines written by Andrea Parziale and published by Taylor & Francis. This book was released on 2022-08-12 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA. Before reaching patients, medicines are extensively tested by manufacturers and approved by regulators to minimise the risk of adverse reactions. However, physicians can prescribe pharmaceuticals for off-label uses, widespread in paediatrics, oncology, rare diseases and, more recently, in treatment for Covid-19. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. Clarification is therefore needed to improve the protection of patients' rights while enhancing legal certainty for health actors. To this end, this work clarifies the regulatory mechanisms and litigation trends concerning off-licence prescriptions in these jurisdictions. It assesses how traditional, prevention-driven regulatory and civil liability rules are being adapted to tackle potential risks and scientific uncertainty. The book outlines the applicable regulations, as well as considering Brexit’s impact on off-label policies in the UK, and EU and national off-label policies in the context of the fight against the Covid-19 pandemic. It also explores under what conditions physicians, manufacturers, or regulators must compensate patients injured by untested prescriptions. The book will be an essential resource for researchers, academics and policy-makers working in the areas of medical law and ethics, public health law, pharmaceutical law and private comparative law.

Download or read book European SPCs Unravelled written by Oswin Ridderbusch and published by Kluwer Law International B.V.. This book was released on 2021-06-18 with total page 898 pages. Available in PDF, EPUB and Kindle. Book excerpt: While supplementary protection certificates (SPCs) are governed by the same substantive rules in all Member States of the European Union and the European Economic Area (EEA), they are national intellectual property rights. The formal requirements and procedural practices of the national patent offices granting SPCs still differ significantly, and these divergences can have a substantial impact on the prosecution of SPCs across Europe. This one-of-a-kind handbook provides an in-depth review of SPC law in Europe, covering all substantive and procedural aspects of prosecution, enforcement and invalidation, as well as SPC-related aspects of unfair competition law. Following an overarching European chapter, which addresses general considerations and the relevant European Union law, including the jurisprudence of the Court of Justice (CJEU) and the EFTA Court, this book contains detailed national chapters for all European states that provide SPCs − i.e., the twenty-seven EU Member States (Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden), the EEA/EFTA states Norway and Iceland, as well as the United Kingdom, Switzerland/Liechtenstein, Serbia, Bosnia and Herzegovina, Albania, and North Macedonia. The contributors to this book, all seasoned experts in the field of SPCs in their respective jurisdictions, provide clear and hands-on guidance on the most pertinent SPC-related topics of practical and strategic relevance. The considerably expanded second edition of this handbook offers a comprehensive analysis of European SPC law and practice, covering all European states with SPC systems in detailed national chapters. As such, this book provides invaluable assistance to IP practitioners in devising successful pan-European SPC filing and litigation strategies. Its practice-oriented approach, in combination with a country-by-country format where all chapters follow the same structure, makes it easy to compare the national practices and the respective national case law of the different European countries. ‘The present work fills a gap and provides, for the first time, an overview of the SPC practice in the EU Member States, which despite the intended harmonization by the respective EU legislation is still decidedly inconsistent in some areas. Altogether, this successful work, with its streamlined structure and clear language that is immediately comprehensible even to non-native speakers, functions not “only” as a source of information for European attorneys, authorities and courts. It also conveys – perhaps not at all intended by the authors – the unique diversity of this European legal regime, which for many exerts a special fascination. The present Practitioner’s Guide can be recommended without reservation and should not be missing in any specialist library.’ – Jürgen Schell, Judge at the German Federal Patent Court, on the first edition of this book.

Download or read book Law and Legacy in Medical Jurisprudence written by Edward S. Dove and published by Cambridge University Press. This book was released on 2022-03-10 with total page 449 pages. Available in PDF, EPUB and Kindle. Book excerpt: Graeme Laurie stepped down from the Chair in Medical Jurisprudence at the University of Edinburgh in 2019. This edited collection pays tribute to his extraordinary contributions to the field. Graeme often spoke about the importance of 'legacy' in academic work and forged a remarkable intellectual legacy of his own, notably through his work on genetic privacy, human tissue and information governance, and the regulatory salience of the concept of liminality. The essays in this volume animate the concept of legacy to analyse the study and practice of medical jurisprudence. In this light, legacy reveals characteristics of both benefit and burden, as both an encumbrance to and facilitator of the development of law, policy and regulation. The contributions reconcile the ideas of legacy and responsiveness and show that both dimensions are critical to achieve and sustain the health of medical jurisprudence itself as a dynamic, interdisciplinary and policy-engaged field of thinking.

Download or read book Digital Contact Tracing for Pandemic Response written by Jeffrey P. Kahn and published by JHU Press. This book was released on 2020-05-29 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: As nations race to hone contact-tracing efforts, the world's experts consider strategies for maximum transparency and impact. As public health professionals around the world work tirelessly to respond to the COVID-19 pandemic, it is clear that traditional methods of contact tracing need to be augmented in order to help address a public health crisis of unprecedented scope. Innovators worldwide are racing to develop and implement novel public-facing technology solutions, including digital contact tracing technology. These technological products may aid public health surveillance and containment strategies for this pandemic and become part of the larger toolbox for future infectious outbreak prevention and control. As technology evolves in an effort to meet our current moment, Johns Hopkins Project on Ethics and Governance of Digital Contact Tracing Technologies—a rapid research and expert consensus group effort led by Dr. Jeffrey P. Kahn of the Johns Hopkins Berman Institute of Bioethics in collaboration with the university's Center for Health Security—carried out an in-depth analysis of the technology and the issues it raises. Drawing on this analysis, they produced a report that includes detailed recommendations for technology companies, policymakers, institutions, employers, and the public. The project brings together perspectives from bioethics, health security, public health, technology development, engineering, public policy, and law to wrestle with the complex interactions of the many facets of the technology and its applications. This team of experts from Johns Hopkins University and other world-renowned institutions has crafted clear and detailed guidelines to help manage the creation, implementation, and application of digital contact tracing. Digital Contact Tracing for Pandemic Response is the essential resource for this fast-moving crisis. Contributors: Joseph Ali, JD; Anne Barnhill, PhD; Anita Cicero, JD; Katelyn Esmonde, PhD; Amelia Hood, MA; Brian Hutler, Phd, JD; Jeffrey P. Kahn, PhD, MPH; Alan Regenberg, MBE; Crystal Watson, DrPH, MPH; Matthew Watson; Robert Califf, MD, MACC; Ruth Faden, PhD, MPH; Divya Hosangadi, MSPH; Nancy Kass, ScD; Alain Labrique, PhD, MHS, MS; Deven McGraw, JD, MPH, LLM; Michelle Mello, JD, PhD; Michael Parker, BEd (Hons), MA, PhD; Stephen Ruckman, JD, MSc, MAR; Lainie Rutkow, JD, MPH, PhD; Josh Sharfstein, MD; Jeremy Sugarman, MD, MPH, MA; Eric Toner, MD; Mar Trotochaud, MSPH; Effy Vayena, PhD; Tal Zarsky, JSD, LLM, LLB

Download or read book WHO guideline on country pharmaceutical pricing policies written by and published by World Health Organization. This book was released on 2020-09-29 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.

Download or read book The Human Medicines Amendment EU Exit Regulations 2021 written by Great Britain and published by . This book was released on 2021-07-13 with total page 4 pages. Available in PDF, EPUB and Kindle. Book excerpt: Enabling power: European Union (Withdrawal) Act 2018, s. 8C (1). Issued: 13.07.2021. Sifted: -. Made: 12.07.2021. Laid: 13.07.2021. Coming into force: 03.08.2021. Effect: S.I. 2012/1916; 2019/775; 2020/1488 amended. Territorial extent & classification: E/W/S/NI. General. This Statutory Instrument has been printed to correct an error in S.I. 2020/1488 (which amended S.I. 2019/775, which amended S.I. 2012/1916) and is being issued free of charge to all known recipients of that Statutory Instrument

Download or read book International Health Regulations 2005 written by World Health Organization and published by World Health Organization. This book was released on 2008-12-15 with total page 82 pages. Available in PDF, EPUB and Kindle. Book excerpt: In response to the call of the 48th World Health Assembly for a substantial revision of the International Health Regulations, this new edition of the Regulations will enter into force on June 15, 2007. The purpose and scope of the Regulations are "to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade." The Regulations also cover certificates applicable to international travel and transport, and requirements for international ports, airports and ground crossings.