A Legal Analysis on the Current Trade Status of Traditional Chinese Medicinal Product in the E.U. -- From the Perspectives of WTO Law and E.U. Pharmaceutical Law PDF Download
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Author: Saisai Wang
Publisher:
ISBN:
Category :
Languages : en
Pages : 26
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Book Description
This paper is based on the investigation and research for a project -- China and Europe Taking Care of Healthcare Solutions and aims to discuss the trading environment of traditional Chinese medicinal product in European Union from the legal aspect including E.U. pharmaceutical law and World Trade Organization rules. It concerns the general knowledge of healthcare issues of WTO law, basic understandings of Chinese and western people concerning Traditional Chinese Medicine and market access provision of E.U. pharmaceutical law, hereinto to discuss the prospect and development difficulties and trend of TCM in E.U., and economic and political concerns are involved. The methodology of qualitative study is used, mainly including literature review, case study, and interview. It concludes that the E.U. law has set up standards to register traditional herbal medicinal products, yet it is very difficult for TCMP producers to reach the standards at this moment due to the lack of scientific data and references. E.U. has recognized the merit of traditional medicine; by comparing with the full acceptance of the efficacy of western conventional medicine, the writers foresee that traditional Chinese medicine will require a more general treatment in law of trade sooner or later.
Author: Saisai Wang
Publisher:
ISBN:
Category :
Languages : en
Pages : 26
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Book Description
This paper is based on the investigation and research for a project -- China and Europe Taking Care of Healthcare Solutions and aims to discuss the trading environment of traditional Chinese medicinal product in European Union from the legal aspect including E.U. pharmaceutical law and World Trade Organization rules. It concerns the general knowledge of healthcare issues of WTO law, basic understandings of Chinese and western people concerning Traditional Chinese Medicine and market access provision of E.U. pharmaceutical law, hereinto to discuss the prospect and development difficulties and trend of TCM in E.U., and economic and political concerns are involved. The methodology of qualitative study is used, mainly including literature review, case study, and interview. It concludes that the E.U. law has set up standards to register traditional herbal medicinal products, yet it is very difficult for TCMP producers to reach the standards at this moment due to the lack of scientific data and references. E.U. has recognized the merit of traditional medicine; by comparing with the full acceptance of the efficacy of western conventional medicine, the writers foresee that traditional Chinese medicine will require a more general treatment in law of trade sooner or later.
Author: Saisai Wang
Publisher: Springer Nature
ISBN: 3030528480
Category : Law
Languages : en
Pages : 202
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Book Description
This book presents an in-depth analysis of issues in trade law and EU pharmaceutical law concerning market access for traditional Chinese medicinal products. It discusses these issues from the standpoints of fundamental law, international law and EU law, so to offer a comprehensive perspective. Specifically, it points out the core legislative issues for EU policymakers who deal with market access for traditional medicinal products; describes the relation between law and science; and offers essential information on herbal medicinal product registration in the EU. Further, it compares EU law and Chinese law in this regard, which can offer inspirations for readers from other counties that have similar medicinal products. The book uses straightforward, accessible language to break down the key issues involved.
Author: Pablo Figueroa
Publisher: Edward Elgar Publishing
ISBN: 1785362615
Category : Business & Economics
Languages : en
Pages : 758
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Book Description
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.
Author: World Intellectual Property Organization
Publisher: WIPO
ISBN: 9280523082
Category : Law
Languages : en
Pages : 259
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Book Description
This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Author: Sally Shorthose
Publisher: Kluwer Law International
ISBN: 9789041169525
Category : Business & Economics
Languages : en
Pages : 639
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Book Description
Guide to EU Pharmaceutical Regulatory Law, which is updated annually to reflect the speed at which the rules and regulations change, provides a comprehensive and practical guide to, and analysis of, the current European Union (EU) Pharmaceutical Regulatory Regime. In the 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 that 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 product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. What's in this book: 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 the 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 IP rights; and advertising. In addition, national variation charts in many of the chapters illustrate how the regime operates in the eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK). Sample forms and URLs for the most important Directives are also included. A brief overview of how the proposed exit from the EU by the UK will affect the regulatory regime is also included. How this will help you: Starting with an overview, this book primarily deals with how pharmaceutical products are brought to market from the conduct of clinical trials through amendments to marketing authorisations and abridged (generic) applications - the routes to obtaining a marketing authorisation covering special regimes such as the paediatric system and conditional marketing authorisations. Thus, this book serves as a guide for pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations. In addition, this book also provides guidance on how ancillary subjects such as IP law, competition law, parallel imports and the regulation of homeopathic products influence pharmaceutical regime.
Author: European Commission
Publisher:
ISBN:
Category : Det indre marked
Languages : en
Pages : 124
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Book Description
Author: National Intelligence Council
Publisher: Cosimo Reports
ISBN: 9781646794973
Category :
Languages : en
Pages : 158
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Book Description
"The ongoing COVID-19 pandemic marks the most significant, singular global disruption since World War II, with health, economic, political, and security implications that will ripple for years to come." -Global Trends 2040 (2021) Global Trends 2040-A More Contested World (2021), released by the US National Intelligence Council, is the latest report in its series of reports starting in 1997 about megatrends and the world's future. This report, strongly influenced by the COVID-19 pandemic, paints a bleak picture of the future and describes a contested, fragmented and turbulent world. It specifically discusses the four main trends that will shape tomorrow's world: - Demographics-by 2040, 1.4 billion people will be added mostly in Africa and South Asia. - Economics-increased government debt and concentrated economic power will escalate problems for the poor and middleclass. - Climate-a hotter world will increase water, food, and health insecurity. - Technology-the emergence of new technologies could both solve and cause problems for human life. Students of trends, policymakers, entrepreneurs, academics, journalists and anyone eager for a glimpse into the next decades, will find this report, with colored graphs, essential reading.
Author: Anu Bradford
Publisher: Oxford University Press
ISBN: 0190088605
Category : Law
Languages : en
Pages : 368
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Book Description
For many observers, the European Union is mired in a deep crisis. Between sluggish growth; political turmoil following a decade of austerity politics; Brexit; and the rise of Asian influence, the EU is seen as a declining power on the world stage. Columbia Law professor Anu Bradford argues the opposite in her important new book The Brussels Effect: the EU remains an influential superpower that shapes the world in its image. By promulgating regulations that shape the international business environment, elevating standards worldwide, and leading to a notable Europeanization of many important aspects of global commerce, the EU has managed to shape policy in areas such as data privacy, consumer health and safety, environmental protection, antitrust, and online hate speech. And in contrast to how superpowers wield their global influence, the Brussels Effect - a phrase first coined by Bradford in 2012- absolves the EU from playing a direct role in imposing standards, as market forces alone are often sufficient as multinational companies voluntarily extend the EU rule to govern their global operations. The Brussels Effect shows how the EU has acquired such power, why multinational companies use EU standards as global standards, and why the EU's role as the world's regulator is likely to outlive its gradual economic decline, extending the EU's influence long into the future.
Author: Pierre Sauve
Publisher: World Bank Publications
ISBN: 0821383434
Category : Political Science
Languages : en
Pages : 246
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Book Description
Trade in services, far more than trade in goods, is affected by a variety of domestic regulations, ranging from qualification and licensing requirements in professional services to pro-competitive regulation in telecommunications services. Experience shows that the quality of regulation strongly influences the consequences of trade liberalization. WTO members have agreed that a central task in the ongoing services negotiations will be to develop a set of rules to ensure that domestic regulations support rather than impede trade liberalization. Since these rules are bound to have a profound impact on the evolution of policy, particularly in developing countries, it is important that they be conducive to economically rational policy-making. This book addresses two central questions: What impact can international trade rules on services have on the exercise of domestic regulatory sovereignty? And how can services negotiations be harnessed to promote and consolidate domestic policy reform across highly diverse sectors? The book, with contributions from several of the world's leading experts in the field, explores a range of rule-making challenges arising at this policy interface, in areas such as transparency, standards and the adoption of a necessity test for services trade. Contributions also provide an in-depth look at these issues in the key areas of accountancy, energy, finance, health, telecommunications and transportation services.
Author: Isabelle Van Damme
Publisher:
ISBN: 0199562237
Category : Law
Languages : en
Pages : 487
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Book Description
This book analyzes how the Appellate Body uses particular principles of general international law in interpreting the WTO covered agreements. It deals equally with general international law and WTO law. The aim is to explain how the Appellate Body interprets and applies customary international law on treaty interpretation in dealing with the WTO covered agreements. The main concern is to analyze the judicial reasoning and ways of justifying judicial decision-making. In particular, it answers the question of how the Appellate Body explains its reading of WTO treaty language. It is argued that the Appellate Body has interpreted the WTO covered agreements in a contextual and effective manner, an approach that corresponds with general international law. The character of the WTO covered agreements has, nevertheless, confronted the Appellate Body with some questions of interpretation that were until recently unexplored or neglected by other courts and tribunals. In that sense, the Appellate Body has contributed to the development of general international law on treaty interpretation, or at least to its practice. WTO law is primarily treaty law, but increasingly soft law and broader themes and values from other disciplines, such as governance, variable geometry and legitimacy, are introduced and discussed. Customary international law - with the exception of the principles of treaty interpretation - and general principles of law are often seen as excluded entirely. An ancillary theme of this proposed monograph is the extent to which customary international law and general principles of law have penetrated WTO law through the technique of treaty interpretation.
