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Please see below for the English version
《医药与法律——中国医药健康产业法律服务与实务指南》（“《医药与法律》”）第一版自2015年面市以来广受读者欢迎。近年来，健康中国战略全面实施，医药卫生体制改革不断深入推进，我国的医药医疗健康产业发生着日新月异的变化，医药工业领域的基本大法先后修订，响应时代呼声的新法新规陆续重磅出台和更新，与国际接轨的各项制度落地实施，“互联网+医疗”等新兴业务迅猛发展，医药反腐风暴力度强劲持续升级……在种种新规、新举、新气象下，《医药与法律》的更新显得愈发重要。
历时超过一年，凝聚了金杜医药医疗板块三十多位合伙人与顾问心血的《医药与法律》第二版顺利付梓、与大家见面！
《医药与法律》 第二版
Second edition of Pharmaceuticals and the Law
亮点解读
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迎合最新热点：
近年来，企业尤其是中央企业合规管理工作全面深入推进，尤其是今年五月以来“史上最强”医药反腐专项行动的雷霆展开，医药医疗企业建立健全合规管理组织体系显得尤为重要。《医药与法律》第二版紧跟时事，结合医药行业企业特点，不仅聚焦大合规管理体系的构建，更在全书贯穿各个具体合规领域的核心重点，详细解读企业合规管理体系建设和各领域合规要求。
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兼具深度与广度：
《医药与法律》第二版对我国最新医药医疗法规政策进行了全方位、多角度的梳理，全面囊括药品、医疗器械和医疗机构等医药医疗行业核心监管领域，同时尝试探讨了医药健康产业全链条、各环节的众多热点法律问题，涉及许可交易、知识产权、反垄断、反商贿、出口管制与制裁、争议解决、医药医疗企业合规体系建设、数据、税务、环保与安全生产、广告、劳动等各业务领域，力求在全面与深入中取得平衡。
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综合指导性和可读性：
在第一版的基础上，《医药与法律》第二版更加注重理论与实务的结合，通篇采用“一问一答”与“以案说法”的形式，解读经典案例，剖析各项基础制度下的运用和实践，给读者直接有效的指引。
内容速览
《医药与法律》第二版共计四编二十二个章节，全书合计超过五十万字。涵盖内容从医药医疗领域的基本监管制度，到行业常见许可及资产交易，横向跨越知识产权、境内外投融资、资本市场、合规、反垄断、进出口贸易、出口管制与制裁等与医药医疗行业相关的多个法律领域。
第一编 监管及基本制度
从医药医疗领域监管的基本概念和基础制度入手，本编系统性、针对性地解读了医药医疗行业核心监管领域和常见交易模式的监管架构和重点，主要包括药品与医疗器械的基本制度、医疗机构的基本制度、药品资产交易等。
第二编 知识产权保护
本编聚焦医药医疗行业的核心知识产权保护策略和争议解决措施，并对医药企业知识产权合规体系和要点、专利链接制度、保护期延长制度和反垄断审查等相关热点问题进行了深入探讨，主要包括药品与医疗器械的知识产权保护、医药知识产权纠纷与解决、医药企业知识产权合规等。
第三编 融资上市
本编以私募股权投融资的基础概念和普适性规则作为切入，针对资本市场板块医药医疗企业的上市情况、考量因素和审核要点进行了系统梳理和分析，主要包括私募股权投融资和医药企业境内上市与境外上市等热点问题。
第四编 医药合规
顺应最新的企业合规尤其是中央企业合规的监管趋势，本编涵盖从最基础的合规管理体系建设，到核心合规领域、部门合规的监管关注点等合规领域的全面解读，不仅包括医药行业合规管理体系建设和运行机制，更全面介绍数据、反垄断、反商贿、税务、进出口贸易、出口管制与制裁、环保、广告、人力资源、安全生产等具体合规部门。
新书推荐
“我向大家隆重推荐《医药与法律》这本书，这本书结构清晰、解答明晰、语句顺畅，是不可多得的关于医药健康产业和法律服务的好书。”
—— 法律出版社 本书责任编辑 韩满春
金杜医药医疗团队
本书作者团队均来自金杜医药医疗大健康板块，其中多名律师连续多年被国际权威机构评选为生命科学领域推荐律师。
金杜是中国为数不多的专门设有医药医疗服务团队的律所之一，团队内的合伙人、顾问和逾百名律师均拥有深厚的法律专业知识和丰富的交易经验，在为全球各地众多医药医疗企业具有国际影响力的各类重大项目提供全方位的法律服务的同时，密切关注医药健康领域法律政策变化与行业市场动向，为我国多部医药医疗法律法规的制订和修订建言献策。
作为行业领先的律师事务所，金杜始终秉持匠人精神。希望《医药与法律——中国医药健康产业法律服务与实务指南》第二版可以为广大的医药医疗行业企业提供法律指引，助力企业发展。
如您希望了解本书详细目录，请点击文末“阅读原文”获取
KWM releases the second edition of Pharmaceuticals and the Law
The first edition of the Pharmaceuticals and the Law - A Guide to the Chinese Pharmaceuticals and Healthcare Market (Pharmaceuticals and the Law) was widely welcomed by readers since its launch in 2015. In recent years, the pharmaceuticals and healthcare industry in China has experienced significant transformations, driven by the full implementation of the Healthy China initiative and deep reforms to the pharmaceuticals and healthcare system. The foundational laws governing the industry have been revised, while new laws and regulations reflecting the changing times have been issued; various frameworks aligning with international standards have been put into practice; emerging businesses such as “online healthcare” are experiencing rapid growth. Additionally, China’s extensive anti-corruption campaign targeting the pharmaceutical and healthcare industry continues to intensify.Against this backdrop, the launch of the second edition of the Pharmaceuticals and the Law takes on greater significance.
The second edition of the Pharmaceuticals and the Law took more than a year to prepare and brings together the diligent efforts of over 30 partners and counsels from KWM’s Life Sciences and Healthcare Group.
《医药与法律》 第二版
Second edition of Pharmaceuticals and the Law
Highlights
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Reflecting the latest industry trends:
In recent years, enterprises, especially central SOEs, have been actively strengthening their compliance management practices. In particular, since the launch of the industry’s anti-corruption campaign in May 2023, it has become increasingly critical for pharmaceutical enterprises to establish and improve their compliance management systems. Closely tracking the latest developments and combining the unique characteristics of pharmaceutical enterprises, this book not only focuses on the establishment of a robust compliance management system, but also delves deeply into every specific area of compliance related to the industry. It provides detailed insights into the designing of corporate compliance management systems and specific compliance requirements in various fields.
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In-depth and extensive analysis:
The second edition of Pharmaceuticals and the Law includes the latest medical regulations and policies in China, offering a comprehensive analysis of the industry’s core regulatory facets in various perspectives including pharmaceuticals, medical equipment, and medical institutions. It further delves into relevant legal matters covering the entire pharmaceuticals and healthcare industry, such as licensing transactions, intellectual property, anti-monopoly, anti-business bribery, export control and sanctions, dispute resolution, establishment of compliance systems for pharmaceutical andhealthcare enterprises and data, tax, environmental protection, production safety, advertising, labour and other practice areas. This book endeavours to strike a balance between comprehensive range and in-depth analysis.
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Comprehensive guidance and readability:
Basing on the first edition, this second edition of Pharmaceuticals and the Law places greater emphasis on the combination of theory and practice. This book adopts the “question and answer” and “case analysis” approaches, offering analysis to typical cases and their application and implementation under basic regulations, in order to provide direct and effective guidance to readers.
Section Overview
The second edition of Pharmaceuticals and the Law consists of four sections, 22 chapters, with over 500,000 words. It covers a wide range of topics from basic regulatory systems to common licensing and asset transactions in the industry, as well as multiple legal fields related to the pharmaceuticals and healthcare industry, including intellectual property, domestic and overseas investment and financing, capital markets, compliance, anti-monopoly, import and export, export control and sanctions.
Section I Regulation and Basic Systems
Commencing with the basic regulatory concepts and systems in the pharmaceuticals and healthcare industry, this Section offers a systematic and focused interpretation of the regulatory structure and critical aspects concerning core regulatory fields as well as common transaction models in the industry. The main topics include the basic systems of pharmaceuticals and medical devices, the basic systems of medical institutions, and pharmaceutical asset transactions.
Section II Intellectual Property Protection
This Section focuses on the core strategies for intellectual property protection and measures for dispute resolution in the pharmaceuticals and healthcare industry. It also discusses in depth some hot issues such as pharmaceutical enterprises’ intellectual property compliance systems and the key points of such systems, patent linkage systems, extension of the protection period, and anti-monopoly clearance. The primary areas of focus are intellectual property protection for pharmaceuticals and medical devices, medical intellectual property disputes and resolution, and intellectual property compliance of pharmaceutical enterprises.
Section III Financing and Listing
Starting with basic concepts and universally applicable rules of private equity investment and financing, this Section systematically summarizes and analyses the listings, considerations and review points for medical and pharmaceutical enterprises in the capital markets. Hot issues such as private equity investment, financing and domestic & overseas listing of pharmaceutical enterprises are covered in this Section.
Section IV Pharmaceuticals Compliance
Following the latest regulatory trend on corporate compliance, especially central SOE compliance, this Section provides a comprehensive overview of compliance related issues, ranging from the establishment of a foundational compliance management system to core compliance fields and sector-specific regulatory considerations. In addition to the establishment and operation mechanisms of compliance management systems in the pharmaceutical industry, this Section offers comprehensive coverage of specific compliance sectors including data, anti-monopoly, anti-business bribery, tax, import and export, export control and sanctions, environmental protection, advertising, human resources, and production safety.
Editor Recommendation
"I strongly recommend the Pharmaceuticals and the Law. This book is well structured, written eloquently and provides clear analysis. It is a rare, good book on the pharmaceuticals and healthcare industry and legal services."
—— Han Manchun, Editor-in-charge of this book, Law Press
KWM’s Life Sciences and Healthcare Team
The authors of this book come from KWM’s Life Sciences and Healthcare Group. A significant number of these authors are seasoned lawyers who are highly recommended in the field of life sciences by leading international legal directories for years.
KWM is among the few law firms in China with a specialized Life Sciences and Healthcare team. Our team comprises partners, counsels and hundreds of associates, all of whom have profound legal expertise and extensive transactional experience. While providing comprehensive legal services for pharmaceutical and healthcare enterprises and advising on their significant global deals, our team also closely tracks law and policy changes and market trends in the pharmaceuticals and healthcare sector. Furthermore, our team offers valuable insights and recommendations for the formulation and revision of multiple pharmaceutical and healthcare laws and regulations in China.
As a leading law firm in the industry, KWM consistently upholds the spirit of craftsmanship. We hope that the second edition of Pharmaceuticals and the Law - A Guide to the Chinese Pharmaceuticals and Healthcare Market can provide legal guidance to the vast number of pharmaceutical and medical enterprises, and assist in their development.
Please click "Read More" at the end to find the detailed catalogue of this edition.
本文作者
Author of this Article
黄建雯
Huang Jianwen
金杜医药医疗板块负责人
Head of KWM Life Sciences & Healthcare Group
一带一路国际合作与促进中心主任
Director-in-Chief of KWM BRCICF
E: huangjianwen@cn.kwm.com
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