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.
Highlights
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.
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 and healthcare 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.
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
About KWM’s Life Sciences and Healthcare Group
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.
