生物技术的发展为人类解决疾病防治、人口膨胀、食物短缺、能源匮乏、环境污染等一系列问题带来了希望。但同时在科学研究、开发、生产和运用中造成对人类健康、生态、伦理、法律等的有害影响。克隆技术对我国现有的民法和刑法带来巨大的挑战;基因技术的发展和应用有可能危及到对人的本质以及与其相关的人道、人性等问题的重新认识,还会引发基因的隐私权、知情权及基因歧视等法律问题。《生物科技、医学与法律》以英文撰写,主要围绕现代生物科技的发展带来的伦理和法律问题,包括基因技术与人的平等权、基因治疗的应用的伦理学与人格尊严、生物医学发展中的知识产权问题、生物数据库与个人隐私权开展研究和讨论。《生物科技、医学与法律》主编为长期从事人权法学和医事法学研究的专家,《生物科技、医学与法律》作者来自中国、法国、荷兰、英国、加拿大、美国等国家,均为在该领域内有长期研究和建树的专家。
It is our great pleasure to introduce this book, the fruit of the cooperation be-tween the Law School of Shandong University and the INSERM Unit 1027 of Paul Sa-batier University.
This cooperation was organized in the context of the Hubert Curien partnershipwith China, Program Cai Yuanpei, coordinated by Campus France. Both teams hadresearchers interested in health law and bioethics. The originality of the program liesin the exchanges of PhD students who have met regularly both in France and China,to discuss their research and to write comparative articles.
Two co - supervised theses were conducted, directed by Dean QI Yanping andDr. Anne - Marie Duguet. PhD students Zihan Chen and Meng Wen made consider-able efforts during their stay in France to adapt to the lifestyle and especially to meetthe French requirements and academic control of their research. The theses defended in China were issued under the double seal of Paul Sabatier University and Law
School of Shandong University.
On the French side, French - speaking PhD students were selected: Mou Li and Chuanjuan Zhuang. Their theses were co - supervised by Dr Anne - Marie Dug-uet, Pr Jacques Lameu and Pr Alexandra Mendoza - Caminade. They traveled to China on several occasions to deepen their research, especially Chuanjuan Zuhang whose thesis focuses on traditional Chinese medicine.
Our project has also allowed visits of Chinese semor researchers in France and vice versa. A workshop was organized by Prof. Hongjie Man at the Law School ofShandong University on the theme \"Biotechnology, medicine and law\" and this book brings together the main works presented. Most authors are lawyers but as well doctors, geneticists, epidemiologists, public health specialists. The multidisciplinar-ity of our teams has enriched the quality of the work. Regarding the authors of the
French team, their contributions are divided into 3 parts of the book.
The first part deals with the genetic information and its protection which are en-sured in Europe by recommendations and a very strict legal framework of the Council of Europe. Thus free access genetic testing that is offered in many countries around the world is not possible in France.
The second part deals with the ethical aspects of biotechnology. All countries are concerned with questions of gene patentability, stem cell use and embryo re-search. The fundamental principles of the dignity of the human being have no bound-aries and the protection of individual rights prevails over the interest of science.
The third part presents the challenges of pharmaceutical law, biotechnology and new therapeutics, but also those of intellectual property law. Finally, China remains very attractive for foreigners as evidenced by the last two articles one medical tourism and the other on the protection of traditional Chinese medicine.
On the Chinese Side, As the Director of PhD students, Pr. Qi Yanping, Direc-tor of the Centre for Human Rights Study at Shandong University, contributes to re-searching the rights systems and has a deep thinking on the issues while the tradition-allegal system facing the challenges in big data era. Pr. Wang Kang, working in Shanghai University of Political Science and Law, Phd in Law is scholar study on bi-omedicine and its legal issues. The writing of his doctoral dissertation opens a new field of vision in related fields. More and more young scholars such as Li Yan and Jin Genlin are also involved in the research of this field, and contribute their own thinking, dates and unique analytical methods.
Preface
Part One The Protection of Genetic Data from the Comparative Perspective
PROTECTION OF GENETIC INFORMATION IN EUROPE AND IN FRANCE
STUDY ON THEORETICAL BASES OF INDIVIDUAL FREEDOM FROM THE
PERSPECTIVE OF PROTECTION OF GENETIC INFORMATION
DIRECT- TO -CONSUMER GENETIC TESTING ON THE INTERNET: COMPARISON BETWEEN
THE LEGAL FRAMEWORKS IN FRANCE AND IN CHINA
THE RIGHT ATTRIBUTE OF THE GENETIC INFORMATION: A KIND OF COMPOUND
INTEREST
LEGAL CONNOTATION AND BOUNDARY OF GENETIC AUTONOMY RIGHT: IN THE BACKGROUND
OF POPULATION GENETIC DATABASE
Part Two Biotechnology and Bioethics
PATENT AND BIOTECHNOLOGY
ETHICAL AND LEGAL FRAMEWORKS FOR EMBRYONIC STEM - CELL BASED RESEARCH
IN FRANCE AND IN EUROPE: ACHALLENGE FOR BIOTECHNOLOGY
HUMAN DIGNITY IN THE LEGAL REGULATION OF HUMAN GENE TECHNOLOGY
INTRODUCTION
THE ASCRIPTION OF RIGHTS TO FROZEN EMBRYOS AND RULES ON EXERCISE
OF RIGHTS
HEALTH AS AN EMBODIMENT ACROSS LIFE COURSE= FROM CELL TO
INTERVENTION
Part Three Medicine and Law under Opportunities and Challenges
IN NEED FOR A MODERN DAEDALUS? THE CHALLENGING REGULATORY PATH
FOR MARKETING GENE THERAPY MEDICINAL PRODUCTS IN CHINA AND
EUROPE
BIOSIMILAR OR BIO -GENERIC IN E. U, FRANCE, CHINA EXCLUSIVE RIGHTS IN PHARMACEUTI-
CAL INDUSTRY
LEGAL ISSUES OF INTERNATIONAL MEDICAL TOURISM TO CHINA
PROTECTION OF INTELLECTUAL PROPERTY AND TRADITIONAL CHINESE MEDICINE=PATENT
SYSTEM IN CHINA
A COMPARATIVE STUDY OF MEDICAL MALPRACTICE LIABILITY BETWEEN CHINA AND
FRANCE