Bangor University DOCTOR OF PHILOSOPHY Regulation, patentability and morality of human embryonic stem cell in China: a comparative study of the US and Europe Jiang, Li Award date: 2019 Awarding institution: Bangor University Link to publication General rights Copyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright owners and it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights. • Users may download and print one copy of any publication from the public portal for the purpose of private study or research. • You may not further distribute the material or use it for any profit-making activity or commercial gain • You may freely distribute the URL identifying the publication in the public portal ? Take down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. Download date: 07. Oct. 2021 Bangor University REGULATION, PATENTABILITY AND MORALITY OF HUMAN EMBRYONIC STEM CELL IN CHINA A COMPARATIVE STUDY OF THE US AND EUROPE Li Jiang Thesis submitted to Bangor University for the degree of Doctor of Philosophy October 2014 REGUATION, PATENABILITY AND MORALITY OF HUMAN EMBRYONIC STEM CELL IN CHINA － A COMPARATIVE STUDY OF THE US AND EUROPE ABSTRACT This thesis is concerned with what is a better way to regulate Human Embryonic Stem Cell (HESC) research in China. It concludes that, neither moral control in the patent law nor federal funding control is a effective way to monitoring HESC research. The best way to control immoral HESC research in China is to regulate research at the international level. HESC holds the promise of treating many incurable diseases such as cancer, diabetes and Parkinson’s Disease; however, the interplay between patent law and moral controversy has generated enormous variations in addition to the jurisdiction complexities. The diversity of HESC regulation has been considered problematic, since varied regulations in states might impede research collaboration and scientific advance. Researchers working across jurisdictions are required to meet different technical, ethical and legal standards. Some developing countries have sought to profit from the regulatory vacuum. Such a situation can be seen in China where unproven and unsafe stem cell therapies are currently offered to patients. While attempts have been made to examine the disparities in HESC regulations across countries, there is little work of significance addressing how to regulate HESC research in China. This thesis attempts to find a better way to control HESC research in China. It is laid out from three perspectives. First, this thesis explores the legal challenges from the emerging areas raised by HESC technology. It illuminate the moral challenges associated with HESC research. It demonstrates that HESC research, like a double-edged sword, might bring tremendous benefits or, on the contrary, irreversible disaster. It can be distinguished that the success of HESC development depends largely on how the law participates in it. Second, the thesis examines two different approaches adopted by the Europe and US in HESC research. Apart from examining the incongruous I interpretations of moral definitions of human embryo in the EUROPE case law, this thesis also explores the inconsistent policies adopted by different administrations in the US. Through a detailed comparison, this thesis observes that both infusing moral exclusions into patent law and federal funding control are inefficient and ineffective ways to supervise immoral research. Third, the thesis explores the reconciling attempts of HESC regulation. Drawing lessons from reconciling attempts, the thesis finds out that minumin standard is practical and applicable since there are various interpretations of moral, human embryo and the commercial or industrial use addressing the adoptions of moral exclusions in national states. The thesis argues that, the best way to control HESC research in China is to regulate research inself in a reconciled regulation at the international level. First, the patent prohibition of HESC related inventions based on morality issues doesn’t seem to be an effective method to control immoral research. Morality is not a criterion that should be determinable by patent authorities. The various interpretations of moral exclusion in patent law result the legal uncertainty. Even if the results of HESC research would not be patented, HESC research could still be performed and funded. Immoral HESC research should be prohibited at the beginning of research instead of at the patent-application stage. Second, even if federal funding cannot be used in HESC research, private funding could still flow into this area. It is a waste of time, money and material resources since some halfway public funding research should be halt and private money reinvest in it. Third, from the economical perspective, regulate research is able to prohibit immoral research at the initial stage which saves time and money and is economically viable and legally feasible. In order to eliminate the phenomenom of “stem cell tourism” in China, it is best to regulate the research at the international level. II CONCISE CONTENTS ABSTRACT.......................................................................................................................................................... I CONCISE CONTENTS .............................................................................................................................. III TABLE OF CONTENTS ............................................................................................................................... V LIST OF CASES .............................................................................................................................................. XI ABBREVIATIONS ..................................................................................................................................... XIII ACKNOWLEDGEMENT ...................................................................................................................... XVII DECLARATION AND CONSENT .................................................................................................... XXI CHAPTER ONE: INTRODUCTION...................................................................................................... 1 CHAPTER TWO: THE MORAL MAZE IN HESC RESEARCH REGULATION ......... 31 CHAPTER THREE: THE CHINA MODE ABOUT MORAL-BASED REGULATIONS OF HESC RESEARCH: INCONSISTENT MORAL STANDARDS BETWEEN PATENT LAW AND PRACTICAL APPLICATION .................................................................. 73 CHAPTER FOUR: THE US MODE ABOUT MORAL-BASED REGULATIONS OF HESC RESEARCH: INCONSISTENT POLICIES ON FEDERAL FUNDING CONTROL OF HESC RESEARCH .................................................................................................... 101 CHAPTER FIVE: THE EUROPE MODE ABOUT MORAL-BASED REGULATIONS OF HESC RESEARCH ： INCONSISTENT INTERPRETATIONS OF MORAL PROVISIONS IN PATENT LAW ....................................................................................................... 145 CHAPTER SIX: THE RECONCILING ATTEMPTS FOR MORAL BASED HESC REGULATION IN THE INTERNATIONAL REGIME ........................................................... 191 CHAPTER SEVEN: CONCLUSION ................................................................................................. 237 BIBLIOGRAPHY ........................................................................................................................................ 255 III TABLE OF CONTENTS ABSTRACT.......................................................................................................................................................... I CONCISE CONTENTS .............................................................................................................................. III TABLE OF CONTENTS ............................................................................................................................... V LIST OF CASES .............................................................................................................................................. XI ABBREVIATIONS ..................................................................................................................................... XIII ACKNOWLEDGEMENT ...................................................................................................................... XVII DECLARATION AND CONSENT .................................................................................................... XXI CHAPTER ONE: INTRODUCTION ......................................................................................... 1 1.1 REASONS FOR CONDUCTING THIS RESEARCH ........................................................................... 1 1.1.1 Values of HESC (HESC) Research ................................................................................................ 1 1.1.2 Inconsistency HESC related regulations across Jurisdictions leads to stem cell tourism in China. ............................................................................................................................................. 3 1.1.3 TRIPS Agreement cannot assure symmetrical coherence between moral provision within patent law and moral