Research Of The Legal Supervision System To Industrialization Of Transgenic Animals In China

The research and application for transgenic animals will be one of the most dynamic areas in the development of biotechnology in the 21st century which shows huge development prospects in the livestock improvement, medical research and especially in the field of drug production. With the deepening of the transgenic animals research, the industrialization of transgenic animals become an irresistible trend. Since transgenic animal technology bears both benefits and risks, the risk which arise by the research, development and application can not be ignored. The development of transgenic animals technology will have an enormous impact and challenges on the existing legal system, thus forcing the existing legal theory and legal system to adjust. The legal regulatory institutional system for transgenic animals research and application has not yet been established in our country, and the main consideration for the existing GMO safety control system is the characteristics of the transgenic plant industrialization which is not entirely suitable for the regulation of the transgenic animals industrialization. To promote the scientific development of transgenic animals industrialization and protect the people’s basic rights not being violated, the research for the strengthening of regulatory system for transgenic animals industry is imperative.This study, which based on the legal perspective, launched deep-seated discussion for the monitoring of transgenic animals research test and industrial applications. In the legal regulatory system for the transgenic animals study in the stage of research and experiment (including closed experiment, intermediate testing, environmental release, production test, etc.), first of all, the paper interprets our existing legal regulatory system and find the flaws and shortcomings, and then establishes the regulatory principles including harmonization regulation, risk preventions, grading and classification, finally, makes regulatory body system, safety assessment system, risk prevention system, improve the emergency management system as the main content, and strengthen the construction of the regulatory system for research of transgenic animals.The specific areas of transgenic animals’ industrial applications can be divided into food production of transgenic animals, bioreactor pharmacy and transgenic animals organ transplant. On the safety supervision of transgenic animals food, firstly, this study introduces related safety regulation system of transgenic animals food, and then analyzes the deficiencies of the existing regulatory system. Adhering to the "from farm to fork" regulatory philosophy, we establish the basic regulatory principles including safety assessment principle, the principle of full control and State responsibility principle, and establish and improve food safety control system, including the management system, market access system, security monitoring system, information disclosure system, traceability and recall system, the responsibility investigated and damage relief system. On the regulatory of transgenic animals bioreactor pharmacy, the paper firstly introduces some relevant laws of transgenic animals bioreactor pharmacy, then analysis the inherent relationship between the current regulatory system and the transgenic animals bioreactor pharmacy and the necessity of its regulation. After then, with the adherence to the "scientific evaluation, the specific analysis" principle, we construct a specific system according to the different segments of pharmaceutical production, processing, sales and so on. These institutions include pre-clinical test system, clinical trial quality management system, management of drug registration system, market access system, adverse reaction reports and recall system, damage relief system and so on.In the field of legal regulatory of transgenic animals organ transplantation, this paper study individually on the two stages of transgenic animals organ transplantation development, one is human test and the other is clinical application. In the stage of human trial, we should set the protection of safety and healthy of the object as the core subject, and establish some basic principles such as according with human ethics, protect privacy and so on. Also, it is necessary to establish some systemes, for instance, ethical review system, informed and consent system, privacy protect system and damage relief system. In the clinical application phase, we have to focus on the maintaining of patients’personal rights and interests, and object to the unique principles of technology access, fairness and justice, prevention and relief, while adhering to the systems of according with human ethics, informed and consent and protect privacy ethics. Upon these, the paper builds a new regulatory system of clinical application, which includes monitoring subject system, technology access system, organ quality review and equal distribute system, responsibility undertake and damage relief system and so on.This paper study all the stages of the industrialization of transgenic animals, from research and test, to product and sale, and provides a profound and specific countermeasures for it. It aims at establish and improve the legal and regulatory system of the research and application of transgenic animals in China, so as to drive it into a orderly and scientific track, and promote the healthy and security for it, and finally achieve a harmonious balance between economic and social benefits.