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The Research on the Development of Law System for Security of the Biotech Drugs

Author: ChengShiZuo
Tutor: LuoYuZhong
School: Huazhong University of Science and Technology
Course: Civil and Commercial Law
Keywords: The biotech drugs Security System development
CLC: D923.4
Type: Master's thesis
Year: 2013
Downloads: 9
Quote: 0
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Abstract


With the development of science and technology, the technology biological drugs brings rapid progress to the industry by creating a substantial market and huge profits while consumers in terms of healing fitness receive help which can not be ignored; however, the biological drug technology outbreaks potential security risk causing unimaginable risk on an individual’s health and social stability. As a result, regulatory becomes necessary on the industrial development of biotechnology drugs, the demand for existing policy practice is also reflected in the legal system build.This paper uses the theory of law, economics and sociology. The need for biotechnology drug safety legislation is due to the following aspects:first, it is to clarify the related concepts of biotechnology and drug safety, outlines the course of development of biotechnology drugs, and the definition from different disciplines of biotechnology and drug safety connotation; second, the article established actors associated with biotechnology drug safety-game model between government, businesses and consumers, analyzing that government regulation is important which can not be ignored, and deducing the common interests between the three actors, which is the core area that should be concerned about the safety of biotech drugs. Demonstrating the best way to achieve common interests is to go through legal collate and summarize our existing biotechnology drug safety laws and regulations on the basis of rules and norms, concluding that the behavior of the actors from the goals, content, the effect of the analysis and evaluation, and inadequacies in the existing institutional structure. This paper argues that the focus on the introduction of biotech drugs security act, is to solve the security issues of biotechnology drugs by standardizing government administrating and guiding enterprise security in R&D and production stage, which would protect the interests of consumers. Based on departure from the characteristics of legal attributes, the paper concludes that there are three steps:first, it is necessary to combine the characters of the business along with the running regulations to see find out if it is possible to adjust the regulation to the new area; second, it is important to pay enough attention on the IPR system, however IPR would bring new problems such as the over protection of advantage of knowledge as private rights causing the unbalance of information which would finally lead to higher risk; at last, it might be considered seriously that there should be another act seen as part of system responding which should be included in the science and technology law system.

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CLC: > Political, legal > Legal > Chinese law > China and France > Intellectual property rights
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