论我国生物技术药物安全的法律制度选择

发布时间：2019-06-15 14:26

【摘要】：随着科学技术的发展，生物药物技术有了突飞猛进的进步，给产业界造就了可观的市场、丰厚的利润的同时，也为消费者在治病健体方面提供了不容忽视的帮助；然而生物药物技术潜藏的安全风险时有爆发，对个体的健康和社会的稳定都造成了难以想象的风险。由此产生了对生物技术药物产业发展的监管的需求，这种需求既存在于政策实践中，也体现在法律制度构建中。本文综合运用法学、经济学学和社会学的理论，对生物技术药物安全立法的必要性进行了阐述：首先，本文厘清了生物技术药品安全的相关概念，简述了生物技术药品的发展历程，从不同的学科领域对生物技术药品安全的内涵进行了界定；其次，文章建立了与生物技术药物相关的行为主体——政府、企业和消费者之间的博弈模型，通过分析推导出生物技术药物安全是核心价值追求，是实现政府、企业和消费者利益平衡的关键。文章在论证了实现安全价值的最好方式是通过法律对行为主体的行为进行制度规范的基础上，对我国现存的与生物技术药物安全相关的法律法规进行了梳理和总结，从目标、内容、效果方面进行了分析和评价，提出了现有制度结构中的不足之处。最后得出结论，要保障生物技术药物的安全，目前的首要任务就是将现行制度规范与生物技术药物的特点，与生物技术药物产业的规律相结合，在制度适用上进行调整；其次从长远看来，由于生物技术药物产业的发展有赖于科技发展，应当充分重视知识产权制度对于促进科技发展的作用，同时考察知识产权制度与生物技术药物安全的关系，并在制度上做出进一步的回应；同时也可以考虑制定一部用于专门用于保障生物技术药物安全的法律，，在与现行制度的有机衔接的基础上以实现生物技术药品安全。
[Abstract]:With the development of science and technology, biological drug technology has made rapid progress, which has created a considerable market for the industry, rich profits, but also for consumers in the treatment of health care can not be ignored help; however, the hidden safety risks of biological drug technology erupt from time to time, causing unimaginable risks to individual health and social stability. As a result, there is a demand for the supervision of the development of biotechnology and drug industry, which exists not only in policy practice, but also in the construction of legal system. Based on the theories of law, economics and sociology, this paper expounds the necessity of biotechnology drug safety legislation. First, this paper clarifies the related concepts of biotechnology drug safety, briefly describes the development process of biotechnology drugs, and defines the connotation of biotechnology drug safety from different disciplines. Secondly, the paper establishes the game model between government, enterprise and consumer, which is related to biotech drugs, and deduces that biotech drug safety is the pursuit of core value and the key to balance the interests of government, enterprise and consumer. On the basis of demonstrating that the best way to realize the safety value is to regulate the behavior of the subject through law, this paper combs and summarizes the existing laws and regulations related to the safety of biotechnology drugs in our country, analyzes and evaluates the objectives, contents and effects, and puts forward some shortcomings in the existing institutional structure. Finally, it is concluded that in order to ensure the safety of biotechnology drugs, the primary task at present is to combine the current institutional norms with the characteristics of biotechnology drugs and the laws of biotechnology drug industry, and to adjust the application of the system. Secondly, in the long run, because the development of biotechnology and drug industry depends on the development of science and technology, we should pay full attention to the role of intellectual property system in promoting the development of science and technology. At the same time, we should investigate the relationship between intellectual property system and biotechnology drug safety, and make further responses in the system. At the same time, we can also consider enacting a law specifically used to ensure the safety of biotechnology drugs, which can be realized on the basis of organic connection with the existing system.
【学位授予单位】：华中科技大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：D923.4

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