【摘要】：隨著科學(xué)技術(shù)的發(fā)展，生物藥物技術(shù)有了突飛猛進(jìn)的進(jìn)步，給產(chǎn)業(yè)界造就了可觀的市場、豐厚的利潤的同時(shí)，也為消費(fèi)者在治病健體方面提供了不容忽視的幫助；然而生物藥物技術(shù)潛藏的安全風(fēng)險(xiǎn)時(shí)有爆發(fā)，對個體的健康和社會的穩(wěn)定都造成了難以想象的風(fēng)險(xiǎn)。由此產(chǎn)生了對生物技術(shù)藥物產(chǎn)業(yè)發(fā)展的監(jiān)管的需求，這種需求既存在于政策實(shí)踐中，也體現(xiàn)在法律制度構(gòu)建中。 本文綜合運(yùn)用法學(xué)、經(jīng)濟(jì)學(xué)學(xué)和社會學(xué)的理論，對生物技術(shù)藥物安全立法的必要性進(jìn)行了闡述：首先，本文厘清了生物技術(shù)藥品安全的相關(guān)概念，簡述了生物技術(shù)藥品的發(fā)展歷程，從不同的學(xué)科領(lǐng)域?qū)ι锛夹g(shù)藥品安全的內(nèi)涵進(jìn)行了界定；其次，文章建立了與生物技術(shù)藥物相關(guān)的行為主體——政府、企業(yè)和消費(fèi)者之間的博弈模型，通過分析推導(dǎo)出生物技術(shù)藥物安全是核心價(jià)值追求，是實(shí)現(xiàn)政府、企業(yè)和消費(fèi)者利益平衡的關(guān)鍵。文章在論證了實(shí)現(xiàn)安全價(jià)值的最好方式是通過法律對行為主體的行為進(jìn)行制度規(guī)范的基礎(chǔ)上，對我國現(xiàn)存的與生物技術(shù)藥物安全相關(guān)的法律法規(guī)進(jìn)行了梳理和總結(jié)，從目標(biāo)、內(nèi)容、效果方面進(jìn)行了分析和評價(jià)，提出了現(xiàn)有制度結(jié)構(gòu)中的不足之處。最后得出結(jié)論，要保障生物技術(shù)藥物的安全，目前的首要任務(wù)就是將現(xiàn)行制度規(guī)范與生物技術(shù)藥物的特點(diǎn)，與生物技術(shù)藥物產(chǎn)業(yè)的規(guī)律相結(jié)合，在制度適用上進(jìn)行調(diào)整；其次從長遠(yuǎn)看來，由于生物技術(shù)藥物產(chǎn)業(yè)的發(fā)展有賴于科技發(fā)展，應(yīng)當(dāng)充分重視知識產(chǎn)權(quán)制度對于促進(jìn)科技發(fā)展的作用，同時(shí)考察知識產(chǎn)權(quán)制度與生物技術(shù)藥物安全的關(guān)系，并在制度上做出進(jìn)一步的回應(yīng)；同時(shí)也可以考慮制定一部用于專門用于保障生物技術(shù)藥物安全的法律，，在與現(xiàn)行制度的有機(jī)銜接的基礎(chǔ)上以實(shí)現(xiàn)生物技術(shù)藥品安全。
[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.
【學(xué)位授予單位】：華中科技大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2013
【分類號】：D923.4

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