| Pharmaceutical industry is an typical innovation-oriented high technique industry.R&D intensity is generally more than15%in developed pharmaceutical countries, and the leading pharmaceutical firms are almost R&D-oriented firms.Depend on technical innovation and intellectual property rights protection system, R&D-oriented pharmaceutical firms take up most market share and earn monopoly profit even by limited "blockbuster medicine".However, this was not the case of development in China pharmaceutical industry.To some extent, even against some base rules of the pharmaceutical industry:on the one hand, the investment of technology innovation is low, not only far lower than the average level of R&D in the international pharmaceutical industry, but also lower than the average level in domestic high technology industry technology innovation input; on the other hand, the State Food and Drug Administration approves hundreds of "new drug" every year, many of them are low-tech drug.At present, the actual national conditions need the pharmaceutical firms engage in technical innovation in China. On one hand the Chinese government is constructing innovation-oriented country. So the as well as the pharmaceutical industry development policies actively guide enterprise to carry out technical innovation. On the other hand, the improvement of the social security system, population increase, the social aging increases the drug market demand; In addition, along with the social economic development, social demand for new drugs, has also encouraged companies to carry out technological innovation. Research on the pharmaceutical enterprise technology innovation has a strong practical significance and value:on the one hand, this study will help to find the deficiency of China pharmaceutical industry technology innovation ability, so puts forward the measures and Suggestions to solve the problem;on the other hand, this study will is also beneficial to promote the development of China pharmaceutical industry.The internal and external factors of firms decide the enterprise’s technology innovation activities. Because new drug regulation and patent protection most directly impact on the benefits of firms technology innovation, this paper selected the two external factors of technology innovation protection as the research object.This paper mainly research on the new drugs research and development for the purpose of technical innovation activities, and research on incentive effect of the two aspects of research new drug regulation and patent protection of pharmaceutical industry technical innovation, and put forward policy measures which based on the two aspects of new drug regulation and patent protection to encourage pharmaceutical industry technical innovation.The main research contents of this paper including:1. Analyze the problems and the basic situation of China pharmaceutical industry technical innovation.This part of the paper analyzes the characteristics of technological innovation in the pharmaceutical industry, and use the industry data, from two dimensions which are not only the home and abroad dimension but also the horizontal and longitudinal dimension analyzes China pharmaceutical industry technical innovation investment (research funding and research and development personnel) and output (patent and the current situation of new drugs), as well as the existing problems. The research results show that China’s pharmaceutical industry technical innovation investment is serious insufficient, which does not match up to the quantity and large scale of new drugs.2. Study the innovation incentive of China drug regulation on pharmaceutical industry technology.Firstly, this part studies the historical evolution process and situation of China drug regulation, which provided institutional background for subsequent analysis. Then, this part analyzes the government new drug regulation effects on investment decisions of enterprise technical innovation. On the basis of theoretical analysis, and use the provincial panel data from2005to2011, this part verifies incentive effect of the new regulation on the pharmaceutical industry technical innovation. The results show that under the condition of China, if relaxing the drug regulation, new drug regulation is negatively related to pharmaceutical industry technical innovation investment. Therefore, in order to improve the technical innovation level of China pharmaceutical industry and promote the firms to enhance investment in technological innovation, the government should raise the standards of drug registration for examination, approval, design scientific and reasonable drug price system.3. Research the innovation incentive of China’s drug patent system on pharmaceutical industry technology.Firstly, this part studies historical evolution process of China’s patent system, analyzes the history of the China’s drug patent system reform. Secondly, on the basis of the optimal patent model, this paper analyzes optimal drug patent design influence on technical innovation. Thirdly, this article innovatively build a new index system of drug patent protection which contains legislation index and law enforcement index, and calculate the strength of the China drug patent protection in1995-2011and provincial drug patent protection strength in2002-2011.Finally, this paper uses the method of measurement test the innovation incentive of China’s drug patent system on pharmaceutical industry technology. The research results show that the relationship between the China’s drug patent protection and technical innovation investment is non-linear, but there is no threshold effect. Namely strengthening drug patent protection is still the effective means to encourage enterprise technical innovation input.4. Improve the technical innovation incentive mechanism of China pharmaceutical industry.This part mainly research the technical innovation incentive mechanism of China pharmaceutical industry from the angle of new drug regulation and patent system.This part analyzes the cost and forecast that earnings of research and development of pharmaceutical enterprise forecast earnings, based on original drug lifecycle, we get the conclusion that the main factors that are influencing the enterprise research and development gains is the drug patent protection period, sales of drugs price, the new production, etc. In order to increase the enterprise research and development of earnings, combined with the listed drug research and development in the process of government regulation policy and the analysis of previous chapters, this part put forward some policy recommendations to encourage companies to increase technical innovation investment from the drug patent system, drug registration and drug pricing system, and the coordination between new drugs regulation and patent system. Based on the existing research results, the possible innovations of this article are as follows:First, the study provides a new perspective for the research on China pharmaceutical industry technical innovation activities. Based on new drug research and development process for the analysis of the main line, this paper studies the drug registration management, drug pricing and drug patent protection on the influence of the pharmaceutical enterprise technical innovation investment, overcome the previous studies just unilateral one impact on the pharmaceutical industry technical innovation.Second, this article innovatively builds a new index system of drug patent protection strength. On the basis of predecessors’ research, this article innovatively builds a new index system of drug patent protection which contains legislation index and law enforcement index. This make patent protection more objectively quantitative evaluation of drug patent system, not only provides a scientific objective basis for drug patent system economics, empirical research, but also in order to strengthen drug patent protection indicates the operational direction.Third, the study put forward a new perspective for improving incentive mechanism on China pharmaceutical industry technical innovation activities. Based on drug research and development as the main line, this paper analyzes the impact of government regulation and drug patent system on enterprise research and development benefit. And based on the above analysis, this paper puts forward some policy recommendations to optimize the technical innovation incentive mechanism of China pharmaceutical industry. |
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