我国制药企业新药研发外包的套牢问题与对策研究

发布时间：2018-02-13 13:11

本文关键词： 新药研发外包套牢问题不完全契约理论可占用性准租　出处：《华南理工大学》2013年硕士论文　论文类型：学位论文

【摘要】：医药产业是国民经济的重要组成部分，是目前世界上发展最快、竞争最激烈的高技术产业之一。在医药产业中，新药往往是人们最为关注的焦点，，新药研发不仅关系着制药企业的命运，也影响着一个国家整个医药产业当前及未来的生存和发展。为了降低研发成本、缩短新药上市周期，有越来越多的制药企业加大了与CRO的研发外包合作。然而在实际的新药研发外包中，制药企业会面临许多问题和障碍，其中因合同不完全被CRO套牢的问题一直困扰着众多的制药企业。套牢问题的存在严重影响了制药企业开展新药研发外包的积极性和研发效果。如何建立有效的机制解决套牢问题已经成为学术界和医药界探讨新药研发外包的重要课题。本文运用不完全契约理论、交易费用理论、博弈论等理论工具和研究方法，并结合实际的案例，对我国制药企业新药研发外包的套牢问题进行了深入地分析。文章首先对我国制药企业新药研发外包的特征、套牢问题的表现形式、产生的后果进行了详细分析，全面的认识了新药研发外包中的套牢问题；其次重点分析了我国制药企业新药研发外包套牢问题产生的原因，从微观和宏观两个层面解释了新药研发外包中套牢问题出现的具体原因；最后从微观和宏观两个层面提出了新药研发外包套牢问题的解决对策，使得有机会主义倾向的CRO在契约不完全的情况下做出有利于制药企业的选择。本文认为，有限理性、新药研发的不确定性和复杂性、高额交易成本等因素，导致了制药企业与CRO外包合同具有不完全性，制药企业会因自身的专用性资产投资而面临套牢问题。文章通过借鉴买方——卖方模型，分析证实了合同不完全所产生的“可占用性准租”是制药企业在新药研发外包中陷入套牢困境的根源。在此基础上，本文进一步认为新药研发外包中出现套牢问题的微观层面原因主要是因合同不完全而导致的制度缺陷，包括权力控制缺陷、价格契约缺陷、信任机制缺陷；宏观层面原因包括CRO外包市场不成熟、法律体系与监管机构不健全以及社会伦理道德缺失等。最后，本文提出了解决新药研发外包中套牢问题的对策。微观层面上制药企业可以从价格控制、权利控制、信任机制三方面采取措施；宏观层面上可以从规范CRO行业的发展、完善经济法律体系、建立健全监管机构、建立良好的社会伦理道德规范等方面做出努力。
[Abstract]:The pharmaceutical industry is an important part of the national economy and one of the fastest growing and most competitive high-tech industries in the world. In the pharmaceutical industry, new drugs are often the focus of most attention. New drug research and development is not only related to the fate of pharmaceutical enterprises, but also affects the current and future survival and development of the entire pharmaceutical industry in a country. More and more pharmaceutical enterprises have increased their cooperation in R & D outsourcing with CRO. However, in the actual new drug development outsourcing, pharmaceutical enterprises will face many problems and obstacles. Among them, many pharmaceutical enterprises have been troubled by the problem that the contract is not completely locked up by CRO. The existence of the latching problem has seriously affected the enthusiasm and effect of drug development outsourcing in pharmaceutical enterprises. How to establish an effective machine. It has become an important topic for the academia and medicine industry to discuss the outsourcing of new drug research and development. This paper uses incomplete contract theory, transaction cost theory, game theory and other theoretical tools and research methods, and combined with practical cases, This paper makes a deep analysis on the problem of drug development outsourcing in Chinese pharmaceutical enterprises. Firstly, this paper analyzes in detail the characteristics, forms and consequences of the new drug development outsourcing in Chinese pharmaceutical enterprises. Comprehensive understanding of the new drug research and development outsourcing in the issue of locking; secondly, focused on the analysis of our pharmaceutical enterprises new drug research and development outsourcing of the reasons for the problem, In this paper, the author explains the concrete reasons of the lock-in problem in the new drug research and development outsourcing from the micro and macro aspects, and finally puts forward the countermeasures to solve the problem from the micro and macro levels. The opportunistic CRO makes the choice in favor of the pharmaceutical industry when the contract is incomplete. This paper holds that limited rationality, uncertainty and complexity of new drug research and development, and high transaction costs lead to incomplete outsourcing contracts between pharmaceutical companies and CRO. Pharmaceutical enterprises will be faced with the problem of holding up because of their own specific assets investment. This paper uses the buyer-seller model for reference. The analysis proves that the "occupancy quasi lease" caused by incomplete contract is the root of the dilemma of pharmaceutical enterprises in the new drug research and development outsourcing. This paper further points out that the microcosmic reasons of the hold-up problem in the new drug research and development outsourcing are mainly the institutional defects caused by incomplete contracts, including power control defects, price contract defects, and trust mechanism defects. The macro-level reasons include immature CRO outsourcing market, imperfect legal system and regulatory bodies, and lack of social ethics and morality. Finally, This paper puts forward the countermeasures to solve the problem of locking in the outsourcing of new drug research and development. At the micro level, pharmaceutical enterprises can take measures from three aspects: price control, right control and trust mechanism; at the macro level, the development of CRO industry can be standardized. Efforts should be made to perfect the economic legal system, establish and improve the regulatory bodies, and establish good social ethics and ethics.
【学位授予单位】：华南理工大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：F273.1;F426.72

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