中药标准化与知识产权战略的协同发展研究

【作者】 张建武；

【导师】 肖诗鹰；

【作者基本信息】 北京中医药大学 ， 中药学， 2010， 博士

【摘要】 中药产业的可持续发展,迫切需要积极推动中药产业政策的相互协调发展。面对当前国际国内形势,国家适时提出中药标准化战略与中药知识产权战略,但就两大战略具有什么样的内在联系,这一问题学术界思考的并不多。即使涉及二者的关系,也只是谈及其相互促进、相互提升的一面,很少谈及相互牵制、相互矛盾的一面。正是对这一问题的忽视,使得我国在推进中药标准化与知识产权战略进程中出现了管理体制严重脱节、政策内容不交融、信息资源不共享、矛盾与冲突频发等一系列问题。造成这种局面的深层次原因是两大战略自成体系,相互分割,缺乏协调机制。因此,如何协调好两大战略的关系,使其相互适应、相互配合、相互协作和相互促进,进而形成协调、同步发展的良性循环态势,最终取得“1+1>2”的战略效果,是当今中药领域迫切需要解决的一个问题。为解决上述关键问题,本文在借鉴国内外关于标准化与知识产权战略发展经验和模式的基础上,运用协同学基本原理,研究了中药标准化与知识产权战略体系的构成及其相关性,梳理和探析了中药标准化涉及知识产权的关键问题及应对策略,设计了中药标准化与知识产权战略协同发展的政策机制,最终提出了“中药标准化与知识产权战略协同发展”的战略思想,以期为相关部门解决中药标准化中的知识产权问题提供理论依据和政策建议。本论文的研究内容主要包括：第1章,介绍了本课题的研究背景、依据与意义,研究的理论基础,研究内容、方法与技术路线以及研究特色与创新点；第2章,分别综述了标准化和知识产权战略研究新进展,国际视野下的药品标准化中的知识产权问题研究新进展；第3章,在梳理中药标准化和知识产权战略体系的构成的基础上,重点分析了中药标准化与知识产权战略的相关性；第4章,系统研究了中药标准化过程中出现的专利、技术秘密、商标、版权、知识产权滥用等关键问题；第5章,选取国内外较为典型、成熟的中药品种进行标准化与知识产权战略融合的个案研究,分析了中药标准涉及知识产权纠纷的典型案例。第6章,探讨了中药标准化与知识产权战略协同发展的机制,设计了中药标准化组织的知识产权政策；第7章,总结了本研究得出的主要结论,待进一步解决的问题以及文章展望。本论文得出的结论主要包括：①中药领域的标准化与知识产权问题具有独特的发展规律。中药标准的管理体制和技术特点决定了中药领域该问题解决的思路和方法不同于其他行业,中药的质量控制模式及其标准体系的复杂性又决定了中药领域该问题比西药领域更为突出,更具理论和实用研究价值。②目前中药标准化与知识产权战略并不协调,中药标准化组织的政策模糊、角色定位不清以及部门协调性差是其重要原因。促进二者的有机融合,使二者达到统一与和谐、协调与同步发展,从而实现“1+1>2”的战略协同效果,将成为历史的必然。本论文提出的对策主要包括：①政府层面：充分发挥政府在两大战略协同发展中的引导职能；构建基于知识产权的中药标准形成机制；构建中药标准制定中的知识产权信息披露制度；构建中药标准实施中的知识产权许可制度；构建基于知识产权保护的中药标准提高激励机制；构建中药标准化与知识产权战略的利益协调机制；构建基于技术标准与知识产权的中药技术性贸易壁垒体系；构建基于技术标准和知识产权的中药技术创新战略。②行业层面：充分发挥协会在两大战略协同发展中的协调职能；构建基于企业联盟的中药技术标准形成机制；组建基于技术标准与知识产权的“中药技术标准联盟”。③企业层面：充分发挥企业在两大战略协同发展中的主体地位；构建符合中药企业发展规律的标准化与知识产权战略协同发展模式；构建企业处理标准化涉及的知识产权纠纷的应对机制。④公众层面：充分发挥公众在两大战略协同发展中的监督作用；建立公众对于中药技术标准和知识产权知情权的保障机制。本论文的创新之处主要包括：①首次基于知识产权保护的视角探讨中药标准化战略的科学内涵；②首次系统研究了我国中药标准化过程中的知识产权政策设计；③首次提出了“中药标准化与知识产权战略协同发展”的战略思想。更多还原

【Abstract】 It was imperative for sustainable development of traditional Chinese medicine (TCM) industry to actively promote coordinated development of its industry policies. Both standardization and intellectual property strategy in TCM were raised at the right moment, but their inherent connections have not been studied in academic circles. Except for the relationship of mutual promoting, the relationship of mutual supervision and mutual conflict have not been mentioned. Just because of the neglect of the above problems, a series of problems arised such as dissociation of management system, conflict of industry policies, no sharing information resource and frequent contradiction and conflict and so on. The fundamental reasons for the above phenomenon were separation, dissection and deficiency of coordination of the two strategies. Thus, how to coordinate the relationship between the two strategies to promote mutual adaptation, cooperation, promotion and concordant and synchronous development, and achive the effect of "1+1>2" was an imperative prbolem in TCM industry.To resolve the above key problems, based on the advanced development and mode of standardization and intellectual property strategy, standardization and intellectual property strategy in TCM and their correlation were studied firstly according to the fundamental principle of coordinated development, then the key problems and coping strategies were summurazed and discussed, and the mechanism and policies were also designed, and the concept of coordinated development between standardization strategy and intellectual property strategy in TCM was finally put forward. The theoretical basis and policy suggestions provided by this study could be used for the solving the promblems in standardization and intellectual property strategy in TCM.The research contents in this paper were as follows:In chapter one, background, significance, theoretical foundation, methods, technical route and innovative points were introduced firstly; in chapter two, new research progress of standardization and intellectual property strategy in macro level and in western medicine were summarized, respectively; in chapter three, standardization and intellectual property strategy were first summarized and then their correlation was discussed; in chapter four, some key problems were studied such as patent, know-how, trade mark, copyright and intellectual property abuse and so on; in chapter five, some cases for integration and dispute about standardization and intellectual property strategy were studied; in chapter six, coordinated development mechanism and framework were establised, and intellectual property policies were designed for standardization organizations; in chapter seven, the main conclusions and some problems to be resolved in the furture and the prospects of the study were arised.The conclusions in this paper were as follows: First, the dispute of standardization and intellectual property strategy in TCM was more distinctive. It was different from the disputes in other industries becouse of its management system and technological characteristics, and was more important than the dispute in western medicine because of the mode of quality control and complexity of standard system. Thus, the study of this dispute was more academic and practical value.Second, the two strategies were not concordant nowadays, and the important reasons included the intangible policies, unclear role orientation and bad harmony of the standardizing bodies in TCM. It will be a historical necessity for TCM to organically merge the two strategies, thus promote the unification, harmony, coordination and synchronization of the two strategies, and finally realize the effect of "1+1>2" of the two strategies.The countermeasures in this paper were as follows:For the government, give full play to the guide function in coordinated development between the two strategies, establish the formation mechanism based on intellectual property, intellectual property information disclosure system in standardization, intellectual property license system in standardization, incentive mechanism based on intellectual property for standard improvement of TCM, interest coordination mechanism between two strategies, technical barriers to trade based on standardization and intellectual property strategy, technological innovation strategy based on standardization and intellectual property strategy.For the industry, give full play to the coordination function in coordinated development between the two strategies, establish the formation mechanism of standardization based on enterprise alliance, technical standard alliances in TCM based on standardization and intellectual property strategy.For the enterprise, give full play to the subject status in coordinated development between the two strategies, establish the mode of integrated development of the two strategies, response mechanism on intellectual property dispute in standardization.For the public, give full play to the supervision function in coordinated development between the two strategies, guarantee the civil rights in standardization and intellectual property strategy.The innovative points in this paper were as follows:The connotation of standardization strategy in traditional Chinese medicine based on intellectual property was first put forward; the polices for standardization and intellectual property organizations were first designed; the concept of coordinated development between standardization and intellectual property strategy in traditional Chinese medicine was first put forward.更多还原