| The current intellectual property system and medicine regulations have played an important role in the protection of the intellectual achievements of traditional Chinese medicines(TCM)and the promotion of the industry,but there are still limitations.China has been searching for a sui generis system in line with the characteristics of TCM.The legal system of protecting TCM varieties is concerned because of its function of promoting the development of TCM technology.At present,the academic circle has preliminary understanding of the function of promoting the development of TCM technology of the legal system of protecting TCM varieties and its complementarity with the patent system,but there are doubts and objections on the feasibility of developing it into a sui generis system of TCM varieties.On the basis of analyzing the basic principle of the current legal system of protecting TCM varieties,evaluating the effect of the current legal system of protecting TCM varieties,sorting out the existing problems and disputes,exploring the potential advantages and interpreting the demand of the TCM industry for the system,this thesis puts forward the idea of transforming the legal system of protecting TCM varieties from the market supervision and management system into a sui generis system of TCM varieties.Then the thesis explores the theoretical basis of the system reconstruction by analyzing the legal attribute of the system and the relationship between the operating mechanism of the system and the basic theory of intellectual property system.Furthermore,a comparative study is conducted on the special protection system of the intellectual property rights of medicines of foreign countries,and experience is drawn on the basis of further verifying the legitimacy of the system reconstruction,then a new model of the legal system of protecting TCM varieties is designed.First of all,puts forward the idea of reconstruction.To improve the quality of TCM varieties,to rectify market competition order of TCM,and to meet public demand for medication are objectives of the existing legal system.Ready-made TCM,extracts and preparations from natural medicinal materials,and artificial TCM substitutes will be protected if they meet the requirements,and the requirements usually concern on “the clinical curative advantage”.The national medical products administration shall permit the applicant a right to produce the relevant varieties for a certain period of time,the production right has exclusivity because of the admittance threshold.This system not only achieves the expected goal,but also plays a role in promoting the development of technology.However,the system is faced with many difficulties,such as the change of the implementation environment,the inconsistency between the purpose of the system and the mechanism,the narrow scope of protection,and the imperfect withdrawal mechanism,which have led to a debate over the abolition of the system.In addition to the achievements,problems and disputes,the system also has the potential advantages of complementing other systems such as patent.Based on the trend of innovation and development of TCM industry and the urgent need for a sui generis system,the function of promoting the development of TCM technology of the system highlights its values of the times.In order to solve the existing problems,stimulate the potential advantages,comply with the new provisions on TCM registration in the “Measures for the Administration of Drug Registration”(2020),and undertake the new mission of promoting the inheritance,innovation and development of TCM varieties,the legal system of protecting TCM varieties should be reconstructed into a sui generis system for TCM varieties.Secondly,proves the feasibility of reconstruction idea.The thesis analyzes the intrinsic property of the system from the aspects of the value of the system,the subject matter of the system and the characteristics of the right,and analyzes the relationship between the operation mechanism of the legal system of protecting TCM varieties and the basic theory of the intellectual property system.The study finds that the value pursuits of improving the quality of TCM,promoting the allocation of resources and implementing the right to health are in correspondence with the value pursuits of innovation,efficiency and justice of the intellectual property system.The protected TCM varieties as the subject matter of the system have the characteristics of intangibility,creativity and value which are similar with the basic characteristics of the subject matter of intellectual property.The expansion of intellectual property and the legislative mode of enumeration and generalization of the subject matter of intellectual property adopted by the Convention on the Establishment of World Intellectual Property Organization and the Civil Code of the People’s Republic of China provide space and legal basis for the protected TCM varieties to become a new subject matter of intellectual property.Though the characteristics of exclusivity,territoriality and temporality of the right granted for TCM varieties have their own features,such as absolute exclusivity and relative exclusivity,they are consistent with the basic characteristics of intellectual property rights.The study further finds that the operation mechanism of the legal system of protecting TCM varieties contains incentive concept,focuses on the balance of interests and the improvement of social welfare.It contains the essence of the basic theory of intellectual property system.There is theoretical basis to reconstruct the legal system of protecting TCM varieties.In addition,the legitimacy of reconstructing the system has been further confirmed by the comparative study of the special protection system of traditional medicine and innovative medicines of the international community,and experience has been learned.Finally,constructs a new model of the legal system.Upholds the system principles of paying same attention to the inheritance and innovation of TCM,clinical value orientation,balance of interests,taking the characteristics of TCM and international practice into account.Expands the protection scope of the subject matter to cover the whole industrial chain of TCM,introduces small pieces of ready-for-use TCM into the protection system,and changes the graded protection into classification protection.Subdivides the ready-made TCM varieties into traditional varieties,innovative varieties and improved varieties according to new provisions of TCM registration categories in the Measures for the Administration of Drug Registration(2020).Establishes the scope of rights holders oriented to the optimal allocation of resources.Beside enterprises,adds drug research and development institutions as the rights holders of protected varieties of TCM,so as to encourage drug innovation,and be consistent with the provisions of Pharmaceutical Administration Law(2019Revision).Builds a right system oriented by innovative development and interests balance.Takes clinical advantages and inheritance values as authorization conditions.Beside the production right with different intensities of exclusivity,entitles the protected varieties the right to use the official mark of "National TCM Protected Varieties".More attention will be paid to the interests balance and the healthy competition.The production right will be alienable,in line with the provisions of Pharmaceutical Administration Law(2019 Revision).Takes public health into account when designing the restrictions on rights and reduces the right term.Establishes a classified protection mechanism to meet the needs of the TCM industry.Improves the withdrawal mechanism and relief approach. |
PDF Full Text Request