我国中药遗传资源获取和惠益分享的制度困境及优化路径  

Institution dilemma and optimization pathway for accessing Chinese materia medica genetic resources and benefit-sharing

作　　者：吴颖雄 茅宁莹[1] 王大壮[3] WU Ying-xiong;MAO Ning-ying;WANG Da-zhuang(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing JIANGSU 211198,China;School of Health Economics and Management,Nanjing University of Chinese Medicine,Nanjing JIANGSU 210023,China;Supervision and Inspection Ofice,Jiangsu Province Hospital of Chinese Medicine,Nanjing JIANGSU 210029,China)

机构地区：[1]中国药科大学国际医药商学院,江苏南京211198 [2]南京中医药大学卫生经济管理学院,江苏南京210023 [3]江苏省中医院监督检查室,江苏南京210029

出　　处：《中国新药与临床杂志》2024年第11期830-836,共7页Chinese Journal of New Drugs and Clinical Remedies

基　　金：2022年度江苏高校哲学社会科学研究项目(2022SJYB0326)。

摘　　要：中药遗传资源是重要的生物资源和卫生资源。随着各领域对中药遗传资源的依赖度不断提高,中药遗传资源的生物剽窃越来越频繁,已经对我国生态安全和人们生命健康权益造成威胁。然而,我国《专利法》确立的遗传资源来源披露制度以及利用合同机制实现中药资源获取和惠益分享制度均有欠缺,不能有效应对生物剽窃问题。因此,为维护我国权益,我国作为《生物多样性公约》和《名古屋议定书》的缔约国,应当参照上述国际条约确立的法律规则并根据我国国情制定或完善国内相关制度,相关举措可包括将来源披露作为专利授权的形式条件,扩大披露的对象和范围,并对不实披露行为追究法律责任;明确中药遗传资源权利主体,并引入公权力对合同的签订和履行过程予以“监测”,以保证公正、公平的惠益分享。Chinese materia medica genetic resources are important biological and health resources.With the increasing reliance on Chinese materia medica genetic resources in various fields,bio-piracy against Chinese materia medica genetic resources is becoming more and more frequent and has posed a threat to China's ecological security and the rights of people's lives and health.However,the system of the source disclosure of genetic resources established by China's Patent Law,as well as the use of contractual mechanisms to achieve access to Chinese materia medica genetic resources and benefitsharing,are both inadequate and unable to effectively deal with the problem of bio-piracy.Therefore,in order to safeguard the rights and interests,China,as a party to the Convention on Biological Diversity and the Nagoya Protocol,should formulate or improve the domestic laws following the legal rules established by the above-mentioned international treaties and China's national conditions.Related initiatives may include taking the source disclosure as a formal condition for the patent grant,expanding the target and scope of the disclosure,and imposing legal liability for defect disclosure;clarifying the subjects of rights to Chinese materia medica genetic resources,and introducing public authority to“monitor”the signing and implementation of contracts to ensure fair and equitable benefit-sharing.

关 键 词：中药 遗传资源的获取与共享 信息披露 合同 生物剽窃 

分 类 号：R288[医药卫生—中药学]