摘要
孤儿药独占许可制度,是域外发达国家为激励孤儿药品研发、保障罕见病人生存权而建立的法规制度。在检视既有药品独占保护制度与梳理孤儿药专门保护法规中,我国孤儿药面临游离专利法与药品管理法保护之外,以及商业秘密保护式微等问题,难以应对孤儿药研发高成本与受益群体少的矛盾冲突。析出孤儿药独占许可制度,是激励我国孤儿药研发的必由之路。由此,基于域外制度启示与我国中药品保护制度的经验,结合法益理论以及法经济学理论,围绕超脱普通药物的多元法益价值体系建构,借鉴《中药品种保护条例》的独占权建构法理,由行政法规建构路径,提出具体法规要件、审批主体以及豁免原则,解决公共健康成本与药企利益二元冲突问题。
The exclusive licensing system for orphan drugs is a legal system established by developed countries outside the region to encourage the research and development of orphan drugs and guarantee the survival of rare patients.In reviewing the exclusive protection system of existing drugs and sorting out the special protection regulations for orphan drugs,orphan drugs in China are facing problems beyond the protection of the free patent law and drug management law,as well as the decline of trade secret protection,and it is difficult to deal with the high cost of orphan drug research and development and the beneficiary groups.Less conflicts.Separating out the exclusive license system for orphan drugs is the only way to encourage the research and development of orphan drugs in my country.Therefore,based on the enlightenment of the foreign system and the experience of the Chinese medicine protection system in China,combined with the theory of legal interest and the theory of law and economics,the construction of a multi-legal value system beyond common medicines,and the legal principle of the exclusive right construction of the "regulations on the protection of Chinese medicines",the path for the construction of administrative regulations,the specific legal requirements,the subject of approval,and the principle of exemption are proposed to solve the dual conflict between public health costs and the interests of pharmaceutical companies.
作者
肖海
饶家宁
XIAO Hai(Intellectual Property Research Center of East China Jiaotong University,Nanchang,Jiangxi,330001,China)
出处
《医学与社会》
北大核心
2022年第12期138-144,共7页
Medicine and Society
基金
江西省高校人文社会科学重点研究基地项目,编号为JD17025。
关键词
药品管理
独占许可
孤儿药
罕见病
Drug Management
Exclusive License
Orphan Drug
Rare Disease
