Study On The Legal Guarantee Of Orphan Drugs In China

In the context of the implementation of the strategy of healthy China,rare diseases as a special disease into the field of vision,internationally,the treatment of rare diseases drugs called orphan drugs.Orphan medicine is different from ordinary medicine,because of the lack of incentive policy of orphan medicine in China,it seriously hinders the research and development and use of orphan medicine.With regard to the protection of laws and regulations,the Measures on the Administration of Drug Registration,which came into effect on 1 October 2007,and the Regulations on the Administration of Special Examination and Approval for the Registration of New Drugs,which came into effect on 7 January 2009,provide for the special examination and approval of new drugs for the treatment of difficult diseases,articles 16 and 96 of the Drug Administration Law,as amended in December 2019 It is proposed that the State encourage research and development of orphan drugs and give priority to the examination and approval of orphan drugs,and that the Law on Basic Health Care and Health Promotion,to be implemented in 2020,provides for priority examination and approval of orphan drugs.However,due to the lack of specific implementation rules,these provisions are difficult to implement.Improving the legal protection of orphan medicine heat gradually heating up,the rights and interests of patients with rare diseases is imperative.This paper analyzes the legal guarantee of orphan medicine by four parts:Overview of legal safeguards for orphan drugs.Orphan drugs are used to treat rare diseases,orphan drugs are different from ordinary drugs,with the characteristics of great difficulty in research and development,market failure and high public welfare.Strengthening the legal guarantee of orphan medicine is of great significance to improve the availability of orphan medicine,protect the health rights and interests of patients,perfect the social security system of our country and promote the economic growth of our country.Foreign experience and evaluation of legal guarantee of orphan medicine.The legal guarantee system of the United States,the European Union,the developed countries and regions of Japan is relatively perfect,the patent protection system of orphan drugs is more mature,and has formed a multi-party joint patient guarantee system.The current situation and existing problems of legal guarantee of orphan medicine in China.There are some problems in our country,such as insufficient patent incentive,unreasonable examination and approval system,lack of policy support for orphan drug operators,and imperfect social security system for orphans drug patients.Suggestions to improve the legal guarantee of orphan medicine in China.First,we should strengthen the patent protection for orphan drugs,including the extension of the patent period for orphan drugs,the establishment of a market-only licensing system for orphan drugs,and the establishment of a data-protection system for orphan drugs.Finally,we should optimize the social security system for orphans and recommend the establishment of a social security system for orphans medical security system,increase the scope of commercial insurance protection,and give play to the active role of public welfare organizations.