Overseas Experiences and Implications of Legal Systems for the Prevention and Treatment of Rare Diseases
This study analyzes the commonalities and differences in rare disease laws and regulations or relevant provisions among four typical countries/regions:the United States,Japan,Australia and the European Union.Special attention is paid to institutional design,enforcement agencies,operational mechanisms,and incentives.The study found that drug accessibility is the key focus of legal systems in each region,but the specific legal implementation of drug coverage varies,as manifested in the choice between standalone regulations and comprehensive legal systems.In addition,the integration of patient perspectives and the strengthening of community governance are experiences worth learning from China.Based on overseas experiences,this paper proposes the optimization of the legal system for the prevention and treatment of rare diseases that is suitable for China's national conditions,covering legislative path,entry points and content,aiming to protect the rights and interests of patients with rare diseases in a more effective and comprehensive way.
NETL
NSTL
万方数据
