日本仿制药促进政策研究及启示

Research on Japanese Generic Drug Promotion Policy and Its Inspiration

日本通过一系列仿制药促进政策,包括仿制药促进行动纲领、供给端仿制药质量保证措施、需求端医保偿付及宣传教育措施,使仿制药替代率大大提高。建议我国通过立法明确仿制药的使用,并从供给端角度加快推进仿制药一致性评价,提升仿制药质量;从需求端角度加强公众教育,提高对仿制药的认识,同时运用医保支付杠杆作用,激励和引导仿制药的使用。

Japan has adopted a series of generic drug promotion policies,including a generic drug promotion action plan,supply-side generic drug quality assurance measures,demand-side medical insurance reimbursement,and publicity and education measures,which have greatly improved the substitution rate of generic drugs.It is suggested that China adopt legislation to clarify the use of generic drugs,and accelerate the evaluation of generic drug consistency from the supply side to improve the quality of generic drugs;strengthen public education from the demand side,increase awareness of generic drugs,and use medical insurance pay leverage to stimulate and guide the use of generic drugs.