英国“同情用药制度”分析及对我国的借鉴

Analysis of the British“compassionate medicine use system”and its reference to China

“同情用药制度”作为药品监管的灵活手段之一,已成为当前满足患者用药可及性的新路径。英国的“同情用药制度”,即早期药物可及性计划,通过不同政府部门间的通力合作,早期介入申请企业的药物开发过程,在保障患者及时获得创新药物的同时,也加快了药物的上市与支付报销流程。当前我国仅对“同情用药制度”作出了原则性规定,并未出台具体的实施细则。建议结合英国的制度经验尽快对我国“同情用药”的准入条件、不同主体的责任与义务、费用支付机制以及如何促进相关部门的合作等内容作出明确规定,以形成规范可操作的适合我国国情的“同情用药制度”。

As one of the flexible means of drug supervision,the“compassionate medicine use system”has become a new way to meet the drug accessibility of patients at present.The“compassionate medicine use system”in Britain,that is,Early Access to Medicine Scheme,intervenes in the drug development process of the applicant enterprises at an early stage through the cooperation of different government departments,which not only ensures patients obtain innovative drugs in time,but also accelerates the drug listing and payment and reimbursement process.At present,China has only made principled provisions on the“compassionate medicine use system”,but has not issued specific implementation rules.It is suggested that the access conditions of“compassionate medicine use”,the responsibilities and obligations of different subjects,the payment mechanism of expenses and how to promote the cooperation of relevant departments should be clearly defined as soon as possible in combination with the system experience of Britain,so as to form a standardized and operable“compassionate medicine use system”suitable for China’s national conditions.