China: 改革动作频频,千亿医疗器械市场面临机遇和挑战

Last Updated: 22 August 2019
Article by DeHeng Law Offices
Most Read Contributor in China, August 2019

近几个月来医疗器械行业内改革动作频频。医疗器械注册人制度试点扩大到21个省,有如释放行业创新活力的一剂良方,监管方通过将产研分开以整合各方优势,志在促进医疗器械产业链的分工高效运作。

同时,国务院办公厅出台的治理高值医用耗材改革方案又让企业为即将巨变的新市场准入态势感到一阵紧张。高层发话,要求从价格形成、医保目录、集中采购等多个环节切入严控高值耗材的不合理使用和价格畸高现象。让人不由联想起5月份医保局、财政部、卫健委等多部门联合发布DRG按病种付费改革,试点正在30个城市探索开展之中。一系列动作表明,国家力图在未来三年以医保等多个抓手综合实现"控费"这一核心医改目标。

日前,药监和卫健委又联合印发了《医疗器械唯一标识系统试点工作方案》,并遴选了第一批试点单位和试点品种。通过UDI统一的编码规则赋予每个产品独一无二的身份证,从而打通从产品生产到流通、使用所有环节的电子数据交换等相关信息接口,可以实现全国范围内器械产品充分可追溯,以及全生命周期的信息交换与共享。可以料想,实现UDI后,产品质量会受到更为有力的监管,价格信息会更为透明,上述高值耗材的带量采购在全国全面落地的速度也会极大加快。

近期的医疗器械行业政策可为宽严相济、推陈出新,中国几千亿元规模、近年以百分之二十增长的医疗器械市场将迎来新的机遇和挑战。以下谨就近期的几项改革政策略做点评。

扩大注册人试点政策颇有亮点、未来可期

2000年《医疗器械监督管理条例》实施,确立了"先生产许可,后产品注册"的管理模式。而在这种制度下生产企业虽然已经合法成立,但在获得注册证之前无法投入生产,而注册证又非朝夕可得,这无疑给生产企业较大压力,阻碍其有序发展。于是2014年《医疗器械监督管理条例》大幅修改,将该模式变更为"现产品注册,后生产许可",即企业可先申请产品注册,拥有注册证后如想要投入生产,再申请医疗器械生产许可证。这一修改有利于生产许可和注册许可的衔接,但由于仍强调主体的同一性,把注册与生产许可捆绑在一起,因此社会成本仍然很高,对行业发展仍构成阻碍。[1]

2017年3月,国务院印发《全面深化中国(上海)自由贸易试验区改革开放方案》,提出:"完善药品上市许可持有人制度。允许自贸试验区内医疗器械注册申请人委托上海市医疗器械生产企业生产产品。"2017年12月1日,上海市出台《中国(上海)自由贸易试验区内医疗器械注册人制度试点工作实施方案》,首次提出医械注册和生产分离。由此标志着注册与生产"解绑"的开始。该制度陆续推广试点城市,包括广东、天津、北京,然而都只限于省内委托。今年8月1日在行业的翘首以盼下,药监发布《关于扩大医疗器械注册人制度试点的通知》,在之前试点的基础上将注册人试点首次扩大至21个省,并允许跨省委托。

医疗器械注册人制度促进行业细分,研发型企业负责推进产品创新能力,生产企业专注提升产品质量,刺激了研发热情和生产动力,也符合国际上的分工代工和供应链趋势。至此,试点省份内的企业和科研机构只要有产品技术和相应的质量体系,无需办厂拿地,即可获得注册证,并能委托所有试点省份内的生产企业进行生产,包括注册前的样品也可以委托生产。注册人制度在现实试点实施中,更是拿证速度相对较快,而且为集团内的资产调拨、收购兼并中的资产重组也提供了便利,以中等风险二类器械居多。

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