我国无创产前检测技术应用与政府监管的定性分析

Qualitative Analysis of Implementation and Governmental Regulation of Non-Invasive Prenatal Testing in China

目的:评估我国无创产前检查技术(NIPT)的实施与政府管理现状,为进一步规范NIPT的临床应用提供决策参考。方法:采用半结构化方式对关键知情人进行定性访谈,共计开展13场焦点小组讨论,访谈了22名政府管理者、92名医务工作人员、20名孕妇。结果:NIPT试点项目中,不同的试点医院对于该技术的实施程度不同。医院实施NIPT主要有以下两种模式:医院自主实施NIPT和医院与第三方检测机构合作开展NIPT,第三方检测机构通常为其他具备高通量基因测序等分子遗传技术能力的生物遗传公司或医疗机构。不同利益相关者对于NIPT技术有不同的诉求与观点。关于NIPT的政府监管,当前存在诸多挑战与不足,如缺乏有效合理的定价与报销决策,对直接面向客户的"B2C"商业模式监管困难等。结论:应明确NIPT在产前筛查与诊断服务系统中的定位与功能,规范NIPT服务模式与资质要求,提高服务质量;建立NIPT技术应用的定价与补偿等配套支持系统,满足孕妇需求;政府对于NIPT的监督管理应在"过度限制"与"全面放开"中平衡决策,使NIPT规范、有序地开展。

Objective： This study aims to examine some initial outcomes of the NIPT pilot project in China, with a view to providing information for policy-makers to guide decision-making regarding governmental regulation of NIPT in China, Methods： Thirteen focus groups （FGs） were conducted in total. 22 relevant government officials 92 health workers and 20 patients were inter- viewed. FGs were conducted with a semi-structured question guide and the interviews were transcribed and analyzed using narrative and thematic approaches. Results： Hospitals differed in the extent of their involvement in NIPT. Two different models were adopt- ed ： hospitals conducting the entire process of NIPT by themselves and hospitals collecting blood samples and having them tested by a third party, mostly companies specializing in genetic testing or other hospitals. With regard to governmental regulation, the gov- ernment faces multiple challenges such as establishing a reasonable price structure for NIPT services, dealing with for-profit genetic testing companies＇ direct-to-clients service model with its considerable ethical, privacy-protection and quality ramifications. Con- clusion ： It is suggested to clearly determine the position and function of NIPT in prenatal screening and diagnosis system, to stand- ardize the NIPT service model and qualification requirements for improving quality, and to establish supporting system of pricing, insurance coverage and market regulation. It is also necessary for government to achieve a balance between under-regulation and o- ver-regulation.