浅谈英国脱欧之后遗症——药品短缺

2018-09-30 佚名 新浪医药

日前,距离英国脱欧的最后期限2019年3月29日也就半年左右的时间,英国与欧盟的脱欧谈判正如火如荼的进行中,最终是否会达成协议或造成无协议脱盟局面,双方都在作积极的努力。

日前,距离英国脱欧的最后期限2019年3月29日也就半年左右的时间,英国与欧盟的脱欧谈判正如火如荼的进行中,最终是否会达成协议或造成无协议脱盟局面,双方都在作积极的努力。

“英国脱欧”(Brexit)对英国制药业的影响有许多的报道,其中让监管机构以及药品生产商最为关注和担忧的就是药品短缺问题。

我们先大致了解一下欧盟的药品审批方式以及EMA和英国医药和保健产品监管机构MHRA之间的矛盾,欧盟药品申请上市的途径一般分三种:欧盟集中审评程序(Centralized Procedure,CP)、成员国互认评审程序(Mutual Recognition Procedure ,MRP)以及成员国单独分散审评程序(Decentralized Procedure,DCP),详细介绍请参见《域外传珍-夜谈英国脱欧对集中审评药品上市后再处置的影响》一文。

EMA总部原来设在英国伦敦,EMA与MHRA这两个机构的职能很相近,而MHRA之前在集中审批制度下参与了较多的药物审批工作,EMA将总部迁至阿姆斯特丹后,要求成员国监管机构之间更平等地分配工作,这样MHRA工作量才明显减少。此外,根据分散的互认程序,由MHRA处理过的上市许可都必须转交给其他成员国的监管机构。已根据欧盟成员国互认程序获得的药品上市许可在英国脱欧后若想继续在英国销售,则也要求在英国重新获得上市许可。在获得欧盟上市许可已经困难的情况下,这也给各个监管机构和EMA带来很大负担。

目前,英国与欧盟的谈判最终结果未出,EMA是否会将英国排除在欧盟监管框架之外也未可知。

8月23日,英国健康与社会保健部门要求制药公司向国民保障服务系统供应超过日常供应量至少6周的药物,这就是由于考虑到在英国脱欧谈判无果的情况下,可能会中断从欧盟进口药品。在欧洲药品供应链方面,英国从供应链起始端到成品端都起着至关重要的作用。根据英国制药工业协会的统计,英国每个月从欧盟进口3700万个药品包装,向其出口400万个包装。英国生产2,600多种药品,其中许多药品出口到欧洲。

尽管英国在脱欧之后仍可能保持欧盟的部分药品审批制度,但是脱欧后药品监管环境的不确定性不得不敦促制药公司作好最差的打算,如作好储备药品,在英国以及欧盟地区重建工厂以及建立替代的贸易路线等。

为了促进这一进程,EMA发布了一份指导意见,帮助企业为英国脱欧做准备。然而EMA最近公布的调查结果显示,一些制药商在英国脱欧后并没有采取足够的措施来维持其产品的持续供应。根据这项调查,共有694种集中授权的产品(661种人药和33种兽药),这些产品或者公司位于英国,或者质量控制、批放行、进口或生产地、药物警戒受权人(QPPV)或药物警戒系统主文件(PSMF)在英国,而根据欧盟法律,上市许可持有人、QPPV、PSMF和某些生产基地必须设在欧洲经济区(EEA),这家公司才能够在欧盟市场销售药品。这项调查显示,694种集中授权的产品中有58%以上的生产商在其监管过程中迈出了重要一步,以确保在英国脱欧后,药品上市许可仍然有效。

另一方面,调查结果显示,仅在英国拥有生产厂地的108种药品(88种人药和20种兽药),将无法及时实施必要的监管措施,以维持英国脱欧后上市许可的有效性。而且更令人担忧的是,在此次调查中10%的产品没有反馈。2018年7月至9月期间,EMA一直在与这些公司联络,确定存在供应短缺风险的药物,并评估这些风险的严重性以减轻预期的供应短缺。经过EMA的多方努力,目前有供应短缺风险的集中授权药品已降至39个,而且这一数字可能会继续减少。

从上述信息看出,任何药品监管机构变革都会带来很多影响,例如药品审评变慢、药品价格波动、药品短缺等情况。这些现象也提醒中国正在进行的药品管理改革需要审慎进行,避免严重后遗症出现。

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    2018-10-02 huirong
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    2018-09-30 医者仁心5538

    知道了

    0

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    2018-09-30 1e145228m78(暂无匿称)

    学习了,谢谢作者分享/

    0

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