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中国仿制药发展亟待提速 走私印度药品案件频发

2017-06-30 09:39:21   经济参考报

记者日前从长春海关了解到,长春海关成功破获了一起案值1300多万元的“电子水客”走私国家禁止进口药品案。案件称,某互联网电商代购平台“印度周先生代购”、“印度行品代购”等5家店铺疑似从印度走私索菲布韦、达卡他韦等十余种国家禁止进口药品入境,并利用网络交易方式在国内高价销售牟取暴利。

随着印度仿制药市场的大繁荣,印度 “世界药房”的身份已经被广泛认可。我国近年来频繁发生走私印度药品案件,由于价格和品质等原因,一些患者依赖印度生产的各类药品,其中仿制药市场最为活跃。专家表示,中国仿制药的发展亟待提速,今年10月底前国务院医改办将完成制定改革完善仿制药管理政策的指导性文件。

  走私印度药品案件频发

仿制药是指与原研药在剂量、安全性和效力、质量、作用以及适应症上相同的一种仿制品。当专利药品保护期到期之后,其他国家和制药厂即可生产仿制药。但在印度,专利法允许药品实施强制许可,在出现“公众对于该专利发明的合理需求未得到满足”,或者“公众不能以合理的可支付价格获取该专利发明”等情况时,印度药厂在本土可以强行仿制尚在专利保护期的新药,并且可以出口到无相关生产能力的地区和国家。

我国近年来频繁发生走私印度药品案件,仅上海市自2013年以来已审结6起海淘洋药案件,并有多名海淘者获得不同程度刑罚制裁。之所以走私药品案件频发,其背后根本原因是我国的仿制药产业发展缓慢。

在海淘仿制药案件当中,最为有名的是陆勇案。2002年,江苏无锡人陆勇被确诊患有慢粒白血病,为控制病情,他必须持续不断地服用瑞士诺华公司生产的“格列卫”抗癌药,该药品每盒售价在23000元至25000元,2004年,在自用印度仿制瑞士抗癌药“格列卫”之后认为性价比非常高且效果完全相同,此后他便开始帮助其他病友购买仿制药。2014年7月21日,湖南省沅江市检察院以妨害信用卡罪、销售假药罪对陆勇提起公诉。之后493名白血病患者联名写信,请求司法机关对陆勇免予刑事处罚。

同时,伴随着互联网科技的不断发展,网络售卖仿制药成了一种新的模式,也带来了更多问题。国家食品药品监督管理局在2014年6月曾发文提示消费者不要通过网络购买海外代购的抗癌药。同时,国家食品药品监督管理局提醒消费者,抗癌药均为处方药。根据《互联网药品交易服务审批暂行规定》,互联网禁止销售处方药。经食品药品监管部门批准的具有网上销售非处方药资质的药品零售企业有184家。然而,据不完全统计,自2010年11月至2015年初,国家食品药品监督管理局已先后9次累计公布122家违法网络购药网站,其中海外代购进口药“屡点屡上”。

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