China: 进口未批的境外新药不按假药论处,但并非就是无罪

Last Updated: 4 September 2019
Article by DeHeng Law Offices
Most Read Contributor in China, October 2019

2019年8月26日,《药品管理法》经修订后通过,其中原法第三十九条第二款的"医疗单位临床急需或者个人自用进口的少量药品,按照国家有关规定办理进口手续。"修改为现在的第六十五条第一款的"医疗机构因临床急需进口少量药品的,经国务院药品监督管理部门或者国务院授权的省、自治区、直辖市人民政府批准,可以进口。进口的药品应当在指定医疗机构内用于特定医疗目的。"和第二款的"个人自用携带入境少量药品,按照国家有关规定办理。"结合第一百二十四条第三款规定"未经批准进口少量境外已合法上市的药品,情节较轻的,可以依法减轻或者免予处罚。"于是有人欢呼《我不是药神》终于在现实中获得回应。

但是,仔细研读修订后的,《药品管理法》,除了得出进口少量境外已合法上市而国内尚未获得批准的药品不再以假药论处这一结论外,恐怕无法得出其他结论,《我不是药神》仍然难言合法。

修订后的《药品管理法》把修订前的第三十九条第二款充实为第六十五条的两款,其第一款不仅是把在《药品管理法实施条例》中行之有效的第三十六条由行政法规擢升为法律规定,更是在用词上完成了不同法律之间的统一,为不同法律从不同角度调整药品进口、进境的情况扫清了障碍。

按照我国《海关法》,对通过贸易渠道把商品输入中国关境的情况称为货物的进口,对个人、进出境旅客通过随身携带、邮寄的方式把合理数量内的自用品输入境内称为物品的进境。《药品管理法》第六十五条改变了原法第三十九条不区分货物、物品一律使用"进口"一词的提法,实际上明确了医疗机构只能通过贸易渠道进口,属于贸易性行为的范畴,因而医疗机构即使通过进境旅客个人携带药品进口也属于贸易性质,必须履行一系列向海关申报货物进口的手续并提交相关批准文件缴纳关税。如果未履行批准和申报手续,虽然按照第一百二十四条第三款可以减轻或者免予处罚,但其行为却会因为逃避海关监管逃避缴纳关税义务而构成走私甚至走私罪。

同时,第六十五条第二款又把个人从国外购入已上市药品的情况限定为携带入境,按照《海关法》,这一方面把这种携带应该定性为非贸易性质的旅客个人物品的进境,可以享受一定额度内的免税优惠,另一方面又排除了邮购、网购等情况,表明其入境途径必须是通过自然人的携带,并且其使用范围限于"自用"。关于"自用"的范围,究竟是指携带人自用还是携带人的亲属、朋友也可以使用,目前似乎还没有明确的界定。如果是仅限于携带者自己使用,那么只有患者本人才可以携带其需要的少量外国已上市药品入境,即使按照《海关法》对自用范围的把握原则,也仅限于携带者本人及其亲属和朋友。

无论是携带者本人还是其亲属朋友使用,其"自用"的性质都决定了其在数量上不可能是大量的,因此《药品管理法》称之为"少量",《海关法》的原则规定是"合理数量";在对进境后药品的处置上,也只能是使用,而不能是销售谋利。

现实中一些海外"人肉代购"利用本该由进境旅客享有的免税优惠,把境外商品免税带入境内,然后销售给不享有这种免税优惠的第三人,从中赚取差价。这种行为尽管是个人行为,但其性质仍然属于贸易,所携带商品属于进口货物,所以其行为已经是逃避应缴关税义务的行为,构成《海关法》规定的走私行为。当逃税达到一定金额后,其行为就构成走私犯罪。

同理,如果以"人肉代购"形式携入国外已上市药品,然后在境内销售,虽然在《药品管理法》的规定中已经不再构成销售假药的行为,但是其仍然是违法甚至是犯罪行为,只不过可以减轻或者免予处罚而已,而且其构成《海关法》上的走私行为。如果把代购药品定性为货物的话,即使按照第六十五条第一款进口药品也要经过国家相关部门批准,而代购行为几乎可以肯定未经批准,那么代购药品除构成逃避应缴关税义务的行为外,还构成逃避国家对禁止进口、限制进口货物的管理的行为,属于比逃税更严重的走私行为,并且构成走私罪的可能性也大大增加。

另外,对于直接向走私人购买走私货物、物品的人,当购买达到一定数额后,法律规定也是按照走私或者走私罪论处的。因此,对明知是代购进境的商品仍然大量购买的人,不得不说其风险也在不知不觉中积聚。

细细想来,代购成不了药神,真药也可能违法。大家在携带、使用虽已在国外上市但还未被批准进口的药品时还应多加谨慎,无法确定时,多问问专家、律师。

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