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left;">最高人民法院审判委员会全体会议近日审议并原则通过司法解释，首次将临床数据造假骗取药品批文纳入刑事处罚，最高可判死刑。我国《药品管理法》《药品管理法实施条例》等对临床数据造假的处罚均有规定，处罚手段包括给予警告、责令限期改正、责令停产、停业整顿、列入黑名单等，因仅限于行政处罚，处罚对象以机构为主，对个人的处罚力度有限。此次将临床数据造假入刑，加大了违法成本，为公民用药安全和生命安全提供了坚实的法治保证。</p><p style="text-indent: 2em; text-align: left;">近年来，医药行业临床数据造假行为屡禁不止。我国每年都有大量新药上市，几乎每天都有药物临床试验进行，先在动物身上试过毒性后，即在健康人身上测试安全性，之后在病人身上测试疗效。因药物的毒副作用等真实临床数字，既可为药企改进配方提供科学依据，也为患者用药提供了安全前提。然而，由于长期以来临床试验多环节存漏洞，药企研发与医院临床医护之间存在利益输送，加上药监局所派驻稽查员的监察力度疲软，稽查手段、技术滞后，致使数据造假现象十分严重。</p><p style="text-indent: 2em; text-align: left;">据《中国临床药理学杂志》统计，2013年我国有85.7%的临床试验机构试验记录不规范，47.4%的试验机构试验实施和试验药物管理不规范。2015年7月，国家食品药品监督管理总局决定对部分已申报生产或进口的待审药品注册申请开展药物临床试验数据核查，一年多之后，超八成新药申请被药企撤回或在食药监总局未通过。这些统计数据虽不能反映全貌，但也足以显示临床数据造假的严重情形。</p><p style="text-indent: 2em; text-align: left;">另据统计，在美国新药的研制费用平均为9亿美元，而人体试验开销就占了40%。按国际药物临床试验通行惯例，药品研发企业或CRO公司会派出监察员（CRA），对临床试验机构进行监督。但在我国，对于药物临床试验行业的质量规范和行业法规，只有一部《药物临床试验管理规范》。尽管对研发、试验及监察员职责有明确规定，但缺乏第三方的监督与制衡，更因位阶较低，缺乏应有的法律尊严和威慑力?？銮倚乱┥笈ǔ！把辖沓觥保粗灰褡冀肓俅彩匝榻锥?，最终大多数都能获得许可证书。以上种种，不同程度上催生了试药市场以及临床数据弄虚作假乱象。</p><p style="text-indent: 2em; text-align: left;">临床试验数据造假后果十分严重。临床试验作为验证药物安全性和有效性的标准，一旦数据出问题，就无法保证上市药物的安全有效，有些被隐瞒了的不良反应，甚至会直接危及患者的生命安全。临床试验作为循证医学的数据基础，只有临床试验的数据真实可靠，在大健康、大数据领域，医药行业的数据才有参考和应用的价值。临床试验数据大量造假，势必造成劣币驱除良币的后果，进而影响药品的研制开发。</p><p style="text-indent: 2em; text-align: left;">必须从源头开始，驱除临床数据造假的恶魔。无论药企还是临床医护都当恪守职业操作，把实事求是作为职业生命予以敬畏，以科学良知为本，对临床试验作真实无伪的记录，加强全过程的监督和程序性约束。当务之急要完善相关法律，将药企、临床医院、试药人及中介监督机构的权力、权利、义务及法律责任规范化程序化，最大限度堵塞人为造假的空间。</p><p style="text-indent: 2em; text-align: left;">在我国医药体制格局中，一些药企处于利益链的顶端，为追逐利润往往无所不用其极。有的药企为缩短流程，尽快上市，或者夸大疗效，或伙同医生或者CRO公司造假。对此唯有严惩，实现刚性约束，才能挤压造假空间，重建市场秩序，彻底铲除弄虚作假的利益链条。最高法原则通过的司法解释，将临床数据造假纳入刑事处罚，为遏制临床数据造假乱象，保障用药安全和生命安全铸就了一柄法治利剑，其治理效果值得期待。</p><p style="text-indent: 2em; text-align: 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