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China threatens prison time and death penalty to fight fraudulent trial data

Published on 12/05/17 at 10:36am

In a drastic move to help solve its notorious problem with fraudulent clinical trial data, China has introduced a policy shift in its criminal code meaning that persons wilfully submitting fake data will be imprisoned or even executed.

Approved last month, the shift essentially expands the original laws which make the manufacture and sale of counterfeit medications a crime to cover clinical trial data in the same manner. The change is expected to come into effect in the coming months and will enforce a ten-year prison sentence or even the death penalty if drugs approved under the pretence of fraudulent data are found to have ill-effects. Where approval is not granted or no one is harmed by the submission of fake data, a three-year sentence is the punishment.

It is still unknown who will hold responsibility for the crime in the event of prosecution. Su Ling, Director of the Institute of Drug Regulatory Science at Shenyang Pharmaceutical University, noted: “Will falsified data for one patient break the law, or would it have to be 10 or 100? The government might make an example of someone.”

In 2015, the China Food and Drug Administration (CFDA) issued an order to companies requiring them to re-examine the “authenticity, integrity and compliance of clinical trial data” in New Drug Applications, under the threat of having all future applications blocked. As a result, over 80% of applications were withdrawn by the firms that filed them, while a quarter of the remainder was plagued by validity issues and ultimately rejected, highlighting the severity of the problem in the nation, with reasons cited being sub-standard documentation and deviance from standard protocols.

The CFDA currently takes around four years to approve a treatment which has already been granted approval in the US or Europe, and it is thought that this policy change could discourage many submissions which otherwise would be intending to put forward false data, and thus free up CFDA resources. Over the last two years, the organisation has quadrupled its staff, adding 450 new regulators with plans to add 300 more this year in the hope of accelerating drug approval timelines.

Matt Fellows

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