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Home > Medical Devices & Pharmaceuticals
Cooking clinical trial data is rampant and now criminally punishable in China
By Henry Chen | 2017/9/20 11:21:52

The falsification of clinical trial data has been serious in China.  For example, in May of 2015, the State Food and Drug Administration of China (“SFDA”) requested pharmaceutical enterprises to do a voluntary self-inspection of their clinical data regarding the drugs to be authorized.  Those who do not would face a more severe punishment.  One month later, 20% of 1622 applications were withdrawn.  It seems an open secret that every link of clinical trial is problematic and it is not surprising at all that clinical trial data could be falsified in a serious way. 

There are several reasons for the falsifications.

First of all, clinical study organizations are extremely insufficient.  By statics of 2012, there were 6000 drug research and development enterprises in China, but there were only 379 clinical study organizations.  In the year of 2012, there were as many as 704 clinical research projects being launched.  Take into consideration the projects that were extended into 2012 from the previous years, every clinical study organization was over-burdened.

2009-2014 approved clinical trial studies in China

Secondly, clinical study organizations are short of experienced doctors to do clinical studies.  In China, clinical study organizations are nothing but well-established hospital; the persons that are responsible for clinical trials are famous doctors.  The famous doctors could be too busy to do studies nicely.  They would let the doctors that are less busy handle the studies, which are usually young and inexperienced.

Thirdly, hospitals usually try to maximize their financial gains from clinical studies regardless the study quality.  The fund that a drug manufacturer pays to a hospital for clinical trial could be hair-cut by hospital and the concerned clinic(s).  Only a portion of the fund could be then used for clinical trials.  Some hospitals try to maximize their earnings by overpromising drug manufacturers, and some hospitals even guarantee that the experiments would 100% meet the targeted indicators.

CROs are not helpful in curbing the falsifications.  Some CROs even charge money on a contingent basis – no success in a clinical trial, no fee.  Some drug manufacturers clearly know that some CROs are cooking data, but keep a blind eye to it.

To crack down on data cooking, the Supreme People’s Court (“SPC”) and Supreme People’s Prosecutors (“SPP”) issued the Interpretations in Several Issues on the Application of Law in Criminal Cases Regarding the Falsifications of Application Materials for the Registration of Pharmaceuticals and Medical Devices on August 14, 2017, and the judicial interpretation has been in effect from September 1.

The judicial interpretation is trying to make Article 229 of China’s Criminal Law more criminally deterring in falsification in the life science industry, which reads: “if a member of an intermediary organization, whose duty is to make capital assessments, verification or validation, to do accounting or auditing, or to provide legal services, etc., deliberately provides false documentary evidence, and if the circumstances are serious, he or she shall be sentenced to fixed-term imprisonment of not more than five years or criminal detention and shall also be fined.”  As such, clinical study organizations (i.e., laboratories and healthcare institutions) and CROs are all subject to this Article 229.

According to the judicial interpretation, serious circumstances which would cause severe punishments include using falsified study-related drugs, failure to report severe adverse events, destroying original study data, falsifying study data, having a history of submitting falsified documents in connection with the registration of drugs or medical devices, or other circumstances that are deemed serious.  In furtherance, soliciting or accepting “money or property” during the course of the aforesaid misconduct can be subject to five to ten years of imprisonment and criminal fines.

Employees of companies applying for drug registration (i.e., sponsors) are subject to criminal liabilities if they knowingly use organizations that do not have the appropriate qualifications to handle clinical trials or non-clinical research, or “the amount of payment is obviously different from usual cost.”

Those who are interested in knowing more the subject matter issues please contact  Henry Chen is licensed to practice law in China and the New York of the USA.  Henry Chen is a member of China delegation to negotiate and draft ISO 19600 Compliance Management System – Guidelines and the Vice Director of the Working Group of China domestic standard on compliance management system.  Henry is the author of the book: Risk Management on Commercial Bribery in China.  Extension reading in Chinese 《合规保障、精准营销 | 中国合规网与康柏汉森达成战略合作在生命科学领域共同推广、实施合规管理

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