A recent judicial interpretation issued by China’s top judicial and prosecutorial bodies now criminalizes submitting falsified nonclinical study or clinical study reports and related materials. This could affect life sciences companies and contract research organizations operating in China.
The judicial interpretation — released last month, effective September 1 — was issued by the Supreme People’s Court and Supreme People’s Procuratorate (SPP). Such judicial interpretations have the force of law in China and give binding guidance to lower courts and prosecutorial organs on how laws are to be interpreted.
The judicial interpretation appears to expand the scope of Article 229 of China’s Criminal Law, 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.”
Based this new judicial interpretation, members of drug-related nonclinical and clinical study organizations (i.e., laboratories and healthcare institutions) and contract research organizations are now covered under Article 229. According to the judicial interpretation, serious circumstances 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. Further, 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) also can be subject to criminal penalties for providing instructions during the aforesaid misconduct, which includes knowingly using 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.”
In addition to drugs, the above provisions also apply in the context of studies and registrations for medical devices.
Like many Chinese laws, the person responsible for the entity or other involved persons can, in some cases, be criminally responsible for the actions of the entity.
This is not the first time that the authorities have interpreted Article 229 to expand the scope. In 2009, in a reply to a local prosecutorial body, the SPP confirmed that a pubic notary can be prosecuted under Article 229 for issuing “significantly untrue” certifications. More recently, in 2015, the SPP made it clear that falsification of geological engineering investigation reports is a crime punishable under Article 229.
This recent judicial interpretation comes as the China Food & Drug Administration continues its emphasis on data integrity in clinical studies.
Life sciences companies operating in China will want to continue to ensure that the studies and reports they conduct and rely upon are accurate, and that the contract research organizations, laboratories, and healthcare institutions they engage are qualified and compensated appropriately.
Eric Carlson, a contributing editor of the FCPA Blog, is a Shanghai-based partner at Covington & Burling LLP. Huanhuan Zhang is an associate in Covington’s Shanghai office. Both specialize in anti-corruption compliance and internal investigations, with a particular focus on China and other regions in Asia. Eric Carlson speaks fluent Mandarin and Cantonese and can be contacted here. Huanhuan Zhang speaks native Mandarin and Cantonese and fluent English and can be contacted here.