China has recently announced a policy shift on 11 May, which sentences those who submit faked clinical trial data into jail; and in extreme circumstances, be executed.

The policy, implemented last month, was one of the measures to speed up its slow drug-approval process – and at the same time keep dangerous and ineffective drugs off the market.

Other measures include expedited reviews and approvals for urgently needed therapies, supportive regime for rare disease cures and market access benefits – where hospitals will be encouraged to prioritise their procurement and use of new drugs, with definite efficacy and reasonable prices, amongst others.

This recent move "is the strongest signal yet, to all drug developers, clinical-trial managers and principal investigators and physicians, that China is now very serious about clinical data," says Dan Zhang, executive chairman of Beijing-based Fountain Medical Development, which carries clinical trials out for companies and itself stands to be held accountable for the policy change.

The shift was sparked after China's Food and Drug Administration (CFDA) ordered companies to re-evaluate "the authenticity, integrity and compliance of clinical trial data" in pending applications for new drugs in 2015.

Policy shifts scare pharmaceutical companies

After the agency told the companies that they would not be able to submit other drugs for approval if CFDA examiners found violations, more than 80% of the applications were voluntarily withdrawn. A quarter of the remainder were also rejected due to problems of authenticity.

Existing laws state that manufacturing and selling counterfeit versions of drugs are a crime, but submission of fake data in the approval process was never regulated. As such, the new policy – approved by a court review committee on 10 April – will broaden current laws to cover submissions of clinical-trial data.

The new policy is expected to go into effect within a few months, making those who submit faked clinical-trial data as guilty as those counterfeiting.

It also states that if an approved drug causes health problems, it can result in a 10-year prison term; or if the drug proved to have severe or fatal consequences, the death penalty.

If the drug does not cause any consequences, is unapproved, or both – those who break the law by submitting fake data may face prison for at least three years. The new policy also subjects those who submit fake clinical trial data to prosecution under a law that forbids bearing false testimony.

How change occurs will determine impact of policy shifts

However, experts say that the impact will depend on how the change is implemented. It is still unclear who among the large number of people involved in a trial would be held responsible for the fake data. The severity of a judgement is also unclear.

"Will falsified data for one patient break the law, or would it have to be 10 or 100?" says Su Ling, director of the Institute of Drug Regulatory Science, at Shenyang Pharmaceutical University. This meant that the first prosecution would be vital as it should clarify this, he adds.

There is also doubt on whether anyone would be executed under the new policy, but it might happen as China executed the former head of its drug agency for accepting bribes to approve medicines – which proved to be fatal – a decade ago.

Experts also say that intent must be proven for the crime to hold, but it is challenging.

Matter must be treaded carefully

In view of the policy shift, the pharmaceutical industry is not the only one to be blamed. Chinese hospitals also showed to fail to document whether trials are double-blinded, whether the study goals are achieved, whether informed consent and ethics approval have been given and whether test and control groups have been randomly selected to decrease bias.

Chinese trials have – not surprisingly– been more likely to show a positive effect for a drug, even if the same drug had failed clinical trials somewhere.

"Most of these problems are the result of people trying to cut corners in order to get papers published in better journals and reap the resulting benefits," says John Ioannidis, a researcher in health policy at Stanford University, in California.

The CFDA has also taken other steps to speed up a four-year regulatory process and make it more rigorous. Between mid-2015 and end of last year, it quadrupled the number of staff and is expecting to hire 300 more regulators.

But experts advise to tread the matter more carefully as efforts might "overheat". Regulators lacking in drug development or regulatory experience could approve ineffective or even dangerous drugs which could be catastrophic, Su says. MIMS

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