Court urges stricter scrutiny of drug firms

A court in Beijing has advised the top drug supervisory authority to strengthen monitoring of pharmaceutical companies' insurance measures to better protect participants in new-drug trials, China Youth Daily reported on Tuesday.

The advice came after a court in Chaoyang district handled a case involving an 84-year-old patient from Beijing suing the Bayer Group in China for compensation.

The patient was admitted to Peking University People's Hospital for bone-joint replacement surgery on her left knee. She took part in the trial of a new Bayer anti-thrombosis drug at the hospital in 2006. But after taking it she had symptoms, including shock, and had to return to the hospital for treatment.

The hospital said it has an agreement with Bayer under which the company is obliged to buy insurance for those receiving drugs, with participants compensated by insurance companies if they are harmed due to the experiment.

But the patient said Bayer only paid 3,296 yuan ($530) to cover part of her medical bills. She later filed a lawsuit against Bayer Group in China and the hospital, asking for 150,000 euros ($194,000) in compensation.

The court ruled in February that Bayer Group in China should pay 50,000 euros to the patient. But unsatisfied with the result, the plaintiff has appealed to a higher court.

With some 800 new drugs being tested in China each year, involving 500,000 people, the court said the case should attract the attention of the drug supervisory authorities. It said Bayer refused to submit the insurance contract related to this case to the court despite repeated requests.

The court said on Tuesday it has advised the China Food and Drug Administration to amend regulations on management of drug registration and establish a system for obligatory recording of insurance. It also advised Peking University People's Hospital to step up inspection of insurance measures and keep relevant records.