India's struggles to regulate its booming clinical research industry are well told, but now China could be headed down the same path, as a Beijing court has taken issue with how trial-runners pay compensation to patients.
As China Daily reports, the concern began over an 84-year-old woman who participated in a trial of a Bayer anti-thrombosis drug, only to need further treatment as a result of the study. The hospital that hosted the trial has a policy of requiring study sponsors to insure patients, but Bayer paid out just $530 to cover the woman's medical costs, the paper reports.
Naturally, she sued, and a local court has ordered Bayer to pay about $64,000 and, perhaps more importantly, is urging China's SFDA to change its regulations on clinical trial compensation.
More than 500,000 people participate in clinical trials each year in China, and the court holds that something must be done to ensure patients are taken care of in the event of study-related injury.
It's a familiar story in the outsourcing business. Emerging markets often offer the cost arbitrage sponsors and CROs are looking for, but their relatively lax regulations can let fester some of the industry's uglier practices. And, as India can attest, amending hole-ridden laws is not always easy; business leaders warn that tightening regulations would likely drive up the cost of conducting trials, possibly chasing investment out of the country.
- read the China Daily story