As I have written about before, while China is preparing to be the biggest pharmaceutical market in the world by 2020, the Chinese government will most likely put in place much stricter safeguards as early as this year to protect its roughly half a million study participants (yearly figure). According to this story from China Daily, an elderly woman participating in a clinical trial sponsored by Bayer Pharmaceuticals, developed serious side effects while on the inpatient unit for the clinical trial. These side effects required her to withdraw from the study and enter the hospital as a patient at which point, the hospital’s mandated insurance to cover clinical trial adverse events would not cover more than $530 US dollars whereas her true medical costs amounted to be around $194,000 US dollars.
This story, much more than an isolated incident, is serving as a wake up call to Chinese regulatory agencies as well as US and European drugmakers who have been expanding into China like crazy these past few years in hopes of establishing their clinical research infrastructure and preparing to capitalize on this large drug market as the local economy improves and the demand for pharmaceutical compounds is on the rise.
US and European drugmakers found themselves in a similar situation last year in India, as the Indian Supreme Court got involved in order to prevent any further cases of study participants not being compensated for their clinical trial adverse effects. Partly due to this reaction by Indian regulatory agencies and partly due to China’s promising future as a nation of consumers, many of these firms continued their expansion further East and settled into China. Well now it is looking like the regulations in China will begin changing as well as it pertains to clinical research and US and European drug makers will have to adapt yet again.