On Sunday night, a draft of the “Vaccine Management Law” was posted online for the public. If passed, the new law will allow people to sue drug makers for punitive damages in cases of death or serious illness caused by faulty vaccines. Due to multiple vaccine safety scandals in the country (a major drug maker was found to have sold 400,520 inferior DPT vaccines and 570 million yuan of improperly stored or expired vaccines were illegally sold across the country for years), the new legislation “is designed to establish a long-term supervision system by integrating articles from different pieces of legislation,” 1 and will allow “patients and families to sue vaccine makers and distributors for punitive damages if they knowingly sell faulty vaccines that cause death or serious illness.”2
This is unprecedented in China. And perhaps the world. And it’s about time.
Under current law, if a vaccine is proved to have caused adverse health effects, victims are liable for compensation (which varies depending on the economic status of where the vaccine is administered) from the local health authority. However, if the vaccine was part of a national immunization programme or from the drug makers, victims get nothing.
“The legislation is being introduced months after China’s second largest rabies vaccine maker Changchun Changsheng Life Sciences was found to have falsified its production records, used out-of-date materials, mixed different batches of products and failed to test them properly.
Fourteen company executives and staff members were detained over the scandal and senior officials were sacked.
Although the company was fined 9.1 billion yuan (US$1.3 billion) and ordered to set up a compensation scheme to pay victims up to 650,000 yuan, demands for tougher regulations have been mounting.”3
“Serious” breaches of the law like fabricating production inspection logs, changing batch numbers, filing fake data for lot releases, or failing to recall substandard vaccine could see firms lose their licenses and or pay fines worth five to 10 times the value of the products in question. Also, legal representatives and key staff involved could have their profits confiscated and be barred from the industry for 10 years. (Oh and officials who fail to catch these issues or who are found to have participated in a cover-up will be punished “severely”.)
Basically, China isn’t messing around.
Can you imagine if vaccine makers here could be held responsible for their product?
It remains to be seen what will happen if this law passes and what the process will look like to prove that a vaccine has damaged someone. We will update you when we have more information.