China adopts tough law to ensure vaccine safety
China's top legislature on Saturday passed a law on vaccine administration, which stipulates the "strictest" management by requiring a whole-process supervision system and toughening penalties on producing and selling fake or substandard vaccines.
The law was adopted after the third reading at a bimonthly session of the Standing Committee of the National People's Congress, which closed on Saturday.
As the country's first legislation dedicated to vaccine management, the new law will go into effect on December 1, 2019.
According to the law, supervision of vaccines will cover the whole process, from vaccine development, production and distribution, to vaccination.
Specialized inspection teams of pharmaceutical professionals will be established at the central and provincial levels to conduct the supervision work.
An electronic information system will be set up to make all information of vaccines trackable, such as production and package information of vaccines, period of validity, date of vaccination, and medical workers who conduct the vaccination and the recipients. The records must be retained for at least five years after the expiry of the vaccine, according to the law.
To increase the transparency of the industry, vaccine license holders are required to publish vaccine information on their websites in a timely manner, including product instructions and labels, official approval, recall information, inspections and punishment received and compulsory insurances covered.
Aside from strengthening the whole-process supervision, the new law also toughens penalties on the production and sale of fake or substandard vaccines.
It stipulates that people whose violations constitute a crime shall bear heavier criminal responsibility in accordance with the law.
Meanwhile, the law imposes heavier fines on producers and sellers of defective vaccines. Those producing or selling fake vaccines shall face a fine of 15 to 50 times the value of the illicit products, while substandard vaccine makers or sellers face a fine of 10 to 30 times the value.
It also raises the threshold for fines, by stipulating that fake or substandard vaccines worth less than 500,000 yuan (about 72,908 U.S. dollars) shall be calculated as 500,000 yuan.
Production and business operation will be suspended for rectification, and drug registration certificates or even pharmaceutical production licenses can be revoked, it said.
The tough punishments will exert positive impacts on the whole-process supervision of vaccines, said Jiao Hong, head of the National Medical Products Administration.
It will further enhance the quality of the country's vaccines and boost the public's confidence on vaccine safety, Jiao said at a press conference held after the five-day legislative session closed.
Compensation for adverse events
Although vaccines are the most effective guard against vaccine-preventable diseases, in rare cases serious side effects are reported.
The law introduces a compensation system for people who suffer adverse events linked to vaccinations.
It stipulates that compensation shall be provided in cases of adverse events leading to death, serious disability or organ damage during or after vaccination, or when the possibility of an adverse event cannot be excluded.
For mandatory vaccination, the compensation must be paid through local fiscal budgets, while for voluntary vaccination, the vaccine license-holder must shoulder the responsibility. Commercial insurance is encouraged to be included in the compensation mechanism.