China's top legislature Tuesday began reviewing a draft law on vaccine administration, which requires the "strictest" management by setting up a whole-process supervision system and toughening penalties for producing and selling fake or substandard vaccines.
The draft was submitted for a third review to the bi-monthly legislative session of the Standing Committee of the National People's Congress, which opened Tuesday.
ALL-ROUND SUPERVISION
According to the draft, supervision of vaccines should be tightened and expanded to cover the whole process, from vaccine development to production, distribution and vaccination.
Specialized inspection teams of pharmaceutical professionals will be established at the central and provincial levels to strengthen supervision of vaccines, the draft law said.
It also introduces an electronic system to track vaccines from production to use. For instance, vaccination data, including a vaccine's information, expiry date, use date, medical workers who issue the vaccines and their recipients should be recorded and retained for at least five years after the expiry of the vaccine, according to the draft.
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.
TOUGHER PUNISHMENT
The top legislature is considering imposing heavier penalties on the production and sale of fake or substandard vaccines.
The draft stipulates that people whose violations constitute a crime shall bear heavier criminal responsibility in accordance with the law.
Meanwhile, the draft 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.
As the country's first legislation dedicated to vaccine management, the draft law was first submitted to the top legislature for review in December 2018.
