China sets stricter controls on vaccines after scandals

China has passed a new law that increases the supervision of vaccines on the market after a series of scandals involving falsified products.

The ‘vaccine management law’ – which was adopted on Saturday – includes tougher penalties for parties that manufacture or distribute counterfeit vaccines, including hefty fines, as well as tighter monitoring of the entire vaccine supply chain. It is due to come into effect on 1 December 2019.

New inspection teams will be set up at the national and local level to supervise production and distribution, and an electronic information system will be set up to make information on vaccines trackable, reports the Xinhua news agency.

The records, which must be retained for at least five years after the expiry of the vaccine, will include data such as production and packaging information, expiry date, the date of vaccination, and the identities of the healthcare workers giving the shots as well as the recipients.

When it comes to penalties, the government has introduced fines of 15 to 50 times the value of falsified/counterfeit vaccines, and 10 to 30 times the value of substandard products, for those involved in their production or sale.

There has been a string of incidents involving unsafe vaccines in the last few years, including a case involving domestic vaccine producer Changchun Changsheng Biotechnology last year in which the company admitted faking production data for 113,000 lots of the childhood rabies vaccine. It was eventually fined $1.3bn, and the case was a major catalyst for the drafting of the new law.

Since then there have been other incidents however, for example earlier this year a private hospital in China was shut down after it was discovered around 40 people had been administered fake human papillomavirus (HPV) vaccines.

Jiao Hong (pictured), head of the National Medical Products Administration (NMPA), told a press conference that in addition to the new supervision framework and penalties, there will also be a formal compensation scheme for people who suffer adverse reactions to vaccines.

Also introduced are various measures to foster and improve the development of vaccine products and ensure that innovative products are approved for use quickly.

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