- June 11, 2019
China’s State Administration for Market Regulation posted notice in November of a draft law to regulate vaccine production, distribution and use. China solicited feedback on the proposal until Nov. 25, 2018.
Fines would be applicable when companies submit false test results, do not recall batches that failed testing, or for other violations. Officials are proposing a sliding scale for fines based on the seriousness of the offense. It is the first regulatory approach in China specific to vaccines after a series of scandals eroded trust in vaccines in the country in recent years.
For the most serious offenses, fines could be up to 10 times the product’s market value, according to the proposal.
During the summer of 2018, Chinese regulators found data integrity problems during a surprise inspection at Changchun Changsheng Life Sciences, triggering a nationwide controversy over rabies vaccines that led to arrests of company executives, plus resignations, demotions and firings for government officials. During the scandal, citizens took to social media to voice distrust in China’s domestic drug industry, prompting President Xi Jinping and Premier Li Keqiang to respond.
Officials eventually fined the company $1.3 billion and re-inspected every other vaccine maker in the country, later clearing them.
The Changsheng episode followed another scandal in China in 2016, when officials discovered that an illegal vaccine ring distributed potentially unsafe vaccines in the Shandong Province for years. The leader of the scheme, Pang Hongwei, received a 19-year prison sentence. In reaction to the scandal, Chinese authorities arrested 324 people and removed or demoted 357 government officials. The situation exposed loopholes in the country’s vaccine distribution system, and lawyers afterward called on the country to bolster its laws to support vaccine safety.
REFERENCE: Fierce Pharma; 14 NOV 2018; Eric Sagonowsky