China Gets Tough With Vaccine Producers

China’s lawmakers are considering a new law aimed at tightening control of a vaccine industry beset by scandals during 2018. 

This proposed law is the latest effort by Beijing to restore public confidence in the vaccine industry after many Chinese have lost faith in the system, reports SCMP.com   

This lack of confidence led many Chinese citizens to visit Hong Kong for their vaccinations. 

The law will introduce the “strictest” ever regulation on vaccines and consolidates existing rules on the industry, was submitted to the Standing Committee of the National People’s Congress on December 23, 2018, after it was approved by China’s cabinet.   

Jiao Hong, director of the National Medical Products Administration, appeared before this committee ‘vowing to impose the “strictest regulatory system to date” on vaccines – including on their research, development, production, distribution, and use,’ reported SCMP. 

Jiao took the helm of the drugs regulator in April, months before two major vaccine makers – Changchun Changsheng Biotechnology and the Wuhan Institute of Biological Products – were found selling faulty diphtheria, whooping cough and tetanus vaccines in Chongqing, Shandong and Hebei provinces.   

Changsheng Biotech was also found to have systematically forged data in the production of rabies shots. 

Changsheng was fined US $1.3 billion for their actions.   

Some 18 people, including Changsheng Bio-tech chairwoman Gao Junfang and other executives, were arrested. Top Chinese officials were also fired. 

In response to these issues, on September 13th, 2018, a recall of various drug and vaccine products containing the active pharmaceutical ingredient valsartan was expanded by the US Food and Drug Administration (FDA).   

The FDA first announced on July 13th a recall of products that contain the ingredient valsartan, supplied by Zhejiang Huahai Pharmaceuticals, Linhai, China. 

Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack and heart failure. 

Additionally, this new law would enable patients to sue vaccine makers and distributors for punitive damages, if they knowingly sold faulty vaccines that caused death or serious illness. 

The draft law also outlines the responsibilities of related government departments and calls for an information sharing system and full disclosure of vaccine safety information. 

In addition to the draft vaccine management law, the NPC Standing Committee is also considering draft legislation on foreign investment and revisions to the land administration and patent laws.