China's vaccine crackdown continues with larger proposed penalties for rogue companies

China flag
China is proposing tough penalties on companies making or selling counterfeit vaccines. (Getty Images)

A second draft of Chinese legislation designed specifically to crack down on vaccine manufacturing or sales malpractices has been put in front of the country’s top lawmakers—and it entails some tougher penalties.

Drugmakers who are found guilty of making or selling counterfeit vaccines can be fined 15 to 30 times the value of the products involved, according to state news agency Xinhua. In the first version the country’s drug regulators published in November for public comments, the punishment level was capped at 10 times.

Hailed as the “strictest” law that aims to “bankrupt” rogue vaccine makers, the proposed law’s numbers are also significantly higher than the five-time penalty cap as stipulated in the current law on drugs in general.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

The law comes as China tries to put a tighter grip on vaccines—which are given in large numbers to children under the national immunization program—in the wake of a high-profile vaccine scandal by one of the country’s largest vaccine companies.

RELATED: After scandals, China proposes new fines in bid to shore up domestic vaccine industry

A national outcry spread across China last summer after Changchun Changsheng Life Sciences was found to have systematically faked manufacturing data in making its rabies vaccines and sold hundreds of thousands of substandard DPT vaccines to children. The company was slapped with a hefty fine of 9.11 billion yuan ($1.3 billion), but that fine included a penalty of only three times the company's illegal revenue.

Several other vaccine safety incidences cropped up afterward, including one case in which a clinic gave at least 145 babies expired polio vaccines.

In the new draft law currently under a second review, people could ask for compensation from a national system if they experience adverse events linked to immunization of publicly covered vaccines, according to Xinhua. Such compensation will be given in cases of death, serious disability or organ injury during or after vaccination.

Suggested Articles

Celltrion Chairman Seo Jung-jin says the South Korean company will spend about $33 billion over a decade on its biologics and pharma businesses.

Takeda releases first post-Shire guidance; Indian generics makers are named in a price-fixing suit; Daiichi's quizartinib fails at FDA.

The price, though a discount from its U.S. sticker, makes Kymriah the most expensive treatment offered on the Japanese public insurance system.