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.
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.
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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.