Draft law to tighten vaccine supervision

Vaccine-producing companies that  fabricate data and fail to act on problematic vaccines could be fined up to 10 times its value, according to a draft law that aims to address loopholes in vaccine management after the Changchun Changsheng scandal.

The 11-chapter draft, which was published by State Administration for Market Regulation on Sunday to solicit public opinions for half a month, states that supervision and management of vaccine market access should be tightened, and requires stricter management on vaccine production, distribution and vaccination.

Illegal behaviors, including the fabrication of data and inaction on problematic vaccines, will be severely punished. Vaccine-producing companies could face fines up to 10 times of the goods value and a halt to its operation. Key staffs from the companies will also be fined and cannot work in pharmaceutical production in 10 years.

Those who participate in illegal behavior, shield or connive with violators, engage in fabrication, or impede investigations will also be severely punished.

Tao Lina, a Shanghai-based vaccine expert, told the Global Times on Monday that the draft law aims to ease public concerns over vaccine safety.

To further enhance public trust in vaccine safety, Tao said the government should reveal the “specific test results” of vaccines to the public, which could help the public make their own decision and further force vaccine companies to produce better vaccines, Tao said.

The draft law said the country will build a nationwide trace platform which will have information on the production and distribution of vaccines, and vaccinations.

The draft law was made after Changchun Changsheng’s fake vaccine incident outraged Chinese in July. Changchun Changsheng Life Sciences Limited was fined more than 9.1 billion yuan ($1.32 billion) for the illegal production of a human rabies vaccine, Xinhua News Agency reported in October.

The Changchun Changsheng incident revealed management loopholes and a system defect in vaccine production and distribution, the administration said in the drafting instruction on Sunday.

Zhou Zijun, a professor at Peking University’s School of Public Health, told the Global Times that the new draft law offers detailed legal basis for the government to manage the industry. Previous legal regulations only had general clauses on regulating vaccines.

The draft law, different from the Regulation on the Administration of Circulation and Vaccination of Vaccines by the State Council revised in 2016, only allows vaccine companies to provide expensive vaccines to provincial-level centers for disease control and prevention, not to county-level centers, Tao said. It will better protect the rights of vaccine companies, he said.