The State Administration for Market Regulation ("SAMR") has recently issued the Law of the People's Republic of China on Vaccine Management (Draft for Comment) (the "Draft for Comment") to solicit public comments by November 25, 2018.
Encompassing eleven chapters, the Draft for Comment provides in detail special requirements for the regulation of vaccines, primarily in consideration of characteristics of the research, development, production and circulation of vaccines and the preventive vaccination. Specifically, the first is stressing the strategic and commonweal properties of vaccines; the second is strengthening the regulation of the vaccine marketing; the third is conducting stricter production management; the fourth is reinforcing the post-marketing vaccine research management; the fifth is tightening the management of the circulation of vaccines and of the preventive vaccination; and the sixth is imposing severe punishments on violators. The Draft for Comment provides that, where a vaccine maker knowingly sells vaccines that are involved in quality problems, individuals who are vaccinated with such type of problematic vaccine may seek punitive damages. If the relevant violation constitutes a crime, the violator will be held criminally liable in accordance with the law. As to the administrative liability, punishments for violations of administrative provisions on vaccines shall be given generally based on the severer punishment criteria provided in the Drug Administration Law.