China's NPC Standing Committee Passes Vaccine Administration Law: Full Lifecycle Oversight from Production to Market

VCBeat (WeChat ID: biobeat1) has learned that the 11th Session of the Standing Committee of the 13th National People's Congress voted to pass the Vaccine Administration Law on the 29th, which will come into effect on December 1, 2019. This marks China’s first specialized legislation on vaccine administration, responding to public expectations and addressing prominent issues in vaccine management. The institutional design fully embodies the “four strictest” requirements for the pharmaceutical and food sectors.

Previously, on November 11, 2018, the National Medical Products Administration released the “Vaccine Administration Law of the People’s Republic of China (Draft for Comment),” which comprised 11 chapters and 99 articles. The 11 chapters are: General Provisions; Vaccine Research and Development and Marketing Authorization; Vaccine Production and Lot Release; Post-Marketing Research and Management; Vaccine Distribution; Vaccination; Monitoring and Compensation for Adverse Events Following Immunization; Safeguard Measures; Supervision and Administration; Legal Liability; and Supplementary Provisions. The focus is to make specific provisions for the special requirements of vaccine regulation, taking into account the characteristics of vaccine research and development, production, distribution, and vaccination.

(1) Highlight the strategic and public-welfare nature of vaccines.The legislative objectives explicitly state the maintenance of national security (Article 1). In terms of administration, emphasis is placed on industrial regulation to guide and encourage vaccine manufacturers toward scaled-up and intensive development (Article 5). Efforts are strengthened in public education and awareness regarding vaccine safety, popularizing laws, regulations, safety standards, and vaccination knowledge related to vaccines (Article 11). Attention is given to information disclosure and risk communication; a unified system for releasing vaccine safety information is implemented, requiring regulatory authorities to organize risk communications concerning vaccine quality, safety, and immunization practices (Articles 75 and 76).

(II) Strengthen the regulation of vaccine marketing authorization.Emphasize biosafety control and the management of bacterial and viral strains and cell lines (Article 14). Clinical trials shall be conducted or organized by tertiary medical institutions or disease prevention and control institutions at or above the provincial level (Article 15). Vaccine clinical trials are required to implement enhanced subject protection, exercise prudence in subject selection, and reasonably define subject populations and age groups; where subjects are persons with limited capacity for civil conduct, written informed consent must be obtained from both the subjects themselves and their guardians (Article 16). It is specified that the drug regulatory department under the State Council shall, when approving vaccines for marketing, simultaneously approve the vaccine manufacturing processes, quality control standards, package inserts, and labels, and shall establish provisions for the public disclosure and continuous updating of package inserts (Article 19).

(3) Implement stricter production management.Strict market access management shall be implemented for vaccine production, requiring sufficient capacity reserves to meet supply demands in emergencies. The legal representative and principal person in charge must have a good credit record, and personnel in other key positions must possess corresponding professional backgrounds and work experience (Articles 20 and 21). Vaccine production shall generally not be entrusted to other enterprises (Article 22). Lot release management shall be implemented for vaccines; each batch of products must undergo review and testing by the lot release authority before being marketed (Articles 25, 26, and 27).

(4) Strengthen the management of post-marketing vaccine studies.Marketing authorization holders for vaccines are required to formulate and implement post-marketing risk management plans, proactively conduct post-marketing studies (Article 31), carry out quality tracking and analysis of marketed vaccines, and continuously optimize production processes and quality control standards (Article 32). Changes that may affect the safety and efficacy of vaccines shall be fully validated and submitted for approval, filing, or reporting in accordance with regulations (Article 33). Where vaccine production processes are outdated and quality control levels are significantly inferior to those of other vaccines of the same variety currently available, process optimization and quality improvement shall be carried out within a specified time limit; if the requirements are not met within the prescribed period, the vaccine shall be withdrawn from the market (Article 34). Vaccine varieties whose product design, production processes, or risk-benefit ratios are significantly inferior to those of other types of vaccines for preventing the same disease shall be eliminated (Article 35).

(5) Strengthen the management of vaccine distribution and vaccination.It is specified that vaccines included in the National Immunization Program shall be subject to centralized bidding or unified negotiations organized by the state, with winning bid prices or transaction prices formed and published; all provinces, autonomous regions, and municipalities directly under the Central Government shall implement unified procurement. Other immunization program vaccines not included in the National Immunization Program shall be procured through unified bidding organized by each province, autonomous region, and municipality directly under the Central Government. Non-immunization program vaccines shall be procured through bidding organized via provincial-level public resource trading platforms by each province, autonomous region, and municipality directly under the Central Government (Article 36). Vaccine prices shall be determined independently and reasonably by the vaccine marketing authorization holders (Article 38). Vaccine marketing authorization holders shall distribute vaccines to provincial-level centers for disease control and prevention (CDCs), which shall then distribute them to vaccination sites (Article 39). Vaccine distribution shall comply with specifications for vaccine storage and transportation management; vaccines must remain within the prescribed temperature environment throughout the entire process, with cold chain storage meeting requirements and temperature being monitored and recorded in real time to ensure vaccine quality (Article 40). CDCs shall request temperature monitoring records for the entire transportation process; vaccines for which such records cannot be provided or whose temperature control fails to meet requirements shall not be accepted or purchased, and the matter shall be reported immediately (Article 42). Expired vaccines shall be stored in isolation, marked with warning signs, and destroyed in accordance with regulations (Article 43). Specific provisions are made regarding the vaccine immunization program, vaccination work standards, management of vaccination units, and verification of vaccination certificates (Chapter VI). Specific requirements are clarified concerning funding guarantees for preventive vaccination and the supply of shortage vaccines (Chapter VIII).

(VI) Impose severe punishment for illegal activities.Resolutely implement the “four strictest” requirements, comprehensively employ civil, criminal, and administrative liability measures, and strengthen the responsibilities of vaccine marketing authorization holders and other relevant parties. Where vaccines with known quality issues are still sold, vaccine recipients may claim punitive damages (Article 84). Where related unlawful acts constitute crimes, criminal liability shall be pursued in accordance with the law (Article 86). With respect to administrative liability, violations of vaccine management regulations shall generally be subject to heavier penalties within the penalty ranges prescribed by the Drug Administration Law (Article 86). In light of the problems exposed by vaccine-related cases in recent years, severe punishments shall be imposed on intentional unlawful acts such as data falsification (Article 89). Implement the requirement of “holding individuals accountable”; where a marketing authorization holder commits serious violations, the legal representative, principal person in charge, and other personnel in key positions shall have their income derived from the entity during the period of violation confiscated, and be fined not less than 50% but not more than 100% of such income; they shall be prohibited from engaging in drug production and business activities for ten years, and in particularly serious circumstances, for life (Articles 88 and 89). Strengthen accountability for regulatory authorities and local governments. Where regulatory authorities fail to perform or improperly perform their duties, resulting in serious consequences, or where local governments provide ineffective leadership and organization, causing serious harm, liability shall be strictly pursued in accordance with the law. Those who participate in, shield, or condone vaccine-related criminal or unlawful acts, engage in fraud, conceal facts, interfere with or obstruct liability investigations, or assist in forging, concealing, or destroying evidence shall be subject to heavier liability in accordance with the law (Articles 96 and 97).

Furthermore, the draft for comments appropriately addresses its relationship with laws such as the Drug Administration Law, clarifying the principle that the Vaccine Administration Law shall take precedence. It stipulates that for matters concerning vaccine administration not covered by this Law, the relevant provisions of other laws, including the Drug Administration Law of the People's Republic of China and the Law of the People's Republic of China on the Prevention and Treatment of Infectious Diseases, shall apply (Article 98).