On June 29, 2019, the Standing Committee of the National People’s Congress adopted the Vaccine Administration Law of the People’s Republic of China (the “Law”), which will put vaccines under the strictest level of administration and puts forward special systems and requirements for the R&D, production and circulation of vaccine development, and vaccination. The Law will go into effect on December 1, 2019.
1. Vaccine development and registration
The state shall, according to the prevalence of diseases, the immunity status of the population and other factors, make relevant research and development plans, allocate the necessary funds, and support the development of polyvalent, multivalent and other new-type vaccines. The state shall organize those that are licensed to distribute the vaccine on the market, scientific research entities and medical institutions to jointly tackle problems, engage in research and development for vaccines urgently needed for disease prevention and control. The clinical trial of vaccines shall be subject to approval by the drug supervision and administration authority of the State Council and shall be conducted or organized by tertiary medical institutions that meet the required conditions, or by disease prevention and control institutions at or above the provincial level. Vaccines marketed within China shall be subject to approval by the drug supervision and administration authority of the State Council and obtain a pharmaceutical registration certificate.
2. Vaccine production and batch release
The state shall implement a strict access system for vaccine production. Those who are engaged in vaccine production activities shall obtain a pharmaceutical production permit with the approval of the drug supervision and administration authority of the people’s government at or above the provincial level. In addition, they shall have attained an appropriate scale with sufficient capacity reserves, possess systems, facilities and equipment that guarantee biosafety, and shall satisfy the requirements for the prevention and control of diseases.
The state shall implement a system for the batch release of vaccines. Before each batch of vaccines are sold or imported, they shall be examined and inspected by the batch release institution designated by the drug supervision and administration authority of the State Council in accordance with relevant technical requirements. However, vaccines that are urgently needed for the prevention and control of infectious diseases or as an emergency response shall be exempt from batch releases with the approval of the drug supervision and administration authority of the State Council.
3. Vaccine circulation
Vaccine prices shall be determined by the market license holders for the vaccine in a legal, independent and rational manner. For vaccines under national immunization programs, the health authority of the State Council shall, in conjunction with the public finance authority of the State Council and other authorities, organize centralized bidding or engage in unified negotiation to reach and announce the bid-winning price or closing price, which shall be applied uniformly in procurement by all provinces, autonomous regions and municipalities under the direct jurisdiction of the State Council. Vaccines that are under immunization programs other than the national programs, and vaccines that are not covered by immunization programs, shall be procured together by all provinces, autonomous regions and municipalities under the direct jurisdiction of the State Council through provincial public resource trading platforms.
Vaccine market license holders shall supply vaccines to the disease prevention and control institution as agreed upon in the procurement contract. The disease prevention and control institution shall supply vaccines to the vaccination entity as required. No entity or individual other than the disease prevention and control institution may supply vaccines to the vaccination entity, and the vaccination entity shall not receive vaccines from those sources.
A vaccination entity shall meet the following conditions: (1) have obtained a medical institution license; (2) have a doctor, nurse or village doctor who has passed the professional vaccination training organized by the health authority of the county-level people’s government and has passed the examination; and (3) have refrigeration facilities, equipment and a refrigerated storage system that meets the administrative rules on the storage and transportation of vaccines.
When the medical staff administers the vaccines, the vaccinated individuals or their guardians shall be informed of important matters such as the type, function, contraindications, adverse effects, and on-site observations. In addition, vaccinated individuals or their guardians shall be asked about their health status and any known counter indications, and both the status of the notifications made and the inquiries shall be truthfully recorded. The vaccinated individuals or their guardians are required to truthfully provide the vaccinated individuals’ health status and counter indications for vaccination. If vaccination is not possible due to vaccination counter indications, the medical staff shall provide medical advice to the vaccinated individuals or their guardians and truthfully record the circumstances in which the medical advice is provided.
5. Adverse effect monitoring and handling
Vaccination entities, medical institutions, and other entities are required to report any adverse effects of vaccination as detected to the disease prevention and control agency pursuant to applicable requirements. The state shall implement a compensation system for adverse effects from vaccinations. Compensation should be provided for injury to the vaccinated individuals such as death, severe disability, organ tissue damage, etc., if such injuries are adverse effects of the vaccination and cannot be avoided. The scope of compensation shall be indexed and dynamically adjusted according to actual circumstances.
6. Post-marketing administration of vaccines
Market license holders for vaccines shall continuously update their instructions and labels according to post-marketing research and adverse effects, and they shall apply for approval or recordation as required. The drug supervision and administration authority of the State Council shall timely release the updated vaccine instructions and labels on its website.
In addition, the Law also stipulates safeguard measures, supervision and administration, and liabilities, thereby increasing the penalties for violations of vaccine administration, and more strongly prosecute activities that constitute a criminal offense.