China Covid Vaccine NFCS
Introduction
China had an existing no-fault compensation scheme for vaccines created 24 March 2005, and which incorporated covid-19 vaccines from 30 December 2020.
This scheme was created under national legislation. Originally it was under the Regulation on the Administration of Circulation and Vaccination of Vaccines 2005 (Order No. 668 of the State Council of 23 March 2005, which was updated in Order No 668 of the State Council of 23 April 2016. The main provisions for vaccine compensation are set out at Article 56 of the Vaccine Administration Law of the People’s Republic of China (2019).[1]
Each province, autonomous region or municipality directly under the Central Government administers their own scheme. As such this is not a single scheme, but a collection of schemes created under local regulations but governed an overarching statutory framework.
The 2019 Law stipulates:-
- The administrative costs of the scheme are met by the financial departments the of provinces, autonomous regions or municipalities directly under the Central Government.
- Compensation for compulsory vaccines given under the national immunization programme is funded by the financial departments the of provinces, autonomous regions or municipalities directly under the Central Government.
- Compensation for voluntary non-immunization programme vaccines shall be paid by the vaccine Marketing Authorisation Holder. Covid Vaccines are voluntary non-immunisation programme vaccines. Vaccination against Covid is encouraged and vaccines are free.
- The State encourages compensating vaccine recipients with adverse reactions of immunization through commercial insurance and other means.
Vaccines Covered
This NFCS covers immunization programme vaccines.
It includes vaccines approved for emergency use and standard approvals.
Injuries Covered
This NFCS appears to cover both temporary and permanent injuries. The 2019 Act specifies
‘The State implements a compensation system for adverse reactions of immunization. Where, during or after the immunization process, a vaccine recipient suffers from harm including death, severe disability, organ and tissue damage, etc., compensation shall be given.’
This creates a two stage test:-
- is the injury an ‘adverse reaction of immunisation’ as defined in the Act, and
- is the injury a qualifying harm including death, severe disability, organ and tissue damage?
An adverse reaction of immunisation is defined in Chapter VI Article 52 of the 2019 Act:-
An adverse reaction of immunization is an adverse drug reaction that causes damage to the vaccine recipient’s body tissue, organ and functions during or following the standard process of administering a qualified vaccine, for which no party involved is at fault.
The following circumstances are not adverse reactions of immunization:
(1) common reactions following immunization caused by the vaccine’s intrinsic features;
(2) injury to the vaccine recipient due to sub-standard vaccine quality;
(3) injury to the vaccine recipient due to the immunization entity's incompliance with the guidance for immunization, immunization procedure, vaccine use guidelines and immunization plans;
(4) coincidental events following immunization in recipients who were in the latent period or prodromal period of a certain disease at the time of immunization;
(5) acute relapse of underlying diseases or worsening of disease conditions in vaccine recipients who have immunization contraindications prescribed on the vaccine package insert and who or whose guardian fails to provide truthful information about his/her health condition and the contraindication for the vaccine prior to immunization;
(6) individual or cluster psychogenic reaction as a result of psychological factors.
To qualify for compensation no relevant party must be at fault. The injury must not be a ‘Common reactions’ to a vaccine as these are not eligible for compensation. The Act does not define a common reaction. Similarly, this NFCS will only recompense injuries which cause ‘severe disablement’, but this is not defined any further in this Act.
Charges for making a claim
There is no mention in the 2019 Act of a charge for making a claim under this scheme.
Claimants
Under this scheme the following categories of individuals are permitted to make a claim.
- Vaccine recipient
- Representative of a vaccine recipient who is a child or under a disability
- Estate/representative of a deceased vaccine recipient.
The 2019 Act does not specify whether a claimant is allowed to nominate a legal representative to make their claim. This is likely to depend on the local vaccine compensation rules. Funding for legal representation may be provided by under some local compensation rules.
Losses covered
The 2019 Act states at Article 56.
‘Compensation for adverse reactions of immunization shall be prompt, convenient and rational. The scope, standards and procedures of compensation for adverse reactions of immunization shall be determined by the State Council, while the specific implementation measures shall be formulated by the provinces, autonomous regions or municipalities directly under the Central Government.’
There is no consistent picture across China. Compensation is individualised - the 2019 Act specifies that the scope of compensation shall be adjusted based on the actual situation. However, the losses covered and the methods for quantifying loss differ by region. Lanfang Fei & Zhou Peng’s 2017 article reports considerable variation between the types of damage compensated and quantification methods used.
Time limits for claims
The Act does not set a time limit between vaccination and the adverse event occurring, but there may be limits set in local vaccine compensation regulations.
The Act does not specify any time limits on when a claim can be brought, this is likely to be specified in local vaccine compensation regulations.
Evaluating claims – standard of proof required
The Act specified that compensation shall be given if their condition is an adverse reactions of immunization or the possibility cannot be ruled out.
Claimants can supply any relevant clinical records and can refer to the Reference Catalogue and Explanations for the Scope of Compensation for Adverse Reactions to Vaccinations (2020), produced by the National Health and Commission of the PRC, to support their claim that their reaction is, or cannot be ruled out as, a vaccination-related abnormal reaction.
Appeals and the right to litigate
This scheme is a removes the right to litigate for vaccine abnormal reactions.
No information is available on an appeal process in the Act. Local processes will apply.
Useful information and links
There is variation between the data produced by each local scheme.
Legislation
Regulation on the Administration of Circulation and Vaccination of Vaccines (2016 Revision) in English
Guidelines
Reference Catalogue and Explanations for the Scope of Compensation for Adverse Reactions to Vaccinations (预防接种异常反应补偿范围参考目录及说明（2020年版）).
Academic Articles
Lanfang Fei, Zhou Peng, No-Fault Compensation for Adverse Events Following Immunization: A Review of Chinese Law And Practice, Medical Law Review, Volume 25, Issue 1, Winter 2017, Pages 99–114, https://doi.org/10.1093/medlaw/fwx001
Other literature/resources
CMS (2021). COVID-19 Vaccine Compensation Regimes in China. CMS Guide, available at: https://cms.law/en/int/expert-guides/cms-expert-guide-to-vaccine-compensation-regimes/china
[1] Other (untranslated) laws and guidance relevant to vaccine compensation include:- Order of the Ministry of Health of the PRC Identification Methods for Adverse Reaction Following Immunisation (Order no. 60, 11 September 2008) (预防接种异常反应鉴定办法); Civil Code of the People’s Republic of China, Interpretation of the Supreme People's Court on Several Issues Concerning the Application of the Law in Hearing Cases of Disputes over Liability for Medical Damage (Revised in 2020) (最高人民法院关于审理医疗损害责任纠纷案件适用法律若干问题的解释); and Provisions of the Supreme People's Court on Several Issues Concerning the Application of Law to the Trial of Food and Drug Dispute Cases (Revised 2020) (最高人民法院关于审理食品药品纠纷案件适用法律若干问题的规定)