Research On Comprehensive Compensation System Of Adverse Reactions Caused By Immunization

Adverse reactions caused by immunization(hereinafter as adverse reactions of immunization,ARI)refers to the personal injury suffered by the vaccine recipient.The scope of ARI is much smaller than the one of immunization damage,and is different from Adverse Events Following Immunization(AEFI)in terms of whether it is directly caused by medical risk.Based on different contexts,there are different understandings of ARI damage in legal researches.The AEFI in medical concept is similar to immunization damage in legal concept,which all belongs to the general conception of ARI.The Adverse Effect of Immunization(CAEI)in China refers to those severe ARI with no faults of any party.The immunization policy is set with considerations of immunization contribution,and influences the legal character of immunization acts.From the perspective of vaccination policy and immune contribution,varies the legitimacy basis for adverse reactions of different types of immunization.The limitation of vaccine recipient's self-determination and the theory of National Solidarity justify the ARI remedy of planned immunization,while ARI of extra-planned immunization should be borne by the recipient.In terms of immune contribution,“risk borne by the gainers” as well as “loss shared among the gainers” can justify the remedy: any group member who gets benefits from the voluntary immunization with herd immunity should share loss caused by recipient's adverse reaction and vaccine manufacturers who gain economic interests from the immunization with individual immunity should share the loss caused by recipient's adverse reaction.Since the ARI cannot attribute to fault of any party's in the immunization,the loss of ARI should not be indemnity.Legal researchers generally regard the ARI remedy as a matter of issues in public law and social law.Actually,the ARI remedy aims at sharing losses caused by instinct risk of immunization,therefore both administrative and civil compensation are competent methods for loss sharing.Thus,the remedy for adverse reactions of extra-planned immunization provided by Article 56 of Vaccine Management Law is reasonable.With different considerations of compensation mode and funds,exist various options of ARI compensation.The often-adopted remedy regimes can be divided into four modes,among which the Distinguished one is an ideal model for the comprehensiveness and efficiency of remedy.The ARI loss-sharing methods include the financial subsidy,insurance compensation and compensation fund.The remedy rules in comparative law aim in general at effectively sharing the losses.The remedy of ARI is an important part of vaccine damage compensation system in foreign countries which prefer to setting up no-fault compensation systems for ARI.Based on the particularity of vaccine production process,it's often difficult to prove or identify the fault of vaccination provider or the vaccine defects.Besides,due to the uncertainty,there are different criteria to determine the causation between fault and the damage or the one between the vaccine defects and damage,which leads to the distinction between the remedy methods of ARI and the tort law.It should coordinate the remedy methods of ARI and tort law in accordance with the principles of benefiting the victims' compensation,realizing the fair sharing of losses as well as promoting the immunization.There exist two functions of ARI remedy: the supplement of tort liability and the substitution of tort liability.In terms of the order of application,there are also two choices: ARI remedy with priority and no priority application.A clear authority and clear procedure rules are set for the compensation,where exist less-demanding standard in deciding the causation,the minimum criterion can be “not excluding the ARI causation”.The difficulty in determining the fault and vaccine defects,as well as obstacles in determining the causal relationship between fault and the damage or between the vaccine defects and damage,leads to the distinction of remedy methods.There are two kind of function for ARI remedy to tort liability: the supplement and the substitution,as well as two choices of application order: ARI remedy with priority and without priority.Foreign vaccine cases about product liability and medical damage liability show some room for remedy of product liability by waring defect but little room for design defects in the qualified vaccines.Foreign courts determine strictly the immunization damage causation,but there is also the practice of adopting less-demanding criterion of causation immunization damage through the presumption of facts.The coordination of remedies at the foreign judicial level mainly focuses on the determination of product liability and medical damage liability,and there are no remedy room for design defects in the qualified vaccines of diverse processes,but there is room for setting up warning defects.When there is the scientific uncertainty in proof,foreign countries usually strictly determine the causation of immunization damage based on the criteria of balance of probability.However,there is also the practice of relaxing criterion of determining the causation of immunization damage through the presumption of facts.The Compensation of Adverse Effect of Immunization(CAEI)can provide compensation for some serious adverse immunization reactions,the system adopts a two-track remedy model: administrative compensation for adverse effects caused by planned immunization and civil compensation for those caused by extra-planned immunization.Compared with the compensation regime of foreign countries,CAEI has only a single function,and the legislative provisions of “no fault of all parties involved” in the definition of adverse reactions of immunization make the judicial determination of immunization adverse reaction identification and adverse reactions immunization in practice excludes too much.Therefore,the causation of immunization should be the core part of identifying adverse reactions.Based on the civil compensation of extra-planned immunization,Compensation for abnormal responses to alternative extra-planned immunizations with significant public immunization contribution and alternative extra-planned immunizations with group immunity contribution should apply as a priority the loss-sharing path such as compensation fund or liability insurance path making the loss-sharing path playing a complementary role in the compensation system.As far as path coordination is concerned,when there is scientific uncertainty,the criteria of "cannot be excluded" should be adopted for the determination of causality of adverse immunization reactions,but the criteria for determining causation between immunization fault or vaccine defects and damage should not be lowered too much,and adverse reactions of immunization should be avoided through tort law.