Establishment Of Remedy System For Adverse Drug Reaction Damage Under MAH System

The Drug Administration Law(revised in 2019)requires the state to implement a drug marketing authorization holder(MAH)system for drugs.MAH is the first person responsible for the entire life cycle of a drug,which provides a policy basis for the construction of the ADR damage remedy system in China.The issue of remedy and compensation for patients with adverse drug reactions(ADR)is traceable.Based on domestic and foreign literature research,this thesis investigates the trial situation of MAH drug insurance in five provinces and cities in China,and uses questionnaire surveys,interviews with key figures,grounded theory,and economic statistics principles to construct a combination of compulsory and commercial insurance ADR damage remedy model.Foreign literature research shows that there are four types of ADR damage remedy:insurance remedy,fund remedy,fund joint insurance remedy,general tax remedy.The domestic and foreign literature research shows that the ADR damage remedy in China can refer to insurance remedy,fund remedy or fund joint insurance remedy.Field survey of MAH pilot and drug insurance pilot in Guangdong Province,Zhejiang Province,Shandong Province,Jiangsu Province and Shanghai.Through the case analysis of the existing insurance in Shanghai Jiangsu Province and Guangdong Province,this paper shows the current situation of drug insurance,points out the problems existing in the ADR insurance design,and points out the necessity of building the ADR damage remedy model combining compulsory insurance and commercial insurance.Using the questionnaire "ADR damage relief system construction and analysis of influencing factors under the MAH system" designed by the research team,and through expert demonstrations,which was conducted on drug manufacturing enterprises,medical institutions and drug operating enterprises in Shaanxi Province.A total of 640 units were investigated,of which 217 were pharmaceutical manufacturers,200 were medical institutions,and 223 were pharmaceutical dealers.640 questionnaires were issued and 559 questionnaires were valid,with an effective rate of 87.3%.The questionnaire survey was conducted in three stages:the first stage formed a questionnaire through literature research and expert consultation;the second stage conducted a pre-investigation to assess the reliability and validity of the questionnaire;the third stage issued a comprehensive questionnaire,collected data and used SPSS 24.0 software The single factor X2 test and multiple logistic regression analysis were performed on the questionnaire data to obtain the influencing factors of constructing the ADR damage remedy system under the MAH system.The results show that 87.1% of the respondents agree with the establishment of an ADR damage remedy system under the MAH system,and 76.0% prefer the combination of compulsory insurance and commercial insurance.The main influencing factors of establishing ADR damage relief system under MAH system are the degree of ADR specialist’s familiarity with the policies related to ADR in MAH system,the working years of medical staff and the level of cognition of medical staff to ADR.The results of the questionnaire provide a scientific basis for the construction of ADR damage relief model combining compulsory insurance and commercial insurance.Based on the semi-structured interview of 28 experts,the qualitative data of the interview were analyzed by using grounded theory,and the construction path of ADR damage insurance relief system under MAH system was deduced.23(82.1%)of the experts interviewed agreed on the joint remedy model of compulsory insurance and commercial insurance.The construction path of insurance remedy model provides scientific basis for constructing ADR damage remedy model combining compulsory insurance and commercial insurance.In summary,under the current MAH system,the mode of remedy for adverse drug reaction damage in China is a combination of compulsory and commercial insurance.Based on the previous research,this study designs the "ADR damage remedy model combining compulsory insurance and commercial insurance".The model is designed from three aspects: insurance type setting,insurance level division and the guarantee object of compulsory insurance.(1)Types of insurance are set to compulsory insurance and commercial insurance.The compulsory insurance is liability insurance for adverse drug damage,which is covered by all MAHs(large pharmaceutical manufacturers as MAHs may initially implement a risk deposit system,and if the solvency is insufficient,they are forced to purchase ADR damage liability insurance).Commercial insurance is set up as comprehensive liability insurance for drug quality,liability insurance for drug clinical trials,drug recall insurance,cold chain transportation insurance and liability insurance for errors and omissions.Different MAH choose their own types of insurance.(2)The insurance grade is divided into three processes according to the drug category.The first step is to distinguish the drugs held by MAH from innovative drugs or generic drugs;the second step is to consider that the drug delivery route held by MAH belongs to parenteral injection or enteral delivery;the third step is to distinguish western medicine and traditional Chinese medicine.(3)The objects of compulsory insurance are divided into two categories.The first is compensation object.When the ADR mentioned in the drug specification occurs,but the consequence is serious,leading to the loss of labor capacity,according to the relevant treaties of compulsory insurance,economic compensation shall be made to the patients.The second category is the object of compensation.When the ADR(minor injury does not form the basis of claim)that is not mentioned in the instructions occurs to the patient,the economic compensation shall be made to the patient according to the relevant treaties of compulsory insurance.