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    Home > Medical News > Latest Medical News > Drug Administration: Vaccine Liability Compulsory Insurance Management Measures for Comments.

    Drug Administration: Vaccine Liability Compulsory Insurance Management Measures for Comments.

    • Last Update: 2020-10-17
    • Source: Internet
    • Author: User
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    Medicine Network October 15th, recently, the State Drug Administration, together with the National Health and Safety Commission, the Banking and Insurance Regulatory Commission organized the drafting of the "Vaccine Liability Compulsory Insurance Management Measures (Draft for Comments)."
    draft for comments, the Immune Programme Vaccine and Non-Immune Programme Vaccine Liability Compulsory Insurance has a uniform minimum liability limit throughout the country.
    compensation for death is not less than 500,000 yuan per person.
    Chapter I Of the Measures for the Administration of Compulsory Insurance for Vaccine Liability (Draft for Comments) Article 1 (Legislative Purposes) These Measures are formulated in accordance with the Insurance Law of the People's Republic of China, in accordance with the Vaccine Administration Law of the People's Republic of China, in order to implement the responsibilities of the licensed holders of vaccines for listing and to protect the legitimate rights and interests of the subjects.
    2 (Definition) The term "mandatory insurance for vaccine liability" as used in these Measures refers to insurance subject to the liability of the holder of the vaccine market for damage caused by the vaccine quality problem.
    the quality of vaccines referred to in these Measures refers to vaccines that do not meet national drug standards or drug registration standards and affect safety, effectiveity and quality control.
    3 (Scope of Application) The holders of a listed vaccine listed in the Territory of the People's Republic of China shall, in accordance with the Vaccine Administration Law of the People's Republic of China and the provisions of these Measures, take out compulsory insurance for vaccine liability.
    licensed holders of vaccines and insurance companies that underwrite compulsory insurance for vaccine liability shall comply with these Measures.
    : Basic Principles: Compulsory insurance for vaccine liability adheres to the principles of compulsory insurance, risk prevention and control, and credit management.
    Article 5 (Departmental Responsibilities) The drug regulatory department under the State Council shall organize supervision and inspection of the participation of vaccine listing license holders in compulsory insurance for vaccine liability.
    the Insurance Regulatory Authority of the State Council shall, in accordance with law, exercise supervision and management over the compulsory insurance business of vaccine liability carried out by insurance companies.
    supervision and administration department of the people's government of a province, autonomous region or municipality directly under the Central Government shall be responsible for the supervision and inspection of the participation of vaccine listing license holders in the compulsory insurance of vaccine liability within their administrative areas.
    6 (Local Responsibilities) The implementation of the compulsory insurance system for vaccine liability shall be included in the assessment of the work of vaccine safety by the people's governments of provinces, autonomous regions and municipalities directly under the Central Government, as well as the relevant local departments.
    drug regulatory departments and other relevant departments shall regard the compulsory insurance coverage of vaccine liability as an important part of the credit supervision of vaccine market license holders.
    Article 7 (Social Co-Management) encourages vaccine licensees, insurance companies and relevant trade associations to establish communication and consultation mechanisms to strengthen vaccine safety management.
    Chapter II Insurance and Underwriting Article 8 (Scope of Insurance Liability) The insurance liability of compulsory insurance for vaccine liability shall be the economic liability of the holder of the vaccine listing license in accordance with the law if the subject is maimed or killed due to the quality of the vaccine.
    Article 9 (Exclusion Liability) The insurance company shall not compensate: (1) an abnormal reaction to vaccination, a general reaction after vaccination due to the characteristics of the vaccine itself, an induced or pre-vaccination period in which the subject is in the incubation or pre-vaccination period, and an occasional onset of the disease after vaccination, and if the subject has a vaccination taboo as stipulated in the vaccination instructions, the subject or his guardian does not truthfully provide the health status of the infected person. In cases such as vaccination taboos, acute recurrence or exacerbation of the original disease of the subject after vaccination, psychoactive reactions of individuals or groups due to psychological factors, and other circumstances that are not part of the vaccine quality problem, (2) quality problems caused by vaccine quality problems caused by reasons other than those of the vaccine listing license holder or the unit entrusted with storage and transportation; (3) the quality of the vaccine due to intentional violations committed by the vaccine listing license holder; and (4) vaccination accidents.
    Article 10 (Insurance Terms and Rates) The mandatory insurance provisions for vaccine liability shall implement the industry model insurance provisions.
    mandatory insurance rates for vaccine liability are determined by consultation between vaccine-listed licensees and insurance companies.
    insurance industry associations, in association with vaccine industry associations, may develop mandatory insurance benchmark rates for vaccine liability.
    11 (Insurance Rate Fluctuations) Vaccine liability compulsory insurance shall be subject to floating rates according to the insured's credit supervision level, etc.
    12 of the National Insurance Program Mandatory Insurance for Immunization Programme Vaccines and Non-Immune Programme Vaccine Liability is subject to a uniform minimum liability limit throughout the country.
    compensation shall not be less than 500,000 yuan per person, and the disability compensation shall be determined according to the disability appraisal certificate issued by the disability appraisal institution.
    encourages companies to purchase insurance coverage with higher liability limits based on their own circumstances.
    13 (Contract Conclusion) After the vaccine has been licensed for listing and before it is put on the market for sale, the license holder of the vaccine listing shall enter into an insurance contract with the insurance company in accordance with the law to insure the compulsory insurance of vaccine liability.
    the conclusion of the insurance contract, the license holder of the vaccine listing shall submit the insurance contract to the drug regulatory department and the competent department of health and health in the province, autonomous region or municipality directly under the Central Government.
    Article 14 (Insured Mode) The holder of a vaccine listing license shall be insured with compulsory insurance for vaccine liability, and all vaccines for which he has obtained a market license may be insured in the same way or separately.
    Article 15 (Obligation to Inform) When a vaccine listing license holder enters into an insurance contract with an insurance company, he shall truthfully inform the insurance company of the basic situation of vaccine development and the relevant risks.
    if the insured intentionally or through gross negligence fails to perform the obligation of truthful notification in accordance with the law, which is sufficient to affect the insurance company's decision to agree to underwrite or raise the insurance rate, the insurance company shall have the right to terminate the contract.
    after the listing of the insurance company, if the risk of vaccine increases significantly, the insurance company shall be notified in a timely manner, and the insurance company may increase the premium or terminate the contract in accordance with the agreement of the insurance contract.
    the holder of the vaccine listing license has failed to fulfill the notification obligation stipulated in the previous paragraph, the insurance company shall not be liable for compensation for the insurance accident which occurs as a result of the significant increase in risk.
    16 (Risk Assessment) An insurance company shall carry out a vaccine risk assessment and form a risk assessment report before underwriting the compulsory insurance of vaccine liability.
    licensees should actively cooperate with insurance companies in carrying out risk assessments.
    Article 17 (Risk Check) The insurance contract shall agree to carry out the relevant matters of vaccine safety risk detection within the validity period of the contract.
    insurance companies and vaccine listing licensees may jointly entrust risk assessment agencies or jointly form teams of experts to regularly or irregularly investigate vaccine safety risks of vaccine listing licensees.
    licensed holders of vaccines should cooperate with the screening process.
    if a vaccine safety hazard is found and the vaccine listing licensee refuses to rectify or delay the rectification, the insurance company shall have the right to increase the premium or terminate the contract and report it to the drug regulatory authority.
    Article 18 (Contract Dismissal) Except in cases stipulated in the Insurance Law of the People's Republic of China, an insurance company may not terminate a compulsory insurance contract for vaccine liability after it has been established.
    termination of the insurance contract, the insurance company shall withdraw the insurance policy and notify in writing the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the vaccine listing license holder is located.
    termination of the insurance contract, the holder of the vaccine listing license shall immediately report to the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government, and shall promptly insure the compulsory insurance for vaccine liability.
    19 (Contract Term) The holder of a vaccine listing license shall be insured in time before the expiration of the insurance contract.
    Article 20 If the license holder of the vaccine listing failes to insure or renew the insurance in accordance with the provisions, the drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall order the suspension of the listing and sale of the relevant vaccine, order the insurance or renewal within a time limit, and, if he refuses to correct or if the circumstances are serious, he shall be punished in accordance with Article 83 of the Vaccine Administration Law.
    the vaccine may continue to be on the market after the relevant vaccine market license holder has insured or renewed the compulsory insurance of vaccine liability.
    21 (Information Disclosure) Vaccine listing license holders shall establish an information disclosure system and promptly disclose the compulsory insurance coverage of vaccine liability on their website in accordance with the provisions.
    The drug regulatory department under the State Council, the insurance regulatory authority under the State Council and the competent department of health and health under the State Council shall gradually establish information-sharing mechanisms on vaccine supervision, compulsory insurance for vaccine liability, and investigation and punishment of vaccine safety violations.
    Chapter III Compensation Article 22 (Insurance Liability Trigger) If, during the validity period of the insurance contract, the subject causes personal injury to the subject due to the quality of the vaccine, the subject shall file a claim for damages against the holder of the vaccine listing license in accordance with the law.
    shall be liable for compensation in accordance with the law by the license holder of the vaccine listing, the insurance company shall make compensation within the limits of compulsory insurance liability for vaccine liability in accordance with the law.
    23 (Request for Payment of Insurance Premiums) When a vaccine listing license holder requests an insurance company to pay insurance premiums in accordance with an insurance contract, he shall provide the insurance company with the relevant certificates and information that he can provide in connection with the confirmation of the cause of the injury or loss, the extent of the loss, etc.
    insurance company, in accordance with the agreement of the insurance contract, considers that the relevant certificates and information are incomplete, it shall promptly notify the vaccine listing license holder of the supplementary provision.
    the holder of a vaccine listing permit neglects to seek compensation from the insurance company, the subject may also claim the insurance premium directly from the insurance company in respect of the portion of the insurance company in which he or she is due compensation.
    If the insurance company needs to pay or advance the rescue expenses for rescuing the injured person, the insurance company shall pay or advance the necessary expenses to the medical institution in a timely manner within the limits of liability if the insurance company has received the vaccine listing permit holder, which is checked as an insurance liability.
    insurance company shall compensate the insurance in accordance with the law or the contract.
    Article 24 "Accident Approved" After receiving the request for compensation insurance premiums and relevant certificates and information, the insurance company shall make the approved decision in a timely manner; if the situation is complicated, it shall make the approved within 30 days, unless otherwise agreed in the insurance contract.
    The insurance company shall notify the vaccine listing license holder and the subject of the approved results, and, if it is insured, perform the obligation of compensation insurance within 10 days after reaching an agreement with the vaccine listing license holder.
    personal injury or death, the insurance company shall actively advance the compensation and speed up the progress of the claim.
    25 Accident Identification: An insurance company, a vaccine listing license holder or a subject may entrust an appraisal and evaluation institution or a team of experts to issue an assessment opinion on damage appraisal as an important reference for insurance claims.
    facts that have been determined by civil public interest litigation, the effective judgment of tort civil litigation or the administrative penalty decision of the drug supervision and administration department may be directly used as the basis for the determination of liability, and the insurance company shall make compensation according to the degree of damage stipulated in the insurance contract.
    , Chapter IV, By-laws, Article 26 (Time of Implementation) These Measures shall come into effect as of June 2020.
    .
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