Vaccine manufacturers or importers shall pay a certain fee to serve as the Vaccine Injury Compensation Fund; a levy of NT$1.5 shall be collected for each dose of vaccine. The central competent authority may adjust the levy based on the utilization of the Fund when the balance of the Fund is less than NT$150 million or exceeds NT$400 million.
The standards for fee collection of the Fund under the preceding paragraph are as follows:
1. Per dose fees are collected by the number of doses qualified by testing; and
2. For vaccines purchased for emergency reasons pursuant to Article 51 of the Act, per dose fees are collected by the number of doses manufactured or imported.
Fees under Paragraph 1 hereof are waived if:
1. The vaccines are manufactured for export;
2. Vaccines purchased by competent authorities under special case status are for giving aid to foreign countries; or
3. Other vaccines under special application for fee waiver are approved by the central competent authority.
Upon receiving a claim application under the preceding article, the local competent authority shall conduct an investigation of the alleged vaccine injury within 7 days.
The local competent authority shall record the findings on the vaccine injury investigation report, and send the report together with the Application, medical records of the alleged victim, and related supporting information to the central competent authority for review.
The Working Group shall comprise 19 to 25 members whom shall be appointed on a part-time basis by the central competent authority from experts in the fields of medicine and health, anatomy and pathology, or law, or just and impartial persons in the community; one of the members shall be appointed convener.
The total number of experts in the field of law and just and impartial persons in the community shall be not less than one third of the Working Group members; the total number of members in either gender shall comprise not less than one third of the Working Group members.
Members will serve a term of two years and may be re-appointed after expiry of the current term. When there is a vacancy during the term of members, a person with same or similar background as that of the original member may be appointed to fill the vacancy and serve until the end of the original term of office.
The convener of the Working Group shall be responsible for calling meetings and shall serve as the chairperson. In cases where the convener cannot attend a meeting for some reasons, members will elect one among themselves to chair the meeting.
Conclusions of causality between vaccination and the alleged injury as assessed by the Working Group are classified as follows:
1. Unassociated: The assessment result will be “unassociated” if any of the following situations applies:
(1) Clinical examination or the laboratory test result substantiates that the injury was caused by something other than vaccination.
(2) Medical evidence shows no causality or medical evidence does not support causality.
(3) Medical evidence supports causality. However, the injury did not occur during a reasonable period of time following vaccination.
(4) It is determined in consideration of medical principles and following a comprehensive review that there is no support for causality between the alleged injury and vaccination.
2. Associated: The assessment result will be “associated” if the following situations all apply:
(1) Medical evidence, clinical examination or the laboratory test result supports causality between vaccination and the alleged injury.
(2) The alleged injury occurred within a reasonable period of time following vaccination.
(3) After a comprehensive review, it is determined that a significant association exists.
3. Indeterminate: The case is free of the situations described in the preceding two subparagraphs and causality cannot be determined following a comprehensive review.
“Medical evidence” referred to in the preceding paragraph is defined as evidence from a population-based study or pathogenesis study that is published in a domestic or foreign journal.
“Determined following comprehensive review” referred to in Paragraph 1 is defined as professional medical judgment made after giving considerations to the medical history of the alleged victim before and after vaccination, the alleged victim’s family history, adverse reactions experienced by the alleged victim in the past after receiving analogous vaccines, medications taken by victim, victim’s exposure to toxins, biologic coherence and other relevant factors.
The Working Group will determine the amount of compensation for vaccine injuries based on the criteria provided in the attachment.
The amount of compensation to be awarded to victims shall be determined based on victim’s course of seeking medical care for the injury, medical treatments received, actual injury sustained, death or degree of physical/mental disability, association with vaccination and other related matters.
The degree of disability shall be determined in accordance with the types and degrees of disability set forth in the People with Disabilities Rights Protection Act.
Severe illnesses shall be determined in accordance with the Catastrophic Illness List from the National Health Insurance or based on severe adverse reactions of medicament use as defined in the Regulations for Reporting Severe Adverse Reactions of Medicaments.
Where there is any conflict or concurrence of the types of compensation, victims shall be compensated at the higher amount of payment; if victims have been paid at the lower amount, the differences shall be made up.