藥害救濟申請及審議委員會審議辦法

These Regulations are enacted in accordance with Article 4, Paragraph 2; Article 12, Paragraph 2; and Article 15, Paragraph 1 of the Drug Injury Relief Act (hereinafter referred to as the "Act").

The eligibility of claimants for drug injury relief is prescribed under Article 12, Paragraph 1 of the Act.

1When applying for drug injury relief, applications shall submit an application form along with the following documents and information to the competent authority or its designated entities, including commissioned authorities, institutions, juridical persons, or organizations (collectively referred to as the "Commissioned Institutions"):

21. The victim's medical records and other documents reflecting the victim's health condition prior to the occurrence of the drug injury.

32. Records and information detailing the victim's medical treatment and health condition following the occurrence of the drug injury.

43. A certificate of diagnosis issued by a medical institution for the victim after the occurrence of the drug injury.

54. Proof of the relationship between the applicant and the victim.

65. A copy of the receipt issued by a medical institution showing the necessary medical expenses incurred for the victim's application for severe illness payment due to the drug injury.

76. A copy of the disability identification for the victim's application for disability payment due to the drug injury.

87. A copy of the death certificate for the victim's application for death payment due to the drug injury.

98. Any other documents or information deemed necessary by the competent authority.

1If the documents and information submitted by an applicant do not comply with legal formalities or are incomplete, the competent authority or the Commissioned Institutions shall notify the applicant to make corrections or provide additional documents within a specified deadline. If the applicant fails to make corrections or provide the required documents by the deadline, the application shall be rejected.

2However, if the claimant has a legitimate reason, an extension may be requested before the deadline.

Upon receiving an application, the competent authority or the Commissioned Institutions may collect information in accordance with Article 10 of the Act, prepare a report, and submit the report, along with the documents and information specified in Article 3, to the Drug Injury Relief Review Committee of the Ministry of Health and Welfare (hereinafter referred to as the "Committee") for review.

1The Committee shall perform the following duties:

21. Determining the scope of the injury sustained.

32. Determining the amount of drug injury relief payments.

43. Deliberating on other matters related to drug injury relief.

1The Committee shall consist of 11 to 17 members, appointed by the competent authority from professionals in the fields of medicine, pharmacy, and law, as well as impartial members of society. One member shall be designated as the convener by the competent authority.

2The total number of legal professionals and impartial members of society, as mentioned in the preceding paragraph shall constitute no less than one-third of the total number of the Committee members. The number of members of each gender shall constitute no less than one-third of the total number of the Committee members.

3Committee members shall serve a term of two years and may be reappointed upon the expiration of the term. If a vacancy occurs during a term, a replacement may be appointed to serve until the end of the original term.

1The convener shall convene and chair the Committee meetings. If the convener is unable to attend, the members shall elect one among them to serve as the chairperson.

2Resolutions at a Committee meeting shall be adopted by a majority vote of the members present, provided that more than half of all members are in attendance.

3Committee members shall attend the meetings in person. Proxy attendance is not permitted.

1The Committee shall make a determination in accordance with Article 16 of the Act within three months of receiving a drug injury relief application. If necessary, this period may be extended, but the extension shall not exceed one month.

2If the documents and information submitted by the applicant are found to be incomplete after the application is received by the competent authority or the Commissioned Institutions, the Committee shall notify the applicant to make corrections or provide required documents by a specified deadline. The period for making corrections or providing required documents shall not be included in the determination period specified in the preceding paragraph.

3The determination results under Paragraph 1 shall include detailed reasoning.

When reviewing an application for drug injury relief, the Committee may designate a member(s) to conduct a preliminary review. If necessary, relevant authorities, institutions, professional organizations, experts, or scholars may be invited to provide written opinions or participate in consultations.

When reviewing an application for drug injury relief, the Committee shall base the evaluation on the documents, information and the report specified in Articles 3 and 5, along with the review, written opinions, or consulting opinions described in the preceding paragraph. If necessary, the Committee may designate medical institutions or relevant physicians to reexamine the victim and may appoint an individual to interview the victim, the applicant or other parties of interest or to collect relevant evidence.

The competent authority may authorize the Commissioned Institutions to require tax authorities, medical institutions, and other relevant authorities or institutions to provide documents and information in accordance with Article 10 of the Act. These required parties shall not refuse, avoid, or impede such requirements.

1If, after review, the Committee determines that an application submitted under Article 3 indicates that the cause of death is related to a drug injury, a death payment shall be provided in the following amounts:

21. For drug injuries occurring on or before September 2, 2021, the maximum payment amount is two million New Taiwan dollars (2,000,000 NTD).

32. For drug injuries occurring on or after September 3, 2021, the maximum payment amount is three million New Taiwan dollars (3,000,000 NTD).

4If the cause of death cannot be conclusively determined to result from a drug injury after review, the competent authority may, at its discretion, grant a death payment within the limits specified in the preceding paragraph, considering the specific circumstances of the case.

1If, after review, the Committee determines that an application submitted under Article 3 indicates that the cause of disability is related to a drug injury, a disability payment shall be provided in the following amounts:

21. For drug injuries occurring on or before September 2, 2021:

3(1) Profound disabilities: Maximum of two million New Taiwan dollars (2,000,000 NTD).

4(2) Severe disabilities: Maximum of one million five hundred thousand New Taiwan dollars (1,500,000 NTD).

5(3) Moderate disabilities: Maximum of one million three hundred thousand New Taiwan dollars (1,300,000 NTD).

6(4) Mild disabilities: Maximum of one million one hundred fifty thousand New Taiwan dollars (1,150,000 NTD).

72. For drug injuries occurring on or after September 3, 2021:

8(1) Profound disabilities: Maximum of three million New Taiwan dollars (3,000,000 NTD).

9(2) Severe disabilities: Maximum of two million two hundred fifty thousand New Taiwan dollars (2,250,000 NTD).

1If, after review, the Committee determines that an application submitted under Article 3 indicates that the cause of severe illness is related to a drug injury, a payment for necessary medical expenses incurred during the hospitalization period or an extended period at a medical institution, supported by official receipts, shall be provided to the victim. If the victim's condition requires admission to an intensive care unit or a burn unit intensive care ward, the amount may be increased at the discretion of the competent authority.

2If the cause of severe illness cannot be conclusively determined to result from a drug injury after review, the competent authority may, at its discretion, grant a sever illness payment within the limits specified in the preceding paragraph, considering the specific circumstances of the case.

3The severe illness payments described in the preceding two paragraphs shall not exceed six hundred thousand New Taiwan dollars (600,000 NTD). If the total amount of necessary medical expenses is less than ten thousand New Taiwan dollars (10,000 NTD), the payment shall be ten thousand New Taiwan dollars (10,000 NTD).

If a situation qualifies for multiple types of drug injury relief payments, the highest payment amount shall be granted. If a lower amount has already been granted, the difference shall be paid to make up the shortfall.

The Committee's review results shall be communicated to the claimant upon approval by the competent authority.

1The recusal of Committee members shall be governed by the Administrative Procedure Act.

2The provisions of the preceding paragraph shall apply, mutatis mutandis, to the experts and scholars specified in Article 10 and the physicians specified in Article 11.

Committee members and relevant personnel shall maintain the confidentiality of all documents and information related to the victim and the claimant, including meeting minutes, consulting opinions, Committee members' opinions, and meeting conclusions. Such information shall not be disclosed without justified reason.

These Regulations shall take into force on the date of promulgation.