Drug Injury Relief Act
2020-01-15
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Chapter I General Principles
Article 1
This Act is enacted to provide timely relief to victims affected by the proper use of legal drugs.
Article 2
For purposes of this Act, the term "competent authority" shall refer to the Ministry of Health and Welfare.
Article 3
The terms used in this Act are defined as follows:
1. Drug Injury: Death, disability or severe illness caused by an adverse reaction to a drug.
2. Legal Drug: A drug with a drug permit issued by the competent authority for manufacturing, importation, or sale in the market.
3. Proper Use: The use of a drug in accordance with the instructions provided by medical professionals or as stated on the drug's labeling.
4. Adverse Reaction: A harmful effect associated with the use of a specific drug.
5. Disability: A condition that meets the criteria for type and level of disability as defined under the People with Disabilities Protection Act, excluding conditions caused by mental factors.
6. Severe Illness: An illness recognized by the competent authority as listed under the Major Illness and Injury in the National Health Insurance system, or as defined in the Regulations for Reporting Serious Adverse Reactions of Medicaments.
1. Drug Injury: Death, disability or severe illness caused by an adverse reaction to a drug.
2. Legal Drug: A drug with a drug permit issued by the competent authority for manufacturing, importation, or sale in the market.
3. Proper Use: The use of a drug in accordance with the instructions provided by medical professionals or as stated on the drug's labeling.
4. Adverse Reaction: A harmful effect associated with the use of a specific drug.
5. Disability: A condition that meets the criteria for type and level of disability as defined under the People with Disabilities Protection Act, excluding conditions caused by mental factors.
6. Severe Illness: An illness recognized by the competent authority as listed under the Major Illness and Injury in the National Health Insurance system, or as defined in the Regulations for Reporting Serious Adverse Reactions of Medicaments.
Article 4
A person who sustains a drug injury due to the proper use of a legal drug may claim relief under this Act.
The relief specified in the preceding paragraph shall include death payments, disability payments, and severe illness payments. The standards for these payments shall be established by the competent authority.
The relief specified in the first paragraph may be provided in phases, depending on the financial situation of the Drug Injury Relief Fund and the urgency of the drug relief, as determined by the competent authority.
The relief specified in the preceding paragraph shall include death payments, disability payments, and severe illness payments. The standards for these payments shall be established by the competent authority.
The relief specified in the first paragraph may be provided in phases, depending on the financial situation of the Drug Injury Relief Fund and the urgency of the drug relief, as determined by the competent authority.
Chapter II Drug Injury Relief Fund
Article 5
To provide drug injury relief services, the competent authority shall establish the Drug Injury Relief Fund ("the Fund"), financed by the following sources:
1. Levy imposed on drug manufacturers and importers.
2. Penalties for late payments.
3. Income from subrogation claims.
4. Donations.
5. Interest generated by the Fund.
6. Other relevant income.
1. Levy imposed on drug manufacturers and importers.
2. Penalties for late payments.
3. Income from subrogation claims.
4. Donations.
5. Interest generated by the Fund.
6. Other relevant income.
Article 6
The competent authority may commission other authorities, institutions, or organizations to handle the following matters and, if necessary, provide funding to establish a corporate foundation for this purpose:
1. Provision of relief payments.
2. Collection and management of levies.
3. Other matters related to drug injury relief.
Based on the commission set forth in the preceding paragraph, the competent authority may require the commissioned authorities, institutions, or organizations to submit service and financial reports. The competent authority may also assign officials to inspect service conditions and review documents, including accounting records.
1. Provision of relief payments.
2. Collection and management of levies.
3. Other matters related to drug injury relief.
Based on the commission set forth in the preceding paragraph, the competent authority may require the commissioned authorities, institutions, or organizations to submit service and financial reports. The competent authority may also assign officials to inspect service conditions and review documents, including accounting records.
Article 7
Drug manufacturers and importers shall pay a specified percentage of their sales from the previous year as a levy into the Drug Injury Relief Fund by the deadline set by the competent authority.
The levy rate specified in the preceding paragraph shall be one-thousandth (1%o) of sales when the Fund's balance is below three hundred million New Taiwan dollars (300 million NTD). When the Fund exceeds three hundred million New Taiwan dollars (300 million NTD), the competent authority may adjust the rate within the range of two ten-thousandths (0.2%o) to two-thousandths (2%o) of sales, based on the actual financial condition and cash flow of the Fund.
If drug manufacturers or importers are unable to provide sales data from the previous year, the levy shall be based on an estimate of the current year's sales. If the estimate differs from the actual sales, any difference shall be refunded or collected retroactively in the following year.
For drug manufacturers or importers who pay the levy in accordance with this Act and whose drugs have caused drug injury, the competent authority may increase the levy rate to ten-thousandths (10%o). The rate specified in Paragraph 2 shall not apply in this case.
The levy rate specified in the preceding paragraph shall be one-thousandth (1%o) of sales when the Fund's balance is below three hundred million New Taiwan dollars (300 million NTD). When the Fund exceeds three hundred million New Taiwan dollars (300 million NTD), the competent authority may adjust the rate within the range of two ten-thousandths (0.2%o) to two-thousandths (2%o) of sales, based on the actual financial condition and cash flow of the Fund.
If drug manufacturers or importers are unable to provide sales data from the previous year, the levy shall be based on an estimate of the current year's sales. If the estimate differs from the actual sales, any difference shall be refunded or collected retroactively in the following year.
For drug manufacturers or importers who pay the levy in accordance with this Act and whose drugs have caused drug injury, the competent authority may increase the levy rate to ten-thousandths (10%o). The rate specified in Paragraph 2 shall not apply in this case.
Article 8
If drug manufacturers or importers fail to pay the levy by the deadline and do not remit the payments after receiving written notice, a late payment penalty of one hundredth (1%) of the levy shall be imposed for every two days of delay. However, the total late payment penalty shall not exceed twice the original levy amount.
Chapter III Services for Drug Injury Relief
Article 9
Drug manufacturers and importers shall submit information and relevant documents regarding the estimated sales for the current year or the sales figures from the previous year by the deadline specified by the competent authority.
To facilitate drug injury relief and related services, the competent authority may require drug manufacturers and importers to provide relevant documents. Drug manufacturers and importers shall not refuse, avoid, or impede such requirements.
To facilitate drug injury relief and related services, the competent authority may require drug manufacturers and importers to provide relevant documents. Drug manufacturers and importers shall not refuse, avoid, or impede such requirements.
Article 10
To facilitate drug injury relief and related services, the competent authority may require tax authorities, medical institutions and other authorities, institutions, or organizations to provide relevant documents and information. These required parties shall not refuse, avoid or impede such requirements.
Article 11
Personnel responsible for drug injury relief and related services under this Act shall not disclose any confidential information pertaining to drug manufacturers, importers, or drug injury victims obtained in the course of performing duties. Additionally, the use of such information for personal gain is prohibited.
Article 12
Claimants eligible for drug injury relief are specified as follows:
1. Death payment: The heirs of the deceased victim.
2. Disability payment or severe illness payment: The victim or the victim's statutory agent.
The competent authority shall establish regulations regarding the application procedures, required documents, and other obligations for the claimants mentioned in the preceding paragraph.
1. Death payment: The heirs of the deceased victim.
2. Disability payment or severe illness payment: The victim or the victim's statutory agent.
The competent authority shall establish regulations regarding the application procedures, required documents, and other obligations for the claimants mentioned in the preceding paragraph.
Article 13
Drug injury relief shall not be granted under any of the following circumstances:
1. The drug injury is proved to be the responsibility of the drug injury victim, drug manufacturer or importer, physician, or other parties.
2. The drug injury occurred prior to the implementation of this Act.
3. The injury resulted from vaccination and is eligible for relief under other laws and regulations.
4. Compensation or indemnification has already been received for the same basis and facts, excluding benefits received from personal insurance.
5. The adverse reactions caused by drug use do not meet the severity criteria of death, disability or severe illness.
6. The injury resulted from a drug overdose during emergency medical care.
7. The injury resulted from the use of investigational drugs.
8. The injury resulted from off-label use of a drug, defined as usage not aligned with the indications or purposes stated on the drug permit, unless such use aligns with current medical practice and is deemed appropriate.
9. The injury resulted from common and foreseeable adverse reactions to the drug.
10. Other conditions as promulgated by the competent authority.
1. The drug injury is proved to be the responsibility of the drug injury victim, drug manufacturer or importer, physician, or other parties.
2. The drug injury occurred prior to the implementation of this Act.
3. The injury resulted from vaccination and is eligible for relief under other laws and regulations.
4. Compensation or indemnification has already been received for the same basis and facts, excluding benefits received from personal insurance.
5. The adverse reactions caused by drug use do not meet the severity criteria of death, disability or severe illness.
6. The injury resulted from a drug overdose during emergency medical care.
7. The injury resulted from the use of investigational drugs.
8. The injury resulted from off-label use of a drug, defined as usage not aligned with the indications or purposes stated on the drug permit, unless such use aligns with current medical practice and is deemed appropriate.
9. The injury resulted from common and foreseeable adverse reactions to the drug.
10. Other conditions as promulgated by the competent authority.
Article 14
The right to claim drug injury relief shall be extinguished by prescription if not exercised within three years from the date the claimants become aware of the drug injury.
Article 15
The competent authority shall establish the Drug Injury Relief Review Committee (hereinafter referred to as "the Review Committee") to review drug injury relief cases and determine the amount of relief payments. The regulations governing the committee's organization and reviewing procedures shall be established by the competent authority.
The Review 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. At least one-third of the members shall be legal experts and impartial members of society.
The Review 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. At least one-third of the members shall be legal experts and impartial members of society.
Article 16
The Review Committee shall make a determination 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.
Article 17
A person who has received a drug injury relief payment and other compensation or indemnification for the same fact and reason shall return the payment to the extent of the amount compensated or indemnified.
Article 18
The competent authority may exercise subrogation rights within the amount already paid if any party liable for the drug injury is identified after the payment has been made.
Article 19
The right to claim drug injury relief shall not be transferred, offset, seized, or used as collateral.
Drug injury relief payments are exempt from personal income tax, and the right to receive such payments is exempted from inheritance tax.
Drug injury relief payments are exempt from personal income tax, and the right to receive such payments is exempted from inheritance tax.
Chapter IV Administrative Remedy
Article 20
If applicants for drug injury relief disagree with the decision, an administrative appeal may be filed, and litigation may be initiated in accordance with relevant laws.
Article 21
If a drug manufacturer or importer disagrees with the levy, late payment penalties, or fines, an administrative appeal may be filed, and litigation may be initiated in accordance with relevant laws.
Chapter V Penal Provisions
Article 22
Any person violating Article 9 shall be fined not less than sixty thousand New Taiwan dollars (60,000 NTD) but not more than three hundred thousand New Taiwan dollars (300,000 NTD). Repeated non-compliance may result in additional fines for each instance of violation. In cases of omission or under-reporting in the declaration, the violator shall be fined two to three times the difference in the levy amount that should have been paid.
Article 23
Any medical care institution or relevant authority, institution, or organization that violates Article 10 shall be fined not less than twenty hundred New Taiwan dollars (20,000 NTD) but not more than one hundred thousand New Taiwan dollars (100,000 NTD). Repeated non-compliance may result in additional fines for each instance of violation.
Article 24
Any person violating Article 11 shall be fined not less than six thousand New Taiwan dollars (6,000 NTD) but not more than thirty thousand New Taiwan dollars (30,000 NTD).
Article 25
(Deleted)
Article 26
The fines specified in this Act shall be imposed by the competent authority.
Chapter VI Supplementary Provisions
Article 27
(Deleted)
Article 28
This Act shall take into force on the date of promulgation.