• 發文/公布日期：2000-05-13
• 文件類別：law & regulations
• 分類：安全資訊風險溝通表
• 點閱次數：218

主旨：

Drug Hazard Relief Act

說明：

Drug Hazard Relief Act (amended on May 31, 2000) Chapter I General Provisions Article 1 This Law is enacted to provide timely relief to victims sustaining injury from the proper usage of legal drugs. Any matters not provided for in this Act shall be governed by the provisions of other relevant laws. Article 2 The term "competent authority" used in this Act shall be the Department of Health of the Executive Yuan. Article 3 The terms as used in this Act are defined as follows: 1. "Drug hazards" mean death, disability, or serious illness caused by adverse reactions of drugs 2. "Legal drug" means a legally manufactured, imported, or sold drug holding permit license issued by the competent authority. 3. "Proper usage" means the use of a drug according to the directions of medical and pharmaceutical professionals, or according to the label or instructions of the medicament. 4. "Adverse reaction" means a hazardous reaction to the human body due to use of the medicament. 5. "Disabled" means persons who conform under the disability categories and levels provided under the Physically and Mentally Disabled Protection Act, not including conditions caused by mental factors. 6. "Serious illness" means illnesses proclaimed by the competent authority in accordance with serious diseases falling within the National Health Insurance, and serious ill reactions listed by the announcement regulations for adverse reaction of drugs. Article 4 Person(s) who have sustained drug hazards due to the proper usage of legal drugs may request relief in accordance with the provisions under this Act The relief referred to in the preceding Paragraph shall be classified as death payments, disability benefits, and serious illness payments, the standards of which shall be otherwise established by the competent authority. The competent authority shall take into consideration the financial situation of the Drug Hazards Relief Fund when necessary, and carry out the relief referred to in the first Paragraph in gradation, according to levels of urgency of drug hazards relief. Chapter II Drug Hazards Relief Fund Article 5 The competent authority shall establish the Drug Hazards Relief Fund, for the purpose of conducting drug hazards relief affairs, the funds of which shall originate from the following: 1. Levies received from drug manufacturers and importers; 2. Late payment penalties; 3. Income from subrogation claims; 4. Donations; 5. Interest generated by the Fund; 6. Other related incomes The Executive Yuan shall establish measures for the revenues/expenditures, safekeeping, and use of the fund referred to in the preceding Paragraph. Article 6 The competent authority may commission other institutions or organizations to conduct the following, for the purpose of conducting drug hazards relief affairs. When necessary, the competent authority may endow the establishment of a juridical person, and commission the said juridical person to conduct the following: 1. Payment of relief fund; 2. Collection and management of levies; 3. Other affairs related to drug hazards relief. The competent authority may, at any time, request the commissioned institution or organization referred to in the preceding Paragraph, to submit business and financial reports, and may assign officials to inspect the financial situation and account books of said institution or organization Article 7 Drug manufacturers and importers shall pay a levy of a certain ratio in accordance with the sales volume of drugs of the previous year, within the time limit established by the competent authority, towards the Drug Hazard Relief Fund. The ratio of the levy as referred to in the preceding Paragraph shall be one thousandth (0.1%) of the sales volume when the total amount of the Fund has not reached NT$300,000,000. The competent authority shall, based on actual circumstances and after due considerations of the financial situation of the Fund, adjust the levy ratio between two ten-thousandths (0.02%) and two thousandths (0.2%) of the sales volume, once the total amount of the Fund has reached NT$300,000,000. In the case that drug manufacturers and importers do not have information regarding the sales volume of the previous year, the levy shall be collected based on estimates of the sales volume of the current year. In the case that there is discrepancy between sales volume estimates and actual sales volume, the discrepancy amount shall be refunded or pursued in the following year. In the case that drugs manufactured or imported by said drug manufacturers and importers who pays levies in accordance with this Act are the cause of drug hazards, the competent authority shall adjust the levy for said drug manufacturers and importers for the next year to ten thousandths (1%) of the sales volume, and shall not be restricted under the provisions of the second Paragraph of this Article. Article 8 The drug manufactures and importers which do not pay the levy within the time limit specified, and still to comply with written notice, shall be subject to a late payment penalty of one hundredth (1%) of the original levy for every two days delayed. However, the total amount of the late payment penalty shall not exceed twice the amount of the original levy. Chapter III Drug Hazards Relief Operations Article 9 Drug manufacturers and importers shall declare information regarding estimates of sales volume for the current year or the sales volume for the previous year in the time limit specified by the competent authority. For the purposes of administering drug hazards relief and other related operations, the competent authority may request drug manufacturers and importers to provide related information, and the drug manufacturers and importers shall not refuse, avoid, or impede. Article 10 For the purposes of administering drug hazards relief and other related operations, the competent authority may request finance and tax organizations, medical care institutions, or other related institutions or organizations to provide related information, and institutions and organizations requested shall not refuse, avoid, or impede. Article 11 Persons conducting operations related to drug hazards relief as referred to in this Act, shall not reveal confidential information acquired or possessed by virtue of his/her function regarding drug manufacturers, drug importers, or victims of drug hazards without good cause; and shall not use said confidential information for personal interest. Article 12 Applicants for drug hazards relief are as follows: 1. The victim's legal successor in the case of death payments; 2. The victim or his/her legal agent in the case of disability payments or serious illness payments. In the case of death benefits referred to in Subparagraph 1 of the preceding Paragraph, provisions under Articles 1138 through 1144, Article 1146, Article 1151, Article 1152, Article 1164, and Article 1166 of the Civil Code shall apply mutatis mutandis. Regulations regarding the procedure, required information, and other observances for relief application by person having the right to make claim, as referred to in Paragraph 1, shall be established the competent authority. Article 13 Persons under the following conditions may not apply for drug hazards relief: 1. That there appears concrete factual situation where the result of drug hazards is the responsibility of the drug hazard victim, drug manufacturer or importer, physician, or other persons. 2. That the occurrence of the drug hazards appeared before implementation of this Act 3. That the hazards resulted from immunization, in which case relief is provided under other laws and regulations. 4. That compensation or indemnification, excepting personal insurance, has already been received for the same situation. 5. That the adverse reaction caused by the drug does not result in death, disability, or serious illness. 6. That the damage caused is due to excess-medication during emergency medical care. 7. That the damage caused is due to use of experimental drugs. 8. That the use of the drug did not follow in accord with efficacy or indications stated on the drug permit. 9. That the adverse reaction caused by the drug is common and foreseeable. 10. Other situations announced by the competent authority. Article 14 The right to claim drug hazards relief shall be extinguished if not exercised within three years from the time the person having the right to make claim learns of the drug hazards Article 15 The competent authority shall establish the Drug Hazards Relief Review Committee (hereinafter referred to as "the Review Committee"), for the purposes of conducting drug hazards relief and determining amount of payments. Regulations regarding the organization and review procedures of the said committee shall be established by the competent authority. The Review Committee referred to in the preceding Paragraph shall be composed of eleven to seventeen committee members, to be appointed medical, pharmaceutical, and legal experts and impartial members of society by the competent authority, at least one third of the number of which shall be legal experts and impartial members of society. Article 16 The Review Committee shall make the determination within 3 months of receiving application for drug hazards relief. The said 3 month period may be extended as necessary. However, in no event shall the extension be longer than 1 month. Article 17 Persons who have already received drug hazards relief, and receives other compensation or indemnification for the same reason, shall return the received drug hazards relief within the limits of the compensation or indemnification he/she has received. Article 18 In the case that the competent authority discovers there exists a party responsible for compensation of drug hazards after relief has been paid to the victim by the competent authority, the competent authority shall request for compensation within the scope of settlement in subrogation. Article 19 The right to apply for drug hazards relief shall not be used for transference, cancellation, mortgage, or guarantee. The acceptance of drug hazards relief shall be exempt from income tax; the acceptance of the right to drug hazards relief shall be exempt from inheritance tax. Chapter IV Administrative Relief Article 20 In the case that a drug hazards relief applicant is unwilling to accept the relief payment decision, he/she may process an appeal or litigation in accordance with the law. Article 21 In the case that a drug manufacturer or importer is unwilling to accept the imposition of levies, late payment penalties, or fines, he/she may process an appeal or litigation in accordance with the law. Chapter V Penal Provisions Article 22 Any person who violates the provisions under Article 9 shall be subject to a successive fine of not less than NT$60,000 but not more than NT$300,000. In the case of failure to declare or omission of declaration, the offender shall be subject to a fine of two to three times difference between paid levy and due levy. Article 23 Any medical care institution or other related institution or organization that violates the provisions under Article 10 shall be subject to a fine of not less than NT$20,000 but not more than NT$100,000 successively. Article 24 Any person who violates the provisions under Article 11 shall be subject to a fine of not less than NT$6,000 but not more than NT$30,000. Article 25 Any person who fails to pay the levy, late payment penalty, or fine imposed upon him/her under this Act within the time limit set in a notice given to him/her shall be turned over to the court for compulsory execution Article 26 The fines specified in this Act shall be imposed by the competent authority. Chapter VI Supplementary Provisions Article 27 Relief affairs conducted by pharmaceutical related associations or academic associations in accordance with the Directions for Drug Hazards Relief established by the competent authority prior to the promulgation of this Act, shall be received and continued by the competent authority. Persons qualifying as drug hazards relief recipients under the Directions for Drug Hazards Relief shall not be restricted under the provisions of Subparagraph 2 of Article 13. Article 28 This Act shall become effective as of the date of promulgation.