生產事故救濟條例

To alleviatethe risks towomen during childbirth, a national relief mechanism is established to ensure timely relief forpuerperae, fetuses, and newborns in case of accident during the childbirth process. This Act is enacted to reduce medical disputes, promote the partnership between puerperaeand medical personnel, and enhance the health and safety of women during childbirth.

The competent authorities referred to in this Act are the Ministry of Health and Welfare atthe central level, the municipal governments atthe municipal level, and the county (city) governments atthe county (city) level.

1Terms used in this Act are defined as follows:

21. Childbirth accident: refering to serious harm or death of puerperae, fetuses, and newborns resulting from childbirth.

32. Childbirth accident dispute: refering to a dispute arising from the fact that in the belief ofpuerperae or their family, the medical personnel, medical care institutions or midwiver agenciesmay be responsible for a childbirth accident.

43. Parties concerned: refering to the medical personnel, medical care institutions, midwifery agencies, puerperae, or other people who may legally bring an action due to a childbirth accident dispute.

54. Systematic error: refering to adverse outcomesfrom medical or midwifery behaviors due to structural problems with the organization, system, decision-making, or equipment and facilities of a medical care institution or midwifery agency.

1Hospitals shall set up a childbirth accident care group to explain to and communicate with puerperae, their family, or representatives and to provide assistance and care service within two working days afterthe occurrence of a childbirth accident.

2When childbirth accident disputes occur in a clinic ormidwifery agency, a professional shall be designated to provide the care services mentioned in the previous paragraph.

3Members of the childbirth accident care group shall include professionals in law, medicine, psychology, and social work, etc. Wherethepuerpera, her family or representative hascommunication difficulties due tohearing or speech impairment or any other problems, members with relevant training shall be responsible for providing explanation, communication, and care.

4The central competent authority shall set upfundsto strengthen care personnel’s training in providing explanation, communication, and care, so that childbirth accident disputes may be resolved more efficiently.

1In the event of a childbirth accident dispute, the medical care institution or midwifery agency shall provide a copy of personal medical records, all examination reports, NHI medical orders, etc. within three working days upon the request of the puerpera, her family or representative; the information shall be provided within seven working days at the latest if the information is in a large amount.

2The cost incurred for copying the information mentioned in the previous paragraph shall be borne by the applicant.

During the process of explanation, communication, providing assistance or care services as stipulated in this Chapter, the medical personnel’s or other representative’s regret, apology, or similar statement shall not be used as evidence or basis of judgment for the relevant litigation.

1The central competent authority shall set up funds for offering childbirth accident relief. Sources of the funds include as follows:

21. Grantsfromthe government budget

32. Health and Welfare Surcharges on Tobacco Products

43. Donation income

54. Interest income from funds

65. Other sources of income

1Types of childbirth accident relief and target applicants to be granted relief are as follows:

21. Death benefit: Where the puerperaor newborn dies, the payment is made to the statutory heir. Where the fetus is stillborn, the payment is made to the mother.

32. Major injury benefit: The victim himself/herself.

4Regulations concerning the procedure of application for relief benefit, the criteria of granting relief, the scope of major injuries, the amount of money given, method and standard of relief, the information to be attached, and other matters for compliance as stated in the previous paragraph shall be laid down by the central competent authority.

1The central competent authority shall set up the Childbirth Accident Relief ReviewCommittee to review childbirth accident relief cases.

2The ReviewCommittee mentioned in the previous paragraph shall be formed by medical and legal experts, representatives of women’s organizations and impartial parties in society, and institutional representatives selected by the central competent authority. The number of representatives in the following categories shall not account for less than one-third of the total number of representatives in the Review Committee:

31. Any single sex

42. Representatives of legal experts, women’s organizations, and impartial parties in society

5Regulations concerning the Review Committee members’ qualifications, terms of service, dismissal, review procedures, and other matters for compliance shall be regulated by the central competent authority.

When handling childbirth accident relief cases, the central competent authority shall make a decision within three months from the receiptof an application; the deadline may be extended for up to three months when necessary, and only one extension is allowed.

1The childbirth accident relief is available only for cases that have causation with childbirth or such causation cannot be excluded. However, no relief will be given in any one of the following circumstances:

21. The adverse outcomesuffered by the pregnant woman orpuerperaand the fetus is caused by termination of pregnancy for non-medical causes.

32. Fetal death (including stillbirth) or adverse outcomes on a newborn caused by severecongenital malformation, gene defect, or premature birth at less than 33 weeks’ gestation.

43. Psychological or psychiatric disorders suffered by the pregnant woman or puerperaare caused by pregnancy or childbirth.

54. A childbirth accident for which a civil action, or private prosecution or accusation of a criminal case has already been filed. However, this does not apply to the following situations:

6(1) The civil litigation is withdrawn before the conclusion of the court trial hearing in the first instance.

7(2) For cases indictable only upon complaint, the accusation is withdrawn before the end of the investigation; or the private prosecution is withdrawn before the conclusion of the trial hearing in the first instance.

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1In any one of the following circumstances, the central competent authority shall issue a written disciplinary measure to order the beneficiary of the granted relief to return the benefit:

21. A concrete evidence shows that no relief should have been granted according to the provisions stated in the previous Article.

32. Private prosecution or chargefor criminal case or a civil litigation is lodged after relief has beengranted for the same childbirth incident.

1After relief is granted in cases indictable not upon complaint with no situations stipulated in Item 2 of the previous Article, if the court decides that the medical personnelis liable, the relief fund paid by the central competent authority to the beneficiary for the same childbirth accident shall be deemed part or the entirety of the compensation for which the medical care institution, midwifery agency, or medical personnel ought to bear, without being subjectto the limitation of the previous Article.

2The central competent authority shall request the medical care institution, midwifery agency, or medical personnel to return the relief paid as mentioned in the previous paragraph in the amount of the compensation due.

3When the central competent authority request the medical care institution or midwifery agency to return the relief paid, the institution or agency shall not request reimbursement from medical personnel where the cause of the accident involves a systematic error.

The right to claim childbirth accident relief expires in two years whereno claim is made from the time when the eligible applicant becomes aware of the childbirth accident; the same applies to childbirth accidents thatoccurred over ten years ago.

1The right to claim childbirth accident relief shall not beassigned, offset, confiscated, or provided forguarantee.

2Relief payment received for a childbirth accident is exempted from income tax and estate tax, and is not subject toexecution.

For processing childbirth accident relief, the central competent authority may request medical care institutions, midwifery agencies, and other relevant organizations (agencies) to provide necessary medical records, treatment records, books and papers, or other relevant information bya specified deadline. The institutions/agencies/organizations shall not evade, hinder, or refuse the request.

1In any one of the following circumstances, members of the Childbirth Accident Relief ReviewCommittee shall recuse themselves:

21. Being the party concerned or the spouse, lineal relative, relative within the third degree of kinship or relative by marriage of the party concerned.

32. Being the representative of the party concerned.

43. Working in the same medical care institution or midwifery agency as the party concerned or his/her representative.

5When the applicant is aware of the result of a relief review, which involves the above-mentioned recusal items in the previous paragraph with the member(s) concerned not recuse themselves, the applicant may apply for review again. However, this does not apply to applicants who have filed an appeal or taken an administrative action.

Applicants who object to the ruling concerningthe relief payment may file an appeal or take an administrative action pursuant to laws.

1The central competent authority shall allocate funds for the administrative work of childbirth accident relief, and shall commission a corporate body, other institution (agency) or organization to perform the following tasks:

21. Review, give payments, and other general affairs relating to relief applications

32. Assist in the collection and management of the relief fund

43. Undertake statistical analyses of childbirth accidents

54. Create, analyse and usea childbirth accident relief database

65. Other matters relating to childbirth accident relief work

7The central competent authority may request the commissioned corporate body, other institution (agency) or organization provided in the previous paragraph to submit a business and financial report at any time, and may send personnel to inspect the status of work, accounting books and ledgers, etc.

Personnel who become aware of or possess confidential information of another person due to their performance of duties relating to childbirth accident relief payments shall not disclose the information without reason or use it for their own or others’ interest.

1R.O.C. nationals’ applications for childbirth accident relief areeligible only for childbirth accidents that occur within R.O.C. territory.

2Foreign spouses of R.O.C. nationals are eligible for making the aforesaid applications.

3Apart from the aforesaid applications, non-R.O.C. nationals may apply for childbirth accident relief pursuant to an established convention, agreement, protocol, or their own country’s or region’s laws or customary rules; this applies to countries or regions where R.O.C. nationals enjoy the same rights.

1To prevent and reduce childbirth accident risks, medical care institutions and midwifery agencies shall develop in-house risk control and incident reporting mechanisms. They shall analyze the root causes of severe childbirth accidents and make proposals for improvements. They are required to report incidents and to be investigated as per the central competent authority’s request.

2The competent authority shall monitor the implementation of the improvement proposals within one year after an incident is reported.

3The reporting and investigation regulations mentioned in the previous two paragraphs shall be established by the central competent authority.

4The content of analysis for the root causes of severe childbirth accidents shall not be used as evidence in judicial cases.

The competent authority shall perform statistical analyses and publish the results annually for the childbirth accident relief cases processed. The aforesaid publication of the results shall include analyses of cases in accordance with levels of medical care institution, region, and sex.

1For medical care institutions and midwifery agencies where childbirth accident disputes or childbirth accidents occur, the central competent authority may analyze the causes when necessary and order the institution/agency to conduct a review and make an improvement proposal.

2Theinstitutions or organizationswith credibility may be commissioned to perform the analyses mentioned in the previous paragraph, and regard shall have had to the principles of anonymity, confidentiality, and mutual learning. Also, the analysesshall not aim at punishment or attribution of responsibility.

1Where medical care institutions and midwifery agencies violate the provision stipulated in Paragraph 1 of Article 22 in any of the following conditions, each institution/agency shall be fined between NT$20,000 and $100,000:

21. Has not developed the in-house risk control and incident reporting mechanism.

32. Has not analyzed the root causes of severe childbirth accidents and made improvement proposals.

43. Has not reported an accident and undergonean investigation as per the central competent authority’s request.

Medical care institutions, midwifery agencies, or other relevant institutions (organizations) which evade, hinder, or refuse the request of the competent authority pursuant to Article 16 shall be fined between NT$50,000 and $250,000 by the central competent authority.

Hospitals that have not established a childbirth accident care group pursuant to Article 4, or medical care institutions and midwifery agencies that have not provided information by the deadline as per the provision in Paragraph 1 of Article 5, shall be fined between NT$20,000 and $100,000 by the municipal and county (city) competent authority.

Personnel handling childbirth accident relief cases and violating the provision stipulated in Article 20 shall be fined between NT$10,000 and $50,000 by the central competent authority.

This Act shall take into effect six months after its promulgation.