Republic of China Artificial Reproduction Law

Republic of China Artificial Reproduction Law Promulgated: March 21, 2007 (R.O.C. Year 96)

Chapter One: General Provisions

Article 1: In order to promote healthy development of artificial reproduction, protect the rights and interests of infertile couples, artificially reproduced children, and donors, and maintain national ethics and health, this Act is enacted.

Article 2: Terms used in this Act are defined as follows:

1. Artificial Reproduction: A technique whereby non-sexual artificial methods, with the assistance of reproductive medicine, are used to achieve conception and reproduction.
2. Reproductive Cells: Sperm or eggs.
3. Treatment Recipients: A husband and wife receiving artificial reproduction wherein the wife is capable of carrying and delivering the fetus.
4. Embryo: A fertilized egg in the stage of cell division not exceeding eight weeks.
5. Donor: A person who provides sperm or eggs without compensation to treatment recipients for the purpose of conception and reproduction.
6. Asexual Reproduction: A technique whereby offspring are produced using a single somatic cell without fertilization by sperm and egg.
7. Egg and Sperm Exchange: A situation whereby two pairs of treatment recipients have agreed that sperm from one husband and eggs from the other wife are combined, such that each wife becomes pregnant.
8. Artificial Reproduction Institution: A medical institution or public-interest legal entity licensed by the competent authority to carry out artificial reproduction-related operations.

Article 3: The competent authority responsible for implementing this Act is the Department of Health under the Executive Yuan.

Article 4: The competent authority shall convene scholars, experts, and representatives from civic organizations to consider social ethical concepts, medical developments, and public health maintenance, establishing a consultative committee to periodically review implementation of this Act.

The female committee members on the committee referred to in the preceding paragraph shall constitute at least one half of the total committee membership.

Article 5: Artificial reproduction between spouses implemented by extracting the husband’s sperm and implanting it into the wife is not subject to the provisions of this Act, except for Article 16, Subparagraph 3 and penalties related to violations thereof.

Chapter Two: Management of Medical Institution Implementation of Artificial Reproduction

Article 6: Medical institutions must obtain permission from the competent authority before implementing artificial reproduction or receiving, storing, or providing reproductive cells.

Public-interest legal entities must obtain permission from the competent authority before receiving, storing, or providing sperm.

The validity period of the permission referred to in the preceding two paragraphs shall be three years; should an institution wish to continue such activities after the expiration period, it must apply for permission at least three months before expiration. The regulations governing the application conditions, application procedures, and other matters to be observed shall be established by the competent authority.

Article 7: Before implementing artificial reproduction or receiving donated reproductive cells, artificial reproduction institutions shall conduct the following examinations and assessments on treatment recipients or donors:

1. General physical and psychological conditions.
2. Family disease history, including genetic disease records of the person and blood relatives within four degrees of kinship.
3. Hereditary or infectious diseases that may harm reproductive health.
4. Other matters as announced by the competent authority.

A record of the examinations and assessments referred to in the preceding paragraph shall be prepared.

Article 8: Artificial reproduction institutions may only accept reproductive cell donations from donors meeting all the following requirements:

1. Males aged twenty years and above but under fifty years; females aged twenty years and above but under forty years.
2. Passing the examinations and assessments conducted in accordance with the preceding article and determined to be suitable for donation.
3. Making donations without compensation.
4. Never having donated previously, or having donated previously without resulting in live birth and without frozen storage.

Within amounts or values determined by the competent authority, treatment recipients may request that artificial reproduction institutions provide nutrition fees or nutritional supplements to donors, or bear necessary examination, medical, lost income, and transportation expenses. For the situation specified in Item 4 of the preceding paragraph, artificial reproduction institutions shall verify with the competent authority and may not use the materials until confirmation is received.

Article 9: When receiving reproductive cell donations, artificial reproduction institutions shall explain relevant rights and obligations to donors and obtain their understanding and written consent before proceeding.

When receiving reproductive cell donations, artificial reproduction institutions shall prepare a record containing the following information:

1. Donor’s name, residence, national ID number or passport number, date of birth, height, weight, blood type, skin color, hair color, and race.
2. Donation items, quantity, and date.

Article 10: An artificial reproduction institution shall not simultaneously provide reproductive cells from the same donor to more than two pairs of treatment recipients, and must cease providing use immediately upon one pair achieving successful pregnancy. After that pair completes live birth, it shall handle the matter according to the provisions of Article 21.

Chapter Three: Implementation of Artificial Reproduction

Article 11: Medical institutions may implement artificial reproduction for couples meeting all the following requirements:

1. Passing examinations and assessments conducted in accordance with Article 7 and determined to be suitable to receive artificial reproduction.

2. One spouse has been diagnosed with infertility, or has been diagnosed with a major hereditary disease announced by the competent authority, with natural reproduction showing obvious risk of bearing abnormal children.

3. At least one spouse possesses healthy reproductive cells and does not require donation of sperm or eggs from others.

Should couples lack the circumstances of Item 2 in the preceding paragraph but possess medical justification, they may implement artificial reproduction upon reporting to and receiving approval from the competent authority.

Article 12: When implementing artificial reproduction, medical institutions shall explain to treatment recipients the necessity of artificial reproduction, the implementation method, success rate, possible complications and dangers, and other possible alternative treatments, obtaining their understanding and written consent from both members of the couple before proceeding.

When implementing artificial reproduction as described in the preceding paragraph, for treatment recipients receiving artificially reproduced services using donated sperm, institutions must also obtain written consent from the male of the couple; where using donated eggs, they must also obtain written consent from the female member.

The written consent referred to in the preceding paragraph shall also be subject to notarization by a notary public.

Article 13: When implementing artificial reproduction, medical institutions shall not, at the request of treatment recipients, use reproductive cells from a specific donor, nor shall they, at the request of a donor, use their reproductive cells for a specific pair of treatment recipients.

Medical institutions shall provide donors’ information regarding race, skin color, and blood type for reference by treatment recipients.

Article 14: When implementing artificial reproduction, medical institutions shall prepare a record containing the following information:

1. Treatment recipients’ names, residences, national ID numbers or passport numbers, dates of birth, heights, weights, blood types, skin colors, and hair colors.

2. Donors’ national ID numbers or passport numbers and patient record numbers at the medical institution.

3. Details of artificial reproduction procedures performed.

(Continued in subsequent chapters covering provisions on child status, data management, penalties, etc.)