Regulatory Framework and Requirements for IVF business in Taiwan – Lexology

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The Central Intelligence Agency predicts that Taiwan will have the lowest fertility rate in the world in 2021, with an average of 1.07 births per woman of childbearing age. According to the government data, getting married later in life and increasingly delaying childbirth are the trends in Taiwan. As of 2019, the average marriage age for men is 32.6 years old and 30 years old for women. This also leads to the delaying childbearing age at which women give birth to their first child climbed to an average of 31.01 years old. Due to the delaying marriage and late childbearing age, the declining birth rate is getting worse and the proportion of infertility is increasing, making them a serious national security issue for the Taiwan government. With the low birth rate, more and more people suggest that the government should do more to provide access to assisted reproduction technologies and that besides providing childbirth subsidies, the government should address the issue of infertility.
Assisted Reproduction Act (hereinafter referred to as “ARA”) is the fundamental law in Taiwan in regard to assisted reproductive technology; therefore, for the means not involving sexual intercourse but with reproductive techniques or treatment in order to achieve conception and birth shall comply with the ARA, whether they are internal fertilization or external fertilization. However, according to Article 5 of the ARA, the ARA shall not apply to such assisted reproductive technology where the sperm of the husband was taken out to be implanted into the uterus of the wife, except for the cases regarding selection of the sex of the embryo and the related penalty provisions provided in the ARA. Nonetheless, such cases in relation to selection of the sex of the embryo are required to follow the ARA if the selection is due to hereditary diseases. From the perspective of the ARA, the aforementioned assisted reproductive technology is essentially the same as “natural” reproduction and pregnancy without the assisted reproductive techniques or treatment; thus, such assisted reproductive technology would not be subject to the ARA.
Speaking of IVF, people may refer IVF to the general medical intervention reproductive technology; nevertheless, our reference later would be based on the purpose of the ARA, which is exclusively for the heterosexual married couples as a medical treatment for infertility, and the conditions that the married recipient couples should follow if they would like to receive assisted reproduction technologies: (1) only if the wife’s uterus can carry a fetus and are able to give birth to a child; (2) the husband or wife of the married couple has been diagnosed as suffering from infertility, or has been diagnosed as suffering from a major hereditary disease designated by the competent authority, and it is suspected that natural conception and birth will cause abnormal children; and (3) at least one member of the married couple possesses healthy reproductive cells (e.g. sperm or ova).
The applicable laws and regulations which regulate IVF business in Taiwan.
There is no laws and regulations specifying IVF business in Taiwan. Nevertheless, for the means not involving sexual intercourse to achieve conception and birth but with assistance from reproductive medicine and with aforementioned conditions and purpose of the ARA, the applicable laws and regulations in this regard are as follows: (1) the ARA; (2) Regulations for Artificial Reproduction Information Notification and Administration; (3) Regulations for Artificial Reproduction Institution Permit; (4) Regulations for Verification on Kinship between the Sperm/Ova Donor and the Recipient; (5) Regulations for Inquiring Kinship Information of Concern to the Children Born Through Assisted Reproduction and (6) the public announcements dated on March 06, 2013 regarding the maximum amount that the donors may request, via assisted reproduction institutions, the recipient couples to provide the nutrition fees or nutritious supply, bear her necessary check, medical, loss of working times, and transportation fees .
The general regulatory framework in respect of egg freezing in Taiwan
1. Applicable Laws and Regulation—
Ova (egg) freezing process in Taiwan is regulated under the ARA. Applicable legal requirements and permit/license application requirements include but not limited to “Regulations for Artificial Reproduction Institution Permit” for requirements concerning setting up of the licensed medical institutions, and “Regulations for Artificial Reproduction Information Notification and Administration” if the ova would be used for donation.
2. Practicing Institution—
Only medical care institutions licensed by the competent authority are allowed to perform assisted reproduction or store the ova (egg). The requirements, including the qualifications for the personnel and the required facilities and equipment for the licensed medical care institutions can be referred to at “Regulations for Artificial Reproduction Institution Permit” and its attachment “Facilities and equipment requirements for a medical care institution applying to establish an artificial reproduction institution” respectively.
3.Practicing Personnel—
As only the licensed medical institutions are allowed to perform assisted reproduction and ova (egg) storage/preservation, women who intend to undergo egg freezing treatment may solely refer to medical practitioners at those licensed medical institutions.
4.Limitation—
While in some countries only single woman may freeze their eggs, there is no such limitation in Taiwan. Regardless of marital status, age, or other status, women are all allowed to freeze their eggs.
5.Freezing to donation—
If the egg freezing is for donation purpose, licensed medical institutions are further required to conform to the “Regulations for Artificial Reproduction Information Notification and Administration.”
The general regulatory framework in respect of egg donation in Taiwan
2.1 Requirements and limitation on donors—
Article 8 of of the ARA requires donors to be (1) above the age of 20 but under the age of 40; (2) fit to donate after checking/assessment; (3) doing such donation for free; (4) never donated before or had donated but the fetus was not lively born and the eggs were not stored; and (5) within the amount or price range set by competent authorities (currently set as NTD. 99,000). Donors can request, via assisted reproduction institutions, the recipient couples to provide her nutrition fees or nutritious supply, bear her necessary check, medical, loss of working times, and transportation fees. Article 19 of the ARA also makes it clear that once the eggs are donated, donors cannot request a return.
2.2 Donation Process—
The licensed medical institutions are required to submit and apply the donation checking application to the competent authority prior to receiving the ova donation. The licensed medical institutions shall perform the tests and assessments of recipient couples and donors regarding their (1) general psychological and physiological state; (2) family disease history; and (3) suspected hereditary or infectious diseases affecting ability to give birth, before performing assisted reproduction or accepting the donated eggs. The licensed medical institutions shall further make records of those who donate their eggs. Also, medical institutions are required to submit the eggs donors’ health examination and assessment within 14 days after completing such examination and assessment.
3. Duty to report, restriction on multiple donations, and duty to cease
3.1 Duty to report—
In the event that the recipient couple use the donated eggs or embryos created from the donated eggs, the licensed medical institutions are required to submit the donated eggs operation results notification to the competent authority and submit such notification again after the estimated date of childbirth.
3.2 Restriction on multiple donation and duty to cease—
The licensed medical institutions shall not provide the donated eggs from a woman to two or more recipient couples at the same time, and shall immediately cease providing such donated eggs after the recipient couple successfully achieves pregnancy. The licensed medical institutions shall destroy the donated eggs once the recipient couple completes a live birth.
4. Restrictions on the implementation of assisted reproduction and the protection of the donated ova and embryos created from the donated ova
4.1 Restriction on recipient women—
Only married women who have been diagnosed as suffering from infertility, pass the aforementioned tests and assessments, and her husband possesses healthy sperm, are allowed to receive the donated eggs and undergo assisted reproduction treatment.
4.2 Specific donor or recipient not allowed—
When performing the assisted reproduction treatment, licensed medical institutions shall not use a specific donor’s eggs as requested by the recipient couple. The licensed medical institutions shall not use donated eggs for a specific recipient couple as requested by the donor. The licensed medical institutions shall merely shall provide information concerning the donor’s ethnicity, skin color, and blood type for the reference of the recipient couple.
4.3 Kinship prevention process required—
When donated eggs are used for assisted reproduction, licensed medical institutions shall follow the “Regulations for Verification on Kinship between the Sperm/Ova Donor and the Recipient” to avoid embryos from being created from certain blood relatives or kinships.
4.4 Return of ova not allowed unless proven impairment—
Donors shall not request the return of any donated eggs, unless such eggs donor is diagnosed or proven as having a functional impairment of reproduction by a physician. The donated eggs may be transferred to another licensed medical care institution for assisted reproduction purpose.
4.5 Duty to report—
In the event of the failure to complete the eggs donation and also in case of returning, destruction, or transfer of the donated eggs or embryos created from the donated eggs, the licensed medical institutions are required to submit the reason(s) incurred to the competent authority, including: (1) the donors are found to be unsuitable for the donation after the health assessment or the donors give up her eggs donation (reasons for failure to complete the donation); (2) the donors request for returning those undestroyed eggs (reasons for returning the donated eggs); (3) one live birth was completed by the donated eggs or the donated eggs were preserved for more than 10 years or the donated eggs were found to be unsuitable for assisted reproduction after the donation (reasons for destructing the donated eggs).
The general regulatory framework in respect of surrogacy in Taiwan
Based on one of the drafts, surrogacy is expected to be legalized with a number of conditions, including (1) a surrogate mother will have to be a Taiwanese citizen who has already given birth; (2) only married women who have been diagnosed as suffering from infertility or diagnosed as being ametrous (absence of uterus) are allowed to enter into the agreement with a surrogate mother; (3) payment will be allowed in the form of reimbursement for treatment, nutrition and transportation, and a woman will only be allowed to serve as a surrogate for 3 times; (4) the surrogate mother will not be able to use her own eggs and will need to gain approval from her spouse if she’s married and the surrogate mother cannot use her spouse’s sperm either; and (5) there shall be an agreement between the recipient couple and the surrogate mother.
3. Requirements on surrogacy agreement
Health officials estimate that there are about 400,000 couples affected by fertility problems in Taiwan. The Ministry of Health and Welfare in Taiwan has been subsidizing fertility treatments since 2015 to help these couples, beginning with mid-to-low income households. However, due to the aforementioned income restrictions, only 7 births have been achieved through the subsidizing program in the past 6 years. Therefore, advocates of assisted reproduction technologies consider the government should adjust the population policies to give more support to families that want to conceive. Also, for the recent amendment drafts of surrogate pregnancy, it’s been a long-awaited revision in the ARA. With many provisions of the legislation struck, advocates are urging the government to pass it to provide more rights to infertile couples and the surrogate mothers.
 
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