Third-Party Reproduction in Japan: A Guide for Asian Intended Parents

Summary: Third-Party Reproduction in Japan

Japan has among the highest utilization rates of IVF and other assisted reproductive technologies (ART) in the world; about 8.6% (1 in every 11.6) of babies born in 2021 were conceived through IVF (1, 2). In 2021, there were 625 ART facilities reporting in the Japan Society of Obstetrics and Gynecology (JSOG) registry(1). In April 2022, ART treatments were brought under Japan's public health insurance, with patients paying approximately 30% of costs out of pocket; the prior subsidy program was rolled into insurance coverage (3, 4). For patients undergoing IVF, preimplantation genetic screening is restricted, and sex selection is prohibited unless medically indicated (6, 7).

Despite this, Japan lacks comprehensive statutory regulation of third-party reproduction and has been slow to clarify many aspects of the law. While egg donation is legal in Japan, it is extremely rare in practice (8). The legal landscape is not conducive to third-party reproduction, and many Japanese intended parents seek care abroad. Those who stay in Japan may operate in a gray area of the law; legal advice is strongly recommended for any intended parents considering this.

In the absence of clear government laws and regulations, professional societies have issued their own non-legally binding guidelines for members. In general, commercial gamete donation is not permitted. Noncommercial, anonymous donation is allowed in principle, as are known donors (e.g., friends or family of the intended parents). Surrogacy is understood to be prohibited under JSOG and Science Council of Japan guidance, although no statute explicitly bans it (9, 10).

Is Egg Donation Legal in Japan?

Japan passed the Act on Assisted Reproductive Technology Offering and the Special Provisions of the Civil Code Related to the Parent-Child Relationship of a Child Born as a Result of the Treatment (Act No. 76 of December 11, 2020) (11). The law stipulates that a woman who delivered a child conceived via egg donation is the mother, and a husband who consented to sperm donation is the father. Beyond this, the Act left many issues unresolved, such as regulation of ART, regulation of donated gametes, and disclosure of information to children born through donated gametes. The Act recommended that these issues be resolved within two years, but to date, they have not been clarified (4, 12).

The practice of egg donation is regulated by professional society guidelines rather than national statute, and there are specific conditions under which it can occur. Donors do not receive payment, though they may be reimbursed for actual expenses, and any children born as a result of egg donation must be informed of their origin before entering elementary school. At the age of 15, under the JISART guidelines, they have the option to learn the identity of the donor (8, 13).

In the absence of clear government laws and regulations, professional societies started issuing their own guidelines for their members in the early 2000s. The guidelines are not legally binding, but in practice, nearly all IVF clinics in Japan are members of these societies and thus follow the guidelines. This included the Japan Society of Obstetrics and Gynecology's guidelines in 2004, and the Japan Society of Reproductive Medicine's guidelines in 2009. These guidelines are generally based on a 2003 report by the Ministry of Health, Labour and Welfare, described below (14). All have concluded commercial egg donation should be prohibited, and only 'altruistic' donation should be permitted. They also recommend that surrogacy should be legally banned.

Around the same time, the Japanese Institution for Standardizing Assisted Reproductive Technology (JISART) was organized by the private sector in 2003 and formulated its own guideline. Following this, JISART's member clinics established voluntary egg donation programs among known donors, typically relatives or close friends of recipients (so-called 'known' donors). A separate non-profit, the Oocyte Donation Network (OD-NET), was established in 2013 to recruit anonymous volunteer egg donors; the first child born from an anonymous donor egg in Japan via OD-NET was reported by Kyono ART Clinic in 2017 (8, 13).

The Ministry of Health, Labour and Welfare's Science Council Subcommittee on Assisted Reproductive Medicine issued a 'Report on the development of assisted reproductive health care system by providing sperm, eggs, embryos, etc.' in 2003 (14). The report concludes that egg and sperm donation should be limited to legally married couples diagnosed with infertility, and should not apply to non-married couples or couples who cannot achieve pregnancy due to 'aging.' The report suggests an age cut-off of 50 years for recipients of donor gametes (14). Embryo donation does not appear to be allowed unless exceptional review and permission is granted. The review must be carried out by the ethics committee of the medical facility and the review board of the public management and administration organization.

Pursuant to Article 772, para.1 of the Civil Code (Presumption of Child in Wedlock) "a child conceived by a wife during marriage shall be presumed to be a child of her husband." If a woman who uses assisted reproductive technology using donated eggs gives birth to a child, the woman giving birth is the child's mother (Article 9 of Act No. 76 of 2020). A husband cannot rebut the presumption of the child born in wedlock conceived by his wife as a result of assisted reproductive technology using the sperm (including the embryo originating from that sperm) of another with the consent of the husband, notwithstanding the provisions of Article 774 of the Civil Code (Article 10 of Act No. 76 of 2020) (11).

Availability of Donor Eggs, Sperm and Embryos in Japan

The availability of donor eggs and sperm is very limited in Japan due to the lack of a clear legal and regulatory framework for donation. The legal framework allows for egg donation, but traditionally, donations have been from relatives or friends. It was only recently that donations from anonymous volunteer donors became permissible under certain ethical guidelines; the first child born from an anonymous donor egg in Japan was reported in 2017 (13). At the time of writing, there are no operating commercial frozen egg banks in Japan.

A few clinics in Japan have established their own ethical standards and offer egg donation to a very limited number of couples. However, the conditions to meet these standards are rigorous, such as several years of ethical review (for the couple) before the actual treatment. Under the JISART guidelines, eggs may be retrieved up to three times from the same donor. The maximum number of children born by a recipient who has received assisted reproductive technology using sperm, eggs, or embryos donated by the same person is 10.

Egg sharing is also allowed in principle, though uncommon in practice. In egg sharing, the recipient and the donor must enter into a contract in a manner that guarantees anonymity regarding various conditions such as the recipient's monetary contribution and the number of eggs to be donated. If this is chosen, then the person donating the eggs does not need to already have a child.

The rarity of egg donation in Japan is due to various cultural and legal factors, including the absence of comprehensive legislation and societal attitudes towards third-party reproductive assistance. As a result, many Japanese intended parents have sought egg donation abroad, historically in the United States, and more recently in Taiwan after Thailand banned commercial surrogacy and egg donation for foreigners in 2015 (8, 15). Note, however, that for Japanese IPs seeking treatment with donor eggs from a known, Japanese donor, Thailand still offers a pathway.

Sperm donation is legal in Japan, but it operates within a highly regulated and somewhat restrictive framework. The primary legal method for sperm donation is through anonymous donors at medical institutions registered with the Japan Society of Obstetrics and Gynecology. These donations are used for artificial insemination (intrauterine insemination, or IUI) by donor (AID). AID requires medical and ethical review by a committee at the medical institution. IVF with donor sperm is uncommon, as it is not recommended by the Japan Society of Obstetrics and Gynecology in its guidelines.

However, the practice of sperm donation is not very common, with only a small number of clinics performing AID in recent years. This is partly attributable to cultural attitudes and legal complexities surrounding donor anonymity and parental rights; in 2018, Keio University Hospital stopped accepting new patients due to a shortage of donors after global trends toward non-anonymity raised concerns about potential disclosure of donor identities (8). There has been an increase in demand, with some Japanese women opting to use overseas sperm banks through clinics that arrange importation (16). Japan's first domestic, private sperm bank opened in 2021 in an effort to formalize the donor process and reduce informal online sperm sales (17).

The Ministry of Health, Labour and Welfare 2003 report suggests that:

•       Sperm donors should be adults under the age of 55.

•       Egg donors must be adults who already have children and must be under the age of 35.

In principle, it is possible to request ABO blood type matching between the sperm, egg, or embryo donors and donor recipients. Other attributes, such as physical appearance, are not allowed to be requested.

Pre-implantation genetic testing for aneuploidy (PGT-A), is tightly restricted in Japan and is not covered by health insurance. The Japan Society of Obstetrics and Gynecology has regulated the use of PGT-A, limiting it primarily to research-pilot settings and to clinical use for couples with recurrent implantation failure or recurrent pregnancy loss following ethics-committee review on a case-by-case basis (6, 7), primarily due to ethical concerns and the potential for misuse. Embryo selection on the basis of non-medical traits, including sex selection, is not permitted (7).

Egg Donor Compensation in Japan

The Japan Society of Obstetrics and Gynecology strictly prohibits exchanging rewards or money to secure egg or sperm donors; in other words, commercial gamete donation is not permitted. However, intended parents bear the cost of the retrieval and may bear other associated costs, such as transportation expenses, communication expenses, and lost income due to a leave of absence from work, under the Ministry of Health, Labour and Welfare 2003 report recommendations (14). It is recommended that the medical facility acts as the middleman to estimate the costs and transfer funds between intended parents and donors, which also helps to ensure anonymity in the case of anonymous donation.

Anonymous, Open, and Known Donation in Japan

Originally, professional societies recommended that only anonymous donations be allowed in Japan. Yet, in practice, some clinics report that the majority of donors are 'known', meaning that they are friends or family of the intended parents. JISART's egg donation pathway has historically depended almost entirely on known donors, with only 18 cycles reported between 2008 and 2011 (15). Non-commercial, anonymous donation in principle is allowed, but rare.

The Ministry of Health, Labour and Welfare has called for a legal system to allow children aged 15 or older to request disclosure of who donated eggs or sperm. However, this has not yet been resolved. Medical facilities must submit the personal information of children born through sperm, egg, and embryo donation to a public management organization, which will retain it for 80 years. Donor-conceived individuals can ask public officials before marriage whether intermarriage (marriage to a relative) would result, when the individual is 18 years old for males and 16 years old for females.

Import and Export of Embryos to and from Japan

Japan has no single statute governing the import and export of human gametes (eggs and sperm) or embryos. Movement of reproductive cells across Japan's border is instead shaped by a patchwork of customs rules, professional-society guidelines, individual clinic policies, and the destination or source country's own rules. For intended parents, the picture differs depending on (a) the direction of movement, (b) whether the material is sperm, eggs, or embryos, and (c) whether the gametes are from the intended parents themselves or from a third-party donor. The summary below describes the rules as written; seek qualified legal and medical advice before relying on any cross-border plan.

Import of donor eggs and of embryos created with donor eggs

Importing fresh or frozen donor eggs into Japan is, in practice, not available to intended parents. There are no operating commercial frozen egg banks in Japan, and Japanese clinics that perform egg donation generally use eggs retrieved domestically from known donors (through the JISART program) or anonymous volunteer donors (through OD-NET) (8, 13). Importing embryos that were created abroad using a third-party egg donor — for example, embryos created in the United States or Taiwan using a donor egg and the intended father's sperm — is similarly difficult, and most Japanese clinics will not transfer such embryos. Japanese intended parents who pursue donor-egg IVF abroad typically undergo embryo transfer in the country where the eggs were donated and return home pregnant or with a newborn (8, 15).

Import of donor sperm

Importation of donor sperm is more established than importation of donor eggs or donor-egg embryos. Several international sperm banks operate distributors or shipping partners in Japan to send donor sperm to licensed Japanese clinics for use in artificial insemination by donor (AID) or IVF (16). Because the supply of domestic Japanese sperm donors has fallen sharply in recent years, the use of imported donor sperm has grown, though it remains expensive and is generally only offered through a small number of clinics. Single women and same-sex couples, who cannot access AID at JSOG-registered clinics, have in some cases obtained sperm directly from overseas banks for self-administered insemination, although this practice carries medical, legal, and identity-disclosure risks (8).

Export of the intended parents' own gametes and embryos

Exporting the intended parents' own frozen gametes or embryos from Japan to a clinic abroad has become an increasingly common pathway for Japanese intended parents pursuing surrogacy overseas (because surrogacy is not available in Japan) or seeking treatments not offered domestically. Specialized cryoshipping services now coordinate transport of frozen embryos and gametes from Japan to receiving clinics, including preparation of consent forms, medical documentation, and customs paperwork (18). Where the embryos will be transferred to a gestational carrier in the United States, the U.S. Food and Drug Administration requires a Donor Eligibility Determination under 21 CFR Part 1271 for the gamete providers; some screening tests must be performed at the time of gamete collection and cannot be done retroactively (19).

Export of embryos created in Japan using a third-party donor

Where the embryos to be exported were themselves created using a third-party gamete donor, the destination-country donor-eligibility rules become more demanding, and additional consents may be required from the donor or donor agency. Practically, intended parents who anticipate needing to ship embryos abroad are usually better served by undertaking the entire treatment cycle in the destination country (or in a third country with established cross-border logistics), rather than creating donor-gamete embryos in Japan.

TAKE AWAYS:

Because the legal and regulatory landscape is unsettled and clinics differ significantly in what they will accept, intended parents considering any cross-border movement of gametes or embryos involving Japan should:

•       Confirm in writing, before retrieval or shipping, that both the sending and receiving clinic will accept the planned movement;

•       Use a specialized cryoshipping provider experienced in Japan;

•       Verify destination-country donor-eligibility testing requirements (e.g., U.S. FDA testing) before retrieval, since some tests must be performed at the time of egg or sperm collection;

•       Obtain Japanese legal advice on the parent-child status of any child born from these embryos, particularly where surrogacy or third-party gamete donation is involved (12).

Surrogacy in Japan

According to the Report on the development of assisted reproductive health care system by providing sperm, eggs, embryos (2003) by the Health and Welfare Science Council Subcommittee on Assisted Reproductive Medicine, surrogacy is recommended to be prohibited (14). In April 2008, the Science Council of Japan proposed a ban on surrogacy and said that doctors, agents and their clients should be punished for commercial surrogacy arrangements (10). Other than that, it remains unregulated by statute, though JSOG members are barred from performing surrogacy under the society's 2003 ethical guidance (9).

Legally, issues related to parenthood in the case of surrogacy outside of Japan are unresolved. In a case concerning cross-border surrogacy and the status of a child born as a result, the Supreme Court of Japan in its March 23, 2007 ruling involving television personality Aki Mukai (the Mukai-Takada case) held that a woman who had delivered a child (the surrogate) was the legal mother of the child (20, 21). The 2008 "Baby Manji" case, involving a Japanese couple's surrogacy in India, reinforced the same position. Japanese intended parents who pursue surrogacy abroad therefore typically rely on adoption procedures (e.g., a Japanese family-court adoption order) to establish legal parentage in Japan for a child born to a foreign surrogate (20).

How to Choose an IVF Clinic in Japan

Refer to our section on choosing an IVF clinic for a list of full considerations. In Japan, assisted reproduction using donated sperm, eggs, and embryos can only be performed at medical facilities designated by the Minister of Health, Labor and Welfare or the head of a local government. In designating these facilities, in order to ensure safety and improve technology, they must meet the standards set by the government:

•       Attachment 7 Standards for facilities, equipment, and equipment at implementing medical facilities and providing medical facilities

•       Attachment 8 Providing Medical Facilities and Providing Medical Facilities

•       Staff who meet the standards set by the government based on human resources requirements shall be assigned

Intended parents should ensure that their clinic is designated by the Ministry. In addition, intended parents should seek clinics that have membership in the Japanese Society for Reproductive Medicine, Japan Society of Obstetrics and Gynecology, and Japanese Institution for Standardizing Assisted Reproductive Technology.

Legal Assistance and Counseling for Intended Parents in Japan

Due to the uncertainties around Japanese laws and regulations, intended parents are strongly recommended to find legal assistance prior to pursuing treatment. Clinics are required to have rooms for counseling and provide counseling for intended parents. The Ministry of Health, Labour and Welfare suggests that intended parents are provided with counseling on the medical treatments, the implications of donor conception, support in the case of unsuccessful treatments, and therapeutic counseling on infertility (14).

Costs of IVF in Japan

Since April 2022, IVF, ICSI, and frozen embryo transfer using the intended parents' own gametes have been covered under Japan's public health insurance, with patients paying approximately 30% of costs out of pocket. Out-of-pocket costs for an insured IVF cycle have been reported at roughly ¥300,000 to ¥500,000 (around US$2,000 to US$3,300), substantially lower than the ¥500,000 or more typically paid per cycle before April 2022 (3, 4). Insurance coverage applies to women up to age 42, with limits on the number of covered cycles. ART involving third-party gametes (egg or sperm donation) is not covered by insurance, and intended parents who pursue donor-gamete IVF in Japan should expect to pay all associated medical and donor-related costs out of pocket.