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2@Forms of Regulation and Improvement of Conditions

(1) Forms of regulation

›The following acts shall be regulated by law with penal provisions:
  • Offering and receiving sperms, eggs or embryos for profit-making purposes, or brokering such arrangements.
  • Performing medical treatment for the purpose of surrogate conception, or arranging such treatment.
  • Divulging confidential information concerning reproductive treatment using donor sperms, eggs or embryos acquired through the performance of one's professional duty without good reason
›The conclusion referred to in III-1 "individual reproductive treatments using donor sperms, eggs or embryos" shall not be regulated by law with penal provision except for the above-mentioned matters. Instead, it shall be regulated in any other form that can secure the effectiveness of the guidelines and rules established under the law.

›There are various forms of regulation that can secure the conclusions contained in this committee's report, including regulation: by voluntary guidelines set by specialists, regulation by guidelines established under the law and regulation by a law with penal provisions.@The Constitution states that "the (all people) rights to life, liberty, and the pursuit of happiness shall, to the extent that it does not interfere with the public welfare, be the supreme consideration in legislation and in other governmental affairs" (Article 13 of the Constitution of Japan).@In accordance with this provision, careful consideration must be given before imposing legal regulations.@In particular, the greatest care must be taken when considering imposing regulations with penal provisions under which the personal freedom of the violator will be restricted or the violator's property rights will be infringed, which is the strictest form of regulation.

›Such basic policy on regulations as stated above should be applied to the regulations on reproductive treatment using donor sperms, eggs or embryos, the main subject of the discussions or this committee.@Therefore, when considering the form that regulations on such reproductive treatment should take, we need to balance the people's rights to the pursuit of happiness with public welfare so that excessively strict regulations will not be imposed.

›Furthermore, given that reproductive treatment is a field of advanced medical technology in which rapid technological progress is still being made, it would appear difficult to construct a law to keep pace with such advances in the light of some of our proposals, which are not suited to legal regulation.@In order to deal flexibly with actual circumstances, regulation in a form other than a law, which can secure the effectiveness of such proposals, should be considered.

›On the other hand, as pointed out at the beginning of this report, it has become almost impossible to ensure appropriate implementation of reproductive treatment using donor sperms, eggs or embryos only by regulating with voluntary guidelines compiled by specialists.@Therefore, the establishment of effective regulations on such reproductive treatment is urgently needed.

›After taking all the factors into consideration, this committee concluded that the most appropriate form of regulation on reproductive treatment using donor sperms, eggs or embryos is one that can deal with actual circumstances flexibly while securing their effectiveness to a minimum necessary extent without imposing excessively strict regulations.

›The question of the extent to which legal regulations with penal provisions will be applied, namely the strictest form of regulation, should be discussed further at the legislative level while maintaining a balance with the penal provisions of other laws.@Based on this concept, this committee concluded that it is appropriate to regulate the following acts by law with penal provisions for the following reasons:

›With regard to the proposal made in III-1, "individual reproductive treatments using donor sperms, eggs or embryos", this committee concluded that, in the light of the people's rights to the pursuit of happiness and public welfare, those matters referred to in such proposals, excluding the matters that should be regulated by a law with penal provisions as listed above, should not be regulated by a law with penal provisions. Regulation should take another form that can secure the effectiveness of the guidelines or regulations established under the law. We consider this to be the most appropriate way to deal flexibly with actual circumstances while securing the effectiveness of the regulations.

(2) Improvement of conditions

1) Establishment of parenthood

›The following provisions shall be stipulated in the law:
  • A woman who conceives and gives birth to a baby as a result of reproductive treatment using donor, eggs or embryos shall be deemed to be the mother of the baby.
  • A baby who is conceived and born to a woman as a result of reproductive treatment using donor sperms or embryos performed with the consent of the husband of the woman shall be deemed to be the child of the husband.
  • If a woman has conceived and given birth to a baby as a result of reproductive treatment using donor sperms or embryos, it shall be presumed that the husband of such woman has given consent.
  • The donor of sperms, eggs or embryos shall not be deemed to be the parent of the baby born as a result of reproductive treatment simply because he/she donated the sperms, eggs or embryos.

›In Japan, the following problems exist concerning the establishment of the parenthood of a child born as a result of reproductive treatment using sperms, eggs or embryos.

›Article 772 Section 1 of the Civil Code stipulates that "a child conceived by a married woman shall be presumed to be the child of the husband of such woman."@It is also stipulated in Articles 774, 775 and 777 of the same code that a husband may deny the legitimacy of a child only via a lawsuit and that such lawsuit must be filed within 1 year of the husband becoming aware of the birth of the child.

›According to these stipulations, the husband of a woman who conceives and gives birth to a child as a result of reproductive treatment using donor sperms or embryos cannot file a lawsuit denying the legitimacy of a child who did not inherit his genetic characteristics if one year has elapsed since he became aware of the birth of such child. Consequently, the father-child relationship will be legally established unless any special circumstances exist such as where it is clear that the couple was virtually divorced and they were not living in a married state when the wife was presumed to have conceived the child.

›On the other hand, it is possible that the husband of a woman who conceives and gives birth to a child as a result of reproductive treatment using donor sperms or embryos may file a lawsuit denying the legitimacy of the child within 1 year of the husband becoming aware of the birth of such child on the grounds that the child did not inherit his genetic characteristics.@In this case, even if the wife has obtained the husband's consent to conceive and give birth to a child through reproductive treatment, it is possible that the legitimacy of the child will be denied and the child be deemed to have no legal parent-child relationship with the husband unless the husband acknowledges the legitimacy of such child under Article 776 of the Civil Code.

›Regarding the relationship between the mother and illegitimate child, the Supreme Court decided on April 27, 1962 that "in principle, the mother-child relationship is naturally established by the fact of childbirth without requiring acknowledgement by the mother".@However, this decision was not made for cases where the child does not inherit genetic characteristics from the person who conceives and gives birth to him/her.@In Japan, there is no statute that expressly defines the legal relationship between a child born as a result of reproductive treatment using donor eggs or embryos and the person who conceives and gives birth to the child.@Therefore, under existing legislation, the person who conceives and gives birth to a child as a result of reproductive treatment using donor eggs or embryos is not necessarily regarded as being the child's mother if the child did not inherit her genetic characteristics of such person.

›The Civil Code in Article 779 also stipulates that "an illegitimate child may be affiliated to its father or mother".@According to this provision, it is possible for the person who donated sperms, eggs or embryos for the purpose of reproductive treatment to acknowledge a child born as a result of reproductive treatment, who has inherited the donor's genetic characteristics if the child has not been legitimated.@In such cases, given that there is no statute in this country that expressly defines the legal relationship between the person who donated the sperms, eggs or embryos and the child born as a result of reproductive treatment using same, it is possible for such child to become affiliated to the person who donated the sperms, eggs or embryos.

›Under existing conditions in this country, there is a lack of a legal basis for the establishment of the parenthood of a child born as a result of reproductive treatment using donor sperms, eggs or embryos. Therefore, a married couple who have received reproductive treatment using donor sperms, eggs or embryos by mutual consent are not always considered to be the parents of the child born as a result of such reproductive treatment.@On the contrary, it is possible that the person who donated the sperms, eggs or embryos for the purpose of such reproductive treatment could be considered to be the parent of the child born as a result of such reproductive treatment regardless of his/her volition.

›Under these circumstances, the legal status of a child born as a result of reproductive treatment using donor sperms, eggs or embryos is unstable.@It is inappropriate from the viewpoint of the welfare of the child to promote such reproductive treatment without addressing this issue.

›This committee concluded that in-vitro fertilization using donor sperms, in-vitro fertilization using donor eggs and the transplantation of donor embryos, which are not permitted under the rules of the Japan Society of Obstetrics and Gynecology, should be permitted.@As already stated, as a prerequisite for permitting these practices, statutory regulations concerning the establishment of the parenthood of the child to be born as a result of reproductive treatment using donor sperms, eggs or embryos must be established in order to secure the welfare of the child.

›Reproductive treatment using donor sperms, eggs or embryos will be performed at the request of a couple who desire a child but are unable to conceive due to infertility.@Naturally, a couple who receives such reproductive treatment wish to become the parents of the child to be born, and the person who donates the sperms, eggs or embryos does not have the intention to become the parent of the child.@Therefore, it is not appropriate to consider the person who donates the sperms, eggs or embryos to be the parent of the child simply because that child has inherited the genetic characteristics of the donor. The welfare of such child and the intention of the donor have to be taken into account.

›Although the wife of a couple who receives reproductive treatment using donor eggs or embryos will not be genetically related to the child born as a result of such reproductive treatment, it is expected that motherly love for such child will be cultivated during the 10 months period in which she nurtures such child in her womb and motherhood will therefore be established.@This process of establishing motherhood is considered to be crucial for the welfare of the child.

›Taking all factors into consideration, this committee concluded that it should be stipulated in law that: the person who conceives and gives birth to a child as a result of reproductive treatment using donor eggs or embryos shall be considered to be the mother of such child; that the person who consents to his wife's conceiving and giving birth to a child through such reproductive treatment shall be considered to be the father of such child, and that the person who donates sperms, eggs or embryos for the purpose of reproductive treatment shall not be considered to be the parent of the child born simply because they made the donation.

›Although it should be stipulated that reproductive treatment using donor sperms, eggs or embryos must be performed after the wife has obtained written consent from the husband, some measures should be taken to secure the legal status of a child born as a result of such reproductive treatment if such was performed without the above process having been@ followed. This is important in view of the welfare of the child.

›Based on this concept, we propose to stipulate that if a woman conceives and gives birth to a child as a result of reproductive treatment using donor sperms eggs or embryos, it is presumed that the husband of such woman has given his consent.

2) The right to know about one's birth

›A child born as a result of reproductive treatment using donor sperms, eggs or embryos may, after reaching adulthood, obtain the portion of personal information on the donor by which such donor will not be identified to the extent that the donor has consented to the disclosure to such child.
›The donor of the sperms, eggs or embryos may change the scope of his/her personal information that he/she consented to disclose provided that such information has yet to be disclosed.
›Notwithstanding the foregoing, a child born as a result of reproductive treatment using donor sperms, eggs or embryo may request confirmation that the person whom he/she desires to marry is not a close relative of his/hers.

›It is important for a child born as a result of reproductive treatment using donor sperms, eggs or embryos to know that he/she was born as a result of such reproductive treatment and to obtain personal information on the donor of the sperms, eggs or embryos used for such reproductive treatment in the process of establishing his/her identity.@Therefore, it is necessary to comply with such requests as far as possible.

›However, if it is made possible for a child born as a result of such reproductive treatment@to obtain personal information on the donor of the sperms, eggs or embryos which the donor does not want disclosed, the privacy of such donor will not be protected.

›Furthermore, if a child born as a result of reproductive treatment using donor sperms, eggs or embryos is allowed to obtain personal information on the donor to such an extent that the donor can be identified, it might bring about undesirable consequences, including cases where the relationships among the family of the child or the donor are affected, as pointed out in III-1 (3) 3) "Anonymity of the donor of sperms, eggs or embryos".

›Even if the personal information on the donor of sperms, eggs or embryos is disclosed to the extent that both the child born as a result of reproductive treatment and the donor have consented to such disclosure, it is difficult to predict the impact that such disclosure may have on the child and the donor.@We must remember that such disclosure has the potential to cause serious consequences that could be irreparable.

›If a child born as a result of reproductive treatment is allowed to obtain the personal information on the donor of the sperms, eggs or embryos to such an extent that the donor can be identified, it is possible that the child and the donor will meet and introduce themselves to each other.@In this case, if either the child or the donor does not want further involvement, it will be practically impossible to reject it after this first meeting.@Such a situation might have a serious impact on the life of the child or the donor.

›The risk of such undesirable consequences being brought about by allowing a child born as a result of reproductive treatment using donor sperms, eggs or embryos to obtain a wide range of personal information on the donor might result in a decrease in the number of donors of sperms, eggs or embryos, making it difficult to perform reproductive treatment.

›After considering these factors, this committee concluded that a child born as a result of reproductive treatment using donor sperms, eggs or embryo should be allowed, after reaching adulthood, to demand confirmation that he/she was born as a result of reproductive treatment, and obtain the portion of personal information on the donor. This information will not disclose the identity of the donor to the child unless consent is given.

›In addition, considering that a person who donates sperms, eggs or embryo may want to change the scope of the personal information that he/she has consented to disclose to the child born as result of reproductive treatment, we propose to stipulate that the donor may change the scope of the personal information that he/she has consented to disclose if such information is yet to be disclosed to the child.

›It is important to establish at what age a person should be allowed to confirm that he/she was born as a result of reproductive treatment using donor sperms, eggs or embryos and at which such a child born as a result of such reproductive treatment should be allowed to obtain the personal information on the person who donated the sperms, eggs or embryos used for such reproductive treatment. This committee concluded that it should be 20 when the child comes of age. At 20, they should be old enough to have the ability to judge the possible impact of knowing that they were born as a result of such reproductive treatment or by knowing such personal information.@However, we agreed that if a child born as a result of reproductive treatment using donor sperms, eggs or embryos requests confirmation that the person whom he/she wishes to marry is not a close relative in order to avoid a consanguineous marriage, the above requirement of age should not be applied.

›As stated above, it is difficult to predict how the disclosure of the personal information on the donor of sperms, eggs or embryos will affect the child born as a result of reproductive treatment and the donor. Such a disclosure has the potential to cause serious consequences that are irreparable after the disclosure.@Therefore, when a person who is going to donate decides the scope of the personal information that they are willing to disclose, or when the child born as a result of reproductive treatment decides that they want personal information disclosed to them, adequate explanation and counseling must be provided.

3) Establishment of a framework for the implementation of reproductive treatment using donor sperms, eggs or embryos

›A public council shall be established to discuss ethical, legal and technical aspects of the issues related to the use of individual reproductive treatments, and to make necessary proposals.
›A public administrative organization shall be established to administer the practice of reproductive treatment using donor sperms, eggs and embryos.

›Discussion concerning reproductive treatment often requires that consideration is given not only to the medical aspect, but also to the ethical and legal aspects.@Therefore, we propose that a public council consisting of specialists in these fields be established to discuss the ethical, legal and technical aspects of the issues related to the implementation of individual reproductive treatments and to make necessary proposals.@These issues include: the establishment of guidelines for the implementation of reproductive treatment using donor sperms, eggs or embryos, the establishment of standards for the designation of medical institutions that can perform such reproductive treatment, and judgement on whether or not newly developed technology for reproduction should be made available for practical use.

›In order to ensure the appropriate implementation of reproductive treatment using donor sperms, eggs or embryos based on the conclusions stated in this report, it is necessary to establish an organization to control and administer the implementation of such reproductive treatment.@The functions required of such organization are: to archive the written consents of couples who have received reproductive treatment submitted by the medical institutions that performed such reproductive treatment and the personal information on the donors of the sperms, eggs or embryos used for such treatment; to collect reports on such reproductive treatment including the records of implementation by each medical institution concerned; to examine such reports; and to compile statistics based on such reports.@We propose that such public administrative organization be established.

4) Designation of medical institutions that can perform reproductive treatment using donor sperms, eggs or embryos

›Reproductive treatment using donor sperms, eggs and embryos shall not be practiced by any medical institutions other than those designated by the national government using standards that are based on the opinions of a public council.

›Reproductive treatment requires the wife of the couple who receive such reproductive treatment and the person who donates eggs for the purpose of such reproductive treatment to take physical risks of side effects from the ovulation inducer, including ovarial hyperstimulation syndrome and damage to the ovary or womb by egg retrieval.@Prior to reproductive treatment, the couple who are going to receive reproductive treatment and person who is going to donate sperms, eggs or embryos must be provided with an opportunity to receive appropriate counseling.@For this reason, the medical institution that performs reproductive treatment must have staff, facilities and equipment that reach the required level for the appropriate implementation of such reproductive treatment.

›Reproductive treatment using donor sperms, eggs or embryos, should only be performed within the scope of the 6 basic principles agreed upon by this committee, including that "priority shall be given to the welfare of children to be born".@Furthermore, it should be performed ,necessary for the purpose of enabling married couples who are unable to conceive due to infertility to have a child. The implementation of such treatment for the purposes of convenience should not be permitted.@After considering these factors, as stated in III-1 "Individual reproductive treatments using donor sperms, eggs or embryos", this committee concluded that AID, in-vitro fertilization using donor sperms, in-vitro fertilization using donor eggs and transplantation of donor embryos should be permitted provided that strict conditions are imposed on the persons who receive such reproductive treatment and the persons who donate the sperms, eggs or embryos.

›The judgement as to whether a person who is going to receive reproductive treatment or a person who is going to donate sperms, eggs or embryos satisfies such conditions will be left to the discretion of the individual medical institutions that perform the reproductive treatment.@Therefore, such reproductive treatment must be performed by medical institutions that have the ability to make such judgement fairly and appropriately.

›Therefore, in order to ensure the appropriate implementation of reproductive treatment using donor sperms, eggs or embryos, we propose to stipulate that such reproductive treatment shall not be performed by any medical institution other than those designated by the national government according to the standards for such designation set by the government based on the opinions of the public council.

›In addition, in order to ensure the appropriate implementation of reproductive treatment using donor sperms, eggs or embryos, thorough examination including on-the-spot-inspections must be carried out prior to the designation of the medical institutions that can perform such reproductive treatment.@After the designation, periodical inspections should be carried out to examine whether reproductive treatment is being appropriately performed at each of the designated medical institution.


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