III@Main Subjects
1. Individual reproductive treatments using donor sperms, eggs and embryos
@This special committee discussed carefully whether to permit individual reproductive treatments using donor sperms, eggs and embryos based on 6 basic principles agreed upon the@@committee: It also considered the importance of the appropriate implementation of such treatment within the permissible extent, and based on generally accepted ideas and bioethics, while also recognizing how such treatment offers married couples who are unable to conceive an opportunity to have a child.@As a result, we came to the following conclusion.
(1) Conditions imposed on reproductive treatments using donor sperms, eggs and embryos
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| | From the viewpoint of bioethics, reproductive treatment that artificially creates a new life should not be carried out without restriction.@In a case where the conception and birth of a child are possible even without reproductive treatment, the performance of such treatment for the purpose of convenience should not be permitted |
| | Based on this concept, we limited the patients who can receive reproductive treatment using donor sperms, eggs and embryos to those who want to conceive but are unable to do so due to infertility. |
| | Given that reproductive treatment using donor sperms, eggs and embryos uses sperms, eggs or embryos donated by a third person who takes risks without receiving any payment, strict conditions should be imposed which are to be satisfied by those who receive such treatment. |
| | We also limited the patients who can receive reproductive treatment using donor sperms, eggs and embryos to legally married couples. This is on the grounds that if a child is born to a single woman or a couple that are not legally married, problems may could arise which may adversely affect the welfare of the child since such a child will have only one parent from the outset and its legal status will not be secure. |
| | Couples who are unable to conceive due to old age are excluded from those who can receive reproductive treatment using donor sperms, eggs and embryos. This is not only because their inability to conceive is not infertility, but also because there are risks involved in late-childbearing and problems related to child-rearing in later life. |
| | We concluded that those who can use their own sperms and eggs should not be allowed to receive donor sperms and eggs: This was agreed because: strict conditions are to be imposed on the use of sperms, eggs or embryos donated by a third person who takes risks without receiving any payment; reproductive treatment using donor sperms, eggs and embryos should be performed, within the extent necessary, for the purpose of enabling married couples who are unable to conceive due to infertility; the performance of such treatment for convenience should not be permitted and sperms and eggs should be donated only when the recipient is unable to have a child without using them. |
(2) Permissibility of individual reproductive treatments
| | A child born as a result of reproductive treatment using donor sperms, eggs or embryos does not inherit the genetic characteristics of either of the couple who have been the recipients of reproductive treatment, except for the cases of the 'host mother' system.@Within the argument of whether such reproductive treatment should be permitted in Japan where people traditionally attach great significance to blood relationships, the first question is whether it is right to give birth to a child through such reproductive treatment. |
| | In this regard, however, the Civil Code in Japan does not necessarily adhere to the concept that blood is most important, as is seen in the system which presumes the legitimacy of a child and the affiliation system.@Adoption is also recognized as a legitimate parent-child relationship. |
| | In this country, AID has been performed for more than 50-years since the first baby was born as a result of this treatment in 1949 and more than 10,000 children have been born since. To date, no serious problems have been reported related to the fact that a child born as a result of AID does not inherit the genetic characteristics of his/her father. |
| | It has been pointed out that the legal status of a child born as a result of reproductive treatment using donor sperms, eggs or embryos is insecure because the husband of the woman who gave birth to such a child might file a lawsuit denying the legitimacy of a child who did not inherit his genetic characteristics.@This issue can be resolved by creating legal regulations on the establishment of the parenthood of a child born as a result of such reproductive treatment as mentioned in III-2 (2) 1) "Establishment of parenthood". |
| | In our opinion, the concept that the blood relationship is most important is not an absolute, binding principle and it should be left to the judgement of the individual as to whether significance is given to this idea.@Furthermore, it is not possible to say that reproductive treatment using donor sperms, eggs and embryos is not desirable for the welfare of a child because the child will not inherit the generic characteristics of both or either of the parents. |
| | Thus, this committee determined it to be inappropriate for them to judge the validity of individual reproductive treatments in consideration of the fact that child to be born as a result of reproductive treatment using donor sperms, eggs and embryos will not inherit the generic characteristics of both or either of the parents. However, it may provide a couple with the basis for deciding whether to use individual reproductive treatments. |
| | Based on these ideas, this special committee decided to permit reproductive treatments using donor sperms, eggs and embryos which are deemed to cause no problem in the light of the six basic principles agreed by this committee. This is as long as the conditions specified in III-1 (1) 'Conditions imposed on reproductive treatment using donor sperms, eggs and Embryos' and III-1(3) 'Conditions imposed on the donation of sperms, eggs and embryos' are satisfied and based on the assumption that the necessary system referred to in III-2 "Means of Regulation and Improvement of Conditions" will be established. |
| | At the same time, we decided to prohibit surrogate conception on the grounds that it treats a person as a reproductive tool and requires a third person to take great risks: This is not desirable from the viewpoint of the welfare of the child to be born.@With regard to other types of reproductive treatment using donor sperms, eggs and embryos, we concluded that they should be permitted on the following conditions. |
1) AID (Artificial Insemination by Donor)
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| | This committee decided to permit AID because it satisfies the criteria laid out in six basic principles. |
| | Reproductive treatment using donor sperms, eggs and embryos should be performed, as@ necessary, for the purpose of enabling married couples who are unable to conceive due to infertility to have a child. It should not be performed for the purposes of convenience.@For that reason, we limited the patients who can receive AID treatment to couples who are unable to conceive without receiving donor sperms. |
| | The performance of AID involves a risk of HIV infection from the donor sperms.@Therefore, preventive measures such as careful examination should be carried out when donor sperms are collected and used. |
2) In-vitro fertilization by donor sperms
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| | In order to retrieve eggs to be used for in-vitro fertilization by donor sperms, the wife of the patient couple is given an ovulation inducer and eggs are retrieved via her vagina using a needle.@The wife takes physical risks of side effects from the ovulation inducer such as ovarial hyperstimulation syndrome and damage to her ovary or womb caused by egg retrieval.@However, these risks are being taken by the person who desires in-vitro fertilization by donor sperms, and the degree of risk is not beyond the medically permissible level. |
| | All things considered, this committee decided to permit in-vitro fertilization by donor sperms because it is deemed to satisfy the criteria set out in the six basic principles, including the principle of safety. |
| | We limited the performance of in-vitro fertilization to that in "cases where there is medical reason for a woman to undergo in-vitro fertilization because she and her husband are unable to conceive without receiving donor sperms". The committee agreed on this limitation because if there is no medical reason for the woman to undergo in-vitro fertilization, AID is preferable because it is safer in that it brings about internal fertilization. It also agreed that reproductive treatment using donor sperms, eggs and embryos should be performed, where necessary, for the purpose of enabling married couples who are unable to conceive due to infertility to have a child. It should not be performed for the purposes of convenience. |
| | The performance of in-vitro fertilization using donor sperms also involves the risk of HIV infection from the donor sperms.@Therefore, preventive measures such as careful examination should be carried out when donor sperms are collected and used. |
3) In-vitro fertilization by donor eggs
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| | In order to retrieve the eggs to be used for in-vitro fertilization by donor eggs, it is necessary to give an ovulation inducer to the donor of the eggs and to retrieve the eggs from her vagina using a needle.@Consequently, this process requires a third person who donates the eggs to takes the physical risk of the side effects of the ovulation inducer including ovarial hyperstimulation syndrome and damage to her ovary or womb caused by egg retrieval. |
| | Therefore, the nature of in-vitro fertilization by donor eggs is different from that by donor sperms in terms of the risks taken by the donor because in the latter, physical risks are taken only by the person who undergoes in-vitro fertilization. |
| | Considering the basic principle "careful consideration shall be given to safety", reproductive treatment using donor sperms, eggs and embryos should not force the donor of sperms, eggs or embryos to take unreasonable physical risks. |
| | The relationship between the above-mentioned principle and the risks taken by the egg donor caused heated discussion among the members of this committee.@We finally came to the conclusion that the donation of eggs should not be prohibited uniformly and it should be permitted if eggs are donated for no fee. This is what happens in the case of a voluntary egg donation by a third person to a couple who are unable to conceive, and is in line with other basic principles. That is to say, these are donors who fully understand the risks involved in egg donation and who have consented to take such risks. |
| | In this regard, as stated in III-1 (3) 2) "Fees for donating sperms, eggs and embryos", payment of any fees for the donation of eggs is prohibited.@In consideration of these factors, this committee decided to permit in-vitro fertilization by donor eggs because it satisfies the criteria set out in the other basic principles. |
| | Reproductive treatment using donor sperms, eggs and embryos should be performed as necessary in order to enable married couples who are unable to conceive to have a child and should not be performed for the purposes of convenience.@For this reason, we limited the patients who can receive in-vitro fertilization treatment by donor eggs to "couples who are unable to conceive without receiving donor eggs". |
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*We decided to permit eligible couples to receive some of the eggs taken from another couple for the purpose of in-vitro fertilization and that they should incur less than half the medical expenses during the period of the retrieval. These eggs will be used for in-vitro fertilization on the grounds that such cases do not differ from cases where the recipient of the eggs pays the medical and other costs incurred by the person who donated eggs in other ways. | ’ b b b b b £ |
4) Transplantation of donor embryos
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| | The committee limited the transplantation of embryos to that of surplus embryos (embryos which were developed by another couple for the purpose of embryo transplantation for themselves, and which they decided not to use) because the transplantation of new embryos that were developed using donor eggs retrieved by a donor who undertook physical risks should not be permitted.@If the donor embryos are limited to surplus embryos, embryo transplantation will be deemed to create no problem in the light of the six basic principles, including that of safety.@Therefore, we decided to permit the transplantation of surplus embryos. |
| | Reproductive treatment using donor sperms, eggs and embryos should be performed as necessary to enable married couples who are unable to conceive to have a child. It should not be performed for the purposes of convenience.@For that reason, we limited the patients who can undergo transplantation of surplus embryos to "couples who are unable to conceive without receiving donor embryos," in principle. |
| | However, as stated in III-1(3) 2) "Fees for donating sperms, eggs and embryos", the donation of eggs which requires the donor to take physical risks ispermsitted on condition that the donor is prohibited from receiving any fee for the egg donation.@Therefore, it is possible that a couple who are eligible to receive donor eggs are unable to do so under existing circumstances where by the donation of surplus eggs is difficult because the technology of in-vitro fertilization using frozen eggs has yet to be established. |
| | Unlike the donation of eggs that requires the donor to take physical risks, the donation of embryos does not force the donor to take additional physical risks. |
| | Taking these factors into consideration, we decided to permit "couples who are unable to conceive without receiving donor eggs," as an exception, and can undergo transplantation of surplus embryos provided it is difficult for such couples to receive donor eggs. |
| | On the other hand, if a child is born to a couple as the result of reproductive treatment using surplus embryos donated by another couple who have received reproductive treatment, this child will inherit genetic characteristics from both members of the donor couple.@It is quite possible that the donation of surplus embryos will not happen frequently because this concept may not be acceptable. |
| | Considering these factors, we decided to permit "couples who are unable to conceive without receiving donor embryo," as an exception, to undergo transplantation of embryos that were developed using donor sperms and donor eggs provided it is difficult for such couple to receive surplus embryos. |
5) Surrogate conception
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| | There are 2 types of surrogate conception. The 'surrogate mother' system is to inject the husband's sperms into the womb of a woman other than his wife, who will conceive and give birth to a child.@This is performed in cases where the wife's eggs are not available because her ovary and womb have been removed or for other reasons and she is unable to conceive a child.@The 'host mother' system is to implant embryos developed as a result of in-vitro fertilization using the husband's sperms and the wife's eggs in the womb of a woman other than the wife, who will conceive and give birth to a child.@This is performed in cases where the wife is unable to conceive although the sperms and eggs of the couple are available. |
| | Both systems force a third person other than the wife of the couple who want a child, conceives and give birth to a child on behalf of the wife.@In such a process, the body of a third person is used as a tool for pregnancy and childbirth.@Surrogate conception runs counter to the committee's basic principle "the human body shall not be used merely as a mean of reproduction". |
| | Moreover, a third person who conceives and gives birth to a child by surrogacy must take great risk 24 hours a day including the risk to her life that pregnancy involves@and after childbirth for as long as 10 months.@In this sense, surrogate conception should not be permitted according to the basic principle "Careful consideration shall be given to@safety". |
| | In addition, it is possible that a surrogate or host mother, unlike a donor of sperms, eggs or embryos, will feel attachment toward the child she has given birth to just like an ordinary mother because the child has been developing inside her womb for approximately 10 months.@In such instances, as illustrated by actual examples from the United States where some statespermsit surrogate conception, it is possible that there will be competition over the parental rights of the child between the couple who requested the surrogate conception and the surrogate mother.@In this regard, surrogate conception is not advisable according to the principle agreed by this committee that "priority shall be given to the welfare of the children to be born". |
| | Thus, this committee concluded that surrogate conception should be prohibited on the grounds that it treats the human body merely as a reproductive tool, in that it forces a third person to take great risks, and that it is not desirable from the viewpoint of the welfare of the child to be born. |
(3) Conditions imposed on the donation of sperms, eggs and embryos
1) Conditions imposed on the donation of sperms, eggs and embryos
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| | Although the correlation between aging and the incidence of sperms abnormalities is unclear, some studies report that a correlation exists.@Therefore, an age limit should be set for sperms donors.@However, if an unreasonably strict age limit is set, it may lead to a decrease in the number of sperms donors and, at the same time, it might mislead people into thinking that the sperms of men over this age limit have problems.@Taking these factors into consideration, this committee decided to limit the donors of sperms to those who are under 55 years old, setting the same age as in the UK.@Considering the age range in which men are generally engaged in reproductive activity, we believe this age limit to be appropriate. |
| | With regard to the donors of eggs, we cannot deny the possibility that a woman who donates eggs may become infertile due to the side effects of the ovulation inducer given for the purpose of retrieving eggs or as a result of damage to the ovary or womb caused by egg retrieval.@For that reason, we limited donors of eggs to those who have already had children. |
| | However, if a woman donates part of the eggs retrieved for the purpose of in-vitro fertilization for herself, she will not be taking the additional physical risk as described above.@In this case, therefore, we concluded that the egg donor is not necessarily required to have given birth. |
| | If the egg donor is over 35 years old, it is expected that the potential for pregnancy will decline and that for miscarriage caused by problems in the eggs will increase.@Taking these factors into account, we decided to limit donors of eggs to those under 35 years old. |
| | In addition, in view of the physical risks taken by the egg donor, we limited egg retrieval from one woman to 3 times. |
2) Fees for donating sperms, eggs and embryos
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| | As a measure to prevent commercialism in the donation of sperms, eggs and embryos, we decided to prohibit the offer of any money, etc. to the donor of sperms, eggs or embryos as well as the receipt of any such fee by such donor. |
| | However, in some cases, the donor of sperms, eggs or embryos needs to cover transportation or correspondence expenses for their donation. Therefore, we agreed to permit payments equivalent to the actual costs incurred by the donor of sperms, eggs or embryos for their donation and the receipt of such money by the donor. |
| | If a couple undergoes in-vitro fertilization using donor eggs that are part of the eggs removed from another couple for the purpose of in-vitro fertilization and cover less than half of the expenses incurred by the donor couple, including the medical expenses incurred during the period of retrieval of such eggs, such an act is considered to be equal in substance to the recipient's covering expenses such as the medical expenses incurred by the egg donor donated in other ways. |
3) The anonymity of donor sperms, eggs or embryos
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| | If sperms, eggs or embryos donors do not remain anonymous, a situation may arise where by the donor's privacy will not be protected. |
| | If a child born as a result of reproductive treatment using donor sperms, eggs or embryos becomes acquainted with the donor, the family relationship of the child or the donor might be adversely influenced.@Such a situation is undesirable as regards the basic principle of this committee "priority shall be given to the welfare of children to be born". |
| | In addition, if the donor of sperms, eggs or embryos does not remain anonymous, the recipient might be given the opportunity to select the donor of sperms, eggs or embryos. |
| | The harmful effects of not maintaining donor anonymity of sperms, eggs or embryos might lead to a decrease in the number of donors, making it difficult to perform reproductive treatment. |
| | All things considered, this committee concluded that the donor of sperms, eggs or embryos should remain anonymous in order to prevent the occurrence of undesirable situations as described above and to ensure the realization of reproductive treatment using donor sperms, eggs and embryos by preventing a decrease in the number of donors. |
4) Donation of sperms, eggs and embryos by siblings, etc.
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| | Given that the receipt of any payment for the donation of sperms, eggs and embryos is to be prohibited, it is possible that few people will be willing to donate sperms, eggs or embryos except for a sibling, etc. of the recipient, especially in the case of egg donation where the donor must take physical risks. |
| | Also, considering the fact that the Japanese still attach great significance to blood relationships, it is possible that both the recipient and the donor of sperms, eggs or embryos will desire that reproductive treatment be performed using sperms, eggs or embryos donated by a sibling, etc. |
| | However, if the donation of sperms, eggs and embryos by a sibling, etc. of the recipient is permitted, the donor of the sperms, eggs or embryos will not remain anonymous. The donor of the sperms, eggs or embryos, who becomes the genetic parent of the child born as a result of reproductive this treatment will be a close relative of the recipient and child.@In such instances, relations among the parties concerned are likely to become more complicated than where the donor is not a sibling, etc. and various undesirable situations from the viewpoint of the welfare of the child are expected to arise. |
| | Furthermore, if the donation of sperms, eggs and embryos by ta sibling, etc. of the recipient ispermsitted, it is possible that a sibling, etc. will be put under pressure or forced into donating sperms, eggs or embryos. |
| | On the other hand, it would be inappropriate to uniformly prohibit the donation of sperms, eggs and embryos by a sibling, etc. of the recipient due to concerns for the possible problems described above. The sperms, eggs or embryos can be donated after adequate explanations, and consultation on the possibility of problems arising have been given to the donor. Then, the recipient of such sperms, eggs or embryos and the donor are both fully aware of, and have accepted the risks. |
| | Although there was strong opposition to the donation of sperms, eggs and embryos by a sibling, etc. of the recipient, this committee, after considering all these factors, concluded that, as an exception to the principle of donor anonymity, the donation of sperms, eggs and embryos by a sibling, etc. should be permitted if; 1) there is no donor of sperms, eggs or embryos other than a sibling, etc. of the recipient, and 2) such donation is not regarded as being as a result of the recipient's selecting the donor on condition that; 1) the recipient and the donor of these sperms, eggs or embryos must also be given adequate explanations and counseling on the possible problems that may arise in connection with a donation from a sibling, etc., 2) the donation of such sperms, eggs or embryos must not create problems for the welfare of the child to be born and no psychological pressure must be put on the donor, and 3) no payment must be made for such a donation. |
| | Judgement on whether the above conditions are met will be left to the medical institution that performs the reproductive treatment.@The donation of sperms, eggs or embryos by a sibling, etc. ispermsitted as an exceptional case only when the above conditions are satisfied.@Therefore, strict regulations should be established to prevent such medical institution from granting such exceptions too often based on arbitrary judgements. |
| | As a measure to prevent medical institutions from granting such exceptions too often based on arbitrary judgements, we added a provision stipulating that a medical institution which performs reproductive treatment using sperms, eggs or embryos donated by a sibling, etc. of the recipient must report the details of and the reason for such treatment to the public administrative organization referred to later. Such a public administrative organization must examine whether such reproductive treatment will be performed in line with the above requirements prior to its implementation. |
| | When it comes to the question of the extent to which exceptions to the principle of donor anonymity should be granted if when the above requirements are met, the opinions of the members of this committee were divided.@Among these, there were opinions that it should be limited to the siblings of the recipient, that blood relatives should be included, or that, if blood relatives were included, those other than close relatives such as close friends who donate sperms, eggs or embryos without receiving any fees should also be included.@Many hours were spent discussing this issue. |
| | In the end, this committee concluded that, in regard to the donation of sperms, eggs and embryos by a sibling, etc. of the recipient, no limit should be set on the extent to which exceptions to the principle of donor anonymity should be granted. In addition, the appropriacy of such treatment should be determined in a case by case basis by the public administrative organization using the above requirements. |
5) Written consent
(a) Written consent of the couple receiving reproductive treatment using donor sperms, eggs or embryos
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| | As stated in III-1(3) 6) (a)"Adequate explanations to be given to the couple receiving reproductive treatment using donor sperms, eggs or embryos", reproductive treatment artificially creates a new life. Reproductive treatment using donor sperms, eggs and embryos requires the wife of the couple who receive such reproductive treatment to take physical risks including the side effects of the ovulation inducer such as ovarial hyperstimulation syndrome and damage to the ovary or womb caused by egg retrieval. |
| | Given that it is stipulated by law that "a child 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 such woman shall be deemed to be the child of such husband" as stated in III-2 (1) 1) "Establishment of parenthood", the couple's consent to the performance of such reproductive treatment is vital. This is not only for the establishment of legal status of the child born as a result of such reproductive treatment but also for its welfare. |
| | Therefore, reproductive treatment using donor sperms, eggs and embryos should be performed only with the express consent of both the husband and wife who are to receive the treatment. Such consent should be expressed in a clear and recordable form. |
| | Taking these factors into consideration, we propose to stipulate that medical institutions which perform reproductive treatment using donor sperms, eggs and embryos must obtain the written consent of both the husband and wife who are to receive such reproductive treatment to the performance of such reproductive treatment on each occasion when it performs such reproductive treatment. |
| | On the other hand, if the written consent of a woman and her husband who have received reproductive treatment using donor sperms, eggs or embryos has not been maintained properly, in cases other than those in which it is confirmed that the patient is not pregnant, the secure legal status of the child to be born as a result of such reproductive treatment could be placed in jeopardy.@Therefore, as a measure to ensure that written consent is properly maintained, we added a provision stipulating that a medical institution which performs reproductive treatment using donor sperms, eggs or embryos must submit the written consent to the public administrative organization unless it is confirmed that the woman who has received such reproductive treatment is not pregnant. |
(b) Written consent of the donor of sperms, eggs or embryos and the donor's spouse
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| | As stated in III-1 (3) 6) (b)"Adequate explanations to be given to the donor of sperms, eggs or embryos", donation of sperms, eggs or embryos for the purpose of reproductive treatment requires the donor to take physical risks and it might produce unexpected side effects. |
| | In addition, the person who donates sperms, eggs or embryos for the purpose of reproductive treatment is required to disclose a certain amount of personal information and such a disclosure might create unexpected consequences. |
| | Moreover, in the case of the donation of sperms, eggs or embryos by a sibling, etc. of the recipient permitted as an exception to the principle of donor anonymity, relations among the parties concerned are likely to become complicated and a siblings, etc. might feel under pressure. |
| | These potential situations affecting the donor of sperms, eggs, or embryo for the purpose of reproductive treatment will also influence the donor's spouse. |
| | Therefore, the performance and use of reproductive treatment using donor sperms, eggs and embryos should be based on the express consent of the donor and the donor's spouse, and such consent should be expressed in a clear and recordable form. |
| | Taking these factors into consideration, we propose to stipulate that medical institutions which receive donor sperms, eggs or embryos for the purpose of reproductive treatment (hereinafter referred to as "medical institutions receiving sperms, eggs or embryos") must obtain the written consent of the donor and the donor's spouse. |
| | Prior to obtaining the written consent described above, it is necessary to decide who should bear the responsibility for potential damages incurred by the egg donor including the side effects of the ovulation inducer such as ovarial hyperstimulation syndrome, and damage to the ovary or womb caused by egg retrieval. |
6) Adequate explanations
(a) Adequate explanations to be given to the couple receiving reproductive treatment using donor sperms, eggs or embryos
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| | Reproductive treatment is different from other medical treatment in that it results in the artificial creation of a new life.@It should be performed while taking into account various issues such as the impact on the couple who receive reproductive treatment, the welfare of the child to be born as a result of reproductive treatment, and the impact of the birth on family relationships. |
| | In the case of reproductive treatment using donor sperms, eggs and embryos, the child born as a result of such reproductive treatment will not inherit the genetic characteristics of either the husband or wife who has received such reproductive treatment.@Accordingly, it involves various problematic issues such as the legal status of the child born as a result of such treatment and the child's right to know about his/her birth. These are not issues when performing other kinds of reproductive treatment. |
| | In addition, reproductive treatment using donor sperms, eggs and embryos involves the problem of requiring the wife of the couple undergoing such reproductive treatment or the donor of sperms, eggs or embryos to take physical risks. These include the side effects of the ovulation inducing such as ovarial hyperstimulation syndrome and damage to the ovary or womb caused by egg retrieval. |
| | Considering these factors, couples who desire to receive reproductive treatment using donor sperms, eggs or embryos should decide whether to receive such reproductive treatment only after they are made fully aware of the problems described above and have given careful consideration to such problems. |
| | In this respect, it is necessary for the couple who desire to receive reproductive treatment using donor sperms, eggs or embryos to be given adequate explanations of such treatment prior to deciding whether or not to receive it.@Therefore, we propose to stipulate that medical institutions which perform reproductive treatment using donor sperms, eggs or embryos must provide adequate explanation on the treatment to be preformed to the couple before obtaining their consent to receive such reproductive treatment. |
| | The information which should be given to the couple by the medical institution which is to perform the reproductive treatment are: the risks involved in such reproductive treatment; the prospect for success of such reproductive treatment; the cost of such reproductive treatment; the possibility that the child will have a blood type which will not match that of the parents; the legal status of the child; donor anonymity of sperms, eggs or embryos used for reproductive treatment and the fact that the child to be born as a result of such reproductive treatment has the right to know about his/her birth. This includes the right to know that he/she was born as a result of such reproductive treatment by filing a request with the public administrative organization. |
| | In addition, if a medical institution which performs reproductive treatment using donor sperms, eggs and embryos considers, judging from the circumstances of the couple, that other types of reproductive treatment are available to them, the medical institution must provide an explanation of the alternative treatment on offer. |
(b) Adequate explanation to the donor of sperms, eggs or embryos and the donor's spouse
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| | The person who donates sperms, eggs or embryos for the purpose of reproductive treatment is required to take risks involved in such donations.@For example, the egg donor takes the physical risks of the side effects of the ovulation inducer such as ovarial hyperstimulation syndrome and damage to the ovary or womb caused by egg retrieval.@The sperm donor also takes the risks of unexpected consequences of the donation such as the fact that the sperms examination conducted prior to the donation of sperms may reveal that the sperm donor is infected with HIV or other viruses, or the donor is azoospermsia. |
| | In addition, the person who donates sperms, eggs or embryos for the purpose of reproductive treatment is required to disclose a certain amount of personal information to the child born as a result of the treatment.@As stated in III-2 (2) 2) "The right to know about one's birth", such disclosure might lead to unexpected consequences. |
| | In the case of the donation of sperms, eggs or embryos by a sibling, etc. permitted as an exception to the principle of donor anonymity, as stated in III-1 (3) 4) "Donation of sperms, eggs and embryos by siblings, etc.", relations among the parties concerned are likely to become more complicated than in cases where the donor is not a sibling, etc. of the recipient and a siblings, etc. might feel under pressure. |
| | These potential situations affecting the person who donates sperms, eggs, or embryo for the purpose of reproductive treatment will also influence the donor's spouse. |
| | Considering these factors, the donor of sperms, eggs or embryos and the donor's spouse should decide whether to donate sperms, eggs or embryos after they are made fully aware of the problems involved in such donation as described above, and have given careful consideration to such problems. |
| | In this respect, it is necessary for a person who donates sperms, eggs or embryos for the purpose of reproductive treatment and their spouse to be given adequate explanations prior to deciding whether to donate.@Therefore, we propose to stipulate that the medical institution receiving donor sperms, eggs or embryos must provide adequate explanations@to the donor and the donor's spouse before they consent to the donation. |
| | The information which should be given to the donor and their spouse by the medical institution receiving donor sperms, eggs or embryos should include the following issue: the risks involved in the donation of sperms, eggs or embryos and the potential for unexpected consequences; the legal status of the child to be born as a result of reproductive treatment using the donated sperms, eggs or embryos; donor anonymity in reproductive treatment; the fact that the child to be born has the right to know that he/she was born as a result of such reproductive treatment by filing a request with the public administrative organization;@the fact that the donor's personal information will be disclosed to the child to be born as a result of such reproductive treatment and the possible consequences of such disclosure. |
| | In the case of the donation of sperms, eggs or embryos by a sibling, etc. permitted as an exception to the principle of donor anonymity, adequate explanation should be given on the possible problems that may arise in connection with the donation of sperms, eggs or embryos by a sibling, etc. |
7) Opportunity for counseling
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| | Couples desiring reproductive treatment using donor sperms, eggs or embryos or the person who donates sperms, eggs or embryos for the purpose of such reproductive treatment and the donor's spouse need to be able to seek advice on reproductive treatment or making donations and to make the best decision according to their circumstances. Therefore, a medical institution which performs such reproductive treatment or a medical institution receiving donor sperms, eggs or embryos need to provide adequate explanation on such reproductive treatment and donations and grant receiving couples/donor couples an opportunity to receive counseling from a person with specialist knowledge of such reproductive treatment. |
| | It is necessary for those who receive counseling to have access to proper advice from a specialist in a neutral position.@For this reason, it is desirable that such counseling be offered by a person who does not belong to the medical institution which performs such reproductive treatment or the medical institution receiving donor sperms, eggs or embryos. It should also be recognized by a special organization as having specialist knowledge of such reproductive treatments. |
| | Therefore, we propose to stipulate that couples who receive reproductive treatment using donor sperms, eggs or embryos, and persons who donate and their spouse must be given an opportunity to receive counseling from a person with specialist knowledge of the reproductive treatment to be performed. This person should be authorized by a special organization other than a medical institution which is to perform the reproductive treatment or the medical institution receiving the donor sperms, eggs or embryos, prior to the treatment or the donation taking place. |
| | At present, there is no authorization system commonly applied to counselors who have specialist knowledge of reproductive treatment using donor sperms, eggs or embryos.@Even though such counseling is offered at every medical institution, it is given by resident doctors or nurses. |
| | It is desirable that an authorization system be established for counselors who have a specialist knowledge of reproductive treatment using donor sperms, eggs and embryos by a special organization to objectively certify that a person has the required specialist knowledge.@However, the establishment of such a system and the education of prospective applicants is expected to take some time. |
| | Under these circumstances, we consider that until a system to authorize the counselors by a special organization is established, the couple who receive reproductive treatment using donor sperms, eggs or embryos, or the donor and their spouse should be given an opportunity to receive counseling with a person with specialist knowledge of such reproductive treatment. This should be an individual who does not belong to the medical institution which is to perform the treatment or the medical institution receiving the donor sperms, eggs or embryos. |
8) Protection of personal information of the donor of sperms, eggs or embryos
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| | As stated in III-1 (3) 2) "Fees for donating sperms, eggs and embryos", donor sperms, eggs and embryos used for reproductive treatment are donated by a third person who takes risks without receiving any payment.@The privacy of such donors must be adequately protected so that the donation of sperms, eggs or embryos will not affect the donor. |
| | If the privacy of the person who donates sperms, eggs or embryos for the purpose of reproductive treatment were not protected, it would lead to a decrease in the number of donors, making it difficult to perform such reproductive treatment.@For this reason, the privacy of the donor needs to be protected. |
| | We concluded that the person who donates sperms, egg or embryos for the purpose of reproductive treatment should not be required to provide any personal information other than that which is required by the medical institution receiving the donor sperms, eggs or embryos under III-1, (3) 9) "Submission and maintenance of the personal information on the donors of sperms, eggs or embryos" unless there is an appropriate reason to do so, and such as that the donor consents to its provision. |
| | Moreover, in order to adequately protect the privacy of the donor of sperms, eggs or embryos for the purpose of reproductive treatment, the holders of the personal information of such donor, such as the medical institution receiving donor sperms, eggs or embryos and the public administrative organization must maintain such personal information in an appropriate way. |
| | Therefore, we propose to stipulate that the medical institution or the public administrative organization holding personal information on the donor of sperms, eggs or embryos that was submitted in connection with such reproductive treatment must properly maintain this personal information. |
9) Submission and maintenance of personal information on the donors of sperms, eggs or embryos
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| | As stated in III-2 (2) 2)"The right to know about one's birth", a child born as a result of reproductive treatment using sperms, eggs or embryos has the right to know a certain portion of the personal information on the donor from whom the child has inherited genetic characteristics. |
| | For the performance of reproductive treatment using donor sperms, eggs and embryos, a certain amount of personal information on the donor may be required in order to match the blood type of the child to that of the parents or for other reasons. |
| | After considering these factors, we concluded that the medical institution receiving donor sperms, eggs or embryos must receive such sperms, eggs or embryos only after receiving such personal information submitted by the donor. This is vital for the performance of reproductive treatment using donor sperms, eggs or embryos and is also the information that the donor has consented to disclose to the child born as a result of such reproductive treatment. |
| | Except for cases where it is confirmed that the person who has received reproductive treatment using donor sperms, eggs or embryos is not pregnant, if the portion of the donor's personal information held in accordance with the above stipulation which the donor of such sperms, eggs or embryos has consented to disclose to the child to be born as a result of such reproductive treatment has not been properly maintained, it might become impossible to disclose this information in response to a request from the child.@Therefore, we decided to require the medical institution which performs such reproductive treatment to submit such personal information to the public administrative organization mentioned below in order to ensure that such personal information is properly maintained. |
| | In order to ensure that the personal information on the donor of sperms, egg or embryos used for reproductive treatment is given to the child born as a result of such reproductive treatment in response to the request of such child, the personal information on the donor of such sperms, eggs or embryos needs to be maintained until the child dies.@However, it is practically impossible to check when every person born as a result of reproductive treatment dies. |
| | For this reason, we propose to stipulate that the public administrative organization must maintain such personal information submitted in accordance with the above requirement for a certain period necessary for disclosing the personal information on the donor of sperms, egg or embryos used for reproductive treatment to the child born as a result of such reproductive treatment in response to the request of such child instead of requiring such organization to maintain such information until such child is confirmed to be dead. |
| | As to the specific period which is necessary for disclosing the personal information on the donor of sperms, egg or embryos used for reproductive treatment to the child born as a result of the reproductive treatment in response to the request of such child, 80 years from the birth of such child is deemed to be appropriate taking into consideration the average life expectancy of men and women in Japan.@One of our suggestions is that a provision be added which makes it possible to extend this storage period if a child born as a result of reproductive treatment using donor sperms, eggs or embryos requests an extension. |
10) Restrictions on the use of sperms, eggs or embryos donated by one person
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| | As proposed in III-2 (2) 2) "The right to know about one's birth", a child born as the 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 in order to prevent a consanguineous marriage.@As the number of sperms, eggs or embryos donated by one person increases, the possibility of the formation of a couple comprising close relatives becomes higher.@Consequently, the number of cases may increase in which couples find out that their marriage could be a consanguine marriage after either of them made a request for the confirmation mentioned above. |
| | In order to prevent such situations from arising, the number of children to be born as a result of reproductive treatment using the sperms, eggs or embryos donated by the same person must be limited to as small a number as possible.@However, considering that such limit will reduce the number of donor sperms, eggs or embryos used for reproductive treatment, we need to be careful not to impose an excessive restriction on the number of children to be born as a result of this reproductive treatment. |
| | This committee aims to strike a balance between the reduction of the possibility of the formation of a couple comprising of close relatives and the securement of certain number of sperms, eggs and embryos that can be used for reproductive treatment. Therefore, after referring to U.K. regulations, it has concluded that it should be stipulated that if the number of children conceived by persons who undergo reproductive treatment using sperms, eggs or embryos donated by one donor reaches 10, the sperms, eggs or embryos donated by this donor should not be used for reproductive treatment again. |
| | In addition, it is possible that one person may donate sperms, eggs or embryos to more than one medical institution, or that the sperms, eggs or embryos donated by one person are used at more than one medical institution.@In order to limit the cases, information of the donor, such as their name needs to be managed by a centralized system. |
| | To this end, we propose to stipulate that a medical institution which performs reproductive treatment using donor sperms, eggs or embryos must submit information on the details of the reproductive treatment which are necessary for limiting the use of sperms, eggs or embryos donated by the same person, to the public administrative organization. |
11) Restrictions on the number of embryos implanted in the womb
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As stated in the appendix "Multifetal Pregnancy Reduction", we concluded that the number of embryos implanted in the womb at one time in-vitro fertilization, embryo transplantation or implantation of donor embryos should be limited to 2 in principle, and up to 3 embryos may be implanted depending on the condition of the embryos to be implanted or the womb: This is because of concern for the risk of possible damage to the mother's body caused by multifetal pregnancy.