Legal Regulations on the Advanced Science and Technology 04

Section 2: Details and History of Regulations in Several Countries

1. History until Legislation (by Individual Country)

The birth of the first externally conceived baby, i.e. the test-tube baby, in the UK in July 1978 triggered a round of arguments over advanced reproductive medical technology in the US and in European countries.

Regarding reproductive medicine, artificial abortion and contraception were already the focus of arguments starting in the 1960s and in Europe, artificial abortion laws were established in succession in several countries. The argument was a social issue over the woman's freedom to choose whether or not to have a baby, since the abortion technology itself was already existing. On the other hand, the first baby conceived out of the mother's body had an enormous impact on society as did the first performance of heart transplantation surgery in South Africa in 1967, since both were regarded as signaling an advanced medical revolution. These events also raised the issue of whether such advanced medical science technology is acceptable by society.

Regarding reproductive medical technology, each country conducted its own investigations and called for legislation to control reproductive medical technology including in vitro fertilization. Specifically, starting around 1984, several countries established their own councils consisting of well-informed persons from many fields to discuss the issue. On the basis of their reports, the legislative bodies of these countries made a variety of examinations and amended their legal systems to regulate advanced medical technology in 1990 through to 1994. From now on, the authors will present in brief the status of investigations performed in major countries (mainly according to documents provided by Mitsubishi Kasei Institute of Life Sciences) and in the subsequent sections, will introduce outlines of legislation in each of these countries and the basic ideas underlying the legislation.

The authors will discuss legal issues related to application of reproductive medical technology (with special regards to human cloning technology) in Japan in Section 3 onwards. We should therefore, prior to such discussion, briefly describe the status of legal regulations in foreign countries. However, for background the relevant references and documents listed in the Table on the following page are provided. In this Section, the authors will only introduce information necessary to gain a view of the overall picture. Nevertheless, we have found that when laws in foreign countries are introduced, representative reports which indicate and organize the basic ideas behind the establishment of such legal systems in these foreign countries (although not all ideas stated in these reports were employed) or decisions of constitutional courts have so far not been introduced in detail. The authors will thus explain these points.

Table: Investigations of Regulations on Reproductive Medical Technology in Major Foreign Countries

UK
1984: Warnock Report

1986: Consultation Paper

1987: White Paper (indicating the framework of legislation)

1989: Pokinghorn Report (regarding use of aborted embryos for research)

1990: Establishment of Act
Germany
1985: The German Federation Medical Association sets guidelines for in vitro fertilization and embryology.

1985: Benda Report

1988: The Federation-State Working Group Report (surrogacy banning is added to embryo protection)

1990: Establishment of Act
France
1982-: National Advisory Committee on Life Sciences and Medical Ethics

1985-: Open forums, etc. sponsored by the Government are held.

1988: Bureban Report

1991: Lenoir Report

1992: Bill proposed by the Ministry of Justice is submitted.

1993: Mattei Report

1994: 3 Acts are passed by Parliament.

Reference Information: the US

1979: The Ethics Advisory Board (EAB), Department of Health & Human Services, issues a report (in which in vitro fertilization is approved).

(1983:The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavior Research issues a report on genetic engineering.)

1988-1989: The Biomedical Ethics Advisory Committee (BEAC) is established in Congress (but is disorganized and fails to issue a report)

2. Outline of Legislation in Each Country

Outlined below are legal systems in the UK, Germany and France (for comparison, refer to Reference 1).

(1) UK

In the UK, the "Human Fertilization and Embryology Act 1990" established in 1990 provides regulations. (The information described below is derived from data and documents provided by the Life Sciences Department of the Japanese Science and Technology Agency.)

The Act regulates the general handling of embryos and gametes in connection with human fertilization and development of embryos. If the prescribed conditions are met, research using embryos and gametes and practice of reproductive medicine are allowed after obtaining licenses from the administrative authority to do so.

The Act prescribes the activities governed by the Act in connection with embryos and gametes individually.

In connection with embryos, bringing about the creation of a human embryo, or keeping or using an embryo are prohibited (Article 3-(1)). In addition, placing a live embryo other than a human embryo in a woman (and placing any live gametes other than human gametes in a woman) is prohibited (Article 3-(2)).

The Act also prescribes that a license cannot authorize keeping or using an embryo after the appearance of the primitive streak (i.e. an embryo at 14 days after fertilization), transplanting a nucleus to an embryo, or keeping an embryo in an animal body (Article 3-(3)).

Except in pursuance of a license, storing any gametes, using gametes (excluding cases of providing treatment services between the man and the woman concerned), mixing gametes with the live gametes of any animal, and placing any gametes in the woman are prohibited (Article 4).

<Establishment, etc. of the Administrative Authority>

The Act prescribes the foundation of the Human Fertilization and Embryology Authority which is entitled to make a judgment of granting licenses to activities using embryos and gametes. The Act also prescribes penal codes (penalty of imprisonment or fine) to behaviors violating the prescribed rules.

License for treatment, storage and research may be granted (Schedule 2).

In the course of providing treatment services, a license may authorize using and examining gametes (i.e. mixing sperm with the egg of a hamster, or other animal specified in directions, for the purpose of testing the fertility or normality of the sperm, but only where anything which forms is destroyed when the test is completed and, in any event, does not exceed the two cell stage), bringing about the creation of embryos in vitro, keeping embryos, testing embryos, and placing of an embryo in the woman. A license may authorize keeping gametes and embryos.

In addition, for the sole purpose of research, a license may authorize bringing about the creation of embryos as well as keeping and using embryos.

The Surrogacy Arrangements Act 1985 prohibits, among others, surrogacy arrangements for profit-making purpose and advertisement on offering surrogate mothers.

For handling of human cloning, the licensing body has indicated its policy of not granting licenses for bringing about the creation of embryos outside the body for the purpose of creating cloned humans, or keeping or using such embryos.

(2) Germany

In Germany, the "Embryo Protection Act" established in 1990 provides regulations. (The information described below is derived from "Embryo Protection Act: Overseas legislation Vol. 30, No. 3" authored by Junko Saito.)

This Act is a special criminal law, which lists individual prohibitions in connection with various reproductive technologies and prescribes criminal penalty (imprisonment or fine) against violations. This Act prescribes diverse prohibitions against a variety of technologies in connection with embryos and gametes.

This Act as a rule prohibits any artificial changes to be made in the genetic characteristics of human germ cell lines and prohibits the use of such changes for fertilization (Article 5).

This Act as a rule prohibits artificial gender selection through the use of identified sperm cells (Article 3).

This Act prescribes regulations regarding various reproductive technologies such as artificial insemination and prohibits the following: artificial fertilization of an egg cell retrieved from a woman for any purposes other than pregnancy of that woman; artificial introduction of human sperm cells into a human egg cell; and retrieval of an embryo for the purpose of transplanting the embryo into another woman (Article 1). It also prohibits artificial insemination using sperm from a dead man (Article 4).

In addition, the Act prohibits artificial insemination in a surrogate mother or transplantation of an embryo to a surrogate mother (Article 1).

For handling of embryos created outside the body or embryos taken from the woman, the Act prohibits selling such embryos as well as transferring, obtaining, or using such embryos for any purposes other than that required for maintaining such embryos. It also prohibits development of a human embryo outside the body for any purposes other than pregnancy (Article 2).

The Act prohibits artificially bringing about the creation of embryos which possesses the same genetic characteristics as those of other embryos, fetuses or humans, and also prohibits transplanting of such embryos to the women (Article 6).

The Act prohibits inducing cell fusion of multiple embryos (including human embryos) which possess different genetic characteristics, and producing embryos, which are able to undergo mitosis, by fertilization between an animal gamete and a human gamete. It also prohibits transplantation of embryos thus produced to a woman or animal, and transplantation of human embryos to animals (Article 7).

(3) France

In France, three acts collectively called the "Bioethics Act" were established in 1994, which are based on common ethical principles and provide comprehensive regulations over the entire advanced medical technology field (organ transplantation and reproductive technology). (The information described below is derived from "Total Picture of French Bioethics Act: Overseas legislation Vol. 33, No. 2" authored by Miyuki Ohmura.)

The three acts are "Human Body Respect Act," "Transplantation and Reproduction Act," and "Registered Data Act." These acts introduced relevant prescriptions into the Civil Code, the Penal Code, and the Health and Medical Care Code.

The "Human Body Respect Act" incorporated principles providing the foundation to regulate various advanced medical technologies, into the Civil Code, and related criminal regulations into the Penal Code.

The "Transplantation and Reproduction Act" incorporated regulations on technologies related to removal and transplantation of organs, reproductive medicine, pre-delivery diagnosis, gene examination and any other relevant matters, into the Health and Medical Care Code.

The "Registered Data Act" incorporated, within the same ethical principles, special regulations, among others, regarding procedures to be followed when utilizing personal medical information for studies, into the Information Protection Act.

These changes made in the French legal system resulted from substantial amendments such as changes in civil law principles. It is therefore difficult to introduce them in the organized manner used for the UK and Germany. Instead, the main points of the amendments will be examined by individual major code.

A philosophy constituting the basis of regulations was incorporated. The amended Civil Code secures the superiority of the individual, prohibits invasion of the dignity of the individual, and secures respect for the individual from the very beginning of life (Article 16). It prescribes the rights according to which the human body is given respect and the rule of making the human body inviolable (Article 16-1). It prohibits invasion into the integrity of the human species, eugenic behaviors intended to organize selection of human beings, and conversion of genetic characteristics leading to any change in descendants of humans (except for studies aiming at prevention and treatment of hereditary diseases) (Article 16-4).

Furthermore, in connection with issues related to the contract act and the Family Act, the amended Civil Code invalidates all contracts made for the purpose of reproduction and pregnancy for others (Article 16-7). It also prescribes that in the case of medically assisted reproduction in which a third party is involved as a donor, no parent-child relation is to exist between the donor and the baby thus born (Article 311-19). (This issue will be discussed again in Section 5, Item 3-(2).)

The amended Penal Code prescribes penalty of imprisonment and fine against the behaviors listed below.

Implementation of eugenic activities intended to organize selection of human beings (Article 511-1).

Practice of obtaining human embryos by gaining equivalent value to this action, offering embryos thus obtained, and transfer of such embryos for value (Article 511-15). Creation of human embryos outside the body for industrial or commercial purposes and use of such embryos (Article 511-17).

Creation of human embryos outside the body for the purposes of examination, research and experiments, and performance of experiments with human embryos (except for the case of testing an embryo of a man/woman couple for the purpose of reproduction ) (Articles 511-18 and 511-19).

This Code prescribes the rules pertaining to reproductive medicine. It is prescribed that medical assistance to reproduction shall be performed to meet the request made by a man/woman couple to be parents, provided that this man/woman couple are alive, in the range of reproductive age, are married or can show evidence that they have lived together for at least 2 years, and give prior consent to embryo transplantation or artificial insemination (Article L152-2).

It is prescribed that creation of an embryo outside the body is only allowed when such creation is within the range of scope of the objective to be achieved by medical assistance for reproduction and also follows the objective (Article L152-3).

It is also prescribed that a man/woman couple who obtains an embryo is not allowed to know the identity of the man/woman couple who donates the embryo, and vice versa, and is not allowed to pay remuneration to the couple who donates the embryo (Article L152-5).

It also prescribes necessary administrative procedures: collection, treatment, storage and transplantation of gametes shall only be performed by nonprofit public or private health organizations or institutions which have obtained licenses from the administrative authority to do so (Article L673-5).

In response to recent advances in cloning technology, the National Ethics Advisory Committee examined the relevant issues and submitted "Recommendations on Reproductive Cloning" to the President, in which the Committee made a statement that human cloning violates Article 16-4 of the Civil Code and also mentioned the criminal penalty prescribed in Articles 511-1 and 511-18 of the Penal Code.

(4) Status of Responses by International Organizations

In addition to actions taken in individual countries, international activities are undertaken, which will in brief be described below (according to the data and documents provided by the Life Sciences Division of the Japanese Science and Technology Agency).

< Council of Europe >

At the Council of Europe which consists of European countries, a treaty which controls in vitro fertilization and handling of human embryos, i.e. the "Convention on Human Rights and Biomedicine" was signed in April 1997. This Treaty prohibits creation of human embryos for the purpose of research. Thirteen countries of the 40 in Europe signed this Treaty.

In January 1998, the "Additional Protocol to the Convention on Human Rights and Biomedicine" was signed, which prohibits all cloning technology for the purpose of creating genetically identical humans. (Twenty-four countries signed the Protocol.) (Note that the above-stated number of countries which signed the Treaty and the Protocol are as of November 5, 1998.)

In May 1997, the World Health Organization (WHO) adopted the "Resolution Concerning Cloning Technology," according to which no application of cloning technology to human beings is acceptable.

At the Denver Summit held in June 1997, French President Chirac proposed a human cloning ban as an agenda at the Summit and the other attending countries agreed with this proposal. The Summit adopted the "Eight-Country Summit Declaration" which emphasizes the necessity of national activities and international cooperation to prohibit nuclear transplantation of somatic cells for the purpose of creating descendants.

In November 1997, UNESCO adopted the "Universal Declaration on the Human Genome and Human Rights" which is a general declaration regarding handling of the human genome and human rights. This Declaration prescribes that no research or its applications concerning the human genome will prevail over respect of human rights, fundamental freedoms and human dignity of individuals or, where applicable, of groups of people and that practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted.

(References)

Jiro Nudeshima, Yoshitaka Ichinogawa, et al.: "Actions taken in industrialized countries to cope with reproductive technology ? comparison between Europe, the US and Japan" Studies on Life, People and Society (Mitsubishi Kasei Institute of Life Sciences)

Reproductive Technology Study Team, Bioethics Study Group, Mitsubishi Kasei Institute of Life Sciences: "Let's think of pre-birth diagnosis"

Miyuki Ohmura: "Total Picture of the French Bioethics Act" Overseas legislation Vol. 33, No. 2

Jiro Nudeshima: "Structure of Advanced Medical Regulations in France" Horitsu-Jiho Vol. 68, No. 10

Osamu Niikura: "In vitro fertilization between non-spouses and legislation in foreign countries ? with special regard to French legislation" Horitsu-No-Hiroba, April 1998

Ichiro Kitamura: "Summary of French legislation leading to the Bioethics Act" Jurisuto No. 1090

"Background of French legislation leading to the Bioethics Act ? interview with Mrs. Lenoir" Jurisuto No. 1092

French Criminal Law Study Group: "Bioethics and Laws in France" Kokugakuin Hogaku Vol. 34, No.5 and Vol. 35, No.2

Junko Saito: "Embryo Protection Act" Overseas legislation Vol. 30, No. 3

Authored by Deutche and translated by Hidehiro Takashima: "Embryo Protection Act in Germany" Sandai Hogaku Vol. 28, Nos. 3 and 4

Kazuichiro Iwashi: "In vitro fertilization between non-spouses and legislation in foreign countries ? with special regard to German legislation" Horitsu-No-Hiroba, April 1998

Kazuichiro Iwashi: "Background and outline of the German 'Law to Amend the Parent-and-Child Relation Act'" Waseda-Hogaku Vol. 72, No. 4

Taeko Miki: "Judicial precedents regarding artificial insemination in the UK ? as a case study to consider in vitro fertilization between non-spouses" Horitsu-No-Hiroba, April 1998

Authored by Warnock and translated by Koji Uwami: "A Question of Life"

Katsunori Kai: "Reproductive medicine and criminal regulations ? an investigation of the UK 'Warnock Committee Report (1984)'" Hanzai-To-Keibatsu No. 7

Megumi Nakamura: "Artificial reproduction and the parent-child relation ? with special regard to US laws" Jochi-Hogaku-Ronshu Vol. 41, No. 3

Koichi Bai, et al.: "Comparative study of artificial reproduction" Comparative Study No. 53

Edited by Koichi Bai and Minoru Ishikawa: "Family and medicine ? legal discussion"

3. Thoughts Supporting Legislation

(1) UK: Warnock Report

(i) In the UK, the Warnock Report of 1984 was the earliest regarding advanced reproductive medical technology. (At a local government level, the Warler Report was issued in Victoria, Australia.)

The Warnock Report was concerned with the results of investigations and discussions by an advisory committee, consisting of 16 members with Mary Warnock as the chairperson, which was organized at the request of the UK national Government in July 1982. The Committee investigated and discussed future possibilities in medical and scientific developments in connection with human fertilization and embryology, and evaluated the social, ethical and legal significance of results attained by such developments as well as any relevant policies. The Warnock Report was issued in June 1984. (The information described below is derived from "A Question of Life" authored by Mary Warnock and translated by Koji Uwami, with the Japanese version published by Kyodo Shuppan.)

The Committee consisted of a philosopher, a theologian, an administrator, a midwife, 3 medical doctors, 2 psychologists, a medical researcher, a head of an examination division, a social worker, 2 lawyers, a person from a foster parent association, and a foundation director general. Considering the fact that there were diverse opinions in different sections of the society, the Committee tried to collect testimonies from as many organizations as possible and at the end of the Report, attached is a list of 254 organizations or associations from which they obtained testimonies, and the statement that they additionally received 659 letters and documented comments.

The Report addressed the following issues in connection with technologies to treat infertility: (a) common problems; (b) individual technologies, such as (1) artificial insemination, (2) in vitro fertilization, (3) egg donating method, (4) embryo donating method, (5) surrogacy, (6) application of infertility treating technologies (discovery of hereditary diseases, gender identification, and gender selection), and (7) cryopreservation of sperm, eggs and embryos; (c) problems, studies, and future prospects in scientific research; and (d) regulations of contraceptive treatment services and studies. At the end of each chapter, recommendations based on the conclusions were stated.

Each chapter consisted, for individual technologies, of (1) definitions and details, (2) opposing opinions, (3) supporting opinions, and (4) conclusions based on opinions of the Advisory Committee and matters requiring attention. These conclusions vary in nature depending on technologies, from those which are very concise to those which are extremely long. The members of the Advisory Committee reached a consensus regarding almost all issues. When a small number of members had different opinions, they were stated in the section entitled "expression of different views" at the end of the Report.

(ii) The opinions of the Committee on individual technologies are outlined as follows. First of all, the Advisory Committee's opinions on technologies to treat infertility are introduced.

1) Artificial insemination: Artificial insemination by a donor (AID; the sperm for artificial insemination comes from a donor) in accordance with the statutory licensing authority's licensed/approved procedures at a proper medical institution should be permitted.

2) In vitro fertilization: The Committee recommends continuous provision of in vitro fertilization in accordance with similar licensing/approval and examination procedures as those recommended in connection with the rules for AID.

3) Egg donating method (i.e. a method according to which a matured egg is taken from a woman donor, the egg is fertilized in a test tube in the presence of the semen taken from the infertile woman's husband, and the resulting embryo is then implanted into the uterus of the infertile woman): The Committee recommends that this method be accepted as an approved technology to treat infertility in accordance with similar licensing/approval procedures as stated above and under the supervision of the relevant authority.

4) Embryo donating method (note that there are several methods of donating embryos and one example is as follows: when a woman and her husband are infertile, both an egg and a sperm are donated and the resulting embryo is implanted into the uterus of the infertile woman): The Committee recommends that this method be accepted as a technology to treat infertility in accordance with similar licensing/approval procedures as stated above and under the supervision of the relevant authority.

5) Surrogacy: The Committee recommends a call for legislation to prescribe the following actions in the UK as a crime whether they are performed for profit-making or non-profit-making purposes: to recruit women for surrogate mothering; and to establish or organize any institution intended to help individuals or couples who want to use surrogacy services, find surrogate mothers. Since all surrogacy contracts are illegal, the Committee recommends to establish laws which invalidate such contracts in court.

Only for surrogacy, among the above-listed technologies, 2 members expressed different opinions from the recommendations made by the Committee. Their opinion was: no matter what recommendations were made by the Advisory Committee, the demand for surrogacy may remain in changing forms or even increase; it is therefore wrong to totally close all doors to provide surrogacy as a treatment measure for infertile couples and the authorities should have the power to grant licenses to all non-profit-making institutions which help surrogacy contracts.

(iii) Next, the authors will introduce what was reported by the Committee in the chapter regarding problems, studies, and future prospects in scientific research. The Committee's discussions about this matter were complicated and no consensus was achieved. The authors will therefore provide a detailed introduction.

(a) The opinion against research using human embryos was predominantly based on the premise that human embryos are human beings and as such research using human embryos is morally wrong. In addition, the opponents of research using human embryos noted that many people show instinctive resistance against studies which manipulate creation of a human life, and are afraid that there may be the following risk: scientists may try to create hybrids or may tamper with the reproductive process in order to play with theories of artificial selection or eugenic selection.

On the other hand, the opinion in favor of research using human embryos was based on a diverse range of ideas. Some claimed that a human embryo does not have any personal character but is a complex of cells and therefore, there are no reasons why we should protect the identity of these cells. Others commented that when using human embryos for research purposes, greater respect should be given to such human embryos than to experimental animals, although such respect is never absolute and should be weighed with the expected benefit of such research.

(b) The Advisory Committee first acknowledged that embryos existing inside the living body are given some protection under Common Law, and then discussed about embryos outside the body. As a result, the Committee recommended that human embryos be given a certain level of protection. Specifically, the Committee recommended that research using human embryos outside the body as study subjects and handling of such human embryos shall be permitted only when such research or handling is licensed or approved by the statutory licensing authority: in other words, use of human embryos outside the body without obtaining a license or approval shall constitute a crime. (A)

According to the technical conclusions drawn by the Advisory Committee, the Committee recommended that attention be directed to the appearance of the primitive streak (which is noted on the 15^th day of fertilization) and recommended that any human embryo derived from in vitro fertilization, whether it is frozen or not, shall not be allowed to live beyond the 14^th day of fertilization onwards if such an embryo is not to be placed in the woman's uterus for the purpose of reproduction, and that no studies will be permitted using human embryos which are alive beyond the 14^th day of fertilization. The Committee continued to recommend that use of any live human embryo beyond the 14^th day of fertilization derived from in vitro fertilization as a subject of any study or for any other purposes shall constitute a crime. They also recommended that no embryo which has been used for study purposes shall be placed in the woman's uterus under any circumstances.

In the case of embryo handling, the following three types of embryos require particular caution: reserve embryos (extra embryos) obtained as the result of in vitro fertilization; embryos created outside the body for the sole purpose of research; and embryos created by chance in studies, the primary objective of which was not creation of an embryo. The Advisory Committee recommended that the reserve embryos can be used in studies, provided that the method of using or disposing such reserve embryo shall be approved by the donor. For the other types of embryos, there was no consensus of opinion within the Committee, which therefore issued the following recommendation on the basis of the opinion of the majority: a law shall prescribe that keeping or using these types of embryos will only be permitted for a period not later than the end of the 14^th day of fertilization, under the condition that all regulations prescribed by the statutory licensing authority will be observed. (B)

(c) Regarding the conclusions drawn by the Advisory Committee, there existed "expression of different views." For (A), 2 members expressed the differing opinion that experiments using human embryos will not be permitted, whereas handling of human embryos for the sole purpose of implantation will be permitted. For (B), 4 members did not agree with the opinion that studies using human embryos other than the reserve embryos may be permitted.

As described above, all members of the Committee agreed with implementation of all technologies to treat infertility, with the exception of surrogacy, whereas they had different views regarding studies using human embryos. In the chapter "studies and future prospects in scientific research," the Report mentioned, among others, fertilization between different species, development outside the body, cloning, embryonal biopsy, nuclear transplantation, and prevention of hereditary diseases as future possible technologies. The Committee did not make any particular recommendation regarding cloning on the premise that artificial cloning of human embryos is not conducted.

On the basis of the above-described Warnock Report, including recommendations made in chapters not mentioned here, the "Human Fertilization and Embryology Act 1990" was established. For surrogacy, the "Surrogacy Arrangements Act 1985" already prohibits recruiting women for surrogate mothering for commercial purposes but permits recruiting for non-profit-making purposes, which is less stringent than the recommendations made by the Warnock Report. However, the Surrogacy Arrangements Act 1985 expressly stipulates that it is illegal for third parties to negotiate or facilitate any surrogacy for payment, which was controversial.

(2) Germany: Benda Report

In Germany, a report issued by a federal government council, which was entrusted with investigation of present status and future issues to be addressed in connection with in vitro fertilization, gene analysis and utilization of such analysis in treatment (commonly known as the Benda Council), was important in laying the foundation for legislation, prior to establishment of the Embryo Protection Act. (The information described below is derived from "Let's think of pre-birth diagnosis," a report issued by the Reproductive Technology Study Team, Bioethics Study Group, Mitsubishi Kasei Institute of Life Sciences.)

The Benda Council was organized in May 1984 at the co-request of Hans A. Engerhart, Minister of the Federal Ministry of Justice, and Heintz Rezenhuber, Commissioner of the Federal Science and Technology Agency. The chairperson of the Council was Erunsuto Benda, a former commissioner of the Federal Constitutional Court. The Council consisted of a total of 19 members, whose diverse professions included scientists, medical doctors, individuals involved in the Protestant Church or the Roman Catholic Church, philosophers, lawyers, and representatives of management and labor. The Council held 19 meetings and submitted a report entitled "In vitro fertilization, gene analysis and gene therapy" in November 1985.

The Benda Report includes conclusions and recommendations for legislation based on these conclusions, with regard to three issues, namely: (i) in vitro fertilization and family; (ii) regulations for implementation of studies using embryos; and (iii) introduction of genetic engineering. The conclusions and reasons for drawing the conclusion are outlined below.

(i) In vitro fertilization and family

Outlined conclusions: In vitro fertilization between spouses is as a rule not a problem. However, artificial insemination by a donor (AID) or in vitro fertilization using an egg provided by a donor may cause a number of problems and shall only be permitted under certain conditions. No one will be entitled to deprive the resulting baby of a right to know his/her own identity. Donation of an embryo shall only be acceptable when such donation will improve the embryo's change of survival under extenuating circumstances and the couple who are going to receive the embryo has a strong commitment to raising a baby born from the embryo as their own child. The Council objects to a surrogacy system.

As described above, the Council was in favor of in vitro fertilization between spouses but was against in vitro fertilization between non-spouses. The reasons for this conclusion were that in vitro fertilization between non-spouses removes biological maternity/paternity, which may endanger the child's sense of belonging and identity, and therefore is not in the interest of the child.

(ii) Regulations for implementation of studies using embryos

Outlined conclusions: Creation of any human embryo for research purposes shall as a rule be unacceptable. However, experiments using embryos will be accepted only when such experiments will be useful for discovery, prevention and elimination of diseases of the embryo concerned, as well as for obtainment of medical knowledge which is clearly of an advanced level (to which some Council members were opposed). Storage of frozen human embryos may only be allowed in the future in either of the following two cases: (1) when placing an embryo in a woman is transiently impractical and it is expected that the frozen fertilized egg be placed in the woman within 2 years; or (2) when it is reasonable to make an attempt of placing an embryo in a woman during the next menstrual cycle or following ones in order to increase implantation rate. Cloning through the use of any procedure will be unacceptable. Similarly, forming chimeras or hybrids from animals and humans will be unacceptable.

In its introduction section, the Benda Report stressed the judgment made by the federal court that when freedom of research conflicts with any of the other basic rights protected by the Basic Law, the former right will never be superior to the latter, and confirmed that "freedom of research" can be limited by the following: protection of life and body; respect for autonomy of the individual concerned; considerations of the happiness of children; and more importantly, protection of human dignity. Under this basic philosophy, the Council acknowledged that studies using embryos are useful for discovering treatments of cancer, immunological disease, hereditary disease and other relevant conditions, but regarding creation of embryos for research purposes, the Council indicated that it favors prohibition, as a rule, since such research may use human life as a means of achieving its own goals. The Council prohibited storage of frozen human embryos except for the above-described cases (1) and (2) because such freezing and storage may damage an embryo, or may bring into question the legitimate identity of a child derived from such an embryo. In addition, storage was prohibited by the Council for the purpose of preventing production of reserve embryos, which could be used for research purposes. Furthermore, the Council prohibited creation of clones, chimeras and hybrids since such creation is extremely experiment-oriented and therefore a substantial violation of human dignity.

(iii) Introduction of genetic engineering

The Council considered that introduction of genetic engineering is never a problem as far as a series of restricted conditions are met, e.g. obtainment of informed consent from the subject. However, the Council called people's attention to various problems resulting from genetic engineering, and stressed the necessity of considering if screening for hereditary disease may lead to unreasonable discrimination against the subject concerned, if a subject should have the right not to know his/her own hereditary constitution, and other relevant matters.

As described above, the Benda Report outlines restrictions on reproductive medicine and freedom of research based on highly ethical reasons, i.e. the necessity of giving considerations to the happiness of children in (i) and the necessity of protecting human dignity in (ii).

The Benda Report also included two important viewpoints that contrasted with the consensus of the Council. The first was of Council member Walter Dorfuller, a geneticist and professor at the University of Köln. He objected against the idea that freedom of research is to be controlled by a law (criminal law) and protested against the contents of the Report. The other viewpoint was that of Council member Peter Paterzen, a psychiatrist at Hannover Medical College. He expressed favor for the Report itself but had some doubts about surgical in vitro fertilization treatments which fail to consider the mental factors involved in infertility. At the same time, he expressed his own opinion that studies using human embryos should be more strictly controlled.

Regarding in vitro fertilization (i), the Embryo Protection Act prohibits donating eggs, creation of embryos for the purpose of donating such embryos, and surrogacy. In these respects, the Act reflects the stand of the Benda Report. On the other hand, the Act does not expressly set forth prohibition of artificial insemination using sperm from a donor and accordingly, the Act does not completely reflect the Report's opposition to in vitro fertilization between non-spouses. Regarding regulations for implementation of studies using embryos (ii), the Act incorporates the contents of the Report, and prohibits human cloning, and forming chimeras or hybrids between humans and animals. Regarding the issue of handling of embryos for research purposes, the Benda Report did not propose stringent prohibition: the Report stated that creation of embryos for research purposes will as a rule be prohibited, whereas experiments using embryos will be accepted only when such experiments are deemed useful for discovery, prevention and elimination of diseases of the embryo concerned, as well as for obtainment of medical knowledge which is clearly of an advanced level. On the other hand, subsequent discussion leading to legislation moved toward the direction of prohibition and the Act prohibits not only creation of embryos for research purposes but also use of embryos.

(3) France: Bureban Report

In France, three reports were submitted to the national government during the preparatory process of the Bioethics Act which was established in 1994. The process leading to legislation in France is outlined below. (The information described below is derived from: "Actions taken in industrialized countries to cope with reproductive technology" Studies on Life, People and Society, authored by Jiro Nudeshima et al. (Mitsubishi Kasei Institute of Life Sciences); "Structure of Advanced Medical Regulations in France" authored by Jiro Nudeshima, Horitsu-Jiho Vol. 68, No. 10; "Background of French legislation leading to the Bioethics Act ? interview with Mrs. Lenoir" Jurisuto No. 1092; and "Bioethics and Laws in France" Kokugakuin Hogaku Vol. 34, No. 5 and Vol. 35, No. 2.)

Of the three reports, the Bureban Report was first submitted in 1988. In 1986, President Chirac requested the Conseil d'Etat (the Legislation Bureau/Administrative Supreme Justice Council) to draft a law covering various aspects of bioethics for human organ donation, including life and death. In the Conseil d'Etat, a committee was organized. In 1988, the Bureban Report established its basic philosophy, including "rights of a human body," on the basis of which a bill consisting of 89 articles was submitted in 1989. (In this bill, assisted reproduction and pre-birth diagnosis were individually addressed and constituted independent chapters.) This bill caused arguments not only among those involved but also in the general public. There was strong protest by cautious individuals who claimed that this draft was incomplete and that opinions from relevant individuals and the general public were required. Accordingly, the national government judged it impractical to immediately introduce this bill in Parliament.

The second investigation results were submitted as the Lenoir Report in 1991. This report was based on investigation from the viewpoint of comparative law, and consisted of three sections. Section 1 was concerned with, among others, the current circumstances surrounding embryos and the human genome, the current status of artificial reproduction and organ transplantation, issues related to gene examination and pre-birth diagnosis, issues involving information processing and computer-aided processing of individuals' personal gene data, and issues related to death and euthanasia. Section 2, together with attached data of comparative law, identified countries in which legislation was enacted, countries in which only guidelines announced by medical associations or other relevant organizations were observed, and laws, if any. Section 3 was a proposal which differentiated fields for which immediate legislation was considered necessary from those which required a certain length of time to allow deliberation since sufficient discussion had not yet taken place. The fields which were considered to require immediate legislation were those for which no regulations existed, such as organ transplantation including not only removal of organs but also other matters, and information processing, and illegal practical fields such as gene information files and computer data. The reason why these practices were illegal is because at the time in France all information obtained in connection with medical care had to be kept strictly confidential and medical doctors were not allowed to transfer any information for any purposes other than medical care related purposes, e.g. they were not allowed to transfer such information even for research purposes (note that this was amended according to legislation). On the other hand, discussion of artificial reproduction drew out a great variety of opinions, due to the positioning of the human body, which was then related to various issues of reproductive selection and a couple's freedom to choose abortion. The Report concluded, however, that artificial reproduction was not a field which was sufficiently mature to call for legislation.

In light of this Report, the national government introduced a bill (which did not include pre-birth diagnosis and embryo-related research but only prescribed assisted reproduction) in Parliament in March 1992. In November 1992, the First Reading of the National Assembly adopted three bills, which constitute the current three acts (which introduced regulations on pre-birth diagnosis and embryo-related research).

Subsequently, the general election in 1993 resulted in a change in political power (from the social party to the conservative-centrist force). The then new President Paradieu entrusted Assembly member Mattei, who belonged to the majority, to head an investigation to determine whether the new administration should take over adoption of the bills or reconsider them from the very beginning. The third report, i.e. the Mattei Report, was submitted to the President in November 1993. The Mattei Report, as a result of reexamination of the bills adopted by the former Assembly, basically supported the bills and concluded that regarding the prohibition of embryo-related research in particular, the new administration should follow these bills. In the end, little amendment was made to the bills.

In June 1994, the Bioethics Act was passed by the French Parliament. Several members of the Assembly, however, applied for an examination of the constitutionality of these bills. Their arguments are described below.

First of all, regarding the prescribed regulations on medical assistance to reproduction, several principles including, among others, the embryo's right to live, the embryo's right to be treated equally, respect for the integrity of a human being, and protection of genetic characteristics, the family's rights, and the rights in connection with the health of children were questioned. The Constitutional Council concluded that the legislation provides substantial protection for embryos regarding its formation through fertilization, transplantation and storage and that the Constitutional Council did not have the authority to raise questions about the regulations formulated by the legislation. At the same time, the Constitutional Council indicated the following: there exist no constitutional principles nor regulations which damage the protection of genetic characteristics; the Preamble to the Constitution of 1946 will not hinder development of a family through the utilization of an embryo provided from a donor; it is not considered that prohibition of searching for a donor will violate the child's right of health; and even if the legislative body prescribes that with regard to decisions to be made concerning studies for medical care purposes, the administrative committee should have a collective view, and such decision will be effective as long as the jurisdiction of the committee is not neglected. Secondly, regarding the prescribed regulations on pre-birth diagnosis stipulated by the Transplantation and Reproduction Act, the relation between pre-birth diagnosis and the right of embryos or fetuses to live was questioned since pre-birth diagnosis may facilitate artificial abortion. The Constitutional Council concluded that this Act does not accept a new form of abortion and that these regulations are constitutional.

Next, regarding the civil law-related principles, etc. for medically assisted reproduction which are prescribed by the Human Body Respect Act, the anonymity of a donor was questioned in connection with the principles that individuals assume personal responsibilities and the child's right to identify his/her parents. The Constitutional Council concluded that this Act does not set forth any condition to identify a parent-child relation in the case of medically assisted reproduction and also pointed out that the Constitution does not ban prohibition of setting a parent-child relationship between a donor and a child derived from the donor nor prohibition of calling for a donor's responsibilities.

In addition, the Constitutional Council made its judgment that the entire law (consisting of the three Acts) is constitutional since these Acts prescribe the superiority of the individual, the necessity of respecting the individual from the very beginning of life, the principles that the human body is inviolable, has integrity and is not to be treated as property, and the integrity of the individual as part of a species: these Acts protect the dignity of individuals secured by the Constitution and in other words, promote implementation of the constitutional code within its scope of application.

4. Summary

(1) The contents and historical background of the regulations provided in the above-described countries are summarized below. Generally speaking, the European legal systems concerning reproductive technology show a positive attitude toward acceptance of practical reproductive medical technology, whereas the regulations strictly control studies.

Even in the area of reproduction assisting technology, however, each country has its own policy regarding which reproduction related items are legally regulated. As listed in Reference No. 1 entitled "Outline of Legal Systems," it is convenient to divide reproduction assisting technology into the following items when considering the overall picture: (1) storage and use of gametes; (2) gender selection; (3) post-death artificial insemination using stored gametes; (4) change in germ cells; (5) creation of a human embryo outside the body; (6) removal of embryos; (7) storage, use and examination of embryos; (8) creation of cloned humans; (9) creation of chimeras and hybrids; (10) artificial insemination; (11) donating an embryo; and (12) surrogacy. At least one country has established legal regulations for each of these items. The UK, Germany and France have all established legal regulations regarding Items (4), (5), (7), (8), (10) and (12) (note that some of the countries prohibit Item (8) on the basis of legal interpretation), although these countries substantially differ from one another in terms of the specific actions taken in accordance with these regulations (e.g. regarding Item (12) surrogacy, the UK prohibits only commercial surrogacy, whereas Germany and France prohibit all forms of surrogacy).

Regarding the justification and philosophy resulting in establishment of legal regulations, in particular, these three countries substantially differ from one another. It cannot be claimed that similar regulations are set forth because they share similar ideas. In each of the countries, prior to legislation, a committee or council was organized to discuss these matters from a comprehensive viewpoint and to submit reports. These reports indicate distinct character and individuality. The Report in the UK was extremely practical: it introduced various public opinions and divided them into pros and cons, for each of which acceptability was discussed (the introduction section of this Report stated that social barriers against introduction of new technology are absolutely necessary and at the same time, stressed that moral feelings are not universal). The Report in Germany concluded that the protection of life and body, the respect for autonomy, the considerations given to the happiness of children, etc. shall have priority over the freedom of research, and in particular, ruled out creation of embryos for research purposes since such research may turn life into a means of achieving something else. The Reports in France focused on the necessity of respecting the dignity of the individual, and the principles that the human body shall be inviolable and not treated as property.

These reports summarized their own conclusions and included the different opinions raised, in addition to the opposing opinions on those issues where a consensus was not reached. Relative evaluation of these reports reveal that the German Report recommended the most stringent regulations, whereas the Report in the UK drew relatively modest conclusions. In Germany, the opinion opposing regulations on the freedom of research was introduced. In the UK, there was opinion calling for regulations on studies using embryos.

The authors also found some changes made in the philosophy regarding regulations when the laws or acts were established as compared to that stated in the reports (i.e. prohibition of surrogacy was relieved in the UK, experiments using embryos were completely prohibited in Germany, and prescribed regulations regarding pre-birth examination and embryo research were added in France). In France, the application for examination of unconstitutionality was made at the very last stage of legislation. These results may indicate that legislation was never an easy process.

One of the factors which may have played an important role when legal regulatory systems were evaluated in these countries was the opinion from the religious world. In Germany, individuals with affiliation to the Protestant Church or the Roman Catholic Church were members of the Council. In the UK and France, no such representatives of the religious world were included on the council or committee. It is therefore considered that in each of these countries, the council or committee described in this section was not the sole means to forming a consensus but various opportunities were set for discussion. In light of these facts, the authors do not consider that the outlines described in this section are necessarily complete enough to understand the basic philosophy in the individual countries, although these outlines may help provide insight to part of the overall picture.

Application of cloning technology is expressly prohibited in German Law. In the UK and France, the national government announced its legal interpretation, which resulted in prohibition in the real world of applying cloning technology to humankind.

In the US, despite advanced studies of medical technology and life sciences technology, investigation of legal regulations has been discontinued. The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research was organized in 1981, and issued 5 reports concerning allocation of health care and 5 reports regarding research over a period from 1981 to 1983. However, the Biomedical Ethics Advisory Committee (BEAC), which was established in Congress in 1985 following the President's Commission, was disorganized and did not issue any specific report. Since then, no government reports regarding reproductive medical technology have been submitted in the US.

For reproductive medical technology, the President's Commission submitted a report regarding genetic engineering in 1983. This report was the result of a request made by representatives of the three major religious faiths in the US, i.e. Protestant, Roman Catholic and Jewish, to President Carter to investigate genetic engineering. The report made the following statements:

1) It is quite evident that genetic engineering is a challenge to individuals and families.

2) The fact that genetic engineering has a possibility of contributing to human happiness is a logical reasoning for promotion of genetic engineering.

3) Application of genetic engineering can be similarly regarded as diagnosis and treatment as with other technologies, but careful caution should be exercised when considering any procedure that changes genes which will be transmitted to descendants.

4) Any manipulation intended not to correct gene deficits but to make an attempt at improving a normal individual is problematic. Once the door to such improvement is opened, there is a risk that, without any definite principles, manipulations may be undertaken in an attempt to create the perfect human being.

5) The criticism that the human is performing the part of God is valuable since this reminds us of the principle that an enormous power is always associated with an enormous responsibility.

6) The majority of current experiments regarding gene manipulation are performed on the assumption that they are safe if careful attention is paid during experiments. If one opposes these experiments, then this assumption needs to be proved.

Subsequently, in 1995, President Clinton established the National Bioethics Advisory Council (NBAC) which was intended to make recommendations to the national government regarding bioethical problems resulting from biological and behavioral research (note that this Council was temporarily organized until October 1999). It is understood that this Council was established in response to a request made by Congress, which required organization of an advisory body involved in protection of privacy of gene information obtained in connection with human genome analysis in the Human Genome Project. Following its establishment, the Council worked in a timely manner, e.g. in 1997, in response to the request made by the President, the Council issued reports and made recommendations in connection with the birth of the first cloned sheep.

(2) The authors so far have described the currently effective legal systems in several foreign countries and the philosophy represented by the reports submitted prior to legislation that resulted in the legal systems, in light of which the authors would like to discuss what regulations should be imposed on life sciences in Japan. Key countries in Europe have already established legal systems to control life sciences-related studies and as we have already described in the previous section, the authors consider it necessary, in Japan also, to impose some regulations on such studies.

As stated in the Warnock Report in the UK that "if someone pretends to behave as if moral feelings are universal whether this is based on religion, philosophy or humanistic brief, such appearance is deceptive," it is not always likely that a uniform philosophy will be acceptable regarding what and how regulations should be imposed. On the other hand, in the EU and UNESCO, there is a clear move toward international regulations to be imposed on life sciences under the leadership of the industrialized European countries, on the basis of the already established legal systems. The authors consider that Japan should first search for regulations which are suited to Japanese conditions, e.g. in terms of religious and cultural status, and the Japanese legal system, while referring to the regulations enforced in several European countries and the philosophy leading to those regulations, and after that, Japan should promote international cooperation. This may be important in particular when focusing on the fact that across the world, many countries consist of people following religions other than Christianity or Judaism: these countries may refer to Japan's way of seeking out its own philosophy to impose regulations on life sciences.

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