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Reference 1 Outline of the Legal System by Country Regarding Bioengineering and Reproductive Technology, including Cloning


Britain

Germany

France

U.S.

Law

Human Fertilization and Embryology Act (1990)

The Embryo Protection Law (1990)

The Bioethics Laws (1994): the Human Body Respect Act, the Transplant and Reproduction Act, and the Named Data Act.

No Federal laws established.

Presidential ordinance (1997) and presidential bill (1997, not passed)

Legal form

Covers the handling of human embryos and gametes.

Some studies and reproductive treatment using embryos and gametes are permitted subject to authorization by administrate bodies.

Administrative regulations with punishments.

Provides punishable prohibitive regulations for each reproductive technology using embryos and gametes.

Advanced medical technology in general is regulated by the above three acts, including organ transplants and reproductive technology.

The Human Body Respect Act added basic regulations to the Civil Code and criminal provisions to the Criminal Code.

The Transplant and Reproduction Act added regulations on organ transplants and reproductive treatment to the Health and Medical Code.

The Named Data Act added the procedures for using personal medical data to the Information Protection Law.


Backgrounds, purpose, etc.

Legalized based on the Warnock Report (1984).

Intended for adequate administration of reproductive technology.

Legalized based on the Benda Report (1985) Aims to protect human life and dignity.

Legalized after a number of professional reports, including the Renoir Report. Ideal include respect for and inviolability of the human body and prohibition of infringement on the integrity of human races.

Recommendations and answers were provided by the National Bioethics Advisory Committee concerning embryonic stem cells in humans and other species.

Storage and use of gametes

[Storage and use of gametes are possible subject to authorization.]

Unauthorized storage or use (Article 4, Paragraph 1, a and b)

Detention up to 2 years, penalties or both. Under summary prosecution, detention up to 6 months, penalties or both (excluding use between a male and female as part of medical treatment).

Subject to permission, human sperm may be hybridized with eggs of special species, such as hamsters, for the purpose of checking the sperm rate or sperm normality tests. After testing, fertilized eggs must be destroyed not later than the first cell division. (Appendix 2, 1-(1)(f))




Sex selection

(identification of gametes and insemination)


[Prohibited]

Insemination of eggs with sperm identified by sex chromosome.

Freedom restricting punishment up to 1 year or penalties (Article 3), except for authorization by a state law to prevent serious cases of sex-linked inheritance.



Post-mortem artificial insemination using stored gametes


[Prohibited]

Artificial insemination using from dead males.

Freedom restricting punishment up to 3 years or penalties (Article 4).

[Prohibited]

Applies to a couple alive in reproductive years. (The Health and Medical Act, Article L152 (2))


Modification of reproductive cells

[Permitted subject to authorization except for partial modification of the embryo]

Storage or use of gametes (Article 4, Paragraph 1)

Detention up to 2 years, penalties or both. Under summary prosecution, detention up to 6 months, penalties or both.

Modification of the general structure is not approved if the reproductive cell constitutes part of the embryo. (Appendix 2, 3-(4))

[Prohibited with some exceptions, including a case in which reproductive cells are not used for insemination]

Artificial modification of genetic characters of human reproductive cells.

Application to insemination of reproductive cells containing artificially modified genetic characters.

Freedom restricting punishment up to 5 years or penalties. Also applies to abortive attempts. (Article 5)

As exceptions:

Artificial modification of in-vitro reproductive cells, which are not to be used for insemination.

Artificial modification of genetic characters of reproductive cells taken from dead fetuses or dead humans, which are not to be used in transplants to embryos, fetuses or humans, or which are not to develop into new reproductive cells.

Application to vaccinations, or radioactive, chemical or other types of treatment not intended for modification of genetic characters of reproductive cells.

[Presumably prohibited under the following provisions]

Prohibition of infringement on the integrity of human races. Prohibition of eugenic acts intended for human selection. (The Civil law 16(4))

Eugenic acts intended for human selection.

20-year imprisonment with forced labor (The Criminal Law, Article 511(2))


Artificial in-vitro creation of human embryos, isolation of embryos from females, and artificial insemination

[Permitted subject to authorization for medical treatment and research]

Creation, storage or use of embryos without permission. (Article 3(1))

Detention up to 2 years, penalties or both. Under summary prosecution, detention up to 6 months, penalties or both.

[Prohibited]

Isolation of embryos before imbedding from females for the purpose of transplants to other females or use not intended for embryonic preservation.

Artificial invasion human spermatids into human egg cells.

Freedom-restricting punishment up to 3 years. Aborted attempts also punished (Article 1)

[Prohibited]

Prohibits in-vitro creation or use of human embryos for commercial or industrial purposes.

Detention up to 7 years and fine of Fr700,000. (The Health and Medical Law, Article L152(7), and the Criminal Law, Article 511(7))

Prohibits in-vitro creation of human embryos for the purpose of research or experiment.

Detention up to 7 years and fine of Fr700,000. (The Criminal Law, Article 511(18))


Storage or use of embryos and inspection or experiment using embryos

[Permitted subject to authorization]

Creation, storage or use of embryos without permission. (Article 3(1))

Detention up to 2 years, penalties or both. Under summary prosecution, detention up to 6 months, penalties or both.

Prohibits use or storage of embryos after appearance of the primitive streak. (Article 3(3a)

(the primitive streak is considered to appear within 14 days of gametic mixture.

Detention up to 10 years, penalties or both.

[Prohibited except for purpose of conception]

Sales of human embryos created in vitro or isolated from females before imbedding in the womb.

Transfer, acquisition or utilization of such embryos for purposes not intended for embryonic preservation.

In-vitro embryonic development for other purposes than conception.

Freedom-restricting punishment up to 3 years. Aborted attempts also punished. (Article 2)

[Prohibits use of embryos for commercial purposes or for inspection, with some exceptions]

Prohibits in-vitro creation or use of human embryos for commercial or industrial purposes.

Detention up to 7 years or fine of Fr700,000.

(The Health and Medical Law, Article L152(7), and the Criminal Law, Article 511(7))

Prohibits inspection or experiments regarding human embryos except inspection for couples.

Detention up to 7 years and fine of Fr700,000.

The Health and Medical Law, Article L152(8), and the Criminal Law, Article 511(19))


Human cloning

(embryonic manipulation)

[Partially prohibited. Practically prohibits by not giving permission.]

Prohibits substitution of the nucleus of an embryo with the nucleus taken from human cells, embryos or developed embryos. (Article 3(3d))

Detention up to 10 years, penalties or both.

Prohibits creation, storage or use of embryos except for the purpose of medical treatment subject to authorization. (Article 3(1))

Detention up to 2 years, penalties or both.

The authorizing agency made public its intention not to approve human cloning.

[Prohibited]

Artificial creation of embryos having the same genetic information as in other embryos, fetuses and humans.

Transplants of such embryos to females.

Freedom-restricting punishment up to 5 years or penalties. Abortive attempts also punished. (Article 6)

[Prohibited by presidential discretion under the following provisions]

Prohibits infringement on the integrity of human species. Prohibits eugenic acts for the purpose of human selection. (The Civil Law, Article 16(4))

Implementation of eugenic measures for the purpose of human selection.

Detention with hard labor up to 20 years. (The Criminal Law, Article 511(1))

In-vitro creation of embryos for the purpose of research or experiment.

Detention up to 7 years and fine of Fr700,000. (The Criminal Law, Article 511(18))

No federal regulations

Suspension of governmental financial support of human cloning using body cell nuclei (Presidential Decree, 1997)

A Presidential Draft (1997) prohibits human cloning using body cells (to be reviewed in 5 years)

The NBAC recommendations cited ethical concerns and scientific uncertainties while admitting the usefulness of body cell transplant.

Chimeras and hybrids

(between humans and animals)

(Manipulation of gametes and embryos)

[Permitted subject to authorization]

Mixture of human gametes with animal gametes without permission. (Article 4(1c))

Placement of embryos in the animal body. (Article 3(3b))

Detention up to 2 years, penalties or both.

[Prohibited]

Cell junction of more than one embryo having different genetic characters using at least one human embryo.

Junction of human embryos with other cells that have different genetic characters and are capable of dividing after joint with the human embryos.

Creation of divisible embryos by insemination of animal sperm into human egg cells or insemination of human sperm into animal eggs.

Transplant of such embryos into females or animals.

Freedom-restricting punishment up to 5 years or penalties. (Article 7)


The NBAC answers (1998):

It should not be permitted to maintain conception through fusion of human cells with animal eggs.

There are ethical concerns about embryonic development through fusion of human cells with animal eggs. However, human embryonic stem cells will not develop by themselves, causing no direct concerns.

No ethical problems will be caused if fusion of human cells with animal eggs do not produce embryos with development potential.

Artificial insemination and transplant of gametes or embryos to females

[Permits transplant of gametes and embryos subject to authorization.]

Prohibits the placement of sperm or eggs in the female body without permission. (Article 4(3))

Detention up to 2 years, penalties or both. Under summary prosecution, detention up to 6 months, penalties or both.

Permits the placement of embryos in the female body subject to authorization. (Appendix 2, 1-(1)(e))

[Prohibits transplant to other humans than gamete donors. Limits the number of gametes and embryos to be transplanted.]

Transplant of unfertilized eggs from other females.

Artificial insemination of egg cells for other purposes than for conception.

Transplant to females of more than three embryos during the same menstruation period.

Fertilization of more than three egg cells during the same menstruation period by transplanting gametes to the fallopian tube.

Insemination during the same menstruation period of more egg cells than should be transplanted.

Artificial insemination or transplant of human embryos to surrogate mothers.

Freedom-restricting punishment up to 3 years or penalties. (Article 1)

[Permits embryonic transplant as part of reproductive treatment]

Permits in-vitro creation of embryos intended only for medical intermediation in reproduction. These embryos require insemination with gametes from at least one partner of the couple. (Heath and Medical Law, Article L152(3))

As an exception, couples are permitted to receive embryos after unsuccessful effort in medical intermediation without the help of any third party. (Heath and Medical Law, Article L152(5))


Transfer and trading of embryos


[Prohibited]

Sales of human embryos created in vitro or isolated from females before imbedding in the womb. Transfer, acquisition or use of such embryos for purposes other than for maintaining them.

Freedom-restricting punishment up to 3 years or penalties. Also punishes aborted attempts. (Article 2)

[Prohibited except for reproductive treatment.]

Prohibits acquisition of human embryos to receive compensation, intermediation for such acquisitions, and offering of human embryos to receive compensation.

Detention up to 7 years and fine of Fr700,000. (The Criminal Law, Article 511(15))

Prohibits acquisition of human embryos except for reception of embryos by couples as part of reproductive treatment.

Detention up to 7 years and fine of Fr700,000. (The Criminal Law, Article 511(16))


Conditions for application of reproductive technology (including consent of donors of sperm and eggs)

[Consent required]

Requires consent on use of gametes or embryos. (Appendix 3)

[Consent required.]

Artificial insemination without consent of donors of eggs or sperm.

Transplant of embryos to females without their consent.

Freedom-restricting punishment up to 3 years or penalties. (Article 4)

[Consent required]

Prior consent required regarding artificial insemination or embryonic transplant of living couple who are married or have lived together at least 2 years and are in reproductive years. (The Health and Medical Law, Article L152(2))

Donors and recipients of embryos shall not be identifiable. (However, information available to physicians when necessary in treatment.) Donors shall not be paid. (The Health and Medical Law, Article L152(5))


Surrogate motherhood

[Prohibits commercial surrogate motherhood.]

The Surrogate Mother Contract Law (1985)

[Prohibited]

Artificial insemination of surrogate mothers or transplant of human embryos to them.

Freedom-restricting punishment up to 3 years or penalties. (Article 1)

[Prohibited]

Contract on reproduction and conception for the sake of others is invalid. (The Civil Law, Article 16(7))



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