Legal and Ethical Aspects of Cloning

- Jurgen Simon, Ph.D. and Brigitte Jansen, Ph.D.
Research Centre for Biotechnology and Law
European Academy for Environment and Economy
Am Berge 33, 21335 Lueneburg, Germany
Email: jansen@euroacademy.com
Eubios Journal of Asian and International Bioethics 9 (1999), 98-99.


In the last two or three years the subjects of animal and human cloning have been discussed very intensively in Germany. The Bureau for Technical Assessment of the German Bundestag demanded the Research Centre for Biotechnology and Law of the European Academy for Environment and Economy at the end of 1997 to make a report concerning the legal aspects of animal and human cloning. The report will be presented to the German Bundestag to help them decide if certain regulation is needed.

In this report the legal situation of animal and human cloning has been examined in the United States and some other countries of the European Community including Great Britain, France, Austria, the Netherlands, Switzerland and Greece. This paper reports the results of this report as a short overview about animal and human cloning in Germany, other European countries and the United States

1. Legal aspects of human cloning in Germany

Human cloning by embryo-splitting is prohibited by ß6 of the Embryo Protection Law (Embryonenschutzgesetz ñ ESchG), a federal law. By interpretation of this article nuclear cell transfer will be prohibited too. ß 5 ESchG is not applicable for both cloning methods.

On the European level there is currently no regulation, applicable in Germany. Germany hasn't signed the Convention on Human Rights and Biomedicine nor the additional protocol containing an explicit prohibition of cloning. The convention and the protocol are both international treaties having no national effect if they aren't signed and ratified.

The examination of the permission of this human cloning prohibition under constitutional law aspects shows that ß 6 ESchG corresponds to the Constitution and isn't an intrusion into the fundamental rights of Art. 5 Abs. 3, 12 Abs. 1, 2 Abs. 2 and 2 Abs. 1 GG.

An intrusion into the liberty of research after Art. 5 Abs. 3 GG by a cloning prohibition is allowed because of human dignity. Human dignity, regulated in Art. 1 Abs. 1 GG, is the highest value of the Constitution and will not be changed even if the Constitution changes, so it is fixed in Art. 79 Abs. 3 GG. Human dignity means the identity and the self-value of a person by use of his personality. A person shouldn't become a simple object or be treated by a measure denying his subject quality. By his role as an organ donor or other materials a person should not become a simple object or a "spare part stock" for other people. Human dignity collides with another fundamental right, that of the liberty of research and in this way this dignity is a limit coming out of the Constitution itself.

An intrusion in the protected area of the freedom of choose and carrying out one's career is justified by the limit of Art. 12 Abs. 1 S. 2 GG. The cloning of many people is in any case a violation of humans dignity, Art. 1 GG. So there are some reasons of common law justifying a cloning prohibition.

The intrusion in Art. 2 Abs. 2 GG is justified by the limits of Art. 2 Abs. 2 S. 3 GG. Furthermore there is no intrusion in Art. 2 Abs. 1 GG because the prohibition of applying a cloning method for reproduction corresponds to the Constitution under the aspect of preservation of human dignity. People have the right to reproduction which is part of the personality right protected by Art. 2 Abs. 1 GG but this right includes only the methods of sexual reproduction. The nuclear cell transfer without any fertilization isn't protected by Art. 2 Abs. 1 GG. There is a fertilization by embryo-splitting but the cloned person would become in any case an object so there will be a violation of Art. 1 Abs. 1 GG. Human cloning is prohibited.

2. Legal aspects of human cloning in foreign countries

The constitutional situation and the laws concerning human cloning in Great Britain, France, Austria, the Netherlands, Greece, Switzerland and the United States are described below. Human cloning is explicitly prohibited in the European countries or can be concluded by interpretation of the Constitution.

In Switzerland there is a Constitutional prohibition of human cloning by embryo-splitting and nuclear cell transfer, Art. 24 novies par. 2 c. Intrusions into the genetic material of human germ cells and embryos are inadmissible ( Art. 24 novies Abs. 2 a). The planed entire revision of the Federal Constitution Art. 111 Abs. 2 letter a should be introduced and then all kinds of cloning and intrusions into genetic material of human germ cells should be prohibited.

In Great Britain sect. 3 of the Human Fertilization and Embryology Act prohibits the human cloning by nuclear cell transfer expressively. Furthermore the authority giving the research authorizations previewed in this act, the human Fertilization and Embryology Authority, has clearly decided not to allow the research of embryo-splitting and nuclear cell transfer. This authority is an ethical committee. The British government has condemned human cloning under ethical aspects. The Science and Technology Committee as well as the Human Fertilization and Embryology Authority and the Department of Health demand for a clear prohibition for human cloning by law .

In Austria cloning is prohibited after ß 9 Abs. 1 S. 1 of the Medical Reproduction Act (Fortpflanzungsmedizingesetz). This Act only allows reproduction methods to be practiced for a pregnancy. In this way every research with in-vitro embryos is prohibited. Intrusions into germ cells aren't allowed, ß 9 Abs. 2.

In France the wording of Art. 16 Abs. 4 Code civil, changed by the Bioethic-Law number 94-653 from 24.07.1994, contains no human cloning prohibition. The French president has asked the national ethical committee, the Comite Consultatif National d'Ethique (CCNE), to make an entire report about the existing regulations of the Bioethic-Laws and the probable need of regulations concerning the human cloning. In its response to the president in 1997, the CCNE shows that human cloning violates the human dignity, so that after Art. 16 Abs. 4 Code civil human cloning is prohibited. This is the special case that the prohibition itself isn't mentioned in the article but is interpreted in this regulation by the CCNE, a committee without legislative competence. The Bioethic-Law number 94-654 from 29.07.1994 contains the regulation that in-vitro fertilization of human embryos for research or experiments is not allowed. The regulation applies to embryo-splitting but not the nuclear cell transfer.

France, Greece and the Netherlands have signed the Convention on Human Rights and Biomedicine as well as the additional protocol. In France both treaties have to be ratified. In Greece the Convention is already ratified. The law for the protocol is being prepared. Human cloning is a technique violating human dignity protected by the Constitution. Under this aspect a limitation of the liberty of search is possible. In the Netherlands a law is being prepared prohibiting human cloning.

In the United States until now, there is no law regulating human cloning or prohibiting it. The American president asked the National Bioethics Advisory Commission on 24.02.1997 to examine the legal and ethical aspects of the use of the new cloning methods. The Commission only examined the method of nuclear cell transfer and reported that at moment neither in private area nor in public area, that means in research or in medicine, it is justifiable to reproduce a child by nuclear cell transfer. In consequence the American president proposed the congress the Cloning Prohibition Act. Till now it hasn't become a law. Beside this the president ordered a memorandum prohibiting the use of federal funds for human cloning. Some different State laws even prohibit the private founded research.

Legal aspects of animal cloning in Germany
The German law of animal breeding (Tierzuchtgesetz) contains no regulations for animal cloning. The Animal Protection Law (Tierschutz-gesetz - TierSchG) has no regulation too. The cloning methods are always in an experimental stage so that ß 7 Abs. 1 TierSchG could be applicable. But the cloning methods of embryo-splitting and the nuclear transfer aren't at any time an animal experiment. In consequence ß 7 Abs. 1 TierSchG doesn't protect the animals against cloning.

Neither the extraction of an egg or a body cell nor the artificial fertilization nor the finally extraction of the totipotent cells are an animal experiment in consideration of ß 7 Abs. 1 TierSchG. The transplantation of the cloned, but by embryo-splitting not genetically changed, egg cells to the mother (pregnant) animal doesn't correspond to the conditions of ß 7 Abs. 1 TierSchG.

The extraction and the transfer of the nuclear of a body cell aren't involved by ß 7 Abs. 1 TierSchG too. The extraction of the cell nuclear of the egg cell is not an animal experiment because this cloning method doesn't cause a genetic change in a jurisprudential sense. That is the reason why the transfer of the egg cell into the mother (pregnant) animal is not an animal experiment.

The animal cloning for the research will not be limited by ß 11 b TierSchG. The cloning methods are still in an experimental stage. ß 11 b TierSchG will be applicable, when these methods are ready to be practiced and are used for example for the production of agricultural working animals.

On the European level neither the "Treaties of Amsterdam", signed the 02.10.1997, nor the "European regulation from 18.03.1986 for the protection of the vertebrates used for experiments and other scientific aims" contain any regulation about animal cloning.

Under constitutional law aspects the introduction of a regulation of cloning as a cloning prohibition would violate the fundamental rights of the researcher after Art. 5 Abs. 3 and 12 Abs. 1 GG (Constitution), the rights of the other working people and employers after Art. 12 Abs. 1, Art. 5 Abs. 3 and Art. 12 Abs. 1 GG too. A cloning prohibition or another limitation of the cloning would be an intrusion on the liberty of science guaranteed by the Constitution. A limit coming out of the Constitution by itself and justifying the intrusion doesn't exist. Animal protection isn't till now regulated by the Constitution. With respect to Art. 20 a GG the animal protection is involved in this article as basic of humans life under the aspect of preservation of the different sorts of animals and protection of the habitat of free living animals. But this article means not an individual animal protection. An Art. 20 b is planed to be introduced to be introduced into the Constitution. This regulation foresees the respect of animals as "Mitgeschˆpf", this means member of life, and their protection of avoidable pain and suffering. In May 1998 the German Bundestag has discussed about the introduction of this article without any concrete decision. We have to wait for the next parliamentary term.

After Art. 12 Abs. 1 GG a cloning prohibition is against the Constitution because it doesn't correspond to the common will and is not involved by the legal reserve of Art. 12 Abs. 1 S. 2 GG. Only in the agricultural area would a cloning prohibition be acceptable. The cloning would only be used to increase the yield because the supply of foods for the people is assured. The need of increased quality cannot be understood because healthy nutrition can be guaranteed. The cloning methods first would serve to higher the profit motives of the agricultural enterprises.

Art. 2 Abs. 2 GG contain no duty of the State to limit the animal cloning for the protection of third people not be violated in their physical health. That is the reason why the protection area of this article is not touched. Thus animal cloning is possible.

Legal aspects of animal cloning in foreign countries

There is no cloning prohibition in any of the examined countries. Only in the Switzerland it could be possible because of the Art. 24 novies Abs. 3 of the Federal Constitution makes animal protection a constitutional right. Furthermore in this country an entire reformation of the Constitution is prepared as well as law projects concerning non human gene technology.

A law about animal cloning only exists in the Netherlands (Animal Health and Welfare Act of 1992) regulating that animal cloning by nuclear cell transfer needs an authorization. This authorization is given by the Minister of Agriculture, Nature conservation and Fishery. He will be assisted by a Biotechnology Committee "Commissie Biotechnologie bij Dieren". The members of this Committee are fixed by the Animal Biotechnology Decree from 09.12.1996. There should be only nine members from the ethical area, the social science, the veterinary medicine and the biology. The authorization has to be given, when there is an important interest in nuclear cell transfer or in a genetic changing of an animal as well as the ethical acceptance of the project. Unacceptable effects for health and welfare of the animals shouldn't exist. In Greece is no specific regulation. Cloning experiments are under the constitutional protection of the liberty of research.

There are no laws about cloning in the other countries. Indeed there exist animal protection laws but only living animals are protected by them and not foetuses. So in fact animal cloning is not regulated by the animal protection laws.

In Great Britain the "Animal Act" from 1996 regulates the realization of animal experiments, controlled by the "Animal Procedures Committee". This is the only law, whose protection area includes beside the living animals, living foetuses. But nevertheless this law isn't applicable for cloning till the scientific proof is given that cloning creates pain and suffering for the animals.

Result

Animal cloning is allowed in Germany, Great Britain, France, Austria, the Netherlands, Switzerland, Greece and The United States. There are no animal protection laws regulating the methods of animal cloning.

Human cloning is prohibited by law in Germany, Great Britain, France, Austria and Switzerland. No regulation and no prohibition exist in the Netherlands, Greece and the United States. But the Netherlands and Greece have signed the European Biomedicine Convention as well as the additional protocol.

References
BVerfGE 30, 1 (25).
BVerfGE 50, 166 (175).
Royal Society, Whither Cloning, January 1998, p. 7.
Human Genetics Advisory Commission and Human Fertilization & Embryology Authority, "Cloning issues in reproduction, science and medicine, 1998, p. 11.
House of Commons Official Report, Parliamentary Debates (Hansard) 26 June 1997, Column 615.
Fifth report from the Science and Technology Committee, Session 1996-97, p. 13.
CCNE, "Reponse au President de la Republique au sujet du clonage reproductif" from 22.04.1997, p. 34.
Report and recommendations of the National Bioethics Advisory Commission, Cloning human beings, June 1997, p. iii.
White House Press Releases Database: Memorandum of March 4, 1997.
Schmidt-Bleibtreu/Klein, Art. 20 a, Rz. 11.


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