Tuesday, February 26, 2008

Part IV: The International Situation
2. Europe

World policies on human or reproductive cloning range from partial prohibition to no policies on record. France, Germany, and the Russian Federation have bans in place that ostensibly [1] prohibit human cloning for any purpose. Fifteen countries, including Japan, the United Kingdom, and Israel, have banned human cloning for “reproductive” purposes, but permit the creation of clones for research and require that they be killed before certain arbitrary limits of development. A few countries such as Hungary and Poland do not explicitly prohibit embryonic stem cell research or therapeutic cloning, partially because their legislation was drafted before embryonic stem cells were first produced (1998). Many other countries, similar to the United States, have yet to pass any official legislation concerning human cloning.

The European Union

In January 1998, 19 countries of the European Union signed an agreement that prohibits the cloning of human embryos for “reproductive” purposes. The clause that was shortly to be added to the European Convention on Human Rights and Biomedicine banned “any intervention seeking to create human beings genetically identical to another human being, whether living or dead.”

The European Convention on Human Rights and Biomedicine (Article 3) prohibits the cloning of human beings, but only for “reproductive purposes.” As with most countries of the world, the EU accepted the false distinction between “therapeutic” and “reproductive” cloning. The creation of cloned human embryos to be used for research is not prohibited under the convention.

As with most countries passing “cloning bans”, in the European law, “human being” meant a child brought to the gestational age normal for birth. The clause, therefore, accepts the widely disseminated falsehood that banning “human cloning” meant prohibiting only the creation of cloned babies for “reproductive” purposes, but allowed the creation of the same cloned children to be killed at an earlier stage for research purposes.

The original 19 signatories were Denmark, Estonia, Finland, France, Greece, Iceland, Italy, Latvia, Luxembourg, Moldova, Norway, Portugal, Romania, San Marino, Slovenia, Spain, Sweden, Macedonia and Turkey.

Britain and Germany -- two of Europe's biggest nations -- did not sign the protocol.

Germany said the measure is weaker than German law that forbids all research on human embryos -- a reaction to Nazi genetic engineering experiments. Britain was shortly to grant permission for all human cloning experiments requested by researchers. Germany maintained opposition to the EU’s flawed cloning prohibition until July, 2006 when, together with Slovenia, the German government accepted EU assurances that no EU money would directly be spent on projects in which human embryos would be destroyed.

The EU announced the same year that it had allotted €37bn to an omnibus science budget in which revised rules allowed for some human embryonic stem cell research, in what were called by EU ministers as undefined “subsequent steps” to be taken in the future.

The European Union remains one of the major lobbying forces in favour of using embryos for medical research. In June 2002 former Member of the European Parliament for Ireland, Dana Rosemary Scallon, warned that the European Union was pressuring the Irish Government to support funding for destructive research on human embryos. Scallon revealed that people at the highest level in Bertie Ahern's government are being pushed to assist the use of EU money for experimentation with embryos.

It is essential to carefully monitor developments in European Union law since under various agreements the laws of the various member states are frequently subject to revision.

Austria [2]

The law [3] does not explicitly prohibit the cloning of human beings, but it limits research on human embryos (defined as “developable cells”). Its central principle is that reproductive medicine is acceptable only within a stable heterosexual relationship for the purpose of reproduction.

Article 9 states that fertilized human oocytes (embryos) and cells derived therefrom may not be used for purposes other than medically assisted reproduction, and any intervention into the germline is strictly prohibited. Any violation or attempt at violation is subject to administrative or criminal prosecution.

Belgium

Prohibits only “reproductive” cloning, allows the creation of embryos for research if “the objective of the research cannot be achieved by research on excess embryos and in as much as the conditions of the present law are met.”

The law further states, “It is forbidden to effect research or treatments with a eugenic purpose, in other words focused on the selection or amplification of non pathological genetic characteristics of the human species.”

Denmark

The act on Medically Assisted Procreation in connection with medical treatment, diagnosis and research” (June 1997, amended June 2003) forbids research “on human reproductive cloning and somatic cell nuclear transfer (therapeutic cloning)”.

Under the Act on a Scientific, Ethical Committee System and the Handling of Biomedical Research Projects” (1992) “The following experiments shall be prohibited:

1. experiments whose purpose is to enable the production of genetically identical (full gestational age) human beings;

2. experiments whose purpose is to enable the production of (full gestational age) human beings by the fusion of genetically different embryos or parts of embryos prior to their implantation in the uterus;

3. experiments whose purpose is to enable the production of (full gestational age) living human beings who are hybrids with a genetic constitution including components from other species; and

4. experiments whose purpose is to enable the development of (full gestational age) human beings in the uterus of another species.”

France

Bioethics Law on Respect for the Human Body and Law, Donation and Use of Elements and Products of the Human Body, Medically Assisted Procreation, and Prenatal Diagnosis. July 2004, amended July 1994.

The bioethics legislation and its amendments specifically prohibit human cloning for reproductive and therapeutic purposes, germline gene therapy and the creation of embryos purely for research purposes.

Human reproductive cloning is considered a “crime against the human race” and has been criminalized with jail sentences of up to 20 years and the imposition of fines; research or therapeutic cloning is punishable with up to 7 years in prison and fines.

Finland

“The Act on Medical Research, No. 488/1999” (1999). Conditions governing research involving embryos: Research on embryos outside a woman’s body may be carried out only by agencies that have been granted the appropriate licence by the National Authority for Medicolegal Affairs. Medical research shall be permitted on embryos only if no more than 14 days have passed from their formation. Research on embryos outside a woman’s body may not be undertaken without the written consent of the persons who donated the gametes.

The production of embryos exclusively for the purpose of research shall be forbidden. Embryos that have been used for research may not be implanted in a human body or be kept alive for longer than 14 days from their formation, not including any time during which they have been kept frozen.

Research may use embryos that have been stored for up to 15 years, after which the embryos must be destroyed. Research on embryos and gametes for the purpose of developing procedures for modifying hereditary properties shall be prohibited, unless the research is for the purpose of curing or preventing a serious hereditary disease.

Germany

Germany, in most other ways regarded as the most liberal of states on most social issues, retains strong opposition to bioengineering. Germans of all political persuasions are widely opposed to scientific research that tends to manipulate or exploit human life.

“Federal Embryo Protection Law” (1990) stipulates that any person who “artificially causes a human embryo to develop with the same genetic information as another embryo, foetus, living person, or deceased person shall be punished by up to five years' imprisonment or by a fine. The same penalty applies to the transfer of embryos into a woman.

The law prohibits germline alteration and the use of human germ cell with artificially modified genetic information for fertilization, the creation of chimeras and hybrids or their implantation in a woman or an animal.

For the purpose of the German law, the term "embryo" is defined as the “human egg cell, fertilized and capable of development, from the time of fusion of the nuclei, as well as each totipotent cell removed from an embryo that is capable, in the presence of other necessary conditions, of dividing and developing into an individual”

In August 2004, in response to the permission given by the UK’s Human Fertilisation and Embryology Authority (HFEA), the German Medical Association and leading political parties called on the German government to take a firmer stand within the European Union against cloning. German Medical Association spokesman, Jörg-Dietrich Hoppe, appealed to the government: "We can't allow embryos to be harvested like raw materials.” Frank Ulrich Montgomery, chairman of the Marburger Association of Doctors said, “The indivisibility of human rights are being eroded under the blanket of research freedom.” Wolfgang Wodarg - a member of the ruling Social Democratic Party and chairman of Germany's official bio-ethics commission - called Britain's decision a "catastrophe".

Human cloning remains illegal in Germany; many feel that the country's ethical stand on cloning should be more vigorous, and that cloning should be banned throughout the European Union.

Iceland

Research on embryos is entirely prohibited under the Artificial Fertilisation Act May 1996. Experiments and operations on embryos are permitted:

  • to carry out research on embryos for research into in vitro fertilisation treatment
  • if the intention is to diagnose hereditary diseases in the embryos
  • if the purpose is to advance the treatment of infertility, or
  • if the purpose is to improve understanding of the causes of congenital
  • diseases and miscarriages.

The law prohibits:

  • the cultivation or production of embryos solely for research purposes;
  • for more than 14 days outside the body or once the primitive streak has appeared;
  • the transplanting of human embryos into animals, and
  • cloning.

Ireland

Experiments on human clones are prohibited under the Irish constitution. Article 40: “The State acknowledges the right to life of the unborn and, with due regard to the equal right to life of the mother, guarantees in its laws to respect, and, as far as practicable, by its laws to defend and vindicate that right.” The Constitution is interpreted as an implicit prohibition on human cloning.

Italy

“Assisted Medical Procreation Law” (February 2004). Article 13 prohibits the creation of embryos solely for research purposes or any other purpose not explicitly authorized in the law. It further prohibits the “selection, manipulation or any other procedure directed at altering the genetic patrimony/heritage of the embryo or the gamete. This is to predetermine their genetic characteristics, with the exception of diagnostic and therapeutic purposes. The law also forbids “cloning interventions by means of nuclear transfer or early embryo splitting whether for reproductive or therapeutic purposes.

The Netherlands

“The Embryos Act” (July 2002). The Embryo Act bans the production of embryos purely for research purposes. Scientific research using embryos are allowed if “the results is expected to yield must be of medical importance”. If there are alternative methods, they must be used. All research programmes must be approved by the Central Committee on Research involving Human Subjects. The Embryos Act prohibits human “reproductive cloning”.

Norway

“The Biotechnology Law” (December 2003, amended December 2002)

Research on fertilized eggs, human embryos, and cell lines cultured from fertilized eggs or human embryos shall be prohibited. The law prohibits the production of human embryos by cloning.

It shall be prohibited:

  • to produce human embryos by cloning;
  • to carry out research on cell lines cultured from human embryos produced by cloning; and
  • to produce embryos by cloning through the introduction of heritable material from a human being into an egg cell of an animal.

Cloning means techniques for producing heritable identical copies.”

Poland

"Law on Family Planning, Protection of Human Foetuses, and the Conditions under which Pregnancy Termination is Possible" (January 1993). The law prohibits human reproductive cloning. In July 2006, the Polish parliament issued a resolution against research using human embryos, in response to the European Union’s vote to provide funding for embryonic stem cell research. The Sejm, the lower chamber of the Polish parliament, issued the resolution, which passed with a strong majority of 341 votes in favour and only 47 against. 20 votes were withheld.

The resolution stated: “Sejm of the Republic of Poland points out that those reprehensible practices (human embryo experimentation) are inconsistent with Polish law. [The destruction] of human embryos purposefully to receive stem cells is against the Polish Constitution, Chapter II, article 38, which states ‘The Republic of Poland shall ensure the legal protection of the life of every human being.’”

Human embryo experimentation would violate article 157 of Poland’s Penal Code, which protects human life from the moment of conception. Further, it would be inadmissible under the Medical Ethic Code.

Russian Federation

Law on the Temporary Prohibition of Human Cloning” (April 2002). The creation of “a human being, genetically identical to another one, dead or alive, by means of implantation of a human body cell into a female gamete preliminary deprived of it nucleus” is subject to a temporary 5-year ban.

The law also prohibits import and export of human cloned embryos for the same period. Persons violating the law will be prosecuted in accordance with the federal legislation. However, neither the Criminal nor Administrative Code provides punishment for cloning acts.

Slovakia

“The Health Care Law” (1994). “Any intervention seeking to create a human being genetically identical to another human being, whether living or dead, is prohibited.”

Research cloning is implicitly prohibited under Article 42.3c) “research without medical indication is not permitted on human embryos and foetuses.”

Slovak Penal Code (Amended September 2003). “Any person who performs any intervention seeking to create a human being in any stage of development genetically identical to another human being, whether living or dead, shall be sentenced from 3 to 8 years of imprisonment or shall be punished by a prohibition of activity or pecuniary penalty.”

Slovenia

“The Law on Medically Assisted Reproduction” (2001). Penal Code (2002). Human cloning for reproductive, research or therapeutic purposes is forbidden as are inheritable genetic modification procedures.

Spain

The election in March 2004 of a government headed by the Spanish Socialist Workers' Party (PSOE), Spain has enacted a host of anti-life and anti-family measures. Since allowing, in 2003, the use of “spare” embryos in medical research, the country has allowed sex selection of embryos in IVF facilities. In July 2005, Health Minister, Elena Salgado said the government intended to enact legislation allowing cloning for “non-reproductive” purposes.

Switzerland

Federal Act on Research on Surplus Embryos and Embryonic Stem Cells (Embryonic Research Act). (Approved by Referendum November 2004). The Act prohibits both the creation of embryos for research purposes (therapeutic cloning) and cloning for reproductive purposes. “Human beings shall be protected against abuse with regard to medically assisted procreation and genetic engineering.

“The Confederation shall legislate on the use of the human germline and genetic heritage. In doing so, it shall ensure that human dignity, personhood, and the family are protected and that the following principles are respected: any form of cloning and any intervention involving the genetic heritage of human gametes and embryos is prohibited.

“Recourse to medically assisted procreation methods may be authorized only in cases where sterility or the danger of the transmission of a serious disease cannot be averted in any other way, and not for the development of certain qualities in the child or for research; the fertilization of human oocytes outside the body of a woman shall be authorized only under the conditions laid down by law; only the number of human oocytes that may be immediately implanted may be developed to the embryo stage outside the body of a woman. There may be no trade involving human germline material or products resulting from embryos.”

“Federal Act on Research on Surplus Embryos and Embryonic Stem Cells(Embryonic Research Act),” (April 2004). Under the Act, it is forbidden to:

  • produce an embryo for research purposes, produce stem cells from such an embryo or use such stem cells;
  • modify the hereditary patrimony of germ cells, produce embryonic stem cells from an embryo whose germline was modified, or use such cells;
  • create a clone, a chimera or a hybrid, produce embryonic stem cells from a clone, a chimera or a hybrid, or use such cells;
  • develop a parthenote[4], produce embryonic stem cells from a parthenote, or use such cells;
  • import or export an embryo of the kind described in a. or b., a clone, a chimera, a hybrid or a parthenote.”



[1] “ostensibly prohibit” - Legislative “cloning bans”, being largely drafted by bioethicists and research lobbyists without reference to international standards of scientific nomenclature have been found by experts to frequently contain ambiguous or erroneous definitions that some have contested would render null prohibitions against the procedures thus mis-defined. This use of indefinite and inaccurate terminology has created immense confusion even among those sincerely concerned with prohibiting cloning and embryo research. Whether the cloning prohibitions of these or other countries have been rendered ineffective for these reasons is beyond the scope of this work, but remains a matter of serious concern to pro-life people and warrants continued close monitoring.

[2] Information for much of this section was taken from a research document compiled for the website of Global Lawyers and Physicians, a non-profit non-governmental organization that focuses on health and human rights issues. http://www.glphr.org/genetic/europe2-7.htm

[3] “Federal Law Regulating Medically Assisted Procreation (The Reproductive Medicine Law), Amending the General Civil Code” (1992):

[4] a cell resulting from parthenogenesis

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