II. Legal aspects
From the legal standpoint, the production of cloned human embryos in order to obtain embryonic stem cells touches on issues of embryo protection as well as questions relating to the use of cloning methods on humans. Furthermore, there are also questions concerning patent law (see module patentability of embryonic stem cells)
1. International regulations
There are currently no concrete, binding regulations governing the use of cloning methods on humans at either the level of the United Nations (UNO / UNESCO) or on the pan-European level (Council of Europe / European Union). However, on both levels there are pertinent regulatory attempts as well as opinions/statements that - while not legally binding - have the status of recommendations.
Article 11 of the Universal Declaration on the Human Genome and Human Rights (see module UNESCO) adopted by UNESCO on 11th November 1997 states that "practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted". The legal status of cloning for research purposes is thus left open.
On 8th March 2005 the General Assembly of the United Nations adopted the Declaration on Human Cloning (see module UN: Negotiations on the Elaboration of an International Convention against the Reproductive Cloning of Human Beings) on the basis of the recommendation of the Sixth Committee (see module Recommendation of the Sixth Committee) (Legal) of 24th February 2005. It includes a call to all UN Member States to take all measures necessary to prohibit all forms of human cloning, including cloning for medical purposes, so-called "therapeutic cloning". The Declaration states that all forms of human cloning are incompatible with human dignity and the protection of human life. The vote (see module UN: Negotiations on the Elaboration of an International Convention against the Reproductive Cloning of Human Beings) reflects the deep division between supporters and opponents of the Declaration. Supporters consider it a milestone for the protection of human dignity and promotion of human rights. Opponents criticised the linking of the ban on reproductive cloning with the ban on cloning for medical purposes, believing that an important opportunity to adopt a legally binding convention on the worldwide prohibition of reproductive cloning had been missed. The current Declaration is not binding and merely has the status of a recommendation. Representatives of governments that voted against the Declaration - including China, Belgium and the United Kingdom - made it clear that the decision would have no effect on their position with regard to "therapeutic cloning".
The draft resolution had been tabled in 2003, initially by Costa Rica, with a call for a comprehensive ban on all forms of human cloning, including "therapeutic cloning". The counterdraft proposed by Belgium similarly included a ban on reproductive cloning, but it left the decision on "therapeutic cloning" to the discretion of individual national governments. In November 2004, despite protracted negotiations, neither of the draft resolutions was able to secure a majority.
Council of Europe
The pertinent passage in the Convention on Human Rights and Biomedicine (see module Council of Europe (COE)) of 04th April 1997 (see Module 10c) reads "the creation of human embryos for research purposes is prohibited" (Art. 18 §2). This refers to any form of creation, hence also those created through embryo splitting (see module Embryo Splitting) and cell nuclear transfer (see module Cell Nuclear Transfer). § (1) of the same Article allows research on human embryos provided "adequate protection of the embryo" is ensured under national legislation. The Additional Protocol (see module Council of Europe (COE)) of 12th January 1998 on the Prohibition of Cloning Human Beings prohibits the creation of "a human being genetically identical to another human being, whether living or dead". Germany is not to date a signatory to the Convention or the Additional Protocol.
Article 3 (2) of the Charter of Fundamental Rights of the European Union (see module European Union) proclaimed by the European Parliament, the Council and the Commission on 7th December 2000 prohibits reproductive cloning. The Explanations on the Charter (see module European Union) state in this respect: "The Charter [...] prohibits [...] only reproductive cloning. It neither authorises nor prohibits other forms of cloning. Thus it does not in any way prevent the legislature from prohibiting other forms of cloning". The Charter therefore adopts a neutral position on the creation of human embryonic stem cells through "therapeutic cloning".
In its resolution on human cloning of 15 January 1998 (see module European Parliament), the European Parliament affirmed "that the cloning of human beings must be prohibited". Furthermore, it calls on "the Member States of the Council of Europe to sign and ratify the Council of Europe Convention on Human Rights and Biomedicine and its Additional Protocol on the Prohibition of Cloning Human Beings" In a further resolution on human cloning of the 7th September 2000 (see module European Parliament) the Parliament expresses the view "that 'therapeutic cloning', which involves the creation of human embryos solely for research purposes, poses a profound ethical dilemma, irreversibly crosses a boundary in research norms and is contrary to public policy as adopted by the European Union". Resolutions adopted by the European Parliament have no legally binding force, although they normally exert a formative influence on future legislation and case law in the European Union.
2. Regulations in individual countries
A detailed overview of the legal situation in various countries is provided by the DRZE-Expert Report Sachstandsbericht "Präimplantationsdiagnostik, Embryonenforschung, Klonen - Ein vergleichender Überblick zur Rechtslage in ausgewählten Ländern" (German).
There are some issues concerning the legal situation in Australia regarding biopolitics (see module Australia) . Tension arises between the legislation of the Commonwealth and the federal state on the one hand, and between the individual states and territories on the other hand. At a federal level both the "Research Involving Human Embryos Act 2002" as well as the "Prohibition of Human Cloning for Reproduction Act 2002" apply. Both laws are supposed to provide a frame for their own specific legal regulation in the individual states. The "Prohibition of Human Cloning for Reproduction Act 2002" which is authoritative for research cloning, prohibits therapeutic as well as reproductive cloning. Embryo production containing DNA from more than two people as well as the development of embryos in laboratories in excess of 14 days after the fertilization is prohibited. However the Australian parliament repealed the research cloning prohibition in November 2006. So far research on stem cells was permitted to be carried out if the stem cells were derived from redundant embryos before the year of 2002. In 2006 the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act came into effect. In 2008 the law was revised and affirmed. Reproductive cloning remains prohibited in Australia. However, federal states can decide whether they approve cloning for research- and therapeutic ends. For example, research-cloning is permitted in the states of Victoria, New South Wales, Queensland, etc.
In Belgium (see module Belgium) all forms of reproductive cloning are prohibited. In principle, cloning for research purposes is also prohibited pursuant to the "Law on Research on Embryos in vitro" (2003). However, since research on embryos in vitro is permitted within the first 14 days of life provided a therapeutic benefit can be attained with such research in the long term, embryos may be created artificially for research purposes. Nevertheless, this only applies if the research goals cannot be achieved solely using stem cells from so-called surplus embryos.
In Denmark cloning for the purpose of creating genetically identical persons as well as experiments intended to facilitate human cloning are prohibited. The Danish Council on Ethics provides some possible pointers as to whether this ban should be interpreted as referring solely to reproductive cloning or also research cloning. On 1st March 2001 the Danish Council on Ethics (Det Etiske Raad) (see module Denmark), acting on behalf of the Danish Parliament (Folketing), published an opinion on human cloning in Denmark (see module Denmark). The opinion comes out against "reproductive cloning". A majority of the Council's members conclude that while human embryonic stem cells derived using a cloning method or by natural means can in principle be used for therapeutic purposes, there is currently no need for such authorisation to create embryonic stem cells for research and possible therapeutic purposes on the grounds that effective treatment of diseases with the aid of stem cells is still far too remote a prospect. Furthermore, the Council warns of the risk of possibly descending down a "slippery slope". For this reason, the Council recommends that research on and using embryonic stem cells should be limited to surplus embryos from artificial insemination.
Following the revision of the Bioethics Act in 2004 the creation of embryos for research purposes and so-called "embryo-consuming research" - and hence "therapeutic cloning" as well as the derivation of ES cells - continue to be banned in France (see module France) under Loi n° 2004-800 du 6 août 2004 relative à la bioéthique (see module France) nor is reproductive cloning allowed. The general prohibition of research on human embryonic stem cells has, however, been suspended by a five-year moratorium (until 2009) subject to compliance with certain conditions. Further details of the regulations governing stem cell research in France are to be found in the "In Focus" issue on "Human embryonic stem cell research".
In the Federal Republic of Germany (see module Germany - Statutory Regulations) the Embryo Protection Act (see module Germany - Statutory Regulations) (Embryonenschutzgesetz) (ESchG 1991) prohibits the production or use of embryos for any purpose other than to initiate pregnancy. What is more, all forms of manipulation performed on an embryo created outside the body that do not serve its preservation are prohibited. This means that all creation of and research involving embryos that does not serve the preservation of the embryo is banned. In addition, § 6 (1) states: "Anyone who artificially brings about the creation of a human embryo with the same genetic information as another embryo, a foetus, a human being or a deceased person will be punished with imprisonment for up to five years or a fine." Embryo-consuming research is thus banned in Germany. While many legal experts affirm that the aforementioned technique of "therapeutic cloning" after cell nuclear transfer is therefore precluded by law, the issue is still hotly debated. From the standpoint of constitutional law (see module German Constitutional Law) the question as to whether the embryo is already to be protected "from the moment of nuclear fusion" or only from a later point in its development cannot currently be considered to have been unambiguously resolved.
Issues relating to the importation and utilisation of human embryonic stem cells for research purposes are regulated by the Stem Cell Act (Stammzellgesetz) (StzG 2002). Under the Act, the importation and utilisation of embryonic stem cells are prohibited as a general rule and allowed only under certain conditions. For example, such stem cells must have been created prior to 1st January 2002 from so-called surplus embryos. Further details of the regulations governing stem cell research in Germany are provided in the "In Focus" issue on "Human embryonic stem cell research".
The ongoing debate in Germany is still a controversial one at the present time. Numerous opinions have been published by various relevant institutions such as the German Research Association (see module German Research Foundation) (Deutsche Forschungsgemeinschaft), the Study Commission on Law and Ethics in Modern Medicine of the German Federal Parliament (see module Study Commission on Law and Ethics in Modern Medicine of the German Federal Parliament), the National Ethics Council (see module Assessment Options of the National Ethics Council) and the German Federal Parliament (see module German Federal Parliament: Decision on the Importation of Embryonic Stem Cells).
The opinion of the Bioethics Committee of the Council for Science and Technology in Japan (see module Japan) supports the view that embryos should not be created purely for research purposes. It recommends using only those embryos for research purposes that were produced in the context of infertility treatment from oocytes fertilised in vitro and are no longer being used for this purpose, provided the written consent of both biological parents is obtained. The research is linked to a number of conditions (high priority research goals, lack of available alternatives etc.). Research aimed at developing a complete individual from human ES cells - for example through cell nuclear transfer to an enucleated oocyte - is to be banned.
In the Netherlands (see module The Netherlands) the creation of embryos for research purposes is forbidden by the Embryos Act. This ban can, however, be lifted by Royal Decree within five years of the Embryos Act coming into force in June 2002, so it is perhaps more appropriate to speak of a moratorium. Were the current ban on research cloning to be lifted, section 11 of the Embryos Act already provides that such research may only be carried out in order to obtain embryonic stem cells for use in transplantations if this cannot be made possible by other means. Irrespective of the above, however, the derivation of stem cells from so-called surplus embryos is currently permitted within the first 14 days of fertilisation provided the donors have given their consent.
In Switzerland (see module Switzerland) all forms of human cloning, i.e. both for reproductive purposes and in order to obtain human embryonic stem cells for research purposes, are banned. Article 119, Paragraph 2 of the Federal Constitution states: "All forms of cloning and interventions in the genome of human germ cells and embryos are prohibited." Nevertheless, under certain conditions stem cells may be obtained from surplus embryos or imported for research purposes. (See the "In Focus" issue on "Human embryonic stem cell research")
In the United Kingdom (see module United Kingdom) research involving human embryos is permitted with the first 14 days for certain purposes. The early embryo is given graduated protection between that afforded to humans from the fourteenth day of life onwards and that afforded to animals. In addition, human embryos can be created in vitro for research purposes. Both activities, that is the creation of and research involving human embryos, are subject to the "Human fertilisation and embryology act" (see module United Kingdom) (1990) and the "Human fertilisation and embryology (research purposes) regulations 2001 (statutory instrument 2001 No. 188)" (see module United Kingdom) of 24th January 2001. Under these regulations, the creation and keeping of embryos and research conducted on them requires the prior consent of the regulatory agency, namely the Human Fertilisation and Embryology Authority (HFEA). Cloning for reproductive purposes is prohibited in the United Kingdom by the 2001 "Human reproductive cloning act" (see module United Kingdom).
Current law in the United States (see module USA) does not prohibit the removal of stem cells from human embryos. However, the US Congress does not provide any federal funding for research that may harm a human embryo. Consequently, the only research carried out involving human embryonic stem cells is privately funded. On the basis of the position adopted to date by the NIH (National Institutes of Health), no federal funds may be made available for the establishment of human ES cell lines or for research on already established pluripotent stem cells obtained from foetal human tissue or from human embryos.
The "Department of Health and Human Services" had determined (HHS Fact Sheet (see module USA), 19th January 1999) that federally funded research on already established ES cells was not prohibited since it does not involve research on human embryos. An amendment of the NIH guidelines was announced. On 25th August 2000, following extensive public and political debate and after advice was obtained from the National Bioethics Advisory Commission (NBAC) (see module USA) the NIH "Guidelines for Research Using Human Pluripotent Stem Cells" (see module USA) came into effect. The ban on deriving stem cells from embryos with the support of NIH funding remained in place. Under the new guidelines, however, NIH funds can - subject to certain conditions - be used for research on already established embryonic stem cell lines provided such stem cells originate from measures connected with infertility treatments and the donors have given their informed consent. The guidelines stipulate an application procedure that is to be overseen by the newly created "Human Pluripotent Stem Cell Review Group" and prohibit the use of embryonic stem cells for certain research fields (e.g. production of a human embryo, creation of animal-human hybrids). "Therapeutic cloning" and the associated cell nuclear transfer method, as envisaged in the aforementioned UK report "Stem Cell Research: Medical Progress with Responsibility" (see module United Kingdom), are still excluded from federal funding under the new rules. The US Congress is currently discussing a draft bill ("Stem Cell Research Act of 2000" (see module USA)) as an amendment to the "Public Health Service Act". This would permit research involving human ES cells to receive federal funds. The bill is under consideration by the "Committee on Health, Education, Labor, and Pensions" (see module USA) and the "Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies" (see module USA).