SECTION I. CLONING REGULATION IN THE COUNCIL OF EUROPE
I.I. Council of Europe Convention on Human Rights and Biomedicine
I.II. Council of Europe Protocol banning human (reproductive) cloning
I.III. Futures additional protocols to this convention
SECTION II. EMBRYO REGULATION IN EU COUNTRIES
II.I. No position
II.II. "Moderate" countries
II.III "Conservative" legislation
II.IV Countries with "liberal" legislation
A.II Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings
A.III Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine
A. IV. EP Resolution on human cloning, of the 2000-09-07
A. V European Parliament resolution on the decision of the Patent Office on the cloning of human beings
A. VI. European Group on Ethics opinion : "Ethical aspects of human stem cell research and use".
By Grgor PUPPINCK, CFJD
with the use of a E.C. DG III document
CLONING REGULATION IN THE COUNCIL OF EUROPE
I.I. Council of Europe Convention on Human Rights and Biomedicine
This convention "is supposed to" put the interest of human beings before the interests of science or society. This is a mandatory principle except in certain circumstances where "public health or safety are at risk or where crime prevention or the rights and freedoms of others may be seriously jeopardised".
Article 18 - Research on embryos in vitro - provides that "Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. The creation of human embryos for research purposes is prohibited".
There is actually an attack against this article, through the future additional protocol on embryo protection.
The convention was opened for signature in Oviedo on 4 April 1997. It entered into force on 1st December 1999 in Denmark, Greece, San Marino, Slovakia and Slovenia (the first five states having ratified it). This text also entered into force for Spain on 1 January 2000 and will enter into force for Georgia on 1st March 2001. 22 other States have signed it.
I.II. Council of Europe Protocol banning human (reproductive) cloning
The Protocol on the Prohibition of Cloning Human Beings entered into force on the 1st of March 2001, after the required five ratifications - from Slovakia (22.10.98), Slovenia (05.11.98), Greece (22.12.98), Spain (24.01.2000) and Georgia (22.11.2000).
This Additional Protocol to the Council of Europe Convention on Human Rights and Biomedicine is designed to prevent abuses of such techniques by applying them to humans, banning "any intervention seeking to create a human being genetically identical to another human being, whether living or dead," i.e. reproductive cloning.
The Protocol leaves it to countries' domestic law to define the scope of the term "human being".
Cloning of cells and tissues for research purposes covers three situations: cloning of cells as a technique, use of embryonic cells in cloning techniques, and cloning of human beings. The third situation, the prohibition of cloning human beings, is within the scope of this Protocol. The second situation will be examined in a protocol on embryo protection (still under process in the CDBI).
The Protocol has also been signed by 24 countries: Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Moldova, the Netherlands, Norway, Poland, Portugal, Romania, San Marino, Sweden, Switzerland, "the former Yugoslav Republic of Macedonia" and Turkey.
I.III. Futures additional protocols to this convention
Drafting work on protocols, done by an intergovernmental group (CDBI) concern :
- protection of the human embryo and fetus; (The CDBI has huge difficulties finding an agreement). The USA is an observer in this group and may have all the documents
- biomedical research : this draft is currently being finalised and should be declassified for public consultation before the end of the year;
- transplantation of human organs and tissue: This draft has been sent to the Parliamentary Assembly for a second debate at a Plenary Session. It must then be submitted to the Committee of Ministers for final adoption;
EMBRYO REGULATION IN EU COUNTRIES
II.I No position
Portugal does not have any legislation regulating medically assisted procreation and the status of the in vitro embryo. However on 1 April 1997, the National Council on Ethics for the Life Sciences (CNEV) adopted Opinion 21/CNEV/97 on the ethical implications of cloning, following a formal request from 15 representatives of the National Parliament, (27 February 1997). The Opinion recommended that cloning should be prohibited.
Law No. 94-654 of 29 July 1994 and its amendments restrict the use of reproductive technology to procreative cases. Research can be carried out only where it is seen to offer direct benefit to the embryo or to reproductive medicine. This has been supplemented by Decree No. 97 - 613 of 27 May 1997, inserting a new section into Division 2 of the French Public Health Code. The consent of both donors is required, and a 7-day time limit with specific prohibitions on certain types of research is imposed.
The National Ethical Consultative Committee for Life and Health Sciences, established in 1983, (CCNE) expressed opposition to Directive 98/44/EC on the patenting of biotechnological inventions, but accepted with a very small majority the "therapeutic cloning" (2001-01-18) . The French prime minister, Lionel Jospin also gave his support to "therapeutic cloning". The President Jacques Chirac has an ambiguous position, mostly against cloning on new "embryos". He prefers using adult stem cell technics.
This year, and every five years, the "bio-ethic " laws (of 29 July 1994) will be re-vote on.
Belgium does not have a legislative framework for therapeutic cloning. Research touching on this type of cloning, like other human experimentation, is not subject to any national protocol, but research projects are under the control of local ethics committees.
Yvon Englert, Vice-President of the Consultative Committee on Biothethics, has suggested that Belgium could be inspired by recent British legal developments. There are current proposals to allow research on embryos under the tightest conditions. A report from the Bioethics Committee is expected at the end of 2001.
In September 2000 the Minister of Health instituted a committee, presided over by Nobel Prize winner Renato Dulbecco. It aimed at monitoring research from a scientific and ethical perspective. In December 2000, the committee published its conclusions. Its opinion was divided - some members absolutely rejected all research on embryonic stem cells, while others highlighted the "potential" benefits of such research.
The 1988 Law on Techniques of Assisted Reproduction states that research can take place within the first 14 days with the progenitor's consent. However, it must be applied research of a diagnostic character or have a therapeutic purpose. Non-therapeutic research is permitted "on non-viable embryos and where it cannot be undertaken on an animal". Section 20 prohibits "human cloning", without precision. The Spanish Committee of Experts on Cloning published a report in June 1999 supporting legislation to lift the existing ban on cloning in order to allow the creation of tissue to cure certain diseases. It strictly opposed the legalisation of the reproductive cloning of human beings.
Embryo research is governed by two statutes, the Swedish "in vitro" Fertilisation Act 1988 and the Act Concerning Measures for Research or treatment involving Fertilised Human Ova 1991. The 1988 Act regulates the practice of assisted reproduction and permits some research on human embryos. The research must be performed within 14 days of fertilisation and can be carried out only with the consent of the progenitors. Any research which seeks to genetically modify the embryo is prohibited. Once the research process has been completed the embryo must be destroyed. The implantation of a research embryo "in utero" is absolutely forbidden. The 1991 legislation addresses the issue of embryo storage. The period for which an embryo may be cryopreserved has been extended from one year to five years following amendments to the law in 1988.
II.II. Countries with "liberal" legislation
The Human Fertilisation and Embryology Act 1990 created a regulatory authority responsible for licensing the practice of embryo research. Licences were issued only for research conducted before the "primitive streak" at 14 days. In January 2001 the House of Lords voted in favour of allowing the Human Fertilisation and Embryology Authority, a public and independent authority supervising research into embryos and IVF techniques, to authorise research into therapeutic cloning.
In September 2000 a bill governing intervention on human gametes and embryos ("Embryos Bill") was put before Parliament and is expected to be debated during 2001. The Bill contains a number of bans on procedures involving gametes and embryos - such as the production of genetically identical individuals, the production of human/animal combinations and the application of sex-selection techniques. Other procedures involving gametes and embryos are made contingent on certain conditions (i.e. consent, therapeutic purposes). Research must satisfy certain criteria (listed in the Bill) and must not be performed without a research proposal having first been approved. The Bill includes the provision that, as soon as is deemed appropriate, the total ban on the creation of embryos for research purposes can be replaced by a ruling which permits this, under strict conditions.
The Ethics Committee has accepted at the end of February the "therapeutic cloning".
Law No. 460 of June 1997 which regulates artificial fertilisation in connection with treatment, diagnosis and research. Article 25 of the law states that embryo research can take place only where the purpose is to improve in vitro fertilisation techniques or preimplantation diagnosis. All research projects are subject to the approval of an ethics committee.
The April 1999 Medical Research Act establishes a 14-day time limit on embryo research, which is subject to the prior consent of the progenitors. Section 13 states that the creation of embryos purely for the purposes of research is prohibited. Chapter 3 specifies that research can be performed only by agencies with the appropriate licence from the National Authority for Medico - Legal Affairs. Section 14 states that research on a fetus must be done only with the written consent of the pregnant woman. Section 15 explicitly prohibits any research which has the objective of modifying the genetic line unless undertaken for the purpose of preventing or curing a serious hereditary disease.
Embryo research is not subject to explicit regulation, but falls under the terms of the General Council for Health Statement of 1988, which specifies that embryo research is permitted until 14 days post conception with the approval of the appropriate ethics committee. The statement explicitly prohibits reproductive cloning.
II.III "Conservative" legislation
The eighth amendment to the 1983 Constitution Act acknowledges the right to life of the unborn, with due regard to the equal right to life of the mother. This is interpreted as an absolute prohibition on embryo research.
Embryo research is tightly constrained by the 1992 Act on Procreative Medicine. The central principle of this legislation is that reproductive medicine is permissible only within a stable heterosexual relationship for the purposes of procreation. Embryo donation is forbidden and the number of ova that can be fertilised is restricted.
The current government will not change this legislation.
The 1992 Embryo Protection Act is a criminal statute with sentences up to five years imprisonment for those who breach its provisions. The law prohibits all forms of consumptive research on human embryos and it is an offence to attempt to fertilise an egg for any purpose other than bringing about a pregnancy. However, the law covers only in utero implantation and, while expressly forbidding human cloning, does not outlaw the removal of embryonic stem cells from cadaveric fetuses. Germany has promised to support the French in their demand for the revision of Directive 98/44/EC on the patenting of biotechnological inventions. Julia Nida-Rmelin, Federal Minister of Culture, has taken a controversial stand explaining that the cloning of embryos does not undermine human dignity. Gerhard Schroder is advocating a debate in Parliament.
A.I. CHRONOLOGY OF EVENTS
(Source : European Commission)
20 July 1988
Proposal for a Council Decision adopting a specific research programme in the field of health: Predictive Medicine: Human Genome Analysis ( 1989-1991 )
/* com/88/424final - syn 146 */ (Official Journal C 027 , 02/02/1989 p. 0006 )
19 December 1988
Rothley Report (Committee on Legal Affairs and Citizens' Rights) on the ethical and legal problems of genetic engineering. (A2-327/88)
30 January 1989
Haerlin Report (Committee on Energy, Research & Technology) on Predictive Medicine: Human Genome Analysis (A2-0370/88)
30 January 1989
Casini Report (Committee on Legal Affairs and Citizens' Rights) on artificial insemination "in vivo" and "in vitro" . (A2 372/88)
15 February 1989
Legislative Resolution (Cooperation procedure - first reading) setting out the opinion of the European Parliament on the proposal from the Commission to the Council for a decision adopting a Specific Research and Technological Development Programme in the field of Health: Predictive Medicine: Human Genome Analysis (1989 - 1991) (Official Journal C 069 , 20/03/1989 P. 0095)
16 March 1989
EP Resolution on artificial insemination " in vivo " and " in vitro " (Official Journal C 096 , 17/04/1989 p. 0171) called for the number of embryos to be limited to what can be successfully implanted and for the prohibition of any experimentation outside the womb. It stated that embryos should not be cryopreserved under any circumstances for a period in excess of three years.
16 March 1989
EP Resolution on the ethical and legal problems of genetic engineering (Official Journal C 096, 17/04/1989 p. 0165) called for legislation prohibiting any gene transfer to human germ line cells and defining the legal status of the human embryo in order to provide unequivocal protection of genetic identity. It stated that the zygote needed protection and must not be subject to arbitrary experimentation, that it should be a criminal offence to keep embryos alive with a view to removing tissues or organs as the need arose and that human cloning should be a criminal offence. It stated that research on human embryos would be justified only "if they are of direct and otherwise unattainable benefit in terms of the welfare of the child concerned and its mother and respect the physical and mental integrity of the woman.'
16 April 1990
Decision (Cooperation procedure: second reading) on the common position drawn up by the Council with a view to the adoption of a decision on a Specific Research and Technological development programme in the field of Health: Human Genome Analysis (1990 -1991)
Official Journal C 149 , 18/06/1990 p. 0080
11 June 1990
Re-examined Proposal for a Council Decision adopting a Specific Research and Technological Development Programme in the field of Health: Human Genome Analysis ( 1990-1991 )
/* COM/90/251FINAL - SYN 146 */
29 June 1990
Council Decision 90/395/EEC adopting a specific Research and Technological Development Programme in the field of Health: Human Genome Analysis (1990 to 1991) (Official Journal L 196 , 26/07/1990 p. 0008 ). Objectives included: the use and improvement of new biotechnologies in the study of the human genome for a better understanding of the mechanisms of genetic functions as well as the prevention and treatment of human diseases; drawing up an integrated approach to the medical, ethical, social and legal aspects of possible applications of results to ensure that they were not misused; establishing a set of bioethical principles to be followed for future developments. The alteration of germ cells at any stage of embryo development with the aim of modifying human genetic characteristics in a hereditary manner was excluded.
28 October 1993
EP Resolution on the cloning of the human embryo (Official Journal, C 315 , 22/11/1993 p. 0224)
1 March 1995
Decision on the joint text approved by the Conciliation Committee for a European Parliament and Council Directive on the legal protection of biotechnological inventions (C4- 0042/95 - 94/0159(COD) rejected by the EP by 240 votes against, 188 for and 23 abstentions. (Official Journal C 068 , 20/03/1995 p. 0026)
24 October 1995
Directive 95/46/EC of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data
(Official Journal L 281 , 23/11/1995 p. 0031 - 0050)
13 December 1995
Commission adopted a new proposal for a directive on the protection of biotechnological inventions.
28 February 1997
Commission requested an opinion from its Group of Advisers on the Ethical Implications of Biotechnology (GAEIB) on the ethical implications of cloning techniques, in particular animal cloning, and their potential impact on human beings.
12 March 1997
EP resolution B4-0209 on the cloning of human beings, (Official Journal No. C 115 , 14/04/1997 P. 0092). In response to the ethical issues surrounding cloning and the alarm caused by the production of a sheep cloned from an adult cell, the resolution urged Member States to ban the cloning of human beings and urged the Commission to report any research carried out in this field and on the legal framework in the Member States. Proposals concerning the establishment of an EU Ethics Committee to monitor developments in the area of gene technology were also requested.
30 April 1997
Proposal for a Parliament and Council Decision regarding the Fifth Framework Programme of the European Community for Research, Technological Development and Demonstration Activities (1998-2002) - Article 6 concerning compliance with fundamental ethical principles.
6 June 1997
EP Resolution on the mandate of the European Commission's Group of Advisers on the Ethical Implications of Biotechnology (GAEIB) reaffirming its belief that it was essential to establish ethical standards, based on respect for human dignity, in the areas of biology, biotechnology and medicine, and that such standards should apply, if possible, globally and afford a high level of protection. The Commission was asked to bring forward proposals to guarantee Parliament's involvement in ethical questions relating to biotechnology.(Official Journal C 200 , 30/06/1997 p. 0258)
16-17 June 1997
Declaration by the European Council in Amsterdam on banning the cloning of human beings, requesting that the Council and Commission confirm this by incorporating their amendments into the directive on the legal protection of biotechnological inventions (Official Journal C222, 21/07/1997, p.0017)
16 July 1997
Parliament adopted amendments to the Commission proposal for the directive on legal protection for biotechnological inventions.
15 January 1998
EP Resolution B4-0050/98 on the cloning of human beings (Official Journal C 034, 02/02/1998 p. 0164) called on Member States to sign and ratify the Council of Europe 'Convention on the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine' (Bioethics Convention) and its additional protocol prohibiting human cloning. The EU Member States and the UN were also requested to take all the necessary steps to bring about a legally binding ban on the cloning of human beings.
10 June 1998
Proposal for a Council decision concerning a Specific Programme for Research, Technological Development and Demonstration on Quality of Life and Management of Living Resources - footnote 8 on ethical requirements.
6 July 1998
Directive 98/44/EC of the European Parliament and the European Council on the legal protection of biotechnological inventions stipulated what was and was not patentable in the area of living organisms, together with the precise significance of the intellectual property rights conferred by a patent. It cited patenting as being out of the question for all processes resulting from research on embryos that were not for direct benefit, inventions based on modification to the genetic identity of human germ line cells and cloning process for the purposes of human reproduction.
11 September 1998
Commission requested the opinion of the EGE on amendment N 36 tabled by the European Parliament, which proposed to exclude from Community funding research projects that "result in the destruction of human embryos" in the context of deciding on the Fifth Framework Programme.
22 December 1998
Decision No 182/1999/EC of the European Parliament and the Council concerning the Fifth Framework Programme of the European Community for Research, Technological Development and Demonstration Activities 1998 to 2002 (Official Journal L 026 , 01/02/1999 p. 0001 - 0033)
25 January 1999
Council Decision 1999/167/EC adopting a Specific Programme for Research, Technological Development and Demonstration on Quality of Life and Management of Living Resources, 1998-2002. (Official Journal L 064 , 12/03/1999 p. 0001 - 0019) stated that 'no research activity which modifies or is intended to modify the genetic heritage of human beings by alteration of germ cells or by acting at any other stage in embryonic development and which can make such alteration hereditary will be supported under the present framework programme. In the same way, no research activity understood in the sense of the term 'cloning', with the aim of replacing a germ or embryo cell nucleus with that of the cell of any individual, a cell from an embryo or a cell coming from a later stage of development to the human embryo, will be supported.'
30 March 2000
EP Resolution B5-0288 on the decision by the European Patent Office with regard to patent No EP 695 351 granted on 8 December 1999 objected to the University of Edinburgh being granted a patent which could be used to cover the cloning of human beings. It called for this patent to be revoked and for the swift incorporation of Directive 98/44/EC on the legal protection of biotechnological inventions into national law.
6 September 2000
Commissioner for Research, Philippe Busquin, addressed the EP during a debate on human cloning in which he highlighted the importance of shared ethical values through Europe and 'Commission plans to adopt initiatives such as strengthening the links between ethics committees across Europe and the exchange of good practice in the ethical assessment of research projects.' He also reiterated Mr Prodi's hopes that there could be an enlightened debate in close co-operation with the EP on the value of research into human embryo stem cells and their therapeutic application within a legal and ethical framework.
7 September 2000
EP rejected a joint motion for a resolution on the cloning of human embryos for therapeutic ends.
7 September 2000
EP resolution B5-0710 on human cloning emphasised the need to respect human dignity and human life, called on the UK Government to review its position on human embryo cloning and repeated calls for each Member State to enact binding legislation prohibiting all research into human cloning and to provide for criminal penalties. It stated that any temporary committee set up by the EP on human genetics should take previous resolutions into account and examine questions on which the EP had not yet expressed a clear position.
7 September 2000
Conference of Presidents discussed the powers, composition and term of office of the Temporary Committee on Human Genetics (temporary committee responsible for considering the ethical and legal issues raised by new developments in human genetic engineering).
19 October 2000
Letter from Mr. Behrend (Secretary - General, of the VERTS/ALE Group), forwarding a proposal drawn up by the political group co-ordinators concerning the powers and responsibilities, membership and terms of reference of the Temporary Committee on Human Genetics and Other New Technologies in Modern Medicine. (PE 296.482)
13 December 2000
EP Decision to set up a Temporary Committee on Human Genetics and Other New Technologies of Modern Medicine (B5-0898/2000)
16 January 2001
First meeting of the Temporary Committee on Human Genetics and other New Technologies of Modern Medicine.
29-30 January 2001
Temporary Committee on Human Genetics and other New Technologies of Modern Medicine hearing with experts Professor Derek Burke, member of the Life Sciences High Level Group and Ms Noelle Lenoir, chair of the Commission's European Group on Ethics.
RELATED DOCUMENTS & EVENTS
The first successful cloning experiment in vertebrae animals, frogs, was reported.
James Watson (Winner, with Francis Crick and Maurice Wilkins, of the 1962 Nobel Laureate in Medicine for discovering the structure of DNA) wrote an essay for Atlantic Monthly called "moving towards clonal man" - in it he warned that human clones were coming and society was unprepared.
The first baby conceived by "in vitro" fertilisation outside the mother's body is born in the United Kingdom. No specific regulations in existence concerning human embryo research.
24 September 1986
Recommendation 1046 of the Parliamentary Assembly of the Council of Europe on the use of human embryos is adopted., forbidding "the creation of identical human beings by cloning or any other methods".
21 October 1988
An initial proposal for a directive on the protection of biotechnological inventions is adopted by the European Commission.
2 February 1989
Council of Europe Parliamentary Assembly Recommendation 1100 on the use of human embryos and fetuses in scientific research to the effect that the Committee of Ministers should provide a framework of principles from which national laws or regulations can be developed in as universal and uniform a manner as possible and encourage Member States to increase the level of public information and understanding concerning biomedicine and human reproduction.
20 November 1991
A Group of Advisers on the Ethical Implications of Biotechnology (GAEIB) is set up by the Commission, composed initially of six experts - later expanded to nine - in various fields and from different countries.
14 April 1994
Council of Europe Parliamentary Assembly Recommendation 1240 on the protection and patentability of material of human origin, asking the Committee of Ministers to adopt the text of the Bioethics convention, thereby providing Europe with a reference to fundamental moral principles in the field of bioethics, and to initiate preparation of a protocol to the draft convention setting limits to the application of the genetic manipulation of human beings.
5 July 1996
Birth of a cloned lamb in the UK by the transfer of a nucleus from an adult lamb.
19 November 1996
Council of Europe Parliamentary Assembly Opinion No.184 for the Protection of Human Rights and the Dignity of the Human Being with regard to the Application of Biology and Medicine (Bioethics Convention) is adopted by the Committee of Ministers. DIR/JUR(96)14.
4 April 1997
The Bioethics Convention is signed. Article 13 implicitly forbids the cloning of human beings.
14 May 1997
50th World Health Assembly meeting in Geneva adopts a resolution affirming that the use of cloning for the replication of human beings is ethically unacceptable and contrary to human dignity and morality. The Director General was requested to inform Member States in order to foster a public debate on the issues.
28 May 1997
GEAIB submits opinion No.9 to the Commission on the ethical aspects of cloning techniques in which it states 'particular attention should be paid to the need to preserve genetic diversity ... any attempt to produce a genetically identical human individual by nuclear substitution from a human adult or child cell ('reproductive cloning') should be prohibited ...The European Community should clearly express its condemnation of human reproductive cloning ... in the relevant texts and regulations in preparation.' It calls for a distinction between cloning and embryo splitting, and therapeutic and reproductive cloning.
16 July 1997
Steering Committee on Bioethics (CDBI) gives opinion to the Council of Europe Parliamentary Assembly on the draft additional protocol to the Bioethics Convention on the prohibition of the cloning of human beings. 'Considering the purpose of the Convention on Human Rights and Biomedicine, in particular the principle mentioned in Article 1 aiming to protect the dignity and identity of all human beings, the CDBI is of the opinion that specific binding provisions should be adopted within the Council of Europe to prohibit any intervention seeking to create a human being genetically identical to another human being, whether living or dead'.
31 July 1997
Expiry of the mandate of the GAEIB.
23 September 1997
Council of Europe Parliamentary Assembly Opinion No.202 recommending the rapid adoption of the draft additional protocol to the Convention on Human Rights and Biomedicine on the prohibition of the cloning of human beings.
10 -11 October 1997
Final Declaration adopted by the Second Summit of the Council of Europe, in which the Heads of State and Government undertook to prohibit all use of cloning techniques aimed at creating genetically identical human beings and instructed the Committee of Ministers to adopt an additional protocol to the Bioethics Convention.
6 November 1997
Council of Europe adopts the Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Human Beings.
11 November 1997
Universal Declaration on the Human Genome and Human Rights and a resolution for its implementation adopted by the General Conference of the United Nations Educational, Scientific and Cultural Organisation (UNESCO) Article 5b stated the need for prior free and informed consent for research and treatment. Article 6 stated no one should be subject to discrimination based on genetic characteristics. Article 11 asserted that practices contrary to human dignity such as reproductive cloning should not be permitted.
11 December 1997
The GAEIB issues Opinion No.10 on the ethical aspects of the 5th Framework Research Programme. Article 2.3 stated that the Commission should ensure that an ethical assessment is made of the research projects submitted to it, that the analysis of ethical questions on controversial research issues such as gene therapy (excluded from the Framework Programme) should be undertaken and studies should take place on interaction between research development and society. It Recommended the Commission set up an information system concerning all the related legal and ethical data at international and national levels, which should be regularly updated.
16 December 1997
The European Group on Ethics in Science and New Technologies (EGE) replaces the GAEIB. The EGE, essentially similar to national ethics committees, should be independent, multi-cultural and multi-disciplinary.
12 January 1998
The additional protocol to the Bioethics Convention relating to the prohibition of cloning of human beings is signed.
7 May 1998
Executive Board of UNESCO established the International Bioethics Committee
23 November 1998
Opinion No.12 of the EGE considers that, according to the ethical dimension of the Community's Fifth Framework Programme, respect for pluralism of cultures and ethical approaches in Europe, which is reflected by the extreme diversity of national regulations, should not a priori exclude European financial support for human embryo research carried out in countries where it is permitted, but that this funding should be granted only under strict conditions. This type of research is forbidden by law, notably in Germany, Austria and Ireland. In France research projects that ultimately lead to the destruction of the embryo are prohibited. However, studies which do not interfere with the integrity of the embryo are permitted. In Denmark, the United Kingdom, Spain and Sweden human embryo research is allowed by law under certain conditions. Laws concerning this issue are at the preparatory stage in the Netherlands, Belgium and Finland.
8 December 1998
Joint report in the UK by the Human Genetics Advisory Commission and the Human Fertility and Embryology Association recommending that human cloning be banned but that the 1990 Human Fertility and Embryology Act be altered for therapeutic uses.
9 December 1998
United Nations General Assembly Resolution 53/152 endorsed the Declaration on the Human Genome and Human Rights. It Stated that it was convinced of the need to develop international rules and develop a life sciences ethic at national and international levels. It invited governments to establish independent, multidisciplinary and pluralist committees of ethics, notably in conjunction with the International Bioethics Committee, with a view to promoting exchanges of experience.
3 February 2000
Report of the EGE on the Charter of Fundamental Rights in relation to new technology, emphasizing the serious risk of the instrumentalisation of human beings through genetic manipulation. This is deemed ethically unacceptable but it is acknowledged that it could become a reality at a time when human power over life is increasing considerably.
UK Department of Health Report from the Chief Medical Officer's Expert Group reviewing the potential of developments in stem cell research and cell nuclear replacement to benefit human health. The report concludes that the great potential to relieve suffering and treat disease means that research is warranted across the whole range of possible sources of stem cells in the first instance, including embryos. Provided the need to use embryos created by cell nuclear replacement is clearly demonstrated on a case by case basis with proper consent of the donors and under the regulatory control of the Human Fertilisation and Embryology Authority, the Expert Group is willing to support it and concludes that the potential benefit of discovering the mechanism for reprogramming adult cells and thereby providing compatible tissue for treatment justifies this transitional research involving the creation of embryos by cell nuclear replacement.
14 November 2000
Opinion No 15 of the EGE attached to the Commission, "Ethical Aspects of Human Stem Cell Research and Use", recommending that a specific Community budget for research on alternative sources, especially adult stem cells, be provided and an ethical assessment of research on stem cells financed by Community appropriations be carried out before the launching of a project and also when monitoring its implementation.
7 December 2000
The Charter of Fundamental Rights, is proclaimed at the European Summit of Nice. Under Article 3 of Chapter 1 on Dignity the reproductive cloning of human beings is prohibited.
17 December 2000
British MPs vote in favour of allowing scientists to harvest special stem cells for early stage embryos in order to grow skin and organ tissue for research. This vote is passed as an amendment to the 1990 Human Fertilisation and Embryology Act, which allows 14-day-old embryos left over from IVF treatment to be used for research on infertility only.
11 January 2001
Scientists at the Oregon Regional Primate Research Centre in the United States produce the first genetically modified monkey.
22 January 2001
Members of the House of Lords approve government plans to allow the cloning of human embryos for research purposes. They also decide that a select committee should begin an inquiry into the implications of the decision.
Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings
The member States of the Council of Europe, the other States and the European Community Signatories to this Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine,
Noting scientific developments in the field of mammal cloning, particularly through embryo splitting and nuclear transfer;
Mindful of the progress that some cloning techniques themselves may bring to scientific knowledge and its medical application;
Considering that the cloning of human beings may become a technical possibility;
Having noted that embryo splitting may occur naturally and sometimes result in the birth of genetically identical twins;
Considering however that the instrumentalisation of human beings through the deliberate creation of genetically identical human beings is contrary to human dignity and thus constitutes a misuse of biology and medicine;
Considering also the serious difficulties of a medical, psychological and social nature that such a deliberate biomedical practice might imply for all the individuals involved;
Considering the purpose of the Convention on Human Rights and Biomedicine, in particular the principle mentioned in Article 1 aiming to protect the dignity and identity of all human beings,
Have agreed as
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