Austria
Decision of the Bioethics Commission at the Federal Chancellery of 12 February 2003
1. General:
“…In light of these preconditions, the Commission’s rejection of reproductive cloning... reproductive cloning is considered to be a process that is to be rejected …”
3. Recommendation
“…However, at the same time, it would have to be clearly evident from the formulation that this ban involves a deterrent measure from which no assessment can be derived about so-called therapeutic cloning.”
Belgium
Law on Research in Embryos In Vitro (11 May 2003)
-“Everything that is not forbidden by this law is allowed”
-The law does not prohibit therapeutic cloning.
Article 4, Section 1:
The creation of embryos for research is forbidden except when the research goal cannot be achieved by research on supernumerary embryos and when the conditions of the law are fulfilled.
Article 5, Section 2:
Embryos on which research has been conducted should not be placed into a woman except when the research had a therapeutic goal for the embryo itself or when it concerns an observational method that does not harm the integrity of the embryo.
Article 6: Reproductive human cloning is banned.
Bulgaria
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
Oviedo , 4.IV.1997
Chapter V – Scientific Research
Article 18 – Research on embryos in vitro
1. Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo
2. The creation of human embryos for research purposes is prohibited
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
Paris , 12.I.1998
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.
Having agreed as follows:
Article 1:
1. Any intervention seeking to create a human being genetically identical to another human being, whether living or dead, is prohibited.
2. For the purpose of this article, the term human being “genetically identical” to another human being means a human being sharing with another the same nuclear gene set.
Article 4:
…A signatory may not ratify, accept, or approve this Protocol unless it has previously or simultaneously ratified, accepted or approved the Convention...
Croatia
See Bulgaria :
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 ; and
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
Cyprus
See Bulgaria :
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; and
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
Czech Republic
See Bulgaria :
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; and
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
Act on Research on Human Embryonic Stem Cells and Related Activities and on Amendment to Some Related Acts - 227/2006
Section 3
Conditions for research on human embryonic stem cells
(1) Research on human embryonic stem cells may be conducted only on the basis of a permission issued by the Ministry of Education, Youth and Sport (hereinafter referred to as the “Ministry”). This research may be conducted only on workplaces listed in the permission for research on human embryonic stem cells.
(2) Research on human embryonic stem cells may conducted only
a) on imported lines, provided that they were obtained from human embryos in such a way that does not object to the Czech legislation or legislation of the country of origin; their import was permitted by the Ministry and the only reason for their import into the Czech Republic is their usage for research purposes under this Act; or
b) on the lines obtained from redundant human embryos in the Czech health care institutions providing assisted reproduction under a separate regulation1) (hereinafter referred to as the “centre for assisted reproduction”).
(3) Such manipulations with human embryonic stem cells must be prevented within the research which could lead to creation of a new human individual (reproductive cloning).(4) Both lines and human embryos intended for obtaining human embryonic stem cells must be protected against theft or using them for activities being inconsistent with the regulations.
Denmark
Law No 427 of 10 June 2003 amending the Law on artificial fertilization in connection with medical treatment, diagnosis, and research (Research on embryonic stem cells)
Sec. 25 of Law No. 460 of 10 June 1997 is amended to read as follows:
(1) Biomedical experimentation on fertilized human oocytes and gametes intended for use in fertilization may only be carried out in the following cases:
1. for the purpose of improving in vitro fertilization or similar techniques intended to bring about pregnancy;
2. in order to improve techniques for the genetic testing of a fertilized oocyte with a view to establishing the possible presence of a serious hereditary disease or an important chromosome abnormality (preimplantation diagnosis); and
3. if the purpose of experiments involving the use of fertilized oocytes and stem cells derived there from is to obtain new knowledge that could improve the possibilities of treating diseases in human beings
(2) The removal and fertilization of an oocyte in order to carry out experiments other than those referred to in subsection 1 shall be prohibited.”
Estonia
See Bulgaria :
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; and
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
Finland
No. 488/1999 Medical Research Act
Chapter 1: General Provisions
Section 2: Definitions
(2) embryo means a living group of cells resulting from fertilization not implanted in a woman’s body;…
Chapter 3: Research involving embryos and fetuses
Section 11: Conditions governing research involving embryos
…Medical research on embryos is permitted only if no more than 14 days have passed from their formation. The time during which an embryo is kept frozen shall not count for the purposes of calculating this time limit.
Section 13: Restrictions on research on embryos
- The production of embryos exclusively for the purpose of research shall be forbidden…
- …Research may use embryos that have been stored for up to 15 years, after which the embryos must be destroyed.
Section 15: Prohibited research
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.
European Commission, Directorate General: Research. Survey on opinions from National Ethics Committees or similar bodies, public debate and national legislation in relation to human embryonic stem cell research and use. July 2004, Volume I, p. 17.
“The Act on Medical Research (No. 488/1999) covers the preconditions and use of human embryos up to 14 days. The production of human embryonic stem cell from supernumerary embryos is allowed, production of embryos only for research purposes is not allowed. The Act defines also embryo as a fusion of gametes, so the embryo produced by nuclear transfer is not an embryo. Research on reproductive cloning is prohibited in this act. The laboratories that do embryo research need a lisence from the National Authority for Medicolegal Affairs. Written consent from both gamete donors is required.”
Note – Finland is categorized with green and yellow stripes because it does not explicitly permit SCNT to derive new embryonic stem cell lines. However, it is understood that by not prohibiting the technique in the law above, SCNT is allowed in Finland .
France
Bioethics Law in France (2004) (in French) (summary in English here)
Updated
Act 2011-814 on Bioethics (2011) ( in french)
The Law maintains the principle of prohibition of research on embryos and embryonic stem cells, which is only permitted in exceptional cases, subject to approval by the Biomedicine Agency. The following conditions must be met for the research to be authorized:
(1) the scientific importance of the research project must be established;
(2) the research is likely to lead to a major medical breakthrough;
(3) it is expressly established that the result hoped for cannot be achieved by any other means of research; and
(4) the research project and its implementation respect all the ethical principles on research on embryos and embryonic stem cells. In conducting their experiments, researchers may use only surplus embryos from IVF treatments. (Id. arts. 40-44.)
Germany
German parliament passes amendment to stem cell act
By adopting the bill the Bundestag has now decided to move this cut-off date from 1st January 2002 to 1st May 2007. Other proposals had called for maintaining the old cut-off date, for the replacement of the cut-off date regulation by an examination on a case-by-case basis, or even suggested a complete ban on the possibility of importation. By adopting the proposal with 346 out of 580 votes, the members of the Bundestag have also specified the scope of application of the Stem Cell Act: as it explicitly refers to the utilization of human embryonic stem cells in Germany, the work of German scientists abroad (e.g. in the context of international projects) will no longer constitute a criminal offence.
Stammzellgesetz – StZG (For English version, click here)
28 June 2002 (Unofficial Translation)
Section 3: Definitions
2. embryonic stem cells mean all pluripotent stem cells derived from embryos which have been produced in vitro and have not been used to induce pregnancy or which have been taken from a woman before completion of nidation…
Section 4: Importation and utilization of embryonic stem cells
(1)The importation and utilization of embryonic stem cells shall be prohibited.
(2) Notwithstanding part 1, the importation and utilization of embryonic stem cells for research purposes shall be permissible under the conditions stipulated in section 6 if
a. the competent agency has satisfied itself that
i. the embryonic stem cells were derived before 1 January 2002 in the country of origin in accordance with relevant national legislation there and are kept in culture or are subsequently stored using cryopreservation methods (embryonic stem cell line),
ii. the embryos from which they were derived have been produced by medically-assisted in vitro fertilization in order to induce pregnancy and were definitely no longer used for this purpose and that there is no evidence that this was due to reasons inherent in the embryos themselves,
iii. no compensation or other benefit in money’s worth has been granted or promised for the donation of embryos for the purpose of stem cell derivation and if
b. other legal provisions, in particular those of the German Embryo Protection Act , do not conflict with the importation or utilization of embryonic stem cells.
Section 5: Research using embryonic stem cells
Research involving embryonic stem cells shall not be conducted unless it has been shown by giving scientific reasons that
(1) such research serves eminent research aims to generate scientific knowledge in basic research or to increase medical knowledge for the development of diagnostic, preventive or therapeutic methods to be applied to humans and that,
(2) according to the state-of-the-art of science and technology,
a) the questions to be studied in the research project concerned have been clarified as far as possible through in vitro models using animal cells or through animal experiments and
b) the scientific knowledge to be obtained from the research project concerned cannot be expected to be gained by using cells other than embryonic stem cells.
Embryonenschutzgesetz – ESchG (For English version, click here )
13th December 1990
Section 1: Improper use of reproduction technology
(1) Anyone will be punished with up to three years imprisonment or a fine, who
(2) attempts to fertilise artificially an egg cell for any purpose other than bringing about a pregnancy of the woman from whom the egg cell originated…
Section 2: Improper use of human embryos
(1) Anyone who disposes of, or hands over or acquires or uses for a purpose not serving its preservation, a human embryo produced outside the body, or removed from a woman before the completion of implantation in the uterus, will be punished with imprisonment up to three years or a fine.
(2) Likewise anyone will be punished who causes a human embryo to develop further outside the body for any purpose other than the bringing about of a pregnancy.
(3) Any attempt is punishable.
Greece
Law 3089: Medically assisted human reproduction
“CHAPTER EIGHT MEDICALLY ASSISTED HUMAN REPRODUCTION”
Article 1455
Medically assisted reproduction (artificial fertilization) is permitted only in order to treat the incapacity to have children by natural way or to avoid the transmission of a severe genetic disease to the child. Such medical assistance is permissible up to the reproductive age of the assisted person. Human reproduction with the methods of cloning is prohibited…
Article 1459
Persons resorting to assisted reproduction should decide in common, declare their will in a written form and address it to the doctor or the responsible of the fertility clinic before starting the relevant treatment, whether any cryopreserved reproductive material that is not going to be used for their own treatment (surplus):
a) should be donated for fertility treatment of other persons that the doctor or the fertility clinic will decide,
b) should be used for research or therapeutic purposes,
c) should be destroyed.
In case there is no common declaration of the persons concerned, cryopreservation can last up to five years. After this period of storing, cryopreserved material can either be used for research and therapeutic purposes or be destroyed.
Non cryopreserved fertilized ova are destroyed after the completion of 14 days post – fertilization. Any intermediate cryopreservation period is neglected.
See Bulgaria :
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; and
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
Hungary
See Bulgaria :
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; and
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
Iceland
Regulation No. 568/1997 on Artificial Fertilization
Article 1: Definitions
“Artificial Fertilization” – conception as a result of artificial insemination or in vitro fertilization.
“Embryo” – fertilized ovum in any stage of development, from the time of fertilization until it develops into a fetus.
Article 11:
Gamete can only be stored for the purpose of:
a) personal use at a later time,
b) donation for research purposes, or
c) donation of gamete for use in artificial fertilization …
Article 13:
It is permitted to store embryos for the purpose of transplanting them into the woman who provided the ova or the wife or the cohabitant of the man who provided the sperm. The storage of embryos for other purposes is prohibited.
Article 22:
Any research, experiments and operations on embryos shall be prohibited.
Nevertheless, it is permitted to do research on embryos:
a) if it is part of an in vitro fertilization treatment,
b) if the intention is to diagnose hereditary diseases in the embryos themselves,
c) if the purpose is to advance the treatment of infertility, or
d) if the purpose is to increase understanding of the causes of innate disease and miscarriages
Article 23:
It is prohibited to:
a) cultivate or produce embryos solely for research purposes,
b) cultivate embryos for more than 14 days outside the body or once the primitive streak has appeared…
d) perform cloning
See Bulgaria :
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; and
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
Ireland
M R v. T R, et al [2006] IEHC 359
Judgment of Chief Justice McGovern 15/11/2006, in the High Court
“…These remarks seem to further confirm the linking of Article 40.3.3 with the abortion issue. If this is correct then it equates ‘unborn’ with an embryo which has implanted in the womb, or a foetus.”
“Human life may-or may not- being in a test-tube, but the mere existence of a fertilized egg in a test tube does not make the woman who produced the egg pregnant.”
“…Having considered the evidence and the submissions in this case and reviewed the law I have come to the conclusion that the three frozen embryos are not "unborn" with the meaning of Article 40.3.3. and it is a matter for the Oireachtas [“the people”] to decide what steps should be taken to establish the legal status of embryos in vitro.”
Italy
Law 40, 19 February 2004
Part 2 (Prohibited Practices);
Article 13 (Research on human embryos);
Section 9
(1) Research on any human embryo is prohibited.
(1) E' vietata qualsiasi sperimentazione su ciascun embrione umano.
(2) Clinical and scientific research on any human embryos is allowed only if aimed to therapy and diagnosis, with the purpose to preserve the health and the development of the same embryo, and only when no alternative methodologies are available.
(2) La ricerca clinca e sperimentale su ciascun embrione umano é consentita a condizione che si perseguano finalita esclusivamente terapeutiche e diagnostiche ad essa collegate volte alla tutela della salute e allo sviluppo dell’embrione stesso, e qualora non siano disponibili metodologie alternative.
(3) It is nevertheless prohibited:
(3) Sono, comunque, vietati:
(a) the production of human embryos for research purposes;
(a) la produzione di embrioni umani a fini di ricerca o di sperimentazione o comunque a fini diversi da quello previsto dalla presente legge;
(c) any form of cloning by pronuclear transfer, or by early cleavage of the embryo or by ectogenesis, either for procreation or for research;
(c) interventi di clonazione mediante trasferimento di nucleo o di scissione precoce dell’embrione o di ectogenesi sia a fini procreativi sia di ricerca;
European Commission, Directorate General: Research.Survey on opinions from National Ethics Committees or similar bodies, public debate and national legislation in relation to human embryonic stem cell research and use.
July 2004, Volume I, p. 33.
…The opinion of a local ethics committee is required prior to the import of hES cell lines.
Latvia
European Commission, Memo/05/121
Permits some research on supernumerary IVF embryos.
Lithuania
See Bulgaria :
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; and
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
Moldova
See Bulgaria :
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; and
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 Netherlands
Act containing rules relating to the use of gametes and embryos (Embryos Act)
Division 1. General Provisions
Section 1: In this Act the following words shall have the following meanings:
C. embryo: a cell or a complex of cells with the capacity to develop into a human being;
Section 3
1. Research involving embryos, including research involving gametes leading to the creation of embryos, shall be performed in accordance with a specially drafted research protocol which contains a full description of the intended research.
2. The research shall be permitted only if a favourable recommendation on the research protocol is received from the Central Committee.
Division 2. Rules governing control over gametes and embryos
Section 5
1. Adults who are capable of making a reasonable assessment of their interests in this regard may make their gametes available in order to induce pregnancy in another person or for research purposes, without prejudice to cases in which the gametes are intended for the said adult’ own medical use and without prejudice to Section 9.
Section 8
1. Adults who are capable of making a reasonable assessment of their interests in this regard may make available for the following purposes embryos which have been created outside the body for their won pregnancy, but which will no longer be used for this purpose:
…b. to culture embryonic stem cells for medical purposes, medical and biological research and medical and biological education
Division 3. Rules governing research with embryos outside the human body which does not induce pregnancy Section 10: The Central Committee shall deliver a favourable recommendation on a research protocol concerning research with embryos which does not induce pregnancy only if:
a. it can reasonably be assumed that the research will lead to new insights in the field of medical science;
b. it can reasonably be assumed that the insights referred to under a. cannot be achieved through any forms or methods of research other than research with the embryos in question or through a less invasive form of research;
c. the research in question meets the standards of proper research methodology;
d. the research is carried out by or under the direction of persons who are expert in the relevant research area;
e. the research also satisfies requirements which might reasonably be imposed on it in other respects.
Norway
Section 3-1 Use of supernumerary fertilized eggs for research
Leftover fertilized eggs and cells that stem from the fertilized eggs, can only be used for research for the purpose of:
-
1. 1. to develop and improve the methods and techniques for fertilization outside the body for the purpose of achieving pregnancy
-
2. 2. to develop and improve the methods and techniques for genetic examination of the fertilize eggs with a view to determining whether there is a serious monogene or kromosomal hereditary disease (preimplantasjonsdiagnostikk)
-
3. 3. to achieve new knowledge with a view to future treatment of a serious illness in humans
Ot.prp. nr. 26 (2006-2007) Om lov om endringer i bioteknologiloven (preimplantasjonsdiagnostikk og forskning på overtallige befruktede egg)
Kapittel 3 Forskning på overtallige befruktede egg , kloning m.m.§ 3–1 skal lyde:
§ 3–1 Bruk av overtallige befruktede egg til forskning
Overtallige befruktede egg og celler som stammer fra overtallige befruktede egg, kan bare anvendes til forskning når formålet er:
1. å utvikle og forbedre metoder og teknikker for befruktning utenfor kroppen i den hensikt å oppnå graviditet
2. å utvikle og forbedre metoder og teknikker for genetisk undersøkelse av befruktede egg med henblikk på å fastslå om det foreligger alvorlig monogen eller kromosomal arvelig sykdom (preimplantasjonsdiagnostikk)
3. å oppnå ny kunnskap med sikte på framtidig behandling av alvorlig sykdom hos mennesker
Ny § 3–2 skal lyde:
§ 3–2 Vilkår for bruk av overtallige befruktede egg til forskning
Forskning som nevnt i § 3–1 er kun tillatt på befruktede egg som har blitt overtallige etter befruktning utenfor kroppen med sikte på fertilitetsbehandling eller preimplantasjonsdiagnostikk. Det er ikke tillatt å befrukte egg for forskningsformål alene.
Forskning på befruktede egg må ikke foretas senere enn 14 dager etter at egget ble befruktet. Den tiden befruktede egg er lagret nedfryst, medregnes ikke.
Befruktede egg som har vært gjenstand for forskning må ikke settes inn i en kvinne, men skal destrueres.
Forskning som medfører genetiske forandringer som kan gå i arv hos mennesker, er ikke tillatt.
Ny § 3–3 skal lyde:
§ 3–3 Etisk vurdering og godkjenning
Forskning, herunder klinisk forskning, som medfører bruk av overtallige befruktede egg og celler som stammer fra overtallige befruktede egg, skal godkjennes av regional komité for medisinsk og helsefaglig forskningsetikk.
Behandlingsformer som forutsetter bruk av celler fra overtallige befruktede egg, skal godkjennes av departementet. Departementet kan i godkjenningsvedtaket stille nærmere vilkår.
Før departementet avgjør om godkjenning etter annet ledd skal gis, skal søknaden forelegges Bioteknologinemnda.
Ny § 3–4 skal lyde :
§ 3–4 Informasjon og samtykke
Overtallige befruktede egg kan bare anvendes til forskning og behandling etter frivillig, uttrykkelig og informert samtykke fra paret som mottar assistert befruktning. Før samtykket avgis, skal paret motta informasjon om hva forskningen kan innebære, hvordan den blir utført og annen relevant informasjon.
Dersom befruktning foretas med donorsæd, skal også sæddonor avgi frivillig, uttrykkelig og informert samtykke. Sæddonors samtykke skal innhentes i forbindelse med donasjonen.
Samtykket kan trekkes tilbake i tråd med reglene i biobankloven § 14.
§ 3–2 blir ny § 3–5 og skal lyde:
§ 3–5 Forbud mot framstilling av menneskeembryoer ved kloning m.m .
Det er forbudt:
a) å framstille menneskeembryoer ved kloning,
b) å forske på menneskeembryoer og cellelinjer som er dyrket ut fra menneskeembryoer framstilt ved kloning og
c) å framstille embryoer ved kloning ved at arvematerial e fra menneske settes inn i en eggcelle fra dyr.
Med kloning menes teknikker for å framstille arvemessig like kopier.
Act of 5 December 2003 No. 100 relating to the application of biotechnology in human medicine, etc
Chapter 1: Purpose and scope
§1-2 Scope of the Act
This Act applies to the application of biotechnology in human medicine, etc., including medically assisted reproduction, research on embryos and cloning, prenatal diagnosis, postnatal genetic testing, gene therapy, etc.
This Act does not apply to research that has no diagnostic or therapeutic consequences for the participant or where data about an individual person are not linked to that person…
Chapter 2: Medically assisted reproduction
§2-16 Storage of Embryos
Embryos may not be sorted for more than five years, and shall then be destroyed.
Chapter 3: Research on embryos and cloning, etc
§3-1 Prohibition against research on embryos, etc
It is prohibited to carry out research on fertilised eggs, human embryos and cell lines derived from fertilised eggs or human embryos.
§3-2 Prohibition against creating human embryos by cloning, etc
It is prohibited to:
a) to create human embryos by cloning,
b) to carry out research on cell lines derived from human embryos by cloning,
c) to create embryos by cloning by the technique of inserting human genetic material into an animal oocyte. Cloning is here understood to mean techniques for creating copies that are genetically identical.
Poland
Law of 7 January 1993 on family planning, protection of human fetuses, and the conditions under which pregnancy termination is permissible
Section 1:
(1) Every human being shall have a natural right to life as from the time of his conception.
(2) The life and health of the child shall be placed under the protection of the law, as from the time of its conception.
Section 6:
(2) A conceived child shall likewise enjoy legal capacity; it shall acquire the same rights and duties as regards succession insofar as it is born alive.
Section 23b:
(1) An unborn child may not be subject to any procedures other than those intended to protect his life and health, or his mother’s life or health, other than the procedures referred to in subsection 2.
(2) Prenatal examinations that do not significantly increase the risk of abortion shall be authorized in cases in which: 1. the unborn child belongs to a family manifesting a genetic ‘burden”; 2. it is assumed that a genetic condition may be cured or that it is possible to remember that condition or to limit its effects at the fetal stage; and 3. a presumption exists that the fetus presents a serious defect.
See Bulgaria :
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; and
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
Portugal
Parecer 21/CNECV/97 sobre Implicações Eticas de Clonagem (Portuguese)
O conselho Nacional de Etica para as Ciẻncias de Vida emite o sequinte Parecer:
2. A clonagem de seres humanos, pela gravidade dos problemas que põe à dignidade da pessoa humana, ao equilíbrio da espécie humana e à vida em sociedade é eticamente inaceitável e deve ser proibida.
New Rules for Scientific Research with Stem Cells of Human Origin (Portuguese)
The Council of Ministers on 24 February approved a draft law regulating the use of human stem cells for scientific research for the prevention, diagnosis, detection of the origin and treatment of degenerative diseases or resulting from tissue destruction and irreversible organs, many of which no adequate therapy. The aim is to create conditions for scientific research in Portugal, attracting talent, strengthening institutions and scientific research, and removing unjustified barriers to research in this area. It is also intended to stimulate innovation and development of new products and processes by firms, removing the comparative disadvantages that exist with other countries, including Britain, Sweden and Belgium, with regard to Europe. The proposal will be submitted for opinion to the National Council of Ethics for the Life Sciences.
See Bulgaria :
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; and
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
Romania
See Bulgaria :
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; and
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
Russian Federation
Law on the Temporary Prohibition of Human Cloning (April 2002) (article)
-Places a temporary, 5-year ban on 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 preliminarily deprived of its nucleus’.
-Forbids the import and export of human clone embryos for five years.
-Persons violating the law will be prosecuted under federal law, though there is no set punishment for cloning.
San Marino
See Bulgaria :
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; and
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
Slovakia
European Commission, Directorate General: Research. Survey on opinions from National Ethics Committees or similar bodies, public debate and national legislation in relation to human embryonic stem cell research and use. Volume I, July 2004, p.44.
“There is no specific legislation on the issue so far. However, the Slovakia’s signing and ratifying the Convention on Human Rights and Biomedicine and of the Additional Protocol on the Prohibition of Cloning of the Human Beings, already implemented in the national legislature, together with the older provisions contained in the law No. 277/1994 on health care, especially the prohibition of the ‘non-therapeutic research’ to be performed on human embryos and fetuses, were interpreted recently as effectively banning all human cloning (the so-called ‘reproductive’ as well as the ‘therapeutic').
See Bulgaria :
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; and
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
Slovenia
See Bulgaria :
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; and
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
Spain
LEY 14/2007, de 3 de julio, de Investigación biomédica.
…TÍTULO IV
Sobre la obtención y uso de células y tejidos de
origen embrionario humano y de otras células
semejantes
CAPÍTULO I
Sobre la utilización de ovocitos y preembriones
Artículo 32. Donación de ovocitos y preembriones.
1. La investigación con ovocitos y preembriones deberá contar con el consentimiento de las personas de las que provengan, las cuales podrán revocarlo en cualquier momento sin que afecte a la investigación realizada.
2. La donación de ovocitos y de preembriones se regirá por lo dispuesto en la Ley 14/2006, de 26 de mayo, sobre técnicas de reproducción humana asistida. En el caso de los ovocitos, el consentimiento de las donantes hará referencia expresa a su autorización para la utilización de la técnica o técnicas concretas que vayan a aplicarse a los ovocitos que sean objeto de la donación. A tal fin, los profesionales sanitarios responsables de la obtención de dichos ovocitos suministrarán a las donantes la información oportuna previamente a que otorguen el consentimiento, debiendo dejarse constancia escrita de todo ello.
Artículo 33. Obtención de células de origen embrionario.
1. Se prohíbe la constitución de preembriones y
embriones humanos exclusivamente con fines de experimentación.
2. Se permite la utilización de cualquier técnica de obtención de células troncales humanas con fines terapéuticos o de investigación, que no comporte la creación de un preembrión o de un embrión exclusivamente con este fin, en los términos definidos en esta Ley, incluida la activación de ovocitos mediante transferencia nuclear.
…TITLE IV
On the obtaining and use of cells and tissues of human embryonic origin and other similar cells
CHAPTER I
On the use of ovocites and pre-embryos
Article 32. Donation of ovocites and pre-embryos.
1. Research with ovocites and pre-embryos must have the consent of the persons from whom they come from, who can revoke it at any moment without affecting the research undertaken.
2. The donation of ovocites and pre-embryos shall be governed according to that provided in Law 14/2006, of 26 May, on Assisted Human Reproduction Techniques. In the case of ovocites, the consent of the donors shall make express reference to its authorisation for the use of a specific technique or techniques that are going to be applied to the ovocites that are object of the donation. For that purpose, the health professionals who are responsible for the obtaining of these ovocites shall provide the donors the appropriate information before the granting of the consent, leaving clear written record of all of this.
Article 33. Obtaining of embryonic cells.
1. The creation of human pre-embryos and embryos exclusively for experimentation purposes is prohibited.
2. The use of any technique for obtaining human stem cells for therapeutic or research purposes is allowed, always when it does not entail the creation of a pre-embryo or an embryo exclusively for this purpose, in the terms provided in this Law, including the activation of ovocites through nuclear transfer.
Sweden
Swedish code of statutes no 2006:351 - The Genetic Integrity Act
Chapter 5. Measures for purposes of research or treatment using human eggs
Section 3
Experiments for the purpose of research or treatment on fertilised eggs and eggs used for somatic cell nuclear transfer may be carried out no longer than up to and including the fourteenth day after fertilisation or cell nuclear transfer respectively.
If a fertilised egg or an egg used for somatic cell nuclear transfer has been used for such an experiment, it shall be destroyed without delay when the measure has been accomplished.
Provisions on gene therapy are set out in Chapter 2, Sections 3 and 4 of this Act
Switzerland
Federal Constitution of the Swiss Confederation
Medical Assistance to Procreation and Gene Technology in the Human Field
Article 119. (2) The Confederation shall legislate on the use of human reproductive and genetic material. It shall ensure the protection of human dignity, of personality, and of family, and in particular it shall respect the following principles:
a) All forms of cloning and interference with genetic material of human reproductive cells and embryos is prohibited;
b) Non-human reproductive genetic material may neither be introduced into nor combined with human reproductive material;
c) Methods of medically assisted procreation may only be used when sterility or the danger of transmission of a serious illness cannot be avoided otherwise, but neither in order to induce certain characteristics in the child nor to conduct research. The fertilization of human ova outside a woman's body shall be permitted only under conditions determined by statute. No more human ova may be developed into embryos outside a woman's body than are capable of being immediately implanted into her;
d) The donation of embryos and all forms of surragate maternity are prohibited;
e)No trade may be conducted with human reproductive material or with any product obtained from embryos;
f) A person's genetic material may only be analyzed, registered or disclosed with the consent of that person, or if a statute so provides;
g) Every person shall have access to the data concerning his or her ancestry.
Loi fédérale relative à la recherche sur les cellules souches embryonnaires (Loi relative à la recherche sur les cellules souches, LRCS) (in French)
Art. 3 Pratiques interdites
1. Il est interdit:
a. de produire un embryon à des fins de recherche (art. 29, al. 1, de la loi du 18 décembre 1998 sur la procréation médicalement assistée3), de produire des cellules souches à partir d’un tel embryon ou d’utiliser de telles cellules;
b. de modifier le patrimoine héréditaire de cellules germinatives (art. 35, al. 1, de la loi du 18 décembre 1998 sur la procréation médicalement assistée), de produire des cellules souches embryonnaires à partir d’un embryon dont lepatrimoine germinal a été modifié ou d’utiliser de telles cellules;
c. de créer un clone, une chimère ou un hybride (art. 36, al. 1, de la loi du 18 décembre 1998 sur la procréation médicalement assistée), de produire des cellules souches embryonnaires à partir d’un clone, d’une chimère ou d’un hybride, ou d’utiliser de telles cellules;
d. de développer un parthénote, de produire des cellules souches embryonnaires à partir d’un parthénote, ou d’utiliser de telles cellules;
e. d’importer ou d’exporter un embryon au sens des let. a ou b, un clone, une chimère, un hybride ou un parthénote.
Turkey
See Bulgaria :
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; and
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
United Kingdom
Human Fertilisation and Embryology Act 2008
Human Fertilisation and Embryology Act 1990 (c. 37).
Section 1 (Principal Terms Used):
(1) In this Act, except otherwise stated—
(a) embryo means a live human embryo where fertilization is complete
(b) references to an embryo include an egg in the process of fertilization, and, for this purpose, fertilization is not complete until the appearance of a two cell zygote.
(2) This Act, so far as it governs bringing about the creation of an embryo, applies only to bringing about the creation of an embryo outside the human body; and in this Act—
(a) references to embryos the creation of which was brought about in vitro (in their application to those where fertilization is complete) are to those where fertilization began outside the human body whether or not it was completed there, and
(b) references to embryos taken from a woman do not include embryos whose creation was brought about in vitro.
Section 3 (Activities governed by the Act) – (Prohibitions in connection with embryos):
(1) No person shall –
(a) bring about the creation of an embryo, or
(b) keep or use an embryo except in pursuance of a licence…
(3) A licence cannot authorize –
(a) keeping or using an embryo after the appearance of the primitive streak,
(b) placing an embryo in any animal,
(c) keeping or using an embryo in any circumstance in which regulations prohibit its keeping or use, or
(d) replacing a nucleus of a cell of an embryo with a nucleus taken from a cell of any person, embryo or subsequent development of an embryo.
Human Fertilisation and Embryology Act 1990 (c. 37) – Schedule 2.
Section 3 – Licenses for research
(1) A license under this paragraph may authorize any of the following—
(a) bringing about the creation of embryos in vitro, and
(b) keeping or using embryos,
(2) A license under this paragraph cannot authorize any activity unless it appears to the Authority to be necessary or desirable for the purpose of…or for such other purposes as may be specified in regulations.
(3) Purposes may only be so specified with a view to the authorization of projects or research which increase knowledge about the creation and development of embryos, or about disease, or enable such knowledge to be applied.
Human Fertilisation and Embryology Authority Regulation of Research on Human Embryo (2001)
6) Since the Act was passed there have been a number of important developments in this very fast moving area of science…In January 2001, following large majorities in both Houses of Parliament by free votes, the Human Fertilisation and Embryology (Research Purposes) Regulations were passed which added three new purposes for which research on human embryos are permitted:
-Increasing knowledge about the development of embryos
-Increasing knowledge about serious disease, or
-Enabling any such knowledge to be applied in developing treatments for serious disease.
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