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Announcement Of Law On Assisted Reproduction In Connection With Treatment, Diagnostics And Research, Etc.

Original Language Title: Bekendtgørelse af lov om assisteret reproduktion i forbindelse med behandling, diagnostik og forskning m.v.

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Table of Contents
Chapter 1 Scope and so on
Chapter 1 a Offerings for treatment with assisted reproduction in the regional hospitals
Chapter 2 Prohibition of treatment
Chapter 3 Sales, donation and storage of human eggs
Chapter 4 Donation, use and storage of semen
Chapter 5 Control of treatment
Chapter 6 Information and Consent
Chapter 7 Prohibition of research and trials
Chapter 8 Penalty provisions
Chapter 9 The entry into force, etc.

Completion of the law of assisted reproduction in connection with treatment, diagnostics and research, etc.

In the case of medical treatment, diagnosis and research, etc., shall be announced in the case of medical treatment, diagnostics and research etc., cf. Law Order no. 923 of 4. September 2006, with the changes resulting from paragraph 1 of Law No 1. 1546 of 21. In December 2010, Section 47 of Act No. 593 of 14. June 2011, section 1 of law no. 602 of 18. June 2012, section 1 of law no. 1313 of 27. November 2013 and Section 2 of Law No 744 of 25. June 2014.

Chapter 1

Scope and so on

§ 1. The law shall apply to assisted reproduction in connection with treatment, diagnostics and research, etc., carried out by a health expert or under the responsibility of a health-care person, cf. However, paragraph 18, where the pregnancy of a woman is sought in a different way than by a woman and a man. In addition, the Act shall apply to the activities of tissue-scents in respect of benefits related to the assisted reproduction in connection with treatment, diagnosis and research, etc.

Paragraph 2. The law also applies to biomedical research and experiments in which gender cells are included in human beings, fertilised eggs and foetal facilities.

Paragraph 3. For the purposes of this Act :

1) Woman : a person with a uterus or an ovarian hover.

2) Man, a person with at least one testicle.

Chapter 1 a

Offerings for treatment with assisted reproduction in the regional hospitals

§ 1 a. The regions of the regions must be treated only with assisted reproduction for single women who do not have children and couples who do not have shared children, cf. however, paragraph 1 2 and section 7 (4). One and three.

Paragraph 2. For a single woman or a pair who has had a child at assisted reproduction and which have continued to continue to have frozen eggs, the regionals of their hospitals may be available within the time limit laid down in section 15 (5). 1, offer to set up an egg for the single woman or the pair of children to have more children.

Chapter 2

Prohibition of treatment

§ 2. Assisted reproduction shall not take place unless it is made to reconcile a genetically modified egg cell with a genetically altered (unmodified) sepcell.

§ 3. (Aphat)

§ 4. The same time or subsequent identical unfertilised or fertilised eggs shall not be placed at one or more women in fertilizer namsi; or subsequently.

§ 5. Reproduction shall not be established unless the egg cell is derived from the woman who is to bear the child or the semen of the semen is derived from her partner.

§ 5 a. Reproduction shall not be established in the situations in which a health person or person under the responsibility of a health-care person is aware that the egg cell and semen are derived from genetically closely related or, incidentally, genetic-related products ; people.

Paragraph 2. Reproduction shall not be established in the situations in which a health person or person under the responsibility of a health-care person is aware that either egg cell or semen is derived from relatives of the same sex in the down and ascending line.

§ 6. Assisted reproduction must not take place in cases where the woman who is to bear the child is older than 45 years old.

§ 6 a. If the person responsible for handling assisted reproduction of a person resident in this country considers that there is doubt about a single woman's or a parse's ability to raise the necessary care for a child after birth, shall be required : the health care staff with the exclusive right of the single woman or the party to submit information to the state administration, requesting that State administration decide as to the extent to which the operation of assisted reproduction can be carried out. In the absence of the consent of the single woman or the party to the disclosure of information to the State administration, the health care staff shall reject the initiation of assisted reproduction.

Paragraph 2. The State administration shall decide on the implementation of the assisted reproduction process. The Member State ' s administration may include other expertise in the evaluation of parental suitability prior to treatment by the single woman or the party's consent. In the absence of consent, State administration shall reject the initiation of the treatment of assisted reproduction.

Paragraph 3. Decisions taken pursuant to paragraph 1. 2 may be brought to the Board of Appeal (s) within four weeks of the decision.

Paragraph 4. The Ministry of Health and Prevention may lay down detailed rules on the provisions of paragraph 1. 1-3.

§ 6 b. If the person responsible for handling the assisted reproduction of a single woman or a couple who is not domiciled in this country shall consider that there is a clear doubt about the ability of the single woman or the party to take appropriate care in the case of a child after birth, the health care staff shall be denied treatment with assisted reproduction.

§ 7. Genetic examination of a fertilised egg must be carried out only in cases where there is a known and significant increased risk of the child being given a serious hereditary disease.

Paragraph 2. In addition, genetic testing may be carried out in the case of assisted reproduction outside the body of the female body, because of the imposition of irfertility, where such a study may be demonstrated or ruled out by a significant chromosomal abnormality.

Paragraph 3. However, in specific cases, the Board of Health may authorize the use of pre-implantation diagnostics in case of assisted reproduction, where weighing for the treatment of a child with life-threatening conditions may be authorised ; The disease in this family speaks for this.

Paragraph 4. The Ministry of Health and Prevention shall lay down detailed rules on authorisation pursuant to paragraph 1. 3.

§ 8. Assisted reproduction with the selection of sperm or fertilised eggs before setting up in a woman's womb with a view to choosing the sex of the child must not be made unless this is done to prevent the child ' s serious hereditary disease in the child.

§ 9. The further development of a human individual must not be allowed to happen outside the womb of a woman.

§ 10. The use of eggs and ovaries of abortive female foetuses, stillborn female children or departed women must not be allowed to take place.

§ 11. Transplant of egg stocking for a woman with the purpose of alleviating the infertility (infertility) may not take place.

Chapter 3

Sales, donation and storage of human eggs

§ 12. It is not permitted to sell, disseminate sales or otherwise contribute to the sale of unfertilised or fertilised human eggs.

§ 13. Assisted reproduction shall not take place when there is an agreement between the woman where the pregnancy is sought and another of the fact that the woman is to bear a child to this (surrogate maternity).

§ 14. (Aphat)

§ 15. The coated and unfertilised human eggs may be retained for up to five years, after which the eggs must be destroyed. The competent doctor may decide to extend the retention period in addition to five years and until the date of the age of 45, if the single woman or the one party in marriage, the recorded relationship or the relationship is suffering from a person ; Serial disease. The competent doctor may recant a decision pursuant to 2. pkton, where conditions after 2. Act. is no longer fulfilled.

Paragraph 2. In the event of the death of a woman or in the event of the separation or divorce or the end of the marriage, the preserved fertilised eggs must be destroyed.

Paragraph 3. There must be destruction of the spouse or the confeisted egg kept intact in the event of the death of the woman.

§ 16. (Aphat)

§ 17. The Ministry of Health and Prevention may lay down detailed rules on donation, including anonymity and conditions of compensation, for storage, for use, including the number of pregnancies per year. the donor and the production of human eggs.

Paragraph 2. The Board of Health shall be empowered to lay down health professional rules for the donation, use, set-up and storage of human eggs.

Chapter 4

Donation, use and storage of semen

§ 18. Assisted reproduction using the use of the semen of semen, including varieties, must not be carried out by persons who are not doctors or who are not under the responsibility of a doctor.

§ 19. (Aphat)

20. The Minister for Health and Prevention may lay down detailed rules for donation, including anonymity and conditions of compensation, and the use of donor semen, including the number of pregnancies per donor, and for the purpose of the retention of doned semen.

Paragraph 2. The Board of Health shall be empowered to lay down health professional rules for the donation, use and storage of semen, including in order to prevent the transmission of diseases.

Chapter 5

Control of treatment

§ 21. It is not permitted to take new treatment and diagnosis methods, etc. in the case of assisted reproduction in use, before the Health and Health Minister has approved these on the grounds of ethical and health care.

Paragraph 2. The minister for health and prevention lays down rules for the notification and approval of new treatment and diagnosis methods, etc. in the assisted reproduction.

§ 22. The processing points shall report information to the Board of Health for the treatment of assisted reproduction. The Board of Health shall lay down rules.

Chapter 6

Information and Consent

-23. Prior to processing of assisted reproduction proceedings, written consent shall be obtained for the examination of the woman and from his or her possible spouse, registered partner or partner. The healthier health experts shall ensure that the consent remains valid when the treatment begins.

Paragraph 2. The consent may be issued only on the basis of a written and oral information on the effects and adverse reactions of the treatment, including the risks associated with the treatment. The information must also include information on adoption.

Paragraph 3. In cases where donations of eggs or semen have been donated, there must also be written consent from the donor or female donor.

§ 24. The handling health expert shall ensure that information is provided on the civilian effects of a woman or a pair receiving donated germ cells in the case of assisted reproduction.

Chapter 7

Prohibition of research and trials

§ 25. In the following cases, health-scientific experiments on fertilised human eggs and on the genitals used for fertilisation must be carried out only in the following cases :

1) If they are designed to improve in vitro fertilization or similar techniques in order to convene pregnancy.

2) If they are designed to improve the techniques for the genetic examination of a fertilised egg to determine whether there is a serious hereditary disease or a substantial chromosomal abnormality (pre-implantation diagnostics).

3) If the trials of the use of fertilised egg and stem cells are intended to obtain new knowledge, which will improve the opportunities for treating diseases in human beings.

Paragraph 2. The sampling and fertilization of eggs in order to carry out tests other than those referred to in paragraph 1. Paragraph 1 shall not be permitted.

SECTION 26. The ensuing eggs may only be kept alive outside a woman's womb for 14 days from the fertilization has happened. The time in which the fertilised human eggs have been frozen is not included.

§ 27. Wine-smelled human eggs that have been the subject of health scientific research, including general quality assurance research on egg production, may only be set up in a womb of a woman, if the fertilised eggs are genetically unchanged ; (unmodified) and the prior research into a professional assessment may not be presumafied to have damaged the egg in its further development.

Paragraph 2. Research projects in accordance with section 25 must be approved in the scientific committee system, which, prior to any approval, assesses whether the projects have the intended purpose.

§ 28. The following tests may not be carried out :

1) Attempts intended to make the manufacture of an inherically identical human specimens.

2) Attempts intended to facilitate the manufacture of human beings by means of melting of genetically different foetal sites or parts of amnipals before they are attached to the uterus.

3) Attempts intended to make the manufacture of live human beings which are hybrids with an arable mass in which constituent parts of other species are used.

4) Attempts designed to allow the development of a human individual in the species alien womb.

Chapter 8

Penalty provisions

§ 29. Unless higher penalties are inflited on the other legislation, the person who is in breach of sections 2 to 6, 7 13, 15, 18, section 21 (2) shall be penalised. 1, and § § 22-28, with a fine or prison up to four months.

Paragraph 2. The person who donates semen or eggs, and the woman or pair consenting in an assisted reproduction, cannot be penalised under this law, as is the woman who surdracts eggs, unless the transfer is contrary to section 12.

Paragraph 3. The rules laid down under the law may be punished for the penalties imposed on the provisions of the provisions of the regulations.

Paragraph 4. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.

Chapter 9

The entry into force, etc.

-$30. The law shall enter into force on 1. October 1997. However, sections 6, 15 and 16 shall enter into force on the day following the notice in the law.

Strike two-five. (Udelades)

§ 31. (Udelades)

§ 32. The law doesn't apply to the Faroe Islands and Greenland, but he knows how to nail. the device shall be put into force for the Faroe Islands, with the deviations which the particular feroted conditions are attributed.


Law No 535 of 8. June 2006 (Scope of treatment in regional hospitals, the equality of women's access to artificial fertilisation regardless of civil status and sexual orientation, assessment of parental utensities, relaxation of the egg donation rules and the extension of the the storage time for frozen eggs) contains the following entry into force and transitional provisions :

§ 2

Paragraph 1. The law shall enter into force on 1. January, 2007.

Paragraph 2. Section 15 (3). 1, in the case of artificial fertilisation in medical treatment, diagnostics and research, etc. as amended by this Act ` s § 1, nr. However, 6 shall enter into force on the day following the notice in the law and shall also apply to the eggs in force on the entry into force and the frozen eggs.


Law No 1546 of 21. December 2010 (The payment for the treatment of artificial fertilisation, the reference and the sterilisation of public health services and the alignment of rules on the assessment of parental fitness for the treatment of artificial fertilisation and v.) shall include the following : effective provision :

§ 3

Paragraph 1. The law shall enter into force on 1. In January 2011, however, cf. paragraph 2

Paragraph 2. (Udelades)


Law No 593 of 14. June 2011 includes the following entry into force :

§ 43

Paragraph 1. The law shall enter into force 1. in January 2012 and in the case of health-science research projects notified after the entry into force of the law.

Strike two-seven. (Udelades)


Law No 602 of 18. June 2012 (Expansion of the scope of the artificial fertilisation area, the possibility of anonymous and non-anonymous eggs and sperm donation in connection with the treatment of artificial fertilization, the establishment of fatherhood in the case of artificial fertilisation, adoption of : in the case of a registered partner's child and a meeting in adoptions, etc.), the following entry into force shall include :

§ 4

Paragraph 1. The law shall enter into force on 1. -October 2012.

Paragraph 2. (Udelades)


Law No 1313 of 27. November 2013 (Assisted reproduction as terminology, dispensation with regard to the retention time of eggs, consent to treatment and the extension of the group of persons responsible for reporting serious adverse events and adverse reactions in the form of genetic diseases, etc.) shall include the following entry into force :

§ 7

Paragraph 1. The law shall enter into force on 1. December, 2013, cf. however, paragraph 1 2-5

Strike two-five. (Udelades)


Law No 744 of 25. June 2014 (Criteria for castration and adjustment as a result of the introduction of legal sex change etc.) shall include the following entry into force :

§ 4

Paragraph 1. The law shall enter into force on 1. September, 2014, cf. however, paragraph 1 2

Paragraph 2. (Udelades)

The Ministry of Health and Prevention, the 19th. January 2015

Nick Hood up.

/ Lene Brøndum Jensen