Ordinance On Artificial Insemination

Original Language Title: Bekendtgørelse om kunstig befrugtning

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Overview (table of contents)



Chapter 1



Storage and donation of unfertilized and fertilized human eggs





Chapter 2



Storage and donation of semen





Chapter 3



Approval of new treatment and diagnostic methods in the field of artificial insemination





Chapter 4



Entry into force of the



The full text of the Ordinance on artificial insemination

Under section 17, paragraph 1, article 20, paragraph 1, and article 21, paragraph 2, of the law on artificial insemination in connection with treatment, Diagnostics and research, etc., see. lovbekendtgørelse nr. 923 of 4. September 2006, as amended by Act No. 602 of 18. June 2012, fixed: Chapter 1 Storage and donation of unfertilized and fertilized human eggs § 1. Human eggs are taken from a woman, must not be stored for more than 5 years. At the latest after the expiry of the 5 years, the eggs shall be destroyed.

§ 2. Storage of human eggs must only be carried out with a view to: 1) later return to the woman who has made the egg, 2) donation for research purposes or 3) donation in order to produce a pregnancy with another woman, see. However, section 7.

(2). Storage of human eggs must only be carried out for the purpose of treatment and research.

§ 3. Before storage of samples, unfertilized human eggs takes place, the woman must give written consent to storage. The woman in question shall be informed orally and in writing in advance about the consequences of their storage.

(2). The woman in question must, at the same time declare that she is made aware of the terms and conditions of storage, which is laid down in the law on artificial insemination and in this Ordinance.

§ 4. Before storing the retrieved, fertilized human egg takes place, the lone woman or couple give written consent to storage. The woman or couple must previously be informed orally and in writing about the consequences of their storage.

(2). The woman or couple must also declare that they are made aware of the terms and conditions of storage, which is laid down in the law on artificial insemination and section 5 of this order. Stored, unfertilized human eggs must be destroyed if the woman, who has made the eggs die within 5 years from the beginning of the future storage, unless the eggs are donated to the in section 2 (1) (8). 2 and 3, the said purposes.

§ 6. Stored, fertilized human eggs must be destroyed in the event of the death of the woman, as well as by the couple's separation or divorce or by samlivets termination, within 5 years from the beginning of the future storage.

(2). Fertilized human eggs may only be used if the woman or the couple gives written consent before each treatment cycle.

§ 7. Donation of fertilized human eggs are allowed only for research purposes.

§ 8. Donation of unfertilized human eggs must only be done if it is done for the purpose of: 1) to achieve a pregnancy with another woman or 2) research.

§ 9. Donor of an unfertilized egg must give written consent to the donation. First to donor be informed orally and in writing about the implications of the donation.

(2). The donor must declare that she is made aware of the terms and conditions provided for in the law on artificial insemination and donation of this order.

§ 10. Donor of an unfertilized egg can be anonymous or non-anonymous. In connection with an anonymous egg donor can only obtain information about the donor's skin color, hair color, eye color, height and weight. There can also be obtained information about the donor's blood type, where it is considered necessary by health professional reasons.

Chapter 2 Storage and donation of semen section 11. Storage of semen may only be carried out with a view to: 1) to achieve a pregnancy either from's own partner or with another woman or 2) research.

§ 12. Sperm donor must give written consent to the donation. First to donor be informed orally and in writing about the consequences of the sæddonationen.

(2). The donor must declare themselves in agreement with the terms and conditions provided for in the law on artificial insemination and donation of this order.

§ 13. Sperm donor can be anonymous or non-anonymous. In connection with the use of an anonymous sperm donor can only obtain information about the donor's skin color, hair color, eye color, height and weight. There can also be obtained information about the donor's blood type, where it is considered necessary by health professional reasons.

§ 14. The Te, which distributes semen, must ensure that the number of viable pregnancies established with sperm from one donor do not exceed 12 with geographical spread, see. However, paragraphs 2 and 3.

(2). In cases where the number of pregnancies with sperm from one donor is at least 12, can distribute sperm from donor sperm bank in exceptional cases, if it only happens with a view to the application of the semen from this donor to treatment with artificial insemination with a view to more sibling children by the same donor.

(3). Frozen eggs, fertilized with sperm from one donor, where the number of viable pregnancies established with the same sperm donor subsequently overstiget 12, however, can continue to be used.

§ 15. The Te, which distributes semen, must ensure that the sperm donor has not previously worked or still works as a sperm donor in another sperm bank.

§ 16. If a treatment-seeking woman or a treatment-seeking couple wants to use a particular sperm donor, as the lone woman or couple even carried in connection with treatment at a hospital, the Regional Council may refer to the hospital, to sperm donation, including testing and evaluation, must be made through an authorised tissue establishment (sperm bank). Expenditure in connection with the authorised tissue centers (the sperm bank's) test and evaluation, etc. shall be borne by the treatment-seeking woman or the treatment-seeking couple.

Chapter 3-approval of new treatment and diagnostic methods in the field of artificial insemination, section 17. It is not allowed to take new treatment and diagnostic methods, etc. in connection with artificial insemination in use before the Minister for health and prevention has approved these out from the ethical and medical considerations.

(2). By new treatment or diagnostic method in this context means a treatment or diagnostic method, which represents something important and in principle new compared to previous clinical use in Denmark.

(3). Health the person's application will be sent to the health protection agency. The notification shall be sent simultaneously to the Danish Council of ethics, which shall deliver its opinion on the method for the health protection agency.

(4). A new type of treatment or diagnostic method, which put into service as part of a scientific ethical committee system of the approved research project, is not subject to the notification and authorisation obligation until that may, in the light of the results obtained, a decision to seek the procedure taken in use outside the auspices of the research project.

(5). A health care professional can in case of doubt consult Health Agency, whether a given treatment or diagnostic method must be considered subject to the notification and authorisation obligation.

§ 18. The health protection agency are conducting a professional assessment of applications under section 17 and shall prepare on that basis and on the basis of the Danish Council of ethics ' opinion a statement and recommendation to the Minister for health and prevention.

(2). The reviewer receives the copy of the National Board of Health's option for the Interior and the Minister of health and of the Danish Council of ethics ' opinion to the Board of health.

§ 19. The National Board of health shall inform the country's health-care professionals about the Minister for health and prevention decision concerning the notified new treatment or diagnostic form.

Chapter 4 the entry into force of § 20. The notice shall enter into force on 9 November. November 2012.

(2). At the same time repealed Executive Order No. 1724 by 21. December 2006 on artificial insemination.

The Ministry of health and prevention, the 5. November 2012 Astrid Krag/John Erik Pedersen