The Danish Council of Ethics was created under Danish Act No. 353 of June 3rd 1987 on the Establishment of an Ethical Council and the Regulation of Certain forms of Biomedical Experiments. The Act has been amended partly by Act No. 315 of May 16th 1990 to Amend the Act on the Establishment of an Ethical Council and the Regulation of Certain forms of Biomedical Experiments, and partly by Act No. 503 of June 24th 1992 on a Scientific-Ethical Committee System and the Treatment of Biomedical Research Projects.
The Council was formed by the Minister of the Interior in 1987, but on the creation of the Ministry for Health later in the year the Council passed into the organizational jurisdiction of the Minister of Health. The subsequent amendments to said Act have been incorporated in the below wording of the Act.
§ 1. (1).
The Minister of the Interior shall set up a Council of Ethics for the health care services and biomedical research involving human subjects. The Council shall work in cooperation with the health authorities and the scientific ethical committees. The Council shall carry out its work on the assumption that human life begins at the moment of fertilization.
§ 2. (1).
The Council shall consist of 17 members, to be appointed by the Minister of Health according to the following rules:
1) Eight members shall be appointed by the Minister of Health. The appointment shall consider the appointees' publicly substantiated knowledge of the ethical, cultural and social questions of importance to the work of the Council.
2) Nine members shall be appointed by the committee mentioned in Section 10. Said persons must not be members of parliament, of a municipal council or of a county council. Where the committee cannot agree on an appointment, the majority of the committee shall decide on the appointment.
(2).
The appointments made under subsection 1.1 shall ensure equal representation of men and women. As regards the appointments made under subsection 1.2 there may be only one more of one sex than of the other.
(3).
The chairman is appointed by the Minister of Health from among the appointees on the recommendation of the committee mentioned in Section 10 of this Act.
(4).
The members and the chairman are appointed for a term of 3 years. Reappointment may take place once.
(5).
The Council shall lay down its own rules of procedure.
§ 3. (1).
The Council of Ethics shall have a permanent secretariat, the staff of which shall be employed and dismissed by the Minister of Health on the recommendation of the chairman of the Council.
(2).
The necessary funds for the work of the Council shall be granted in the annual budgets.
§ 4. (1).
The Council shall submit a recommendation to the Minister of Health concerning the establishment of rules on the protection of fertilized human ova, living embryos and fetuses. The same shall apply to genetic experiments on human gametes used for fertilization. The recommendation shall include a report on the current state of research and an evaluation of probable developments within the next few years. Furthermore, said recommendation shall include an evaluation of any ethical problems potentially resulting from such developments as well as an assessment of the question of legal regulation in the event of violation of the rules to be laid down according to the recommendation.
§ 5.
The Council shall submit a recommendation to the Minister of Health on the possibility of carrying out genetic treatment on human gametes used for fertilization and of fertilized human ova, embryos and fetuses. The recommendation shall include a report on the current state of research and of the individual procedures and probable developments in this field within the next few years. Furthermore, the recommendation shall include an assessment of the ethical and legal problems that may result from such developments, as well as propositions for possible rules governing the right to carry out the treatments in question.
§ 6.
The Council shall submit a recommendation to the Minister of Health on the possibility of using new diagnostic techniques in order to detect congenital defects or diseases in fertilized human ova, embryos and fetuses. The recommendation shall include a report on the current state of research as well as probable developments in this field within the next few years. Furthermore, the recommendation shall include an assessment of any ethical and legal problems potentially resulting from such developments as well as propositions for possible rules governing the right to use the techniques in question.
§ 7.
The Council shall submit a recommendation to the Minister of Health on the establishment of rules for the cryopreservation of human gametes intended for fertilization and of fertilized human ova. The recommendation shall include a report on the current state of the technique and an evaluation of the results thus achieved. Besides this, such recommendation shall include an assessment of any ethical and legal problems potentially resulting from such techniques.
§ 8.
Apart from performing the tasks assigned to the Council in pursuance of § 4-7 of the Act, the Council can:
1) Discuss general ethical questions in connection with experiments on human subjects in cooperation with the scientific ethical committees.
2) Advise health authorities on the assessment of general ethical questions of major importance to the health care services relating to the use of new methods of treatment, new diagnostic techniques and new medical technology, as well as take up problems within its scope at its own initiative.
3) Advise public authorities in connection with the ethical evaluation of questions on registration, disclosure and use of information on hereditary diseases or characteristics of individuals or groups of persons.
§ 9. (1).
The Council shall follow developments in the fields mentioned in §§ 4-7. The Council shall inform the public on developments and on the work of the Council, and it shall take the initiative in making any ethical problems that may arise subject to public debate. The Council can arrange public enquiries and set up working parties to report on special problems.
(2).
The Council can make use of special experts.
(3).
The Council shall simultaneously submit an annual report to the Minister of Health and to Parliament.
§ 10. (1).
At the beginning of each parliamentary year and after general elections Parliament shall appoint a committee of nine members (made up in the same proportions as Parliament). An alternate shall be appointed for each member in the same manner.
(2).
The committee shall appoint the members mentioned in subsection 1.2. of Section 2.
(3).
The committee shall follow the work of the Council of Ethics by means of joint meetings etc. Furthermore, the committee can ask the Council of Ethics to deal with specified subjects within the Council's terms of reference.
§ 13.
The Minister of Health shall introduce the bill mentioned in § 4.1 during the parliamentary year of 1990-91 at the latest.
§ 14. (1).
This Act shall come into force on the day following its publication in the Danish Official Gazette.
(2).
The committee mentioned in Section 10 shall be set up for the first time immediately upon the coming into force of this Act.
§ 15. (1).
This Act does not extend to the Faroe Islands or Greenland, but can be extended by Royal Decree to the Faroe Islands and Greenland subject to such adaption as may be required by circumstances peculiar to those parts.
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