Foetal tissue law

Original Language Title: Wet foetaal weefsel

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Law of 8 November 2001, laying down rules for the provision and use of foetal tissue (Wet foetal tissue)

We Beatrix, at the grace of God, Queen of the Netherlands, Princess of Orange-Nassau, etc. etc. etc.

All of them, who will see or hear these, saluut! do know:

In this regard, we have taken the view that it is desirable to regulate the conditions under which the use of foetal tissue may be made available and used;

In this way, we, the Council of State, and with the mean consultations of the States-General, have been well-regarded and understood to be right and to be understood by the following:


Article 1

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  • 1 In this Act the following definitions shall apply:

    • a. Our Minister: Our Minister of Health, Welfare and Sport;

    • b. Human fruit: result of the amalgamation of human germ cells;

    • Foetal tissue components which form part of an unlifeless of less than twenty-four weeks of gestation in the world, or human fruit deceased within twenty-four hours of birth, or parts thereof;

    • d. woman: the woman from whom the human fruit has come to the world.

  • 2 This Act does not apply to the storage and use of foetal tissue for pathological-anatomical research for the benefit of women.


Article 2

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  • 1 The storage and use of foetal tissue is permitted only for medical purposes, medical and biological sciences, and medical and biological sciences.

  • 2 Use of foetal tissue is not permitted for medical treatment of persons designated by the woman.


Article 3

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  • 1 For the storage and use of fetal tissue, consent is required of the woman. The authorisation shall be granted in advance in the case of a declaration which has been signed and signed at least in manuscript.

  • 2 Is the wife of the underage and has not yet reached the age of twelve but has not yet reached the age of 12, then the consent of those who exercise authority over her is subject to consent.

  • 3 Is it 12 years of age or above and is not capable of appreciating its interests in this respect, then the consent of those who exercise authority or, if she is of the age of the law, of the legal representative, or, if missing, from her spouse, registered partner or other life companion.

  • 4 The retention and use of foetal tissue shall not be carried out if the spouse, registered partner or other person's spouse is objected to that passage. If it is found that the person from whom the sperm originates is a person other than the spouse, registered or other companion of the woman, detention or use of the foetal tissue shall not be carried out if requested by the latter.


Article 4

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  • 1 Before consent is requested, the person whose consent is required shall be informed of the nature and purpose of the intended use of the fetal tissue.

  • 2 The information and questions of consent shall be given by the care of the attending physician, and not before it is established that the fetal tissue will be available. The treating physician, who may not be involved in the performance of the intended use of the fetal tissue, shall also ensure that the information is provided in a manner that ensures that the woman can decide freely.

  • 3 The information shall be provided in such a way that it is reasonably certain that those whose consent is required have understood them to its content. In the case of: Article 3, third paragraph , the woman is informed in a manner that fits with her comprehension.

  • 4 In any event, the information shall include the information referred to in the Annex to Directive 2004 /23/EC of the European Parliament and of the Council of 31 March 2004 setting standards of quality and safety for the donation, procurement, testing, the processing, storage and distribution of human tissues and cells (PbEU L 102).

  • 5 An amendment to the Directive referred to in paragraph 4 shall apply to the application of this Article as from the date of implementation of the amending Directive in question.


Article 5

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  • 1 The care of the institution where fetal tissue is available shall be recorded in the woman's file and an objection shall be made in the case.

  • 2 The wife, or the one who has given permission in her place, may withdraw the consent at any time, without justification, provided that the revocation does not affect the extent to which the fetal tissue has already been used. The first paragraph shall apply mutatis mutandis.

  • 3 Is the consent refused, then the relevant fetal tissue is no longer preserved. The same applies if the authorisation is withdrawn, objections have been raised or a request was made as referred to in the second sentence of Article 3 (4) Unless the fetal tissue can no longer be traced back to the person who made it available.


Article 6

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  • 1 An institution in which fetal tissue is available shall adopt a regulation on the arrangements for the application of this law in the institution. In any case, the Rules of Procedure cover the following subjects:

    • a. The choice of women to whom consent to the use of fetal tissue is requested;

    • b. the manner in which the necessary information is given and consent is requested;

    • c. the manner in which and the conditions under which the fetal tissue is made available to the user;

    • d. public reporting on the application of parts (a), (b) and (c).

  • 2 In the case of, or under general management, detailed rules may be laid down concerning the content of the Regulation referred to in paragraph 1. A general measure of management established pursuant to the first sentence shall not be in force until eight weeks from the date of issuance of the Official Gazette in which it is placed. Notice of the placement shall be communicated without delay to the two Chambers of the States-General.


Article 7

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  • 1 Foetal tissue, unless it is necessary for the nature of the intended use, shall not be kept in such a way that it can be traced back to the wife or her spouse, registered partner or other single-life partner. If the spouse, registered partner or other life companion has not been given the opportunity to make use of the Article 3 (4) This entitlement shall be retained in such a way as to keep the foetal tissue in such a way that it is not to be retraceable to the wife or to her spouse, registered partner or other single-life. If the person from whom the sperm originates is a person other than the spouse, registered partner or other companion of the woman, the fetal tissue shall be kept at his request in such a way that it is not retraceable to him.

  • 2 An institution or person in possession of foetal tissue in the exercise of a medical profession or holding shall lay down rules governing the manner in which and the period of time for which the fetal tissue is kept.

  • 3 In the case of a general measure of management, detailed rules may be laid down concerning the content and detailed arrangements for the establishment of the rules referred to in paragraph 2.


Article 8

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The supervision of compliance with or pursuant to this Act shall be subject to public health officials.


Article 9

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It shall be prohibited to be reimbursed or received for the purpose of making available fetal tissue for safekeeping or use.


Article 10

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The preservation and use of sex cells and other constituents derived from a human fruit for reproductive purposes and non-medical purposes shall be prohibited.


Article 11

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It shall be prohibited to use cells brought from foetal tissue for purposes other than medical purposes, medical and biological sciences, or medical and biological sciences.


Article 12

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It shall be prohibited to remove from a world that human fruit that has come into existence for the purpose of the intended use of foetal tissue components.


Article 13

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  • 1 imprisonment of a maximum of one year or a fine of the fourth category shall be punished by the person who, intentionally, acts in contraa with the provisions of or under the conditions of Articles 2 , 3 , 4 , 6 , 9 , 10 and 12 .

  • 2 imprisonment of up to six months or a fine of the fourth category shall be subject to the penalties of the person acting in violation of the provisions of the fourth category or under the conditions of Articles 5 , 6 and 11 .

  • 3 The offences referred to in paragraph 1 are offences; the offences referred to in the second paragraph are offences.


Article 14

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Article 15

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This Law shall enter into force on a date to be determined by Royal Decree.


Article 16

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This law is cited as: Wet fetal tissue.

Burdens and orders that it will be placed in the Official Gazette, and that all ministries, authorities, colleges and officials who so concern will keep their hands on the precise execution.

Issued in Gravenhage, 8 November 2001

Beatrix

The Minister for Health, Welfare and Sport,

E. Borst-Eilers

The Minister of Justice,

A. H. Korthals

Published on 4 December 2001

The Minister of Justice,

A. H. Korthals