Law of 20 June 2002, laying down rules for activities with sex cells and embryos (Embryowet)
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 our view, it is desirable from a point of view of respect for human life to prohibit certain acts with human reproductive cells and embryos, under which conditions other acts with human sex should be prohibited. the use of sex cells and embryos to improve medical care and to regulate the control of sex cells and embryos;
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:
For the purpose of this Act:
a. Our Minister: Our Minister of Health, Welfare and Sport;
b. sex cells: human seed and ova;
c. embryo: cell or coherent body of cells with the ability to grow out into a human;
d. fetus: embryo in the human body;
e. Central commission: the commission, referred to in Article 14 of the Law Medical Scientific Research with People ;
(f) the person who carries out the scientific research: the person who commissioned the organisation or conduct a scientific examination;
g. the person carrying out the scientific investigation: the person responsible for the actual execution of the study. If the actual execution is carried out by an employee or other auxiliary, the person taking advantage of that person shall be deemed to be the person carrying out the investigation.
1 The management of an institution from which embryos are established or otherwise carried out outside the human body shall, after the opinion of the committee responsible, draw up the opinion of the Committee on the Law Medical-Scientific Research with People Is responsible for assessing research proposals for medical-scientific research in the institution, a protocol dealing with sex cells and embryo-related acts. Amendments and additions to the Protocol shall also be required prior to the opinion of the said Committee.
2 To the extent that the institution applies, the Protocol shall, subject to the conditions laid down in Annex I, Articles 5 to 9 rules on the control of sex cells and embryos, the creation of embryos outside the human body, the creation of a pregnancy with those embryos and the use of sex cells and embryos for the purpose of carrying out embryos; other purposes.
3 In any case, the Protocol shall contain rules concerning:
a. the method of ovulation simulation;
b. the method of obtaining germ cells;
c. Method of fertilisation and development and implantation of the embryo collection and development of embryos;
d. the storage conditions for sex cells and embryos to be recorded in the institution's records of origin and preservation;
e. the period during which the reproductive cells and embryos are kept and the course of events thereafter;
f. method of making use of germ cells and embryos for other purposes and use after death;
g. the manner in which the person concerned is supported when making a decision on the donation of sex cells for the purposes of pregnancy of another person, if for the purpose of obtaining sex cells an invasive procedure in the case of the person concerned necessary.
1 Scientific research with embryos, including scientific research involving sex cells in which embryos are established, shall be carried out in accordance with a research protocol to that effect which shall include a full description of the embryos. of the proposed investigation.
3 The investigation, intended to Section 5 , may be authorised if:
a. Scientific research in respect of which the foetus is not subjected to invasive acts or where the condition of the foetus is not intentionally altered and the examination protocol is a positive assessment of the foetus. Commission referred to in Article 16 of the Law Medical Scientific Research with People ; or
b. scientific research in which the fetus is subjected to invasive acts or where the condition of the foetus is intentionally altered and on the examination protocol is a positive judgment of the central foetal system. Commission.
4 By way of derogation from paragraph 3 (a), the central committee may provide that the assessment of protocols relating to a form of scientific research which it has designated as intended to be carried out in accordance with Section 5 shall be done.
The committee referred to in Article 16 of the Law Medical Scientific Research with People , shall forward to the Central Committee copy of any judgment given by it pursuant to this Act and of the relevant research protocol or main cases thereof. In addition, the committee referred to in Article 16 of the Law on Medical Scientific Research and the Central Commission shall notify the Commission of the Article 22, third paragraph , the communication referred to.
1 The central committee shall report annually to our Minister on the application of this Act, paying particular attention to new developments concerning sex cells and embryos, to the extent that they appear to be the research protocols submitted.
2 Our Minister shall send this report to the two Chambers of the States-General and shall give its opinion on the new developments which have been identified by the Central Committee.
3 In the case of general management measures, rules may be laid down on the way in which our Minister prepares the view referred to in the second paragraph.
1 Adult-year-olds capable of reasonable appreciation of their interests in the matter may be different from that for the purposes of their own medicinal use and without prejudice to the Article 9 , making available their sex cells for the purpose of pregnancy of another or for the benefit of scientific research.
2 The posting may be made only in writing and in order not to be done, and not after a person referred to in the first paragraph has been informed by the care of the sex cells of the nature and purpose of the sex cells. The person concerned may, in so far as the sex cells have not been used, revoke the posting at any time, without justification.
3 If, for the purpose of obtaining sex cells, an invasive procedure is necessary for the person concerned, it shall also be informed by the person carrying out the procedure of the risks and risks thereof. If the sex cells are made available for the purpose of scientific research, then the consent of the in- Article 2, first paragraph The Commission, which assesses whether it is proportionate to the decision making provision in proportion to the risks and objections of the procedure, also taking into account the circumstances of the person concerned. For as much as is required Article 5 of the Law of Medical Scientific Research with People does not apply in that case.
4 The information referred to in paragraph 2 shall, in any event, 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 laying down standards of quality and safety of the environment donation, acquisition, testing, 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.
1 The information shall be provided in such a way as to ensure that it is reasonably certain that the person concerned has understood it to its content and, in the case of Article 5, third paragraph , moreover, in writing. The person concerned shall be given a period of reflection so that, on the basis of the information given, he can take a carefully considered decision on the posting of the goods.
2 The provision shall be made for the purposes of which uses the germ cells may be used and the period during which they are to be retained for that purpose. The person who keeps the germ cells and the person at the disposal of them can jointly change the objectives and extend the deadline.
3 When making available the person concerned, the person concerned may provide that only scientific studies with the relevant germ cells may be carried out after being informed of the purpose of the investigation, and expressly authorised therein. has been given for.
4 When sex cells are made available for the purpose of pregnancy of another person, the person concerned shall be given the opportunity to provide that the embryos to be used with their sex cells are to be used for other purposes. It shall be subject to its consent.
In any case, the germ cells shall be destroyed if they are not made available for other purposes, after the expiry of the period for which they are made available, and after the termination of the posting. The germ cells are also destroyed after the person who holds them has become known to have died unless they have expressly given their consent in writing for use following his death.
1 Aged-olds who are capable of a reasonable appreciation of their interests in this respect may, but no longer be used for the use of embryos which have been removed from the body for the benefit of their own pregnancy, but shall not be used for the purpose of Decision relating to:
a. the pregnancy of another;
b. The use of embryonic cells for medical purposes, medical and biological sciences, and medical and biological sciences;
(c) the carrying out of scientific research which is admissible under this law with those embryos.
2 The posting may be made only in writing and not after the person concerned, including the person whose consent is required under Article 6, paragraph 4, by the care of the person responsible for the production of the embryos, have been informed of the nature and purpose thereof. In the event of a difference of opinion between the parties concerned, the posting shall not take place. Any person concerned may, in so far as the embryos have not been used, revoke the posting at any time, without justification.
3 The provisions of Articles 6 and 7 shall apply mutatis mutandis.
This part has not (yet) entered into force; see the summary of changes
The Central Commission gives only a favourable opinion on a research protocol on scientific research with embryos not being established, if:
a. reasonably plausible that the investigation will lead to the establishment of new insights into the field of medical science;
(b) it is reasonable to assume that the determination referred to in point (a) cannot be carried out by other forms or methods of scientific research than research with the embryos concerned or by research of less substantial nature;
c. the research complies with the requirements of a correct methodology of scientific research;
d. the research is carried out by, or under the direction of, persons who are competent in the relevant field of scientific research;
(e) The investigation also satisfies reasonably reasonably requirements.
This part has not (yet) entered into force; see the summary of changes
1 It shall be prohibited to carry out scientific research with embryos without such embryos or the reproductive cells from which they are produced, made available for that purpose and applicable, if applicable, or corresponding given to the third and fourth member of Article 6 .
The person carrying out the scientific investigation shall ensure compliance with Article 3 .
The person carrying out the scientific research shall ensure that the privacy of those whose reproductive cells originate and those who have made the embryo at the disposal of the embryo are protected as far as possible.
The person carrying out the scientific investigation shall ensure that, before the execution of the study begins, those whose professional cooperation is required to carry out the examination of the nature and purpose of the investigation shall be responsible for the conduct of the investigation. Have been notified.
The Central Commission gives only a favourable opinion on a research protocol on scientific research with embryos outside the human body intended to create a pregnancy, if:
a. reasonably plausible that the investigation will lead to the identification of new findings concerning research or treatment methods, aimed at establishing pregnancy and the birth of a healthy child;
(b) it is reasonable to assume that the determination referred to in point (a) cannot be carried out by other forms or methods of scientific research than research with embryos intended to achieve a pregnancy, or studies of less substantial nature;
(c) it is reasonably likely that the research should be proportionate in relation to the objections and risks to the future child and to the wife and
d. comply with the requirements, specified in the Parts c, d and e of Article 10 .
1 It is prohibited scientific research as intended in Article 16 to perform without the written consent of the wife and her spouse, registered partner or other living person. Consent may be granted only by majority-year-olds who are capable of reasonable appreciation of their interests in this respect.
2 Before consent is requested, the person carrying out the scientific investigation shall ensure that those of whom consent is required are informed in writing of the purpose and nature of the investigation, the provisions of the third party. a sentence of the third paragraph and the fifth paragraph of this Article and the provisions of Article 14 .
3 The information shall be provided in such a way that it is reasonable to ensure that those whose consent is required have understood them to their content. The information supplied shall be supplemented on request. Those of whom consent is required shall be given a period of reflection in such a way as to enable them to give a carefully considered decision on the requested consent on the basis of this information.
4 The manner in which implementation is given to this Article shall be laid down in the research protocol.
5 The person who has given their consent may withdraw them at any time, without giving reasons. He shall not be liable for damages in respect of revocation.
The central committee or the committee referred to in Article 16 of the Law Medical Scientific Research with People , provides only a positive opinion on a research protocol on scientific research involving foetuses, including scientific studies on pregnancy support tissues, if:
a. It is reasonable to assume that the investigation will lead to the establishment of new findings in the field of medicine regarding unborn and newborn children, or on the completion of pregnancies;
b. It is reasonable to assume that the objective referred to in point (a) cannot be achieved by other forms or methods of scientific research than foetuses, including studies on pregnancy support tissues or by research of less substantial nature;
c. reasonably plausible that the interest to be investigated is proportionate to the concerns and risks to the foetus and the pregnant woman and
d. comply with the requirements, specified in the Parts c, d and e of Article 10 .
1 foetus-natal scientific study with pregnancy support tissues is permitted if it can contribute to the diagnosis, prevention or treatment of serious disorders in the field of pregnancy. the foetus, including scientific studies on pregnancy-supportive tissues, and which cannot be postponed until after birth.
2 Scientific research which cannot contribute to the diagnosis, prevention or treatment of serious diseases in the foetus in question shall be permitted only if:
a. It can contribute to the diagnosis, the prevention or treatment of serious ailments in other foetuses;
b. the objections and risks to the foetus and pregnant women are minimal; and
c. it cannot be delayed until after the birth.
1 It is prohibited to conduct scientific research with a foetus including scientific studies with pregnancy supportive tissues without the written consent of the pregnant woman. If she is a minor and has not yet reached the age of sixteen, written consent shall be given to those who exercise authority over it.
2 If the pregnant woman is unable to reasonably appreciate her interests in this respect, consent may be given by those who exercise authority or, if she is a majority, by her legal authority. representative or, if this is missing, by her spouse, registered partner or other living person.
3 Before consent is requested, the person carrying out the scientific investigation shall ensure that the persons of whom consent is required, be informed in writing of:
a. the purpose, nature and duration of the investigation;
b. the risks that the study can bring to the health of the pregnant woman and the foetus;
c. the risks that the interim termination of the research for the health of the pregnant woman and the foetus can bring with and
d. the objections that the research can bring with it for the pregnant woman and the foetus.
4 third and fourth member of Article 17 shall be applicable mutatis mutandis.
5 The pregnant woman or, if this is not authorised under this Article, to give consent, the person empowered to do so may withdraw the consent at any time, without any justification. It shall not be liable for damages in respect of revocation.
1 If the scientific study takes a course of action less favourable to the pregnant woman or the foetus than is provided for in the research protocol, the person carrying out the investigation shall forthwith communicate that information to the person concerned. the person who has given their consent, and to the following Article 3 competent committee which, as the latter, has given its opinion with a request for a judgment. Until such time as a further judgment is given, the examination shall be suspended unless the health of the pregnant woman or of the foetus suspension is not immediately available.
2 If the judgment is negative, the execution of the study shall be terminated unless the health of the pregnant woman or the foetus of the foetus does not permit an immediate cessation of the study.
3 The person carrying out the scientific investigation shall, stating the reasons for the investigation, Article 3 (i) the competent committee which, as the latter, has given its opinion, also, communication of the premature termination of an investigation.
It shall be prohibited:
a. to establish an embryo specifically and to use embryos specially created for scientific research and other purposes other than the creation of a pregnancy;
b. [ Red: this part has not yet entered into force;];
c. To use sex cells and embryos other than those specified in part (b) for purposes other than those for which they may be made available under this law;
(d) use sex cells and embryos for purposes authorised under this Law without being made available for them;
e. to allow an embryo outside the human body to develop for more than 14 days;
f. To perform sexual or embryonic acts for the purpose of the birth of genetically identical human individuals;
g. intentionally altering the genetic material of the nucleus of human germ cells with which a pregnancy is to be established;
It shall be prohibited:
a. A human and an animal sex cell to be brought together for the purpose of creating a multi-cell hybrid;
b. A chimère created from human and animal or human embryonic cells only to develop or to develop in a human or animal species for more than 14 days;
(c) to introduce an embryo to an animal;
d. to bring an animal embryo into a human.
1 It is prohibited to conduct sex cells or embryos for the purpose of choosing the sex of a future child.
2 The prohibition referred to in paragraph 1 shall not apply where the risk of serious sex-related hereditary disease in the child and operations is carried out for the purposes of scientifically responsible medical knowledge and shall be carried out to prevent of these.
3 It is prohibited to offer services consisting of acts, prohibited in this Article.
It is prohibited to provide for the provision to others of sex cells and embryos based on the Articles 5 , 8 and 9 of this Act to apply for a fee which exceeds the costs which are a direct consequence of the transactions carried out with the germ cells or embryos.
1 With a term of imprisonment of up to one year or a fine of the fourth category, the person who, whether intentional or not, shall be punished in breach of a prohibition, contained in the Articles 12 , 17, first paragraph , 21, 1st Member , 24 , 25 , 26 or 27 .
3 The offences referred to in paragraph 1 are offences; the offences referred to in the second paragraph are offences.
1 With the supervision of compliance with or under this Act, public health officials shall be entrusted with the task of ensuring that the public health care is provided.
2 The persons referred to in paragraph 1 do not have the powers specified in the Article 5:19 of the General Administrative Law .
Our Minister sends every five years to the States-General a report on the effectiveness and effects of this law in practice.
1 This Law shall enter into force on a date to be determined by Royal Decree, which may be determined differently for the various articles or parts thereof; Articles 9 , 11 and 24, part b , entry into force at the time referred to in paragraph 2.
2 Section a of Article 24 shall expire at a time to be determined by royal decree. The proposal for this Decision shall not be taken more than four weeks after the draft of the decision has been submitted to both Chambers of the States-General, or if, within that period, by, or on behalf of, one of the Chambers or at least a fifth the constitutional number of members of one of the Chambers has been given a wish that the time at which part a of Article 24 shall be settled by law.
This law is cited as: Embryolaw.
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.
Given at The Hague, 20 June 2002
The Minister for Health, Welfare and Sport,
The Minister of Justice,
A. H. KorthalsPublished second July 2002
The Minister of Justice,
A. H. Korthals