Key Benefits:
Law of 6 February 2003, laying down rules on the safety and quality of bodily material which may be used in medical treatment (Safety and Quality of Body Material)
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:
Thus, we have taken the view that it is desirable to require the treatment of human body material intended for use in medical treatment;
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:
1 The following shall be understood in this Act and the provisions which are based thereon:
a. Our Minister: Our Minister of Health, Welfare and Sport;
b. body material: tissue, cells, constituents of an embryo, fetal tissue within the meaning of the Foetal tissue law , as well as from tissue or cells, or from constituents of an embryo, or from foetal tissue in culture, intended for human use;
c. fabric: all parts of the human body that consist of cells;
d. cells: separate cells of human origin or a set of cells of human origin that are not linked to each other by connective tissue;
e. obtain: a process through which bodily material or a donated organ becomes available;
f. Editing: all acts performed in the preparation, manipulation, preservation and packaging of bodily material;
g. preserves: the use of chemical substances, changes in ambient conditions or other means during the operation, intended to prevent or delay biological or physical deterioration of the body material or intended to prevent or reduce the risk of deterioration of the body. to prevent or delay biological or physical deterioration of the organs of the time from procurement to transplantation;
h. storage: maintain the body material under appropriate controlled conditions until its distribution;
distribute: the transport and delivery of bodily material;
j. human application means the use of bodily material on or inside a human recipient, as well as applications outside the body;
a tissue establishment: a tissue bank, a hospital unit, or any other body in which work on the processing, preservation, storage or distribution of bodily material is carried out;
(l) organ organ: a tissue establishment approved for the receipt of bodily material after obtaining it;
Organ Organ system: an institution as intended Article 24 of the Organ Donation Act ;
n. EU Directive tissues and cells: the Directive to be adopted by our Minister;
o. EU organ transplantation directive: the Directive to be adopted by our Minister;
p. organ: a differentiated, vital part of the human body, made up of different tissues and its structure, vasculation and ability to develop with considerable autonomy physiological functions, is retained. A part of an organ is also considered to be a body if it is to be used in the human body for the same purposes as that of the whole organ, while maintaining the requirements of structure and vasculation;
q. donor: any human resource, death or living, of body material or a person donating one or more organs to life or after death;
Recipient: a person in whom an organ is implanted;
s. procurement organisation: a health care institution, team or unit of a hospital, or a person or other body that obtains or coordinates organs and has an authorisation based on the acquisition of Article 5, first paragraph, of the Law authorising health care institutions ;
t. transplantation: a process that aims to restore certain functions of the human body by transferring a organ from a donor to a recipient;
u. transplantation center: a health care institution, team or unit of a hospital or other body that transplants human organs and for that purpose on the basis of the Law on special medical operations has a licence;
Disposal: the final destination of an organ when not used for transplantation.
2 An amendment to the Directives referred to in the first paragraph, parts n and o shall apply to the application of the provisions of, or pursuant to, the safety and quality of body material as from the day on which the relevant The amending Directive must be implemented.
This law does not apply to body material taken away in one and the same operation and returned to the same person, blood, taken under the Blood supply law , and on body material, to the extent that they Act on the Supply of Medicinal Products or the Law on medical devices is applicable.
It is prohibited tissue, cells, constituents of an embryo, fetal tissues within the meaning of the Foetal tissue law Cells, whether from tissue or cells, or from constituents of an embryo, or from foetal tissue in culture, intended for use solely for a purpose other than humans, are to be applied for that purpose. use.
The acquisition of organs shall be non-profit-making.
1 The institution where the body material is available or the natural person who is given the disposition of the material in the exercise of a medical profession shall provide that body material to an organ bank.
2 The first paragraph shall not apply in respect of:
a. Body material for which according to the Act on organ donation an allocation has taken place and that, by its nature, is not suitable for being offered to an organ bank;
b. Body material taken away and reposted to the same person in the context of a single medical treatment;
c. cells derived from tissues or cells or from constituents of an embryo or from foetal tissue in culture;
d. reproductive cells for in vitro fertilisation or insemination, except in the case of artificial donor fertilisation, as intended in Article 1 (c) of the Artificial Fertilization data of the Donors Act .
3 In the case of the offer, mention shall be made, where appropriate, of any other purpose for which permission to use the body material has been granted, other than for humans.
An organ bank stores body material from which on the basis of Article 18, 2nd paragraph, of the Organ Donation Act is determined that it should remain available for implantation, at least until the organ center has designated use of that law who is eligible for that body material for implantation, or until the organ center has determined that it is no longer required to remain available.
1 The transfer from another Member State of the European Union to the territory of the Netherlands of bodily material which has not undergone any operation other than its preservation shall be permitted only to tissue establishments which are responsible for this purpose. Minister has been appointed.
2 The export or export of any bodily material or products derived therefrom from among the Member States other than the Member States of the European Union shall only be permitted to tissue establishments designated by our Minister for that purpose.
3 The first and second paragraphs shall not apply in respect of:
a. Blood;
b. Body material which has not undergone any operation other than that intended to be stored for which it has been Act on organ donation an allocation has been made.
4 Any person who brings bodily material into Dutch territory for the purpose of implantation within the meaning of the Act on organ donation , you know, report it to the organ center.
1 In the case of, or under general management, requirements to be met by organ centres and tissue establishments for the safety and quality of bodily material in relation to the acquisition, processing, preservation, to store, distribute or bring any body material or prepared products in the Netherlands.
2 In the case of, or under a general measure of management, requirements for the acquisition, testing and use by other than tissue establishments for the purposes of the safety and quality of bodily material may be further shall be satisfied.
3 In the case of, or under general management, rules may be laid down concerning the endorsement and reporting of adverse effects of bodily material applied to humans.
4 The nomination for a general measure of directors to be adopted under this Article shall not be made more than four weeks after the draft has been submitted to both Chambers of the States General.
The organ centre sets up a protocol on quality and safety for all stages of the chain from donation to transplantation or disposal and provides appropriate guidance to procurement organisations, transplant centres, staff in the health care and other parties involved in the chain from donation to transplant or disposal. The protocol on quality and safety is in accordance with the rules that the EU Organ Transplant Directive lays down in respect of this Protocol.
The acquisition of organs is carried out in a procurement organisation which complies with the requirements of the EU Organ Transplantation Directive.
1 Organ centre keeps a record of the work of procurement organizations and transplantation centres with aggregated numbers of living and deceased donors and the types and numbers obtained and transplanted or not for transplantation used organs.
2 The system of organs shall include the information referred to in the first paragraph in its annual report and shall make it public.
Our Minister shall establish an updated register of procurement organisations and transplantation centres.
1 It is forbidden without recognition of Our Minister to receive bodily material upon receipt after obtaining, or to edit, preserve, preserve, or distribute it.
2 A recognition may be granted for one or more of the acts referred to in paragraph 1 and for one or more types of bodily material.
3 A recognition may be granted only to a legal person who is not a centre of organs and, in the case of an organ bank, whose objective is apparent from the statutes not to make payments to parents or to those who are members of her organs nor to others. A recognition for the reception of body material for implantation purposes within the meaning of the Act on organ donation shall be refused if an effective supply of bodily material is not provided for in the case of a recognition or an effective cooperation with other organs of the organ and organ centres are not insured.
4 In order to implement the rules on recognition, designation, authorization or authorization of tissue establishments adopted pursuant to the EU Directive, regulations are laid down by our Minister, with rules to which In order to qualify for recognition, the institution must fulfil its eligibility.
5 The first paragraph shall not apply in respect of any bodily material for which, according to the Act on organ donation an allocation has taken place and that, by its nature, is not suitable for being offered to an organ bank.
1 A recognition may be granted under restrictions. Rules may be linked to a recognition.
2 In any case, provisions on the techniques of preparation for tissues and cells for the implementation of the provisions on preparation techniques for tissues and cells under the EU Directive should be laid down in each case: tissues and cells.
3 Any restriction or regulation may be amended or withdrawn. Restrictions may also be imposed after the granting of approval, or rules related thereto.
4 A tissue establishment may not substantially modify its operations without prior written permission from Our Minister.
A recognition may be withdrawn if the provisions of this law or the rules relating to recognition are no longer fulfilled or if it has been contrary to a restriction under which recognition has been granted.
1 It is forbidden for donors to carry out tests of bodily material without authorization from Our Minister.
2 Our Minister shall grant only a laboratory authorisation which has made it possible to comply with the requirements for laboratory tests required by the EU Directive on tissues and cells.
3 The Articles 10 and 11 shall be applicable mutatis mutandis.
1 The costs associated with the granting of the approval provided for in Article 9 , may be charged to the applicant for the document.
2 A fee may be charged annually to the holder of the approval referred to in paragraph 1.
3 The amounts to be reimbursed for the costs and the amount of the annual fee shall be determined by means of a ministerial arrangement.
The supervision of compliance with or pursuant to this Act shall be subject to public health officials.
Without prejudice to the foregoing provisions, it shall be prohibited to the person who has possession of bodily material for delivery, which he knows or may reasonably suspect that the suitability for human application is completely or seriously lacking. to deliver the body material.
Our Minister has the power to impose an administrative fine of up to € 900 000 on a conduct contrary to the provisions of, or on the basis of, the Article 3 , 4, first or third member , 5 , 7, first, second or fourth members , or 20 .
1 Unauthorised access to data or systems allowing the identification of donors or recipients shall be prohibited.
2 Subject to the provisions of the Articles 8 and 21 of the Personal Data Protection Act , is any use of systems or data that enables the identification of donors or recipients with the purpose of tracing donors or recipients for purposes other than their medical treatment prohibited.
1 The system of organs is to monitor organ exchange with a country other than a Member State of the European Union. For this purpose, the organ centre can enter into an agreement with its counterparts in third countries.
2 Organ exchange with a country other than a Member State of the European Union may take place only if the institution:
a. From the donor to the recipient and vice versa can be traced;
b. meets the quality and safety requirements equivalent to the requirements of the EU Organ Transplant Directive.
A permit, granted to an organ bank on the basis of Article 28 of the Organ Donation Act , shall be treated in the same way as a recognition under this law.
This Law shall enter into force on a date to be determined by Royal Decree, which may be adopted in a different way for the various articles or parts of such articles.
This law is cited as: Law safety and quality body material.
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, 6 February 2003
Beatrix
The Minister for Health, Welfare and Sport,
A. J. de Geus
Published on 4 March 2003The Minister of Justice,
J. P. H. Donner
