Posted the: 2012-08-24 Numac: 2012024263 PUBLIC SERVICE FEDERAL public health, food chain safety and environment July 3, 2012. -Act to amend the law of June 13, 1986, collection and transplantation of organs and the Act of December 19, 2008 on the obtaining and use of human body material intended for human or for purposes of scientific research ALBERT II, medical applications King of the Belgians, to all, present and future, hi.
The Chambers have adopted and we endorse the following: title 1. -Provisions General Article 1.
This Act regulates a matter referred to in article 78 of the Constitution.
S. 2. this Act partially transposes Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation.
TITLE 2. -Amendments to the law of 13 June 1986 on the levy and the transplantation Chapter 1. -Provisions amending art. 3. in the law of 13 June 1986 on the removal and transplantation of organs, the words "chapter I:. General provisions' shall be replaced by the words "chapter I:. Scope, definitions and general principles.
S. 4. article 1stmini the Act, as amended by the laws of December 22, 2003 and December 19, 2008, is replaced by the following: «art.» 1. this Act applies donation, control, characterization, collection, preservation, transport and transplantation of organs for transplantation.
Where such bodies are used for research purposes, the Act applies only if they are intended to be transplanted into the human body. » Art. 5 article 1bis, § 2, of the Act, inserted by the Act of February 25, 2007, is replaced by the following: "§ § 2 2» The King may take all necessary measures for an optimal organization of the removal of organs as well as to improve detection, selection and management of donors. » Art. 6. in the Act, it is inserted an article 1B as follows: «art.»
1B. for the purposes of this Act shall mean: 1 ° "disposal": the final destination of a body when it is not used for purposes of transplantation;
2 ° "donor": a person who makes one or more organ donation, the donation takes place in his lifetime or after his death.
3 ° 'gift': donating organs for transplantation purposes;
4 ° "characterization of the donor": the collection of the relevant information regarding the characteristics of the donor needed to assess eligibility for organ donation, so as to carry out a proper assessment of the risks, reduce as much as possible risks for the recipient and optimise the allocation of organs.
5 ° 'European organ Exchange organisation': a non-profit, public or private organization, dedicated to national and cross-border organ Exchange and whose member countries are majority of the States members of the Union;
6 ° 'body': part differentiated from the human body, formed by different tissues, that maintains largely independently, its structure, vascularisation and capacity to perform physiological functions. Part of body is also considered to be a body if it is intended to be used in the same fi ns as the entire organ in the human body, structure and vascularization criteria being kept;
7 ° "characterization of the body": the collection of relevant information on the characteristics of the organ needed to assess if it lends itself to transplantation, so as to carry out a proper assessment of the risks, reduce as much as possible the risks to the receiver, and optimize the allocation of organs.
8 ° 'levy': a process allowing the availability of donated organs;
9 ° 'conservation': use of chemical agents, change the ambient or use other processes, to prevent or retard biological deterioration or physics of the bodies from their levy until their transplant;
10 ° "recipient": a person receiving an organ transplant.
11 ° "serious adverse event": any incident undesired and unexpected linked to a step any of the chain from donation to transplantation, which could lead to the transmission of a communicable disease, to death or to life-threatening, result in disability or incapacity for work in the patient, or cause or prolong, hospitalisation or morbidity;
12 ° "serious adverse reaction": a reaction unintended, including a communicable disease, in the living donor or the receiver, which could be linked to a step any of the chain from donation to transplantation that is fatal, endangers life, results in a disability or incapacity for work, or causes or prolongs hospitalisation or morbidity;
13 ° "modus operandi": written instructions describing the steps in a specific process, including the equipment and methods to be used and the final deliverable;
14 ° "transplantation": the process supposed to restore some functions of the human body by the transfer of an organ from a donor to a recipient;
15 ° 'transplantation centre': a medical service authorized under the Act to hospitals and other care facilities, coordinated on July 10, 2008. » Art. 7. in the Act, it is inserted an article 1erquater as follows: «art.» 1erquater. the gametes, gonads, embryos and bone marrow are considered as bodies under this Act. » Art. 8. article 3 of the same Act, as amended by laws of December 22, 2003 and December 19, 2008, is replaced by the following: «art.» 3 § 1. All medical activities relating to the removal of organs, such as the selection and assessment of donors, are performed by a doctor, on the basis of their State of health and their medical history.
If the gift of a living person presents an unacceptable health risk to it, the doctor should exclude it from the selection.
§ 2. Any samples and any transplant of organs from deceased persons are performed by a doctor of a transplant centre in a transplant centre or a hospital as defined in the Act to hospitals and other care facilities, coordinated on July 10, 2008, provided that the hospital has concluded a cooperation agreement with a transplant center that is responsible for the removal and transplantation.
Notwithstanding in 1st paragraph, levy and a heart or a heart-lung transplant may be performed outside a transplantation centre, by a team of care "cardiac pathology" T program who has entered into a collaboration agreement with a transplant center.
§ 3. Any samples and any transplant of organs from living persons are performed by a doctor of a transplant centre in a transplant centre. » Art. 9. in the same Act, it is inserted an article 3bisredige as follows: «art.» 3A. A framework for quality and safety covering all stages of the chain from donation to transplantation or disposal, must be established.
Health personnel involved in each step of the chain that goes from donation to transplantation or disposal, is adequately qualified or trained and competent. This staff follows specific training programmes implemented in their intention. » Art. 10. in the same Act inserted an article 3ter as follows: «art.» 3B. § 1. All bodies collected and all donors must be a characterization prior to transplantation, in accordance with the model laid down in the annex to this Act.
The King may set additional criteria within this model, relating to characterization physiological, immunological and histologically of the donor, the functional characterization of the organ, the detection of communicable diseases and the situation of the patient.
§ 2. All the necessary information from living donors should be collected.
In the case of a deceased donor, these information are obtained from the family of the deceased donor or others where possible.
All parties are sensitized to the importance of a rapid transmission of such information.
The analysis necessary for the characterization of organs and donors are carried out by laboratories equipped with a properly qualified or trained and competent staff as well as facilities and equipment adequate.
The King may lay down criteria that laboratories must meet under the analysis necessary for the characterization of organs and donors. » Art. 11. in the Act, it is inserted an article 3quater as follows: «art.» 3quater. for transport of organs, procedures appropriate to ensure the integrity of the organs during transportation and sufficient duration of transport must exist. » Art. 12. in the Act, it is inserted a 3D section as follows: «art.» 3D. all bodies collected, allocated and transplanted in Belgium are subject to traceability from the donor to the recipient and vice versa, so as to protect the health of donors and recipients.
This traceability implies the implementation of a system of identification of donors and recipients to identify each donation and each of the bodies and recipients who are associated.
required to ensure traceability at all stages of the chain from donation to transplantation or disposal, and information relating to the characterisation of bodies and donors must be kept for at least thirty years after the gift. These data can be saved in an electronic form. » Art. 13. in the same Act, it is inserted an article 3E as follows: «art.» 3E. § 1. There should be a notification system reporting, examine, register and transmit relevant information concerning serious adverse events that may affect the quality and safety of organs that could be attributed to the control, characterization, sampling, for the preservation or transport of organs, as well as any serious adverse reaction observed during or after transplantation which may be related to these activities.
§ 2. A procedure for the management of incidents and serious adverse reactions must be put in place.
3. Procedures should be put in place for timely notification: has) any incident or serious adverse reaction to the European organ Exchange organisation or the transplantation centre concerned;
(b) management measures with regard to the incidents and serious adverse reactions to the European organ Exchange organisation.
4. An interconnection between the reporting system referred to the § 1 and the system of notification provided by the Act of December 19, 2008 procurement and use of human body material intended for human medical applications or for purposes of scientific research, must exist. » Art. 14. article 4 of the same Act, as amended by laws of December 22, 2003 and December 19, 2008, is replaced by the following: «art.» 4 § 1.
Donations of organs from deceased donors and living donors are voluntary and non-remunerated.
Neither the donor nor relatives cannot assert a right against the receiver.
2. The principle of unpaid donation does not living donors to be compensated, provided that it is limited to direct and indirect expenses and the loss of revenue related to the donation.
The King defines the conditions under which compensation may be granted and shall ensure that it is not a financial incentive or benefit to a potential donor.
§ 3. Any measures making public the need or the availability of organs which is intended to offer or seek financial gain or comparable advantage, shall be prohibited.
§ 4. The removal of organs must be carried out on a non-profit basis. » Art. 15. in the same Act, it is inserted an article 4A as follows: «art.» 4bis. unless the donor and the recipient know their respective identities in the context of a levy on a living person, the identity of the donor and the receiver shall not be disclosed. » Art. 16. article 5 of the same Act, as amended by laws of December 22, 2003 and December 19, 2008, is supplemented by a paragraph as follows: "no removal of organs from a living person may be carried out on a person who has reached the age of eighteen years who is not able to express their will."
S. 17 ÷ article 6 of the Act, as amended by the laws of 22 December 2003, February 25, 2007 and December 19, 2008, the following changes are made: 1 ° in the § 1, the word "serious" is inserted between the word "consequences" and the word "for".
2 ° § 2 is repealed.
S. 18. in article 7 of the same Act, § 2, amended by law of December 7, 2001 and February 25, 2007, is replaced by the following: "§ § 2 2» The levy referred to the § 1erne can be carried out on a person who has reached the age of twelve, which is able to express their will and which consents prior to sampling. » Art. 19. article 8A of the Act, inserted by the Act of February 25, 2007, is replaced by the following: «art.» 8bis. any levy on living persons should be subject to a prior multidisciplinary consultation between doctors and other providers of care, with the exception of doctors and care providers who deal with the receiver, or to undertake the removal or transplantation.
The pluridisciplinary members evaluate the potential donor in an independent manner, particularly its capacity to consent to an organ retrieval.
The King may lay down rules for the application of paragraph 1.
» Art. 20. in the Act, it is inserted in chapter II an article 9bis worded as follows: «art.» 9A. A registry or a file of living donors must exist.
A system of follow-up of living donors to identify, report and manage any incident potentially linked to the quality and safety of the body given and, consequently, to the security of the recipient, as well as any adverse reactions serious in the living donor which may result from the don, is implemented.
» Art. (21 ÷ section 10 of the Act, as amended by the laws of February 17, 1987, 22 December 2003, June 14, 2006, 25 February 2007 and December 19, 2008, the following changes are made: 1 ° in the § 1, the following changes are made: a) a paragraph worded as follows is inserted between paragraphs 1 and 2: "the physician who intends to carry out the sampling must inform of the existence of an opposition expressed by the potential donor.
(b) in paragraph 2 current, which becomes paragraph (3), "before" shall be replaced by the words ' paragraph 1 ';
2 ° it is inserted a § 2A, as follows: "§ 2A.» Anyone able to manifest his will can only express its express desire to be donor after death. »;
3 ° it is inserted a § 3a, as follows: "§ 3A. '. Opposition to sampling registered according to the procedure laid down by the King at the request of competent persons under this article at the date of the expression of opposition, ceases to have effect when the person referred to in § 2, paragraphs 2 and 3, the age of majority. The King lays down the procedures relating to the cancellation of this opposition.
The person concerned is informed of the cancellation in accordance with the procedures laid down by the King.
The cancellation referred to in paragraph 1, does not apply with respect to the person referred to in § 2, paragraph 4.
People who are major at the time of the entry into force of this paragraph are also subject to cancellation referred to in paragraph 1. » Art. 22. in the same Act, it is inserted a chapter III/1, entitled "Provisions relating to the allocation of organs", comprising articles 13bis to 13ter.
S. 23. article 13bis of the Act, inserted by the Act of February 25, 2007, is replaced by the following: «art.» 13bis. § 1.
The King means the Organization European organ Exchange responsible for activities relating to the exchange of bodies within the Belgium as with abroad, as well as for the following tasks in the framework of quality and safety set out in the Act: 1 ° the holding and management of a system of traceability and identification of donors and recipients;
2 ° the holding and management of a system of notification and management of incidents and serious adverse reactions;
3 ° the holding and management of a registry and a system of follow-up of living donors.
The organization designated by the King under paragraph 1, is responsible for processing within the meaning of article 1, § 4, of the Act of 8 December 1992 on the protection of privacy with regard to processing of personal data, for the processing of data referred to in paragraph 1, 1 ° to 3 °.
§ 2. In the context of its mission for the exchange of bodies, the European organ Exchange organisation designated by the King guarantees: 1 ° an optimal compatibility between the organs and candidates recipients;
2 ° a reasonable balance between the number of organs exported from the Belgium and the number of organs that is imported;
3 ° taking account of medical urgency, waiting time effective recipient candidates and the distance from the Center where the body is taken and that where it is transplanted.
§ 3. The King may clarify the tasks assigned to the European organ Exchange organisation.
§ 4. The Organization European exchange of designated bodies is committed to respecting the provisions of this Act, the Act relating to hospitals and other care facilities, coordinated on July 10, 2008, of the law of 8 December 1992 relative to the protection of privacy with respect to the processing of data personal, and of the law of 4 July 1962 on official statistics , as well as the execution of these orders. » Art. 24. in the same Act, it is inserted an article 13bis/1 as follows: «art.» 13A/1. The exchange of organs with third countries to the European Union is permitted only if bodies are subject to traceability from the donor to the recipient and vice versa, and if the bodies meet quality and safety standards equivalent to those laid down in Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation. » Art.
25. in article 13ter, of the same Act, inserted by the Act of February 25, 2007, the words "or recognized" are repealed.
S. 26. article 14 of the Act is repealed.
S. 27. in article 17, § 1, of the Act, 'in article 3' shall be replaced by the words "articles 3 to 3E.
S. 28. in the same Act, it is inserted an annex read as follows: "annex to act of 13 June 1986 on the levy and the characterization of the donor and the organ transplantation.
Minimum data set to be collected in the characterization of donors and bodies, in accordance with article 3ter, § 1, of this Act.
1 ° establishment in which the levy is location and other data of a general nature 2 ° Type of donor blood group 3 ° + type HLA 4 ° sex 5 ° Cause of death 6 ° Date of death 7 ° Date of birth 8 ° weight 9 ° size 10 ° addiction by intravenous route (history or current condition) 11 ° malignant neoplasia (history or current condition) 12 ° another communicable disease (history or current condition) 13 ° Tests HIV HCV, HBV, CMV 14 ° basic information to assess the operation of the given body 15 ° data to general coordinates of the care facility in which the levy, necessary for the coordination, allocation of organs and their traceability from the donor to the recipient and vice versa.
16 ° donor data demographic and anthropometric required to ensure pairing satisfactory approved between the donor and the receiver.
17 ° medical history of the donor medical history of the donor, in particular conditions that might affect the extent in which organs are suitable for transplantation and might lead to the risk of disease transmission.
18 ° physical data and clinical data from a clinical examination which are necessary for the assessment of maintaining physiological potential as well as any findings dealer revealing which were not detected during examination of the donor medical history and conditions that could impact where organs are suitable for transplantation and result in the risk of transmission of disease.
19 ° laboratory parameters data necessary for the evaluation of the functional characterization of organs and for the detection of potentially communicable diseases and possible contraindications to organ donation.
20 ° medical imaging Explorations by medical imaging needed to assess the morphological status of organs for transplantation.
21 ° therapy treatments administered to the donor and that should be taken into account in the evaluation of the functional status of the organs and the eligibility for the donation of organs, in particular the use of antibiotics, the inotropic support or transfusions.
22 ° hot and cold ischemia. "CHAPTER 2. -Provisions finals s. 29. the King sets the date of entry into force of article 21, 3 °.
S. 30. the Act of 14 June 2006 amending the Act of 13 June 1986 on the levy and the transplantation of organs is removed.
TITLE 3. -Amendment of the Act of December 19, 2008 to obtain and use of human body material intended for human medical applications or scientific research purposes art. 31. in article 2 of the law of 19 December 2008 on obtaining and use of material body human for human or for purposes of scientific research, medical applications 7 is replaced by the following: ' 7 ° 'body': body as defined in article 1B, 6 °, of the law of 13 June 1986 on the removal and transplantation of organs.
Promulgate this Act, order that it self under the seal of the State and published by le Moniteur.
Given to Brussels, July 3, 2012.
ALBERT by the King: the Minister of Social Affairs and public health, Ms. L. ONKELINX sealed with the seal of the State: the Minister of Justice, Ms. A. TURTELBOOM _ Note (1) Session 2011-2012.
House of representatives Documents. -Bill, 53-2158, no. 1. -Report on behalf of the Committee, 53-2158, no. 2. -Text corrected by the Commission 53-2158, no. 3. -Text adopted in plenary meeting and transmitted to the Senate, 53-2158, no. 4 complete record.
-31 May 2012.
Senate: Documents. -Project mentioned by the Senate, 5-1641/1. -Report on behalf of the committees met, 5-1641/2. -Text Correggio by the committees met, 5-1641/3.
-Decision not to amend, 5-1641/4 annals of the Senate. -26 June 2012.