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3 JULY 2012. - An Act to amend the Act of June 13, 1986 on organ transplantation and transplantation and the Act of December 19, 2008 on the obtaining and use of human body material for human medical applications or for scientific research purposes

ALBERT II, King of the Belgians,
To all, present and to come, Hi.
The Chambers adopted and We sanction the following:
PART 1^er. - General provisions
Article 1^er. This Act regulates a matter referred to in Article 78 of the Constitution.
Art. 2. This Act partially transposes the Directive 2010/53/EU of the European Parliament and the Council of 7 July 2010 on standards for the quality and safety of human organs for transplantation.
PART 2. - Amendments to the Act of 13 June 1986
on organ removal and transplantation
CHAPTER 1^er. - Amendments
Art. 3. In the Act of 13 June 1986 on organ transplantation and transplantation, the words "Chapter I^er. General Provisions are replaced by the words "Chapter I^er. Scope of application, definitions and general principles".
Art. 4. Article 1^erthe Act, amended by the Acts of 22 December 2003 and 19 December 2008, is replaced by the following:
“Art. 1^er. This Act applies to the gift, control, characterization, collection, conservation, transportation and transplantation of organs intended for transplantation.
Where such bodies are used for research purposes, this Act applies only if they are intended to be transplanted into the human body. »
Art. 5. Article 1^erbis, § 2, of the same law, inserted by the law of 25 February 2007, is replaced by the following:
“§2. The King may take appropriate measures to ensure optimal organ sampling and to improve the detection, selection and management of donors. »
Art. 6. In the same law, an article 1 is inserted.^erter as follows:
“Art. 1^erter. For the purposes of this Act:
1° "disposal": the final destination of an organ when it is not used for transplantation;
2° "donor": a person who gives a gift of one or more organs, whether the gift takes place from his or her life or after his death;
3° "donation": giving organs for transplantation;
4° "donor characterization": the collection of relevant information regarding the donor's characteristics necessary to assess the donor's eligibility for organ donation, so as to conduct an appropriate risk assessment, minimize the risks to the recipient and optimize the allocation of organs;
5° "European Organization for the Exchange of Organs": a non-profit, public or private organization dedicated to the national and cross-border trade of organs and whose member countries are predominantly Member States of the Union;
6° "organic": a differentiated part of the human body, consisting of different tissues, which maintains its structure, vascularisation and its ability to perform physiological functions in a largely autonomous manner. A part of organ is also considered as an organ if it is intended to be used for the same fi ns as the entire organ in the human body, the criteria of structure and vascularization being maintained;
7° "organ characterization": the collection of relevant information concerning the characteristics of the organ required to assess whether it is suitable for transplantation, so as to conduct an appropriate risk assessment, minimize the risks to the recipient, and optimize the allocation of organs;
8° "sample": a process allowing the availability of the given organs;
9° "preservation": the use of chemical agents, the modification of the environment or the use of other processes, in order to prevent or delay the biological or physical deterioration of organs from their removal to their transplantation;
10° Receiver: a person receiving an organ transplant;
11° "serious adverse incident": any unintended and unexpected incident related to any stage of the donation chain to transplant, likely to lead to the transmission of a transmissible disease, to cause death or to endanger life, to cause disability or incapacity for work in the patient, or to cause or prolong hospitalization or morbidity;
12° "serious adverse reaction": an unintended reaction, including a communicable disease, in the living donor or recipient, that could be linked to any stage of the donor chain to transplantation, which is fatal, endangers life, causes disability or incapacity for work, or causes or prolongs hospitalization or morbidity;
13° "operational mode": written instructions describing the stages of a specific process, including the material and methods to be used and the expected final result;
14° "transplanation": the process supposed to restore certain functions of the human body by transferring a donor organ to a receiver;
15° "transplant centre": a medical service approved under the Hospitals and Other Care Facilities Act, coordinated on July 10, 2008. »
Art. 7. In the same law, an article 1 is inserted.^erquater as follows:
“Art. 1^erquater. Ggamets, gonads, embryos and bone marrow are not considered organs by this Act. »
Art. 8. Section 3 of the Act, as amended by the Acts of 22 December 2003 and 19 December 2008, is replaced by the following:
“Art. 3. § 1^er. All medical activities related to organ removal, such as donor selection and evaluation, are carried out by a doctor, based on their health status and medical history.
If the gift of a living person presents an unacceptable health risk to the living person, the doctor must exclude him from the selection.
§ 2. Any removal and transplantation of organs of deceased persons shall be carried out by a physician from a transplant centre in a transplant centre or hospital as defined in the Hospitals and Other Care Establishments Act, coordinated on July 10, 2008, provided that the hospital has entered into a collaborative agreement with a transplant centre that is responsible for the removal and transplantation.
Derogation from paragraph 1^er, the removal and transplantation of a heart or heart-inch may be carried out outside a transplant center, by a team of the "cardiac pathology" T program that has concluded a collaborative agreement with a transplant center.
§ 3. Any removal and transplantation of organs of living persons shall be carried out by a doctor at a transplant centre. »
Art. 9. In the same law, an article 3bisdrafted as follows:
"Art. 3bis. A quality and safety framework covering all stages of the donation chain to transplantation or disposal must be established.
Health personnel participating in each of the chain's stages that goes from donation to transplantation or disposal are adequately qualified or trained and competent. These staff are trained in specific training programmes. »
Art. 10. In the same law, an article 3ter is inserted as follows:
"Art. 3ter. § 1^er. All organs taken and all donors must be characterised before transplantation in accordance with the model set out in the schedule to this Act.
The King may set additional criteria to this model, concerning the physiological, immunological and histological characterization of the donor, the functional characterization of the organ, the detection of communicable diseases and the patient's situation.
§ 2. All necessary information from live donors must be collected.
In the case of a deceased donor, this information is obtained from the deceased donor's family or others where possible.
All parties are sensitized to the importance of rapid transmission of this information.
§ 3. The analyses necessary for the characterization of organs and donors are carried out by laboratories with appropriately qualified, trained and competent personnel, as well as adequate facilities and equipment.
The King may set criteria to which laboratories must meet as part of the analyses necessary for the characterization of organs and donors. »
Art. 11. In the same Act, an article 3quater is inserted as follows:
"Art. 3quater. For the transport of organs, appropriate operating modes to ensure the integrity of the organs during carriage and sufficient transport time shall exist. »
Art. 12. In the same law, an article 3quinquies is inserted as follows:
"Art. 3quinquies. All organs taken, attributed and transplanted into Belgium are subject to traceability of the donor to the recipient and vice versa, in order to protect the health of donors and recipients.
This traceability involves the establishment of a system for identifying donors and recipients to identify each donation and each of the organs and receivers associated with it.
All data required to ensure traceability at all stages of the donation chain to transplantation or disposal, as well as information on the characterization of organs and donors must be kept for at least thirty years after the donation. This data may be recorded in an electronic form. »
Art. 13. In the same law, an article 3sexies is inserted as follows:
"Art. 3sexies. § 1^er. There must be a notification system to report, review, record and transmit the necessary relevant information regarding serious adverse events that may affect the quality and safety of organs that may be imputed to the control, characterization, removal, conservation or transport of organs, as well as any serious adverse reactions observed during or after transplantation that may be related to these activities.
§ 2. A procedure for managing serious adverse incidents and reactions must be put in place.
§ 3. Procedures must be established for timely notification:
(a) any serious incident or adverse reaction to the European organ exchange organization or the transplant centre concerned;
b) management measures with respect to serious adverse incidents and reactions to the European organ exchange organization.
§ 4. Interconnection between the notification system referred to in § 1^erand the notification system under the Act of 19 December 2008 relating to the obtaining and use of human body equipment for human medical applications or for scientific research purposes must exist. »
Art. 14. Section 4 of the Act, as amended by the Acts of 22 December 2003 and 19 December 2008, is replaced by the following:
“Art. 4. § 1^er. Donations of deceased donors and living donors are voluntary and unpaid.
Neither the donor nor his relatives can claim a right to the receiver.
§ 2. The principle of non-remuneration of the donation does not prevent live donors from receiving compensation, provided it is limited to cover direct and indirect expenses as well as the loss of income related to the donation.
The King defines the conditions under which this compensation can be granted and ensures that it is not a financial incentive or a benefit to a potential donor.
§ 3. Any action making public the need or availability of organs that is intended to offer or seek a financial gain or a comparable benefit is prohibited.
§ 4. The removal of organs must be carried out on a non-profit basis. »
Art. 15. In the same law, an article 4bis is inserted as follows:
"Art. 4bis. Unless the donor and the receiver know their respective identity as part of a debit on a living person, the identity of the donor and the receiver cannot be communicated. »
Art. 16. Section 5 of the Act, as amended by the Acts of 22 December 2003 and 19 December 2008, is supplemented by a paragraph written as follows:
"No organ removal on a living person can be carried out on a person who has reached the age of eighteen who is not capable of manifesting his will. »
Art. 17. ÷ section 6 of the Act, as amended by the Acts of 22 December 2003, 25 February 2007 and 19 December 2008, the following amendments are made:
1° in § 1^erthe word "serious" is inserted between the word "results" and the word "for";
2° § 2 is repealed.
Art. 18. In Article 7 of the Act, § 2, as amended by the Acts of 7 December 2001 and 25 February 2007, is replaced by the following:
“§2. The sampling referred to in § 1^ermay only be performed on a person who has attained the age of twelve, who is capable of manifesting his or her will and who consents before sampling. »
Art. 19. Section 8bis of the Act, inserted by the Act of 25 February 2007, is replaced by the following:
"Art. 8bis. Any sampling of living persons must be the subject of a pre-disciplinary multidisciplinary consultation between physicians and other caregivers, with the exception of physicians and caregivers who treat the receiver or perform the removal or transplantation.
Members of the multidisciplinary dialogue independently assess the potential donor, including its ability to consent to organ sampling.
The King may determine the terms and conditions for the application of paragraph 1^er. »
Art. 20. In the same Act, an article 9bis is inserted in chapter II, which reads as follows:
"Art. 9bis. A register or file of live donors must exist.
A tracking system for live donors to identify, report, and manage any potential incidents related to the quality and safety of the given organ and, consequently, to the security of the receiver, as well as any serious adverse reactions to the live donor that could result from the donation, is in place. »
Art. 21. ÷ section 10 of the Act, as amended by the Acts of 17 February 1987, 22 December 2003, 14 June 2006, 25 February 2007 and 19 December 2008, the following amendments are made:
1° to § 1^erthe following amendments are made:
(a) a paragraph to read is inserted between subparagraphs 1^erand 2:
"The doctor who plans to take the sample must inform himself of the existence of an opposition expressed by the potential donor. »;
(b) in current paragraph 2, which becomes paragraph 3, the words "before" are replaced by the words "in paragraph 1^er »;
2° it is inserted a § 2bis, written as follows:
“§ 2bis. Any person capable of manifesting his or her will can express his or her express will to be a donor after death. »;
3° it is inserted a § 3bis, written as follows:
“§3bis. The opposition to the withdrawal registered under the procedure established by the King at the request of the competent persons under this article at the date of the expression of the opposition shall cease to produce its effects when the person referred to in § 2, paragraphs 2 and 3, reaches the age of the majority. The King sets out the terms for the annulment of this opposition.
The person concerned is informed of this cancellation in accordance with the terms and conditions established by the King.
Cancellation referred to in paragraph 1^er, does not apply to the person referred to in § 2, paragraph 4.
Persons who are major at the time this subsection comes into force are also subject to the cancellation referred to in paragraph 1^er. »
Art. 22. In the same Act, a chapter III/1, entitled "Organization Allocation Provisions", including sections 13bis to 13ter, is inserted.
Art. 23. Section 13bis of the Act, inserted by the Act of 25 February 2007, is replaced by the following:
"Art. 13bis. § 1^er. The King shall designate the European organization for the exchange of competent bodies for activities relating to the exchange of organs in Belgium and abroad, as well as for the following tasks provided by the quality and security framework set out in this Act:
1° the maintenance and management of a traceability and identification system for donors and recipients;
2° the maintenance and management of a reporting and management system for serious incidents and adverse reactions;
3° the maintenance and management of a register and a tracking system for live donors.
The organization designated by the King under paragraph 1^er, is responsible for processing within the meaning of section 1^er, § 4, of the Act of 8 December 1992 on the protection of privacy with respect to personal data processing, for the data processing referred to in paragraph 1^er1° to 3°.
§ 2. As part of its organ exchange mission, the European organization for the exchange of bodies designated by the King guarantees:
1° optimum compatibility between the organs taken and the candidates received;
2° a reasonable balance between the number of organs exported outside Belgium and the number of organs imported there;
3° taking into account the medical emergency, the actual waiting time of the recipient candidates and the distance between the center where the organ is taken and the place where it is transplanted.
§ 3. The King may specify the missions assigned to the European Organ Exchange Organization.
§ 4. The European Organization for the Exchange of Designated Organs is committed to complying with the provisions of this Act, the Hospitals Act and other Care Institutions Act, coordinated on 10 July 2008, the Protection of Privacy Act of 8 December 1992 in respect of personal data processing, and the Act of 4 July 1962 on public statistics, as well as the decrees for the execution of such data. »
Art. 24. In the same law, an article 13bis/1 is inserted as follows:
"Art. 13bis/1. The exchange of organs with third countries to the European Union is permitted only if the organs are subject to traceability of the donor to the receiver and vice versa, and if the bodies meet standards of quality and security equivalent to those established by the Directive 2010/53/EU of the European Parliament and the Council of 7 July 2010 on the standards of quality and safety of human organs intended for transplantation. »
Art. 25. In section 13ter of the Act, inserted by the Act of February 25, 2007, the words "or recognized" are repealed.
Art. 26. Section 14 of the Act is repealed.
Art. 27. In Article 17, § 1^er, in the same law, the words "at section 3" are replaced by the words "at sections 3 to 3sexies".
Art. 28. In the same Act, an annex is inserted as follows:
"Appendix to the Act of June 13, 1986 on organ transplantation and transplantation
Characterization of the donor and organs.
Minimum set of data to be collected as part of the characterization of donors and organs, in accordance with Article 3ter, § 1^erof this Act.
1° Establishment in which sampling takes place and other general data
2° Type of donor
3° Blood group + type HLA
4° Sex
5° Cause of death
6° Date of death
7° Date of birth
8° Weight
9° Size
10° Intravenous drug abuse (previous or current condition)
11° Malignant neoplasia (previous or current condition)
12° Other communicable diseases (previous or current condition)
13° HIV tests, HCV, HBV, CMV
14° Basic information to assess the operation of the given organ
15° General data
Coordinates of the care facility in which the removal takes place, necessary for the coordination, allocation of organs and their traceability of the donor to the receiver and vice versa.
16° Donor data
Demographic and anthropometric data required to ensure a satisfactory match between the donor, lorgan and the receiver.
17° Medical history of the donor
Medical history of the donor, in particular the conditions that might affect the extent to which organs lend themselves to transplantation and could lead to the risk of disease transmission.
18° Physical and clinical data
Data arising from a clinical examination that is necessary for the assessment of the physiological maintenance of the potential donor as well as any evidence of conditions that have not been identified during the examination of the donor's medical history and that may affect as the organs lend themselves to transplantation and lead to the risk of disease transmission.
19° Laboratory parameters
Data required for the assessment of the functional characterization of organs and for the detection of potentially communicable diseases and possible contraindications to organ donation.
20° Medical imaging
Medical imaging explorations necessary to assess the morphological status of organs intended for transplantation.
21° Therapy
Treatments administered to the donor and should be taken into account in assessing the functional status of organs and the eligibility for organ donation, in particular the use of antibiotics, inotropic support or transfusions.
22° Ischemia hot and cold. »
CHAPTER 2. - Final provisions
Art. 29. The King sets the effective date of Article 21, 3°.
Art. 30. The Act of June 14, 2006 amending the Act of June 13, 1986 on organ removal and transplantation is withdrawn.
PART 3. - Amendment of the Act of 19 December 2008 on the obtaining and use of human body equipment for human medical applications or for scientific research
Art. 31. In section 2 of the Act of 19 December 2008 on the obtaining and use of human body equipment for human medical applications or for scientific research purposes, the 7° is replaced by the following:
"7° "organic": organ as defined in Article 1^erter, 6°, of the Act of 13 June 1986 on organ transplantation and transplantation".
Promulgation of this law, let us order that it be clothed with the seal of the State and published by the Belgian Monitor.
Given in Brussels on 3 July 2012.
ALBERT
By the King:
Minister of Social Affairs and Public Health,
Ms. L. ONKELINX
Seal of the state seal:
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 Commission, 53-2158, No. 2. - Text corrected by the Commission, 53-2158, No. 3. - Text adopted in plenary and transmitted to the Senate, 53- 2158, No. 4
Full report. - 31 May 2012.
Senate:
Documents. - Project referred to by the Senate, 5-1641/1. - Report on behalf of the committees convened, 5-1641/2. - Text corroborated by the committees convened, 5-1641/3. - Decision not to amend, 5-1641/4
Annales of the Senate. - 26 June 2012.