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Bone Marrow Donors Registry Law, 5771-2011

חוק מרשם תורמי מוח עצם, תשע"א-2011

Published: 2011-03-10Consolidated Hebrew text as of 2025-08-14 · Last amended 2024-08-14✓ Amendment status checked against the Knesset legislation record on 2026-09-29
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Unofficial English translation — for reference only. It may contain errors or omissions and cannot be relied on as a legal text. Only the Hebrew text published in Reshumot is legally binding.More

This English text was translated from the official Hebrew using a range of translation tools, and it undergoes ongoing checks and updates. It is not a certified translation.

Despite these checks, it may contain errors, omissions, or imprecise renderings of legal terminology and cross-references, and it may not yet reflect the latest amendments. It cannot be relied upon as a legal text.

The Hebrew text as published in Reshumot (ספר החוקים) and on the Knesset website is the sole authoritative and legally binding version. In any discrepancy, the Hebrew text prevails.

This translation is provided for informational purposes only and does not constitute legal advice. For use in legal proceedings, request a certified Expert Legal Opinion.

Definitions§

1.

In this Law –

"compatibility test" – tissue typing of a biological sample of a person for the purpose of finding a match for a bone marrow donation;

"permit" – a permit for the establishment and operation of a bone marrow donors registry granted pursuant to the provisions of Section 6;

"informed consent" – as defined in section 13 of the Patient Rights Law, 5756-1996;

"the Committee" – the Health Committee of the Knesset;

"Privacy Protection Law" – the Privacy Protection Law, 5741-1981;

"Genetic Information Law" – the Genetic Information Law, 5761-2000;

"World Data Bank" – the worldwide database for the identification of bone marrow donors – Bone Marrow Donors Worldwide (BMDW);

"genetic institute" and "laboratory for genetic tests" – as defined in the Genetic Information Law;

"the Director" – the Director General of the Ministry of Health, or a person authorised by him for the purposes of this Law;

"bone marrow donors registry" – a database that includes information about compatibility tests of examinees from whom a sample was taken in Israel, including the results of compatibility tests and additional particulars listed in the Schedule;

"tissue typing" – tests conducted for the purpose of determining the genetic compatibility between two tissues (Tissue typing);

"family member" – a parent, brother or sister, son or daughter, uncle or aunt, grandfather or grandmother and their descendants, of a person who requires a bone marrow donation;

"stem cells" – cells capable of producing all types of blood cells in the human body (Hematopoietic Stem Cells);

"donor" – a person who donated a bone marrow donation;

"bone marrow donation" – a unit of stem cells taken from a donor for the purpose of producing therefrom stem cells for transplantation;

"the Minister" – the Minister of Health.

Exclusivity of actions§

2.

A compatibility test shall not be conducted for the purpose of registering the result in a bone marrow donors registry except in accordance with the provisions of this Law.

Conducting a compatibility test§

3.
(a)A compatibility test conducted in Israel for the purpose of registration in a bone marrow donors registry shall be conducted only in a genetic institute, in a laboratory for genetic tests or in a laboratory for tissue typing; nothing in the provisions of this subsection shall prohibit the taking of a biological sample for the said purpose from a person at a place that is not an institute or laboratory as aforesaid.
(b)A compatibility test shall be conducted within a reasonable time from the day the biological sample was taken.
(c)The Director may prescribe rules to regulate the conduct of compatibility tests pursuant to this Section, including with respect to the period within which a compatibility test shall be conducted.
(d)Biological samples taken for the purpose of a compatibility test shall be stored in a genetic institute, in a genetic laboratory or in a laboratory for tissue typing.

Informed consent§

4.

A biological sample shall not be taken from a person for the purpose of conducting a compatibility test and the results thereof shall not be registered in a bone marrow donors registry without obtaining the written informed consent of the examinee, and the provisions of sections 11, 12, 14, 19 and 20 of the Genetic Information Law shall not apply to the conduct of compatibility tests; the informed consent form, including consent to the transfer of the information, of the compatibility tests and of the biological samples to another database pursuant to the Director's guidelines under Section 9, shall be in the form prescribed by the Director.

Bone marrow donors registry§

5.
(a)A permit holder shall establish, operate and manage a bone marrow donors registry; a bone marrow donors registry shall serve for the purpose of finding donors for the transplantation of stem cells in patients who require transplantation thereof.
(b)The registry shall include results of compatibility tests, in an identifiable manner, and additional particulars concerning examinees, enumerated in Part 1 of the Schedule (in this Law – identifying particulars), required for the purpose of finding a match of donors for stem cell transplantation and locating the suitable donors; particulars enumerated in Part 2 of the Schedule shall be included in the registry in such manner that the identifying particulars are separated therefrom, at the earliest possible time, and they shall be stored in an unidentified manner; the Minister, with the consent of the Minister of Justice and with the approval of the Committee, may amend the Schedule.

Permit for the establishment and operation of a bone marrow donors registry§

6.
(a)A bone marrow donors registry shall not be established and shall not be operated unless a permit has been received from the Director.
(b)The Director shall not grant a permit unless satisfied that all of the following conditions are met:
(1)the needs of the population in Israel, in whole or in part, justify the establishment of a bone marrow donors registry;
(2)the applicant has demonstrated that it is capable of testing at least 50,000 examinees within the first 12 months of the registry's operation; the Director may, for reasons that shall be recorded, grant a permit for a registry of a smaller scope than that stated;
(3)the applicant possesses the infrastructure, equipment and manpower required to maintain a bone marrow donors registry for at least ten years;
(4)the applicant employs a permanent medical adviser who is a specialist physician in haematology, with experience in the field of bone marrow transplants or in the field of transfusion medicine and blood bank management;
(5)the applicant has proven that it is capable of complying with the provisions pursuant to this Law;
(6)the applicant complies with the Director's requirements with respect to procedure and organisation;
(7)the applicant has submitted an opinion of an information security expert confirming that the hardware and software systems of the registry are reliable, afford a reasonable level of availability and reliability and provide reasonable protection against intrusion, disruption, interference or the causing of damage to a computer or computer material as defined in the Computers Law, 5755-1995, having regard to the sensitivity of the information, and that the technological system to be used by the applicant will meet the requirements set out in section 10(c) and the Director's guidelines issued pursuant to that subsection.
(c)A permit shall not be granted if the permit applicant or the person designated to manage the bone marrow donors registry has been convicted of an offence which, by reason of its nature, severity or circumstances, renders him unfit to operate or manage, as the case may be, a bone marrow donors registry.
(d)A permit is not transferable to another except with the prior approval of the Director.

Application for a permit for a bone marrow donors registry§

7.

An application for a permit shall be submitted to the Director in writing; the Director may prescribe procedures for the submission of an application for a permit, including with respect to documents that the permit applicant is required to attach to the application.

Revocation, restriction or suspension of a permit§

8.

The Director may revoke, restrict or suspend a permit, as the case may be, after the permit holder has been given an opportunity to state his case, upon the occurrence of one of the following:

(1)the permit holder requested to revoke the permit granted to him, subject to the provisions of Section 9, or did not establish a bone marrow donors registry within the period specified in the permit, or is not operating the registry;
(2)the permit holder or the registry manager has breached a material condition of the permit pursuant to Section 6;
(3)the permit holder or the registry manager has been convicted of an offence which, by reason of its nature, severity or circumstances, renders him unfit to operate or manage, as the case may be, a bone marrow donors registry;
(4)the Director has found that it is required for reasons of protecting public health.

Cessation of operation of a bone marrow donors registry§

9.
(a)A permit holder shall notify the Director at least three months in advance of his intention to cease the operation of a bone marrow donors registry and shall place the information in the registry, the compatibility tests and the biological samples in his possession (in this Section – information) at the disposal of another bone marrow donors registry pursuant to the Director's instructions.
(b)Where a permit holder has given notice as provided in subsection (a), or a bone marrow donors registry has ceased to operate or the permit has been revoked, the Director shall order the transfer of all the information to another bone marrow donors registry or to whomsoever the Director shall direct, and may prescribe any instruction necessary to prevent the loss of the information or to protect the privacy of the examinees.

Confidentiality§

10.
(a)The results of a compatibility test conducted on a person and a biological sample taken from a person for the purpose of conducting a compatibility test shall be used solely for the purpose of finding a match between that person and a person who requires a bone marrow donation in accordance with the provisions of this Law, and shall not be transferred to any other body, including the security forces and law enforcement authorities, except to a medical institution for the purpose of performing a stem cell transplant, and shall not serve as evidence in any legal proceeding that is not connected to the transplantation or the management of the registry.
(b)Identifying particulars registered in a bone marrow donors registry concerning a person shall not be disclosed from the registry except for the implementation of the provisions of this Law; however, a donor registered in the registry may consent to the disclosure of identifying particulars concerning him to an adult bone marrow donation recipient, if the bone marrow donation recipient so requested or consented thereto, provided that at least 12 months have elapsed from the date of performance of the stem cell transplant.
(c)The technological system to be used by the registry shall minimise, to the extent possible and having regard to accepted technological alternatives, the risk of harm to the privacy of the examinees or to the integrity of the information, pursuant to the Director's guidelines with respect to information security, the manner of access to identified information, the storage of information in an unidentified manner, the encryption of information, those authorised to access the information, the deletion of information from the registry and any other instruction the Director sees fit with respect to this matter; such guidelines shall be issued after consultation with the Head of the Privacy Protection Authority and shall be published on the website of the Ministry of Health; in this subsection, "Head of the Privacy Protection Authority" – the head of the authority as defined in the Privacy Protection Law.

Recruitment of examinees for compatibility tests§

11.
(a)A campaign for the recruitment of examinees for compatibility tests shall be conducted by bone marrow donors registries only and under their responsibility, after receiving the Director's approval and in accordance with his instructions, including with respect to the types of population to be tested; the Director may issue instructions as aforesaid also with respect to the recruitment of examinees otherwise than in the framework of a recruitment campaign.
(b)Donations and funds for the purpose of financing the conduct of compatibility tests shall not be raised except by bone marrow donors registries, or with the Director's approval.

Transfer of information to the World Data Bank§

12.

A bone marrow donors registry shall be a member of the World Data Bank and shall transfer to the World Data Bank all the results of compatibility tests registered in the registry, in a manner that does not permit the identification of the examinees; the results of compatibility tests as aforesaid shall be transferred to the World Data Bank no later than three months from the date of their receipt.

Conducting a compatibility test on a minor, a ward or a legally incompetent person§

13.
(a)A biological sample shall not be taken for the purpose of conducting a compatibility test for the purpose of registration in a bone marrow donors registry from a minor, a ward or a legally incompetent person.
(b)Nothing in the provisions of subsection (a) shall prevent the conduct of a compatibility test on a minor, a ward or a legally incompetent person for the purpose of a bone marrow donation to a family member, provided that the results of the test shall not be registered in a bone marrow donors registry.

Compatibility test for a family member§

14.

A compatibility test conducted for a family member of the examinee shall not be included in a bone marrow donors registry unless the examinee, who is not a minor, a ward or a legally incompetent person, consented to the inclusion after the significance thereof was explained to him.

Savings provisions§

15.

The provisions of this Law are in addition to the provisions of any law and shall not derogate therefrom, insofar as special provisions have not been prescribed in this Law.

Annual report to the Committee§

16.

The Director shall report to the Committee, once a year, commencing from the end of one year from the date of commencement of this Law, on the implementation of the provisions of the Law.

Implementation and regulations§

17.
(a)The Minister is responsible for the implementation of this Law.
(b)The Minister, with the approval of the Committee, shall prescribe provisions with respect to the following matters:
(1)the period of validity of a permit;
(2)medical equipment and instruments required for the purpose of operating a bone marrow donors registry.

Commencement§

18.

This Law shall commence six months from the day of its publication (hereinafter – the commencement day).

Transitional provisions§

19.
(a)Notwithstanding the provisions of Section 6, the Director may grant a permit to a person who, on the commencement day, operated a registry containing information concerning bone marrow donors, if the conditions prescribed in paragraphs (3), (4), (5) and (7) of section 6(b) are met in respect of that person and he operated such a registry within the framework of a hospital registered pursuant to the Public Health Ordinance, 1940, or if he operated a registry in which, on the commencement day, at least 50,000 compatibility tests were registered.
(b)Where a person who operated a registry containing information concerning bone marrow donors on the eve of the commencement day has submitted an application for a permit within 60 days from the day on which procedures for its submission were prescribed pursuant to Section 7, he may continue to operate the registry until the Director's decision on his application.
(c)The Director shall issue to a registry containing information concerning bone marrow donors that was operated on the eve of the commencement day and was not granted a permit pursuant to this Law, instructions with respect to the transfer of the information, as defined in Section 9, and may issue any instruction to prevent the loss of the information or to protect the privacy of the examinees.

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Schedule (Section 5(b))

Part 1 – Identifying Particulars

(1)first name and surname;
(2)identity card number;
(3)date of birth;
(4)sex;
(5)address;
(6)telephone number.

Part 2

(1)nationality;
(2)country of origin.

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LawHealth

חוק מרשם תורמי מוח עצם, תשע"א-2011

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