Uganda Act or statute

Parliament of Uganda

Uganda Human Organ Donation and Transplant Act

Jurisdiction: Uganda
Structure: 49 provisions
Citation: Chapter 311
Dates: As at 31 Dec 2023

More statute details

Dates: As at 31 Dec 2023

Source attribution: Source: Uganda Legal Information Institute

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Purpose and legislative effect

“The provision lists what constitutes the funds of the Council, including parliamentary appropriations, money accrued in performing functions, approved grants or donations, borrowed money under this Act and the Public Finance Management Act, and other sources approved by the Minister and the Minister responsible for fin”

The provision lists what constitutes the funds of the Council, including parliamentary appropriations, money accrued in performing functions, approved grants or donations, borrowed money under this Act and the Public Finance Management Act, and other sources approved by the Minister and the Minister responsible for finance. The Council must follow sound financial principles and conduct its business so revenue, depreciation provision, and loss offsets are properly provided for. The Council must, with the Accountant General's authorisation, open and maintain necessary bank accounts; the Chairperson must bank money received promptly and must ensure no withdrawals occur without Council authority. Sets duties for preparing and approving the Council's estimates: the Executive Secretary must prepare and submit estimates to the Council within three months before year-end; the Chairperson must submit Council-approved estimates to the Minister within two months after receipt; the Minister must forward the estimates to the Minister responsible for finance for budget approval under the Public Finance Management Act. The Chairperson must keep proper books and prepare an annual financial statement (subject to Council directions); the Auditor General or an appointed auditor may require further financial information in writing.

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Finances of Council - Funds of Council

Section 19

Quality assurance and quality control - Quality assurance programmes

A designated transplant centre must establish quality assurance programmes as prescribed by regulations and must investigate and report any adverse reaction information to the Council for review within thirty days in the manner prescribed by regulations.

Section 40

Transplant of organs, tissues and cells - Donor screening

A designated transplant centre must have a consistent policy and operational procedures for conducting and documenting donor examinations and related record and death-investigation documentation.

Section 56

Offences and penalties - Prohibition of commercial dealings in human material for transplantation

Commercial dealing in human organs, tissues or cells for reward or payment is prohibited, with narrowly defined reimbursements and penalties for offences.

Section 84

Miscellaneous - Power to amend Schedules

The Minister may amend Schedule 1 by statutory instrument with Cabinet approval, and may amend Schedules 2 and 3 by statutory instrument.

Section 96

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Showing 49 of 49 provisions

Provision 35Offence 11Interpretation 2Amendment

Part III

Finances of Council

§ 19Finances of Council - Funds of CouncilProvision

Section Funds of Council Section The funds of the Council shall consist of— moneys appropriated by Parliament for the purposes of the Council ; money that may accrue to the Council in the discharge of its functions; grants or moneys donated to the Council with the approval of the Minister and the Minister responsible for finance; money borrowed by the Council in accordance with this Act and the Public Finance Management Act; and money from any other source as may be approved by the Minister and the Minister responsible for finance.

Section 19Verify source

§ 20Finances of Council - Duty to operate on sound financial principlesProvision

The Council must follow sound financial principles and conduct its business so revenue, depreciation provision, and loss offsets are properly provided for.

Section Duty to operate on sound financial principles Section The Council shall, in the performance of its functions under this Act, have due regard to sound financial principles and shall conduct its business in such a manner that, taking one transaction with another, and taking one year with another— ensure its revenue is sufficient for meeting all charges, including interest on capital and loans properly chargeable to revenue account; ensure sufficient provision is made to provide for depreciation of assets; and ensure that where any loss or bad debt arises in respect of any transaction, provision is made in respect of other transactions, whether of a similar nature or otherwise, to offset the amount of that loss or debt.

Section 20Verify source

§ 21Finances of Council - Power to open and operate bank accountsProvision

The Council must, with the Accountant General's authorisation, open and maintain necessary bank accounts; the Chairperson must bank money received promptly and must ensure no withdrawals occur without Council authority.

Section Power to open and operate bank accounts Section The Council shall, with the authorisation of the Accountant General, open and maintain such bank accounts as are necessary for the performance of the functions of the Council . The Chairperson of the Council shall ensure that all money received by or on behalf of the Council is banked as soon as practicable after being received. The Chairperson of the Council shall ensure that no money is withdrawn from or paid out of any of the bank account of the Council without the authority of the Council .

Section 21Verify source

§ 22Finances of Council - EstimatesProvision

Sets duties for preparing and approving the Council's estimates: the Executive Secretary must prepare and submit estimates to the Council within three months before year-end; the Chairperson must submit Council-approved estimates to the Minister within two months after receipt; the Minister must forward the estimates to the Minister responsible for finance for budget approval under the Public Finance Management Act.

Section Estimates Section The Executive Secretary shall, within three months before the end of each financial year, cause to be prepared and submitted to the Council for its approval, estimates of the income and expenditure of the Council . The Chairperson shall, within two months after receipt of the estimates referred to in subsection (1) , cause to be submitted to the Minister for his or her approval, the estimates of income and expenditure as approved by the Council . The Minister shall submit the estimates of the Council to the Minister responsible for finance for approval of the budget containing estimates of income and expenditure of the Council for the next financial year in accordance with the Public Finance Management Act.

Section 22Verify source

§ 23Finances of Council - AccountsProvision

The Chairperson must keep proper books and prepare an annual financial statement (subject to Council directions); the Auditor General or an appointed auditor may require further financial information in writing.

Section Accounts Section The statement of account shall include— The Chairperson shall cause to be kept, proper books of accounts and records of the transactions of the Council in accordance with accepted accounting principles. Subject to any direction given by the Council , the Chairperson shall cause to be prepared an annual financial statement stating the basis of accounting and shall identify any significant departure from it and the reasons for the departure. a balance sheet, an income and expenditure account and a source and application of the funds of the Council ; and any other information in respect of the financial affairs of the Council as the Auditor General or an auditor appointed by the Auditor General may, in writing, require.

Section 23Verify source

§ 24Finances of Council - AuditProvision

The Auditor General (or an auditor appointed by them) must audit the Council's accounts every financial year under the National Audit Act; the Council must submit its statement of accounts to that auditor within three months after each financial year-end.

Section Audit Section The Auditor General or an auditor appointed by the Auditor General shall, in each financial year, audit the accounts of the Council in accordance with the National Audit Act. The Council shall ensure that within three months after the end of each financial year, a statement of accounts is submitted to the Auditor General or to an auditor appointed by the Auditor General for auditing.

Section 24Verify source

§ 25Finances of Council - Annual reportProvision

Requires the Council to submit an annual report (including audited accounts and the Auditor General's report) to the Minister within three months after each financial year, requires the Minister to send the report to Parliament within two months of receipt, and requires the Council to publish the report and audited accounts in a national newspaper within six months after each financial year.

Section Annual report Section The report referred to in subsection (1) shall contain— The Council shall submit to the Minister , as soon as practicable, and in any event not later than three months after the end of each financial year, a report of the activities and operations of the Council during the year to which the report relates. the audited accounts of the Council and the report of the Auditor General on the accounts of the Council ; and such other information as the Council may consider necessary. The Minister shall, within two months after the receipt of the annual report, submit the report to Parliament with any statement which he or she considers necessary. The Council shall cause to be published, the annual report and audited accounts in a newspaper of national circulation within six months after the end of each financial year.

Section 25Verify source

§ 26Finances of Council - Compliance with Public Finance Management ActProvision

The Council must at all times comply with the Public Finance Management Act.

Section Compliance with Public Finance Management Act Section The Council shall at all times comply with the Public Finance Management Act.

Section 26Verify source

Part IX

Post-mortem examination of confirmed brain dead donor

§ 77Post-mortem examination of confirmed brain dead donor - Requirements for carrying out post-mortem examinationProvision

People who perform post-mortem or anatomical examinations or collect tissue must perform a post-mortem on all cadaveric donors at the same time as organ harvesting to determine cause of death and donor suitability, avoid unnecessary mutilation, and conduct the work in an orderly and decent manner.

Section Requirements for carrying out post-mortem examination Section A person who performs a post-mortem or anatomical examination or collects tissue from a body under this Act, shall— A post-mortem shall be carried out on all cadaveric donors and shall be conducted at the same time as the harvesting of the organs to determine the cause of death and the suitability of the donor . do so in a manner that avoids unnecessary mutilation of the body; and conduct the examination or collection in an orderly and decent manner.

Section 77Verify source

Part V

Additional requirements for organ, tissue and cell banks

§ 37Additional requirements for organ, tissue and cell banks - Organ, tissue and cell bankingProvision

Sets testing, preservation, processing, storage and distribution requirements for removed organs, tissues and cells via Minister-approved banks; requires authorisation from the Council to import human organs, tissues or cells for transplantation; mandates inspections of approved banks at least every two years; and tasks the Minister with prescribing detailed requirements by regulations.

Section Organ, tissue and cell banking Section Where applicable, removed organs, tissues or cells which are not immediately used for transplantation shall be tested, preserved, processed, stored and distributed by banks approved by the Minister under section 33 . Only organs, tissues and cells supplied by approved banks shall be used for purposes of transplantation. A person shall not import into Uganda human organs, tissues or cells for transplantation without the authorisation of the Council . All approved banks shall be inspected by the Council , an authorised person or an independent qualified person authorised by the Council at least every two years to ensure that they comply with this Act, regulations made under this Act and international standards. The Minister shall, by regulations, prescribe detailed requirements for approved banks.

Section 37Verify source

§ 38Additional requirements for organ, tissue and cell banks - Minimum standards for banksProvision

The Minister must issue standards for banks, and a bank approved under this Act must comply with standards issued by the Minister in consultation with the Council.

Section Minimum standards for banks Section The Minister shall issue standards to be followed by banks. A bank approved under this Act shall comply with standards issued by the Minister in consultation with the Council .

Section 38Verify source

Part VI

Quality assurance and quality control

§ 39Quality assurance and quality control - Organ donation and transplant quality control systemProvision

The Council must establish and operate an organ donation and transplant quality control system; the Council must ensure adverse-event information is shared with transplant professionals; the Minister may make regulations imposing further requirements.

Section Organ donation and transplant quality control system Section The system established under subsection (1) shall provide for— The Council shall establish an organ donation and transplant quality control system which ensures equitable access to quality donation and transplantation services to donors and potential recipients. quality control and testing of all donations, procurement , testing, processing, preservation, storage and distribution activities to ensure the quality and safety of organs, tissues and cells used in transplantation; the identification, reporting, investigation and management of serious adverse events relating to the donation or transplantation activity; the waiting list of recipients; the donor list; a database for all potential recipients and donors; measures for traceability of donated and transplanted organs, tissues and cells ; a system for recall of organs, tissues and cells ; and any other information that the Council may deem necessary. The Council shall ensure that information relating to adverse events is brought to the attention of all health professionals involved in transplantation and other transplant organisations. The Minister may, by regulations, prescribe additional requirements for the Organ Donation and Transplant Quality Control System.

Section 39Verify source

§ 40Quality assurance and quality control - Quality assurance programmesProvision

Section Quality assurance programmes Section A designated transplant centre shall put in place quality assurance programmes in a manner prescribed by regulations, including requirements for— facilities; environmental control; equipment; supplies and reagents; recovery; processing and processing controls; labeling controls; transportation; storage; receipt, pre- distribution shipment and distribution ; donor eligibility determination , donor screening and donor testing; tissue evaluation ; access control; and internal audit or risk management. A designated transplant centre shall perform an investigation and report any adverse reaction information within thirty days to the Council for review in a manner prescribed by regulations.

Section 40Verify source

§ 41Quality assurance and quality control - Recall proceduresProvision

A designated transplant centre must have a written recall procedure covering recall of organs, tissues or cells; notifying recipient hospitals about possible contamination or defects; and other suitability factors.

Section Recall procedures Section A designated transplant centre shall establish a written procedure for— recall of organs, tissues or cells ; notification of recipient hospitals of the possibility of contamination, defects in processing, preparation or distribution ; and other factors affecting the suitability of the organs, tissues or cells . The procedure referred to in subsection (1) shall be included in the policies and procedures of the designated transplant centre . The Minister may, in consultation with the Council , by regulation, prescribe additional requirements for recall procedures.

Section 41Verify source

§ 42Quality assurance and quality control - Look back proceduresProvision

Banks and designated transplant centres must have look-back procedures to notify relevant parties if they may have received infected organs, cells or tissues, and documentation of those procedures must be included in their policies.

Section Look back procedures Section Each bank shall establish procedures for notifying a designated transplant centre or registered medical practitioner that it may have received infected organs, cells or tissues. Each designated transplant centre shall have procedures for notifying the transplanting bank or designated transplant centre or registered medical practitioner that it may have received infected organs, cells or tissues. Documentation of look back procedures shall be included in the policies and procedures of the bank and designated transplant centre .

Section 42Verify source

§ 43Quality assurance and quality control - Notification requirementsProvision

Test results must be notified to donors and recipients of organs, tissues and cells in a manner prescribed by regulations.

Section Notification requirements Section Notification of test results to donors and recipients of organs, tissues and cells shall be in a manner prescribed by regulations.

Section 43Verify source

Part VII

Storage of organs, tissues and cells outside the body

§ 44Storage of organs, tissues and cells outside the body - Preservation of organs, tissues and cellsProvision

After removal of an organ, tissue or cell for transplantation, the registered medical practitioner must take steps to preserve it in accordance with the Act, regulations and Ministerial standards.

Section Preservation of organs, tissues and cells Section After the removal of any human organ , tissue or cell from the body of any person for transplantation, the registered medical practitioner shall take such steps as are necessary for the preservation of the human organ , tissues or cell removed in accordance with this Act, regulations made under this Act and standards issued by the Minister .

Section 44Verify source

§ 45Storage of organs, tissues and cells outside the body - Storage of organs, tissues and cells outside the bodyProvision

The Minister must, in consultation with the Council, establish standards for storage of harvested organs, tissues and cells; designated transplant centres and approved banks must ensure their facilities and equipment comply with those regulations and standards.

Section Storage of organs, tissues and cells outside the body Section The Minister shall, in consultation with the Council , establish standards for storage of harvested organs, tissues and cells . A designated transplant centre and an approved bank shall ensure that the facilities and equipment of the designated transplant centre and approved bank comply with the regulations made by the Minister and standards prescribed under subsection (1) .

Section 45Verify source

§ 46Storage of organs, tissues and cells outside the body - Packaging and labeling of storage containersProvision

Approved banks and designated transplant centres must package human organs, tissues and cells as prescribed by regulations and standards issued by the Minister, and banks or designated transplant centres must ensure storage containers are clearly and indelibly labeled as prescribed by regulations.

Section Packaging and labeling of storage containers Section Approved banks and designated transplant centres shall ensure that human organs, tissues and cells are packaged in a manner prescribed by regulations and in accordance with standards issued by the Minister . Each tissue , cell or organ for distribution shipment shall be individually packaged and sealed with a tamper-evident seal or enclosed in a tamper-evident container . A bank or designated transplant centre shall ensure that each tissue , cell or organ storage container is clearly and indelibly labeled in a manner prescribed by regulations.

Section 46Verify source

Part VIII

Transplant of organs, tissues and cells

§ 51Transplant of organs, tissues and cells - National waiting listProvision

The Council must establish and maintain a national waiting list for potential organ, tissue and cell donors and recipients drawn from designated transplant centres, hospitals and health centres.

Section National waiting list Section The Council shall establish and maintain a national waiting list for potential organ , tissue and cell donors and recipients drawn from designated transplant centres, hospitals and health centres.

Section 51Verify source

§ 52Transplant of organs, tissues and cells - Fair and equitable systemProvision

The Council must ensure organs, tissues and cells are allocated to patients on the national waiting list fairly and equitably as prescribed by the Minister; if no suitable recipient is on the list the Council may authorise allocation or sharing with recognised national or international transplant organisations.

Section Fair and equitable system Section The Council shall ensure that organs, tissues and cells are allocated to patients on the national waiting list in a fair and equitable manner as shall be prescribed by the Minister by regulations. Where no suitable recipient is identified on the national waiting list , the Council may authorise the allocation of the organ , tissue or cells to another recognised national or international transplant organisation with which the Council has an agreement. The Council may also authorise the sharing of organs, tissues and cells from an international transplant organisation referred to in subsection (2) . Documentation relating to the distribution of organs, tissues and cells , including date of requests for, offer of, and delivery of organs, tissues and cells shall be available for examination by the Council or an authorised officer . Access to organs, tissues and cells shall be provided without regard to the recipient ’s sex, age, religion, race, creed, color or financial standing or any other discriminatory ground.

Section 52Verify source

§ 53Transplant of organs, tissues and cells - Transplantation activitiesProvision

Transplant procedures must be carried out by registered health professionals and the Council must set donor-identification criteria and dispatch retrieval teams; the team confirming brain death must not be involved in harvesting.

Section Transplantation activities Section The harvesting, retrieval, preservation and transplantation of human organs, tissues and cells shall only be performed by a registered health professional and in accordance with this Act, regulations made under this Act, any other applicable law and standards issued by the Minister . The Council shall establish a criteria for identifying, at the appropriate stage, all brain dead persons who are potential organ donors and the criteria of notification to the organ designated transplant centres. Transplantation of human organs, tissues or cells shall only be carried out in designated transplant centres. All transplant activity shall be performed to the highest professional and ethical standards as may be prescribed by the respective professional bodies. When a person has been confirmed brain dead by the team in care, the Council shall immediately be notified to send an independent team to confirm the death for purposes of donation. The team that confirms the death of a brain dead donor shall not be involved in the harvest or transplantation activity. The notification referred to in subsection (5) shall take place even if the attending clinical staff believe that donation, after death has been confirmed by an independent team might be contraindicated or inappropriate. The independent team referred to in subsection (5) shall consist of a neurosurgeon, neurophysician and an anesthesiologist or intensivist. Where a person has been declared and confirmed brain dead in accordance with subsection (5) , in an Intensive Care Unit of a hospital which is not a designated transplant centre , a retrieval team shall be dispatched by the Council to retrieve the potential donor to a designated transplant centre . Where the brain death of a potential organ donor occurs in circumstances that require notification to the police, notification shall be done before donation takes place, even where a donor has explicitly stated a wish to donate. A patient who is a potential organ donor shall be provided with the best possible treatment, in the best interests of the patient, in the hope or expectation that the patient shall survive.

Section 53Verify source

§ 54Transplant of organs, tissues and cells - Authorised transplantation activitiesOffence

Persons must not perform transplants without prior authorisation from the Council; the Council must give authorisation expeditiously, may exempt certain transplant processes by statutory instrument, and persons and designated transplant centres that perform exempted transplants must report to the Council within twenty-four hours. Contravention is an offence punishable by a fine up to fifty thousand currency points or up to ten years imprisonment, or both.

Section Authorised transplantation activities Section The authorised activities for purposes of this Act are listed in Schedule 2 to this Act. A person shall not perform a transplantation activity without the prior authorisation of the Council . The authorisation under subsection (2) shall be given expeditiously. Notwithstanding subsection (3) , the Council may, by statutory instrument, exempt certain transplant processes from the prior authorisation of the Council , including tissue , bone marrow and emergency transplants. Any person and the designated transplant centre that performs a transplant under subsection (4) shall immediately, but in any case not later than twenty four hours after the transplant procedure, submit a report to the Council . A person who contravenes subsection (2) commits an offence and is liable, on conviction, to a fine not exceeding fifty thousand currency points or to imprisonment for a term not exceeding ten years, or both.

Section 54Verify source

§ 55Transplant of organs, tissues and cells - Council not to authorise transplant activities in certain casesOffence

The Council must not authorise removal of organs, tissues or cells from a dead person when the death is suspicious until a police investigation is completed and notification under section 53(10) is given; and a person entrusted with a body solely for interment, cremation or disposal must not give authority for removal. Contravention is an offence punishable by a fine up to ten thousand currency points or imprisonment up to seven years, or both.

Section Council not to authorise transplant activities in certain cases Section The Council may not authorise the removal of an organ , tissue or cell from a dead person where the Council has reason to believe that the person’s death is suspicious and may require police investigation, until the police investigation is completed and notification has been given in accordance with section 53(10) . No authority for the removal of any human organ , tissue or cell from the body of a deceased person shall be given by a person to whom the body has been entrusted solely for the purpose of interment, cremation or other disposal. A person who contravenes this section commits an offence and is liable, on conviction, to a fine not exceeding ten thousand currency points or to imprisonment for a term not exceeding seven years, or both.

Section 55Verify source

§ 56Transplant of organs, tissues and cells - Donor screeningProvision

A designated transplant centre must have a consistent policy and operational procedures for conducting and documenting donor examinations and related record and death-investigation documentation.

Section Donor screening Section The removal of organs, tissues or cells from a potential donor person shall not be performed unless the donor has been examined and tested for evidence of transmittable diseases in accordance with this Act, regulations made under this Act, standards issued by the Minister and internationally recognised standards. Prior to making an eligibility determination, the donor shall be screened and tissue evaluated for suitability in a manner prescribed by regulations and in accordance with standards issued by the Minister . A designated transplant centre shall have a consistent policy for conducting and documenting the examination and consistent operational procedures for examination and documentation of the prospective donor ’s available medical record and death investigation, where applicable.

Section 56Verify source

§ 57Transplant of organs, tissues and cells - Organ, tissue and cell samplingProvision

A registered medical practitioner may, with relevant consent and in accordance with the Act, remove any organ, tissue or cell from a potential donor to examine its viability for transplantation and the safety for the recipient.

Section Organ, tissue and cell sampling Section A registered medical practitioner may, in accordance with this Act and with the relevant consent , remove any organ , tissue or cell from a potential donor for examination to determine the viability of the organ , tissue or cell for transplantation, including the safety of the transplant for the person who is to receive it. Organ, tissue or cell testing and sampling under subsection (1) shall be in accordance with this Act, regulations made under this Act, standards issued by the Minister and internationally recognised standards.

Section 57Verify source

§ 58Transplant of organs, tissues and cells - Testing requirementsProvision

A designated transplant centre must carry out tests to determine a donor's suitability before harvesting an organ, tissue or cell, following this Act, regulations and Ministerial standards.

Section Testing requirements Section A designated transplant centre shall, before harvesting an organ , tissue or cell from a donor , carry out tests in accordance with this Act and in a manner prescribed by regulations and according to standards issued by the Minister , to determine the suitability of the donor . The suitability of a specific individual for organ , tissue or cell donation shall be determined in accordance with this Act and regulations made under this Act.

Section 58Verify source

§ 59Transplant of organs, tissues and cells - Preservation for transplantationProvision

Hospitals, nursing homes or institutions must preserve and transfer suitable parts of a brain-dead person's body to a designated transplant centre; the designated centre must notify the Council immediately and within seven hours, and must not harvest organs, tissues or cells without Council approval.

Section Preservation for transplantation Section Where part of the body of a brain dead person in a hospital, nursing home or other institution is or may be suitable for use for transplantation, the hospital, nursing home or institution shall preserve the body and transfer it to a designated transplant centre for harvesting in accordance with this Act. A designated transplant centre receiving a preserved body under subsection (1) shall immediately, and in any case not later than seven hours after receipt of the body, notify the Council . A designated transplant centre shall not harvest any organ , tissue or cell from a brain dead person referred to under subsection (1) without the approval of the Council .

Section 59Verify source

§ 60Transplant of organs, tissues and cells - Harvesting of organs, tissues and cellsProvision

The registered medical practitioner in charge of a designated transplant centre must ensure consent (documented in writing) is obtained before harvesting organs, tissues or cells; a designated transplant centre must ensure personnel are trained about obtaining and documenting consent.

Section Harvesting of organs, tissues and cells Section The registered medical practitioner in charge of a designated transplant centre shall ensure that, before the harvesting of any organ , tissue or cell from a donor , consent for donation is obtained in accordance with this Act and documented in writing. A designated transplant centre shall ensure that personnel are trained regarding obtaining and documenting consent for donation. The original signed Consent Form shall be kept as part of the patient’s hospital medical record if signed at a hospital. A copy of the original signed Consent Form shall be retained in a designated transplant centre ’s donor record. The Consent Form shall state the organ , tissue or cell for which permission is granted such as bone from the upper, lower extremities, bone from below the waist, heart, liver, kidney or skin. Information provided under this section shall be written or spoken in a language understandable to the donor or the donor ’s close relation . Permission to retrieve organs, tissues or cells from nonliving donors shall be sought from the close relation of the donor in accordance with this Act, where the deceased did not give consent before his or her death.

Section 60Verify source

§ 61Transplant of organs, tissues and cells - ReconstructionProvision

A designated transplant centre must have a policy for reconstruction of a donor's body to maintain the donor's dignity; the Minister may issue regulations for reconstruction after donation.

Section Reconstruction Section A designated transplant centre shall have a policy for the reconstruction of the body of the donor which is integral to maintaining the dignity of the donor . Notwithstanding subsection (1) , the Minister may issue regulations for reconstruction of bodies after donation.

Section 61Verify source

Part X

Human organ and tissue database and reporting requirements

§ 78Human organ and tissue database and reporting requirements - Establishment of human organ, tissue and cell databaseProvision

The Council must establish and maintain a human organ, tissue and cell database in a manner prescribed by regulations.

Section Establishment of human organ, tissue and cell database Section The database referred to under subsection (1) shall contain— The Council shall establish and maintain a human organ , tissue and cell database in a manner prescribed by regulations. a list of potential donors; a list of potential recipients; the type and number of human organs, tissues and cells harvested or transplanted; demographic details of donors and recipients; information on successful transplants; information on failed transplants; any complications or deaths registered; and any other information as the Council may determine. Subject to the Constitution and the Access to Information Act, information contained on the database may be made available to the public in a manner prescribed by regulations.

Section 78Verify source

§ 79Human organ and tissue database and reporting requirements - Data collectionProvision

Designated transplant centres must collect, maintain and quarterly report specified donor, recipient, organ, processing, distribution, revenue and expense data to the Council.

Section Data collection Section Each designated transplant centre shall collect, maintain, and report to the Council , on a quarterly basis, the following data— the number of donors received by age, sex and race; the number of recipients received by age, sex and race; the type of donations received; the cause of death of donors, where applicable; the donor source hospital or designated transplant centre ; the number of organs retrieved; the disposal of processed organs, tissues and cells ; the distribution of organs, tissues and cells ; revenues derived from retrieving, processing, storing or distributing organs, tissue and cells ; and expenses associated with retrieving, processing, storing or distributing organs, tissues and cells .

Section 79Verify source

§ 80Human organ and tissue database and reporting requirements - Records and information on harvest and use of parts of organs, tissues or cells for transplantationOffence

Designated transplant centres must keep prescribed records about organs, tissues and cells; those records are submitted to the Council quarterly; the Council must report annually to the Minister; contraventions are an offence punishable by a fine not exceeding twenty thousand currency points or up to four years' imprisonment, or both.

Section Records and information on harvest and use of parts of organs, tissues or cells for transplantation Section The records and information referred to in subsection (1) shall include— A designated transplant centre involved in the harvesting or transplantation of human organs, tissues and cells shall keep records and information in a manner prescribed by regulations. the human organs, tissues and cells collected; the human organs, tissues and cells transplanted; the names and addresses of donors; the names or recipients; information on successful transplants; information on failed transplants; any complication or deaths registered; and any other information as the Council may deem necessary. The records and information maintained under subsection (1) shall be submitted to the Council , quarterly. The Council shall, annually, submit to the Minister , a report on the activities of the Council under this Act. A person who contravenes this section commits an offence and is liable, on conviction, to a fine not exceeding twenty thousand currency points or to imprisonment for a term not exceeding four years, or both.

Section 80Verify source

§ 81Human organ and tissue database and reporting requirements - Additional recordsInterpretation

Banks and designated transplant centres must keep full, legible, confidential records about donors and recipients, ensure medical reviews and traceability, assign unique identification numbers to donated materials, maintain equipment and inspection records, and enable authorised access for inspection.

Section Additional records Section All records kept under this section shall— Records of function checks requiring interpretation of findings shall include the interpretation of— Subject to the Constitution and the Access to Information Act, every bank and designated transplant centre shall keep accurate, complete and confidential records of donors and recipients in a manner prescribed by regulations. Donor medical records and a final hard copy of the results of all laboratory tests shall be reviewed and affirmed in writing by a registered medical professional to ensure the suitability of the donated organ , tissue or cell for the intended application. Documentation shall be concurrent with the performance of each activity in the retrieval, preparation, testing, storage and distribution of organs, tissues and cells in such a manner that all activities can be clearly traced. be legible and indelible and shall identify the person performing the procedures or tasks; include dates of entries and test results with the expiration period assigned to specific categories of processed organs, tissues or cells recorded in accordance with the policies and procedures of the designated transplant centre ; be as detailed as necessary for a clear understanding of each activity and shall be available for inspection by the Council or an authorised officer , upon request; assign each organ , tissue or cell and any components derived from the organ , tissue or cell in addition to generic designation, one unique identification number which shall serve as a lot number to identify the material from retrieval through distribution and utilisation; and identify the donor , document the pathological and microbiological evaluation of the donor , verify the conditions under which the organ , tissue or cell is retrieved, processed and stored, if applicable, and indicate disposition of the transplanted organ or tissue . Maintenance of records kept under this section shall, as applicable, be the responsibility of the designated transplant centre . Subject to the Constitution and the Access to Information Act, records concerning donor history and processing information shall be made available to the transplant surgeon, upon request. Subject to the Constitution and the Access to Information Act, all records and communication between the designated transplant centre and its donors and patient recipients shall be regarded as confidential and privileged. The Council or an authorised officer shall, subject to subsection (7) , have access to records and communication upon request at the time of the inspection. Maintenance and certification of records on facilities, instruments and equipment, including their monitors, shall be maintained. The records kept under'this section shall indicate dates of inspection, the name of the facility and performance evaluations. A bank or designated transplant centre shall include in its procedures manual, the monitoring, inspection and cleaning procedures and schedules for each piece of equipment. temperature of incubators when in use; spore lot number and expiration date used for autoclave function check; control and test results; and any other purpose approved by the Council . A designated transplant centre shall maintain a file on adverse reactions. The records kept under this section shall be retained in a manner prescribed by regulations.

Section 81Verify source

§ 82Human organ and tissue database and reporting requirements - Information for donor, recipients and close relationsProvision

A registered medical professional authorised to harvest or transplant organs, tissues or cells must provide accurate information in a form that the donor, close relation or recipient can understand.

Section Information for donor, recipients and close relations Section A registered medical professional authorised to harvest or transplant organs, tissues or cells must provide accurate information in a form that the donor , close relation or recipient can understand. Donor and recipient screening forms and copies of relevant medical records reviewed shall be completed and retained for all donated organs, tissues or cells . A unique donor and recipient identifying number including hospital medical record number, National Identification Number or driver’s licence number shall be obtained and recorded in the donor record. A close relation to a brain dead donor and a potential recipient shall be informed about the implications of testing required to ascertain donor suitability and the nature and consequences of the donation.

Section 82Verify source

§ 83Human organ and tissue database and reporting requirements - ConfidentialityProvision

All data collected under the Act, including genetic data, must be kept confidential and subject to internationally agreed medical and personal data protection rules; data accessible to third parties must be anonymized. Medical information necessary for treatment and traceability may be transmitted. Donor information may be communicated to a recipient with both parties' consent only after at least five years from donation/transplant and as prescribed by regulations.

Section Confidentiality Section Subject to the Constitution and the Access to Information Act, all data, including genetic data, collected in relation to activities under this Act is subject to internationally agreed rules on medical and personal data protection. Data to which third parties may have access shall be rendered anonymous to ensure confidentiality. Subsections (1) and (2) shall not prevent the transmission of medical information about the donor or recipient required for medical purposes and required for traceability . Information about a donor may be communicated to a recipient with the consent of both parties, after a period of at least five years from the date of donation and transplant and in a manner prescribed by regulations.

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Part XI

Offences and penalties

§ 84Offences and penalties - Prohibition of commercial dealings in human material for transplantationOffence

Commercial dealing in human organs, tissues or cells for reward or payment is prohibited, with narrowly defined reimbursements and penalties for offences.

Section Prohibition of commercial dealings in human material for transplantation Section A person who— publishes or distributes or causes to be published or distributed any advertisement— A reference in this section to “ reward ”, in relation to the supply of any human organ , tissue or cell does not include payment in money or money’s worth for defraying or reimbursing— Monetary or any other form of compensation for organs, tissues or cells is prohibited, except justifiable expenses approved by the Council . The sale of one of a pair of organs such as an eye or kidney by a living donor for financial or any other form of compensation is prohibited. gives or receives a reward for the supply of, or for an offer to supply, a human organ , tissue or cell; seeks to find a person willing to supply for payment , any human organ , tissue or cell; offers to supply any human organ , tissue or cell for reward ; initiates or negotiates any arrangement involving the giving of a reward for the supply of, or for an offer to supply, any human organ , tissue or cell; takes part in the management or control of a body of persons, corporate or unincorporated, whose activities consist of or include the initiation or negotiation of arrangements to seek or offer human organs, tissues or cells for reward ; takes part in the management or control of a body of persons, whether a society, firm or body corporate, whose activities consist of or include the initiation or negotiation of any arrangement referred to in paragraph (d) ; or inviting persons to supply for payment , any human organ , tissue or cell; offering to supply any human organ , tissue or cell for payment ; or indicating that the advertiser is willing to initiate or negotiate any arrangement referred to in paragraph (d) , A person who contravenes subsection (1) or (2) commits an offence and is liable, on conviction, to imprisonment for life. A person who commits an offence under subsection (3) is liable, on conviction, to a fine not exceeding one hundred thousand currency points or to imprisonment for a term not exceeding twenty years, or both. any expenses incurred in, or in connection with, transporting, removing, preparing, preserving or storing any human organ , tissue or cell; any liability incurred in respect of expenses incurred by a third party in, or in connection with, any of the activities mentioned in paragraph (a) ; or any expenses or loss of earnings incurred by the person from whose body the organ , tissue or cell is removed so far as reasonably and directly attributable to his or her organ , tissue or cell, for a period of six months from the date of donation. In this section— “advertisement” includes any form of advertising whether to the public generally, to any section of the public or individually to selected persons; and “ reward ” means any description of financial or other material advantage.

Section 84Verify source

§ 85Offences and penalties - Removal of human organ, tissue or cell without authorityOffence

It is an offence for a person providing services at or outside a hospital to remove human organs, tissue or cells for transplantation without authority; penalties include a fine up to one hundred thousand currency points or up to twelve years' imprisonment (or both) for hospital-related offences and life imprisonment for removals outside hospital.

Section Removal of human organ, tissue or cell without authority Section A person who renders his or her services to or at any hospital and who, for purposes of transplantation, conducts, associates with, or helps in any manner, in the removal of any human organ , tissue or cell without authority and contrary to this Act commits an offence and is liable, on conviction, to a fine not exceeding one hundred thousand currency points or to imprisonment for a term not exceeding twelve years, or both. Where a person convicted under subsection (1) is a registered health practitioner, he or she shall be referred to the appropriate professional body for necessary action, including the removal of his or her name from the register of the Council for a period of ten years for a first offence and permanently, for a subsequent offence. A person who renders his or her services outside a hospital environment for purposes of transplantation, conducts, associates with or helps in any manner, in the removal of any human organ , tissue or cell without authority and contrary to this Act commits an offence and is liable, on conviction, to imprisonment for life.

Section 85Verify source

§ 86Offences and penalties - Prevention of organ, tissue and cell traffickingOffence

The section prohibits trade and trafficking in human organs, tissues and cells, bans using force for donation, allows certain non-gain payments with Council approval, requires Council authorisation for publicity about transplantation, and makes contravention an offence punishable by life imprisonment.

Section Prevention of organ, tissue and cell trafficking Section The following activities are prohibited— trade in human organs, tissues and cells ; trafficking in human organs, tissues and cells ; obtaining unjustifiable financial gain or comparable advantage from the medical and scientific use of the human body and its parts. The prohibition under subsection (1) shall not prevent payments which do not constitute a financial gain or comparable advantage, in particular compensation for living donors and any other justifiable expenses caused by the removal of human organs, tissues or cells or by related medical examinations, as may be approved by the Council . Transplantation of organs, tissues or cells from a living or brain dead donor shall be carried out solely for the therapeutic benefit of the recipient where there is no alternative therapeutic method of comparable effectiveness. All publicity relating to transplantation activities shall be authorised by the Council . The use of force or any form of coercion to obtain donation of organs, tissues or cells is prohibited. A person who contravenes this section commits an offence and is liable, on conviction, to life imprisonment.

Section 86Verify source

§ 87Offences and penalties - Removal of human organ, tissue or cell from living donor without consent or authorisationOffence

It is an offence for a person to remove an organ, tissue or cell from another person for transplantation without authorisation and appropriate consent; the offender is liable on conviction to imprisonment for life.

Section Removal of human organ, tissue or cell from living donor without consent or authorisation Section A person commits an offence who, without authorisation and appropriate consent in accordance with this Act, removes an organ , tissue or cell from the body of any person intending that it be used for transplantation. A person who commits an offence under subsection (1) is liable, on conviction, to imprisonment for life.

Section 87Verify source

§ 88Offences and penalties - Restriction of activities in relation to donated materialOffence

Prohibits a person from using or storing donated material for purposes that are not qualifying purposes and sets penalties on conviction.

Section Restriction of activities in relation to donated material Section A person commits an offence who— uses any donated organ , tissue or cell for a purpose which is not a qualifying purpose ; or stores donated material for use for a purpose which is not a qualifying purpose . A person who commits an offence under subsection (1) is liable, on conviction, to a fine not exceeding fifty thousand currency points or to imprisonment for a term not exceeding seven years, or both.

Section 88Verify source

§ 89Offences and penalties - Offences by bodies corporateOffence

If an offence under the Act by a body corporate is proved to have been committed with the consent or connivance of, or attributable to neglect of a director, manager, secretary or similar officer, that person as well as the body corporate commits the offence and may be prosecuted and punished.

Section Offences by bodies corporate Section Where an offence under this Act is committed by a body corporate and is proven to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of— A reference to the director, manager or secretary of a body corporate includes a reference— For purposes of this section— any director, manager or secretary of the body corporate; or any officer who was purporting to act in that capacity, he or she, as well as the body corporate, commits the offence and is liable to be prosecuted and punished for the offence under this Act. to any similar officer of the body; and where the body is a body corporate whose affairs are managed by its members, to any officer or member of the body. “body corporate” means any company and includes a firm or other association of individuals; and “director” in relation to a firm, means a partner in the firm. A person who commits an offence under subsection (1) is liable, on conviction, to a fine or imprisonment prescribed by the relevant section, under this Act. A body corporate which commits an offence under subsection (1) is liable, on conviction, to a fine not exceeding five hundred thousand currency points.

Section 89Verify source

§ 90Offences and penalties - General penaltyOffence

A person who contravenes this Act, its regulations, or a designation condition with no separate punishment is liable on conviction to a fine up to one hundred thousand currency points, or imprisonment up to twelve years, or both.

Section General penalty Section A person who contravenes a provision of this Act or any regulations made under this Act, or any condition of a designation granted under this Act for which no punishment is separately provided in this Act, is liable, on conviction, to a fine not exceeding one hundred thousand currency points or to imprisonment for a term not exceeding twelve years, or both.

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Part XII

Miscellaneous

§ 91Miscellaneous - Counselling for donors and recipientsProvision

A designated transplant centre must ensure donors, recipients and their families receive appropriate counselling as prescribed by regulations.

Section Counselling for donors and recipients Section A designated transplant centre shall ensure that donors, recipients and their families are given appropriate counselling in a manner prescribed by regulations.

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§ 92Miscellaneous - Revocation of consentProvision

A person who gave consent may revoke it at any time before harvesting without justification; after harvesting or transplantation, a person may not revoke consent or demand the return of an organ, tissue or cell.

Section Revocation of consent Section A person who gives consent for any purpose under this Act may revoke the consent at any time before harvesting, without giving any justification. For the avoidance of doubt, a person shall not revoke consent or demand for the return of an organ , tissue or cell after the harvesting or transplantation has taken place.

Section 92Verify source

§ 93Miscellaneous - Power to inspectProvision

Council or authorised officers may inspect regulated premises, require and copy records, seize and retain items for Council purposes, and designated transplant centres or banks must comply with facility requests.

Section Power to inspect Section Where records which a person is required to keep under this Act are stored in any electronic form, the power under subsection (2) includes the power to require the records to be made available for inspection— The Council or an authorised officer may, at any reasonable time, enter and inspect any premises carrying out any activity regulated under this Act. A person carrying out an inspection under subsection (1) may require a person to produce for inspection, any records which he or she is required to keep under this Act. in a visible and legible form; or in a form from which they can readily be produced in a visible and legible form. A person carrying out an inspection under subsection (1) may inspect and take copies of any records produced for inspection in pursuance of a requirement under this section. Entry and search shall be at a reasonable time unless the person carrying out the search or inspection thinks that the purpose of the search may be frustrated on entry at a reasonable time. A person carrying out an inspection under subsection (1) may seize anything on the premises which he or she has reasonable grounds to believe may be required for purposes of the functions of the Council under this Act or which the person believes to have been used in contravention of this Act, regulations made under this Act or standards issued by the Minister . The Council may require any designated transplant centre or bank to make available for purposes of the Council , any facilities including laboratories, and the designated transplant centre or bank shall comply with the request. Where a person has power under subsection (5) to seize anything, he or she may take such steps as appear to be necessary for preserving the thing or preventing interference with it. The power under subsection (5) includes power to retain anything seized in exercise of the power for so long as it may be required for the purpose for which it was seized. Where, under this section, a person seizes anything, he or she shall leave, on the premises from which the thing was seized, a statement giving particulars of what he or she has seized and stating that he or she has seized it.

Section 93Verify source

§ 94Miscellaneous - RegulationsOffence

The Minister must make regulations by statutory instrument to carry the Act into effect and lay them before Parliament.

Section Regulations Section Notwithstanding the general effect of subsection (1) , regulations made under this section may provide for— Regulations made under subsection (1) may, in respect of any contravention of any of the regulations— The Minister shall, by statutory instrument, make regulations generally for the better carrying into effect of the provisions of this Act and shall lay the regulations before Parliament. the criteria for accreditation and designation of transplant centres; transplant quality control systems; transplantation activities; the transplantation of organs, tissues and cells ; the harvesting and use of human organs, tissues and cells ; the national waiting list ; the donor list; donor screening; tissue and cell banking; preservation of organs for transplantation; application procedures; organ donations; consent ; cadaveric donations; post-mortem examinations; fees to be charged by the Council ; recall procedures; look back procedures; procedures for sharing of organs; the manner in which, and the conditions subject to which, any donor may authorise removal, before his or her death, of any human organ , tissue or cell of his or her body under this Act; the form and the manner in which a brain dead person is to be certified and the conditions and requirements which are to be satisfied for that purpose under this Act; the form and the manner in which any of the parents may give authority, in the case of brain-death of a child , for the removal of any human organ , tissue or cell under this Act; the manner in which all possible effects, complications and hazards connected with the removal and transplantation is to be explained by the registered medical practitioner to the donor and the recipient under this Act; the standards to be enforced by the Council for designated transplant centres and approved banks engaged in the removal, storage or transplantation of any human organ , tissue or cell under this Act; the specialised services and facilities to be provided, skilled manpower and the equipment to be possessed and the standards to be maintained by a designated transplant centre ; giving any notice required under this Act; the organ , tissue and cell database; confidentiality of information; records and documentation; reporting mechanisms; and any other matter related or incidental to the functions under this Act. prescribe a penalty of a fine not exceeding thirty thousand currency points or to imprisonment for a term not exceeding twelve years, or both; in the case of a continuing contravention, prescribe an additional penalty not exceeding one thousand currency points in respect of each day on which the offence continues; and prescribe a higher penalty not exceeding thirty thousand currency points in respect of a second or subsequent contravention. For the purposes of this section, “sharing of organs” means medically sanctioned movement of body organs, tissues or cells from one bank to another.

Section 94Verify source

§ 95Miscellaneous - Code of practiceInterpretation

The Minister may issue a code of practice (in consultation with the Council) and must consult stakeholders before preparing it and publish it in the Gazette; the code may provide for specified matters such as storage, use, removal, post-mortem procedures, consent, import/export and disposal of relevant material.

Section Code of practice Section The Minister may, in consultation with the Council , issue a code of practice for the purpose of— The code of practice referred to under subsection (1) may provide for— the storage for use for a scheduled purpose, and the use for such a purpose, of— giving practical guidance to persons carrying out activities under this Act; and laying down the standards expected in relation to the carrying-out of activities under this Act. the carrying-out of anatomical examinations; the storage of anatomical specimens; the storage and disposal of former anatomical specimens; the definition of death for the purposes of this Act; communication with the family of a brain dead person in relation to the making of a post-mortem examination ; the making of post-mortem examinations; communication with the family of a brain dead person in relation to the removal from the body of the brain dead person, for use for a scheduled purpose, of any relevant material of which the body consists or which it contains; the removal from a human body, for use for a scheduled purpose, of any relevant material of which the body consists or which it contains; the body of a brain dead person, or relevant material which has come from a human body; the storage for use for a scheduled purpose; the import or the export of the body of a brain dead person or organ , tissue or cell from a human body for use for a scheduled purpose; issues of consent ; and the disposal of relevant material which has been removed from a human body for use for a scheduled purpose. Before preparing the code of practice under this section, the Minister shall consult any other stakeholders as he or she deems necessary. The Minister shall publish the code of practice issued under this section in the Gazette . The code of practice issued under this section shall come into effect on the date of its publication in the Gazette .

Section 95Verify source

§ 96Miscellaneous - Power to amend SchedulesAmendment

The Minister may amend Schedule 1 by statutory instrument with Cabinet approval, and may amend Schedules 2 and 3 by statutory instrument.

Section Power to amend Schedules Section The Minister may, by statutory instrument, with the approval of Cabinet, amend Schedule 1 to this Act. The Minister may, by statutory instrument, amend Schedules 2 and 3 to this Act.

Section 96Verify source

Legislative relationships

5 referenced instruments

Names are derived from the stored provision headings and citation-enrichment layer. Treat this as a research index and verify each relationship against the source text.

A–F

4 instruments

Council - Compliance with Public Finance Management Act
Section 26
Council for the next financial year in accordance with the Public Finance Management Act
Section 22
Council in accordance with the National Audit Act
Section 24
Council under this Act
Sections 80, 93

N–S

1 instrument

Schedule 1 to this Act
Section 96

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31 Dec 2023 · currentEnglish

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