Uganda Human Organ Donation and Transplant Act

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 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 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 The Chairperson of the Council shall ensure that no money is withdrawn from or paid out of any of the bank account of the Council without the authority of the Council .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 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 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 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 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 Compliance with Public Finance Management Act Section The Council shall at all times comply with the Public Finance Management Act.

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 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 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 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 regu...

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 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 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 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 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 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 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 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 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 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 clinica...

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 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 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 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 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 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 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 b...

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 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 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 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 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 transplan...

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 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.

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...

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 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 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 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 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...

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.

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.

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 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...

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...

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...

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.