S.I. No. 251/2025 - Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) (Living Donor Reimbursement Scheme) Regulations 2025

1. An appeal of a determination of a claim for reimbursement may be made where a claim for reimbursement or part thereof is not reimbursed by the Living Donor Reimbursement Office.

2. An appeal shall be submitted to Organ Donation and Transplant Ireland for determination.

3. All communication relating to an appeal must be in writing with appropriate record-keeping by all parties.

4. The appeals officer in Organ Donation and Transplant Ireland shall, where possible, be of a grade higher on the Health Sector Consolidated Salary Scales than the decision-maker in the Living Donor Reimbursement Office.

5. Upon receipt of an appeal, Organ Donation and Transplant Ireland shall acknowledge receipt to the appellant and identify the appeals officer who will consider the appeal.

6. Any officer previously involved in the decision-making process regarding the claim for reimbursement which is the subject of the appeal shall not take part in the determination of any appeal concerning that claim.

7. The Living Donor Reimbursement Office shall provide a full copy of any file associated with the appellant to Organ Donation and Transplant Ireland to assist in considering the appeal.

8. In considering an appeal, an appeals officer shall

(a) act professionally and impartially;

(b) only consider the documentation available;

(c) not rely on non-documented evidence; and

(d) only consider the appeal within the conditions set out in these Regulations.

9. An appeals officer may request any information or clarification, as he or she deems necessary, to consider the appeal.

10. An appeals officer shall have ten working days from the date of receipt of an appeal to make a decision, unless otherwise notified in writing to the appellant.

11. An appeals officer shall issue the appeal decision to the appellant in writing.

12. The decision letter shall include

(a) the decision of the appeals officer;

(b) the rationale for the decision;

(c) information as to their right to complain to the Office of the Ombudsman if they are dissatisfied with the outcome of the appeal.

13. Upon issuing the decision, the appeals officer shall send the appeal file, either in its original form or as a copy, to the Living Donor Reimbursement Office.

GIVEN under my Official Seal,

12 June, 2025.

JENNIFER CARROLL MACNEILL,

Minister for Health.

EXPLANATORY NOTE

(

This note is not part of the Instrument and does not purport to be a legal interpretation.

)

These Regulations provide a statutory basis and conditions for the Living Donor Reimbursement Scheme as provided for in

section 12

of the

Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024

. These Regulations allow for the reimbursement of the costs and expenses incurred by an eligible donor as part of the donation process.

14. (1) Self-employed eligible donors shall submit a Notice of Assessment and the Revenue Commissioner’s Form 11 as relevant supporting information in any claim for reimbursement for loss of income.

(2) Reimbursement for a 12 week period will be calculated as the proportion of the eligible donor’s income corresponding to twelve weeks of the preceding 12 month tax period.

(3) Written confirmation of the date of return to work for self-employed donor shall be provided by the donor’s treating consultant or GP as relevant supporting information in any claim for reimbursement for loss of income.

(4) A self-employed eligible donor may make a claim for the expense of a person to replace himself or herself in his or her business for a period of up to 12 weeks, up to an upper limit of €15,000.

(5) Where a claim for the replacement of a self-employed eligible donor in his or her business is submitted, the claim shall include relevant supporting documentation.

(6) Where a claim for the replacement of a self-employed eligible donor in his or her business is submitted, and the person replacing him or her is already an employee of the self-employed eligible donor, it will be necessary for the self-employed eligible donor to demonstrate the additional hours that employee has incurred in his or her duties to replace the self-employed donor.

(7) Only the additional hours worked by the employee of the self-employed eligible donor will be eligible for reimbursement.

(8) A self-employed eligible donor can only make a claim for either loss of income or for the cost of engaging a replacement employee in his or her business, but not both.

Reimbursement for Donors from Outside the State

15. (1) Where a donor from another jurisdiction travels to the State for the purpose of donation under the clinical supervision of Beaumont Hospital, travel and accommodation costs may be reimbursed in accordance with the conditions set out in these regulations.

(2) Where testing of a donor from another jurisdiction is conducted prior to donation, any associated costs or expenses incurred while present in the State during the donation process may be reimbursed in line with the conditions set out in these regulations.

Determination of Claims

16. (1) A decision of the Living Donor Reimbursement Office will set out in writing the claim(s) for reimbursement made by an eligible donor which have been approved or declined and the value of the reimbursement payment for any approved claim for reimbursement.

(2) There is no discretion for reimbursement to be paid to an eligible donor outside the provisions of these Regulations.

(3) There is no discretion for the grant of an

ex gratia

scheme or once off payment to an eligible donor outside of the provisions of these Regulations.

Exemption from tax

17. Payments for reimbursement made under these Regulations are exempt from income tax and are not reckoned in computing income for the purposes of the Income Tax Acts, in accordance with section 204B of the

Taxes Consolidation Act 1997

, as amended.

Limitation

18. The Minister, the Department of Health, or the Executive do not bear any responsibility for the loss by an eligible donor of any entitlement as a result of their becoming an eligible donor.

Appeal

19. (1) Where a claim for reimbursement or part thereof is not reimbursed, an appeal of the decision of the Living Donor Reimbursement Office may be made by the eligible donor to Organ Donation and Transplant Ireland.

(2) Appeals will be determined under the procedure set out in Schedule 1 of these regulations.

Governance

20. (1) The Living Donor Reimbursement Scheme shall be administered by the Living Donor Reimbursement Office.

(2) The Executive shall, in consultation with Organ Donation and Transplant Ireland, the Living Donor Reimbursement Office, and the Living Donor Programme, establish a governance structure for the purposes of administering the Living Donor Reimbursement Scheme.

(3) The Living Donor Reimbursement Office shall establish appropriate procedures to ensure that all reimbursements are correct and legitimate and that appropriate records are kept.

(4) All information, in whatever form, on the implementation of the Living Donor Reimbursement Scheme shall be made available to Organ Donation and Transplant Ireland and the Department of Health upon request.

Review

21. (1) The Minister shall, not later than 3 years following the commencement of these Regulations, carry out a review of the operation of the Living Donor Reimbursement Scheme.

(2) In carrying out a review under Regulation 21(1), the Minister may consult with such persons as he or she considers appropriate.

Schedule

Regulation 19

Appeals procedure

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

17

th June,

2025.

I, JENNIFER CARROLL MACNEILL, Minister for Health, in exercise of the powers conferred on me by

section 3

of the

Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024

(No. 5 of 2024), hereby make the following regulations

Citation and Commencement