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

Application to Panel for donation of regenerative tissue and cells by living adults who lack capacity

30. (1) Where a donation of regenerative tissue and cells is proposed in accordance with section 25 (3), the tissue establishment or procurement organisation, as the case may be, with clinical responsibility for the removal of the regenerative tissue and cells shall apply to the Panel for approval for such proposed donation.

(2) An application under subsection (1) shall be made to the Panel in such form and manner as may be specified by the Panel.

(3) On receipt of an application under subsection (1), the Panel shall appoint a suitably qualified professional, who shall not be a member of the panel, to prepare a report as to whether the appropriate consent has been provided for the purposes of such donation.

(4) The person appointed under subsection (3) shall prepare a report in accordance with that subsection and furnish the report to the Panel not later than 15 days after his or her appointment.

(5) The Panel shall take into account the report prepared in accordance with subsection (3) when making any decision regarding an application under subsection (1) which decision shall be made as soon as may be after receipt of the report.

(6) The Panel may approve an application under subsection (1) where it is satisfied that—

(a) having taken account of the report prepared in accordance with subsection (3), appropriate consent has been provided in accordance with section 10 ,

(b) the adult who lacks capacity, the subject of the application, does not object to the proposed donation,

(c) the proposed recipient is a parent, child or sibling of the donor and there is no other compatible donor with the capacity to consent available,

(d) there is no alternative therapeutic intervention of comparable effectiveness available,

(e) the donation of the regenerative tissue and cells by the donor has been clinically assessed by a registered medical practitioner as having the potential to be life-saving for the recipient, and

(f) the specified person and, where applicable, the proposed donor has been given sufficient information.

(7) The Panel shall refuse an application under subsection (1) where it is not satisfied that the conditions specified in subsection (6) are met.

(8) In considering an application under subsection (1), the Panel shall have regard to—

(a) the report under subsection (3), and

(b) the opinion of the proposed donor, the subject of the application.

(9) The Panel shall give notice in writing of a decision to approve an application in accordance with subsection (6) or to refuse an application in accordance with subsection (7) to—

(a) the proposed donor the subject of the application, or any person acting on his or her behalf or the specified person concerned, as the case may be, and

(b) the tissue establishment or procurement organisation which caused the matter to be referred to the Panel under subsection (1).

(10) A copy of the report provided in accordance with subsection (3)

(a) shall be retained by the tissue establishment or procurement organisation, which carried out the procedure, for a period of not less than 30 years—

(i) with the medical records of the person donating the regenerative tissue and cells, and

(ii) by the tissue establishment or procurement organisation which carried out the procedure,

and

(b) shall be offered to the person providing consent and shall, on his or her request, be given to that person.