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The remarks came when the Authority’s Board discussed correspondence from the Department of Health in relation to HIQA’s function under the General Scheme of the Human Tissue Bill at its meeting in July.
Under the Bill, it is envisaged that HIQA will become the regulator for pathology, while other regulators will be responsible for other aspects of the proposed legislation.
According to the meeting minutes, HIQA’s Director of Regulation Ms Mary Dunnion, who delivered a briefing on the issue, explained there were a number of issues to be clarified, such as the nature of inspection and enforcement powers.
“The Board expressed the view that the approach to this function is somewhat disconnected from broader legislative developments and will also generate a considerable reporting burden for services,” the minutes state.
“It was suggested that this function should be part of the licensing legislation and that this should be communicated to the DoH [Department of Health].”
A spokesperson for HIQA told the Medical Independent (MI) the Authority is still awaiting direction from the Department on these issues.
The Department of Health told MI it is proposed to bring the legislation to Cabinet for approval, along with a regulatory impact assessment, early this month.
On 11 July 2017, the Government approved the preparation of the General Scheme and Heads of a Human Tissue Bill.
It was proposed that the General Scheme will regulate the removal, retention, storage, use and disposal of human tissue from deceased persons; provide general conditions for the removal, donation and use of organs and tissues from deceased and living persons for the purposes of transplantation; and provide for an opt-out system of consent for organ donation and for an associated register.
The Human Tissue Bill will implement the key recommendation of the Madden Report on Post-Mortem Practices and Procedures that no hospital post-mortem examination should be carried out and no tissue retained for any purpose whatsoever without authorisation.