Cystinosis Ireland welcomes the Government decision to publish the General Scheme of a Human Tissue Bill which includes provision for “soft opt-opt” organ donation. More details from the Department of Health are below.
Press Release Thursday 2nd May 2019Minister for Health welcomes Government approval to Publish Human Tissue Bill
Minister for Health Simon Harris TD has today welcomed the Government decision to approve the publication of the General Scheme of a Human Tissue (Transplantation, Post-Mortem, Anatomical Examination, and Public Display) Bill.
The Bill 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;
• provide for an opt-out system of consent for organ donation and for an associated register; and
• provide for non-directed altruistic kidney donation.
Speaking today, Minister Harris said: “I am delighted that the Government has approved the drafting of the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination, and Public Display) Bill. This Bill, which will implement the recommendations of the Report of Dr Deirdre Madden on Post-Mortem Practice and Procedures (2006), will provide comprehensive protection to all persons, whether living or dead, in relation to consent for the use of their bodies, organs or tissue. Detailed consultation was involved in finalising these proposals and I acknowledge the input of all involved”.
“For almost 200 years the only primary legislation governing the use of human tissue was the Anatomy Act of 1832. The Bill will repeal that Act and create a modern legislative framework of consent.”
The Bill, which is wide-ranging, will include provisions on:
• organ donation and transplantation;
• hospital post-mortems;
• anatomical examination (including medical education and training); and
• public display of bodies after death.
Significantly, the Bill provides for the introduction of an opt-out system of consent for deceased organ donation and an associated register.
Minister Harris said: “I am really pleased to progress this vital piece of legislation which is a key commitment of mine and of the Government.
“In recent years,” continued the Minister, “significant progress has been made by Organ Donation & Transplant Ireland, the three transplant centres at Beaumont Hospital, St Vincent’s University Hospital, and Mater Misericordiae University Hospital, and my Department to increase the number of transplantations carried out in Ireland.” The further development of organ donation and transplant services is a key part of the Sláintecare Action Plan.
“I strongly believe that this opt-out system could transform organ donation in Ireland. In order for it to be most effective, it will be supported by a series of other measures. It is so important we do everything we can to make organ donation the norm in Ireland when people pass away in circumstances where donation is a possibility.”
Minister Harris acknowledged the contribution made by Senator Fergal Quinn to organ donation and transplantation in Ireland.
He added: “The late Senator Fergal Quinn introduced a Private Members Bill, ‘Human Body Organs & Human Tissue Bill’ in 2008. Senator Quinn was a committed advocate for organ donation. While it has taken some time, I think that the publication of the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination, and Public Display) Bill and the commencement of drafting work, is a fitting tribute to him at this time.”
Minister Harris was joined at the event by liver transplant recipient Edel Cashman and double lung transplant recipient David Crosby, and Martina Goggin representing donor families.
Prof Jim Egan, Director of HSE’s Organ Donation & Transplant Ireland, stated: “The opt-out system is one of a number of measures required to optimise our organ donation rates.”
“The plan is that the legislation will dovetail with awareness campaigns, enhanced infrastructure, training for medical staff and audit, to ensure that all opportunities for transplantation are followed through.”
Notes to the Editor
The General Scheme will provide for consent procedures and general conditions on the removal, donation and use of organs (e.g. kidney) and tissue (e.g. bone marrow) from the deceased and the living for transplantation and for human application. It will also include a provision to prohibit the trafficking of organs and the removal and transplantation of organs outside of an official transplant centre (i.e. a centre licensed by the HPRA).
Opt-Out System of Consent for Organ Donation
The General Scheme will introduce a soft opt-out system of consent for organ donation. Under this system, consent will be deemed unless a person has, while alive, registered their wish to not become an organ donor after death.
If a person is on the opt-out register, their next-of-kin will not be approached to discuss organ donation and their organs will not be removed.
If a person is not registered on the opt-out register, the next-of-kin will always be consulted before any organ is removed. If the next-of-kin objects to the donation, then the donation will not proceed.
Non-Directed Altruistic Kidney Donation
The General Scheme will expand the living kidney donor programme to include non-directed altruistic kidney donation (adults only). At present, living kidney donors can donate to a family member or a close friend,
Non-directed altruistic kidney donors make a donation to the transplant pool, but do not direct their donation to a specific person.
While the number of altruistic transplants that may take place is difficult to predict, it is estimated that between 2-5 altruistic transplants could take place each year.
Independent Panel for Living Donation
The General Scheme will provide for the establishment of an independent panel to approve the following applications for living donation:
o non-directed altruistic kidney donation;
o donation of regenerative tissue (e.g. bone marrow) from a child or adult who lacks capacity to close relatives (sibling, parent or child).
The panel must be satisfied that there is no element of coercion and that there is no financial incentive being given to the potential donor. The panel will include an ethicist, a legal practitioner, an independent physician and a psychiatrist.
Post-Mortem Practice and Procedure
The General Scheme will implement the relevant recommendations of the Report of Dr Deirdre Madden on Post Mortem Practice and Procedures relating to, inter alia, consent provisions for hospital post-mortems and provisions on the retention, storage, use and disposal of organs and tissue from deceased persons following a hospital post-mortem.
The General Scheme will repeal the Anatomy Act 1832 and put in place arrangements in relation to the donation of bodies to anatomy schools and provisions for the setting of standards to be met in the practice of anatomy. The provisions for anatomical examination will include medical education and training activities using donated human tissue.
Public Display of Bodies
The General Scheme provides that a license will be required for the public display of bodies after death. The provisions will outline the consent arrangements required for the donation of a body or body parts for public display, and ensure the provenance of the specimens used.
Transplant services are provided at 3 transplant centres:
• Beaumont Hospital – National Renal (Kidney) Transplant Service
• Mater Misericordiae University Hosptial – National Heart & Lung Transplant Service
• St Vincents University Hospital – National Liver & Pancreas Transplant Service
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