Frank Feighan (Sligo-Leitrim, Fine Gael) | Oireachtas source

I thank the Senator for bringing this important Commencement matter to the floor of the Seanad.As committed to in the programme for Government, the enactment of the human tissue (transplantation, post-mortem, anatomical examination and public display) Bill remains a priority for the Government. It is complex legislation that will include provisions on organ donation, transplantation, hospital post mortem practice and procedures, anatomical examination and public display of bodies after death. In particular, the Bill seeks to further embed in legislation the idea that consent is a defining principle across all of these sensitive matters.

A key priority for the Government in bringing forward the Bill is to increase organ donation and transplantation rates and to make organ donations the norm in Ireland in situations where the opportunity arises. The human tissue Bill will help to achieve this through the introduction of a soft opt-out system of consent for organ donation under which consent will be deemed unless a person has registered a wish to not become an organ donor after death. The Bill will also legislate for living organ donation and altruistic donation, both of which will help to increase the donor pool in Ireland.

Given the complexity of the Bill, a number of challenges have been encountered in drafting the legislation that have had to be resolved before publication is possible. Among other things, officials have had to develop three separate regulatory frameworks and amend the extant EU directives of 2006 and 2012 accordingly. This has necessitated intensive engagement between the Department of Health and the Health Products Regulatory Authority, the Health Information and Quality Authority and the Medical Council. Department of Health officials have also undertaken an intensive round of engagement with stakeholders engaged in organ donation and transplantation over recent months to ensure the legislation meets the needs of this very important community.

As Senator Lombard is aware, as well as providing a legislative basis for organ donation and transplant the Bill will introduce a regulatory regime for the conduct of post mortems in hospital settings. Under the general scheme of the Bill provisions were to be restricted solely to hospital post mortem activities. However, in light of recent events a review is being undertaken to see whether an expansion of provisions to encompass certain aspects of coronial post mortem activities might be possible. Intensive engagement is ongoing between officials in the Department of Health and the Department of Justice with the Attorney General and his officials to find a resolution to this issue. Any solution found will be complementary to the recommendations of the recent HSE internal audit report on compliance by hospitals with the HSE standards and recommended practices for post mortem examination services and the work of the post mortem examination services group that is working on updating guidelines for post mortem practice. Department of Health officials continue to work on finalising the legislation and drafting the Bill and it is at an advanced stage. Government approval for publication of the human tissue Bill will be sought as soon as possible and is expected this Oireachtas term.