Press Release

Minister Harris gets green light to move ahead with legislation to provide for an opt-out system of consent for organ donation

Government approves drafting of Human Tissue Bill

Public Consultation to be held before the end of the summer

Minister Harris announced today (Tuesday) that the Government has approved the preparation of the General Scheme and Heads of a Human Tissue Bill, giving him the green light to move ahead with legislation to provide for an opt-out system of consent for organ donation. A Public Consultation will be held before the end of the summer.

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

Minister Harris said “The Human Tissue Bill will give effect to the Programme for Partnership Government commitment to propose legislation for family consent and an opt-out register for organ donation. Under this system, consent will be deemed unless the person has, while alive, registered their wish not to become an organ donor after death. It is proposed that the next of kin will always be consulted prior to removing any organ.”

Stressing the importance of organ donation, Minister Harris said “Organ donation is among the most selfless acts we can bestow upon another person. An opt-out system of consent for organ donation and accompanying publicity campaign will raise awareness among individuals and encourage discussion among families of their intentions in relation to organ donation. In this way individuals can increase the chances that their organs might be utilised after their death, and can ensure that those left behind will have the satisfaction of knowing that their wishes were carried through.”

Minister Harris further stated “Ireland needs to change its attitude to organ donation, and adopt an opt-out system of consent for organ donation. I want to see a time where organ donation is the norm when people pass away in circumstances in which donation is a possibility.”

The Human Tissue Bill will also 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.

Minister Harris said “This implementation of the Madden Report has been a long time coming and I’m very glad to bring this legislation forward. The Human Tissue Bill will ensure that the principles of protection of the bodily integrity of the individual before and after death; respect for the autonomy of the individual and the rights of the bereaved; and promotion of the public health benefits of post-mortem examination and tissue donation are enshrined in legislation.”

The Minister concluded by saying that “Work is continuing on the preparation of the legislation and a public consultation will be held on the proposals before the end of the summer. I would encourage everyone to make their voices heard.”

Notes for Editors

Main Provisions of General Scheme of a Human Tissue Bill

The General Scheme will provide for:

  • Post-mortem practice and procedures
  • Anatomical Examination
  • Organ Donation and Transplantation
  • Donation of Regenerative Tissue
  • Importation of Human Organs and Tissue
  • Public Display of Bodies after Death
  • Education and Training

The proposals will:

  • Provide a framework of informed consent for the following designated activities:
    • Hospital Post Mortem
    • Organ Donation and Transplantation
    • Anatomy
    • Public Display
    • Education & Training
    • Import/Export
  • Formalise practice and procedure e.g. Regulating codes of practice in anatomy and post mortem
  • Allow for the dignified disposal/return of by- products of these activities, or for their consent to be used in research
  • Provide for an opt-out system of consent for organ donation and for an associated register.



The General Scheme will provide for regulation of:

  • compliance with the legislation;
  • licencing and the undertaking of inspections of licence holders;
  • adopting, developing and approving guidelines and or standards e.g. pathology practice, anatomical examination etc.; and
  • compliance with consent provisions.


Public Consultation:

Public consultations on the development of a Human Tissue Bill and the provision of a system of consent for organ donation have been held previously in 2007, 2009 and 2013.  Given the passage of time since, a further public consultation on the proposals will be initiated before the end of the Summer.


Transplant and Donor Information:

 To the end of June 2017, 124 transplants have been carried out as follows:

  • 80 kidney transplants *
  • 26 liver transplants
  • 14 lung transplants
  • 2 heart transplants
  • 1 pancreas transplant *
  • 1 heart/lung transplant

* Simultaneous Kidney/Pancreas Transplant

Overall, 280 organ transplants were carried out during 2016. This marked the second highest yearly performance achieved, with an average rate of 23 transplants per month.

The organ transplant figures for 2016 were:

  • 172 kidney transplants at National Renal Transplant service, Beaumont Hospital;
  • 58 liver transplants at National Liver transplant service, St Vincent’s University Hospital;
  • 35 lung transplants and 15 heart transplants at the National Heart lung transplant service at the Mater Misericordiae University Hospital.

A notable highlight is the record performance for the Living Kidney Donor Programme which reached a milestone of 50 living donor transplants for the first time and saw and an increase in living donor transplants from 33 in 2015.

The reality of organ donation and transplantation is that very limited number of people die in circumstances where organ donation is a possibility. The number of deaths in Ireland annually is in the region of 30,000 and, in 2016, there were a total of 190 donor referrals in our hospitals, from which 77 deceased donors were identified.

Funding for Organ Donation and Transplantation 

Additional funding of over €3m per annum has been made available to the HSE since 2014 to facilitate an increase in the levels of organ donation and transplantation mainly through the appointment of 19 whole-time-equivalent personnel.

Madden Report

The Madden Report sets out the general facts in relation to paediatric post-mortem practice in Ireland from 1970 to 2000, the way in which information was communicated to parents of deceased children in relation to post-mortem examinations, and how these practices might be improved upon for the future.