Speak Up!
The commencement of the public consultation on the content of the Human Tissue Bill


On 9 April the Minister for Health and Children announced the commencement of a public consultation on proposals for a Human Tissue Bill. It is intended that the resulting Human Tissue Act will regulate the removal, retention, storage, use and disposal of human tissue from deceased persons, and address the issue of consent for the use of donated tissues from living persons for the purposes of transplant and research.

The draft General Scheme of the Human Tissue Bill runs to 200 pages and only a broad outline is set out here. The Department aims to present the final proposals for approval by the Government later in the year.

Post Mortem Examination and Research

The proposed legislation will address as a primary issue the concerns raised by the Madden Report on Post Mortem Practice and Procedures (December 2005). The draft lays down the defining principle as being that of consent, or the lesser concept of authorisation for any of the activities specified (post-mortem, anatomical examinations, public display, transplantation and research). The draft scheme contains detailed provisions regulating post-mortem examination including the removal, retention, storage, use and disposal of tissue. It provides that no post-mortem examination may be carried out or tissue retained without authorisation or consent. The draft covers voluntary hospital post-mortems only. Coroners post-mortems will be dealt with separately in the Coroners Bill 2007, which is awaiting Committee stage in the Seanad. The intention is that a human gamete or embryo will be excluded from the definition of “tissue” for these purposes.

Transplant

This “Request for Views” follows a related exercise carried out earlier this year seeking submissions from the public on systems of consent, specifically for the donation of organs for transplantation after death, another of the core issues addressed in the General Scheme. Over 1,000 submissions were received by the Department. Interest was such that the closing date for receipt of submissions was extended and the results are still being analysed.

There is currently no legislative framework in Ireland governing the use of or consent relating to the donation of body organs, in contrast with much of the rest of Europe. The current position is that an individual must record his willingness to donate organs by either carrying a donor card or ticking the box on that back of the driving licence. It is also possible to state ones intentions by will but the difficulty is that it is generally only some time after death that the will is read. Any expressed wishes can be and often are in practice superceded by the wishes of next of kin who are always consulted. The result of public consultation indicated that the public would support a move towards granting precedence to the express wishes of the deceased and it is the hope of the Department that new legislation might prompt a change in mindset to increase levels of organ donation.

Whilst many Irish people in theory agree with organ donation it seems the actual rate of donation does not accord with that sentiment and it is proposed that the HSE will now carry a statutory responsibility to promote organ donation. Criticisms have been levelled at the current regime and at a lack of national co-ordination on organs that are donated. This has lead to a situation where donated organs may not actually be utilised. It is the view of many interest groups that the priority at this point should be to set up a transplant authority to oversee and co-ordinate allocation.

The first draft of the Bill as it relates to organ donation suggests an “opt-in” system where the potential donor must actively indicate consent to donation as opposed to the “opt-out” system of donation. The Minister has made it clear that this was done only to offer an initial focus for public debate given the importance of the issues involved and that all options are being considered. It seems likely that public opinion will prefer some form of “opt-in” system, perhaps involving mandatory reporting of intention to donate (or otherwise) by all capable citizens (there are separate provisions on adults lacking capacity and on children) and/or required request of the next of kin.

Conclusion

The draft General Scheme provides for the appointment of one or more regulators for the different purposes and for stiff penalties not exceeding those in place for offences against the living. It is already a very detailed document and merits close scrutiny, dealing as it does with some of the last taboos in our society.

The Department has strongly advised stakeholders to submit substantive suggestions before 29 May 2009 as making further significant change will become progressively more difficult as the process progresses. The draft Proposal is available on the D.O.H.C. website (www.dohc.ie/consultations) or can be requested by telephone or email ().

For further information, please contact Louise O’Rourke at