There are no proposals before my Department at present for the development of xenotransplantation in this country. I do not propose, at this point, to introduce guidelines in this area.
I am aware that advances have been made in international research into xenotransplantation. However, it is important to state that xenotransplantation is not yet an established clinical practice. Indeed it is difficult to predict with any degree of certainty when, if ever, it would be feasible to introduce this procedure into practice in this country.
If xenotransplantation is to become routinely available as a medical therapy, a number of technical, ethical and clinical issues will first need to be addressed. It will be necessary, in particular, to ensure that all necessary safeguards are in place to address safety concerns arising from the transplantation of animal organs into humans. In addition, the potential impact on the patient, the family and the wider population will need to be identified and addressed.
My Department will continue to monitor developments in the area of xenotransplantation in association with international colleagues. The Council of Europe has established a working group to examine this area and the work of the group will be closely followed by my Department. I am also aware that the United Kingdom Xenotransplantation Interim Regulatory Authority – UKXIRA – has recently circulated a draft document on infection surveillance for consideration and discussion within the UK in relation to xenotransplantation. The discussion document proposes, among other requirements, that lifelong compliance with the post-operative regime for any xenotransplantation is likely to require the patient to agree to use barrier contraception for life and to refrain from pregnancy or fathering a child. The option of developing guidelines in Ireland in this area will be reviewed in the light of further advances.