Alex White (Dublin South, Labour) | Oireachtas source

The Irish Medicines Board has an excellent reputation, and considerable experience in authorising blood and tissue establishments as set out in other EU directives on quality and safety. It made sense to expand the remit of the IMB to include the inspection and authorisation of procurement and transplantation centres. It is also wholly appropriate that a separate agency is tasked with ensuring our health system is meeting required standards of quality and safety.

Similarly, it is appropriate that the HSE should be the competent authority for quality and safety aspects of the regulations. The HSE, through its National Organ Donation and Transplantation Office, is best placed to develop a framework for quality and safety in relevant hospitals to ensure the standards of quality and safety as set down in the regulations are met. The HSE is already the agency responsible for the broad oversight of hospitals and is responsible for ensuring standards for equipment and theatres are adhered to throughout the system. The appointment of two competent authorities for the implementation of the directive is not unique to Ireland, and, indeed, similar arrangements apply in countries such as the United Kingdom, France and the Netherlands.

The question of consent to organ donation and related issues are appropriate for primary legislation and will be provided for in the human tissue Bill, the heads of which are being drafted by my Department. In addition to the area of organ donation and transplantation, the human tissue Bill will cover a range of other issues including post mortems, research and anatomical examination.

The Department has recently initiated a public consultation process on the issue of consent to organ donation. Members referred to that matter. We are inviting interested parties to submit views by 20 September. Following the receipt of submissions and the distillation of the views received, the Department plans to host a focused workshop on the findings of the consultation. It is proposed that the workshop will involve clinicians, representatives of the Irish Donor Network and other relevant parties to inform the next steps of the legislative process.

Ireland has a solid history of organ donation and transplantation and ranks favourably among other EU countries. A total of 5,182 transplants have been performed to the end of 2012 in this country. In 2012, 78 persons donated their organs after death. In addition, 32 living persons donated a kidney. As a result of the gift of life given through the families of the 78 deceased donors, 239 organ transplants were performed in the three transplant centres in Ireland - the Mater Hospital, Beaumont Hospital and St Vincent's Hospital. To the end of July this year, 53 people had donated their organs after death. In comparison with the same time last year, there has been a significant rise in heart and lung transplants, with kidney transplants being at a similar rate to last year.

The Government looks forward to working in partnership with the HSE and the voluntary sector in developing policies and actions to further improve organ donation rates. The HSE's National Organ Donation and Transplantation Office will continue to work in a collaborative fashion to develop a plan for the introduction of changes and improvements in donation and transplantation systems and practices so that as many patients as possible benefit from a well-functioning and successful programme of organ donation.

It must be reiterated that my Department complied with all relevant procedures in drafting and bringing into effect of the European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012. I am satisfied that these regulations comprehensively transpose the provisions of EU Directive 53/2010 and set out a clear legal framework for the quality and safety standards for organs intended for transplantation in Ireland.

Apart from the issue that has been raised in respect of a single authority, with respect, I must say that no argument was made to the effect that the regulations did not faithfully transpose what is provided for in the directive, with which Senator Darragh O'Brien states fairly he has no difficulty and about which many others say the same. There is absolutely no reason to annul this statutory instrument. Apart from putting Ireland in conflict with European legislation, such an approach would remove the statutory basis for vital aspects of a quality system for an organ donation and transplantation service, thus exposing the citizens of our country to unnecessary risks.

We all have the same goal here, that is, a high quality, safe and functional organ donation and transplantation system which is of the highest international standard. With the highest respect to all Members of this House, no one who believes in the regime - a high-quality, safe and functional organ donation and transplantation system which is of the highest possible international standard - could in all seriousness support a motion to annul these regulations. I simply cannot see how a serious parliamentarian, acting in good faith, could possibly do that. I appeal to the Opposition. It may be unhappy in general, as some are, with the progress of the policy in respect of the opt-in or opt-out and all of that debate that we need to have, the question of resources, and the question of co-ordinators in hospitals, which Senator Power and others raised. One is entitled to be unhappy and frustrated. Senator Quinn made the point that things happen so slowly, and I understand that. I am inside and often I share the frustration. One should pursue that in here, but to turn around and annul these regulations which set a solid basis for safety on all the issues that we have gone through would fly in the face of our shared objective, which is to advance and improve a system and to ensure we have a proper system in place. I profoundly disagree with Senator Crown and others who say the thing to do is to annul these regulations. It seems to me that would be a genuine setback, not a step forward. I would say to Senator Ó Murchú, who asked why one would not annul, that there is no basis for annulling these regulations. I ask Members who have concerns about the broader policy question to use the opportunity that will undoubtedly be afforded here and elsewhere, whether in the Seanad or publicly, to pursue their genuine concerns but not to turn around and throw out the directive, which, by the way, Senator Daly says is disastrous but with which Senator Darragh O'Brien states he has no difficulty. As Senator Darragh O'Brien stated this morning on the radio, it is not what is in the regulations, it is what is not in them.