merrion street

I am pleased to have the opportunity to address Seanad Éireann today (20th August 2013) to endorse Statutory Instrument No. 325 of 2012 - European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012 as a comprehensive transposition of EU Directive 2010/53, which sets out a clear legal framework for the quality and safety standards for organs intended for transplantation in Ireland.

The requirement for an EU Directive arose from the increased demand for organ donation and transplantation across the EU. Each Member State developed systems to meet this demand. These systems generally reflected the cultural values of Member States and were developed in accordance with the legal, administrative and organisational frameworks of each Member State.

Given the importance of having in place appropriate systems for the authorisation of organ procurement and transplantation centres, an EU Directive was drafted based on common quality and safety criteria. The aim was to ensure the safety and quality of organs, as well as the protection of organ donors and recipients throughout the EU, and also to allow for the safe exchange of organs between Member States.

The draft text of the EU Directive was examined by the Joint Oireachtas Committee on European Scrutiny on 27 January 2009. The Directive was subsequently finalised and published at EU level in mid- 2010.

Following considerable discussion with key stakeholders, my colleague Dr James Reilly T.D. Minister for Health, transposed the Directive into Irish law by means of the European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012 (S.I. No 325 of 2012) which were signed on 27 August 2012. These Regulations were laid before both Houses of the Oireachtas, providing an opportunity within the ensuing 21 sitting days for the Houses to approve or to annul the Regulations. This period expired on the 14th of November 2012 and no objections were raised.

As previously stated, the European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012 set out a clear legal framework for the quality and safety standards for organs intended for transplantation.

The Regulations provide for

• the establishment of a framework for quality and safety to cover the entire chain from donation to transplantation or disposal;

• the authorisation of procurement and transplantation centres and activities;

• the establishment of traceability systems;

• the management and reporting of serious adverse events and reactions;

• requirements for the safe transportation of organs; and

• the characterisation of every donor and organ.

I think we will all agree on the necessity of ensuring that every link in the chain from donation to transplantation observes the highest possible standards of quality and safety. In relation to organ donation and transplantation this involves ensuring that those who donate organs and those who receive organs can be fully confident that the system meets the very best standards of international practice.

So why would the Seanad support a motion to annul a Statutory Instrument:

• that enshrines in Irish law a system for quality and safety for organs for transplantation;

• that establishes an inspectorate function whereby an independent agency is tasked with ensuring that our procurement and transplantation centres meet quality and safety standards;

• that provides for sanctions if safety standards are not met;

• that provides that it is an offence to traffic human organs; and

• that ensures that we can continue to exchange organs with the UK to our mutual benefit?

In any case Ireland is legally obliged to transpose the EU Directive into Irish law and we would face sanctions if we failed to do so.

I accept that the current infrastructure for organ donation and transplantation in Ireland can be improved. However, I firmly believe that this infrastructure must be built on a solid foundation of quality and safety. The Regulations facilitate this.

Every effort must continue to be made to increase organ donation rates and to enhance our transplantation system. The HSE’s National Organ Donation & Transplantation Office is playing a lead role in determining practices and organisational changes that will further improve donation rates in this country.

Ireland, working with its EU counterparts in line with the EU Action Plan on Organ Donation & Transplantation, will continue to develop strategies and practices aimed at optimising outcomes of the organ donation and transplantation system. These will include deployment of donor co-ordinators, increased living donation, and a change to the current consent system. The ultimate goal is to save lives and improve the quality of life of transplant recipients.

Donor Co-ordinators

The HSE is working to assign donor coordinators across the hospital system. This is an administrative process independent of the EU Directive, and it will certainly help to further improve organ donation rates in Ireland.

Competent Authorities

The Directive specifically provides that Member States may designate one or more competent authorities. In an Irish context, the Government believes that it is entirely appropriate to assign competent authority functions between the Irish Medicines Board and the Health Service Executive.

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 that 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, in order to ensure that 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 that standards for equipment and theatres are adhered to throughout the system.

The appointment of two competent authorities for the implementation of the Organs Directive is not unique to Ireland, and indeed similar arrangements apply in countries such as the UK, France and the Netherlands.

Human Tissue Bill/Consent for Organ Donation

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 of Health has recently initiated a public consultation process on the issue of consent to organ donation, and is inviting interested parties to submit their views on the practical aspects of introducing an opt-out system. The closing date for receipt of submissions is September 20th and I would encourage all interested parties to consult the Department’s website and to submit their views.

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. The objective we wish to attain is for organ donation to become the norm, and for the number of organs available for transplantation to be increased.

Organ Donation Rates

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 Ireland.

In 2012, 78 people donated their organs after death. In addition, 32 living people 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 have 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 & 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.

Conclusion

In conclusion, 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 2010/53, and set out a clear legal framework for the quality and safety standards for organs intended for transplantation in Ireland.

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, I believe, have the same goal here - a high quality, safe, and functional organ donation and transplantation system which is of the highest international standard.

I commend the European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012 and urge Members to reject the motion before the House.