European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012: Motion

Senator Darragh O'Brien

I move:

That Seanad Éireann resolves that Statutory Instrument No. 325 of 2012 - European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012 be annulled.

On 27 August 2012, the Minister for Health, Deputy Reilly, signed this EU directive into law without any consultation with the Seanad, the Joint Oireachtas Committee on Health and Children or the Dáil. Over the past two years, many members of Government and Opposition parties and those of none in this House have rightly called for a greater degree of scrutiny of EU directives and statutory instruments. Unfortunately, that has not happened and we have not had the degree of scrutiny of EU directives, in particular this one, which is required before legislation becomes law. I commend my colleague, Senator Mark Daly, on arranging this sitting.

This is not necessarily about what is in this directive but about what the Government is choosing not to do with it, and I will outline those points shortly. Most of our citizens would expect that Oireachtas Members would not simply pass legislation on the nod. That applies not only to this Government but to successive Governments which have failed miserably to scrutinise EU directives before they become law. The issue over the past two to three weeks has been whether people believe it is necessary for us to have a proper public discussion on organ donation and transplantation and the structures under which the State and the health service operate. Interest groups, including the Irish Donor Network and the Irish Kidney Association, have welcomed the fact a proper focus has been brought to bear on this whole area of organ transplantation.

The statutory instrument itself, dated 7 July 2010, is on standards of quality and safety of human organs intended for transplant. We are in agreement with most of what is in it. This is not specifically about the area of consent, opt-ins or opt-outs. A glaring omission from this legislation and the reason we want to have a constructive debate today is the creation of a national transplant authority. I ask Members to read paragraph 24 of the directive carefully. It states: "As emphasised by the Recommendation Rec(2006)15 of the Committee of Ministers of the Council of Europe to Member States on the background, functions and responsibilities of a National Transplant Organisation (NTO), it is preferable to have a single non-profit making body which is officially recognised with overall responsibility for donation, allocation, traceability and accountability." The Government does not propose to do that.

What we have currently is an organ donation and transplant office. How well resourced is this office? The organ donation and transplant office in the Republic of Ireland has one full-time staff member, Dr. Jim Egan, and one sixth of a principal officer.

Whatever regulations one wants to bring in to implement what this directive states, that is not being resourced and the creation of a national transplant authority has not happened. There is no organised, dedicated specific transplant co-ordinator in each of our main hospitals. The structure is not in place. That is the reason this debate today affords an opportunity for the Minister and the Minister of State at the Department of Health to answer the questions. The Minister for Health, Deputy Reilly had signed the directive into law without any further debate, the draft of the directive he signed was not circulated to anyone, be it the Oireachtas Committee on Health and Children, the Dáil, the Seanad or the interested groups, be it the Irish Donor Network and others prior to him signing this directive. Let me remind people that we called for a recall of the Seanad last year to deal with this specific issue - well in advance of the proposed referendum on the abolition of the Seanad. This is not about that referendum. We tabled an amendment to the Order of Business which was defeated 27:18 to have this discussed. Time is running out because within the course of the next two weeks, this becomes law.

I wish to put a number of questions to the Minister of State directly. The EU organ transplant expert, Dr. Rafael Matesanz who has advised on best practice has been exceptionally critical of how governments are dealing with this directive and the fact that they are not creating a single body with responsibility for the area of organ donation. My colleagues will give examples of best practice in Europe. I put it to the Minister of State, Deputy White and to the Minister for Health and his officials that what is being proposed is simply a box ticking exercise. It would have been worse than that, if the Seanad had not been recalled to debate it. In the past two weeks, we have seen the Government now talking about fully funding and staffing the organ donation and transplant office. I welcome that. We cannot have an organ donation and transplant office that has one doctor and the equivalent of one sixth of a staff member. Let me put it to my colleagues that if this debate had not happened here today and if the topic of this debate had not received the coverage in the previous two weeks we would not have seen Government move to fully resource this office. I ask the Minister of State, Deputy White, to state how many staff members he intends to allocate to the national organ donation and transplant office and when the staff will be in place? Second, other legislation coming down the track, such as the human tissue Bill, was listed on the Government schedule, but no date had been given for it. Now because of this debate today in advance of Government preparations to respond to the recall of the Seanad, the Government is talking about dealing with the human tissue Bill in the next session. That is very welcome. Surely the role of Senators is to scrutinise legislation and to hold Government to account on important issues such as this and to propose improvements and options to what has been proposed by Government, instead of simply allowing an EU directive to be transposed into national law without discussion or debate. Let me repeat that has been a failing of successive governments and not just this Government. A Government that talks about reforming the way we do business should take into account that more than 90% of our laws are driven by both directives and statutory instruments signed by Ministers that have not been debated in the Oireachtas. That is not something we can countenance, especially on this issue. I wish to put the following questions directly to the Minister of State, Deputy White. Why did the Government not publish the draft directive prior to the Minister for Health, Deputy Reilly signing it? Why was it not circulated to interested parties and other stakeholders? Why has the Government decided to set aside paragraph 24 of that directive by not creating a national transplant organisation with responsibility for transplant and organ donation? That is what has happened in countries with best practice such as Spain, which has been the most successful in achieving organ donation rates, and Croatia.

I would also like to ask the Minister of State about the announcement made in advance of this debate to the effect that the Government is now seeking to staff the organ donation and transplant office. How many members of staff does the Government propose to put into that office? How soon will it be set up? When will it have the necessary resources to deal with people on transplant waiting lists and to co-ordinate transplants? Why has the Government not deemed it necessary to identify and appoint specific transplant co-ordinators in each of our major hospitals?

Many aspects of this directive are positive. One could disagree with very little of it. Like my colleagues, who will outline their concerns later in this debate, I disagree with the Government's decision to set aside the most important point in all of this without any consultation. I will conclude by putting this point directly to the Leader of the House. Over the last two and a half years, with his agreement and the agreement of most Senators, this House has sought to be given the ability to play a part in the scrutiny of EU directives. We have not been given the resources to do that, however. I ask for a commitment from the Leader to set aside specific time for debates on directives like this one, in advance of their being signed into Irish law, so that it will not be necessary to recall the Seanad from future recesses.

Senator Feargal Quinn

I second the motion. I am always puzzled that it takes so long to get anything done in the State bodies. I come from a business background where things seem to happen much more quickly. I am just stunned. The debate on the Human Body Organs and Human Tissue Bill 2008, which I introduced, was adjourned in October 2008 because the Minister of the day wanted to consult more widely on the matter. Admittedly, the Bill related to the opt-out issue and the question of presumed consent, which we are not debating today. It seemed to me at that stage that the Minister would come back to us very shortly after the consultation had taken place. Nothing has happened since October 2008, which was almost five years ago. I appreciate that the legislation in question related to presumed consent to facilitate organ transplantation, which is not what we are talking about in this case. It seems that many things need to take place if we are to achieve what needs to be achieved. There does not appear to be any sense of urgency at State level in this regard.

We saw the figures that were published during the week comparing the numbers of organ transplants that take place in Ireland and in other countries. They showed the very low standard we have in this country. We have not managed to make the first moves towards achieving what we need to achieve. I welcome the debate here today. I am delighted that Senator Daly has encouraged us to get involved in this matter. It seems to me that we need to get it higher on the agenda. The current system does not work too easily because of the delay in getting it off the ground. When I studied this matter in 2008 - as I have said, it was almost five years ago - my belief was that we should introduce a system of presumed consent. I have learned from the great work the Irish Kidney Association has been doing that this aspect of the matter is peripheral, to a certain extent, in the absence of co-ordinators and a single central body for organ donation and transplant. I think Dr. Jim Egan is the only person who has been there up to now. I am delighted to know that something is to happen. If we do not move on these things now, nothing will happen. This debate will be welcomed by those who are waiting for an organ donation.

I introduced the 2008 Bill because three people associated with one of the shops I was involved in at the time were waiting for transplants. Two of them got transplants in time. The third person - the son of one of our employees - got his transplant too late, however.

On Good Friday he had his transplant and he was awake and was able to watch the races in Fairyhouse on Easter Monday. He had a setback on the Wednesday and died on the Friday. It seems he had been waiting far too long for his transplant. We have many people waiting and waiting for transplants while most countries in Europe have a better and higher standard than we have.

I urge the Minister of State to use today's debate to good effect. We have not debated this issue. The Minister signed the European Union document last year, but we did not get the chance to debate it. I welcome the debate today, even if all it means is that we now move at a faster pace to ensure a single body for organ donation and transport comes into being and that we find we can establish co-ordinators in the various hospitals. On that basis, we will save the lives of many people who are waiting for transplants. Today's debate is an opportunity to do something about the situation. I look forward to hearing what the Minister of State will say and hope he will say that he recognises the need for something to be done and that the Government will do it. I urge him to do that today.

Senator Maurice Cummins

The Government opposes the motion before us today, that the European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012, SI 325/2012, transposed EU Directive 2010/53, which came into effect on 27 August 2012, be annulled.

Since last September, Senator Daly and the Fianna Fáil group in the House have had eight opportunities, during Private Members' business to raise this matter in the House and no less than 110 sitting days to submit a request for an Adjournment debate on the matter. These opportunities were not availed of by them. I believe it is a political stunt to call the House at this time to discuss this statutory instrument. We all want to see more organ donations, more organ donors and to see the issue highlighted, but the issue of opting in or opting out of donation is not the matter we are discussing today. However, I am sure we will have a debate on organ donations and that many people will use this time to discuss organ donations.

The motion before us deals specifically with the EU directive and that is the issue I will speak about here. In signing the regulations, the Minister for Health signed Ireland up to a clear legal framework for quality and safety standards for organs intended for transplantation. The aim is to ensure the safety and quality of organs and the protection of organ donors and recipients. The regulations provide for the authorisation of procurement and transplantation centres and activities, for traceability systems and for the reporting of serious adverse events and reactions. Moreover, they set requirements for the safe transportation of organs and for the characterisation of every donor and organ.

The Irish Medicines Board is the competent authority under the regulations for the authorisation of procurement and transplantation centres, in accordance with the requirements of the regulations. The HSE is the competent authority for the quality and safety aspects of the regulations, including the development of a framework for quality and safety in relevant hospitals to ensure the standards of quality and safety set down in the regulations are met. Under the regulations, every hospital or health care facility in which any activity relating to a donation, testing, characterisation, procurement, preservation, transport or transplantation of organs takes place must be authorised by the Irish Medicines Board.

Following the granting of an authorisation the hospital or health care facility in question will be inspected by the Irish Medicines Board at regular intervals to ensure compliance with the requirements of the regulations. The Irish Medicines Board has an excellent reputation and considerable experience in the context of authorising blood and tissue establishments as set out in other EU directives and it was deemed appropriate to expand its remit to include organs as another area of its responsibility. Oversight of certain aspects of hospitals, for example, standards of equipment and theatres, rests with the HSE in consultation with the Irish Medicines Board.

I hope other speakers will stick to speaking about the actual directive and the regulations. I do not propose to accept the motion as proposed this morning.

Senator Jillian van Turnhout

I welcome the Minister of State. Today we are being asked to annul SI 325 of 2012 which gives effect to the European Union directive on standards of quality and safety of human organs intended for transplantation. We all know that Ireland was legally obliged to legislate under EU law to ensure a common set of standards throughout the European Union and that is something we can all agree on.

I signed the motion for recall last year but I did not sign it this year. I signed the motion last year because a statutory instrument was being brought in without consultation or debate. However, since last year I have participated into two Oireachtas debates on organ donation as a member of the Joint Oireachtas Committee on Health and Children. We have had two hearings in preparation for the forthcoming legislation, the human tissue Bill, and we will be continuing our work in this area in the autumn. On 18 April we heard personal experiences relating to organ donations and we heard from advocacy groups representing those affected by organ donations. On 25 April we heard from medical professionals working at the coal-face of organ donation and from representatives of hospitals throughout the country as well as from the legal community. I would have thought that was the ideal opportunity for Senator Daly to raise the issues, or, in his words, flaws, that bring us here today. At the hearing on 18 April I raised the issue of the absence of primary legislation in Ireland and I noted that we only had the statutory instrument to introduce the European directive requirements. Anyway, I have argued inside and outside the Chamber that too often Ireland gold-plates EU directives when we should be dealing with issues in primary legislation instead.

The EU directive deals with standards of quality and safety of human organs intended for transplantation. There is nothing in the EU directive to preclude Ireland from dealing with the issues raised in the lead-up to today and the other issues which have not yet been aired when we deal with the human tissue Bill. I have listened with interest to debate on this issue in the lead-up to today's discussion and I believe we are conflating and confusing the issues. One can almost feel the stampede to the high moral ground on this issue, but the reality is that everyone in the Chamber is keen to improve our resourcing and the operational issues in respect of organ donation.

I was struck by the submission we received from the Irish Donor Network in advance of the debate. The submission of the network concluded by stating that people are dying on the waiting lists for transplantation in Ireland, but not because of the EU directive or its transposition into Irish law. The network further stated that to confuse the issue of EU regulation versus the issue of necessary infrastructure and national policy to improve transplant rates is to confuse the debate. Surely the human tissue Bill is the appropriate place for us to deal with the consent arrangements for transplantation and research? We need to deal with the establishment of a single body responsible for co-ordinating the drive to increase transplantation in the country, put in place organ donation co-ordinators in every hospital and ensure we put in place an effective awareness-raising campaign. These are some of the priorities I would set down.

The proposal today is to annul the statutory instrument without anything tabled as an alternative at this juncture. Is the legacy of today's recall to amount to the Seanad leaving a legal vacuum with respect to the quality and safety of the donor and recipient processes which the statutory instrument provides for? The elements purported by Senator Daly to render the statutory instrument flawed - a premise I do not support - should have been raised during the committee hearings on organ donation in April and can be dealt with in the development of the human tissue Bill.

Members might not be aware that a meeting of the Joint Oireachtas Committee on Health and Children is scheduled for 19 September to consider submissions on the introduction of an opt-out system of consent for organ donations. That will provide an opportunity to discuss the issue in detail.

I signed the motion for recall last year but not on this occasion. I have clearly outlined my reasons for taking that position. It is almost as if Senator Daly is trying to invoke the memory of Bobby Ewing stepping out of the shower and forgetting the past year had happened.

Senator John Gilroy

My good friend and colleague Senator Darragh O'Brien argued that the recall of the Seanad has focused attention on this important issue and is facilitating proper debate. If that proves to be the case it is very welcome. I am very happy to be here today but also somewhat puzzled as to what precisely we are discussing. My main concern regarding this emergency recall is that it might create an impression among the general public that there is something wrong with our system of organ donations. We must ensure that message does not go out from today's debate. The Leader indicated that Fianna Fáil Members had eight Private Members' debate slots, 360 Adjournment debate slots, 120 Order of Business slots and 40 health committee slots in which to raise this issue. Their own spokesperson in the other House called on the Minister last April to implement the measure. Yet we are here today discussing it as an emergency issue. There does not seem to be a great deal of logic in that.

There are essentially three strands to the process of organ donations in this State. The first is the EU directive which is about governance and the quality and safety of organs for transplantation. Second is the infrastructure that is necessary to support that process, including transplant co-ordinators in hospitals and so on. Strand three is about increasing the rates of donation. Why on earth are we here today seeking to annul the first strand before we even get on to the second? It does not make any sense. Ensuring the safety, quality and governance of organ donation and transplantation is surely the first and most important step. There is no logic in seeking to annul this regulatory provision.

According to my count, Senator Mark Daly has, in the past ten days, referred to the provision as flawed more than 70 times. I have asked him on four occasions in that period to point out the precise nature of that flaw. In response, he sent me one general press release which referred to the regulation as weak but failed to point out which particular section is flawed. This leads me to wonder whether something else is afoot here. The Irish Kidney Association has also described the regulation as weak. If that is the case, surely we should be seeking to strengthen rather than annul it? As Senator Jillian van Turnhout observed, if an alternative proposal had been brought forward it would give more credibility to what we are doing today. Senators opposite are simply proposing to annul it, and annul it unlawfully if one takes heed of the voice of the Attorney General. We might attribute the lack of an alternative proposal to the constraints of time, but that is hardly credible. We might accredit it to a lack of ability if not for the fact that Senator Darragh O'Brien's undoubted ability negates that argument. Perhaps the answer is to do with a lack of willingness on the part of the Opposition to engage meaningfully on this issue.

I reiterate my concern that recalling the Seanad in emergency session could well give rise to the impression that there is something wrong with the system of organ donations in this State. That is a dangerous impression which could further deter donations. It is an irresponsible stance which does a great disservice to the many excellent people and organisations working in this area. If we wish to be constructive - I intend to make a proposal in this regard in due course - we should establish an inter-party committee of the House which would engage, in the normal, deliberative course of Oireachtas business, with all stakeholders, including organisations and service users. We should be striving to do something constructive about this instead of posturing here in the middle of August.

I thank the Cathaoirleach for allowing the debate to proceed. I examined some of the legal aspects and saw there were grounds on which the motion might well have been ruled out of order.

It is a credit to the Cathaoirleach's generosity, and the generosity of the Government, that the debate was allowed to proceed.

Senator Terry Leyden

I thank the Cathaoirleach for agreeing to recall the Seanad during the summer recess. It is not the first time the Oireachtas has been recalled. I was a Minister when we were recalled to debate emergency legislation on the Goodman organisation and saving jobs. There is precedent, therefore, for recalling Parliament during the summer recess.

Senator Mark Daly has done the State a great service by highlighting this issue because the Government has woken up to the reality of what is involved in the area of organ donations. The fact is that we can save lives as a result of recalling the Seanad and highlighting the issue. The Irish Kidney Association has done tremendous work over the years to ensure the number of organ donations increases and that more people are aware of the situation. That alone more than justifies this House being recalled today.

I take issue with the learned Attorney General in this case, as she is the law officer for the Government-----

An Cathaoirleach

The Attorney General is independent of these Houses.

Senator Terry Leyden

Is she? Who appoints her? I have yet to come across an independent Attorney General, and I am here a while. If the Cathaoirleach goes through the list he will find the number of Attorneys General who were recommended by the Labour Party and appointed by the Government. Let us call a spade a spade.

It is unprecedented for the Attorney General's advice to be sent out. This is a separate House of the Oireachtas with powers of its own separate from the Dáil, and it certainly takes precedence over any sub-committee or joint committee of this House. We should be quite clear about that. I would appreciate it if our learned journalists would look into this matter further because they will find that the advice given is flawed. It is politically biased in favour of the Minister of State's Department, and the Minister is a senior counsel.

An Cathaoirleach

That is completely out of order and is not relevant.

Senator Terry Leyden

In the lead-up to the Minister, Deputy Reilly, signing the law, he had no draft of his own version of the transposition to show the national organ donors group for debate. At a briefing held in April 2012 in Dublin Castle, no draft was available for the group to review. In May 2012, the Irish Donor Network asked the Minister to present his draft legislation to it for review before signing it into law. The Irish Kidney Association asked the Minister to forward it a draft. Senator Mark Daly wrote to the Minister in July 2012 asking for a draft proposal for Irish law to be sent out for review and consultation. No draft was available.

No one saw a draft before it was signed into law. In August 2012, before the law was signed, the Irish Kidney Association wrote to the Minister encouraging the model of one competent authority, which has been adopted by other countries in the European Union with success, to be the main infrastructure in Ireland as well as part of the Minister's drafting. I hope the Minister of State, Deputy Alex White, will announce that there will be one group established within that framework and which was included in the recommendations.

There were 164 directives signed into law in the past year without any debate. These were statutory instruments signed by Ministers. This was never envisaged in the 1972 Act. This House is the one that should be scrutinising legislation. One message that should come from this House today is that it is ready, willing and able to carry out the responsibilities under the Lisbon treaty and it alone deserves to be in that position. The Government should respond to that. The Leader of the House himself has said this on numerous occasions, as has the former Minister of State, Deputy Creighton.

Senator Colm Burke

The motion before us here today is that Statutory Instrument No. 325 of 2012 be annulled. No new written alternative to replace this detailed statutory instrument has been put forward by the proposers or by any other third party.

In opening my speech in this debate, it would be appropriate to quote Ms Phyllis Cunningham, who for the past 26 years has been deeply involved in all aspects of organ donation and transplantation. She is a senior transplant co-ordinator and manages the national organ procurement service. The following is an extract from her presentation to the Joint Committee on Health and Children on 18 April 2013. She read from a letter from a 16 year old recipient of an organ transplant. The letter stated:

I know this time of year is very hard for you but I hope it helps to know that I think of you every day and how grateful I am for the wonderful gift you gave me. Everything I do, everything I achieve, I do it for you. Most especially, I bring your loved one with me and I will try never to let you down. Once again, thank you for changing my life, from a kidney recipient.

The family wrote back: "Our lives will never be the same because of the loss of our loved one but your letter is beautiful remembrance. Take care and best wishes for the future."

It is important, therefore, that we maintain a positive and sensitive approach in dealing with this issue. In this debate, we need to look at where we were, where we are and where we need to be in ten years time in terms of the issue of organ transplant. I will go through some figures.

In 2003, there were 187 transplants in Ireland. In 2010, there were 174. There were on average 214 organ transplants per annum over that seven year period. There was no real progress in increasing the level of organ transplants during those seven years. In 2011, there were 275 organ transplants and in 2012, there were 239. In that two year period, the average was 257 organ transplants per annum.

In 2000, there were 150 persons waiting for kidney transplants. By 2010, this figure had exceeded 650, which is a 333% increase in real terms over that ten years. By comparison, Norway, which has a population of 4.8 million, is doing between 270 and 300 kidney transplants per year, while, in Ireland, we are doing on average 150 kidney transplants per annum. As of 31 December 2012, there were 1,820 persons on dialysis at a cost of more than €118 million per annum. At present, in Norway, there are 370 persons on dialysis.

In 2011, the ESRI noted - its reference given as Activity in Acute Public Hospitals, Annual Report 2010, the last year that Senator Daly's party was in government - that the single highest-ranked procedure for day patient attendances at acute public hospitals was dialysis and that accounted for one fifth of all day care attendances. In 2012, 250,000 dialysis procedures were delivered in Ireland. At present, there are 100 kidney donor recipient pairs awaiting living kidney donation in Ireland.

In 2010, 2011 and 2012, the number of living donors was respectively 23, 27 and 32. Accordingly, it would take three years to deal with the current 100 living donor recipient pairs. The Department of Health and the Health Service Executive, HSE, have committed funding to deliver the first phase of a significant expansion in live kidney donation and have agreed in principle to fund the plan which it is hoped will deliver 100 living kidney donation operations annually over the next three years. The employment of 30 new staff has been sanctioned by the HSE and the Department to facilitate this.

For each kidney transplant, in addition to giving the recipient the opportunity to live a normal life, there is a saving of €750,000 to the taxpayer during the recipient's lifetime. It is clear we have much catching up to do.

Article 14 of the 2010 directive deals with the issue of consent. Article 17 sets out clearly:

Member states shall designate one or more competent authorities.

Member states may delegate, or may allow a competent authority to delegate, part or all of the tasks assigned to it under this directive to another body which is deemed suitable under national provisions. Such a body may also assist the competent authority in carrying out its functions.

The suggestion that a single statutory authority needs to be established to deal with this matter is incorrect. If we accept the motion and annul SI 325 of 2012, we are taking ten steps backwards. It would mean Ireland would be the only member state which would not have coherence and a detailed structure relating to donation, testing, characterisation, procurement, preservation, transport and transplantation of organs. I am, therefore, opposing this motion.

Senator Katherine Zappone

I thank the Minister of State for attending for this important debate. It is a proper gathering and we are taking our responsibilities as lawmakers seriously. I acknowledge Senator Daly’s initiative in this regard. Important points have been raised in this debate. This issue should have been raised during Government business which is why I signed the letter to recall the Seanad both times.

There was no scrutiny of SI 325 of 2012. As the Minister of State pointed out, the draft EU directive was placed before the European scrutiny committee in 2009. However, there was no discussion on it and the committee decided it did not warrant further scrutiny and, instead, should be forwarded for information purposes to the Joint Committee on Health and Children. It was not placed before any committee in 2012 before it was signed.

There are three actions required to annul a statutory instrument. Although I disagree with Senator Leyden's point on the objectivity of the Attorney General, I accept her advice that the statutory instrument cannot be annulled unless there is a recommendation from an Oireachtas committee and it is agreed by the Dáil and the Seanad. However, the European Communities (Amendment) Act 1973 does not lay down a sequence to this. Accordingly, the Seanad can argue for an annulment without needing the recommendation of a committee. The bottom line is we could not have the recommendation for the annulment of the statutory instrument because it was not reviewed by a committee.

The statutory instrument is a very big document. The Government thinks it sufficient that the directive, which is a smaller document, was barely looked at by one committee and thinks that the big document needs no scrutiny. We do not have a recommendation because it was not looked at by the committee so at the very least, it is important that it is being debated by one House.

The Government promises that with the abolition of the Seanad, we will have a committee that will scrutinise EU legislation and directives and statutory instruments coming from the EU. However, it is not even doing that now. I do not understand why it could not have acquired the required signatures for the Dáil if there was commitment to the importance of reviewing EU legislation. In respect of the substance of the issue, the context and the question of whether we and many other Senators referred to this, there is a different interpretation of the context from the Oireachtas Library and Research Service, which I respect highly. We received a document referring to the organ donation rate put out by Beaumont Hospital which states that we have one of the best rates in the world. Yet the article in The Sunday Business Post by Susan Mitchell states that we were one of the lowest ranking member states in the EU in terms of our organ transplant league. There are two very different messages going out. Perhaps we are doing pretty well in the context of developing countries and other countries but in terms of Europe, we are not doing that well.

There are two issues in terms of the wider debate that relate to whether we should have one or two competent authorities and the importance of having organ donor co-ordinators in hospitals. I find it very difficult to accept that no rationale was given by the Department and Government as to why we should have two competent authorities. I do not see why inspection and monitoring cannot be done by the same authority. It is done that way in other countries. The directive does not mandate a separate body for investigation, reporting and reporting of adverse effects, so legally it can be within one body. Dr. Rafael Matesanz, the expert referred to by Senator Darragh O'Brien, said that European countries with the best donation rates have one competent authority in place. I have not seen any evidence or demonstration that the best practice would be to have two competent authorities. As Senator Darragh O'Brien outlined, there is an inequality of resources between those two authorities that makes it very tough to move forward in terms of putting in place a proper infrastructure for increasing our organ donation rates.

Senator Aideen Hayden

In respect of some of the arguments made by Senators Darragh O'Brien and Leyden that what we are really discussing today is whether the Seanad should scrutinise European legislation, I remind them that the motion before us is that Seanad Éireann resolves that Statutory Instrument No. 325 of 2012 (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012 be annulled. Very good arguments have been put forward by Senators Gilroy and Colm Burke as to why this should not be so. I remind the House that the argument is not about the scrutiny of EU legislation and that Members of the House who sat through the debate in this House on the abolition of Seanad Éireann heard very many good arguments as to why the Seanad should scrutinise EU legislation. Senator Cummins is to be congratulated on bringing MEPs into this House on many occasions this year. There has been very robust discourse with those MEPs on EU matters. It is important that we start talking about what we are here to discuss, which is the annulment of the statutory instrument before us and not the scrutinising of EU legislation.

It is important to remember, as has been pointed out, that there are very good reasons we should not do this. The statutory instrument before us puts in place a framework for the authorisation and procurement of transplantation centres, traceability systems, a framework whereby organs may be shared with the UK and other EU countries, including the quality and safety requirements for such a transfer, a reporting system in the case of adverse events and a requirement for due diligence, and consent requirement for donations. The directive deals with consent requirements and these regulations are required by EU law, but they do not introduce an opt-out system. The programme for Government is committed to reviewing an opt-out system but it is not a consideration before us in today's debate.

I have listened to Senator Daly in the media a number of times in the last week, speaking about the creation of a new co-ordinating body. I strongly argue that we have good systems in place and that the Irish Medicines Board has capably presided over all organ donations in Ireland since 2005. In that time there have been 1,835 successful transplants. Like Senator Gilroy, I would not like to see any unintended consequences arising as a result of this debate that would reduce confidence in the Irish organ donation system.

All organ donations are co-ordinated by the organ procurement office at Beaumont Hospital, and have been since 1986. It contacts transplant centres and finds match recipients. The co-ordinator travels with the transplant teams and meets the donor family to answer questions, ensure the family consents to the donation and assess whether the organs are suitable to be transplanted. Therefore there is already a centralised authority to authorise organ donations. It would be a mistake to try to undo a system which is tried and tested and where participants are experienced in the field, and attempt to come up with a new body. At best this would cost a significant amount of money to do a job that is already being done, and at worst it might undo some of the good work that is already in place. Errors can occur when starting from scratch. The Minister has stated he is willing to review the current system if there is an anticipated increase in organ donations when we move potentially to an opt-out system.

This EU directive was introduced to bring clarity to the law surrounding organ donations and particularly to facilitate transfer of organs between EU countries, allowing organs to go where they are needed. Bureaucracy should not and must not be a barrier to saving lives. However, this directive creates a good foundation for organ transplant systems and can be built on later in an Irish context, as the Minister has said. There will be planned improvements in the system. I understand that there are important discussions to be had in the future, particularly surrounding consent. In other jurisdictions the issue of the opt-out of organ donations has been a very traumatic debate, most recently in Wales. I am looking forward to that debate in the Irish context. As things stand, there is no good reason to annul this instrument. The Opposition has made no good argument giving any good reason it should be annulled. We are in danger of throwing out the baby with the bathwater. Worse, given the current debate on the abolition of the Seanad, we are in danger of looking like we are throwing the toys out of the pram. I ask the Opposition to take that into account and withdraw this motion.

Senator Sean D. Barrett

I thank the Cathaoirleach for scheduling this debate and the Leader for facilitating it. We should be here. In one of the Government's strongest constituencies, Cork South-West, where there are two Fine Gael Deputies and one Labour Deputy out of three seats, the Southern Star last Saturday reported that 66% of people, the majority of whom support the Government, said the Seanad should be recalled to discuss organ donation. That is the only opinion poll of which I am aware. It is important we do so and that the House is so splendidly attended.

This is an important matter. As Senator Colm Burke pointed out, there is a three year backlog and it is estimated that 685 people are on the waiting list for organ transplants. It costs €118,000 per year for dialysis while people are on the waiting list. Our rate of donation is too low and we would save substantially if we were able to increase it. The debate the motion has promoted in the media has been most valuable and I welcome the Minister of State to the House. It is an issue on which doctors differ. Page 10 of the note prepared for us by the Library and Research Service states the TCD-HSE specialist training programme in general practice supports opt out while the UCD school of medicine and medical science opposes it. That is another reason we should debate this issue. There are genuine differences of opinion on how we achieve the common goal of a higher rate of organ donation supported by the public.

We have had a consultation on the human tissue Bill dating back to 2009. It is a fault in the system that it will only be completed on 27 September. There has not been a note of urgency about this matter.

Article 4 of the statutory instrument addresses the division of the agencies. It would take many lawyers to figure out what the Government intended. I have been a critic of the statutory instrument procedure in the context of other Departments as well. We should debate statutory instruments fully. As Senator Zappone said, this statutory investment amounts to 14,000 words. It used to be the case that legislation was implemented having been fully discussed by other Houses. Article 4 states:

The IMB shall perform-

(a) the functions of the State under Articles 5(2) and 9(4) of the Directive, and

(b) the functions of the competent authority under Articles 9(2), 11(2) and (3) and 17(2)(b) and (c) of the Directive.

(2) The HSE shall perform—

(a) the functions of the State under Articles 4, 6(2), 7(5) and (6), 10, 11(1), 15(3) and (4), 18(1) and (2) and 20 of the Directive, and

(b) the functions of the competent authority under Articles 17(2)(a), (d) and (g) and 21 of the Directive.

(3) The IMB and the HSE shall jointly perform—

(a) the functions of the State under Articles 11(4), 11(5), 16 and 22(1) of the Directive.

One would have to have a full discussion in Parliament to see what we are doing and not have it signed in August when neither House was sitting

The UK task force made a series of recommendations with the establishment of a UK-wide organ donation organisation. That has been much more successful than our two-organisation model. The division of our organisations is a bureaucratic nightmare. There are differences of opinion on whether people should opt in or out and they should have been discussed.

I have read articles from Turkey and from the JFK school of government that favour compulsion and from the UK and the US that oppose presuming consent. The UK review body started out with a presumption in favour of compulsion and its members gradually changed their minds because of the effect it would have on donors and the distress caused to relatives when harvesting - a word I dislike intensely - of organs takes place. We need to discuss this issue. It has been of value to the House to do so and it is what public opinion wants us to do.

The success of the frequently cited Spanish example is also felt to be not just due to compulsion but to the way they are organised better. Coming from this discussion in this most important House of the Oireachtas should be how we promote on a voluntary basis a much greater rate of organ donation than we have. That would solve the expenses Senator Colm Burke has mentioned and the ill health with which the Minister and his colleagues are trying to cope. We have not faced up to that. The human tissue Bill has been in gestation and consultation since 2009 and still has not appeared. Both Houses of the Oireachtas have been remiss in discharging their duties towards sick people who ask us to assist them in this vital matter.

Senator Cáit Keane

I welcome the people in the Gallery who have come to listen to the debate. I, for one, do not mind being back here to debate this matter. If it raises awareness of organ donation in general it is a good thing because it does not get enough airplay in the media. If, following today's debate, even one extra person decides to donate an organ, it will be a good thing. However, I would have liked to see the debate held in that light so that we can highlight what we need, what is being done and how we do it.

We are here today to debate annulment of a statutory instrument, a point to which I shall stick. While this is also an important issue, what can the Seanad do about it? Under current constitutional legislation the Government signs EU directives via statutory instruments without consulting the Oireachtas. As far back as 1972 when we joined the EEC this, what we might term, undemocratic practice came into being. It may not have been given much attention at the time or since. It is a debate for which we in the Seanad have been calling. To give Senator Daly his due, implementing statutory instruments without discussion is a debate we need to have. I have asked, and many reports on the Seanad have recommended, that this be fully looked at and the Seanad is a place this could be done. However, we are not discussing reviewing statutory instruments in general today, but are discussing annulling one statutory instrument.

The statutory instrument is good, right, legal and proper, and it should be implemented. The Minister of State, Deputy White, has issued a press release stating that there is no reason for it to be annulled and I support that wholeheartedly. The directive provides a clear legal framework for organ donation and transplantation in the European Union. It provides authorisation for procurement and transplantation centres and for traceability systems as well as for the reporting of serious adverse events. Moreover, the directive sets requirements for the safe transportation of organs and for the characterisation of every donor and organ. There is absolutely nothing wrong with that. The motion before us seeks to withdraw a statutory instrument on the quality and safety of human organs intended for transplantation. That regulation is good - why on earth would one want to withdraw that? It is madness to seek to put it back by 20 if not 40 years.

The Minister of State, Deputy White, and the Minister, Deputy Reilly, are working on a human tissue Bill which is out for public consultation. I ask everyone to participate in that by the 20 September deadline the Minister has set - the Minister of State might correct me if I am wrong on that closing date. The public need to be made aware of this public consultation. I congratulate the Minister of State and the Minister on the work they have done since coming into office in advancing the human tissue Bill through the Oireachtas committee which Senator van Turnhout and others have mentioned. I wonder why this was not included at that time.

I commend the Irish Donor Network on the document it provided which has facilitated us in our debate today. I could not say it better than it was reported in yesterday's Irish Independent which stated:

Fianna Fáil's argument has been dramatically undermined by a lobby group saying the EU directive was a "progressive piece of legislation". And it dispels the myth that the legislation is about people having to opt out of the organ donation system.

The [Irish Donor Network] said there were major gaps and weaknesses in the country's organ donation and transplant infrastructure that remained to be addressed by the Government.

It is being addressed.

I reiterate that there are major gaps. The Government hopes to address these in, perhaps, the human tissue Bill. I ask that everybody engage with the committees in this regard. Nobody is denying that there are gaps. The Irish Donor Network has stated that the directive is about ensuring there is a common framework for quality and safety of human organs in Ireland, which framework is quite technical. We will need to ensure this is looked at.

The Seanad has powers that could have been, but were not, used to address this issue. Like Senators van Turnhout and Colm Burke, I would like to know the reason Senator Daly did not raise the matter during the health committee deliberations with the advocacy groups on 18 and 25 April.

Senator Trevor Ó Clochartaigh

Céad fáilte ar ais a chairde. Aontaím leis an méid adúirt an Seanadóir Keane. Seo díospóireacht iontach tábhachtach agus tá áthas orm a bheith anseo le labhairt thar cheann Shinn Féin ar an ábhar seo. Ná déanfaimid dearmad ar na daoine sa chomhthéacs seo. Ceapaim go bhfuil an t-ábhar seo iompaithe isteach ina cluiche peile polaitiúil de phointe áirithe, ach táimid ag caint faoi daoine daonna atá ag fanacht ar orgáin. Is ábhar iontach leochaileach é sin. Beidh siadsan ag faire ar an díospóireacht seo agus caithfimid a bheith cinnte go bhfuil muid ag déanamh ár gcuid ar a son.

Caithfimid an díospóireacht seo a thógáil i bpictúir níos leithne. Caithfimid breathnú ar an gcóras sláinte ina iomlán, mar níl aon mhaith dúinn a bheith ag cur reachtaíochta chun cinn anseo muna bhfuil na háiseanna agus na tacaíochtaí cuí á chur ar fáil tríd an gcóras sláinte agus tríd córas uilíoch sláinte do gach duine. Tá teipthe ag gach rialtas go dtí seo a leithéid sin a dhéanamh. Tá an t-infreastruchtúr easnamhach ó thaobh cúrsaí daonna, cúrsaí fisiciúla agus smaoineamh de.

There can be little doubt but that this debate and the issue of organ donation is one of major importance. That Senators have made an effort to be here today for this debate is evidence of this. I am delighted to be here for the debate.

At a fundamental level, organ donation is essentially a matter of life and death. Let us not today forget the people on the waiting lists and turn this into a political football. No donation is possible without the passing of a human life. More often than not, this tragic passing and resultant donation offers another person the chance of living a full and healthy life, free from ill-health and the probability of an early death.

Simply put, organ donation gives people a second chance at life.

As a matter of party policy, first adopted by the Sinn Féin Ard-Fheis in 2008, Sinn Féin supports the presumed consent or opt-out rather than the opt-in system of organ donation. This position reflects our concern about, and desire to rectify, the current deficiencies in the system. It is clear to all that in recent times demand for donations and transplants has far surpassed availability under the present system. In light of this, as legislators, there is an onus on us to deal with this issue as a matter of urgency in its entirety. Therefore, it is imperative that any discussion about, and solution to, this issue also addresses the much larger issue of health care provision in Ireland. I respectfully suggest that any initiative that abstracts organ donation and transplant from health care in general cannot be taken seriously. The best interests of the population as a whole requires that we do no less.

In terms of basic health care, Sinn Féin believes that everyone, irrespective of socio-economic background, should be entitled, as a basic right, to free and accessible medical care which is of the highest standard. Ireland's failure to provide an efficient and reliable universal health care system for all its people has been the result of deliberate policy decisions by successive Governments. Since the foundation of the State, both Fianna Fáil and Fine Gael have been supporters and advocates of the two tier health system. Thus, we have a health system in this country where money and status determine a person's ability to access urgent and timely medical treatment. In this market driven model of health care provision, the poor, the working class, the vulnerable and those unable to pay are literally at the mercy of an under-funded and badly managed public health system which is in disarray. As we know only too well, this system often extracts a huge price in terms of quality of life and early death from those who are unable to pay in monetary terms for their care. If ever the oft-noted quote that the poor pay more for everything were true, it certainly is the case when it comes to the provision of health care and life chances.

When we discuss the issue of organ donation and transplant, we must, if we are serious about it, acknowledge the severe deficit in the infrastructure for delivering transplants in terms of personnel, physical infrastructures and funding. These are serious issues which must be addressed if any new donor system is to be successful. For example, while research published in 2009 in the British Medical Journal showed that donation rates increase after the introduction of presumed consent system, respected international studies also clearly indicate that changing the donor system is not by any means a panacea. Moreover, the paper in the British Medical Journal also noted that availability of donors, organisation and infrastructure of transplant services, investment in health care and education and positive public awareness of organ donation all play an important role.

This was elaborated on in April of this year by Professor David Hickey, the country's leading transplant surgeon and director of the national kidney and pancreas programme when he addressed the Joint Oireachtas Committee on Health and Children. While acknowledging the importance of the opt-out option, Professor Hickey, none the less cautioned that it should be seen as only a part of a more comprehensive approach. Referring specifically to the opt-out option, Professor Hickey said it must be accepted that in the countries which have seen a significant increase in organ donation, and this increase has been attributed to the adoption of presumed consent, in reality, it has been the result of massive investment in both physical and personnel infrastructure.

It is clear that there is no quick fix to this issue and that organ donation in, and of, itself is not sufficient to address what is a complex and multi-layered issue. If we are to learn from best international practice on this issue, a holistic approach is imperative. In the long term, this has benefits for the State in terms of savings and efficiency. More important, a holistic approach offers real hope to people in need of transplants that maybe they too can live healthy and productive lives free from stress, ill-health and worry.

I welcome the guests in the Visitors Gallery and the members of the press who are here. This is a very important debate and I hope it is part of an ongoing debate on this issue. Mar atá luaite ag mo chomh-Sheanadóirí, seo ábhar iontach tábhachtach agus is cóir nach dtógfadh muid é mar liathróid pholaitiúil agus go ndéanfadh muid rud éigin fónta ar son na ndaoine seo le cinntiú gur féidir le daoine a dteastaíonn aistriú orgáin uathu é sin a fháil.

Senator Jim D'Arcy

The purpose of this directive is to ensure standards of quality and safety of human organs intended for transplantation. I attended the fleadh in Derry last week and I congratulate Senator Ó Murchú in that regard.

At the fleadh dinner I was sitting beside Mr. Joe Brolly, who as Members may know donated one of his kidneys. He is a living donor. As we were in the Maiden City, we both agreed that Senator Mark Daly was talking through his derrière because this is a technical directive to ensure the quality and safety of human organs intended for transplantation. Should the directive be annulled, which it will not be, we will have no objective quality and safety standards. We could continue to take organs from abroad but other countries may not be able to accept what we have to offer. Let us be very careful in what we are proposing. There is no alternative. It is a blunt instrument. It could be said, and I heard the Leader state as much, that it was a political stunt. I know Senator Daly is a campaigning Senator and I will give him the benefit of the doubt that his motives are good, but the result of what he is proposing would be an absolute disaster. We must rule it out.

Senator Darragh O'Brien, with his usual honesty and integrity, said that Fianna Fáil did absolutely nothing about this for ten years, and the rates decreased from 2003 to 2010. It appears to me that his party is better in opposition. The good ideas only come in opposition because in government the Fianna Fáil Party is like a hippopotamus with a violin. I do not know if Members have ever heard it played but it does not sound too good.

Senator Rónán Mullen

A cello might be more appropriate.

Senator Jim D'Arcy

A cello might be more useful. So too would a double bass. I do not think a violin works.

The Opposition proposes to establish a statutory body to deal with organ donations. There are statutory bodies for everything so that everyone can have a job.and nothing gets done. In Haggardstown, when we did not want anything done, we set up a committee and a sub-committee and then we knew nothing would be done. Let us work with the Irish Medicines Board to get progress on this. That is what it is all about. My father-in-law had a kidney transplant, and one of my children was born with reflux in both kidneys which was diagnosed antenatally so that operations could be performed. We still wait and we are still hoping that everything will work out right. Everyone is involved. No one has a monopoly on this issue.

There is movement. The human tissue Bill will bring movement. People talk about presumed consent and the top four countries for organ donation have presumed consent, such as Spain, Lithuania and others. Members will note that in the 30 submissions on human tissue, 29 submissions are not in favour of presumed consent. We must consider that and see how we will create an increase in organ donation. Let us be positive. We need to publish the human tissue Bill, with which all sides agree. Perhaps Senator Daly's motion has accelerated that process. I do not know.

We need put in place a comprehensive awareness campaign. We need to adopt the same approach as the Road Safety Authority by availing of the services of a high profile person like Gay Byrne or Joe Brolly. We need to appoint transplant co-ordinators in all hospitals. We have introduced new driving licence applications. We need to everyone to get the number 115 on their driving licences. We need to work towards having a single transplant unit for the entire country. The Government is doing that. It is also necessary to recruit additional staff. I hear that is on the way. We must consider putting in place a procedure to discharge the out of pocket expenses incurred by living donors. I know money is not everything, but it can be an issue for someone who does not have it. In the UK, £5,000 is paid to cover loss of earnings, travel costs and miscellaneous expenses. We need to work. We should leave with a positive message. I ask Senator Daly to withdraw the muck he threw when he said the Minister is responsible for deaths.

Senator John Gilroy

Hear, hear.

Senator Jim D'Arcy

I could go back ten years, but I do not want to go there. I ask him to withdraw what he said. If he does so, I will be happy to work with him. I accept that he has probably increased awareness. I cannot support the motion because nothing has been proposed to take the place of this regulation, the rejection of which would leave us in a bad place.

Senator Thomas Byrne

I thank my colleague, Senator Daly, who called for and organised today's debate. I know he has worked very hard with his nominating body, the Irish Kidney Association, on this issue. He has played a key role in this regard for quite some time. There has been a great deal of confusion during this debate. It is fair to say that many Members have not had an opportunity to read the relevant legislation. Senator Daly has provided copies of it for anyone who wants it. We are in essence speaking about two pieces of legislation: a directive that was brought into force at EU level in July 2010 and the implementing regulations that have been brought into force by the Minister, Deputy Reilly, to bring the directive into Irish law. There is a difference between the two. We fully support the directive. I understand all the bodies support it too. The issue of consent is referred to marginally in the directive. It is not a major issue at all. As my colleague, Senator Darragh O'Brien, has pointed out, the key issue in the directive is set out in paragraph 24, which states "it is preferable to have a single non-profit making body which is officially recognised with overall responsibility for donation". That is the net issue here. The Minister failed to do that in the regulations.

Senator Cáit Keane

Article 17.

Senator Thomas Byrne

The procedure initiated by Senator Daly is the only avenue open to the Seanad and the Dáil to do anything with these regulations. There is no other avenue, aside from the inherent powers of the Oireachtas to legislate. No other statutory avenue to do this is written down. The Senator has adopted the correct procedure.

It is interesting to note that the Minister implemented the directive by regulations on the very last possible day for him to do so. This was a rush job by the Minister at the very end. The directive mandates that it be brought into force in the member states by 27 August 2012. That was the date on which the Minister signed them. The way the Minister has done the job, by signing the regulations on the last day, must cause us to withdraw our confidence from them. He has signed this into law by virtue of section 3 of the European Communities Act 1972, section 4 of which provides for the annulment procedure.

For the reasons given, Senator Daly's motion and the motions before the House signed by Senators Darragh O'Brien and Quinn must be supported. We believe this regulation is flawed. Senator Daly has received the support of the Irish Kidney Association in taking this step.

It is shameful that extracts from the Attorney General's advice were circulated by the Government Chief Whip in a political fashion. Legal advice is not political and should not be used for political purposes. I imagine the lawyers in there are very upset that extracts from the advice have been sent around.

Senator John Gilroy

The poor lawyers.

Senator Thomas Byrne

Speaking as a solicitor, I can say that one would not expect one's clients - Ministers in this case - to circulate extracts from advice in such a fashion. It was most inappropriate and disrespectful to the Office of the Attorney General that they were sent around the Oireachtas by e-mail. I think the advice given by the Attorney General is arguable.

Senator Daly has adopted the procedure here. It is noteworthy that the procedure was adopted last year, immediately on the signing of these regulations, on 27 August, the last possible date available to the Minister, but the Seanad was not recalled. Legal advice was sought by the Cathaoirleach and the Clerk of the Seanad at the time and I have a copy of that advice here. That legal advice is confidential, but it essentially confirmed that the procedure is correct and that Senator Daly is doing the right thing. This is the only avenue open to us to do anything about statutory instruments which are signed by Ministers during a recess. There is nothing else one can do.

In the Seanad today, the Order Paper has a list of 12 pieces of legislation that are open to annulment. These are 12 pieces of legislation that have been passed by various Ministers over the summer on which there has been no debate whatsoever. It is interesting that among these is at least one from the Minister for Health, Deputy Reilly, the European Union (Microbiological Criteria for Foodstuffs) (Amendment) Regulations 2013, SI 301 of 2013. This was passed a month late by the Minister, but notwithstanding that, we got no opportunity to debate it or any of the other pieces of legislation, many of which create serious criminal offences. The Minister for Finance signed a regulation into law on 6 August this year relating to customs inspections and intellectual property rights. These laws, which are passed by Ministers, deserve scrutiny. They create penalties for people who break the laws and deserve scrutiny in our Parliament.

The essential question today is whether we should discuss organ donation or make laws. Are we a law-making body or do we break laws? Our only function is the making of laws, not that of a debating Chamber. One of the statutory instruments published during the summer break was the Safety, Health and Welfare at Work (Construction) Regulations. Only for the fact the Irish Examiner, and perhaps some other newspapers, highlighted these, there would have been no scrutiny of these whatsoever. Therefore, it is highly appropriate the Seanad be recalled today and I hope it annuls the legislation being discussed today. This would put the ball in the Dáil's court.

There is an inherent legislative power for us to legislate on anything we want and this will then bring pressure on the Minister to rectify the flaws in the legislation. The flaws have nothing to do with consent but with the infrastructure cited by Senator Keane. The problem is not with the directive, which we support, but with the way the Minister implemented the directive into Irish law. There are more than 10,000 words of implementing regulation, but the Government side of the House suggests we should not debate them at all. I suggest that is wrong. We should debate the regulation. In our view, we should annul the regulations which we believe are flawed. I thank Senator Daly and his nominating body, the Irish Kidney Association, for all their work on this issue.

Senator Tom Sheahan

I was contacted during the week by a consultant from a major trauma hospital. What he hopes will come from this debate is that someone will name the hospitals that are not doing their job. He said that in the case of every trauma he deals with where there is a possibility of organ donation, he, personally, speaks to the family involved. The suggestion has been bandied about here that we need a transplant co-ordinator in every hospital. Let us get a grip.

There is no doubt that the advocacy groups for organ donation and transplantation do their work. However, I suggest we put a pilot scheme in place in one of the major trauma hospitals for one year. This would probably cost approximately €60,000. That would be a fair payment for someone to do that job for a year. Such a pilot would let us see how this would work. If, for example, organ donation doubled in this country in the morning , would we have the infrastructure to deal with that and carry out the transplants? Let us not put the cart before the horse. I am not here to throw mud at anyone. This is a serious issue, but we must look for objective, positive outcomes from this debate.

I suggest the Minister or someone else should select a major trauma hospital in which to run a pilot scheme for one year. A transplant co-ordinator should be put into that hospital to see how the system would work and what percentage increase in donations would result. However, have we the infrastructure and the physicians to carry out increased numbers of transplants if organ donation is doubled in the morning?

Senator Rónán Mullen

I add my voice to those who have thanked Senator Mark Daly and the Irish Kidney Association for bringing forward this issue in the way they have done. I have heard a certain amount of squawking from Government quarters - not everyone, it is fair to say - about being interrupted in this way during their summer break. In reality, we should be grateful for the opportunity to discuss an issue that did not get the attention it deserved during the last session.

It is easy to accuse political opponents of opportunism, but we should reflect on the inadequacies in our political system, as we have done previously in this House. It has been pointed out by more than one Fianna Fáil speaker that the party had eight opportunities to bring forward Private Members' motions in the past year. That is very little. The time afforded to the debate of Private Members' concerns in these Houses is paltry and therefore it is no argument to say that the fact that this issue did not make the first eight on the list means it is somehow wrong to bring about a recall of the Seanad in order that it can be debated now.

By bringing forward the issue in the way and at the time that they have done, the Fianna Fáil Senators have triggered an important debate in our society which, rightly, has gone beyond areas touched on or dealt with by the directive and the regulations to implement it. It is absolutely right that we should continue to have a debate about the best means of maximising the availability of organs for donation and transplant, even if that issue is only tangentially dealt with in the directive. As I understand it, these regulations restate what is, in fact, the current position, that is to say, the consent of the next of kin is required where a deceased person's organs are to be donated and transplanted. It is a good thing the discussion has gone beyond the issues directly concerned or dealt with by the directive. As others have said, there is often a remarkable generosity involved to which we ought to pay tribute. Often it is, so to speak, a death and life issue whereby the death of a loved person leads to a silver lining or a light for some other person or family where there is the generous decision to donate an organ. We should pay tribute to those who have had the foresight over the years as a matter of principle and personal concern to carry organ donation cards. We should welcome the option available now to have included on our driving licences our intent that our organs might be used in the event of a tragedy occurring in our lives. We should consider whether there is any other way in which people could be allowed to signal that intent, for example, by using a website and offering people the opportunity to log on and indicate their consent for all time or until further notice that their organs might be used in the event of a tragedy.

It is good that we are thinking about this important issue. We should note that there is a deficiency in the regulations as they were brought forward in so far as there is no key single central authority, and this has been pointed out. This has been challenged, and rightly so. It is for the Government to tell us what it would do in the event that these regulations were annulled rather then merely argue that they should not be annulled. I do not believe the annulment of these regulations would lead to us having no proper regulations in place. It would simply be a matter for the Government to get back to the drawing board and do what it should have done, that is, bring forward regulations and subject them to proper discussion and scrutiny in these Houses.

Much has been said about the question of whether moving to an opt-out system would solve the problems with the current system by leading to a significantly greater availability of organs for donation and transplant. The other side of the argument is that what is needed are other changes, as referred to by various Members, including the question of whether one transplant unit should cover the entire country or the requirement for greater availability of resources and funding. It seems to me it is not a case of either-or but of both-and. This debate has led to people contacting me to signal their concern that we should have an opt-out system. I congratulate my colleague, Senator Feargal Quinn, who has done so much to bring this issue to the attention of the House. We await the current consultation process and the eventual, and hopefully not long delayed, human tissue Bill.

I found myself reassuring people in recent days that this initiative by Senator Mark Daly and his colleagues was not about rejecting an opt-out system. The point is that the directive does not decide the issue one way or the other and nor do these regulations. We have had a very welcome debate on the issue and a greater highlighting of the generosity of the many people who have donated their organs. There is a renewed focus on the requirement to put in place all that is necessary to ensure the maximum availability of organs for donation and transplant. I thank my colleagues on this side of the House for pressing the debate. I will be supporting them today.

Senator Martin Conway

It is quite unusual to be here in August. It would be very easy to play politics with Senator Mark Daly on the issue of the recall of the House, but the matter we are discussing today is far more important than that. I suspect that some of the Senator's colleagues in Fianna Fáil are slightly envious of the publicity he has achieved in recent weeks and are wishing they had come up with the same tactic last year. The level of publicity around the issue of organ donation is very welcome, whatever the background to today's debate.

It is unfortunate that we have not made the type of progress we should have in recent decades in respect of the system of organ donation. There is something slightly mischievous going on here in that the House has been recalled to nullify a directive we should be seeking to enhance. I have spoken to significant numbers of people within the medical profession in recent days and their perspective is that the directive is a stepping stone which should be seen in the context of the human tissue Bill that is due to come before the Oireachtas in the course of the next parliamentary term. I am convinced of the Government's commitment to getting that legislation through, irrespective of what is happening here today. It is a very important issue and part of the Government's work programme. We are committed to facilitating and improving services for people who are on dialysis and awaiting an organ transplant. It is to be hoped the media coverage we have seen in recent weeks will result in more people carrying organ donor cards.

I am convinced that an opt-out clause, according to my understanding of what that means, is what we should strive to achieve. I look forward to debating the human tissue Bill in the House. I sincerely hope we will see the same enthusiastic engagement during the debate on that legislation as we have seen today. Many people might look at our discussion today in a negative way.

I believe it is extremely positive. If the Seanad is to be recalled on any issue, recalling it on this issue is appropriate. This House will be seen to become more relevant in the lives of people who are trying to deal with issues head-on.

We have heard many discussions recently about the role the Seanad could play in European Union legislation, EU directives and so forth. My colleague, Senator Colm Burke, has regularly highlighted the need for the Seanad to become more engaged in that process. It is accepted across the political divide that the Seanad has a role to play in filling the obvious gap that exists within our political structure. At the 2009 MacGill Summer School, the Taoiseach spoke extensively about the role the Seanad could play in the scrutinising of EU directives.

Senator Darragh O'Brien

He has forgotten that.

Senator Paschal Mooney

Which Taoiseach was that?

Senator Martin Conway

The current Taoiseach.

Senator Darragh O'Brien

I would not remind him of that. Let that go.

Senator Martin Conway

It is widely acknowledged and accepted that there is a void in our legislative structure in terms of scrutinising EU legislation. If this debate highlights the importance of organ donation and our poor record in that regard in the past 14 or 15 years, and if it identifies an area within the political and legislative process in which the Seanad can play a useful role, coming back here today will be a good day's work. This day, 20 August 2013, will be seen as one of the interesting days in the history of Seanad Éireann.

Senator Mary M. White

I thank the Leader of the Seanad, Senator Maurice Cummins, for facilitating this event because it is a major event. Year after year people relentlessly lobby Minsters and political representatives to try to get their issues on the radar in the Oireachtas, but many issues never get on the radar. This is a victory for Seanad Éireann, for my colleague, Senator Mark Daly, and for the people in the Visitors Gallery who are here on behalf of their families who are waiting on transplants of various organs. I am sure there is not one person in this room who does not know a person who has been getting dialysis over the years. Directly or indirectly we have all dealt with people who are going through the trauma of having to travel three times a week from all areas of the country to designated centres for dialysis. It is a horror story.

There is no doubt that we have got the issue of the failure of the organ donation system in Ireland on the political radar. The arguments coming from the Opposition are weak and pathetic.

Senator John Gilroy

The Senator is the Opposition.

Senator Mary M. White

I am embarrassed, and they should be embarrassed.

Senator Paul Coghlan

The Senator is the Opposition.

Acting Chairman (Senator Diarmuid Wilson)

The Senator without interruption please.

Senator Mary M. White

Week after week, year after year we raise the matter in this Seanad of having proper study of EU directives. EU directives are brought into this country willy-nilly without major discussion in the Oireachtas and, to our detriment, we have to contend with the consequences of that.

Currently, 650 people in Ireland are awaiting heart, lung, liver, kidney and pancreas transplants, one in ten of whom will die if the person does not get a transplant. There are more than 1,800 people receiving dialysis on a yearly basis at a cost of €70,000 each, which annually amounts to €1.26 million. Over a period of ten years, that brings the figure close to €1 billion.

As I stated earlier, one should think of the trauma of having to travel three times, and we all know patients are making this journey. If we improved the organ transplant system in Ireland, more than 500 patients waiting for kidney transplants could expect to receive a life transforming and life saving operation. We would be more efficient in moving patients off dialysis and on to a transplant operation. The resulting saving to the taxpayer over a ten year period could come to hundreds of millions of euro. Organ donation rates would rise under an improved infrastructure and the cost to the State would tangibly decline, as we have seen in the case of European partners, including Spain and Croatia.

There are two key measures required to have an effective system, both from a patient and cost point of view, the first of which is one single transplant authority, and the second of which is organ donation and transplant co-ordinators in hospitals which carry out transplants. This has proven internationally to be the most effective system. With the correct system in place and sharing of data, patients can be moved off costly dialysis and waiting lists and moved forward for transplants, saving the State money and bettering their lives. This is the reality and it makes sense.

The Minister of State, Deputy Alex White, is present on behalf of the Minister, Deputy Reilly. I presume we will hear a more measured response from him because in his legal profession, one must give an honest answer. The Minister, Deputy Reilly, did not create a clear system for organ donation and transplant, which infrastructure has been implemented in Spain, Croatia, Belgium, Italy and France.

As a former business person, I do not understand how one could have two bodies dealing with the matter. It should be based in the hands of one efficient body. As Senator Quinn so eloquently said and as I have said so many times, as a business person, I do not know how it takes so long for everything to come to fruition in the country when it is left to bureaucracy. The biggest bureaucracy of all with which we are dealing is the EU bureaucracy.

People in Ireland do not understand how difficult it is to get elected to Seanad Éireann. Eleven Members in this Chamber are the Taoiseach's nominees and they cannot remotely comprehend what it is like. Sinn Féin, on the nominating bodies, does not have any competitors and its members are literally appointed into the Seanad. We all must get the nominating bodies to support us to stand for election to the Seanad in the first place. This is an ideal model of a nominating body. Senator Daly's nominating body is the Irish Kidney Association. He has valiantly, over a period of 12 months - it did not work out for him last year but it worked out this year - got on the political radar and got the people engaged in what the Seanad can do. The media are here today. As we have stated here on many occasions, would we not love if they came every day to listen to us? It is a great day for the Seanad. It is a great day for those who are awaiting transplant that the issue of organ donation has got on the political radar. The Members on the Government side are pathetic in giving what they believe are rational arguments for denying that it brings the issue on the radar.

Senator John Crown

I welcome the Minister of State. I also welcome the members of the press to the Seanad. I have been reading their work for many years and I often wondered what they look like.

I generally compliment the tone of the debate. I note, however, that it has been commented by one of my colleagues that Senator Daly, who deserves huge credit for his initiative and dedication in making this debate take place today, reminded her of Bobby Ewing in the famous episode of "Dallas" where he forgot two whole episodes. I do not want to lower the tone of the debate but if Senator Daly reminds them of Bobby Ewing, the other great line from "Dallas" was, "Who shot JR?", and the question today is: "Where is JR?"

Why is the Minister for Health, Deputy James Reilly, not here in the Seanad to answer this charge? It is regrettable he is not here.

This is a critically important debate for several reasons. First, it will spawn debate. Like our smoking Bill three years ago, it will raise awareness on an issue that has fallen off the national radar. It is also worth it if one person, irrespective of whether they agree with this recall or feel it is a cynical exercise, hears the figures for organ donation and decides to sign a donor card as a result. This debate is also important because it will light a fire under the derrières of some officials in the Department of Health and the Health Service Executive who will be charged with introducing this long-promised, much-vaunted directive which has been gestating since 2008.

Ireland has one half of the donor rate of the leading countries for donation, Spain, Belgium and Croatia. Ireland has half the number of pancreas transplants per head of population in comparison to the number one country. We have one eighth of the number of lung transplants. We, with one of the highest incidences of heart disease in the world, have one twenty fourth the rate of heart transplant. Clearly, there is a problem with organ donation which needs to be addressed.

The problem is absolutely not the dedication of the staff who work in transplant services. Like everything else in Irish medicine because of the critical and cynical decisions made by the major political parties since the foundation of the State that has given us a chronically underprovided health service, we have the smallest number of transplant surgeons and support staff of any country in the OECD. If it were not for the UK, which is second worst for most medical specialties, we would be the subject of great scrutiny. We have no network of organ donor co-ordinators. Senator Sheahan suggested the Minister should select a major trauma hospital in which to run a pilot scheme for one year. With great respect to the Senator, we do not need to as the data are out there. Northern Ireland has 24 co-ordinators; we have none.

The EU directive on which SI 325/2012 is based is just a directive, not a regulation. I lived with the consequences of one EU directive before in clinical trials which had the potential to be a disaster. I, along with several colleagues, launched an international campaign to point out the problems with it. The result was that it was more or less ignored in Ireland. If it had not been ignored, we would have had a disaster in clinical research. There is nothing binding about an EU directive. If we vote to overturn this statutory instrument, there is nothing stopping us from voluntarily complying with what it suggests we do while we put better and more definitive legislation in place.

It was suggested that perhaps other countries would reject our organs. They will not. People are crying out for donor organs from western European countries. There would be no question of someone on a life support machine in Paris, Utrecht or Basingstoke being told they will not get an organ transplant from Ireland because the Seanad annulled a statutory instrument.

My main objection to this is that there has been a colossal wasted opportunity associated with this regulation. We are told we are merely transposing a highly technical directive while we will introduce actual legislation sometime over the next year which will plug the gaps. Pardonnez-moi if I am not full of confidence that this will actually happen in the promised timescale. If it does, then I believe the main impetus would be because of Senator Daly’s initiative in putting this on the national political and health care agenda.

Why my lack of confidence? I brought in health legislation concerning smoking in cars with children a year and a half ago which we have been serially told was to be accepted by the Government and the revised heads of the Bill would be ready by the end of January 2013. Nothing has happened. Senator Colm Burke brought in wonderful proposals regarding indemnification.

The Government agreed with the principle and turned its own person down. I have not seen the revised version coming up yet. Similarly, there are a number of other episodes outside the health care arena. The Taoiseach promised that there would be a partial loan guarantee scheme in 2011. It has never happened. The Minister of State with responsibility for training and skills, Deputy Cannon, promised that there would be a FÁS reform Bill in 2012 but it has never happened. What we are finding instead is another example of the Government facilitating the bureaucracy in its flight from proper parliamentary scrutiny, as we saw here with the rushed vote at 4 a.m. or 5 a.m. on the promissory note. There is obfuscation with regard to public scrutiny of regulations which the bureaucrats wish to see implemented.

As I said before, we did not get any chance to look at this legislation or to propose amendments, which we would have done. It will not happen. We know how arithmetic works here. There is nothing stopping us from coming in with an appropriate Bill to deal with the problems in the next few months if sufficient priority is given to it and with the goodwill of both sides of the House, it could happen very quickly. In support of this question regarding obfuscation in favour of bureaucracy, the more I think about it and with the benefit of a few weeks off from the Seanad, I think one of the low points in the parliamentary history of the past year was the Public Health (Tobacco) (Amendment) Bill. This was a Bill that made it easier for the tobacco companies to sell cigarettes. This was not the wish of the Minister for Health who I know is a committed anti-smoking campaigner. It was something which was very unfairly forced on him by the bureaucracy of Europe but it was couched here to make it look like it was advancing public health. There is a real tendency for the Department of Health to do this. It tried to avoid scrutiny at all times and that is why, after much soul searching, I will support the annulment legislation today. If it is passed, I will give a commitment that I will do everything in my power as soon as we come back and even if we come back early to help draft new legislation which would replace it and incorporate the good parts of the European directive and plug the gaps we have very carelessly left out.

Senator Fidelma Healy Eames

The Minister of State is very welcome. It is really nice to have everybody back in the House. It is one of the best attendances I have seen at any debate in this House. I do not particularly care who shot JR. I do not care whether Bobby Ewing forgot the previous year of his life before he stepped out of the shower but I do care about life and life-giving mechanisms. This is a good day for Seanad Éireann where we show we have a value. I do not care whether people consider it a cynical move or political stunt. That is not what this is about. I have reflected on this. In the course of thinking about it, I remember knocking on a door in Oranmore about five years ago. I met this young man and his wife who had a very young family. One could see the angst in their faces. I contacted them prior to the debate. He was a cystic fibrosis sufferer and had his oxygen tank with him. He was waiting four years and finally got his transplant in November 2012. In that time, he had seven calls for a transplant, five of which involved travelling to the UK. He had two acute rejections that were successfully treated and tomorrow, he is hoping to line out for a 5 km walk or jog on the coast road in Oranmore. That is a human story. I have not met him since he received the transplant. I just remember the pain and worry and the times they told me about the number of "goodbyes" they had to make before he went for the transplant because one never knows whether it will succeed. I asked that family what they think we should advocate today and they told me what many people have said here - trained teams to speak to families where organ donation may be an option and dedicated harvesting teams in hospitals. Again, I do not like the word "harvesting" but for want of a better word, that is what they advised. We have a significant problem. I do not think the key issue today should be whether this directive should be annulled, because I know that is the technical issue. It should be about how we can genuinely improve our transplant rates and save lives.

Therefore we are down to the "how", the infrastructure and resourcing. We have a problem. It is clear that we are not doing things effectively in this country when we compare ourselves with other western European countries. In 2011 just 42.7 people per million received a transplant here. Contrast that with Norway and Spain where 91.4 and 86.4 people per million, respectively, received a transplant. The fact that we have no personnel on call to approach relatives at the right time appears to be the critical issue.

Dr. Rafael Matesanz, the director of Spain's organ transplant organisation, where they are extremely successful, said what really matters is how one approaches the moment to death. He said one must break the news of the death well, explain the details of the procedure well and really listen, and the family almost always agrees to donate. Transplant co-ordinators may spend hours listening to relatives in a private room away from the hospital wards, asking them to consider organ donation and particularly asking them to think about how their relative who may be at the brink of death would have wanted it to happen. He said the key is not about donor cards, registers or presumed consent, but about organisation. He said:

European people are not that different from one country to another. What really changes is how you approach the moment of death.

While I have not heard any of the media coverage people said Senator Daly got because I was away, at the weekend we had family around for dinner and of the 12 people present, ten would not have agreed to sign a consent card where the organ would be automatically taken. There were many reasons, including fears of over-regulation and the death being hastened because of the great need. What really mattered was the intervention at the moment of death spoken of here by the countries that do it sensitively. As a result we can see they have higher rates. Patients are twice as likely to receive a potentially life-saving transplant in Norway or Spain.

This is about life, life saving and life giving, and it is well worth recalling the Seanad for that. I am disappointed to hear the Dáil is not being recalled. Does that mean this directive will be automatically signed into law? We should be about serving the needs of our citizens. There are at least 650 people on transplant lists. If Ireland were to match world leaders such as Spain and Norway, fewer patients would die; that is a fact.

It is unwise to sign directives into law without proper discussion and scrutiny. It drives Irish people mad. Look at what is happening with the turf cutting and the special areas of conservation, SACs. Years after those directives were signed into law the Irish people realised we Oireachtas Members had not scrutinised them but had signed them into law willy nilly. It is not good practice and it loses confidence in government. None of us wants that. We are realising it is time we man up, size up to our job, and that is why it is great that we are here today.

I will decide how I will vote when I hear the Minister's answers. They matter to me. I am not one to go around annulling EU directives, however if that is what it takes for us to take EU directives seriously I will vote against it. I will listen to the Minister first because this is about the best measures the Government will commit to within a timeframe so we know we have a better infrastructure and resourcing in place. We want people on the transplant list today, who are clamouring for their lives, to know they have a better chance of getting an organ donation because Irish families will be approached more sensitively at the moment of death.

Senator Denis O'Donovan

Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation states:

As emphasised by the Recommendation Rec(2006)15 of the Committee of Ministers of the Council of Europe to Member States on the background, functions and responsibilities of a National Transplant Organisation (NTO), it is preferable to have a single non-profit making body which is officially recognised with overall responsibility for donation, allocation, traceability and accountability.

The net outcome of the directive and the attempt by the Government to implement same clearly flies in the face not only of the spirit of the directive but also its intent.

The only modus operandi available to Senator Daly to annul this directive was to recall the House. All the talk about Adjournment debates and Private Members' time is a load of nonsense because that would not achieve the full intent of the Senator's annulment. This is a technical but correct point. If we had five Adjournment debates and five Private Members' debates in the past 12 months, none would have resulted in what the Senator has set out to achieve and he deserves full credit for endeavouring to do that.

Since joining the EEC in 1973, successive Governments, including those of which my party was a member, have rubber-stamped willy nilly thousands of EU directives and regulation without any debate. A strong majority of the people gave consent in 1973 to join the EEC but it was never intended that directives and regulations, which currently account for 75% of all laws in the State, should be rubber-stamped. Many people say in the House and other public fora that there is a great deal of scrutiny of EU legislation but that is a load of rubbish. I have been a member of many joint committees and at one stage, as a Member of the Dáil, I served on four committees. When meetings commenced with a discussion of EU legislation, a question was put and agreed without debate. Let us be honest about it. Such legislation was rubber-stamped and it is no wonder the public have rejected various treaties because they have not been consulted. Their public representatives in both Houses do not debate directives and regulations in the way they should. Senator Daly is again correct in what he is trying to achieve in this regard.

When we joined the Union, there were not many directives but there have been several in he past 20 years. We are succumbing to Europe's wishes, whether that relates to planning regulation, turf cutting and so on. There are disparate ways in which the lives of small farmers, fishermen or ordinary people are becoming more controlled by regulations, directives and laws initiated in Europe, which have not been debated by Oireachtas Members who are supposed to be legislators. Great credit is due to the bravery and persistence of Senator Daly, who attempted to do this last year but was diverted because the view was that it could not be done. When he received a legal opinion subsequently, it transpired that this was possible.

Joe Burke from Bantry, County Cork went public yesterday on C103FM. He is currently on dialysis and he made his case clearly. He received a kidney transplant 22 years ago. He is a farmer in his late forties and he was a successful athlete following his transplant for many years but he is now on dialysis waiting and hoping for a second transplant.

What was reported on the local radio station was heart-rending because he obviously has a wife and children at home. He has a farm to run but owing to his dialysis he has low energy and cannot achieve that. I wish him luck and I hope he is successful. People like that who are brave and go public and who have lived for a further 22 years following a transplant, for which he is very grateful, deserve great credit.

This is the first time in my career in both Houses, which spans longer than I might wish, that we have once and for all put a spotlight on the issue of organ donation. As a result of Senator Daly's motion certain things have started to roll on with the Minister and Government reacting to it. If the Minister, Deputy Reilly, were of the view that Senator Daly had a point to make or that there could be some common ground, I am sure he could have called in Senator Daly over the past five weeks and called on him to abandon the motion on the basis that he would take certain actions and that there could be consent. However, he did not bother - he called his bluff. He thought Senator Daly would not get the 20 signatures and he decided to rumble on. As it became clear that the Senator would get the 20 signatories, the Minister then reacted. If we are going to allow governments to legislate and give a little here and there because of reactions to pressure, it is a very sad day. I believe the human tissue Bill would not have taken off were it not for the pressure Senator Daly applied.

The myth that there were other ways to raise this must be buried before I sit down. There was no other way to achieve what Senator Daly wanted to do. That is legally accurate and correct. It could not have happened through the use of the Adjournment matters etc.

Senator John Gilroy

What about Private Members' time?

Senator Denis O'Donovan

As Senators on all sides of the House have said, he has also put a spotlight on the very important issue of organ donation which we neglected for too long. My party when in government also did so. Here Senator Daly in recalling this House to debate this motion has deservedly put the spotlight clearly on that area. There are people like Joe Burke from Bantry on dialysis machines throughout the country waiting for organ donation. I wish them all well. I ask the public to be more forthcoming and generous in signing up to organ donation - a 5% or 10% increase would work wonders. Hats and caps off to Senator Daly for what he is trying to do. If he fails, he will not have totally failed because he has put pressure on an issue that should have been dealt with ten, 15 or 20 years ago.

Senator Labhrás Ó Murchú

I believe Senator Daly has done a service for the people who matter most, the people who require an organ transplant. His extensive research on the matter has been helpful to us all. The raising of awareness of organ donation and transplantation can only be helpful. We have been debating the matter for two and a quarter hours. It has now become very clear that we should have debated the statutory instrument before the regulation was signed into Irish law. That is clear from the contributions coming from both sides of the House. A speaker on the other side has suggested that perhaps all the political parties should sit down with the stakeholders and debate it, which is very reasonable. However, is it not logical that that also should have happened before the regulation was signed into law?

Based on the contributions to the debate from both sides of the House, it is quite clear that the situation that now exists in Ireland regarding organ donation and transplantation is not as good as it should be. There is a suggestion that because the Seanad reconvened and a proposal is made in some way we are being unfair to the work being done in that area. It is also highly disingenuous to use terms such as political stunts when we are dealing with life and death situations.

I have just been looking through a case history of a young woman whose name I will not mention, but she put her name out in public. She is 31 and received a kidney transplant in January 2012.

She waited two and a half years for it, during which time she was on dialysis. This means she had nine-hour treatments at home every night for two and a half years. Prior to this she was one of the campaigners for a national transplant authority. She also put into the public domain the need for a network of transplant co-ordinators in our intensive care units. This is what the debate is about. It is not about partisanship or scoring political points, which, luckily, is not happening today. As stated by Senator Crown the tone of this debate is good. The reason for this is the publicity this matter has been receiving. We have been given an opportunity, through the initiative of Senator Daly, to tap into the wellsprings of experience and diverse opinions on this matter. None of us has all the answers. As rightly pointed out by Senator Zappone, we are talking not about a three or four page statutory instrument but a major comprehensive statutory instrument. This debate is also a watershed.

The issue of the rubber-stamping and acceptance of European directives by this House and the subsequent debate, often two years later, of the flaws therein has been raised weekly on the Order of Business. It does no good for the Houses of the Oireachtas or us as legislators that we accept this. Are we to be cowed by Europe? That is how it appears. Was it felt that this matter meant so little that engagement with the people who matter most was not required and it could be rubber stamped and passed? I find that difficult to comprehend.

During the debate thus far, no member of the Government side has provided a rationale as to why this was not debated. Perhaps the Minister of State, Deputy White, will do so.

Senator Mary M. White

Hear, hear.

Senator Labhrás Ó Murchú

We will be listening with great interest. If that rationale does not stand up, we will be in difficulty because the Dáil will not reconvene. Surely, nobody is suggesting that if we succeed in passing this motion - it is quite clear the system would not disintegrate or fragment as a result of our doing what is proposed therein - the Dáil will not reconvene. I would be very surprised if public opinion would not come in behind us. Senator Crown referred to a specific constituency in Cork in which the Government has a majority. A recent poll carried out there indicated two-thirds of the people believed the Seanad should be reconvened. It is the only poll we have at our disposal. Perhaps another should be taken nationally. I believe that if we did seek public opinion on this matter, which is so important to families as they suffer as much as patients and to other people who have no experience of it but know that at some time in the future they may, the majority of people would expect legislators to return from their holidays and do what they were elected to do. There is nothing sacrosanct about us having to go into recess for two months. The Seanad should reconvene whenever required. This is precisely what is happening today. The procedure in terms of the process in which we are now engaging was properly adhered to.

I listened to the radio and television interviews with Senator Mark Daly. He was very logical. It was clear he knew precisely why he wanted the Seanad to reconvene. He was very courageous and stood by his view despite being somewhat ridiculed. He has won over many people at this point. Let us forget about whether or not this is good or bad for the Seanad: that is not what this is about. This is about people expecting us to give them a voice, particularly the Irish Kidney Association, which I compliment on briefing us every year on its work. It is not as if it exists in some little crystal palace away from the public. It knows the public mood. Senator Mark Daly was nominated by the Irish Kidney Association and has picked up the cudgel in this particular case and done what was right. Let us not be seeking scapegoats or trying to distract from the main debate. The main consideration is people's lives. It is as simple as that. It is clear from the debate that we are not against the main provisions of the statutory instrument. Surely, from an Irish perspective we should be given the opportunity to fine tune it and to debate the national authority and the lack of co-ordinators in the hospitals in this regard, which is a major problem. That is what the debate is about.

One can anticipate the result of the vote. That is part of the system of which we are victims. I believe if the Whip system was removed today Senators would do the right thing-----

Senator Mary M. White

Hear, hear.

Senator Labhrás Ó Murchú

----- and vote for people and their lives. I thank Senator Daly for tabling this motion. He has done a good job in this regard.

Senator Paschal Mooney

Like Senators Ó Murchú, O'Donovan and others I compliment Senator Daly on his initiative. Some of the crude language used in certain sections of the media since Senator Daly first launched his initiative disappointed me. As stated by Members on all sides of the House, what we are dealing with in terms of this motion is matters of life and death. There are people behind me in the Visitors Gallery who have first-hand experience in this regard. I am sure they were appalled at the manner in which Senator Daly's initiative was reported in certain sections of the media. Shame on them. As stated by Senator Mary White, if ever the work of a Senator representing a professional body in this House was to be lauded it is on this particular occasion. If ever an argument was to be made as to the usefulness of Senators being nominated by professional bodies this is a perfect example.

I would like to speak about issues relating to the human tissue Bill. In an article in The Irish Times of 25 April 2013 Professor Jim Egan of, a consultant respiratory physician at the Mater Hospital in Dublin said that there are compelling reasons to address the legislative and organisational structures in relation to organ donation and transplantation. He said that the deployment of these structures would bring Ireland in line with international practice, would reasonably allow enhanced donation rates of 24 per million of population, which would save up to 750 lives and remove 520 additional patients from dialysis over the next ten years. This is what Senator Daly's initiative is about. Professor Egan went on to say that, it would protect against the risk of a fall in organ donation rates, similar to that witnessed in 2010 and that organ donation and transplantation in Ireland is at a crossroads. This is one of the reasons for our being here today to debate this issue.

Senator Barrett spoke in some detail about the statutory instrument. What has not been reported in the media is what a statutory instrument is: it is law. This statutory instrument has the same legal status as legislation enacted having passed five Stages of debate in the Houses of the Oireachtas yet there has been no debate on it. How often would the people of Ireland accept or tolerate the national Parliament increasingly passing into Irish law statutory instruments without any debate? As stated by Senator Daly, 75% of laws passed in this country are done in this way. This statutory instrument is not a trivial document. It is 36 pages of dense legislative proposals agreed at a Council of Ministers meeting that have been transposed by way of signature at the end of the document into Irish law. This is what the statutory instrument is about.

I applaud the Irish Kidney Association on the manner in which it has kept this issue high on the political radar. It talked about a late amendment to the EU directive tabled by the UK allowing for more than one competent authority in each member state. That was to facilitate Scotland, Wales and Northern Ireland having an independent authority. It believes this was the reason the Department of Health used this clause to divide the responsibilities or competencies of the directive to establish competent bodies. The association strongly believes that leadership and infrastructure properly established can, and should, lead to a 50% increase in organ donation and subsequent transplantation in Ireland. It referred to the weak adoption of the EU directive and said this was the last EU country to legislate for organ donation and transplantation and that we succeeded in losing the opportunity to create the necessary infrastructure to drive organ donation into the 21st century. As has been pointed out by a number of speakers on both sides of the House, other countries, specifically Croatia and Norway, have over 50% more organ donation because they established the infrastructure and leadership to do so. The gain by society and the individuals concerned is enormous and the costs are neutral at worst.

Several references have been made to the human tissue Bill. It should be put on record that in April 2009, the then Minister for Health, Ms Mary Harney, announced the commencement of public consultation and proposals for a human tissue Bill. Fast forward to March 2011, there is a new Government and a new Minister for Health, who proposed a new opt-out scheme for organ donation. Responding to Dáil questions, he said the Department was working to finalise the proposals, that he was considering what practices and organisational changes could further improve donation rates in this country and the proposals would be included in a human tissue Bill which would include the recommendations of the Madden report concerning post mortem practices. Two years before that - there was talk about further consultation - the Department of Health, in its report on the public consultation and proposals for the general scheme on the human tissue Bill 2009, said that stakeholders were strongly advised to submit their substantive suggestions before May 2009 since it would become progressively more difficult to make significant changes to the draft the further it is advanced through the legislative process. We now have further consultation and yet a letter sent to a constituent in County Wicklow and signed by the private secretary to the Minister for Health in December 2011 stated that following the public consultation in 2009 and on foot of consultation with the Attorney General, the Department had been redrafting the general scheme of the human tissue Bill to make it clearer and more concise and that when this revision is complete, it could be expected early next year. In December 2011, the Minister stated in a letter to a constituent it was expected in spring 2012. It is now the latter part of 2013.

Today - this is as a direct result of Senator Daly's initiative - the Taoiseach's website states that the human tissue Bill to meet the key recommendation of the Madden report that no hospital post mortem will be carried out and no tissue retained after post mortem without consent will also address other matters relating to human tissue, including consent arrangements for transplantation and research purposes, and that it is not possible to indicate at this stage when publication is expected. Will the Minister of State please reply?

Senator Mark Daly deserves to be applauded for the amount of work he has undertaken over the past number of weeks and months. Indeed, in September of last year, he tried to have this debate but he came up against blockages which were referred to earlier. Senator Daly deserves respect and recognition because he is standing up for vulnerable people in our society who deserve the protection of the Irish Parliament and Irish democracy. We are elected to represent people and that does not stop when we drive through the gates.

As was said, there are currently 650 Irish citizens waiting for a heart, lung, liver, kidney or a pancreas organ transplant. One in ten will never receive that transplantation and will die as a result. The Government has a responsibility to implement the EU directive referred to but it should not selectively implement it and leave Ireland out of sync with other EU countries. We should learn from each other. The 2008 action plan, which was adopted by the European Parliament and European Council, clearly highlighted a ten-point plan where each member state could unilaterally or in co-operation with other member states put in place a plan which would improve donor rates throughout the EU. It is very easy for the Government to say it has done a good job, that it hosted the EU Presidency, that it works well with its colleagues and that it is applauded in Europe on financial or economic issues but on the important issue of organ donation and transplantation, where we can save the lives of our citizens, we decide to opt-out of being great partners in Europe and of following the path laid down by our European neighbours. Why is that?

At a time when we are trying to save the Irish taxpayer money, there is a two-pronged benefit here because we can save the lives of our citizens who are seeking donors and transplantations and we can also cut down on the costs associated with dialysis and other treatments by providing those donors and transplantations. I fail to understand the logic of the Minister for Health and the Government Senators on this issue. They can throw all they want at Fianna Fáil about not doing enough, which I would gladly accept if it meant providing a transplant for one of our citizens, but I do not think that is what this is about. It appears that it is an inconvenience for some that we have had to come back to discuss this issue today. I would gladly sit here for the rest of the recess if it meant the Minister would take on board some of the beneficial things being done in other European countries such as Croatia which in 2000 was one of the poorest countries not only in Europe but in the world in regard to organ donation but is now the world leader. How did it do that? Have Minister for Health, the Ministers of State in the Department and any of the officials in the Department visited Croatia or spoken to the Croatian Ministry for health about how it has done it? Have they even read the information readily available in an opinion paper on bioethics which looked at the Croatian model? It clearly outlined the steps used to implement its strategy which was the nucleus laid down in the 2008 ten-point plan by the European Commission.

That involves co-operation. It would involve using the hospital model, to provide facilities, a point of contact and making an in-house co-ordinator available in each hospital. That is not readily available in this State. It also considers the role of a national organisation with responsibility for organ donations which is totally different from the two pronged approach being taken in Ireland. It also involves approved family approach skills with professional and compassionate communication with the potential donor's family, which has been shown to be crucial in lowering the refusal rate for organ donation. These are examples that I believe should be incorporated in whatever approach this Government signs into law. For God's sake will the Government go back and have another look at this issue and let us sit for the rest of the month to discuss it? I am prepared to do it. I am sure the 20 Senators who signed the pledge are prepared to do it. This is an issue of importance to all of our constituents, and one of my constituents, Mr. Brendan McLaughlin who was the first ever patient to get a kidney transplant, highlighted this week that the Government's policy is wrong. Those are his words, not mine.

Senator Terry Brennan

If we accept this motion and annul the statutory instrument, we will be taking a retrograde step. We will be the only country in the European Union that will not have a coherent and detailed structure relating to donation, testing, characterisation, procurement, preservation, transport and transplantation of organs. To go forward we need the human tissue Bill to be published and public consultation is talking place and I hope this Bill will be introduced during the next term. We need to put in place a comprehensive awareness campaign and adopt the same approach as that of the Road Safety Authority. The Road Safety Authority used a high profile person to sell the importance of road safety and we commend the reduction in accidents on our roads today.

I wish to acknowledge the efforts of Mr. Joe Brolly, who himself is a widely known high profile young man. He donated a kidney to his friend - what a thing to do. He is involved in a sport that is discussed in most houses every week of the year in this country. People in most houses would know who he is. I believe we need a high profile individual in order to create awareness of the importance of being an organ donor. A person of the calibre of Joe Brolly is required.

We need to appoint transplant co-ordinators immediately, as has already been mentioned by previous Senators. Five transplant co-ordinators are based in Beaumont Hospital in Dublin. In Northern Ireland, however, they have put in place 27 transplant co-ordinators in the past five years. As a result there is a 81% increase in organ donation. The appointment of transplant co-ordinators does not require legislation and is of the utmost importance. We have already introduced the new application system for driving licence. This gives the opportunity to tick part four, which allows the licence holder to state that his or her organs can be donated to somebody who needs them. This was a very worthy initiative. We need to work toward having one transplant unit for the entire country. We currently have three transplantation centres at Beaumont. It is also necessary to recruit the additional staff in order to deliver the service that is required. The total number of consultants currently involved in transplantations has not increased significantly in the past ten to 15 years. We must put in place a procedure to discharge the out of pocket expenses incurred by living donors. In the United Kingdom that sum is of the order of £5,000 sterling.

We all have a part to play in bringing about the change that is required. We do not know the day when we are faced with the dilemma of being dependent on an organ transplant. Likewise we do not know the day that tragic circumstances may hit us or a member of our family and we must make the decision on organ donation. Let us leave this House with a positive message. There is a need to deliver an immediate action plan to cater for living donors and the recipients. There is a need to put in place the necessary infrastructure. There is a need to appoint co-ordinators in each of the main medical centres across the country. We all need to become involved in raising awareness of this issue.

I oppose the motion before us.

Senator Jim Walsh

I join those who commended Senator Mark Daly on raising this important issue. It is a matter of life and death for many people. I know he has taken criticism from Members on the other side of the House and from the media. To some extent that is understandable. I too would have been of the view that a simple solution to increasing the availability of organs would have been to move to presumed consent, choosing an opt out instead of the current opt-in system. Having discussed this thoroughly with Senator Daly, I discovered that his insight into donation of organs was superior to mine. That highlights the importance of the vocational system of elections to the Seanad because of his involvement with the body who nominated him, he has developed expertise in the area. I commend him on his interest and for fighting in the face of criticism.

Members on the other side raised the question of annulling the statutory instrument. I support the annulment of SI 325. It should be replaced by a new instrument with the two important characteristics that have been shown clearly in other countries to have been very beneficial, that is a single national transplantation authority and not the present division between the Irish Medicines Board and the HSE. We see the difficulties and the dysfunctionality that persists in the HSE. The second characteristic is that one must have transplant co-ordinators in the hospitals.

The success of organ transplantation in Spain is attributed mainly to the sensitive way the transplant co-ordinators approach the bereaved family. That is a critical factor and they attribute the highest priority to and focus on it which has resulted in increasing the number of organs that have been donated. The number of deceased donors per million, which is the common benchmark for assessing results in this area, has seen an increase from 14 per million of population in 1989 when the system was put in place to between 34 and 35 per million in 2009. That was the highest in the world at that time. That figure may have been surpassed by Croatia in the past year or two and to which my colleague, Senator Brian Ó Domhnaill, referred. The 2008 figures for the comparative rate for the 27 EU members states is 18.2 per million, whereas the corresponding figure for one of the leading countries in this area, the United States, is 26.3 per million. There is a lot of work to be done. We need to achieve progress if we are to meet the existing demand. It is interesting that Italy and Portugal have followed the example of Spain by putting in place a similar system in order to increase the rates of organ donation. It is notable in Spain that transplant co-ordinators spend hours listening to relatives and asking them to consider organ donation in a private room away from the hospital wards. They develop a relationship and a bond with them. Only about 15% of families in Spain refuse consent for organ donation.

That is a significant drop when one considers that a rate of 40% applied in that country in the 1980s. The national organisation of transplants in Spain would like to reduce the overall refusal rate to just 10%. It is interesting that Ireland does not have any particular target, as far as I am aware. A single decision to donate can help up to four patients who need kidney, lung or liver transplants.

I would like to refer to the system that was introduced in Spain. This will help us to understand some of the criticism we have received. Until recently, I would have felt that presumed consent was the sinecure to the issue. No significant increase in donations of organs was noted in Spain after it introduced a system of presumed consent in 1979. As I have said, the organ donation refusal rate in Spain has improved remarkably since the introduction of a comprehensive and nationally organised organ donation system, which included many innovations. In the past 20 years, the organ donation rate in Spain has risen gradually to its current enviable level. As I have said, the refusal rate has also fallen. By comparison, the rate of 14% or 15% recorded in Britain in 1989 has remained static but it is considering whether to follow the Spanish model.

Interestingly, Spain does not have a donor register. The Spanish organ donation organisation does not actively promote donor cards, which play a pivotal role in our promotion of organ donation. At present, just 8% of the population of Spain is covered by donor cards. Transplant co-ordinators in Spain have a unique profile in facilitating the early identification of potential donors, particularly from small hospitals. They can be appointed at hospitals with a potentially low rate of deceased donors. Their daily work is carried out in intensive care units, where most donors are likely to be found. They have a particular focus on the importance of the family. The primacy of the family's wishes must be accepted as it is in Spain. Otherwise, the organ donation process could be greatly undermined. Trust is a crucial issue because of the unique circumstances surrounding deceased organ donation.

I would like to refer Members to an article in last week's The Sunday Business Post, which pointed out that "we rank low in the European organ transplant league, and Irish hospitals have no personnel on call to approach relatives". The article suggested that the whole operation is divided between two entities: the HSE and the Irish Medicines Board. It referred to Dr. Rafael Matesanz who is primarily responsible for what is being done in Spain. It mentioned that the "Minister for Health, Dr. James Reilly, has initiated a public consultative process on the introduction of an 'opt-out' system [which means] everyone is deemed to have consented to donate". According to Dr. Matesanz, the introduction of such a system did not boost Spain's transplant rates in practice, as the family of the deceased was invariably consulted.

Any public dispute about this sensitive topic can damage the image of organ donation and have a negative impact. Brazil had to change its laws again, some years after the adoption of a presumed consent approach was approved, because of public opposition. Surprise has been expressed about the low rate of organ donor referrals from some of the country's biggest hospitals. St. Vincent's Hospital is one of the biggest hospitals in the country. It has referred an average of 1.5 organs per year for transplantation over the past five years. There is a real onus on us to take up this issue. If we are to maximise our potential in this regard and end up with surplus organs, we need to follow the lead that Senator Daly has given us. We should not follow the examples of other areas, which have not led to the achievement of targets or to a reduction in the number of people who die as a consequence of not getting organs. I understand that one in ten of those who need transplants do not get organs and die as a consequence. It behoves us all to come together and ensure that state of affairs is put to rest for once and for all. We can do this by having a proper debate on this statutory instrument and on this area as a whole.

Senator Averil Power

I will be brief. Most of the points I had intended to make have been made by other Members in the past few hours. I do not wish to repeat them. I commend Senator Daly on introducing this motion and on facilitating this extremely important debate. I share the views of those on both sides of the House who have said that this will be a job well done - it will have been worth it for us all to have come back from our holidays - if one more person signs an organ donor card and saves somebody's life as a result of this debate. As we know, some 600 people are waiting on renal transplants this year. The least we need to do as an Oireachtas is do everything possible within our powers to ensure the best possible system is in place to meet the needs of those people.

It has been already said that this debate is not about the text of the directive. The leader of the Fianna Fáil group made that clear in his opening speech. I think we all agree that the directive was an important initiative at European level. The aim of the directive was to put in place proper systems across all countries. Like any legislative initiative, it is only as good as its implementation. Words are all very well. It does not matter whether these things are adopted at European level or through domestic legislation - a proper system for implementing them is needed. It has been pointed out that other countries have taken a much more effective approach. Senator Walsh spoke about what is being done in Spain. Croatia was mentioned earlier in the debate. It is clear from such examples that in addition to giving responsibility for this area to a single agency, in line with the spirit of the directive, we must ensure that people on the ground in hospitals work with families.

Donor co-ordinators need to be able to talk family members through this sensitive process, address their concerns and bring them to a point at which they are comfortable with having the organs of their loved one donated to give someone else an opportunity. That is essential because we all know how crazy our hospital system is at the best of times. All medical professionals have the best of intentions. They would wish to be involved in the conversation that takes place when a life ends with the intention of doing everything possible to facilitate the saving of another life. They are willing to encourage families to become donors, but they also have to deal with the other pressures of the hospital system. For that reason, somebody should be specifically tasked with the responsibility of prioritising organ donation and given the time to do so. It is essential for the proper arrangements to be put in place to that end.

There has been a great deal of debate in recent weeks about whether today's sitting is necessary. Many salvos have been fired between the Government side and the Opposition side on the matter. One of the things that has come out of all the publicity is that there seems to be a greater urgency on the part of the Government to address this issue. I welcome that. I hope it means that the necessary structure which needs to be put in place will be brought forward. If that is done, we will be the first people to welcome it.

I would like to refer to an incredibly important broader issue that has been raised. We have spoken at various points during the year about the lack of EU scrutiny. We spend days and weeks scrutinising the most innocuous domestic legislation. Sometimes the Government makes dozens of amendments to its own Bill a few weeks after introducing it. We spend hours debating how to correct tiny typos in Bills. We go through legislation line by line to make sure we get it right. Approximately 90% of Irish legislation now comes from the EU, and most of it gets very little scrutiny. As Senator Byrne said at the outset, during the summer period there is no opportunity for committees to be looking at legislation. Ministers are signing statutory instruments on important issues that have been initiated at EU level. I refer to legislation on criminal penalties, for example. It is absolutely essential that we examine our approach to legislation. It is crazy to spend long periods of time scrutinising simple and uncontentious domestic legislation while paying no attention to what comes from Europe.

One of the positive aspects of the Lisbon treaty, which was the subject of a contentious referendum that we all fought, is that it provided for new arrangements for the scrutiny of EU legislation by domestic parliaments. It put in place a yellow card procedure whereby initiatives that are proposed at EU level are immediately referred to domestic parliaments. Like other national parliaments, we have an opportunity to use the yellow card system to insist that legislative proposals be looked at again. I understand this system has been used just once by Ireland since it was brought in. I think that is crazy. It shows that the Dáil and the Seanad - both Houses of the Oireachtas as things are currently structured - are not doing their jobs. Incredibly important legislation is coming through Europe every single day. It is placed at the bottom of the agendas of Oireachtas committees, after many other things, and is not given proper scrutiny. We need to address that.

I hope one thing that comes from this debate, whether the Minister of State disagrees with the subject of the debate or not, is a commitment from the Government to put in place better arrangements for dealing with European Union legislation. One of the ways it should be done is through a reformed Seanad. A Government Senator referred to the Taoiseach's previous view on the role this House could play in regard to scrutiny of European legislation. There is an urgent need to address the issue and to look at the job this Parliament should be doing in the European context. If this debate achieves anything, I hope it brings greater urgency to this matter.

Senator Ned O'Sullivan

This is a serious subject and not suitable for joking, but as Charlie Chaplin once said, a day without a laugh is a day lost. The pre-war comedian, W. C. Fields had a lifelong grudge against a certain city in America. As he was approaching death, he was asked what was to be put on his tombstone and he said they should write on it: "All in all, I think I would rather be in Philadelphia." As I travelled to the Seanad, having torn myself away from the fleshpots of Kerry, I was not saying prayers for Senator Mark Daly. I was saying, all in all, I would rather stay in Ballybunion.

That said, by way of levity, Senator Daly has done the Seanad and the State a great service in succeeding with this recall today. I was unsure of this until I listened to the debate over the past two hours and saw the huge attendance from Members and the great and unaccustomed attention we are receiving from the press. This day will go down as an important day in the survival of the Seanad, which seems now to be becoming a reality. It is a pity the Taoiseach did not see fit to avail of the offers Senator Daly, our Leader and we made repeatedly in offering that the Seanad would fill this lacuna in Irish political life. Statutory instruments and directives from Europe are rubber stamped here on a daily basis and we offered to adopt the necessary investigatory and supervisory role. The Taoiseach rejected that and instead ran off with the populist and mad idea to abolish the Seanad altogether. It now seems likely this proposal will blow up in his face.

Senator Mary White pointed out the interesting fact that the Irish Kidney Association should be commended, because as one of the nominating bodies to the Seanad, it nominated Senator Daly and has used its power and facility intelligently and succeeded in having a motion raised on the floor of this House of the Oireachtas. This is real democracy in action - where a worthwhile and worthy organisation avails of its nominating power to have its business dealt with at the highest level. Those of us nominated by other bodies, such as trade unions, the Garda and so on, do our level best. We are not compromised by those nominations. Our obligation is to listen to our nominating bodies and present their concerns on the floor of the House. However, we remain independent and vote according to our own wits. This debate has been a very important exercise.

The recall of the Seanad, if it does nothing else other than heighten the issue of organ donation and if it saves even only one life, will have made this day worthwhile. I commend Senator Daly and commend the motion to the House.

Senator Paul Bradford

I have found what my colleagues have said interesting and would like to add my few inadequate words. I welcome the Minister of State back to the House. It is only a few weeks since we were here debating a matter of life and death. Organ donation is also very much a matter of life and death and we should reflect deeply on the opportunity to give life to hundreds of people across the country.

I would not see eye to eye with Senator Daly on most issues. I am certainly not a member of his Wind that Shakes the Barley school of politics, but I respect his right to have brought about this day of politics. I am rather surprised that so many people have been critical of him for trying to have the Seanad recalled, because during the month of August, virtually the entire political establishment seems comfortable to either attend various summer schools where they give their tuppence halfpenny worth of political ideology or else debate the great matters of politics and public policy across the opinion pages of the various daily papers. Yet, they are all very surprised when the place of politics, where ideas should be debated and policy enacted, the Oireachtas, is called upon to have a political debate. However, I welcome the fact we are here today debating a matter of public concern.

My friend and colleague, Senator Healy Eames, said she would await the Minister of State's response before deciding how to vote. I do not think similarly to Senator Healy Eames on all issues, but I am looking forward to hearing what she has to say. Everybody in the Houses wants to have a system in place where there is a maximum take-up and participation in the donation process. I was surprised to read in the fine note we got from the Library and Research Service of the House about the policy across the European union and beyond, which proves that as in all matters of life, this issue is not as simple as one would expect and that the view that an automatic opt-in would work better is not yet proven. This is a complex policy issue.

I am not an expert on the figures and I do not have significant information on this issue. However, a friend of mine who is in the Visitors Gallery today, has pointed out the situation in Bantry hospital to me. This is a small hospital in a small town in west Cork which, as a result of people being proactive on this issue, has been a major source of organ donation. This proves the need for a hands-on approach. I look forward to what the Minister of State has to say, but it would be remiss of us if we did not all concede that the way we do politics in the Houses and the country needs urgent reform. The fact we have not had this debate heretofore is not just the fault of the Government, but the fault of all governments and politicians because we rubber stamp so many decisions. We have handed over too much power to a central authority, to a small and new elite, the people who run the State. We the elected politicians, whether in the Dáil or Seanad, seem happy to rubber stamp decisions. We must move away from this.

If, by being here today, we show the need for political debate this would be helpful. On the subject of organ donation, we must also work together to engage and expand the programme. If we can do both of these, it would be a good day's work. I look forward to what the Minister of State has to say. I appreciate everyone wants the best possible solution. However, having been in the Houses a long time, I recognise the great fault in Irish politics, that government parties are always seen to be right and opposition parties are always seen to be wrong. It is never as simple as that.

Senator Daly has done us some service by bringing us back. He and his colleagues have made very cogent arguments as to why this motion should be approved. However, the Minister of State may be able to make an equally compelling argument. All I want to ensure is that once we leave here this afternoon, we will have done the best possible job for those people on the various transplant waiting lists and that we will have advanced their case and given them a real reason for hope. I thank the Minister of State for being here and urge him to approach the motion with an open mind. Nothing in politics or life is black and white. Nobody has perfect wisdom or knowledge. Senator Daly and his party colleagues and Independent Senators have put a good case. It remains to be seen how the Minister of State will respond. We will all try to deal with this subject not just sensitively, but in a fashion designed to give a degree of hope and optimism to the hundreds of people who want action.

Senator Paul Coghlan

Like everyone here I will be very interested in all that the Minister of State has to say. I am pleased he is here and, naturally, I welcome him to the House. I am unsure whether today will matter a whit but I thoroughly and utterly respect the right of Senator Daly, or anyone else, as well as the 20 Members who signed the petition to recall the House and have this debate. The debate has been useful and dignified. Many good arguments and points have been made. However, one year ago the Fianna Fáil spokesman in the other House recommended that the Minister should sign the necessary order. Both sides agree that there are many positive aspects in the directive. In fact, there is nothing in it that any of us disagree with. It contains good and sound regulations and I imagine the Minister of State will expound on these when he comes to speak.

Senator Power raised a good point that we have highlighted previously and referred to often in the House, that is, the need for European scrutiny. The Leader, Senator Maurice Cummins, has often referred to this matter and he has implored the Government for the House to be allowed to address those matters in a more detailed and meaningful way. Anyway, sadly, that has yet to happen.

I have nothing further to say. I said to the Minister of State before coming to the House today that I would come, like all of my colleagues, to take part, to enjoy the debate and to listen, but especially to hear the Minister of State and to hear an authoritative word from what I term official Ireland - I will not say "the establishment". We are a constitutional democracy and I have no doubt the matter has been dealt with properly. I will leave it at that and I look forward to hearing from the Minister of State.

Senator Diarmuid Wilson

I, too, welcome the Minister of State, Deputy White, back to the House. I am always pleased to see a former colleague in the House in his rightful place as a Minister of State representing the Government and I hope to see it recurring for many years to come. However, I wonder where his senior colleague, the Minister for Health, Deputy Reilly, is today. Surely he could have taken a day's leave and come before the House for this important matter. Anyway, that is not for the Minister of State to answer.

Certainly, I would not be part of any political stunt. If I thought for one moment that Senator Daly was trying to pull a political stunt I would not have signed his request for the Seanad to be reconvened and I imagine none of my colleagues in Fianna Fáil or my other colleagues in the House would have signed the request if they thought it was a political stunt either. I signed it because I believe it is a genuine and serious matter. Furthermore, I have no doubt that my colleague, Senator Daly, is genuine and serious about this matter. He has been attempting for almost 12 months to have this debated. I bow to the words of my colleague, the eminent lawyer, Senator O'Donovan, who said that this was the only opportunity available to Senator Daly and his colleagues to have this legislation and the EU directive debated and, hopefully, rescinded.

Senator Daly is a colleague of mine but he is also a political opponent. Nevertheless, I will defend his right to raise any matter under the Constitution that could potentially save the lives of 650 people now and thousands of people in future. We have no difficulty with the EU directive signed into law by the Minister for Health, Deputy Reilly, towards the end of August last year. However, as other colleagues have eloquently outlined to the House, it is the bare minimum that was required under the directive. We have serious reservations in respect of several issues he did not include. These include, primarily, why there is no national transplantation office in the country, why the Minister for Health chose to divide the responsibility between the HSE and the Irish Medicines Board and why there are no organ donation co-ordinators placed in the major trauma centres in the country. I gather the number of organ donations could increase by more than 50% if these two simple matters were implemented. I understand that in Northern Ireland, which is small geographically and population-wise, there are 26 such co-ordinators and that it has seen an increase of 50% in organ transplant donations.

Another issue highlighted by the recall of the Seanad relates to all the legislation that is debated in the Oireachtas. We hear a good deal about political reform, which, according to the Government, means getting rid of town councils, reducing the number of county councillors in rural Ireland and moving them to the east coast and getting rid of this House. For every tranche of legislation debated in the Houses of the Oireachtas three further tranches of legislation are signed into law without even being looked at. That is a reality and it has been highlighted today.

I welcome the fact that the Government has entered into public consultation on the introduction of an opt-out system of consent for organ donation and I welcome the fact that a consultation process is under way. However, were it not for this debate I would not even know about that and I am a legislator.

A cousin of mine was the recipient of a kidney transplant 15 years ago as a young man. He has since married and has five beautiful sons. Only for the generosity of his donor and others like him it would not have been possible. I commend and compliment the Irish Kidney Association on the work it carries out. If we can increase the number of donations as a result of this debate today by one or two, then, as some colleagues have said, we will have done a good day's work. I commend all my colleagues who signed the recall petition and in particular I commend Senator Daly on the work he has done in this regard.

Senator Mark Daly

I thank my colleagues on both sides of the House and the Minister of State for attending. The Irish health system has been pockmarked by horrific political and systems failures by successive Governments which have damaged and cost the lives of our citizens. The Minister for Health, Deputy Reilly, had a chance to put in place an effective organ donation and transplantation system that would have saved the lives of hundreds and enhanced the quality of life of thousands as well as saving the taxpayer millions. The Minister ignored the opportunity to put appropriate measures in place by ramming through this flawed EU law on organ donation and transplantation which, I believe, is disastrous.

We sought the recall of the House to seek the annulment and replacement of this flawed EU law. I wanted the Minister to come to the House and listen to his colleagues. I wanted him to hear the advice that we have received from health care professionals and organ donation groups on what should have been done. Since the Minister signed this EU legislation into Irish law some 65 people have died on our waiting lists. There are 650 people waiting for heart, liver, lung, kidney and pancreatic transplants in Ireland and one in ten of these will die. If the 500 people who are awaiting a kidney transplant were to receive one, we would save the taxpayer €325 million. For the 1,800 people who are currently receiving dialysis, it will cost the taxpayer a total of €1.2 billion over ten years. If we had put in place a new system it could have improved the lives of those who are on dialysis and shortened their waiting time for a transplant. It would have ensured that the taxpayer would save money and that hundreds would have been taken off dialysis early. All the Minister had to do was follow what had been done in other countries.

There are those who have criticised this recall in government and among the commentariat. They say that it will achieve nothing.

The evidence, however, is to the contrary. In a departure from its indication at the beginning of the year that no legislation was forthcoming, the Government has now undertaken to publish the human tissue Bill before the end of the year. We hope it will be done. People working in the media have indicated to me that the National Office for Organ Donation and Transplantation is now set to receive funding and staffing. We have succeeded in raising awareness of the catastrophic system that operates in this country. For the first time, a Chamber of Parliament is debating actual legislation, as opposed to theoretical legislation, on organ donation. It is the first legislation in the history of the State on this issue. Until 12 months ago, when the Minister signed it into law, we did not have any such legislation on the Statute Book. The difficulty, as Mr. Mark Murphy of the Irish Kidney Association has described it, is that we have had the worst implementation of the EU directive in any member state.

The reason people on the organ transplant list are dying has nothing to with the medical profession, whose members are doing their best within a system that is far from perfect. The reason we do not have a proper and functioning organ donation and transplantation system is the failure of successive Governments and politicians to legislate properly for systems that actually work. The perception among the public, as my colleagues pointed out, is that the Dáil and Seanad make most of the laws in this State. The reality, in fact, is that it is Ministers who sign EU provisions into law, in some cases after they have amended them in consultation with their officials. These provisions are placed into Irish statute without referral to the Dáil, Seanad or relevant Oireachtas committee. In one 12 month period, Ministers of this Government signed 164 EU directives into Irish law. Over the same period, 49 Acts of the Oireachtas were debated by the 166 Members of the Dáil and the 60 Members of this House.

The transposition of this particular EU provision into Irish law began with a consultation process on 24 May 2012 in Dublin Castle under the aegis of the Health Service Executive and involving experts such as health care professionals, consultants and representatives of the organ donation organisations. Amazingly, those discussions took place in the absence of a draft of the version of the EU law the Minister proposed to transcribe into Irish law. In the same month the Irish Donor Network, representatives of which are in the Visitors Gallery today, wrote to the Minister asking him to ensure that any draft regulations would be put before the Joint Committee on Health and Children and the Oireachtas for debate. In June 2012, the Irish Kidney Association wrote to the Minister adding its voice to the calls for the provision to be examined by the health committee. I wrote to the Minister in July 2012 asking that it be debated by the committee prior to its signing into law. On 27 August 2012, however, without any Member of the Oireachtas having had sight of the instrument, it was signed into law.

Ten days later, as allowed for under the provision we have utilised today, 27 Members of the Seanad wrote to the Minister asking for the House to be recalled to debate the regulations ten to 21 days from the date of receipt of the letter by the Chair. We were prevented from doing so. The Government has now admitted that the House should have been recalled and the debate allowed. In the meantime, however, we have lost votes in this Chamber on proposals to have the provision debated in ordinary time. As my colleague, Senator Denis O'Donovan, pointed out, we are seeking today to have the instrument annulled in order that it can be replaced with better legislation. We are not here to have a debate on it. The legal provision we have availed of today is the mechanism available to annul the provision, not simply to have a debate on it.

What should the Minister have done with this EU law? He should, in the first instance, have appointed a single national transplant authority, an approach which has led to an increase in the organ donation rate in Croatia and Spain. The head of the Spanish transplant authority, Dr. Rafael Matesanz, has described this as the most important thing Ireland could do. I am not in favour of presumed consent, but that is a distraction in this debate. I am in favour of what works. We know that what works is a single transplant authority and a network of organ donor co-ordinators. The Government has conceded that the Seanad should have been recalled last year to discuss this issue. Today we are calling the Government to account for its failure to consult the Seanad, Dáil or health committee before this provision was brought into Irish legislation. It is a flawed provision and a new version is required. Its transposition into Irish law was a missed opportunity for the Government to put in place a 21st century organ donation and transplantation system for the people on the donor waiting list who are anxiously awaiting a telephone call from their hospital. The most disturbing headline in recent weeks was the one on the front page of The Sunday Business Post, in reference to an interview with Dr. Matesanz, which proclaimed "Government's organ transplant policy costing lives". The 650 people awaiting life saving organ donations deserve better from their Government and their public representatives. We must give them every chance as citizens of this State to realise their full potential. That is their entitlement.

Minister of State at the Department of Health (Deputy Alex White)

I am pleased to have the opportunity to endorse SI 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 quality and safety standards in respect of 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 which generally reflected the cultural values of that state and were developed in accordance with its particular legal, administrative and organisational frameworks. Given the importance of having in place appropriate systems for the authorisation of organ procurement and transplantation centres, a directive was drafted based on common quality and safety criteria. The aim was to ensure the safety and quality of organs and the protection of organ donors and recipients throughout the EU, and allow for the safe exchange of organs between member states.

The draft text of the directive was examined by the Joint Committee on European Scrutiny on 27 January 2009. Senator Katherine Zappone made the point that the committee, in its wisdom, determined not to scrutinise the proposal. Although it might sound odd, it is nevertheless true that for the scrutiny committee to decide not to pursue a debate or examination of a particular legislative provision is in fact a decision of the committee. I am sure Members who have had the privilege of sitting on that committee understand what I am saying. I see Senator Mary White is smiling. Several dozens of proposals come before the committee and it must decide which require further debate. That is in itself a decision of substance. Members generally examine the documentation setting out the various proposals - I have done it myself - and will discuss with the Chairman and colleagues which of them require scrutiny. I am not criticising anyone for deciding whether any provision requires debate. I am simply pointing out the reality of what occurs in that committee.

Members referred to the issue of parliamentary reform, with particular reference to EU legislation. I agree with Senator Averil Power and others that we have serious deficiencies in our parliamentary system in regard to the scrutiny of EU proposals. I have no difficulty in conceding that this is manifestly the case. However, even if we had the very best system anyone could possibly conceive, there is no prospect in the wide earthly world that every draft legislative provision, directive or measure coming from the EU could be scrutinised as a matter of plenary debate in a committee. There simply are not enough days in the year or hours in the day. It could not and will not happen. I very much hope we will have a better scrutiny system in place in due course. Whether that is on the basis of one well functioning Chamber or two less well functioning Chambers, as we have at the moment, will be a matter for the people to decide. Whatever the situation, we must have a proper system of scrutiny of EU legislation. I can agree with that much. However, it does not mean we will be scrutinising everything that comes from the EU, because that is not a realistic prospect.

Even if we take the titles on the Order Paper before the House to which Senator Byrne referred, I do not wish to make light of any piece of legislation but under Open to motion to annul, the third last one is the European Union (Conservation of Wild Birds (Horn Head to Fanad Head Special Protection Area 004194)) Regulations 2013. Will we spend time on that, even if we have a first-class scrutiny system? That has to be open to some question. Will we spend time in a properly functioning scrutiny system on the European Communities (Notification of Small Hive Beetle and Tropilaelaps Mite) (Amendment) Regulations 2013? From looking at the title it seems unlikely that we will but that is not to say we would not want to spend a good deal of time on many of the regulations, directives and proposals that come from the European Union such as this one, which manifestly merits discussion and consideration in a parliament.

Very good. We are happy about that.

To come back to this proposal, it went to the European scrutiny committee 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, the Minister for Health, Deputy James Reilly, transposed the directive into Irish law by means of the European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012, which is the measure being addressed today, and were signed by him on 27 August 2012.

On the question of directives, Senator Crown should be aware that it is not true to say that directives are not binding. EU directives are binding as to the result to be achieved. There is no question about that. Unlike regulations they leave open the question of the forms and methods the national authorities choose but they are binding. It is important to remember that. That is one aspect of this debate that should not be forgotten.

The regulations signed by the Minister on 27 August 2012 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. I emphasise "sitting days". The clock starts at the beginning of the 21 days. It does not run through each day the Parliament is in recess. It is sitting days. That period expired on 14 November 2012 and no objections were raised.

I have some difficulty understanding the proposition that it was necessary, without criticising the question of the Seanad not being recalled last year because that is a matter for the Seanad, to recall the Seanad because I know the Seanad was sitting well before 14 February 2012 after the summer recess. I have some doubt in my mind as to why Senator O'Donovan, or perhaps it was Senator Daly, said it was necessary for it to be done on that occasion. It seems to me that was not the case.

Leaving aside the question of whether the Senator would have obtained time on the floor of the Seanad, which is not a matter for me, I have to ask if a motion was put down to annul the statutory instrument.

Senator John Gilroy

No.

Deputy Alex White

No such motion was placed on the Order Paper of the Seanad last year-----

Senator Darragh O'Brien

It cannot be put down unless the House is recalled.

Deputy Alex White

-----and that has to be taken on board. No effort was made. There may have been an effort to recall the Seanad, which seems to have been unnecessary, but no motion appeared on an Order Paper either here or in the other House seeking to annul or set aside the statutory instrument, as was the opportunity afforded to Senators. I am not resiling from what I said earlier about the inadequacy of our system of scrutiny of European legislation. I simply point out that even the limited opportunities the Senators have were not availed of because a motion was not placed on the Order Paper seeking to do so last August. It is not until now that has occurred, just a year later.

As I 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.

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. Regarding 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.

How could the Seanad, with every respect to this Chamber, 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 United Kingdom to our mutual benefit? What conceivable basis could there be for annulling such regulations? That is my answer to Senator Ó Murchú who asked about the Government's position and why they should not be annulled.

Senator John Gilroy

Absolutely.

Deputy Alex White

No case has been made of any strength in this House or elsewhere that these regulations should be annulled-----

Senator Jim Walsh

That is not true.

Deputy Alex White

-----and no serious argument has been advanced. 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 that.

Every effort must continue to be made to increase organ donation rates and to enhance our transplantation system. The Health Service Executive’s National Organ Donation and 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, will continue to develop strategies and practices aimed at optimising outcomes of the organ donation and transplantation system. This 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.

The HSE is working to assign donor co-ordinators across the hospital system. A number of Members raised that issue and I assure them that is being addressed. This is an administrative process independent of the EU directive, and so much of what has been argued for and advocated in the debate are not matters that arise from the directive. These are broader policy issues the Members are properly raising and urging on the Government to advance. I have no difficulty with the Members raising those questions and seeking to pursue them but they are not matters that are germane to the substance of the directive, which is what the Senators are asking to have annulled.

The directive specifically provides that member states may designate one or more competent authorities. This is an issue that was raised by the Members in regard to the directive. In an Irish context, the Government believes it is entirely appropriate to assign competent authority functions between the Irish Medicines Board and the Health Service Executive. It is wrong for anybody to seek to invoke the terms of the directive to justify suggesting that we were not faithful to the directive in regard to the regulations. Point (24) of the preamble to the directive states that the member states should have a key role to play and so on. It goes on to state:

As emphasised by the Recommendation ... of the Committee of Ministers of the Council of Europe to Member States on the background ... it is preferable to have a single non-profit making body which is officially recognised with overall responsibility for donation, allocation, traceability and accountability. However ...

The two or three Members who raised this earlier should have quoted the text after "However". It is interesting the way people selectively quote matters. It goes on to state:

However, depending especially on the division of competences within the Member States, a combination of local, regional, national and/or international bodies may work together to coordinate donation, allocation and/or transplantation, provided that the framework in place ensures accountability, cooperation and efficiency.

There is nothing in the directive of that kind and it is wrong to suggest that there is.

Senator Brian Ó Domhnaill

That was specifically in the UK model.

An Cathaoirleach

The Minister of State, without interruption.

Deputy Alex White

Article 17, which is the operative part of the directive, makes it clear. It reads, "Member States shall designate one or more competent authorities", and Senators should not be referring to-----

Senator Brian Ó Domhnaill

The UK made that application. The Minister of State is misleading the House.

An Cathaoirleach

The Minister of State without interruption.

Deputy Alex White

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.

Barrett, Sean D.
Bradford, Paul.
Byrne, Thomas.
Crown, John.
Daly, Mark.
Healy Eames, Fidelma.
Leyden, Terry.
Mooney, Paschal.
Mullen, Rónán.
O'Brien, Darragh.
O'Brien, Mary Ann.
O'Donovan, Denis.
O'Sullivan, Ned.
Ó Clochartaigh, Trevor.
Ó Domhnaill, Brian.
Ó Murchú, Labhrás.
Power, Averil.
Quinn, Feargal.
Walsh, Jim.
White, Mary M.
Wilson, Diarmuid.
Zappone, Katherine.

Níl

Brennan, Terry.
Burke, Colm.
Burke, Paddy.
Clune, Deirdre.
Coghlan, Paul.
Comiskey, Michael.
Conway, Martin.
D'Arcy, Jim.
D'Arcy, Michael.
Gilroy, John.
Hayden, Aideen.
Henry, Imelda.
Higgins, Lorraine.
Keane, Cáit.
Kelly, John.
Landy, Denis.
Moran, Mary.
Mullins, Michael.
O'Donnell, Marie-Louise.
O'Neill, Pat.
Sheahan, Tom.
van Turnhout, Jillian.
Whelan, John.

Tellers: Tá, Senators Ned O'Sullivan and Diarmuid Wilson; Níl, Senators Paul Coghlan and Aideen Hayden.

Question declared lost.

An Cathaoirleach

As there was an equality of votes, I therefore, pursuant to Article 15.11.2° of the Constitution, have had to exercise my casting vote. I voted against the question in this case. As the numbers are now Tá: 22 and Níl: 23, the question is declared defeated.

The Seanad adjourned at 2.10 p.m. until 2.30 p.m. on Wednesday, 18 September 2013.

Seanad Éireann díospóireacht - Tuesday, 20 Aug 2013

European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012: Motion

Tá

Níl

Seanad Éireann díospóireacht -
Tuesday, 20 Aug 2013