Pearse Doherty (Donegal, Sinn Fein)
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Tá mé buíoch gur roghnaíodh an t-ábhar seo, a bhaineann le seirbhísí máithreachais in Ospidéal na hOllscoile, Leitir Ceanainn. I am appalled to say that this is not the first time I have raised this issue in this House. I refer to the fact that we have a maternity theatre suite in Letterkenny University Hospital that has never been commissioned. Indeed, there was widespread public anger when Senator Pádraig MacLochlainn and I revealed to the people of Donegal that the bespoke facility constructed in 2000 as part of the redevelopment of the hospital's renal dialysis block has never been used. Incredibly, when we pressed the management of Letterkenny University Hospital to explain the rationale behind this at a meeting, we were told that it was a resource issue. The necessary staffing was never put in place, and other resources were never provided, so therefore the theatre was never commissioned.

It is almost two decades since this facility was built. Before I spoke, I thought about the Minister for Health, Deputy Harris, who has to make a decision on this matter. He was 14 years of age when former Taoiseach Bertie Ahern announced the new theatre in Letterkenny University Hospital. He was probably entering secondary school. Today, he is the Minister for Health, and over that whole period not one mother has had the benefit of the use of that theatre, on which the taxpayers of Donegal and elsewhere spent a large amount of money to create. Why is this happening and when will it be put right? It is my view that the problem is down to sheer incompetence on the part of successive governments. At worst, it amounts to neglect of a part of the country which has been neglected time and time again by successive governments. That is shameful, and a dereliction of the duties of those governments towards the people of Donegal. In this instance, it is particularly a dereliction of their duties towards the women of Donegal.

It is a deplorable situation, but to make matters worse it comes at a time when the hospital continues to experience record-breaking levels of overcrowding. Letterkenny University Hospital has been in emergency status since before the start of this year. It has lengthening patient waiting lists. The hospital has four operational inpatient operating theatres at the moment, yet only three of them can be used all the time. The reason is that the fourth theatre is now used as the maternity theatre because the other maternity theatre, built 18 years ago, was never commissioned. This means the hospital is down to three full-time operating theatres. As a result of this, consultants tell us that they cannot get operating theatre time because one of the theatres is now used for emergency caesarean sections and so on. That means that of the five theatres we have in Donegal, only three are used on a full-time basis. That is not an effective use of resources, and it has been the case for the past 18 years.

Ba mhaith liom ceist a chur ar an Rialtas inniu. Cad é atá ag dul a tharlú i dtaobh an ospidéal seo? An bhfeicfimid an seomra seo ar feadh 18 bliain eile, nó an bhfuil Feidhmeannacht na Seirbhíse Sláinte agus an Rialtas chun pacáiste airgid a chur ar fáil sa dóigh is go dtig linn é seo a chur i gceart? It is unbelievable to think that, while lists grow in Donegal and demand for operations and procedures are at an all time high, the hospital has a purpose-built maternity theatre on site that has been lying idle since 2000. It takes up half of the entire floor it is situated on. To make things worse, a mother who is giving birth and who develops complications in the maternity suite, who should go next door to theatre for an emergency caesarean section, now has to be wheeled out of the maternity unit, through the halls, into a lift and taken to a different floor where the theatre she can be operated on is located.

This ensures that reimbursement decisions are made on objective scientific and economic grounds. The HSE has advised the Department that, following an intensive process, it has decided not to reimburse Vimizim, which is for the treatment of Morquio A syndrome. I appreciate that this condition is a serious one and that the families of children diagnosed with this illness are extremely anxious to obtain any treatment which they believe will alleviate its symptoms. The HSE drugs group, which reviewed the effectiveness of the drug, did not consider the evidence for its clinical benefit to be sufficiently strong in the context of the proposed cost and budget impact.

The applicant company was notified on 7 November 2017 of the HSE’s decision not to add Vimizim to its reimbursement list. The HSE advised the company that it would be open to reviewing any additional clinical evidence if this becomes available. The company submitted a new application for reimbursement in December 2017. This was discussed at the January 2018 drugs group meeting and will be considered further by the HSE leadership in the coming weeks.

Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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The HSE drugs group, in its decision not to reimburse Vimizim, has on both occasions stated that there is a lack of clinical evidence on the effectiveness of the drug. They have acknowledged that the budget impact to cover the cost was relatively low. The drugs group itself agreed that cost was not an issue. When we talk about drugs we worry mostly about the cost. The drug is available in most of the European Union, including Northern Ireland, our neighbours, and is actually manufactured in Ireland. The manufacturing company applied again to the HSE drug group with new evidence late last year after the drug was rejected at the September meeting. This evidence was largely from the managed access agreement that the company are running in the UK, which the UK accepted. If the clinical evidence has proven acceptable in other countries and the HSE has acknowledged that the cost is not the primary barrier to reimbursement, then the drug should be made available to those who need it.

In respect of the cost, there are figures in the public domain which indicate a very high costing for the use of the drug per patient. These figures are factually incorrect as we are dealing with a weight-based drug, which means that the publicly quoted amount is substantially higher than what the price per patient would be because they are small and the weight per patient means less cost. It is also worth bearing in mind that in the decision not to reimburse the drug the cost was not cited as a significant factor in the decision.

In respect of the managed access agreement, BioMarin has an arrangement in the UK with the National Institute for Health and Care Excellence, the NHS and the patient group where patients who suffer from Morquio A syndrome sign a contract which states they must attend all medical sessions and that, if after a year the medical records note that there has not been an improvement in their circumstances, they agree to come off the drug. In England, if the drug does not work, there is an agreement to stop using it if it is not having any effect. This has the benefit of ensuring that patients who do benefit from the drug can use it and that those who do not discontinue treatment, ultimately ensuring that the costs associated with the drug are solely associated with those patients who benefit from the drug. Clinicians who currently work in this space in Ireland have drawn up a similar guideline in Ireland and the patients are also willing to engage on this basis going forward.

In respect of the HSE drugs group challenges, the decision-making process is non-transparent which leaves the patients and the pharmaceutical company in the dark. The current nature of the drugs reimbursement process as a whole is unsustainable. There are problems associated with the quality adjusted life year based analysis for rare and orphan drugs.

There are two little girls looking down on the Minister of State here today. Next Friday, they will not have this drug, which has helped them over the past four years. Will the Minister of State please, on humanitarian grounds, bring this issue back to the task force and explain the situation? It will involve only a small cost to the taxpayers of this country.

Jim Daly (Cork South West, Fine Gael)
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I assure the Deputy that I take very seriously my responsibilities in the Department of Health. Indeed, the Deputy takes his responsibilities very seriously, which includes being a representative for his constituents, as indeed does Deputy Martin Kenny. The Deputy makes a very good case, and I certainly will convey the very well presented and well-felt feelings for the two girls, his constituents, who are affected by this.

As the Deputy and the House will appreciate, neither I nor the Minister for Health, Deputy Harris, can tell the Department or the HSE what drugs to okay and what drugs to reject. There is a process in place as a result of the Health (Pricing and Supply of Drugs) Act 2013 which was passed in this House. The criteria is now set in law. It is a strict criteria because we cannot have a situation where drug companies can charge the State, funded by the working and contributing classes of this country, any price they want. There is no magic pot out there. We have to have a structure and there has to be a system in place. While that system is in place, I appreciate that there is a lot of anxiety on the part of the families now. My Department has written to the HSE and asked it to ensure that the care of these two people is paramount in all considerations, and that they will be contacted and kept informed of any decisions and assisted in any way possible. I will redouble those efforts, on behalf of my Department, and convey that to the HSE today, and I can assure the Deputy of that on foot of his request. I cannot go any further and give any confirmation at this stage as to what drugs will or will not be reimbursed by the State.