21. Deputy Billy Kelleher asked the Minister for Health the reason for the record overcrowding in hospital emergency departments to date in 2017; and if he will make a statement on the matter. [48416/17]
Vol. 961 No. 5
21. Deputy Billy Kelleher asked the Minister for Health the reason for the record overcrowding in hospital emergency departments to date in 2017; and if he will make a statement on the matter. [48416/17]
What is the reason for the record overcrowding in hospital emergency departments to date in 2017? Will the Minister make a statement on the matter? He is aware that all overcrowding records have been broken in hospital emergency departments this year to date. As recently as this morning, Temple Street Children's University Hospital has advised people not to attend its emergency department because of overcrowding.
The issue, as it is now November, is very worrying. Are the hospitals prepared for winter? Will they be able to cope? I ask the Minister to make a statement on the record overcrowding in our emergency departments.
I thank Deputy Kelleher for his question. We all acknowledge the distress caused to patients and families, and indeed the impact on staff, when cramped and overcrowded conditions are experienced in some of our hospital emergency departments. I have outlined on many occasions what we need to do to break that cycle. I have referred to the bed capacity review and the need for significant capital investment. We need to turn Sláintecare into a reality and take some services out of our acute hospitals and put them into primary care. I opened a primary care centre in Castlebar, County Mayo, last Friday. In April of this year, there were 517 people were awaiting X-rays at Mayo General Hospital. That figure has now been reduced to zero as a result of the decision to provide such facilities in the primary care system.
By the end of September, emergency department attendances had increased this year by over 1.8%, or more than 16,000 patients. This includes a 5% increase in emergency department attendances by people over the age of 75. In this context, trolley numbers and patient experience times are showing some small improvements on this time last year. That is not to suggest there is anything to be triumphalist about. HSE data show that on 13 November 2017, over 1,000 fewer patients were waiting on trolleys this year compared to last year. It is important to acknowledge the progress that is being made by our hospital and our front-line staff.
According to the HSE's TrolleyGAR figures, which are published on the HSE website at 8 o'clock every morning, every day so far in November there have been fewer patients on hospital trolleys than there were on the same day last year. There have been fewer patients on trolleys 15 days in a row. Winter started on 1 November, presumably, and it is now 15 November. On every single one of those days, there have been fewer patients on trolleys. I accept that the number of patients on trolleys is still far too great. I do not accept the idea of constantly referring to new records at a time when some of our front-line staff and management personnel are making significant progress.
Several hospitals are showing significant overall improvements in trolley numbers. According to HSE data for the period to the end of September, the number of people on trolleys at Mayo General Hospital, Our Lady of Lourdes Hospital in Drogheda and Beaumont Hospital has reduced by between 30% and 40% compared to the same period in 2016. The Deputy is right when he suggests we have an awful lot more to do. I think we all share a view on what needs to be done in the medium term. What are we going to do right now as we come into the winter? I am happy to confirm that €40 million in additional funding has been made available as part of budget 2018 to address winter pressures and waiting lists over the rest of this year. A further €45 million has been allocated for measures to improve access to unscheduled care and other acute hospital priorities. That means more home care packages.
Additional information not given on the floor of the House
Some of this funding is already being utilised within the system, with an additional 45 home care packages and 20 transitional care beds being provided each week for the duration of the winter period. This funding will allow patients to return home or go to an appropriate community setting, when clinically appropriate, thereby helping to alleviate some of the pressures our hospitals are experiencing. Funding will be provided to increase bed capacity this winter and as part of service planning for 2018. The Department of Health is undertaking a health service capacity review in line with a commitment in the programme for Government. The findings of this review, which are due to be published before the end of the year, will provide an evidence base for future capacity decisions. All hospital groups and community health organisations have developed and put in place integrated winter preparedness plans for their localities focused on planning and escalation preparedness, maintaining patient flow processes and ensuring public health preparedness.
The Government is making an effort to normalise misery and mediocrity in all areas of Irish life. The Taoiseach recently spoke about the normalising of homelessness. This can be seen in the crime statistics as well. Now there seems to be an acceptance that having 500 people on trolleys is the new norm. It is simply not acceptable. I recently received information in replies to parliamentary questions about the number of people over 75 years of age who are waiting 24 hours or more on trolleys in emergency departments. The Government is failing to achieve the targets it has set for itself. Elderly people are lying on trolleys. All the clinical evidence shows that if proper wards are not accessed in a timely manner, there are adverse health outcomes. Overcrowding is costing us lives. The statistics are there. This can be seen every day of the week. The individuals behind the statistics are lying on trolleys. Some of them are having adverse health outcomes because of the extraordinary lengths of time that people are waiting in our emergency departments on a daily basis.
With regard to the question of misery, when I refer to publicly available data to counter the figures put forward by the Opposition, why is it acceptable for me to be accused of trying to normalise a bad situation? Nobody, least of all me, has said it is good to have anybody on a trolley. Of course it is not. It is socially unacceptable. We have to do a hell of a lot more. I am not going to stand here and allow Deputy Kelleher to decide the narrative. I am going to follow the evidence and see where it brings us. Every single day so far in November, there have been fewer patients on trolleys. I will send a copy of those figures to the Deputy. Perhaps I will put them on the record of the House. The idea that the Deputy has decided that this is the worst winter ever, even though the winter period just started at the beginning of this month, is not factually backed up. That is not to say we do not need to do much more. The Deputy is particularly right when it comes to older people on trolleys. That is why we are putting in place a programme of frailty teams. This will mean that older people are streamed to geriatricians when they come through the doors of our emergency departments. We need to do more with home care packages. Funding has been provided for an additional 45 home care packages each week from now until the end of the year. This will be sustained throughout 2018. More transitional care beds are being provided. More hospital beds are being opened. An additional 60,000 flu vaccines are being given out this year. We have a lot to do. The statistics show that some hospitals are making progress.
The Minister is quoting statistics for November, but the annualised figures show the reality that the health services are still under huge stress.
Our emergency departments are the point where this is most obvious on a daily basis. The Minister can pick out statistics to show there has been a small reduction in the number of people on trolleys so far in November, but the overall position points to the fact that our hospitals simply do not have sufficient capacity. I refer to the numbers of beds, clinicians and front-line staff dealing with patients. That is manifesting itself in the consistent need to keep elderly people on trolleys for long periods. Front-line staff are saying that this is jeopardising patient safety. With the onset of winter, the concern is that this could have profound implications for the ability of our emergency departments to cope in the event of an outbreak of flu or the winter vomiting bug. I do not believe we are prepared to deal with that if it happens, as it probably will.
I do not disagree with the Deputy's analysis. Our hospitals are overcrowded. There is not enough capacity. We need a bigger health service in terms of bed capacity. The Sláintecare report, which the Deputy helped to co-author, provides a roadmap in this respect. I look forward to going before the Joint Committee on Health and Children next Thursday to outline the steps we have taken in this regard. The bed capacity review I will receive by the end of this year will tell us how many hospital beds and other beds we need right across the health services and for the next 30 years. It will set out how many beds will be needed if we stand still and do nothing and how many beds will be needed if we implement Sláintecare. The Deputy is right when he says we need to get on with expanding capacity. As of today, I have to use all the levers at my disposal, including more social care, more community intervention teams, opening transitional care beds, encouraging people to get the flu and trying to encourage people to go to the appropriate place, which is not always the emergency department.
I am sure the Minister means that people should get the flu injection.
Very much so. People should get the flu vaccine, rather than the flu.
I am pretty sure the Minister does not want to encourage people to get the flu, especially after last year.
22. Deputy Louise O'Reilly asked the Minister for Health when his attention was drawn to the side effects and complications of transvaginal mesh implant procedures; the steps he has taken to address and take control of the situation; if he will instruct the HSE to establish a register of women impacted by complications from the procedure; and if he will make a statement on the matter. [48282/17]
This fairly simple question relates to the complications associated with transvaginal mesh implants. The details of some of the serious complications do not make for easy reading for anyone. Those who have met the people affected by this issue will appreciate that it is serious. This question gives the Minister an opportunity to tell me what he is doing about this matter.
I thank Deputy O'Reilly for bringing this serious matter to my attention. I have been made aware of concerns about complications arising from the use of transvaginal mesh devices in women. Recent media reports here and elsewhere have highlighted concerns that have arisen for some women. A number of women who had these devices inserted for the treatment of specific medical conditions have reported negative experiences. It is important for me to say that these devices have been shown to be as effective as more invasive surgery, with the advantages of shorter operating and admission times, a quicker return to normal activities and lower rates of complications. My Department is not aware of any scientific evidence which concludes that these devices are unsafe when used in line with their intended use. These mesh devices continue to be certified as compliant with EU legislation and have not been removed from the market by regulators in Europe.
As the Deputy will appreciate, there is no such thing as a medical or surgical procedure that does not carry some risk. That is why the Health Products Regulatory Authority monitors the safety of medical devices placed on the market and monitors international data on such matters. The authority has received six incident reports in relation to these devices, four of which have been received following recent media coverage. Perhaps this suggests that more people are coming forward as they are being made aware of this issue. It is important that clinical facts and evidence determine the further response I give to the issues raised by the Deputy. I have asked the Chief Medical Officer to provide a report on the issues raised. He has informed me that the engagements he will require with national and international bodies, the professional colleges and others will require some months to complete before he can make recommendations to me. I ask the Deputy to await the completion of that work. I will keep her and the House informed. In the interim, I advise any woman who experiences or suspects that she has experienced such a complication to discuss this with her GP and indeed with the hospital from which she received the implant. I will ask the Chief Medical Officer to undertake the body of work I have mentioned.
To be honest, I do not think the Minister is taking this matter at all seriously. I asked him when his attention was drawn to this issue. He has advised me that he read about it in the media. It strikes me as odd that his officials have not kept him informed about this problem, especially because multi-party actions in this respect are under way in a number of other countries. We discussed such class actions, as they are also known, in the House last night. I raised this matter over a month ago and I am doing so again today because I think we should all be worried about it. The complications as a result of this device need to be addressed immediately.
I welcome the fact that the chief medical officer will compile a report. It is worrying that we cannot put our hands on the number of these devices that have been used. If we were standing here talking about trans-penile mesh or a men's health issue, we would not be having this conversation. It is outrageous that there is no register of the number of devices that have been used and the women who have used these devices so that at least we would know what the scale of the problem might be. More people are going to come forward as this issue receives more attention.
I thank the Deputy for raising an important issue. She can do so without the political partisanship she brought to the issue or the suggestion that she has a monopoly on concern for women's health and nobody else gives a damn, which she should really reflect on very carefully. Nobody in this House-----
I did not use that language.
The very clear implication that if this was a male rather than a female condition, she would get a different response is utter tripe and the Deputy should reflect on that based on knowing me and all colleagues in this House who take issues seriously regardless of that issue. What I do is follow the evidence and ask the available experts to carry out the necessary studies. I told the Deputy very clearly that the chief medical officer will look into all of the issues that have been raised. He will engage with national and international bodies, professional colleges and others and come back with a series of recommendations. As of today, this device is a regulated device in this country. I have given very clear advice that people can go to their doctors should they have a concern. In terms of having an idea of the number of complaints, the HPRA is able to provide current and up-to-date data on that. I note that last month in the UK, the need for an inquiry was dismissed. I want to follow our own evidence here so that we have the best advice available. Anybody with any concerns should go to their GP.
Regarding the phrase "give a damn", I do not use language like that in here but I stand over what I said. The issue of women's health has been discussed here time out of number and the Minister is aware of that, as am I. It was not intended to be in any way personal. Of course, I welcome the fact that the chief medical officer will examine this but I would like to hear the Minister say that he will instruct the HSE to compile a register of those people who have used this device. I am learning that it does not know how many women have used it and in what context so we do not know. It would be very helpful if the Minister would instruct the HSE to indicate the numbers who may be involved in this. I have spoken to some of the women involved. They are in constant pain. I believe we have an opportunity to get out in front of this issue rather than chase along behind it as we so often do when issues involving women's health come to the fore.
That is a contribution with which I can agree fully. I will ask the chief medical officer to ascertain as part of his work how many women have availed of this procedure and the international experience in this regard. This involves talking to regulators and expert bodies in Ireland and abroad. If anybody in this country has experienced any pain, suffering or difficulty as a result of a procedure performed here or abroad, I take that extraordinarily seriously. I will keep the Deputy informed about this. I am happy to liaise with her with regard to any women she is aware of. I make the point that six women have come forward to the HPRA. If there are other women who have experienced adverse impacts, I respectfully ask that they consider coming forward as well, which would be helpful in terms of getting a full sense of the scale of the challenge, in addition to the chief medical officer's work. The very important message we should all send out is that no woman should suffer or be left in pain and if anybody is, they should revert to their GP or the hospital where the device was fitted so they can receive appropriate medical attention.
23. Deputy Margaret Murphy O'Mahony asked the Minister for Health his plans to review medical card eligibility criteria for persons with disabilities in order to facilitate their participation in the workforce and if he will make a statement on the matter. [48417/17]
Could the Minister tell us his plans to review medical card eligibility criteria for persons with disabilities in order to facilitate their participation in the workforce and to make a statement on the matter?
I thank the Deputy for raising this important issue, which I know she has been pursuing in the Oireachtas Committee on Health and with the Minister of State, Deputy Finian McGrath, and me. An interdepartmental "Make Work Pay" group was set up under the Government's comprehensive employment strategy for people with disabilities. This group was independently chaired by Professor Frances Ruane and I thank her for the wonderful work she did. The group's report sets out findings and recommendations, some of which deal with the potential loss of a medical card, which can act as a barrier to take-up of employment for persons with disabilities who wish to engage in work and have the capacity to do so. When that report was published, I was struck by the concern people with a disability had about losing the medical card. Be it a real or perceived concern, it was one of the biggest barriers in many cases.
The report made two principal recommendations regarding medical cards and people with disabilities. The first was to raise the medical card income disregard from its current level of €120 per week for people on disability allowance or on partial capacity benefit. I am strongly committed to the implementation of this recommendation. To that end, my Department is working with the HSE and the Department of Employment Affairs and Social Protection in order to assess the number of people who would stand to benefit under this measure and, most importantly, to examine the best administrative route to implementing a change in the earnings disregard. I am pleased to inform the Deputy that this work is expected to be completed shortly and it is my intention to implement the recommendation by the end of 2017.
The second recommendation was that the medical card guidelines be amended to remove a requirement that employment be of a "rehabilitative nature" in order for the associated income to be disregarded from the calculation of income when a person with a disability is being assessed for a medical card. I am pleased to inform the Deputy that this recommendation has also been accepted and is being implemented by the HSE.
I very much welcome the Minister's news in this regard. Since my appointment as party spokesperson on disability a year and a half ago, I have met with many groups and advocates for people with disabilities. Across the range, this concern is the biggest fear. It is probably the most mentioned issue. People are very afraid that they will lose their medical card. The medical card opens many doors. It is not just about their medicine. Medical support will be required, particularly for people with a permanent disability, which will improve their quality of life but quality of life extends beyond medical care. These people should be allowed to reach their full potential and get a job for which they are qualified.
The Deputy is entirely correct, which is why it is so important that things like the comprehensive employment strategy for people with disabilities are implemented in full. It is the commitment of the Government to do that. The Deputy is right. People with disabilities that the Deputy and I meet do not just want the State to provide them with a support and say "there you go". They want to be able to get on with their lives and be empowered to do so. When one reads the report published by Professor Ruane and the group in April, it is very clear that one of the reasons why people were often afraid to access the workplace was because they could not manage without that medical card because it is a passport for many other services. I am very pleased to accept the recommendation in full. I expect the new income disregard to be brought in by the end of the year. That, coupled with the removal of the necessity for the work to be rehabilitative in nature, should, hopefully, help fulfil two very important recommendations and make a real difference to people with disabilities.
I will be watching closely for that threshold to be changed. A young person in my constituency and that of the Minister of State, Deputy Jim Daly, had an accident in secondary school. He pushed himself through college and faced many barriers in doing so but is now in a very low-paid job. He is totally overqualified for his position but, again, this is down to his fear of losing his medical card. I can only describe him as a bird with his wings caught. He is a very bright and talented young man and the only reason he cannot pursue a career for which he is qualified and able is his fear of losing his medical card. I ask the Minister to keep all that in mind.
Again, I agree with the Deputy. There are many men and women in positions similar to that of that young man. The interdepartmental "Make Work Pay" group was set up as part of our comprehensive employment strategy. It prepared a report with findings and recommendations, some of which deal with exactly the issue referred to by the Deputy, namely, the interaction between holding a medical card and its potential loss as a barrier to persons with a disability fulfilling their employment ambitions. This concern arises due to the way the current system operates because for persons on disability allowance to retain an automatic entitlement to the medical card, an earnings disregard is applied. This means they can only have weekly earnings of up to €120 per week. This is doing exactly what the Deputy said. There are people who can and want to work more, be promoted or go on to new and exciting job opportunities but they need to hang on to that medical card for very good reasons.
The good news is that the majority of people would still qualify for the medical card. However, we need to remove any ambiguity in that regard and that is what the new income disregard will endeavour to do.
24. Deputy Mick Barry asked the Minister for Health his views on the increase in mental health problems reported in the most recent census; the impact of the level of mental health funding in this regard; and if he will make a statement on the matter. [48284/17]
According to census 2016, the number of people with psychological or emotional conditions increased from 96,004 in 2011 to 123,515 in 2016. The Government has taken action to address this and the consequent increase in demand for services. Over the period in question, there has been a substantial parallel increase in awareness of mental well-being in society and a reduction in the stigma associated with mental health issues.
In budget 2018, the Government provided almost €60 million in additional mental health funding, including €35 million for the development of new services. This means the mental health budget has been increased by approximately €200 million since 2012. A Programme for a Partnership Government contains a clear commitment to increasing our mental health budget annually, as resources allow, in order to expand existing services.
This new investment has facilitated the approval of around 1,500 new posts and a subsequent increase in mental health staffing numbers. At the end of September 2017, there were 9,744 whole-time equivalents employed in the mental health division as opposed to 9,404 in December 2015. The investment in question has also enabled the HSE to provide for an additional 130 undergraduate psychiatric nurses and 40 postgraduate psychiatric nurses each year. In addition, the funding increase has made possible the introduction of 114 assistant psychology posts and 20 psychologist posts in primary care. These will enhance early intervention-primary care counselling services for those under 18 in particular and relieve pressures on specialist child and adolescent mental health services, CAMHS. This new investment has also led to an increase in activity. For example, the number of children attending CAMHS in 2016 was 12,386 while the expected number for 2017 is 14,365.
While the substantial funding increase has helped to fund vital mental health services, it is important to ensure these services are delivered as efficiently and effectively as possible. With this in mind, a number of policy initiatives are being progressed. These include the development of a refreshed policy for mental health and the development of an implementation plan for the Connecting for Life suicide reduction strategy. As well as these, I will be bringing the final recommendations of the national task force on youth mental health to Government in the coming weeks. This initiative will help to develop resilience and coping mechanisms among children and young people. The fourth policy initiative is the pathfinder project on youth mental health. It will address the challenges of implementing youth mental health actions on a cross-departmental and whole-of-Government basis.
When taken together, these policy initiatives illustrate the Government's integrated response to the growing demands on the mental health sector.
Census 2016 tells us there was a 122% increase in mental health conditions for females aged between 13 and 22 in 2016 compared with 2011. The equivalent figure for males was 82%. This is quite clearly connected with the economic and social system and capitalism, which have given rise to precarious work, housing insecurity, increased education costs and so on. The increase in the problem is not being matched by an increase in resources. There is less money going into it than was the case ten years ago. There are fewer staff employed by the State in this area than was the case ten years ago and the percentage of the health budget going to mental health services is less than it was at that time. The latter is a failure by any standards and I challenge the Minister of State to defend that position.
I do not agree with the Deputy's analysis or with how he looks at everything being less ten years on. The €200 million increase in the mental health budget is very substantial and I challenge the Deputy to point to any other area the Government is in charge of that experienced an equivalent pro rata increase during the recession the State has endured.
On the more substantive issue of mental health, it is a very narrow definition. I know the Deputy likes to engage in these narrow, focused analytics. The issue of mental health is not just a function of the Department of Health, it also comes within the ambit of the Departments of Education and Skills, Justice and Equality, and Children and Youth Affairs. Mental health is being addressed across a range of Departments and money is being spent. Comparing the percentage of the mental health budget with the overall health budget is wrong.
How we deal with mental health is really important. Is the Minister of State aware of the report that has emerged in Cork in the past two days of a 14-year-old boy with Asperger's and anxiety who wrote to Cork County Council explaining that he was stressed out because of his family's situation of being on the housing waiting list? Shortly afterwards, his mother received correspondence from Tusla wanting to talk to the family about this letter and the situation in the household. Tusla looked into the matter. The case is now closed because, having interviewed the mother and young fellow, Tusla says there is no case. The social worker has written to the council to say the family should be housed, putting the authority of Tusla behind that. We can leave aside the fact that if anything is to be investigated here, it is the Government's housing policy. I want assurances there will be no repeat of such a situation, whether in Cork County Council or any other council.
I will not comment on a case regarding Cork County Council. If the Deputy has an issue with how Cork County Council dealt with a particular case that has come to his attention, I respectfully suggest he take the matter up directly with Cork County Council, which, I am quite sure, will be more than happy to provide any clarification required on the matter.
25. Deputy Thomas P. Broughan asked the Minister for Health the status of the HSE's approval process for the health technology assessment report from the National Centre for Pharmacoeconomics, NCPE, on the drug Kuvan, which is used to treat persons with phenylketonuria; when he expects the drug to be approved for treatment of these persons; and if he will make a statement on the matter. [48283/17]
The Minister is very familiar with the rare genetic disease phenylketonuria where patients have difficulty processing the amino acid phenylalanine and therefore must live on a very restricted, low-protein diet. We have had the report of the NCPE, which the HSE was considering. We have had two recommendations against sapropterin dihydrochloride, Kuvan, in the past nine years. A meeting was scheduled with the relevant drug company before Storm Ophelia occurred. Has a meeting happened and has information from the meeting been forwarded to the HSE drugs group? When will we get approval for the drug?
I thank the Deputy for raising this issue. The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs scheme, under powers this House gave to the HSE in the Health (Pricing and Supply of Medical Goods) Act 2013. In reaching a decision, the HSE examines all the evidence which may be relevant in its view for the decision and will take into account such expert opinions and recommendations which it has sought including, for example, advice from the NCPE.
Kuvan was considered under the national pricing and reimbursement process in 2009. At that time, insufficient evidence was available to support the pricing and reimbursement application submitted. In 2016, the HSE was advised that a new health technology assessment dossier would be submitted on the drug. The NCPE completed its assessment of the new dossier in September 2017 and did not recommend the drug for reimbursement as it was not deemed cost-effective at the price sought by the company. I highlight that point. The HSE assessment process is ongoing and the HSE will take into account any relevant expert advice when making its decision.
I have been assured by the HSE that commercial discussions are ongoing. I cannot answer the Deputy's question about whether the meeting has taken place. I do not know but I am told commercial discussions are ongoing. I am also told the HSE has received additional submissions from patient groups, via a Member of this House, which will be considered as part of the process. Both the commercial negotiations and the consideration of the patients' submissions will take place before the drugs group finally reviews the matter and takes a decision to the HSE leadership.
I have heard parents campaigning for this drug make a very valid point. They are concerned the system we have in place for assessing drugs for rare diseases is not adequate. A new committee called the rare diseases medicinal product technology review committee has been established by the NCPE. The terms of reference of the committee have been finalised and its responsibilities include the review of proposals for funding of new products for rare diseases or expanded indications for existing products for rare diseases. It will also contribute to the development of clinical guidelines. It is a valid point. We have quite a good assessment process.
Parents argue about the need for a better review when it comes to rare diseases. This committee will carry out a review that is in addition to and separate from the assessment process.
I welcome the comments on the quality-of-life criteria for all rare diseases. The National Centre for Pharmacoeconomics report seems to make it clear that on clinical grounds there is a positive approach. As the Minister has said, it seems to come down to the economics and the difficulty of measuring costings for a very small cohort.
Like the Minister, I am very familiar with this disease and with the needs of families with experience of PKU - my family is one of those concerned. From listening to the PKU Association of Ireland and the various families involved, the Minister will know of the ongoing struggle of trying to live on a low-protein diet. It is a very small cohort. One in 4,500 babies is born with PKU in Ireland with about 20 referrals to the National Centre for Inherited Metabolic Disorders at Temple Street every year. Most Deputies will have received very valuable information from the PKU Association of Ireland.
Go raibh maith agat.
Many parents have outlined their daily struggle and the greater freedom-----
Go raibh maith agat. The Minister has one minute.
----- having access to a wider protein diet would have-----
The Deputy will have another minute.
----- if Kuvan were authorised. I know the Minister is sympathetic, but we need to act soon.
I agree with pretty much everything the Deputy has said. While the PKU Association of Ireland is absolutely campaigning, as would any of us, for their loved ones to have access to this drug, it is also making the broader point about the need to review the equality in the assessment process for rare diseases. I assure the House that process is under way with a new working group of the NCPE.
As I did in my original answer, I assure people, who are wondering about the availability of Kuvan, that this process has not ended. The HSE has informed me that commercial negotiations are ongoing and it is also considering information it has received from patient groups, presumably including the PKU Association of Ireland.
When it comes to drug negotiations pressure is rightly put on me and on the HSE. It is important in a negotiation that companies also negotiate in the interests of patients in terms of a fair price for this country.
As the Deputy probably knows better than I do, PKU is an extraordinarily challenging condition. We have recently expanded the list of products available to PKU patients through our pharmacy and we need to do more in that regard. I will keep the Deputy informed on the process.
The cost outlined in the report for 100% uptake is relatively tiny in the health budget at €12.7 million over five years or €2.5 million a year. The European PKU society which has strongly supported the PKU Association of Ireland has made the basic point that the EU regulatory agencies approved the drug in 2009 for use in 20 European countries at the time. A range of our European partners, including France, Austria, Germany, Bulgaria and Romania as well as the US have access for parents of children with PKU. Given that there is a genetic aspect to our community, it is extraordinary that Ireland is the one country where this medicine is not available. It is potentially life changing for those 800 individuals and their families. I know the Minister is sympathetic. Many of the advocates for rare diseases have forwarded their cases to him and I have supported those also. In this instance it should be approved.
I wish to be very factual. The decision to approve or not is a matter for the HSE leadership team, which will hear from the drugs group under the legislation passed by this House. There may be a view that the process has come to an end and that is it. The NCPE has made its views known and they are a matter of public record. However, commercial negotiations are ongoing. In my 18 months as Minister for Health I have stood in this House quite a few times discussing drugs that patients have sought. Even though it looked extraordinarily difficult to obtain them, through negotiations we have managed to make drugs available. I hope we will continue to make new and innovative medicines available.
The international aspect the Deputy raised is something on which I have been working quite hard. Ireland is a very small country. While he is right in highlighting the comparative incidence of PKU, it is important that we collaborate internationally and share information with other countries on challenges we are experiencing. We need co-operate and scan the horizon jointly. In the coming weeks I hope to be able to make an announcement about how Ireland could formalise its involvement in working with other countries to get better access to new and innovative medicines and better value at the same time.