Adjournment Debate

Medicinal Products Availability

Deputy Richard Boyd Barrett

This is an issue the Government and the new politics urgently has to do something about. The Minister is aware that in the past few weeks, we have had two instances where people who are ill, often with life-threatening illnesses or seriously disabling illnesses, are not able to access certain drugs because of price, rather than the question of their medical efficacy or how they could help people who are sick, suffering or, in some cases, in life-threatening situations.

That is just not acceptable.

Orkambi was mentioned earlier today in the case of sufferers of cystic fibrosis, of which there is a very high instance in this country. The National Centre for Pharmacoeconomics stated it should not be funded at "the submitted price"; therefore, it is price which determines whether ill people will receive a drug that could make a real difference to their health and quality of life. Last week we had the issue of the availability of Pembro for those with melanoma. There has now been movement on this issue, but there had to be a fight over it and it is only occurring because there was an outcry. Last year, with others, I raised the issue of the availability of Fampyra. I had received representations from people with MS, whom this drug assisted in being able to physically walk, but it was not available for them because of price.

It is utterly obscene - that is not too strong a word to use - that the profit line of incredibly profitable big pharma corporations determines whether people will receive life-saving medicines or drugs or medicines that could make an extraordinary difference to their quality of life. Another example is Harvoni, a drug for sufferers of hepatitis C. This issue has been brought to my attention in the past week or two and I do not know whether it has appeared in the public debate. It highlights another aspect of the debate. The cost of Harvoni here is 45 times higher than in Australia because of where we source it and the profiteering of the company which produces it. There are versions of these drugs which are exactly the same, but we pay top dollar, and because of the price, we either pay too much or are not willing to pay the money.

This raises another issue. To what extent is the State looking for value for money and the cheapest versions of these drugs? We have advocated as our policy that there be a State pharmacy, the responsibility of which would be to find the cheapest versions of these drugs or else - this is important as I said earlier - we should produce them ourselves. There is no reason we could not do this. We have thousands of people and in some areas we are producing generic and much cheaper versions of drugs. We should expand this substantially, but there has been no serious push to do so.

Some of the price contrasts are absolutely extraordinary. In the United Kingdom 16 paracetamol tablets costs 35 cent. In Boots in Ireland they cost 99 cent, almost three times as much, and in Tesco, €1.55. I am not sure how much the State pays, but the point is it is an absolutely tiny fraction of the cost, even in the United Kingdom for paracetamol. In Ireland, in the case of Harvoni which I mentioned, the cost is €45,000 for a course of 12 tablets. From the hepatitis C buyers club in Australia the cost is €1,000 for the same course. This is crazy stuff. I appeal to the Government and the Minister of State. This is an issue we must address as a matter of urgency for the sake of sick and vulnerable people and to achieve value for money for the State which spends €2 billion a year on medicines via the HSE.

Minister of State at the Department of Health (Deputy Helen McEntee)

I thank the Deputy for raising this very important issue which has featured in the media quite a lot in recent days in the context of developments in the provision of new cystic fibrosis and cancer drugs. Nobody should have to pay 45 times more than what is paid elsewhere. It is not right. There should always be equal access.

Decisions on the reimbursement of new drugs are matters for the HSE. They are not political decisions, as much as we would sometimes like them to be. Every drug undergoes a scientific and evidence based assessment in line with the HSE's statutory obligations. In many cases, the prices companies seek to charge are most definitely too high and, as a result, the product does not deliver health benefits in a cost effective manner. Unfortunately, we must look at what is cost effective. I know that the Deputy is not suggesting the HSE should simply accept the first price proposed by manufacturers for their products, regardless of their clinical benefits or cost effectiveness.

As with all new drugs developed, the HSE must follow a process. I understand how patients and their families must feel in these circumstances as they await a decision by the HSE on reimbursement. I dealt with a similar matter when a gentleman in my constituency needed a life-saving drug which cost too much. This is something we see all too frequently, which is why I am eager to ensure the process is concluded as efficiently as possible for each drug.

Yesterday the National Centre for Pharmacoeconomics, NCPE, published a recommendation that the cystic fibrosis drug Orkambi not be reimbursed by the HSE, as it was not considered cost-effective at the price of almost €160,000 per patient per year as submitted by the manufacturer. The high number of people who require it means that the cost is absolutely astronomical. The NCPE estimates the cost-effective price in this instance as being closer to €30,000, a significant difference. It estimates the five year gross budget impact of reimbursing Orkambi at more than €390 million and notes the significant opportunity cost associated with reimbursing the drug. Every additional euro paid to pharmaceutical companies is a euro less for investment in other critical health services and public services generally.

This is not the end of the reimbursement process. The HSE will now enter negotiations with the manufacturer to seek significant price reductions. It will then consider the outcome of these negotiations, together with the NCPE's recommendation, in making a final decision on reimbursement. I welcome the confirmation by the company to the NCPE this morning that it will continue to provide the drug for Irish patients who are involved in an expanded access programme until the issue of reimbursement is finalised in Ireland.

Two new cancer drugs have also been discussed by the HSE and in the House in recent days. I welcome yesterday's decision by the HSE to approve Pembrolizumab for reimbursement and I am sure this news will be welcomed by patients affected and their families. For the second drug, Nivolumab, I understand the assessment process is ongoing. I welcome the supplier's decision to extend its compassionate access programme for patients with advanced lung cancer to the end of June 2016 and the confirmation that all patients currently receiving treatment under the programme will continue to receive it.

The single biggest challenge in the assessment of new drugs for reimbursement is, as we have discussed, presented by the very high prices sought by suppliers. Let me be very clear - the process followed by the HSE is scientific, evidence-based and designed to deliver the best health outcomes for the patients in a cost effective manner. It is essential that the HSE have the support of everybody in the House in its efforts to achieve the very best result for Irish patients.

Hospital Services

Deputy Hildegarde Naughton

I thank the Ceann Comhairle for giving me the opportunity to raise this vital health issue for the west and the Minister of State for attending to answer my question. She is aware that the HSE has indicated that it intends to close the DEXA scanning unit in Merlin Park University Hospital in Galway. I am informed a reprieve has been granted at the eleventh hour, but there is absolutely no plan for the service to move forward; nor are we assured that it will not close in the future.

Ireland has approximately 91 DEXA scanners in use. The DEXA scanner situated at Merlin Park University Hospital is the only scanner not privately operated in the entire west. I am told there is a 20 year waiting list, as it stands, for a DEXA scan in Merlin Park University Hospital. No referral has been processed in three years owing to a lack of staff. Even if the unit is not closed, there will be no reduction in the waiting list owing to the lack of staff. Thousands of euros were donated by the local cystic fibrosis chapter and a charitable bequest was made to purchase the machine. Despite this, the HSE seems to be unable to staff the unit.

Since 2009 GUH staff have educated Irish health professionals on best practice for DEXA and other technologies, running International Society for Clinical Densitometry, ISCD, courses and certification examinations, which qualifications are recognised throughout the world.

GUH was a centre of excellence for bone densitometry with the only DEXA specialist radiographer in post in Ireland, Professor John Carey, who is the vice president of the ISCD. GUH also established one of the first DEXA centres in the country in 1999 and one of the first fracture liaison programmes. GUH was the first Irish site to gain recognition from the Capture the Fracture programme, which recognises centres of excellence around the world.

While I could continue to recite reasons for the necessity to make and keep this unit properly operational, I think the Minister would agree that any suggested closure is a highly retrograde step. There is enormous public anger building that such a service could be threatened with closure in the west, forcing people again to travel to Dublin for what is a reasonably basic service. I am told that the difficulty with the service appears to be the hiring and retention of qualified staff.

Osteoporosis is one of the most common diseases in the world today, affecting more than 200 million people worldwide. There are no symptoms or clinical features until a fracture occurs. One in two women and one in five men over 50 will experience a fracture related to osteoporosis in their lifetime. A postmenopausal woman's annual risk of fracture is greater than her combined risk of all cardiovascular disease and invasive breast cancer combined. Ireland has one of the highest incidences of osteoporosis and hip fracture in the world. One in three men and one in five women admitted to our hospitals with a hip fracture are dead within a year following the fracture. This is almost double many other countries and well above the UK and EU norms. Many others require lengthy hospital stays in nursing homes, for example.

The cost of treating osteoporosis-related fractures is close to €1 billion annually. Many fractures are preventable by identifying people at risk or diagnosing osteoporosis before a fracture occurs. DEXA scans play a critical role as they are the gold standard in testing to identify people with low bone mass, to diagnose osteoporosis before a fracture occurs and to monitor those on treatment. DEXA is cheap, very safe and very cost-effective. Identifying people early helps them to reduce their risk of fracture. Musculoskeletal diseases are among the commonest diseases in the world and the commonest cause of disability among men and women over 50 years of age in the developed world.

New staff were promised for the hospital's DEXA service in 2013 after a business plan was approved by the Saolta executive committee for a clinical specialist radiographer, a clinical nurse and a secretary. Only the radiographer post was finally approved for advertising nationally after two years. No one has applied for the position and neither a nurse nor a secretary was provided. It is, therefore, clear why there is a waiting list of 20 years.

The cut-off to the staff for musculoskeletal diseases since the implementation of the moratorium on new staff has had an impact on waiting lists and the welfare of patients. I urge the Minister to intervene directly in this case so this vital service is available for the people of the west and I would also like an assurance that the unit will not again be threatened with closure. It makes no sense ending this service for financial reasons or not staffing the unit properly when keeping it. Making it work effectively will save the taxpayer in the long term.

Deputy Helen McEntee

I thank the Deputy for raising this issue, which is obviously very important to her, her constituents and those in the west. Galway University Hospitals, comprising of University Hospital Galway and Merlin Park University Hospital, provide a comprehensive range of services to emergency and elective patients on an inpatient, outpatient and day care basis across the two sites.

An issue has arisen with respect to the operation of the DEXA scanner situated at Merlin Park Hospital. The Minister for Health has been advised by the Saolta University Health Care Group that the bone density scanning service has been impacted, as the Deputy has rightly pointed out, by a shortage of radiographers. As a result, a waiting list has been building up for some time now.

Galway University Hospitals are actively working to recruit radiographers in order to fill a number of vacancies. One successful candidate will commence work in early July. An additional five individuals have been offered posts and are currently in the process of appointment. Recruitment to three further posts is ongoing. As I mentioned to another Deputy earlier today, recruitment of staff within the whole health sector is a big challenge that we need to overcome and a lot of changes need to happen in that regard. Saolta has advised that GUH plans to treat all patients booked into the bone density scanner service until the end of June 2016. In the interim they are reviewing options to manage the waiting lists after June, and that includes the employment of the agency staff.

The Saolta Group and the HSE are working to put the necessary arrangements in place to ensure the continuity of services from July. In the interim period until the newly recruited radiographers have taken up their posts, the hospital group is progressing a range of options, including staff overtime and outsourcing in order to ensure service continuity for patients. As the Deputy would also know, a number of facilities in Galway can also carry out DEXA scans, including Portiuncula and Sligo University Hospitals, and there are private facilities in the Galway area that also offer DEXA scans. That is her area, so she needs to ensure that the service remains within the hospital.

It is also important to note that major developments are ongoing and planned for Galway University Hospitals. The programme for a partnership Government has committed to progressing a new emergency department facility. Construction work is also ongoing on the new 75-bed ward block as well as a new acute mental health department at the hospital. There will be much focus on making sure that those positions are filled and that the situation is tenable into the future.

Mental Health Commission Reports

Deputy James Browne

I raise the issue of the Mental Health Commission approved centre inspection reports that were published on 26 May 2016, in which 11 units across the country were assessed. As the Minister of State will know, every approved centre registered by the Mental Health Commission must, under law, be inspected at least once a year and during each inspection, the approved centre is assessed against all regulations, rules and codes of practice and section 4 of the Mental Health Act 2001.

These reports have highlighted a number of high-risk practices taking place in a number of psychiatric units throughout the country. For example, the acute psychiatric unit in Cavan General Hospital was found to have been non-compliant in its maintenance of records and had practised the use of physical restraint on high-risk patients. In St. Stephen's Hospital, risk management procedures were found to be at high risk while in the Aislinn Centre, staffing issues were found to be at high risk. In Letterkenny General Hospital, individual care plans and therapeutic services were again found to be high-risk issues while at Le Brun House-Whitethorn House in Clonskeagh, the premises and safety issues were found to be at high risk.

I want to focus, in particular, on the department of psychiatry in St. Luke's Hospital in Kilkenny. The premises was found to be of high risk and, extremely disconcertingly, the admission of children and the relevant code of practice was found to be a high-risk factor. The report states that "the approved centre was deemed non-compliant as there was no evidence of required Children First training or any other relevant training [of] staff [in this area]". The approved centre "was not suitable for the admission of children". The admission of children to adult psychiatric units is an ongoing issue. It is a wholly unacceptable practice and I ask the Minister of State what her proposals are in this regard and when it will stop. The previous Government promised to end this during its lifetime and that pledge was made in 2011 when it had come to power. It can only contribute to the mental health problems of these children by putting them into adult psychiatric units. While the staff will do their best, they cannot be given the full supports these children need, in particular early intervention supports, and many of these children are simply put on suicide watch.

The parents gave their consent to the children being admitted on most occasions to these units out of simple desperation and under a sense of duress as they feel they have no other options for their children who need psychiatric care. This is, of course, also a breach of the UN Convention on the Rights of the Child. There are many issues surrounding mental health - 24/7 care, in particular, is a key issue - but I ask the Minister of State to make this issue the No. 1 priority during her tenure to bring an end to this practice of putting children into wholly unsuitable and unsafe places, namely, adult psychiatric units.

Deputy Helen McEntee

I thank Deputy Browne for his question. The Mental Health Commission is charged with visiting and inspecting every approved mental health centre at least once a year. The commission, as the Deputy has rightly pointed out, has now published its report on St. Luke's Hospital in Kilkenny, Cavan General Hospital, Naas General Hospital and Clonskeagh hospital.

While each premises received excellent and good rankings for elements of their performance, there were concerns about the upkeep of the premises, other issues and the admission of children to the St. Luke's Hospital adult psychiatric ward. A maintenance programme is in place in each of the relevant hospitals to ensure all issues identified in the report on the premises upkeep are addressed. The Government is strongly committed to improving all aspects of our mental health services and, as Minister of State, I am committed to this also. Funding for mental health will increase from the 2015 outturn of €785 million to a projected budget of €826 million in 2016, an increase of €41 million, or 5.2%, which includes €35 million ring-fenced for mental health for new developments.

The admittance of children to adult units is sometimes permitted for reasons of geographic location, the expected length of stay, which is usually short term, and the age of the young persons involved, which is usually between 16 and 18 years. It is seldom a person younger than that is admitted, however it happens. Nobody agrees with this policy, and we all want to ensure it does not happen.

The HSE National Service Plan 2016 aims to improve the placement of children in age-appropriate mental health settings. We have set a target of 95% appropriate placement, and this is indicated in the plan, to allow for some operational flexibility surrounding emergency placements in adult units. I will take on board the Deputy's point that this must be a top priority. While it remains challenging, progress has been significant, despite increased demands on the CAMHS service. In 2008, there were 247 such inappropriate admissions to adult units, whereas in 2015 there were 95. While that was 95 too many, we are moving in the right direction and must continue to do so. It is a priority for the HSE to keep such admissions to a minimum, and this must be kept under constant review. It is not appropriate that anyone under the age of 18 be in a situation in which they feel scared or threatened and we want to ensure it does not happen.

I will continue to prioritise development of all aspects of CAMHS, including timely access to appropriate services, early intervention and an integrated service approach, again bringing it back to the community. A comprehensive approach, sometimes involving services outside of CAMHS or the HSE, is required to further reduce such placements. The admission of a child or adolescent to an acute adult inpatient unit is made following a clinical assessment of the needs of the individual. Sometimes, even if beds are available, they may be at a distance, and other factors must be taken into account.

The HSE is actively managing the issue of the admission of children to adult units. Specific measures adopted include a dedicated notification system to inform the mental health division whenever a child is admitted to an adult unit so it is constantly monitored. This information permits direct engagement with the local management team to develop a timely clinical management response to ensure a child or young person in this position is assessed and, if required, sent to an appropriate CAMHS as soon as possible. The timeframes are generally short. Many of the 95 admissions are, unfortunately, accounted for by a child who has come back a second or third time.

Bearing in mind all the circumstances, the hospitals concerned are making progress on the issues raised, while taking account of the wishes of each young person, his or her parents or guardians, and the complexities of each case. The Department will continue to closely monitor the issues raised in the report, particularly regarding the admission of children to places where they should not be.

The Dáil adjourned at 5.15 p.m. until 2.30 p.m. on Wednesday, 8 June 2016.

Dáil Éireann debate - Thursday, 2 Jun 2016