Vol. 765 No. 4
1Deputy Billy Kelleher asked the Minister for Health the terms of reference of the fair deal review; if this review will take into account broader issues regarding the State’s care for the elderly; the person who will be carrying out this review; if it will be a private company; and if he will make a statement on the matter. [24407/12]
The nursing homes support scheme was introduced in October 2009 with a commitment to review its operation after three years. The reason for allowing this period to elapse was to ensure trends and statistics would be available to inform the work. The review of the scheme will look at, among other issues, the ongoing sustainability of the scheme, the relative cost of public versus private provision, the effectiveness of current methods of negotiating price in private nursing homes and setting price in public nursing homes, and the balance of funding between residential and community care.
The terms of reference for the review are being finalised at present. The Department of Health will seek tenders through the public procurement process for the carrying out of the review. This process will take approximately four months. It is also intended to carry out a public consultation over the summer to inform the review. It is anticipated the review itself will take approximately three months to complete. It is expected the review will commence in the last quarter of this year and be completed in early 2013.
In the context of the fair deal scheme, most people accept it has brought certainty in terms of funding for relatives in nursing homes. It is clear, however, that the longer the review goes on, the more it undermines confidence and certainty in the scheme in terms of ensuring that funding will be in place when people need nursing home supports. I am amazed that in advance of the review up to 1,000 community nursing home beds will be taken out of the system. Some have already been taken out and 100 per month will be lost per month up to the end of October. While the nursing homes scheme has been a success in terms of bringing certainty to the funding, equally, the decision of the Government to reduce the number of nursing home beds in advance of the review being finished and adjudicated upon seems to indicate the cart is well before the horse in this case.
The terms of reference are critical. Public versus private care is an issue. I frequently look back over the transcripts of the Dáil to find out the thinking of the Government when in opposition. It is clear there was much concern at the reduction in the number of public nursing home beds but that seems to have changed completely in the past 12 to 14 months in terms of commitment to funding community nursing home beds.
Could the Deputy ask a question please?
Does the Minister of State not accept that the longer the review goes on - we might have to wait ten or 12 months before the review is finalised and acted upon - the more uncertainty is created? Equally, does she not agree that grave concerns were propagated previously about property and the 5% per year up to a maximum of 15% over three years? The Minister of State has opened up that debate again. What is her thinking behind the reliance on the property aspect of the home for funding the scheme?
There is no uncertainty about the scheme. We could not have made it clearer. The funding is available. It is ring-fenced and will be available in the future. No one who is in need of long-stay nursing home care for older persons will be in any doubt about that.
While I accept that beds are closing, equally, many beds are opening. I refer to Ballincollig, for instance, which the Deputy knows very well, and to other areas of the country where we are opening other beds. It is not the case that we are depleting bed numbers. We are opening a different type of centre and offering a different type of care.
On whether the scheme is sustainable in terms of property values, that is irrelevant at this stage. The review will deal with that. I will not pre-empt what the review will come up with. I am sure the Deputy will appreciate that. Equally, it must be said loud and clear that only 17% of the people who have applied for the nursing home subvention or loan scheme are relying on the sale of property after death. Everyone else is paying upfront. That must be part and parcel of the review.
That reinforces the view that there was a great deal of scaremongering when the scheme was being established in 2009 in terms of the number of people who would be forced to sell their homes to fund the scheme. There is no getting away from the fact there will be fewer beds in the system. There is no doubt about that. The number of beds is being reduced continually and the figures exist to prove it. Not only is the fair deal nursing home scheme going to come under additional pressure because of the reduction in bed numbers but also it will have a knock-on effect on acute hospitals and moving people from the acute setting into community nursing homes. Could the Minister of State provide an assurance, while we await the review, that funding will be available for everyone who applies under the nursing home support scheme? When the review is completed, it will probably be published in January or February 2013. Can the Minister of State indicate whether funding will be available in December, for example, for next year because we need certainty in that regard?
What is certain is that not everyone who applies will receive funding because not everyone who applies is in need of long-term care. From the information available in the reviews completed, it is clear that approximately 40% of people in nursing homes should not be there in the first place. We must seriously examine the situation.
The Minister of State at the Department of the Environment, Community and Local Government with responsibility for planning and housing, Deputy Jan O'Sullivan, and I have been examining other forms of assisted living with all the voluntary groups. We are committed to ensuring funding will be provided for anyone who needs - as opposed to applies for - long-term care. There will be sufficient beds within the system. There are particular areas where we must ensure we act where the Health Information and Quality Authority, HIQA, is involved and has decided the accommodation is not appropriate. I am sure the Deputy would agree with that. HIQA was established by the previous Administration and is one of its most useful initiatives.
2Deputy Caoimhghín Ó Caoláin asked the Minister for Health if he will use his powers under the Hepatitis C Compensation Tribunal Act 1997 to make available the measures provided for the majority who have tested positive, to the small number of women who received blood products from contaminated batches of anti-d in the 1977-79 and 1991-1994 periods but who are testing negative while experiencing severe health problems consistent with testing positive [24409/12]
The Health (Amendment) Act, HAA, card is given to men, women and children who contracted hepatitis C from the administration within the State of blood or blood products. Under the Health (Amendment) Act 1996 the entitlement of an individual to an HAA card and to related services is decided by the chief executive officer of the Health Service Executive. The latter is bound by the definition of eligibility in the Hepatitis C Compensation Tribunal (Amendment) Act 2006, which requires a positive diagnostic test for applications received by the tribunal after the specified date of 20 June 2006.
A great deal of consideration has been given to the issue of recipients of anti-D who have neither tested positive for hepatitis C nor had a positive tribunal decision in their favour. A number of women who have tested negative for hepatitis C have experienced a variety of symptoms. However, there is no scientific proof that these symptoms are specific evidence of hepatitis C infection. In fact, some symptoms of hepatitis C, such as fatigue, fibromyalgia and depression, are common conditions that occur in the general population or are also associated with other illnesses. It is estimated that up to 16,000 women in Ireland were exposed to potentially infectious batches of anti-D and that approximately 1,000 of these were infected with hepatitis C. Extending eligibility for HAA cards to those who have tested negative for hepatitis C would have significant implications for the scheme overall.
I am sympathetic to the women in question. However, taking account of international practice and the rationale which led to the passing of the 2006 Act, I am satisfied that the present arrangements are reasonable in the circumstances.
I understand that the cohort of women described in my question is 15 in number, two of whom are currently seriously ill. I take this opportunity to send my best wishes to them and their families at this very difficult time. The women who make up this tiny minority are very disappointed to have been excluded from the measures provided for the majority who have tested positive, including access to Health (Amendment) Act cards. I strongly urge the Minister to revisit the matter. Section 9 of the Hepatitis C Compensation Tribunal Act 1997 states:
The Minister may, with the consent of the Minister for Finance, by regulations extend the class or classes of persons who may make a claim for compensation before the Tribunal.
This provision provides the Minister with the means to address a long-standing injustice. Given the small number of women involved, where there is a will there must be a way.
Second, funding for the organisations representing the women concerned, both those who have tested positive and those experiencing illness but not testing positive, has been reduced. These bodies were the subject of some very unfair media coverage in recent times, even though their expenditure was in all cases prior-approved by the Department. Will the Minister acknowledge that? I understand he has already met with one of the organisations, Transfusion Positive, on this issue. Will he undertake to meet with representatives of Positive Action as well?
I too send my best wishes to anybody who is acutely ill at this time. I realise the difficulties attaching to this issue and am sympathetic to the plight of those involved. However, as I said in my reply, in the absence of some other method of defining the cause of illness, it is very difficult, under the legislation, to deal with the cases outlined. The Deputy observed that a very small number of women fall into this category, but the symptoms outlined are so prevalent with many other conditions that it would be difficult to confine any measure in this regard to the cohort we are discussing. Having said that, I am certainly prepared to review the matter with a view to finding some definable way of addressing it to everybody's satisfaction.
I have a note before me, which I will pass on to the Minister, setting out the most up-to-date medical information relevant to this case. The absence of serological markers for hepatitis C does not exclude the distinct probability that an individual was exposed to virus-contaminated anti-D immunoglobulin. There is very good evidence that some individuals, when exposed to the hepatitis C virus, have an acute resolving infection that can leave the previously infected person with none of the usual diagnostic metrics of the past infection, such as seropositivity. In regard to the patients we are discussing, the case of donor Y has been described as the clearest example of this progression within the context of the natural history of hepatitis C infection. The details are outlined in the report of the expert group on the Blood Transfusion Service Board of January 1995, pages 29 and 30. The report states that a large volume of plasma was collected from donor Y in 1989. This plasma was found in retrospective testing in 1994 to be positive for the hepatitis C virus, yet donor Y was independently tested by the then BTSB for evidence of hepatitis C viral infection and tested negative under the third-generation ELISA test.
These facts provide a means for the Minister to progress this matter. I do not doubt for one moment that it is his personal wish to do so. As such, I hope that what I have recounted today gives him the formula and wherewithal to proceed. To reiterate, we are speaking about a very small number of women who desperately need our help.
I thank the Deputy for his comments. I will certainly undertake to consult again on this matter. There are specialists particularly proficient in this area who would be of assistance to us. I do not mean this as a defence, but the Attorney General must be consulted in this matter lest it create a precedent which might cause problems. The primary objective must be to support any woman who was infected by or has suffered as a result of receiving infected blood. My goal is to do so within the parameters and strictures under which I must operate. If we can manage it, we will certainly act on this. The Deputy said that where there is a will there is a way. There is a great deal of willingness on this side of the House if we can find a way.
3Deputy Joan Collins asked the Minister for Health the reason holders of the HAA cards under the Health Amendment Act 1996 are being denied access to boceprevir (Victrelis) and Telaprivir; if he will reiterate the obligations this State has to citizens who contracted Hepatitis C through the Blood Transfusion Service Board, especially in relation to access to drugs that increases their quality of life. [24411/12]
I welcome the Minister's reply. There was an intake of breath by members of Positive Action and other organisations representing people infected by hepatitis C when it was indicated that there might not be access to these treatments. The situation has clearly moved on since then. Can the Minister indicate how soon treatment programmes will be initiated and what the associated protocols will be? Positive Action, Transfusion Ireland and other survivors will welcome this news.
I have discussed this issue with Dr. Barry White, national director of clinical strategy and programmes with the Health Service Executive. He is very much involved in this area as somebody who treats patients with haemophilia, many of whom contracted hepatitis C through contaminated blood products. There are medical protocols around this, which I will not go into, because there is a possibility of serious side effects associated with the treatment. For instance, the administration of these medicines to patients who are hepatitis C negative would not be considered justified in terms of the down side that can possibly occur.
Having said that, these drugs are a real breakthrough. They are the first to have been shown to clear the body of the virus. This is a welcome development, one that offers real hope of a normal life for persons who have suffered as a consequence of contracting hepatitis C.
As far as I am aware, some members of Positive Action embarked on the new treatment some months ago and are ready to move. Will the Minister ensure those who have embarked on the programme can move quickly? They were supposed to start the 48 week process in January and then in February. Is the Minister saying those who are on the programme can move quickly to the long-term treatment needed? As he said, the new treatment is fantastic for persons who have been affected by hepatitis C.
I reiterate what my colleague said. There have been requests from Positive Action to meet the Minister to discuss a number of issues that have arisen. I would appreciate it if this meeting could be arranged as soon as possible.
Those who have been assessed and are on the drug will progress quickly, while others must go through the process to ensure they are suitable.
With regard to meeting Transfusion Positive-----
Positive Action.
I am sorry. I have met Transfusion Positive and have no problem meeting representatives of Positive Action.
4Deputy Billy Kelleher asked the Minister for Health if he will consider reversing the decision of the National Centre for Pharmaeconomics to halve the threshold used to measure value for money; if his attention has been drawn to the knock-on effects this decision is having on sufferers of major illnesses including prostate cancer; and if he will make a statement on the matter. [24408/12]
The National Centre for Pharmoeconomics, NCPE, plays an important role in the assessment process for new medicines. Its findings are not, however, the sole deciding factor in the process of allocating resources for new and expensive treatments. Its report is an input into decision making, but it is not the decision. The NCPE investigates the robustness of pricing proposals and cost-effectiveness documentation forwarded by pharmaceutical companies at a range of values. It is entirely appropriate to investigate cost-effectiveness at a range of values. Such investigations provide very useful information for the HSE on the most appropriate use of resources and potential negotiating positions with pharmaceutical companies when discussing price. Furthermore, the assessment process may identify where additional information is required from a pharmaceutical company.
The assessment process conducted by the HSE and the NCPE is a perfectly legitimate tool in assessing the best application of limited resources. It is designed not to prevent access to medicines but to ensure the best value can be achieved in order that more medicines can ultimately be provided from within limited budgets. The NCPE economic assessment process is robust and internationally respected and an important input for decision makers.
There are a number of new and expensive drug treatments being considered by the HSE. Drugs for the treatment of prostate cancer, including Zytiga and Jevtana, are within the decision making process. It would be inappropriate for me to comment further while this process is ongoing.
There has been recent media coverage of reimbursement approval for new and expensive medicines. Following on from recent discussions in this regard, the Chief Medical Officer is exploring with the HSE the adoption of a new and robust system for decision making on drugs in order to promote and drive evidence-based prescribing. This should help to create capacity on a sustainable basis to provide for necessary new drugs when there is evidence to support their use.
I am disappointed with the decision of the HSE to reduce the threshold used for determining cost-effectiveness. The NCPE makes recommendations, but these are based on values of life expectancy and quality of life. The HSE has decided to reduce the threshold from €40,000 to €20,000, which will have a negative impact on many people who are waiting for breakthrough medicines or new drugs that are coming onto the market on a continual basis. The example of Ipilimumab is a case in point. This drug was recommended some time ago for the treatment of melanoma, but the HSE had to be dragged kicking and screaming into making it available. There is a difficulty in that regard. We must get used to the fact that there will be continual advances in technology and increases in the number of available medicines, while life expectancy and survival rates, particularly for people with cancer, will continually increase. That is the most positive thing we can say about the national cancer care strategy. Does the Minister of State accept that reducing the threshold of adjudication from €40,000 to €20,000 will mean that many people may not receive life-saving treatments because of cost-cutting measures and that this will have a detrimental impact on quality of life and even on life itself?
We must consider these matters in the context of the overall cost of the drugs budget. We spend about 16% of the health budget on drugs, which amounts to almost €2 billion. By any standard, that is a very high proportion and it is not sustainable into the future. That is why there is an onus on all of us to ensure we get better value for money in terms of drug costs. We all want to see new and effective drugs coming onto the market as quickly as possible. The HSE estimates that if we were to approve new drugs that are clinically effective, the cost of providing them could be up to €30 million. There is no new pot of money from which we can take more money for the drugs budget. It is a finite budget and there is no potential for increasing it. I do not need to tell the Deputy the reason there is no new money available. We want to ensure these new drugs can be brought onto the market, but it must be done in the context of reducing the prices of other drugs for which we are paying, many of which are over and above the prices in other countries.
I appreciate the Minister of State's reply, but we must recall that the Minister for Health, when on this side of the House, accused a previous Minister of criminal negligence with regard to the delay in the roll-out of the HPV vaccination programme for girls. What we are looking at is a reduction in the threshold for determining value for money which will ensure people will die because they will not be able to access the necessary breakthrough drugs. A case in point was Ipilimumab, but there are many more, including Pradaxa, Sycrest, Victrelis, Brilique and Gilenya. These are all drugs that should be made available, but the HSE has reduced the threshold from €40,000 to €20,000, which means it has put a lower value on life.
The HSE has no role in determining the threshold. It is the role of the NCPE to consider a number of aspects with regard to how new drugs are to be assessed. I want to make it absolutely clear that there was no reduction in the threshold. I was in touch with the unit today and confirmed that since 2009 cost benefit analyses had been done on two levels, €45,000 per quality-adjusted life year, QALY, and €20,000 per QALY. It is absolutely legitimate that new drugs are assessed on this basis and that has been the practice since 2009. There has been no change in this regard.
There has been a change.
Many new drugs either above or below these levels are approved, while many others above or below them are rejected. That input from the NCPE is only one of a number of elements taken into consideration in the decision making process to approve a new drug for reimbursement.
5Deputy Caoimhghín Ó Caoláin asked the Minister for Health if new procedures will be put in place to address both the recurrent problem of supply to pharmacists of vital prescription drugs and the need to make the most effective drugs and treatments available as soon as possible to public patients as shown by the recent case of the cancer drug ipilimumab. [24410/12]
Shortages of essential medicines are a source of concern not only in Ireland but also throughout Europe and the rest of the world. It is a global problem affecting health systems in all countries and impacting on patients worldwide. Medicines shortages can be the result of one, several or any combination of factors throughout the pharmaceutical supply chain such as manufacturing difficulties, industry consolidation and commercial decisions by manufacturers to withdraw unprofitable lines. In some cases, pharmaceutical manufacturing is concentrated to such an extent that a production problem in one pharmaceutical plant can have a wide-ranging and international impact on health systems throughout the world.
Irish medicine regulations place an obligation on both manufacturers and pharmaceutical wholesalers within the limits of their respective responsibilities to ensure the adequate availability and supply of medicines on the Irish market in order to meet patient needs. My Department has been engaging with the Irish Medicines Board, IMB, the Health Service Executive, HSE, and the Pharmaceutical Society of Ireland, PSI, to identify ways in which the Irish system can manage medicine shortages as effectively as possible to minimise the impact on patients. International efforts to manage medicine shortages effectively are also being considered.
Pharmaceutical production is carried out by private enterprises and the State or my Department can only intervene to a limited extent to prevent medicine shortages occurring. The IMB and the HSE continue to work closely to manage operationally medicine shortages when they arise. The PSI works with the pharmacy profession and has recently published guidance for registered pharmacists on managing medicine shortages. Manufacturers, wholesalers and pharmacies all have a responsibility to work together to identify shortages quickly and implement alternative arrangements to meet the needs of patients.
Additional information not given on the floor of the House.
Medicine shortages are not related to the negotiation of pricing and the reimbursement of new and expensive medicines such as Ipilimumab. The recent issue regarding this drug was related to the current pricing and supply agreement with pharmaceutical manufacturers. The Department and the HSE are in contact with the Irish Pharmaceutical Healthcare Association, IPHA, with the intention of securing a new pricing and supply agreement to replace the existing agreement which expired on 1 March. The terms of the previous agreement and savings secured thereunder will continue to apply pending successful negotiation of a new agreement. The Department is committed to securing additional savings in the price of medicines in any new agreement.
There has been recent media coverage of reimbursement approval for new and expensive medicines. The position of the Department and the HSE in the ongoing contacts with the IPHA is that financial space needs to be created within current drug expenditure to facilitate the cost of the new and innovative drugs awaiting reimbursement approval. The Chief Medical Officer is exploring with the HSE the adoption of a new and robust system for decision making in regard to drugs to promote and drive evidence-based prescribing. This should help to create capacity on a sustainable basis to provide for necessary new drugs when there is evidence to support their use.
I welcome the fact that the cancer drug in question has been approved. Given the debate on the issue, will the Minister of State bring forward, in conjunction with her colleagues, the Minister for Health, Deputy James Reilly, and the Minister of State, Deputy Kathleen Lynch, a policy to ensure cancer patients and others who require advanced drugs and treatments will receive what they need as soon as possible? Will the Minister of State take on board the current inequity of access? There is a disparity in the approach of the various HSE regions. Tysabri is available in some HSE regions but not in all and that issue needs to be addressed.
Referencing the Minister's reply to Deputy Joan Collins, will the Minister of State confirm that the triple treatment with protease inhibitors for hepatitis C will be available to all affected women as prescribed? Does the Minister of State accept that under the terms of the Health (Amendment) Act 1996, women have a statutory entitlement to all new prescription drugs, as prescribed? Will she ensure all the women affected who require the medication in question will be able to gain access to it without delay?
On last night's "Prime Time" programme a representative of the National Centre for Pharmacoeconomics stated that in cases in which it had not approved particular drugs because of their cost, it had been able to negotiate a lower price with the pharmaceutical companies involved. Does this not expose excessive profiteering by the pharmaceutical companies? What does the Minister of State and her colleagues intend to do about it? This is an issue on which each of the Ministers has reflected when in opposition.
As I stated, cost is but one of the elements taken into consideration. Whatever recommendation is made by the National Centre for Pharmacoeconomics is but one element in the decision making process. Other issues of concern include clinical effectiveness. This is the main factor taken into consideration. Cost-effectiveness, severity of disease, unmet needs, policy considerations, available funding and other funding priorities must also be examined. We need to be reasonable and balanced when taking these factors into consideration.
As I stated, we have a very large drugs bill and must work very hard to reduce it. There is an onus on all the players concerned to reduce it. We need to address this issue from a prescription perspective and also the overall cost of medicines. That is why it is important that people discuss how we can ensure the supply of medicines is guaranteed on a sustainable basis. As the Deputy stated, we are spending a considerable amount on drugs. Expenditure amounts to almost €2 billion. We need to make space within this budget to allow for new drugs to come onto the market. The Government side, just as much as the Opposition side, and those working in the health service and, most of all, patients want to see the new, effective drugs coming onto the market as soon as possible. This is achieved within a limited envelope. If funding must be provided for new drugs, we must secure a better deal on the cost of existing drugs.
The Minister of State did not address the issue of the availability of tysabri in all HSE areas. Will she, please, do so? Will she reiterate and confirm the position outlined by the Minister in response to Deputy Joan Collin's question on women testing positive for hepatitis C? This is very important. The women concerned have a statutory entitlement under the terms of the 1996 Act.
It is not entirely a question of cost, but it is most certainly is a question of availability. The United States Senate has introduced legislation to address what it is referred to as "price gouging" by certain pharmaceutical companies which are driving up the price by making fewer drugs available than are demanded. Has the Minister of State any concerns that such practices are taking place in this jurisdiction or in supply lines to our market?
My understanding is that tysabri is prescribed on the basis of clinical indications. If there are regional variations, I am not aware of them. I will check and revert to the Deputy later in the day.
I agree absolutely with the Deputy that we need to be very vigilant about the prices charged for medicines. In many cases where new drugs are coming onto the market, the suppliers have a monopoly. That is why we need very rigorous assessment of the value for money achieved in the prescribing of the drugs in question. We cannot accept any new drug coming onto the market. There ought to be a very rigorous assessment and such an assessment is absolutely legitimate. History shows that, in many instances, we paid over the odds for drugs. This is partly the reason our drugs bill has increased from €400 million in 1998 to almost €2 billion today. This is not sustainable. We must ensure drug companies, the presence of which in the country we very much welcome because of their research and the employment they provide, are responsible in their pricing systems. If we are paying more for drugs, the cost must be met somewhere else. It means a service cut somewhere else. That is the reality and there are serious implications on foot of a service cut. It is a question of ensuring we are reasonable and that we can bring the drugs budget under some control while ensuring new drugs are made available.
