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Dáil Éireann debate -
Tuesday, 31 May 2016

Vol. 911 No. 1

Leaders' Questions

I want to raise the unacceptable situation regarding the approval of life-saving drugs. This has come into the public domain again in the past week, in particular in the case of three drugs, namely, Pembro, Nivo and Ibrutinib. Pembro has had an astonishing impact in the treatment of melanomas and the prospects for its impact on lung and kidney cancer are also exciting, something to which most oncologists will testify. Pembro and Nivo deal with melanomas and Ibrutinib deals with CLL, a type of blood cancer. They all have significantly improved survival rates and all are in use in most of the EU25 countries. They have been approved by the FDA and the European pharmaceutical agency, as they have by our own pharmacoeconomic unit, which is normally the area of contention when disagreements arise. It suggested, for example, that with Ibrutinib there was a 90% survival rate, which is quite dramatic, while up to 50% of those treated with Pembro can expect to have significant survival rates.

There has been an unacceptable delay in approving these drugs, because the pharmacoeconomic unit approved them in February. My understanding is that the relevant group within the HSE is not due to meet until June. To be fair to the Minister for Health, he has brought forward that meeting to Wednesday. The compassionate access programme has been closed and it now only applies to existing patients.

No new patient can access these vital drugs. I met a family over the weekend. Other Deputies have met families also. The prospect facing families is having to find up to €10,000 to start paying for a drug that has been approved by the pharmacoeconomics unit. What is going on is scandalous. It speaks to the lack of an overarching policy in this area. I ask the Taoiseach to take every step to ensure the approval process is sorted out as quickly as possible. My understanding is that after the approval of the HSE committee has been secured, the matter has to be referred to to the Government.

I suggest we consider the establishment of a ring-fenced fund that could be top-sliced from overall Government expenditure. If 0.4% were taken from it, approximately €200 million could be put into a separate fund every year. The fund that builds up during the years could be used to deal with new technologies and new drugs. Such an approach would have a real impact from a policy perspective. Alternatively, the proposed sugar tax could be used to finance such a fund. We need to do something that differs from the current ad hoc approach, which involves pushing the can down the road and hoping the issue will not come up straightaway. That is what is going on because of the current budgeting process and lives are being lost as a result. It is just not good enough.

Nobody wants to be put in a position of determining between life and death. This will continue to be an issue because new drugs are being tested, assessed, analysed and created as time passes. A number of new drugs come on stream every year. Deputy Micheál Martin has referred to pembrolizumab and nivolizumab. The new Minister in the Department of Health, Deputy Simon Harris, has asked for a meeting on the availability of these drugs to take place tomorrow. The State pays out €1.7 billion on drugs every year and that figure could potentially grow by approximately €400 million in the coming years. There is always an analysis that has to be carried out. I understand a price cannot be put on a life.

More high-cost treatment drugs are continuously coming out. Like other countries, Ireland needs to ensure those patients who could benefit most have priority access to emerging high-cost treatments. At the same time, we must ensure the drugs are affordable to the taxpayer. It is important to emphasise that these decisions should not be made by the Government or ministerial order. They have to be made through the National Centre for Pharmacoeconomics which makes clinical decisions on the basis of a determination of the value and benefit of drugs for patients who can avail of them. As the Deputy has pointed out, the drugs referred to are being considered by the HSE. I hope the participants at tomorrow's meeting will reach a conclusion on whether these drugs represent value for money. The Minister has asked the HSE to conclude its deliberations quickly because he wants to know the position. A memo has to come to the Government which will have to consider the cost implications of what is involved. No Minister wants to be put in a position in which he or she has to tell people that somebody will die if they do not approve a drug.

As time passes and the years go by, there will be new treatments that will be exceptionally expensive and still have great benefits for people with particular ailments. A drug produced at the AbbVie facility in Sligo is not just a treatment for hepatitis C - it is an absolute cure. It brings joy and consolation to people who are able to avail of it and enjoy its curing qualities. It means a whole new emphasis on life and living for them. As I said, the group is meeting tomorrow and the Minister needs to know. We will wait and see what the group's analysis and conclusion is. The Minister will bring a memo to the Government as soon as possible. I take Deputy Micheál Martin's point that this issue needs to be dealt with as part of an overall strategy within the health system. Given that almost €14 billion is provided for it, it is obvious that one could identify areas where savings of a serious nature could be made. We do not want to be in a position where somebody who needs treatment with a very expensive drug has his or her life taken from them sooner than would naturally have occurred because he or she does not receive this treatment. We want to see a clinical decision by those who understand these things. After the Minister is informed of that decision, the Government will make a decision on the affordability of these drugs in order that taxpayers will know that they are getting good value for the money they are spending and patients can have their lives saved where that is appropriate.

That is exactly what is happening. Patients who are waiting for this medication cannot get it in hospitals. The clinicians are clear.

Any oncologist to whom I have spoken has been very clear about the efficacy of these drugs. The pharmacoeconomics unit which normally makes its determinations after weighing up cost-benefit analyses and survival rates made its decision in February. People were waiting for the HSE committee which was not due to meet until June to decide.

This is not the first time this has happened. There is a significant hiatus between the decisions of the pharmacoeconomics unit and those of the group of HSE officials. In no way is it good enough. What group of officials will second-guess the formal process of evaluation that has already taken place? Greece which is more fiscally challenged than Ireland has these drugs in operation and is using them in its hospitals. We lack any sense of urgency. We need someone to cop on and get at this thing, particularly after they have been approved.

We should encourage and nurture new technologies. That is what the country was about at one time. I am not saying the pharmaceutical companies are angels because they are not. They have to be challenged also. As a country, we are not playing this properly; we are just ambling along. We are delaying while people's lives are at risk. We need to value an approach which wants to encourage innovation and investment in research and development. The MSD plants in Cork and Carlow, for example, are key to the processing of these drugs. We have to fund innovation before we can have generic drugs. The bottom line is that these drugs have been passed by the pharmacoeconomics unit for use. We have an urgent obligation to get this over the line as quickly as possible, especially in the interests of the young people who are awaiting these drugs which can have a dramatic impact.

This issue is going to come at us again in the coming months. As I said, pembrolizumab is going to be available to treat kidney and lung cancer. I have suggested a way to grapple with this issue for once and for all. No one in the country would object to the creation of a ring-fenced fund. I suggest €1 of every €250 spent by the country every year be put aside in a ring-fenced fund to be built up over time and used as leverage to negotiate and develop a strategy. It would be separate from the current health budget which cannot deal with this issue as it is. It is time. I do not want this issue to come up on Leaders' Questions in the next few months as the next drugs come on stream. I welcome innovation. If someone had done this in the last century in the case of penicillin, where would we be?

Of course, the country has invested heavily in innovation and research. A certain number of new and very expensive treatments will be brought forward in the next five or ten years as a result of the work of the many research students working in pharmaceutical companies. We do not know the extent of the cost of these drugs when they are eventually tested and will come on the market. Some of them will be exceptionally expensive. As the Minister has ordered the committee to meet tomorrow, we will have a conclusion. Regardless of the outcome, I expect him to bring a memo to the Government. I am conscious of this. It would be lovely to have a ring-fenced fund for all of the different sectors, but life is really not like that.

The Minister will look at how effectively much of the €14 billion fund is being spent in areas of the HSE. I am quite sure a significant amount can be saved. We can all understand it would be nice to have a specific fund for exceptionally expensive drugs used to treat a smaller number of patients who really need them because of their particular ailments. I would like to think we can speed up the process of getting a decision and a conclusion in order that hope can be restored to these patients and that they can be confident the State has not forgotten about them. There is a balance to be struck in all of these things. We are paying over €1 billion on drugs every year. That figure is going to increase by a further €500 million in the coming years. While these are things that have to be taken into account in respect of the taxpayer, one cannot put a price on human life.

I understand the British National Crime Agency has arrested two people today as part of its investigation into NAMA's Northern loan book, known as Project Eagle. For years now Sinn Féin and others have raised concerns about the sale of NAMA's loan books, including the sale and purchase process for its Northern loan book. The Taoiseach and the former Tánaiste, Deputy Joan Burton, have accused the Opposition of conflating the matter. Deputy Joan Burton described it as just a "Northern tale". I put it to the Taoiseach that it is actually a national scandal and a disgrace. The sale and purchase process for NAMA's Northern loan book has been the subject of serious allegations. It has been alleged that, as part of a cosy cartel that was in operation, insider trading took place, that payments were made to a golden circle and that illegal fixer fees were paid. This was brought to the attention of NAMA by a potential US bidder, Pimco. NAMA previously claimed that its Northern advisory committee was not privy to confidential information on the sale, but it has since been disclosed that the committee discussed potential purchasers on at least two occasions before the loan book was sold at a huge loss to Irish taxpayers.

There are investigations in the North by the National Crime Agency, NCA, the law society and revenue. There was an Assembly inquiry which found the Government's approach very unhelpful. There are also investigations in the USA by the Securities and Exchange Commission, the FBI and other authorities. However, there is no investigation here. In this State, the Minister for Finance, the Government and NAMA have closed ranks. The chairman of NAMA, Mr. Frank Daly, said he briefed the Minister in full, including on the scandal of a fixer fee of £15 million sterling, which is totally irregular and illegal. Despite this, the Minister failed to suspend the Project Eagle sale process or to inform the office of the First Minister or Deputy First Minister. The Assembly inquiry noted this failure with regret. This is a public interest matter, which must be fully investigated.

Get to the question please, Deputy.

Tá mé beagnach críochnaithe anois, a Cheann Comhairle. It must be fully investigated to get to the bottom of allegations of wrongdoing and cosy cartels which have cost the citizens of this State millions of euro. Does the Taoiseach not believe it is time for the Minister for Finance to make a full statement on all of these matters to the Dáil?

The Minister has made a full statement already and there has been quite a deal of discussion at the various Oireachtas committees on the question on NAMA. NAMA personnel at the highest level have responded and given much time on different occasions to discuss these matters.

If two people have been arrested, they have been arrested on suspicion of particular charges and I expect that the court system in the jurisdiction in which they were arrested will follow through on arresting them in the first instance. Obviously, it is not for me to comment on the court system of a different jurisdiction. If they have been arrested, I assume that it is for good reason in respect of activities that would be outside the law. I trust that this will see itself through that process and be judged before the courts.

The Minister for Finance has not made a full statement to the Dáil. It is not just Sinn Féin which has these issues. Others have raised these issues consistently and in a very detailed way. It is impossible to get information from any of the Ministers on issues as serious as this one. The Taoiseach refused to establish a commission of investigation. NAMA is an arm of the State. It is dealing with the people's money. NAMA is not accountable but it should be. It should command public trust and confidence in the business of securing the best possible value for Irish taxpayers and I, for one, have no confidence that it has done this.

I have seen this happen to the Taoiseach in that every so often an issue comes up but for all of his cleverness and skills as a politician, he is like a rabbit caught in headlights. This is a huge issue. There needs to be transparency, confidence and accountability. Why not depoliticise it? Why not simply open it up to those of us in the Oireachtas? The people have suffered grievously because of the kinds of activities involved in selling off what were the people's assets. Given the mounting public concern across the island, will the Taoiseach now commit to establishing a commission of investigation into the sale of Project Eagle?

No, I will not. There has not been any allegation of wrongdoing against NAMA.

The Deputy informs me that two people have been arrested. I assume they have been arrested for good reason. Representatives of NAMA have appeared before the Committee of Public Accounts and have given very lengthy statements. They have been crystal clear that from their perspective, there is no allegation of wrongdoing against NAMA. NAMA has done nothing wrong. It has been completely in compliance with the law and the conditions it was set up under. Coming in and asking for another commission of investigation about this is not the way forward. There is no allegation of wrongdoing against NAMA and at the highest level-----

There is an allegation of incompetence.

There was a fixer fee of £15 million.

Representatives of NAMA have appeared before the Committee of Public Accounts and have given their statements and answered questions at length on all of these issues, and more than once.

Acknowledging that employment law and workers' rights merit but two paragraphs in the programme for Government and on the anniversary of the scandalous treatment of Clery's workers, it is imperative that the recommendations of the University of Limerick report, commissioned by former Minister of State, Gerald Nash, be implemented. These are vital issues for low and middle income workers all over the island of Ireland. Can the Taoiseach tell us which Minister of Government is specifically charged with labour affairs and workplace issues? Will the Government legislate for the proposals in the University of Limerick report on zero-hour contracts, abuses, such as if-and-when contracts, bogus self-employment designation and, above all, protecting workers in so-called informal insolvencies and collective redundancies?

The Ministers responsible are Minister of State at the Department of Jobs, Enterprise and Innovation, Deputy Pat Breen, and the Minister for Jobs, Enterprise and Innovation, Deputy Mary Mitchell O'Connor.

Does the Taoiseach have nothing else to say about the University of Limerick report?

That is all referred to in the Private Members' motion, which is due this evening.

This is Leaders' Questions.

Yes. Government has an amendment-----

Give us a flavour.

Give us a hint.

-----to that motion dealing with the question of the University of Limerick study, which will obviously have to be implemented.

The Taoiseach is on the side of the angels, all right.

This is Leaders' Questions.

One gets used to it after five years.

The Taoiseach is obliged to answer the question-----

Now the Deputy knows how we feel.

-----and not say somebody will answer it in due course. That is not an answer.

A convert, a Cheann Comhairle.

I will ask again. Is it the Government's intention to legislate-----

We spent five years learning-----

Deputy Calleary, please.

Ask Wonder Woman. She will tell the Deputy about it.

Is that the way the Taoiseach spoke to the Deputy at Cabinet?

The Teachtaí from Fianna Fáil should calm down. Calm down a bit, lads.

Do not be provoked, Deputy Howlin. Get on with your question.

I will do my very best. Is it the Government's intention to legislate on the University of Limerick report proposals that were being advanced by former Minister of State, Gerald Nash? The matters I have talked about are of real concern to low and middle income workers and, in fact, to all workers. The issues are zero-hours contracts, abusive if-and-when contracts, bogus self-employment and the protection of workers in insolvencies. Does the Taoiseach agree that there are now sectors of the economy which are vulnerable to exploitation, notably catering and security? Is any statutory provision envisaged by this Government to protect those vulnerable workers?

Deputy Howlin asked me to answer the question. He asked me what Minister was responsible and I said the Minister of State, Deputy Breen, and the Minister for Jobs, Enterprise and Innovation, Deputy Mitchell O'Connor.

That is the closest the Taoiseach came to answering it.

The Government has not considered the outcome of the study of the University of Limerick but it will consider that-----

It has been six months.

-----and make its views known. If there is an opportunity for a debate in the House, we will have that. Minister Howlin, or Deputy Howlin - gabh mo leithscéal - is well aware of the foundation he partly put in place himself. Ireland has moved up nine places to the seventh most competitive economy. The Deputy beside Deputy Howlin, the former Minister for Social Protection, would be interested to know that the unemployment rate is down to 7.8% today, which I am sure is of interest to Deputies.

It is all very interesting but irrelevant to the question.

That is no way to treat the Opposition.

Sectors of the economy, such as catering and security, which the Deputy mentioned, are vulnerable and the Government will reflect on how best to deal with those vulnerabilities in the interest of continued employment in those sectors while taking into account the vulnerability that obviously exists there.

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