Micheál Martin (Cork South Central, Fianna Fail)
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Cystic fibrosis, CF, is a very debilitating condition. Ireland has the largest cohort per capitaof population of people with CF. Consistent research has helped improve the quality of life and extend the lives of people with CF. Given that we have the largest cohort per capitaof population of people with CF, there is an onus on this country to be in the vanguard in terms of research and new technology in respect of extending life and improving the quality of life of people with CF. Orkambi is the first drug to impact on the underlying cause of CF for up to 50% of people with the condition in Ireland. It has been shown to produce both a reduction in the worsening of CF requiring hospital admissions and a sustained increase in lung function and weight, which is an important issue in the context of CF care. Orkambi has been approved by the Food and Drug Administration in the US and could apply to approximately 50% of people with CF in Ireland.

A wonderful article written by Orla Tinsley, a CF patient, that appeared in The Irish Timeson 2 June 2016 details the new life Orkambi has meant for her and those with compassionate access to the drug via the relevant pharmaceutical company. It is worth reading the article to get a sense from somebody who has lived with this condition all her life and who has fought all her life to try to improve quality of life for people with CF. Orkambi has transformed her existence. Ms Tinsley gave an interview on "Today with Sean O'Rourke", some time back to talk about the impact of the drug on her. People such as Jillian McNulty have testified to the positive impact a drug such as Orkambi can have on CF sufferers. Orla Tinsley made the point in respect of one of her friends who has compassionate access to the drug that "Removal of Orkambi is a catapult towards death for her."

This is what it is like in the CF community for those who are taking Orkambi. Others have been waiting for approximately two years since the drug was first approved to gain access to it.

It is not just a Government issue. It is also an issue for the pharmaceutical companies. The pharmacoeconomic unit rejected it in the context of the cost submitted by the company. Negotiations between Government agencies and the company have been going on for a considerable length of time. Is the Government still committed to giving CF patients access to Orkambi? As I have asked before, is it not time for the Government to establish a separate fund from the health budget in which we could continuously invest to provide for new technologies and drugs such as this so we can be at the vanguard of new developments in medications and drug therapies?

Enda Kenny (Mayo, Fine Gael)
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The Deputy's point is best addressed by people who have CF and have to contend with it. The situation has improved for a great number of CF sufferers compared to years ago. After many years of tribulation, there have been formal openings of a number of CF units around the country. From talking to patients who have the use of them, I know provisions such as the recirculation of clean air mean so much to their lives. As the Deputy pointed out, it used to be that the Government would accept or reject the prices put forward by pharmaceutical companies. Now, the decision is based on a clinical assessment of the effective outcome of treating a patient with a particular drug. This is based on the assessment of the improved quality of life for the patient, depending on the nature of the treatment they receive. This also applies to other drugs for other ailments. The Government, the Department of Health, the Minister and the HSE are committed to continually improving the situation for CF sufferers and this is evident in the programme for Government. The evidence is there before our eyes in better facilities.

A process is taking place arising from the clinical assessment of the improved quality of life for CF sufferers who take Orkambi. This means meetings between the HSE, the pharmaceutical company and the clinicians involved. I hope an outcome can be arrived at, as has happened in a number of other cases in which the original price set by pharmaceutical companies was reduced to a level where the clinical assessment was that it was worth the cost in terms of the improved quality of life it could give. These are clinical assessments, as the Deputy is aware. I will have the Minister for Health give me an update on the progress on those meetings on appeal to see if Orkambi can be made available at a price that would justify a clinical assessment of it improving the quality of life for people. It is a very sensitive and important question.

Micheál Martin (Cork South Central, Fianna Fail)
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It is a life and death issue and it is a fundamental imperative that we do everything we possibly can to improve the quality of life and extend the life of those with CF. There is no doubting the health benefits to be derived from Orkambi. In the assessment it was rejected "at submitted cost"; in other words, it was regarded as too expensive. The benefits are well reported not just by those in the clinical trial, but objectively.

There is a cost issue and our policy across this area is somewhat flawed. Regardless of whether we like it, the costs keep interrupting our process. There was a cost element with other drugs that have recently been approved. Until recently, new drugs and therapies had to be approved by the Department of Public Expenditure and Reform.

In the final paragraph of her article in The Irish Times Orla Tinsley wrote:

I am so far away from the constant daily struggle I was once confined by that this thought is newly harrowing. [She is in a better space, having had access to the drug in the United States.] Generations need not suffer because a drug company and a government cannot negotiate a real solution. There must be a price reduction. The results of the Orkambi trial were released two years ago this month. [This was last June.] That's two years the 505 Irish people suitable for Orkambi have been waiting to sail on to that new chapter of their lives.

I respectfully suggest that the process has dragged on for far too long. There needs to be a resolution, an impetus and an injection of urgency in order to get this sorted.

Enda Kenny (Mayo, Fine Gael)
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I thank the Deputy. Obviously, the situation here, as I said, is not a political decision anymore. I recall the interview given on the national news by the specialist involved. On 1 June, the National Centre for Pharmacoeconomics, NCP, recommended that Orkambi for treating cystic fibrosis should not be reimbursed by the HSE. As to the prices submitted by the pharmaceutical company, the cost was €160,000 per patient per year. The NCP indicated that the price would have to be below €30,000 per patient per year to be cost-effective. That is a clinical assessment, not a political one. As Professor Michael Barry stated in his recent expert opinion on the evidence submitted by the manufacturer, the latter got it wrong when it came to pricing. Deputy Martin and I know that the level of cost submitted by some pharmaceutical companies is quite astronomical in the case of certain drugs. Drugs require a clinical assessment as to whether their use is justified.

The NCP estimates that the five-year gross budget impact of Orkambi is more than €390 million and notes the significant opportunity cost of reimbursing the drug as being two thirds of the cost of the children's hospital for one drug alone. If the clinical professor says that the pharmaceutical company got it wrong, is it not important that we should follow through with meetings with those representatives to see can that be reduced? It is not the end of the process and I hope that the HSE will continue to work on price negotiations on Orkambi.

The Deputy made one other point about having a ring-fenced structure for dealing with new drugs that come on the market, which they do every year. That is something that I would be prepared to look at in conjunction with the other parties.

Micheál Martin (Cork South Central, Fianna Fail)
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It is essential.

Gerry Adams (Louth, Sinn Fein)
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On Sunday, Dr. Fergal Hickey, an emergency consultant at Sligo University Hospital, stated that up to 350 patients are dying each year as a result of hospital overcrowding and that delays in securing intensive care beds for patients are increasing the risk of patient mortality. As winter approaches, the number of patients on emergency department trolleys is increasing once again. I do not have the figures for today but 450 patients waiting for beds yesterday. Once again, Our Lady of Lourdes Hospital in Drogheda had one of the highest numbers.

This morning, cardiologists at the Mater hospital serving adult patients with congenital heart defects warned that the service was being stretched to a critical point. The two consultants working in the service stated that they were dealing with approximately 4,000 patients and had insufficient resources, staffing and laboratory access. One of the consultants, Professor Kevin Walsh, told "Morning Ireland" that the service's lack of resources was putting lives at risk. He stated that the service should have four full-time consultants and five full-time nurses. However, it has just two part-time consultants and two nurses. That is for almost 4,000 patients, with 400 accessing the service year on year. There is also a shortage of secretarial and administrative support. The Taoiseach will agree that this situation is shocking.

Last week, Ministers made grand claims about an increase in the budget for the health service.

The reality is these pronouncements were deceptive and grossly exaggerated. The bulk of the increase in funding is required simply to stand still. It will have little impact on waiting lists, the trolley crisis and inadequately resourced services. The Taoiseach knows that when the money required to cover pay restoration, estimated at €97 million, and demographics, estimated at approximately €119 million, is stripped away, the budget increase for health shrinks to just €147 million. I am sure the Taoiseach will acknowledge this as grossly insufficient. Sinn Féin's alternative budget proposed an additional €465 million investment in health over and above payments for demographics and the Lansdowne Road agreement. Our budget is fully costed.

Will the Taoiseach commit to going back to the drawing board to ensure services such as the acute cardiology unit in the Mater can be adequately resourced? Will he take on board what hospital consultants like Dr. Hickey and Professor Walsh are saying?

Enda Kenny (Mayo, Fine Gael)
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I thank the Deputy for his questions. I do not propose to go back to the drawing board but I take a genuine interest in the matter raised by the Deputy. The detail available on the Department of Health website gives a clear understanding, the facts and figures for the budget allocation for 2017 as being the highest ever allocated to the health portfolio. It is an increase of over €500 million to the HSE this year. This has been gone through in great detail both by the HSE and by the Department of Health and its Minister. It is there for all to see.

I listened this morning with interest to the interview with Professor Walsh, who is clearly a very learned man in his profession. Some €900 million more was provided this year, for 2017, when compared with last year. Professor Walsh spoke very clearly about the situation In the national adult congenital centre at the Mater hospital. It is because of the success of the interventions in paediatric services that the numbers of young people requiring the service is growing. It is a challenge of success. The survival rate for paediatric cases, like young Laura Clifford from Sligo, who spoke so well this morning, was 10% but it has now reached 90%, which is of course something that everybody would support. That means an increase in survivors will require a greater need from adult services.

The position spoken of is a highly specialist field. That post is to be divided between the children's hospital in Crumlin and the Mater in order to support the transition from paediatric care to adult care. The money is available for the post. This was advertised in terms of an additional cardiologist post in 2012 and again in 2015 but no application was received for the job. I am not sure if that is because of the range of facilities, remuneration, the structure of the job or whatever else. These jobs are advertised on a worldwide basis. Given the success rate increase from 10% to 90%, and given that the money is there to fill the position, there were no applications. In order for the post to be filled, it is being restructured across both the Mater and Crumlin hospitals and it will be readvertised shortly.

In light of the development of an all-island congenital heart disease network, which the Minister, Deputy Harris, signed recently, children from Northern Ireland will be able to come to Crumlin hospital for very specialist heart surgery. It is expected that a greater pool of potential candidates will now be available for the post and recruitment could well be successful. The money is in place to provide for the cardiologist to be appointed. I hope it happens.

Gerry Adams (Louth, Sinn Fein)
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The Taoiseach states he does not intend going back to the drawing board, which is unacceptable. What are the 350 patients dying each year because of overcrowding to do? Are they to just die? What about the 4,000 patients who have two part-time consultants and two nurses? Do they just have to put up with it? Is that the way it is?

Enda Kenny (Mayo, Fine Gael)
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No.

Gerry Adams (Louth, Sinn Fein)
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The Taoiseach cannot pretend that an expenditure of €147 million will solve the crisis in our health service. These words are not coming from me but from the people working in the services, including in one case - and by the Taoiseach's own acknowledgement - a very learned person. The consultants running the health service say they are dealing with an unsustainable burden caused by poor resources. When resources are not provided, services cannot deliver.

In fairness to the health service, we know that when resources are provided, it does deliver. For the children with congenital heart defects who attend the paediatric unit in Crumlin children's hospital, for example, there is a 95% patient success rate. That particular service is considered to be world class, which is the very least our citizens deserve in all aspects of health care. They do not deserve to have their lives put at risk. They have an entitlement to a wraparound public health services that looks after everyone from cradle to grave. Does the Taoiseach agree that he has failed to provide such a service on because his vision is for a privatised, as opposed to a public, health system?

Enda Kenny (Mayo, Fine Gael)
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The Deputy's final comment is completely false and without any foundation. There are now 600 more consultants in the health service than was the case in 2007 and a bed capacity review is being conducted by the Minister for Health. This is not just about acute hospitals, however. It is also about primary care, new GP contracts, home-care services and packages and so on. It is not all about money either, but €14.6 billion is a very substantial budget with which to attempt to deal with the many challenges in the health care area. Of course problems of a cyclical nature of one sort or another will arise, whether weather-related, epidemics or whatever. The Minister for Health has taken responsibility for the Vote. It is a very challenging position but that €14.6 billion is a very substantial allocation to allow us to proceed with the review that is being carried out in terms of output and the development of the delivery of effective services for all patients.

I reiterate that the vacancy at the Mater hospital is one that is split between itself and Crumlin. The money is in position for a consultant cardiologist. It is a worldwide position and if anybody out there is interested in applying to the Mater, let he or she do so. There is a vacancy there and money to pay the person who fills it.

Brendan Howlin (Wexford, Labour)
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Last week, the Government published a budget that includes tax cuts for landlords, an increase in the threshold for the rent a room scheme and the introduction of a first-time buyer's scheme that has been widely criticised for increasing prices and delivering no meaningful benefit for those at whom it is aimed. The Government managed to introduce those measures while doing nothing for those who rent their homes. New figures published yesterday suggest that the cost of renting a home in Ireland will rise by 25% in the next two years. That is a staggering figure. This projection will alarm hundreds of thousands of people who rent their homes and who have already faced enormous increases in the rents demanded of them. At this point, people deserve assurance from Government that it is aware of their predicament and envisages concrete actions to control rents.

My colleague, Deputy Jan O'Sullivan, has published our party's Social and Affordable Housing Bill, which contains many measures that will be welcomed by Members on all sides of the House. It includes a proposal for a model of rent control to limit increases to changes in the consumer price index.

Brendan Howlin (Wexford, Labour)
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The Taoiseach and I had many conversations when we were in government concerning Fine Gael's decision to block the idea of rent control. In view of the astonishing figures published this morning, I hope the Taoiseach will change his view and accept this is a necessary proposal. The introduction of some model of rent control is now imperative.

I ask the Taoiseach to examine the proposals in Deputy O'Sullivan's Bill or introduce Government legislation to bring certainty and comfort to people who are facing this level of increase into the future.

Enda Kenny (Mayo, Fine Gael)
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The budget dealt with a number of issues in this element of the housing sector. It is important that landlords who have property to let are in a position to do that. It is also important that we have a comprehensive rental strategy. The Minister for Housing, Planning, Community and Local Government is committed to publishing and bringing in such a strategy before the end of this year. I commend Deputy Jan O'Sullivan on producing a Bill in this area. I advise her to talk to the Minister, Deputy Coveney, because some elements of her Bill may be acceptable to him. We want to have a comprehensive rental strategy. It will be produced here before the end of the year. As Deputy Howlin is aware, the Government is focused on supply in its efforts to deal with the question of assistance for first-time buyers of new houses. We have deliberately focused on increasing housing supply over a three-year period. I know there has been some discussion or comment about the headroom given beyond the €400,000 limit, up to €600,000. There can be further discussions on that during the Committee Stage debate on the forthcoming finance Bill.

The Minister for Finance proposed a number of small changes in this regard when he presented the Bill yesterday. Obviously, he is prepared to discuss those changes. We are focused on increasing supply because the more houses there are, the better the opportunity for people to get affordable houses. The programme being advanced by the Minister, Deputy Coveney, aims to deliver 41,000 social housing units over the period. I welcome the Bill proposed by Deputy Jan O'Sullivan and I congratulate her on it. I advise her to sit down with the Minister and his officials because it may well be that the element of rent she has referred to in her Bill can be reflected in some way in the comprehensive strategy being adopted by the Minister. Deputy Howlin is well aware that his colleague, the former Minister, Deputy Kelly, had clear views on rent. I note how the Deputy's language has changed from saying that the Fine Gael Party blocked everything to prevent the Labour Party from getting on with its business or whatever else.

Seán Sherlock (Cork East, Labour)
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We can just tell everybody now.

Enda Kenny (Mayo, Fine Gael)
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In fact, we were focused, as we are now, on increasing the supply of houses for people across the country.

Brendan Howlin (Wexford, Labour)
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Maybe I am encouraged by the new dispensation whereby all rows in government are now public.

John Deasy (Waterford, Fine Gael)
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It sounds like a job for the Citizens' Assembly.

Brendan Howlin (Wexford, Labour)
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The Government appears to want people to save up for homes, but they cannot do so if rents are increasing by 25%. There is no point in putting money into the rent supplement or housing assistance payment schemes, as the Government has done, if there are no measures to control the surge in rents. All the Government is doing is putting State money directly into the hands of landlords. The inescapable reality is that people's salaries are not back to 2007 levels, but rents are now surging beyond 2007 levels. The Government must act now. I do not think it can leave it to the marketplace alone. When will the comprehensive strategy that was mentioned by the Taoiseach be published? Can we have a date for that? Will the Government include in the strategy legislation to create rent certainty into the future?

Enda Kenny (Mayo, Fine Gael)
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The previous Government was very clear in its attitude to supporting people who rent. Many thousands of families benefited from the introduction of the housing assistance payment scheme and the increase in rent supplement. I do not have an actual date for the publication of the comprehensive rental strategy that the Minister will produce. I assure Deputy Howlin that he is committed to bringing it in before the end of this session. I am sure he will do that. The Deputy said that the Government needs to act now. That is what the Government is doing with the introduction of the most comprehensive housing programme in the history of the State and the provision of money to back it.

Brendan Howlin (Wexford, Labour)
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Rents are surging.

Enda Kenny (Mayo, Fine Gael)
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Of course rents will increase if there is a shortage of supply at a time of increased demand. One cannot deal with that without increasing the supply of houses. As the Deputy knows, the five pillars of the programme deal with the homeless and those who are in hotel rooms and inadequate accommodation.

Brendan Howlin (Wexford, Labour)
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Will the Government control rents? That is the question.

Enda Kenny (Mayo, Fine Gael)
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Those who rent will benefit from the comprehensive rent strategy.

Mary Lou McDonald (Dublin Central, Sinn Fein)
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What about rent control?

Enda Kenny (Mayo, Fine Gael)
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Those who need new houses will be assisted through the initiative aimed at those who are buying such houses. The comprehensive rental strategy is one element of the Government's comprehensive housing programme. Deputy Jan O'Sullivan's recommendations will be taken into account in that context.

Brendan Howlin (Wexford, Labour)
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What about the question regarding rent control?

Enda Kenny (Mayo, Fine Gael)
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The comprehensive rent strategy will deal with how the Minister proposes to provide a degree of certainty for renters.

Tommy Broughan (Dublin Bay North, Independent)
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Up to yesterday, 148 of our fellow citizens were killed on the roads. That represents an increase of 25 on last year. Of course, the 148 families of these victims are totally devastated. In communities in virtually every constituency, people are being devastated by the ongoing carnage. Since the Taoiseach came to office in March 2011, approximately 1,000 people have died on our roads and perhaps 15,000 have been seriously injured. The chairperson of the Road Safety Authority, our former Dáil colleague, Liz O'Donnell, has drawn attention once again to the fact that under this Taoiseach, successive Administrations have slashed the size of the Garda traffic corps by half, from approximately 1,200 around the time of the crash down to barely 700 now.

An additional €85 million is included in the budget as part of the Government's plan for the Garda Síochána to have 15,000 members - and 21,000 staff in the service altogether - by 2021. Will the Government bring the strength of the Garda traffic corps back up to what it was in the past? At one stage, we succeeded in halving the number of road traffic deaths from approximately 400 per year to in the region of 200.

My next question relates to the Departments of Transport, Tourism and Justice and Equality. There are, as two Ministers sitting near the Taoiseach who have had responsibility in this area previously are aware, difficulties with traffic law. The Department of Transport, Tourism and Sport makes policy but the Department of Justice and Equality has to implement it. We get many gaps and failures in the Courts Service and the Department of Justice and Equality. I wish to draw the attention of the Taoiseach to one or two of these, in particular section 22 of the Road Traffic Act 2002. This provision makes it an offence not to present a licence in court if requested to do so. Yet, questions answered at the instigation of the outstanding PARC Road Safety Group in 2014 and 2015 suggest that up to 70% of people coming to court did not present their licences. The Tánaiste and Minister for Justice and Equality, Deputy Fitzgerald, undertook to take action on this matter. However, when the first group of 21 such prosecutions were brought forward last November, Judge Marie Keane struck them down. For the past year, the Tánaiste has been in consultation with the Garda Commissioner and there has been consultation between the Departments of Justice and Equality and Transport, Tourism and Sport but nothing has been done. As the two former Ministers for Transport, Tourism and Sport sitting near the Taoiseach are aware, section 42 of the 2010 Act has not yet been brought into force, although it is six or seven years since the legislation was passed. This section relates to the third payment option.

There are many anomalies and there has been a failure to co-ordinate between the Departments of Transport and Tourism and Sport and Justice and Equality. The Courts Service, in particular, needs to be upgraded. The Government only provided approximately €4 million for the upgrading of the information technology systems of the Courts Service. Yet, there is an extraordinary dearth of information going from the Courts Service to the Road Safety Authority and the Department of Transport, Tourism and Sport.

Enda Kenny (Mayo, Fine Gael)
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Deputy Broughan referred to traffic accidents and deaths. These are always tragic and so sad. Despite every encouragement we can provide and every incentive or initiative we can put in place, accidents will continue to happen. We regret the loss of life in that regard.

It is a matter for the Commissioner to determine the allocation of gardaí to the various sections of the Garda, including the traffic corps. That is a matter of day-to-day management. It was a matter of public politics for the Government to make a decision to reopen the training college in Templemore and increase the level of induction thereto. A total of 800 gardaí will now be trained per year. It is a matter for the Government to make a political decision to bring the Garda strength to 15,000. An extra 4,000 civilian staff by 2021 and an extra 2,000 in Garda Reserve numbers will bring the force up to that level. Obviously, budgetary requirements are a factor and these are determined by the allocations to the various sectors.

I am unsure of the position with regard to the issues relating to section 22.

Technology has advanced to a stage where if an arrest is made or somebody is apprehended, it will indicate whether there is a driving licence or insurance or charges pending or whatever. These matters must be looked at.

I do not know the detailed answer to the two questions the Deputy raised in respect of section 22 and section 44 but I will ask the Minister for Justice and Equality to respond to Deputy Broughan in respect of those.

Tommy Broughan (Dublin Bay North, Independent)
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I welcome the Taoiseach’s answer. We have heard often from people in the Road Safety Authority, RSA, about the absolute necessity for additional invigilation. The chairperson of the RSA referred to the European driver attitudes survey which showed that people in this country are half as likely to be stopped in a mandatory alcohol testing, MAT, check, now a mandatory intoxicant testing, MIT, check as people in the rest of Europe. This is an operational matter for the Commissioner.

I commend the Commissioner on waiving fees for documents for families of victims of road traffic crashes. Those fees were incredibly high. Will the Taoiseach ask the Minister for Justice and Equality and the Garda Commissioner to bring the traffic corps back up to strength? There is a strong case for perhaps making it a distinct unit with a separate command within An Garda Síochána. Will he ask the Department of Justice and Equality which has been dragging its heels, and the Courts Service, about IT systems and the transfer of information to the RSA and to bring in the legislation we need? The section 44 I referred to is on the clár. It is the Courts Bill and if we wanted to we could have it passed before Christmas.

Enda Kenny (Mayo, Fine Gael)
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Deputy Broughan raises an interesting point. I am quite sure if he spoke to the Chairman of the Oireachtas Joint Committee for Transport, Tourism and Sport, the Minister for Justice and Equality would be very happy to attend a meeting of the committee and discuss the issues there. The capital expenditure made available by the Government over recent years has been of great assistance in getting new motorbikes and patrol cars to replace the old vehicles. I also see increased evidence of the speed vans in different locations around the country which are having an impact in making people aware that their speeds are being monitored and there are consequences. The Tánaiste and Minister for Justice and Equality would be happy to discuss the allocations to the various sectors of the Garda with the Oireachtas Joint Committee on Transport, Tourism and Sport but it is a decision for the Commissioner. Government will continue to do its best in respect of supplying facilities to the gardaí so that they can carry out their duties in a professional and efficient manner with the best of up to date standards.