I welcome the Minister for Health, Deputy James Reilly.
Adjournment Matters
Drugs Payment Scheme Coverage
This Adjournment matter concerns the drug Fampyra which is used by multiple sclerosis patients. It has been brought to my attention by a patient using the drug on a trial basis with positive effects that it is not covered by the GMS or drugs payment scheme. The patient's consultant, Dr. Brian Sweeney in Cork, has recommended that she continue using the drug, but it is costing her approximately €250 per month. She does not qualify for a refund and the expense is causing her problems. The advantage of the drug is that it improves mobility and reduces fatigue, although it does not work for everyone. That said, it works for a large number of patients and many consultants have recommended its use. It is recognised in many other European countries and I ask the Minister to consider recognising it here, too, in the GMS, the long-term illness scheme and the drugs payment scheme.
I ask for guidance from the Chair. I will respond to Senator Colm Burke. When he has responded to me, will I have a further opportunity to respond?
That is fine. I actually dealt with this issue earlier today but thank Senator Colm Burke for raising it in this House.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. The executive received an application for the inclusion of fampridine or Fampyra in the GMS and community drugs schemes. The application was considered in line with the procedures and timescales agreed by my Department and the HSE with the Irish Pharmaceutical Healthcare Association, IPHA, for the assessment of new medicines. In accordance with these procedures, the National Centre for Pharmacoeconomics, NCPE, conducted a pharmaco-economic evaluation of fampridine and concluded that, as the manufacturer was unable to demonstrate its cost-effectiveness in the Irish health care setting, it was unable to recommend reimbursement of the product. The report is available on the NCPE's website. The HSE assessment process is intended to arrive at a decision on the funding of new medicines that is clinically appropriate, fair, consistent and sustainable. In these circumstances, the HSE has not approved the reimbursement of fampridine under the community drug schemes.
I understand studies are ongoing to assess the wider impact of fampridine on both walking and quality of life for persons diagnosed with multiple sclerosis. The results of these studies will contribute to the evidence base demonstrating the clinical effectiveness of fampridine which can be used to support future applications for its inclusion in the lists of reimbursable items supplied under the community drug schemes. In this context, it is open to the manufacturer, at any time, to submit a new application to the HSE for the inclusion of fampridine in the community drug schemes. The manufacturer has indicated to the HSE that it intends to submit a revised application for fampridine and it is my understanding the company may actually have done so this morning.
The HSE and I fully understand patients are very anxious that this product be made available under the community drug schemes. Therefore, the HSE will reconsider the application on receipt, in line with the agreed procedures and timescales for the assessment of new medicines, in order that the matter will be addressed and dealt with as quickly as possible.
I thank the Minister for his comprehensive reply. I fully understand the position of the HSE and the Department on this issue and accept that pricing is important in the context of drugs being accepted for inclusion in the community drug schemes. In this case the drug has already received approval in a number of other European countries and evidence to support its effectiveness is available, although I am open to correction on this. The patient to whom I referred is responding well to the drug and experiencing obvious beneficial effects, particularly a reduction in fatigue. She contacted me because the drug was proving so successful. She will probably continue to use it, but because it has not received HSE and departmental approval, she will have to fund the treatment herself.
This particular drug costs approximately €6,000 per year. As I understand it, many of the people who are using it are being supplied by the manufacturer on a trial basis. Approximately 7,000 people in this country have multiple sclerosis, which would equate to a bill of €42 million per annum. Fampridine does not work in all cases - far from it. It is estimated that it will only be effective for 20% to 25% of multiple sclerosis sufferers. Admittedly, for those patients for whom it does work, the effects can be dramatic, with the ability to carry out the activities of daily living greatly improved to the point where they can go to work and lead a much more normal life. We would dearly love to be able to provide the drug for them, but we cannot do so at its current costing. We have a limited pot of money available and €42 million would be an enormous sum to take out of it. What other items would we sacrifice to do this? The price of the drug must be more realistic.
I call on the pharmaceutical industry, as I did earlier in Dáil Éireann, to enter into risk sharing with the Government, on behalf of the taxpayer, for whom we are trying to provide services and medication. There is no risk sharing. For example, there is no arrangement whereby we could agree and pay a certain price for those patients for whom the drug is working. In the first instance, we must demonstrate that the drug works, as it clearly does for some. We also need to have a sense of the type of patient for whom it is likely to work and limit its prescribing to such patients.
Subsequently, we would like to enter into a risk-sharing agreement with the drugs companies that reflects, in a more realistic and affordable way, the cost of medications that we want to make available to our people.
The pharmaceutical industry is hugely important to this country, employing tens of thousands of people directly and more than 100,000 indirectly. We are very proud of that industry and supportive of research and innovation to develop new drugs. However, all parties, including policy makers, physicians, patients and drug companies must accept that there is a limited pot of money and if we take a large amount out for one area, that means other areas will suffer. Unfortunately, unlike the United States of America, we cannot engage in printing money or "quantitative easing" as they call it.
One of the saddest things I can recall is seeing my own father recovering from one cerebrovascular accident but making a poor recovery from a second one which took his life many years ago. During the recovery phase after his first stroke he was blessed in that he had wonderful sisters, Florrie, Doreen and Betty, who really took him on board as a project and rehabilitated him. I would like to take this opportunity to acknowledge their wonderful memory. All of them have sadly passed away.
We have 30,000 stroke survivors in our republic. Ireland's national audit of stroke care in 2007 identified rather substantial deficits in the services available to those who survived acute stroke. The main deficits were in the areas of discharge planning, rehabilitation and secondary prevention. There were also many criticisms of communication with both patients and their families in the context of services that were in place. In response, a group of investigators from the Royal College of Surgeons, led by Frances Horgan, Mary Walsh, Chris Macey and Cliona Loughnane performed a national survey of stroke survivorship in 2013 on 200 patients. They found very substantial physical, emotional and psychological problems in the survivors of this dreaded medical catastrophe. Fully 83% of those surveyed had severe mobility problems. In roughly equal proportions, others had fatigue, arm problems, memory problems, unsteadiness leading to falls, emotional problems, concentration difficulties and sphincter problems. Around half of those surveyed said they felt that their problems had not been addressed and that appropriate help was not available to them.
The Minister for Health has an excellent track record in terms of attention given to acute stroke treatment, stroke units and so forth. I ask him to look to the next stage, which is the development of early supported discharge programmes such as those piloted by the Mater Hospital. Can we look at rolling out plans like that nationwide? Can we also look at the implementation plan in respect of the national policy and strategy for the provision of neuro-rehabilitation services in Ireland 2011 to 2015? Given his interest in community-based care, I ask that the Minister devotes his attention and skills to improving the community-based rehabilitation services. Specifically, I ask him to outline the time lines for the implementation of the excellent recommendations of the national policy and strategy.
I thank the Senator for providing me with the opportunity in Seanad Éireann to speak on the subject of rehabilitation services for stroke survivors and neuro-rehabilitation services.
Since the publication in 2010 of the national cardiovascular health policy, significant improvements have been made with regard to access to acute treatments for coronary heart disease as well as the development of stroke units across the country. New and existing stroke units have been provided with additional therapy, nursing and consultant posts. Thrombolysis is now available to acute hospitals admitting stroke patients, 9.5% of whom are being thrombolysed, which compares extremely well with the best European figures. Senator Crown is aware that no less a man than Don Berwick, President Obama's main health adviser, made special mention of the stroke programme here and what can be achieved in a country in pretty dire financial constraints. We have gone from the bottom of the league in Europe to the top in terms of thrombolysis and patient care. All hospitals which accept stroke patients now have stroke units which has improved outcomes hugely.
The stroke programme estimates that the number of people with enduring disabilities as a result of stroke has decreased as the percentage of patients with stroke discharged from acute hospitals to nursing homes has dropped from 17.3% in 2009 to 14.5% in 2012. The percentage of patients discharged directly home has increased from 49.4% in 2009 to 51.1% in 2012. The stroke foundation education programme developed by the stroke programme is leading to improved patient experience of stroke service provision. Patients requiring more intensive rehabilitation are referred to the nearest available rehabilitation service.
The establishment of managed clinical rehabilitation networks for neurological and prosthetic rehabilitation services in each of the four HSE regions contributes to rehabilitation services. The National Rehabilitation Hospital provides specialist stroke rehabilitation as a national hub and links in with regional services. There are plans for a hub and spoke development across the country.
The Department of Health's national policy and strategy for the provision of neuro-rehabilitation services in Ireland, in collaboration with the national clinical programme for rehabilitation medicine provides for improved access to and quality of services for patients requiring rehabilitation. The rehabilitation medicine clinical programme and the HSE disability services division are developing an implementation plan for the neuro-rehabilitation strategy.
A certain percentage of stroke patients will be suitable for early supported discharge, which involves intensive specialised stroke rehabilitation provided in the patient's home for up to eight weeks. This reduces the length of hospital stay, reduces long-term dependency and the risk of further disability after six months, as well as reducing the number of patients requiring long-term care. Early supported discharge services are currently funded in a number of locations, including the Mater Hospital. The feasibility of implementing this model in geographically dispersed populations is limited. The National Clinical Programme for Stroke, NCPS, continues to provide funding to these sites.
Primary care also plays an important role in stroke rehabilitation. The HSE's National Service Plan 2013 provided for additional funding of €20 million to strengthen primary care services and provides for additional primary care posts. As of 6 June 2014, 221.5 of the 264.5 whole-time equivalent posts in the primary care teams have been filled or start dates agreed. The HSE is striving to have the remainder of the posts filled as soon as possible in 2014. Taken together, all these developments show that we have made significant progress in preventing stroke and its complications. Nonetheless, I hear the Senator loud and clear - there is more to be done. I agree that more needs to be done but we face extreme challenges in the health service in the context of our budget which curtail our ability to expand our services in the way we would like.
I thank the Minister for his response. Obviously, with our aging population and the demographic risks we are facing, including the obesity epidemic, diabetes and high blood pressure as well as the smoking problem, cerebrovascular disease will continue to be a huge issue in this country. Not only is it very humane to treat terribly vulnerable people who are at their lowest ebb in terms of the betrayal of their own bodies by their circulation, it also makes great economic sense to try to rehabilitate and treat them as efficiently and quickly as we can. The downstream effects of having bad rehabilitation services in the community for our stroke patients are seen everywhere. Not only do patients get less good care if they are being looked after for extended periods of time in an inappropriate setting, where they run the risk of acquiring hospital infections and so forth, others who could use those hospital services more appropriately are denied them. A vicious cycle can set in. We must try to identify those patients who are good candidates for early, appropriate, humane, well-looked-after, rehabilitation-focused discharge.
Again, I thank the Senator for raising this issue. My own father suffered a stroke at the age of 66 and was left with cortical blindness for his remaining 14 years.
I am acutely aware, therefore, of the impact on families and the stress caused for them. He was a smoker and a doctor.
We have made great progress. The principle underlying health policy is that patients should be treated at the lowest level of complexity that is safe, timely, efficient, and as near to home as possible. Early intervention is part of this to allow for better outcomes for the patient and more treatment nearer to home. We need to develop stroke rehabilitation services in the context of primary care. I have opened many health centres in the past three years. We have opened them at a rate of one a month. Many of them have physiotherapy and occupational therapy facilities; therefore, the service is evolving. I look forward to us continuing to improve outcomes for patients. However, the Senator is correct that prevention is better than cure and in moving from hospital-centric services to primary care we also have to move resources. There is only one pot of money which is constrained, but we continue to move as much of the service as possible out of the hospital into the community where it is more cost effective and convenient for patients to use it.
International Bodies Membership
I thank the Minister of State for attending. Will the Minister for Education and Skills consider joining Ireland to the New York Academy Global Network and attending the global science, engineering, technology and mathematics, STEM, alliance international launch? This is due to happen at the United Nations next September. We all regularly speak about the importance of education and skills and focusing on science, engineering, technology and mathematics. The future of the global economy relies on the education of our children today and the technology and intelligence that can make the planet a better place for us all. A colleague in America mentioned that I was serving as a Senator and I was approached by a staff member of the New York Academy of Sciences. This is a no-brainer. The children of the country would be able to interact and discuss science, technology and mathematics with their counterparts around the world and participate in mentoring relationships with the most brilliant early career scientists through this alliance. I have all the details and I am interested in what the Minister has to say.
I thank the Senator for raising this matter and giving me the opportunity, on behalf of my colleague, the Minister for Education and Skills, to outline the current position to the House.
The Department of Education and Skills recognises the need to provide ready access to STEM career role models-pathways-information for young people. This is the ethos underpinning the Smart Futures programme, the recently launched Government-industry initiative co-ordinated by Science Foundation Ireland. The Government is incorporating STEM for students in primary and post-primary schools across the country, through curricular reform at junior and senior cycle, for example, through the high profile Project Maths initiative.
The ICT action plan 2014-18 was developed as a direct response to specific skills shortages in the ICT sector. It outlines a range of short, medium and long-term measures to develop a sustainable domestic supply of high quality ICT graduates to support the further expansion and development of the ICT sector and support innovation and growth across other sectors of the economy. Ireland's education system will have a critical role to play in the coming decades as we seek to build an innovative, knowledge-based economy that will provide sustainable employment opportunities and an informed citizenship. Central to this is a commitment to build on our provision of STEM in primary, post-primary and third level education. We also need to strengthen and expand the entrepreneurial partnerships that are evolving between industry and schools which will make STEM become a reality for students, not just an academic curiosity. Competitions such as the BT Young Scientist Exhibition and SciFest give students an opportunity to showcase their knowledge.
The Government is promoting science, technology, engineering and maths to students in primary and secondary schools across the country. The message is beginning to get through to school leavers and other potential students that there are increasing employment opportunities for high quality graduates in these disciplines. Such is the priority accorded to it, my colleague, the Minister of State with responsibility for research and innovation, Deputy Sean Sherlock, has responsibility through both the Department of Education and Skills and the Department of Jobs, Enterprise and Innovation for promoting STEM. The Department of Education and Skills considers it to be a priority to focus on the current national initiatives such as the promotion of STEM in schools and the Smart Futures programme in industry and academia which aim to motivate young people's interests and aspirations in the STEM areas. Given the ongoing range of work, it is not considered timely to join the NY Academy Global Network. However, the Department is supportive of this initiative and will be interested to hear about its progress.
I thank the Minister of State for his reply, but I am a little disappointed. I admire the work being done in the STEM area and acknowledge the focus the Department has put on it. I have a little girl aged 14 years and I am well aware of the focus on STEM in the education system. However, this is low hanging fruit. I am sometimes critical of the Internet and the effect it might have on young people, but this is a global social network for highly gifted students to be mentored and network among each other. If the Minister of State does not mind, I will pursue the Department and keep in touch in this regard. In recent weeks the United Kingdom, China, Qatar, Kuwait, Serbia and Nigeria have joined the alliance. I fail to understand why Ireland will not do so and will not sent representatives to attend the launch at the United Nations in September because it is for the good of young people.
The bottom line is that the Department is supportive of the initiative and asked to be kept informed of progress in this regard. The door is half open. I leave it up to the Senator to make sure it will be opened fully.
Road Projects Status
Cuirim fáilte roimh on Aire State. I am sure both of us would prefer to be back in the west in the sun, but we have to do our business in the House.
The issue I raise relates to the N59 between Galway and Clifden which passes through Moycullen and Oughterard, with which the Minister of State will be familiar. I appreciate work is being done on the road and acknowledge that planning for the Moycullen bypass has been advanced. However, I refer to the section of the road between Oughterard and Clifden which passes through Maam Cross in Connemara. What is the state of play in this regard? There have been two An Bord Pleanála hearings on the section between Oughterard and Maam Cross. The route chosen differs from the current one and there are concerns in the community that this might prove detrimental to the area. Environmental concerns have also been raised and we might be in bother at European level if we are not careful. During the An Bord Pleanála hearings the National Parks and Wildlife Service was not as vocal as it should have been.
Given that the Minister of State is from Westport, he will be well aware of the Delphi bridge disaster which happened a number of years ago. Mayo County Council got into a little bother because the European Union felt the habitats directive had not been fully complied with by the council and that insufficient account had been taken of the ecological issues raised by experts at the time. The Government got into trouble over the issue. There is a sense that we might take the same route on the section of the N59 between Oughterard and Maam Cross if the Government is not careful.
I would welcome the Minister of State's thoughts on that.
Issues are also being raised about the failures and the completeness of the environmental impact statement, EIS, and the Natura impact statement, NIS, as well as the fact part of this will be a DBO project. The nature of a DBO project means the plan is not available when the EIS is being prepared, so it is hard to gauge from an ecological point of view what the impact is going to be. This could lead to problems on an environmental level and, although this might have gone through the national planning process, it could be appealed to Europe. I want to know where we stand if that happens.
We all want to see the improvement of the road. It is very important for the people of south and north Connemara that we have good road routes to make the area accessible. Given the Minister of State's own involvement with the Wild Atlantic Way, he will be very aware we need to try to get people through the area in a proper manner but we also need to be very careful that we do it in the best way ecologically and in keeping with the needs and wants of local communities.
I thank the Senator. In a personal capacity, it is an area I love. It is the most beautiful part of Ireland, as far as I am concerned, and I have an interest in the place. With the walks and other projects for which we are providing funding, it has a very bright future. It is one of the most beautiful parts not just of Ireland but of the world. We must make sure we protect it in whatever way we can.
I thank the Senator for the opportunity to discuss this issue in the House on behalf of the Minister, Deputy Varadkar. I am sure all Members of this House will now be well aware that the Minister for Transport, Tourism and Sport has responsibility for overall policy and funding in regard to the national roads programme. The construction, improvement and maintenance of individual national roads, such as the N59, is a matter for the National Roads Authority under the Roads Acts 1993 to 2007, in conjunction with the local authorities concerned.
I am aware that the route in question is well known as one of the most important tourist routes in the country and is the principal access to and through Connemara and the many tourist attractions of the region, including Kylemore Abbey, Connemara National Park, the iconic landscape that envelopes the N59 route and the numerous towns and villages that draw tourists from home and abroad.
The N59 Oughterard to Clifden scheme originally consisted of a 44 km upgrade of the existing road. I understand that, due to environmental issues, it was decided in June 2012 to divide the scheme into two sections, namely, the N59 Oughterard to Maam Cross section and the N59 Maam Cross to Clifden section. The preliminary design, environmental reports and compulsory purchase drawings for the N59 Oughterard to Maam Cross section were prepared first and submitted to An Bord Pleanála for approval in October 2012. As regards the Maam Cross to Clifden section of the scheme, further environmental studies are required before environmental reports can be produced. It is anticipated that this section of the scheme will be submitted to An Bord Pleanála in July 2014. Oral hearings into objections to the N59 Oughterard to Maam Cross section were held in February 2013 and re-opened in August 2013 to revisit some aspects of the environmental impact statement, as well as compulsory purchase order-related issues that arose at the first hearing.
An Bord Pleanála approved the N59 Oughterard to Maam Cross project on 23 December 2013. The highly sensitive and protected environment of Connemara, combined with traffic volumes of fewer than 5,000 vehicles per day, have made it difficult to justify significant realignments. In regard to improvements or realignments to the route, Galway County Council has procured consultants to prepare design and contract documents for the 10 km section of this project between Bunnakill and Claremount. An allocation of €1 million has been provided to Galway County Council for the N59 Clifden to Oughterard scheme in 2014. In addition, stimulus funding of €200,000 has recently been provided to Galway County Council for advance works on the Bunnakill to Claremount section ahead of construction of the N59 Oughterard to Maam Cross scheme. The advance works will include ground investigation, archaeological works, fencing of acquired lands, works on a section of the Connemara greenway and other areas of work related to peat restoration areas and advance bridge works.
As regards the timeframe for completion of the scheme, future progress on this scheme is subject to both the outcome of the decision of An Bord Pleanála on the second section of the project and the availability of future funding. It should be noted that the section of the N59 from Oughterard to Clifden is part of the overall route to Clifden and, of course, the most heavily trafficked section is from Galway to Oughterard. Within a constrained budget, the Department and the NRA continue to improve facilities for both motorists and cyclists along this route. In this regard, my Department recently announced a grant of €2 million for a greenway between Galway city and Moycullen. As part of the recent stimulus moneys, the NRA will shortly commence works on widening a 1.1 km section of road south-east of Moycullen village at a cost of €1.5 million.
I concur with the Minister of State's fine words about the intense beauty of the area in question. I thank him for the full report on the development. To follow on from that, the Minister of State might go back to the Minister and ask whether he is concerned that certain people believe the NPWS took a hands-off approach to the second An Bord Pleanála hearing and that its full input was not given to that hearing. Therefore, there may be questions around the ecological aspect of the development between Oughterard and Maam Cross in particular, which may be challenged at a European level. This could have a serious impact on the development of the road. Parallels are being drawn between what happened in the Delphi bridge disaster and what could happen close to Oughterard. Is the Minister concerned about this and will he address those concerns?
I will bring the Senator's concerns to the Minister's attention. As I said, it is an area I know very well and which I would like to see developed. While making progress, however, we have to retain its natural beauty. People in the area depend on tourism and the jobs it brings. The one thing we have in the area is its natural beauty, for example, at Kylemore and in the Connemara National Park - one could go on and on. We also need to develop infrastructure and roads, however, and I would like to see that happen. If the Minister has anything to correspond to the Senator in this regard, I will ask him to do that.
The Seanad adjourned at 9.20 p.m. until 10.30 a.m. on Wednesday, 18 June 2014.