Written Answers Nos. 442-461
442. Deputy Thomas P. Broughan asked the Minister for Health if he will review and reverse the decision of the HSE not to approve the use of the drug Kuvan for persons with phenylketonuria, PKU, and accept the request by an organisation (details supplied) to provide funding for this drug which has significant long-term health improvements for persons affected by PKU; and if he will make a statement on the matter. [41912/17]
Amharc ar fhreagra443. Deputy Thomas P. Broughan asked the Minister for Health if he will request the National Centre for Pharmacoeconomics to review its decision not to fund the provision of the drug Kuvan for persons affected by phenylketonuria which was approved by EU regulatory agencies in 2009 for use in 20 European countries; and if he will make a statement on the matter. [41913/17]
Amharc ar fhreagraI propose to take Questions Nos. 442 and 443 together.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
In reaching its decision, the HSE examines all the evidence which may be relevant in its view for the decision and will take into account such expert opinions and recommendations which may have been sought by the HSE, including, for example, advice from the National Centre for Pharmacoeconomics, NCPE.
Sapropterin (Kuvan) was previously considered under the national pricing and reimbursement processes in 2009. At that time insufficient evidence was available to support the pricing and reimbursement application submitted by Merck Serono for Kuvan.
In December 2015, Merck Serono advised the HSE that the market authorisation for Kuvan was transferring to Biomarin in 2016. The HSE met with the new market authorisation holder Biomarin in May 2016 and was advised that it would be submitting a health technology assessment dossier in relation to Kuvan.
The NCPE assessment of the Biomarin dossier was completed on 15 September and the NCPE did not recommend Kuvan for reimbursement as it was not deemed cost-effective.
The HSE will take into account the expert advice of the NCPE when making its decision in line with the Health (Pricing and Supply of Medical Goods) Act 2013.
444. Deputy James Browne asked the Minister for Health if the inpatient unit at Linn Dara, Cherry Orchard, Dublin 10, which was partially closed in May 2017, has been fully reopened. [41914/17]
Amharc ar fhreagraAround late May/early June last, due to staffing difficulties, some beds in Linn Dara could not take new admissions. This, unfortunately, left Linn Dara with just half of its 22-bed complement operational. For those discharged for clinical reasons, the HSE provided dedicated follow-on supports from the community-based CAMHS service, where deemed necessary. The Executive has also made available the CAMHS Day Service, as appropriate in individual cases, to enhance supports for young people and their families. The operational difficulties that faced Linn Dara recently, arose from problems in recruiting and retaining mental health professionals. Staffing cover had to be augmented in recent times through methods such as staff working additional hours, overtime and engaging agency staff. Funding availability is not the issue in this case.
A phased opening of the closed beds in Linn Dara is planned for week beginning 30 October, with a graduated increase in bed capacity. The HSE aim to be back at full capacity of 22 beds by mid-November. This is similar to the approach taken when the unit increased bed capacity originally. The HSE is required to provide advance notification to the Mental Health Commission of its reopening plan.
The HSE has been exploring every option to resume normal operational levels and to maximise the use of Linn Dara in the future. The Executive has intensified its efforts on recruitment, and a number of staff have been identified to join the service. There are currently 60 CAMHS beds operational nationally. This is up from 48 in early summer and will increase further once Linn Dara resumes its full capacity of 22. There are currently 20 operational beds in both Cork and in Galway, eight in Fairview and 12 in Linn Dara. The Deputy may rest assured that all efforts will continue to be made to address ongoing service difficulties at Linn Dara, with a view to reopening beds as quickly as possible.
445. Deputy James Browne asked the Minister for Health if the staffing shortage at the Linn Dara, Cherry Orchard, Dublin 10, unit inpatient facilities has been addressed. [41915/17]
Amharc ar fhreagraAround late May/early June last, due to staffing difficulties, some beds in Linn Dara could not take new admissions. This, unfortunately, left Linn Dara with just half of its 22-bed complement operational. For those discharged for clinical reasons, the HSE provided where deemed necessary dedicated follow-on supports from the community-based CAMHS service. The Executive also made available the CAMHS Day Service, as appropriate in individual cases, to enhance supports for young people and their families. The recent operational difficulties that faced Linn Dara arose from problems in recruiting and retaining mental health professionals. Staffing cover had, for example, to be augmented through methods such as staff working additional hours, overtime, and engaging agency staff. Funding availability is not the issue in this case.
The HSE has been exploring every option to resume normal operational levels at Linn Dara, and to maximise the use of the facility in the future. It has intensified its efforts on recruitment, and a number of staff have been identified to join this service. A phased re-opening of beds in Linn Dara is planned for week beginning 30 October next, with a graduated increase in bed capacity. The HSE aim to be back at full capacity of 22 beds by mid-November. This approach is similar to that taken when the unit increased bed capacity originally. The HSE is required to provide advance notification to the Mental Health Commission of its re-opening plan.
There are currently 60 CAMHS beds operational nationally. This is up from 48 in early summer and will increase further once Linn Dara resumes its full capacity of 22. There are currently 20 operational beds in both Cork and in Galway, eight in Fairview and 12 in Linn Dara. The Deputy may rest assured that all efforts will continue to be made to address ongoing service difficulties at Linn Dara, with a view to reopening beds as quickly as possible.
446. Deputy Billy Kelleher asked the Minister for Health the extent to which savings from the State’s agreement with an organisation (details supplied) in 2016 have been applied towards the funding of new medicines; and the processes in place to ensure that in 2018 savings generated under the agreement are applied for the funding of new medicines by the Health Service Executive and transparently reported as such. [41919/17]
Amharc ar fhreagraThe new four-year Framework Agreement on the Supply and Pricing of Medicines, signed in July 2016, which is available at: http://www.ipha.ie/alist/ipha-hse-agreement.aspx, is an agreement between the State and the Irish Pharmaceutical Healthcare Association, IPHA, and is expected to deliver approximately €600 million in savings over the lifetime of the Agreement from IPHA companies and €150 million in savings from non-IPHA companies. These savings have been taken into account in the 2017 HSE National Service Plan.
The savings are a function of the terms of the new agreement. The new Agreement contains a number of features which represent clear additional value over the terms of the previous 2012 Agreement. The reference basket of countries used to set prices in Ireland has been expanded from nine to 14 countries and, importantly, includes lower cost countries. For the first time, the Agreement provides for an annual price realignment, which will ensure that the prices of medicines in Ireland reduce in line with price reductions across the reference countries. This will ensure the State achieves better value for money on the cost of medicines as prices in other basket countries are adjusted downwards over time. In addition, the Agreement secured a 30% reduction in the price of biologic medicines when a biosimilar medicine enters the market.
At the date of signing, the IPHA Agreement was forecast to deliver savings up to €750 million from IPHA and non-IPHA companies.
The figures were calculated on a full year basis as follows:
IPHA Savings*
|
Year 1 |
Year 2 |
Year 3 |
Year 4 |
|
€120m |
€160m |
€200m |
€270m |
*Figures are rounded and subject to annual review as part of the annual estimates process based on the most up to date pricing data at that time.
A key focus of this agreement was to achieve lower prices in the face of both demographic pressures on expenditure and the continued development of new medicines, many of which pose affordability challenges to the Irish health service and indeed internationally. The HSE included a savings target of €148 million in the National Service Plan 2017 for the provision of health services in 2017 arising from the agreement, and the launch of a biosimilar for Embrel in 2016.
As the Deputy will be aware, the HSE will spend approximately €2 billion on new and existing medicines across the health service in 2017 when account is taken of ingredient cost, fees and VAT.
In line with statutory obligations, the HSE operates within the resources provided by Dáil Éireann each year. The HSE has statutory responsibility for decisions on pricing and reimbursement of drugs in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
The allocation of funding is a matter for the annual budget and the HSE's National Service Plan.
447. Deputy Barry Cowen asked the Minister for Health when a person (details supplied) can expect an appointment. [41920/17]
Amharc ar fhreagraUnder the Health Act 2004, the Health Service Executive, HSE, is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
The scheduling of appointments for patients is a matter for the hospital to which the patient has been referred. Should a patient's general practitioner consider that the patient's condition warrants an earlier appointment, he or she should take the matter up with the consultant and the hospital involved. In relation to the specific case raised, I have asked the HSE to respond to the Deputy directly.
448. Deputy James Browne asked the Minister for Health if he will bring forward legislation making it mandatory to make a defibrillator available in each public building; and if he will make a statement on the matter. [41928/17]
Amharc ar fhreagraThis year, the Health Service Executive established an Out-of-Hospital Cardiac Arrest Steering Group. The purpose of this project is to improve survival rates for those who suffer an out of hospital cardiac arrest through the development and implementation of an out of hospital cardiac arrest strategy. This work will support the National Ambulance Service, NAS, and Community First Responder Ireland (CFR Ireland) in their commitment to improve clinical outcomes for Out-of-Hospital Cardiac Arrest, OHCA.
Both the NAS and CFR Ireland are working with other partners to enable a sustainable response to such events.
The HSE National Community First Responder framework for Ireland declared that CFRs offer a valuable and complementary resource to emergency ambulance provision, positively impacts NAS response time and achieves improved survival for OHCA. It demonstrated how the NAS and CFR Ireland intend to consolidate, enhance and implement further CFR schemes over the next five years through a National Community First Responder Framework. Its ambitions over the next few years include increasing the availability of training in CPR in schools, work places and local groups and making Public Access Defibrillators more easily accessible with people knowing how to use them. It also aims to:
- Work in partnership with all relevant organisations (statutory, voluntary, community and private sectors) to increase the availability of Public Access Defibrillators;
- Put in place effective arrangements to ensure that Public Access Defibrillators are mapped, maintained and accessible to the public;
- Commence a public awareness campaign to increase the level of provision of CFR Schemes in geographical areas of priority.
One of the means to help improve outcomes in this area is CFR groups. These are people from local communities who are trained in basic life support and the use of defibrillators that attend a potentially life threatening emergency in their area. They are then able to provide an early intervention in situations such as heart attack or cardiac arrest by providing, among other things, resuscitation and defibrillation.
Cardiac First Responders, CFR, Ireland, launched in 2015, is the national umbrella organisation for Community First Responders Groups. CFR Ireland works with the National Ambulance Service, Pre-Hospital Emergency Care Council and the Centre for Emergency Medical Science UCD. Both the NAS and CFR Ireland currently support over 145 Community First Responder schemes throughout Ireland, who train community members to provide emergency care support.
If an emergency 999/112 call for cardiac arrest, choking, chest pain or breathing difficulties is made to the National Ambulance Service in an area where a CFR group is established, the on-duty CFR member gets a text from the National Ambulance Service at the same time that an ambulance is despatched with location and call details. The First Responder then goes straight to the scene and administers initial care (defibrillation if required) until the National Ambulance Service Emergency resources arrive.
449. Deputy James Browne asked the Minister for Health if funding for a further podiatrist in County Wexford will be included in budget 2018. [41929/17]
Amharc ar fhreagraAs this is a service matter, it has been referred to the Health Service Executive for direct reply to the Deputy.
450. Deputy James Browne asked the Minister for Health the reason for the increase in the number of persons from County Wexford with diabetes requiring a lower limb amputation which is preventable; and if he will make a statement on the matter. [41930/17]
Amharc ar fhreagraAs the issues raised refer to service matters, I have asked the Health Service Executive to reply to the Deputy directly.
451. Deputy Billy Kelleher asked the Minister for Health the outcome of the drugs group meeting on 14 September 2017 following its review of Vimizim; and if he will make a statement on the matter. [41932/17]
Amharc ar fhreagraThe HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013; therefore, the matter has been referred to the HSE for reply to the Deputy.
452. Deputy Timmy Dooley asked the Minister for Health when the Freestyle Libre System will be made available to persons with diabetes type 1 and 2 on the long-term illness scheme; and if he will make a statement on the matter. [41933/17]
Amharc ar fhreagraUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
453. Deputy Michael Healy-Rae asked the Minister for Health if approval will be given to a new general practitioner contract in order to increase general practitioner capacity to cater for chronic diseases such as asthma and COPD; and if he will make a statement on the matter. [41936/17]
Amharc ar fhreagraThe development of primary care is central to the Government's objective to deliver a high-quality, integrated and cost effective health service. The Programme for Government commits to a decisive shift within the health service toward primary care in order to deliver better care close to home in communities across the country. The development of a new, modernised contract for the provision of general practitioner services will be a key element in facilitating this process. The aim is to develop a contract which has a population health focus, providing in particular for health promotion and disease prevention and for the structured ongoing care of chronic conditions.
Since 2015, negotiations have resulted in a number of service developments including the provision of free GP care to under sixes and over 70s, the introduction of a Diabetes Cycle of Care for adult GMS patients with Type 2 Diabetes and enhanced supports for rural GPs. The next phase of discussions on a new GP contract is under way and I expect that proposals around the management of chronic diseases are being discussed in this context.
I understand that the discussions taking place are wide ranging and ambitious in their scope. I think it is important to acknowledge that, as with any negotiation-type process, and given the range and complexity of the issues to be discussed, these engagements take time. It would not be appropriate at this stage to comment on progress to date. I look forward to continued ongoing positive engagement with GP representatives in the months ahead.
In addition, I would like to assure the Deputy of the Government's commitment to the continued development of GP capacity to ensure that patients across the country continue to have access to GP services and that general practice is sustainable in all areas into the future. I want to ensure that existing GP services are retained and that general practice remains an attractive career option for newly qualified GPs.
Efforts undertaken in recent years to increase the number of practising GPs include changes to the entry provisions to the GMS scheme to accommodate more flexible/shared GMS/GP contracts, and to the retirement provisions for GPs under the GMS scheme, allowing GPs to hold GMS contracts until their 72nd birthday, as well as the introduction of an enhanced supports package for rural GP practices. Separately, the State is seeking to train more GPs to provide GP services to the population. In 2009, there were 120 GP training places and in 2017 there were 170 training places filled. The Government is committed to further increasing this number to 259 places annually in future years.
454. Deputy Michael Healy-Rae asked the Minister for Health the way in which he will ensure that the high cost of preventive medication will not be a barrier in effectively controlling asthma under the long-term illness scheme or another targeted scheme such as a chronic disease card; and if he will make a statement on the matter. [41937/17]
Amharc ar fhreagraAsthma is not covered on the Long Term Illness, LTI, Scheme. The LTI Scheme was established under Section 59(3) of the Health Act 1970 (as amended). The conditions covered by the LTI are: acute leukaemia; mental handicap; cerebral palsy; mental illness (in a person under 16); cystic fibrosis; multiple sclerosis; diabetes insipidus; muscular dystrophies; diabetes mellitus; parkinsonism; epilepsy; phenylketonuria; haemophilia; spina bifida; hydrocephalus; and conditions arising from the use of Thalidomide. Under the LTI Scheme, patients receive drugs, medicines, and medical and surgical appliances directly related to the treatment of their illness, free of charge.
There are no plans to extend the list of conditions covered by the Scheme.
For people who are not eligible for the LTI scheme, there are other arrangements which protect them from excessive medicine costs.
Under the Drug Payment Scheme, no individual or family pays more than €144 a month toward the cost of approved prescribed medicines. The scheme significantly reduces the cost burden for families and individuals with ongoing expenditure on medicines.
People who cannot, without undue hardship, arrange for the provision of medical services for themselves and their dependants may be entitled to a medical card. In the assessment process, the HSE can take into account medical costs incurred by an individual or a family.
People who are not eligible for a medical card may still be able to avail of a GP visit card, which covers the cost of GP consultations.
The state is working to combat the high prices of medicines generally and in 2016 signed the Framework Agreement on the Supply and Pricing of Medicines, which is available at: www.ipha.ie/alist/ipha-hse-agreement.aspx. This is an agreement between the State and the Irish Pharmaceutical Healthcare Association, IPHA, and is expected to deliver approximately €600 million in savings over the lifetime of the Agreement from IPHA companies and €150 million in savings from non-IPHA companies.
The new Agreement contains a number of features which represent clear additional value over the terms of the previous 2012 Agreement. The reference basket of countries used to set prices in Ireland has been expanded from nine to 14 countries and, importantly, includes lower cost countries. For the first time, the Agreement provides for an annual price realignment, which will ensure that the prices of medicines in Ireland reduce in line with price reductions across the reference countries. This will ensure the State achieves better value for money on the cost of medicines as prices in other basket countries are adjusted downwards over time.
455. Deputy Seamus Healy asked the Minister for Health the position regarding the masterplan for South Tipperary General Hospital; if he will provide a copy of same; and if he will make a statement on the matter. [41938/17]
Amharc ar fhreagraIn relation to the particular query raised, I have asked the HSE to respond to the Deputy directly.
456. Deputy Mary Butler asked the Minister for Agriculture, Food and the Marine the number of inspections carried out in the 2016-17 season of vessels pair trawling inshore within Irish coastal waters inside six nautical miles; the results of these inspections; and if he will make a statement on the matter. [41244/17]
Amharc ar fhreagraThe monitoring and control of fishing vessels within Ireland’s Exclusive Fisheries Zone are matters for the Irish control authorities. Under the Sea Fisheries and Maritime Jurisdiction Act, 2006, all operational issues of this nature concerning sea fisheries control are, as a matter of law, exclusively for the Sea Fisheries Protection Authority and the Naval Service. As Minister, I am precluded from getting involved in operational matters including in relation to law enforcement.
I have passed on the Deputy's request to the SFPA for direct response.
457. Deputy Thomas P. Broughan asked the Minister for Agriculture, Food and the Marine the number of greyhounds exported to the United Kingdom for sales and trials between 2010 to 2016; the number returned here; and if he will make a statement on the matter. [41326/17]
Amharc ar fhreagraExporters must comply with EU law on the protection of animals during transport (EC No 1/2005), while the transport of animals by air is also governed by the International Air Transport Association, IATA, regulations.
There are no requirements or facilities for recording the breed of dog as part of the export certification process. Once animal health and welfare certification requirements are met, all dogs, including greyhounds, may be exported from Ireland.
With regard to the export of greyhounds to the United Kingdom for sales and trials, Bord na gCon has informed me that it has no statutory function regarding the regulation of greyhound exports and therefore is not in a position to maintain a record of the number of greyhounds exported to and returned from the United Kingdom for sales and trials.
Accordingly, it is not possible to provide the Deputy with the breakdown of export trade statistics that he is seeking.
458. Deputy Charlie McConalogue asked the Minister for Agriculture, Food and the Marine the number of persons applying for ANC, areas of natural constraint, payments in 2017 that have not to date received a payment in view of the fact they do not meet the annual average stocking density of 0.15 livestock units per forage hectare for the calendar year. [41405/17]
Amharc ar fhreagraPayments under the 2017 Areas of Natural Constraints, ANC, Scheme commenced as scheduled in the third week of September. To date, payments worth €170 million have issued to some 80,000 farmers.
As is normal at this juncture, many farmers are not yet eligible for payment as they have not yet fulfilled the necessary stocking requirements under the ANC scheme but can still do so up to the end of the year. Currently there are 11,904 applications that have not yet met the annual average stocking density requirements. Payments are continuing to issue on a twice weekly basis to those cases that become eligible under the scheme rules.
459. Deputy Charlie McConalogue asked the Minister for Agriculture, Food and the Marine the 2017 budget allocation for TAMS 2; and the expenditure to date on same. [41406/17]
Amharc ar fhreagraThe budget allocation for TAMS II in 2017 is €50 million. Total expenditure to date on TAMS II is €23.7 million, of which just under €20 million was paid in 2017.
Payment claims continue to be processed at an average rate of €1 million per week following the busy construction period over the summer months.
All approved participants who have completed the approved works are urged to submit their payment claims to the online system so that payment can issue without delay.
460. Deputy Michael Harty asked the Minister for Agriculture, Food and the Marine his views on whether a year of tragedy on farms means the message of farm safety is not getting through; and if he will make a statement on the matter. [41466/17]
Amharc ar fhreagraFarm safety is a critical issue facing farming today. Statistics show that accidents on farms cause more workplace deaths than all other occupations combined. While the Health and Safety Authority, HSA, has primary responsibility for Health and Safety on farms, the Department of Agriculture, Food and the Marine, DAFM, is fully supportive of their work and assists in the promotion of safe farming practices.
The rate of accidents on farms remains far too high and it is important the focus on farm safety is increased. Safety must become an integral part of farming culture and all people involved in farming must take personal responsibility for improving the culture of safety on farms. No individual action or organisation can solve this difficult problem that impacts so negatively on so many lives each year.
While there are many risks in farming, farming does not have to be a dangerous occupation. DAFM, in conjunction with the HSA, is focused on changing farmer behaviour in relation to Health and Safety. Two of the more significant current initiatives in relation to this are, the requirement for all farmers seeking grant-aid under the TAMS II schemes must have completed a minimum half-day Health and Safety training within the last five years, and that all participants in the Knowledge Transfer groups have to partake in at least one meeting on Health and Safety and to include Health and Safety in the Farm Improvement plan which is updated annually. We must all continue to work together with the single goal of preventing accidents and therefore saving lives and minimising serious injuries.
461. Deputy Tom Neville asked the Minister for Agriculture, Food and the Marine if a decision has been made on a forestry reconstitution grant application by a person (details supplied) in County Kerry; and if he will make a statement on the matter. [41545/17]
Amharc ar fhreagraAn application for the Reconstitution Scheme (Windblow - Storm Darwin) was received from the person named on 28 February 2017. A decision issued from my Department to the applicant and his registered forester on 26 September 2017.
