Written Answers Nos. 365-384
365. Deputy Michael McGrath asked the Minister for Health the position in relation to the commencement of the minimum unit pricing provisions of the Public Health (Alcohol) Act 2018; when these provisions will come into effect; and if he will make a statement on the matter. [39550/19]
Amharc ar fhreagraThe 2013 Government Decision which approved a minimum pricing regime envisaged its introduction in Northern Ireland and in this jurisdiction simultaneously. It is my intention to seek a revised Government Decision to implement minimum unit pricing of alcohol here as soon as possible in order to address the very significant health harms and financial costs of the way alcohol is currently consumed here.
366. Deputy Michael Harty asked the Minister for Health the reason training recognition for registrars in otolaryngology at University Hospital Limerick was withdrawn following a visit by a member of the surgical advisory committee in otolaryngology on 27 August 2014; and if he will make a statement on the matter. [39551/19]
Amharc ar fhreagraAs this is a service issue, I have asked the HSE to reply to you directly.
367. Deputy Robert Troy asked the Minister for Health the status of licensing of the Tagrisso osimertinib drug used for treatment of certain lung cancer; and if he will make a statement on the matter. [39554/19]
Amharc ar fhreagra414. Deputy Peter Burke asked the Minister for Health the status of the application for reimbursement of the drug Tagrisso; if the NCPE will consider recommending the drug for reimbursement in the future based on the clinical need and the fact there are no other drugs available to treat this type of cancer; and if he will make a statement on the matter. [39812/19]
Amharc ar fhreagraI propose to take Questions Nos. 367 and 414 together.
The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines.
In line with the 2013 Act and the national framework agreed with industry, if a company would like a medicine to be reimbursed by the HSE, the company must submit an application to the HSE to have the new medicine added to the reimbursement list.
Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).
I am advised by the HSE that it has received two applications for the reimbursement of Osimertinib (Tagrisso):
1) The treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC). In May 2018, the NCPE recommended that Osimertinib not be considered for reimbursement for this indication unless cost-effectiveness can be improved relative to existing treatments. Following the assessment and after a number of rounds of commercial negotiations, the HSE notified the applicant in February 2019 that it was minded to not approve reimbursement for this indication. The 2013 Act provides for a period of representations after such notifications, before the HSE can make its final decision. The HSE have received representations from the manufacturer and these are under consideration by the HSE leadership team in advance of a final reimbursement decision.
(2) The first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating epidermal growth factor receptor (EGFR) mutations.
In respect of the second indication, a health technology assessment was completed on 6 August 2019 with the NCPE recommending that Osimertinib not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments. The HSE will assess this application for reimbursement in line with the 2013 Health Act.
368. Deputy Robert Troy asked the Minister for Health when the position of audiologist will be filled at the Midland Regional Hospital, Mullingar; the length of time the post has been vacant; and the measures put in place to ensure patients that rely on this service will avail of same. [39555/19]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to you directly, as soon as possible.
369. Deputy Louise O'Reilly asked the Minister for Health the number of outpatient appointments outsourced to the private sector under the NTPF in 2019; the number of these patients that had full treatment in the private sector; and the number back in the public system for outpatient treatment in tabular form. [39576/19]
Amharc ar fhreagraThe National Treatment Purchase Fund (NTPF) advise that in 2019 it placed a particular focus on engaging with hospital groups and individual hospitals to identify outpatient waiting list proposals. The NTPF has further advised that to date in 2019, all of the outpatient appointments it has funded are in Public Hospitals under insourcing initiatives arranged directly with the hospital concerned.
370. Deputy Louise O'Reilly asked the Minister for Health the way in which European health insurance cards will be delivered to persons in Northern Ireland as committed to; and the way in which the applications process will work. [39577/19]
Amharc ar fhreagraThe Government, on 17 September 2019, approved the immediate drafting of the Health and Childcare Support (Miscellaneous Provisions) Bill 2019, which will provide for benefits similar to those available under European Health Insurance Cards (EHIC) to eligible residents of Northern Ireland in the case of a no-deal Brexit. There has been significant work undertaken since, in conjunction with the Office of the Attorney General, to finalise drafting of the Bill with a view to publication at the earliest opportunity.
Practical details including the operational elements are under development and will be made public when they are available.
371. Deputy Mary Butler asked the Minister for Health the reason for the significant fluctuations in the waiting list for placements under the nursing homes support scheme fair deal in 2019 (details supplied); the number of persons in the scheme; if additional places have been provided during the past three months; if further funding has been provided during that time above the increase scheduled in the 2019 HSE service plan; the number of persons waiting for approval under the scheme as of 25 September 2019; and if he will make a statement on the matter. [39578/19]
Amharc ar fhreagraThe Nursing Homes Support Scheme, commonly referred to as Fair Deal, is a system of financial support for people who require long-term residential care. Participants contribute to the cost of their care according to their means while the State pays the balance of the cost.
As outlined in the HSE's National Service Plan for 2019, the NHSS is expected to support 23,042 people in 2019. The NHSS budget for 2019 is €985.8m which is an increase of €24.3m over its 2018 budget.
Over the last two years, an additional €45 million has been provided to NHSS budget for the continued provision of services in line with pricing and demand. As part of normal governance and performance management arrangements The Department and the HSE maintain regular service area engagements, which also form part of ongoing collaborative work on issues relating to older persons policy and service delivery.
The HSE have noted that the number of residents in nursing homes whom are supported by the NHSS to be ahead of forecast for the year to date. The latest available HSE data indicate that there are 23,090 people supported in the Scheme at the end of August this year. This is significantly more people than forecast and this creates a challenge. The HSE has also advised that the cost of care continues to rise and the average weekly cost per bed is higher in 2019 than anticipated.
Having regard to the available budget and the demand for support, the HSE releases funding in a managed way to ensure that the operation of the NHSS remains within the budgetary allocation. The HSE cannot legally fund clients beyond the determined funding allocation, and the appropriate mechanism relating to funding allocations is through the estimates and budgetary process. To manage the available funds throughout the year, a national placement list for the release of funding is operated by the HSE, to enable it to operate within budget. Funding issues to applicants in chronological order, to ensure equity nationally. Approved applicants are placed on the national placement list in order of their approval date and funding is released to applicants in order of their place on this list. The length of time spent on the placement list depends on the number of applicants currently receiving financial support and the number of new applications. Where demand is higher, the time spent on the waiting list may increase having regard for the prudent management of the Scheme's budget.
The HSE has put in place arrangements that a monthly analysis of performance of the Nursing Homes Support Scheme continues to ensure that the maximum number of new entrants are approved with the shortest possible waiting times while remaining on track to deliver a balanced budgetary position by year end. In the context of planning and preparing for the challenges of the winter period, the Department and the HSE have been considering a comprehensive approach to the current high-level of delayed transfers of care (DTOCs). However, recognising the urgency of the situation, approval was provided to the HSE to begin actions immediately to the value of €5m in 2019. As part of these measures the HSE released a significant number of funding approvals within NHSS this month bringing the waiting time for the release of funding back to 4 weeks.
As of 25 September I can confirm that 572 applicants to the Scheme are waiting for funding to be released.
372. Deputy Robert Troy asked the Minister for Health if approved home help hours will be facilitated for a person (details supplied). [39580/19]
Amharc ar fhreagraAs this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
373. Deputy John McGuinness asked the Minister for Health if a date for an operation will be expedited in the case of a person (details supplied); and if he will make a statement on the matter. [39581/19]
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 National Waiting List Management Policy, a standardised approach to managing scheduled care treatment for in-patient, day case and planned procedures, since January 2014, has been developed to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care. This policy, which has been adopted by the HSE, sets out the processes that hospitals are to implement to manage waiting lists.
In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to the Deputy directly.
374. Deputy John McGuinness asked the Minister for Health if funding will be expedited to prevent the closure of a service (details supplied); if the reason for the shortfall in funding over the past five years which has led to the financial crisis causing the threatened closure will be examined; and if he will make a statement on the matter. [39582/19]
Amharc ar fhreagraI understand from the HSE that it does not provide on-going funding to the service referred to by the Deputy nor does it have a service level agreement with them.
In addition, the HSE advises that the service hosted a special CE Scheme for people with addictions, which falls within the remit of the Department of Employment Support and Social Protection (DEASP). In this regard the Deputy may wish to refer his question for answer to that Department.
375. Deputy John McGuinness asked the Minister for Health the number of business cases submitted to the HSE from a service (details supplied) that are still being processed without an indication being given to the service of the timeline for each decision; if the funding required by the service will be calculated and provided as a matter of urgency; if two emergency respite beds for clients of the service will be urgently provided in Kilkenny; and if he will make a statement on the matter. [39583/19]
Amharc ar fhreagraThe Government is committed to providing services and supports for people with disabilities which will empower them to live independent lives, provide greater independence in accessing the services they choose, and enhance their ability to tailor the supports required to meet their needs and plan their lives. This commitment is outlined in the Programme for Partnership Government, which is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities.
The Programme for Partnership Government states that the Government wishes to provide more accessible respite care to facilitate full support for people with a disability.
As the Deputy's question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.
376. Deputy Maurice Quinlivan asked the Minister for Health the number of staff employed by his Department that earn less than the living wage of €12.30 per hour. [39597/19]
Amharc ar fhreagraThe staff of my Department are paid on the basis of centrally negotiated Civil Service pay scales, in line with Government policy and as sanctioned by the Department of Public Expenditure and Reform.
Taking a net working hours requirement of 37 hours per week for a full-time employee, there are no staff in my Department who are currently earning less than €12.30 per hour.
377. Deputy Brendan Griffin asked the Minister for Health his views on a matter (details supplied) in relation to out-of-hours care; and if he will make a statement on the matter. [39601/19]
Amharc ar fhreagraThe Atypical Working Scheme is managed, monitored and administered by the Irish Naturalisation and Immigration Service within the Department of Justice and Equality. The current terms applying to this scheme have been in place since 2015.
The Health Service Executive has recently become aware of challenges faced by agencies providing general practitioner services, particularly GP out of hours services, in relation to the recruitment and retention of suitable locum general practitioners from abroad. The current terms of the Atypical Working Scheme have been identified as a significant factor in these challenges.
GP out of hours services play a key role in the provision of community primary care services, and in this regard the HSE is reviewing this matter and is liaising with the Irish Naturalisation and Immigration Service in the Department of Justice and Equality with a view to examining how best to address the challenges as identified in terms of the Atypical Working Scheme. The HSE is confident that an agreement can be reached that will support recruitment and retention of GPs from abroad.
378. Deputy James Browne asked the Minister for Health if a facility (details supplied) is in use; the date of the construction of the facility; the capacity of same; if the HSE plans to make greater use of the facility in the future; and if he will make a statement on the matter. [39602/19]
Amharc ar fhreagraAs the Health Service Executive is responsible for the delivery of healthcare infrastructure projects, I have asked the HSE to respond to you directly in relation to this matter.
379. Deputy John Brady asked the Minister for Health the status of plans to expand the newborn screening programme; and if he will make a statement on the matter. [39606/19]
Amharc ar fhreagra418. Deputy James Browne asked the Minister for Health the position regarding the extension of the newborn screening programme to cover40 illnesses; and if he will make a statement on the matter. [39842/19]
Amharc ar fhreagraI propose to take Questions Nos. 379 and 418 together.
Currently all newborn babies (between 3 and 5 days old) are offered newborn bloodspot screening (generally known as the ‘heel prick’) through their parents/guardians for eight very rare conditions that are treatable if detected early in life.
A National Screening Committee is being established and will hold its first meeting before the end of 2019, as per recommendation 5, contained within the Scally Review (2018). The Committee’s role will be to undertake an independent assessment of the evidence for screening for a particular condition against internationally accepted criteria and make recommendations accordingly.
I appointed Professor Niall O’Higgins as Chair of the Committee in July and asked that, as part of its initial body of work, the Committee prioritise a review of the national newborn blood-spot screening programme and look specifically at how Ireland should best proceed with an expansion in line with international best practice.
380. Deputy Brendan Griffin asked the Minister for Health his views on a matter (details supplied) regarding mandatory vaccination; and if he will make a statement on the matter. [39616/19]
Amharc ar fhreagraImmunisation is regarded as one of the safest and most cost-effective of all health care interventions. It is also one of the most effective ways a parent can protect the health of their child. The childhood immunisation programme in Ireland has had a huge impact in improving the health of the Irish people. Diseases that used to be common in this country and around the world such as polio, measles, diphtheria, whooping cough and many other serious infectious diseases are now preventable by vaccination. However, due to misinformation vaccination rates are not as high as they should be.
One of my priorities as Minister for Health is to increase vaccination rates across the country and I am exploring several options in this regard. I launched the Vaccine Alliance on the 10 September whose aim is to increase uptake rates of childhood vaccines and reduce vaccine hesitancy. The group includes a wide range of organisations and further organisations will be added once the terms of reference, key target audiences, and priorities for the Vaccine Alliance have been agreed. It is important to note that vaccine hesitancy is not unique to Ireland. It is a global issue and has been identified by the World Health Organisation as one of the ten leading threats to global health in 2019.
As you are aware the immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC). NIAC is a committee of the Royal College of Physicians of Ireland comprising of experts in several specialties including infectious diseases, paediatrics and public health. The committee's recommendations are based on the prevalence of the relevant disease in Ireland and international best practice in relation to immunisation. It makes recommendations on vaccination policy to my Department. NIAC continues to revise recommendations to allow for the introduction of new vaccines in Ireland and to keep abreast of changes in the patterns of disease. Therefore, the immunisation schedule will continue to be amended over time.
The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland. The HPRA and the European Medicines Agency (EMA) continually monitor adverse events to vaccination. The HPRA operates a national adverse reaction reporting system, which members of the public and healthcare professionals are encouraged to submit any suspected adverse reactions to. All Reports received by the HPRA are routinely transmitted to the EMA's adverse reaction database for inclusion in global signal detection and monitoring activities.
I am informed that as all vaccines used in Ireland’s immunisation programmes have been approved for use in the European Union by the EMA there is no requirement for indemnity to be provided to vaccine manufacturers.
Aluminium has been used in vaccines for many decades to improve the body's response to vaccination. It is a component of the HPV vaccine Gardasil and several other vaccines. The World Health Organisation's (WHO) Global Advisory Committee on Vaccine safety (an expert clinical and scientific advisory body) has concluded that there is no evidence of a health risk from aluminium-containing vaccines.
I am also informed by the HPRA that there is no thiomersal in any of the vaccines used in the childhood immunisation programme in Ireland.
My Department has been advised by the HPRA that at present there are three types of vaccine strains authorised in IE which are manufactured in cell lines which were originally derived from foetal tissue. The Rubella vaccine strain is produced in the Wistar RA 27/3 cell line while the hepatitis A and varicella vaccine strains are expressed in the MRC-5 human diploid cell line. No new foetal tissue has been used in the manufacture of either rubella, hepatitis A or varicella antigens since the development of the original cell lines. Following production, the vaccines are purified from the cell line expression system and the purity of the vaccine formulation has to be demonstrated in line with regulatory standards. This includes limiting process-related impurities derived from the manufacturing process i.e. the cell expression system (e.g. host cell proteins, host cell DNA). The WHO has concluded that levels of up to 10 ng of residual host cell DNA can be considered as acceptable.
Prior to use in humans all vaccine formulations undergo preclinical testing. These typically involve a range of in vitro tests followed by a comprehensive range of toxicity studies in animals. These studies identify potential safety concerns and serve to avoid possible harm to human subjects. Clinical safety studies are conducted during the clinical trials and the safety data that is collected is based on events reported after each dose of vaccine and also events reported after a longer time post-vaccination. Clinical trials run for a defined period and safety data will be collected from trial participants for a defined period post vaccination. This period of time may differ between trials. In addition, vaccines on the market are continuously monitored to provide additional safety data and to identify adverse reactions. Under the regulatory framework, benefit-risk evaluations continue to be carried out throughout the product lifecycle.
Manufacture of vaccines must also comply with good manufacturing standards and regulatory requirements in EU and national legislation to ensure that the materials and methods used are appropriate. Vaccine manufactures are subject to independent assessment and inspection by national medicines agencies. It is important to reiterate that all medicines, including vaccines are subject to on-going review and evaluation of all available data from a range of sources, including systematic scientific literature review, to consider any impact that their data may have on the overall assessment of the benefits and risks of a medicinal product. The safety of these vaccines continues to be monitored at EU level through the EMA and its expert committees, which includes representatives from member state competent authorities such as the HPRA.
381. Deputy Pearse Doherty asked the Minister for Health if his attention has been drawn to the significant gap which exists between the funding requirements of a service provider (details supplied) in County Donegal and the core funding allocated to the organisation in 2019; and if he will make a statement on the matter. [39619/19]
Amharc ar fhreagraThe Government is committed to providing services and supports for people with disabilities which will empower them to live independent lives, provide greater independence in accessing the services they choose, and enhance their ability to tailor the supports required to meet their needs and plan their lives. This commitment is outlined in the Programme for Partnership Government, which is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities.
As the Deputy's question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.
382. Deputy Eugene Murphy asked the Minister for Health if some of the workload from the local health office in Ballinasloe, County Galway will be allocated to health offices in west County Galway or Galway city on an interim basis in order to clear the backlog of applications awaiting approval under the HSE community ophthalmic services scheme for medical card patients; and if he will make a statement on the matter. [39643/19]
Amharc ar fhreagraAs this is a service matter it has been referred to the HSE for reply to the Deputy.
383. Deputy Catherine Murphy asked the Minister for Health if he will address a matter regarding the case of a person (details supplied); and if he will make a statement on the matter. [39645/19]
Amharc ar fhreagraAs this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
384. Deputy Catherine Murphy asked the Minister for Health the mental health support services available for inpatients in each hospital nationally; and if he will make a statement on the matter. [39648/19]
Amharc ar fhreagraAs this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
