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Wednesday, 10 Jul 2024

Written Answers Nos. 267-281

Primary Care Centres

Questions (267)

Catherine Murphy

Question:

267. Deputy Catherine Murphy asked the Minister for Health if he will provide a schedule of current services provided by each primary care centre within Kildare, in tabular form. [30048/24]

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Written answers

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Primary Care Centres

Questions (268)

Catherine Murphy

Question:

268. Deputy Catherine Murphy asked the Minister for Health the number of WTE physiotherapists based in each primary care centre within CHO9 in 2023 and to-date in 2024, in tabular form. [30049/24]

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Written answers

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Hospital Services

Questions (269)

Robert Troy

Question:

269. Deputy Robert Troy asked the Minister for Health if he will expedite an operation for a cataract removal at Sligo Hospital (details supplied). [30058/24]

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Written answers

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Hospital Services

Questions (270)

Bernard Durkan

Question:

270. Deputy Bernard J. Durkan asked the Minister for Health when knee replacement surgery/appointment will be facilitated in the case of a person (details supplied); and if he will make a statement on the matter. [30076/24]

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Written answers

Under 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.

In relation to the particular query raised, as this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Hospital Procedures

Questions (271)

Patricia Ryan

Question:

271. Deputy Patricia Ryan asked the Minister for Health the reason behind the ‘late discharges’ which have been ongoing in University Hospital Limerick, where elderly dementia/Alzheimer’s patients are being discharged/removed outside of normal discharge hours; where they are being removed to; and if their next of kin has been informed beforehand. [30083/24]

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Written answers

University Limerick Hospitals Group (ULHG) has advised that the policy regarding the discharge of patients from University Hospital Limerick (UHL), or their return to their long-term residence, is a clinically guided decision that can only be effected with the consent of the patient and their loved ones or caregivers. Discharges typically take place during the daytime and evening. Overnight discharges or return to their long-term care residence are the exception rather than the rule and there has been no change in policy in this regard.

ULHG has also advised that in recent months, of the 4,273 inpatients aged 75 and over discharged from UHL, 19 patients (0.4%) were discharged from the hours of midnight and 7am. For the same 90-day period last year, of the 4,253 inpatients aged 75 and over discharged form UHL, 48 of these discharges (1.1%) took place between the hours of midnight and 7am.

In the majority of cases, these patients are being discharged home, with the consent of the patients and their families. No inpatient was discharged to a nursing home between midnight and 7am during either period examined.

In some cases, patients who have not been admitted to an inpatient bed may be transferred from UHL’s Emergency Department or from a surge area to one of ULHG’s Model 2 hospitals, to continue their care in a more appropriate environment. This is more appropriate than having patients of any age on a busy corridor overnight in the Emergency Department. The consent to a transfer is always sought from the patient, and each transfer is dealt with on a case-by-case basis.

Every effort is made to ensure that the transfer of patients to community settings takes place at an appropriate time for the patient, and with their consent.

Covid-19 Pandemic

Questions (272)

Patricia Ryan

Question:

272. Deputy Patricia Ryan asked the Minister for Health if, in light of the recent rapid rise in new strain Covid-19 cases, he has any plans in place to reinstate the PCR testing, which was discontinued in March 2023; and if he will make a statement on the matter. [30085/24]

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Written answers

Policy relating to testing for COVID-19 is based on public health advice. The HSE has adopted a targeted approach to COVID-19 testing, based on a clinical assessment where a clinician requires the result to contribute to the diagnosis and management of an individual patient. Testing continues in hospitals in accordance with public health advice, in relation to the management of an outbreak or specific public health risk and in community settings where a GP may decide to undertake a swab in relation to the management of an individual patient.

This approach to COVID-19 testing is facilitated by the high level of vaccine-induced and naturally acquired population immunity in Ireland. We have also implemented significant enhancements to infectious disease surveillance systems, which allows on-going assessment and close monitoring of emerging SARS-CoV-2 variants and the assessment of any potential threats to population health from COVID-19. This remains under continuous review from public health experts in the HSE.

Public health advice relating to COVID-19 is available on the website of the HSE at www2.hse.ie/conditions/covid19/. Continuing to follow the public health advice is still important. People who have symptoms of COVID-19 should self-isolate until 48 hours after the symptoms are mostly or fully gone and avoid contact with other people, especially people at higher risk from COVID-19. Anybody who has concerns about an underlying condition or their level of risk in relation to COVID-19 is advised to seek advice from their GP or treating clinician.

Nursing Homes

Questions (273)

Patricia Ryan

Question:

273. Deputy Patricia Ryan asked the Minister for Health the level of engagement between his Department and the HSE and the residents of a nursing home (details supplied) to prevent its closure and the subsequent loss of the residents’ home. [30086/24]

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Written answers

Lucan Lodge is a private nursing home, located in South Dublin, which was operated by Passage Healthcare International (Ireland) Limited.

The HSE was notified on Thursday 16th May 2024 by the Health Information and Quality Authority (HIQA), that HIQA had cancelled the registration of Lucan Lodge Nursing Home with the agreement of the Directors of Passage Healthcare International (Ireland) Limited, who was the registered provider of Lucan Lodge Nursing Home. Since 10am on Friday 17th May, the HSE, in accordance with its statutory requirement under Section 64 of the Health Act 2007, is required to take charge of the nursing home and carry on its business as if it were still registered, pending alternative arrangements.

This means the HSE is performing its function as provider of last resort.

As part of its ongoing assessment, the HSE assessed the nursing home and has engaged with all relevant parties to explore all options as it relates to Lucan Lodge. This assessment has generated a number of significant issues of concern.

Several fire safety concerns have been identified within the existing infrastructure. In line with its obligations, the HSE have put mitigation measures in place to address immediate risks.

As part of the HSE’s responsibilities, routine water quality sampling was undertaken in Lucan Lodge. Positive Legionella results were returned across the site at very high levels.

In consultation with Public Health, a Water Quality Committee meeting was convened on the 21st June 2024 and an immediate plan was put in place to urgently address the situation including the implementation of immediate control measures noting that further permanent water and heating works are required.

Unfortunately, these measures can only address the immediate risk and will not support the safe provision of ongoing care in Lucan Lodge. Extensive infrastructural works are required to remedy both the fire and the water safety concerns. The necessary work could not be done while people remain in the building.

Due to these issues, the HSE plan is to support residents to relocate from Lucan Lodge with immediate effect with the aim of relocation of all residents to be achieved over the next 4 weeks. There are currently 40 residents in situ. Over recent weeks, with assistance from the HSE, 29 residents have transferred of their own choice to 12 other nursing homes.

I am deeply concerned to learn of the challenges facing Lucan Lodge and understand how upsetting this information may be for residents and family members. The HSE team on site in Lucan Lodge are committed to working closely with residents and family members to explore options regarding a move to a new nursing home. The HSE will work with residents and family members to ensure the transition to new nursing homes respects their will and preference.

The HSE team will be available onsite to residents and family members over the coming weeks to answer any questions. Please be assured residents’ safety and ongoing care always remains the highest priority.

I would like to thank residents, families, and staff for their continuing co-operation at this difficult time.

Medicinal Products

Questions (274)

Pádraig O'Sullivan

Question:

274. Deputy Pádraig O'Sullivan asked the Minister for Health to provide a breakdown of the additional costs to the State's pharmaceutical pricing and reimbursement system of changes to the drugs payment scheme thresholds and changes to medical card eligibility; and if he will make a statement on the matter. [30101/24]

View answer

Written answers

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Health Services

Questions (275)

Pádraig O'Sullivan

Question:

275. Deputy Pádraig O'Sullivan asked the Minister for Health the level of growth required in the health service to remain up to date with demographic changes in Ireland; and if he will make a statement on the matter. [30102/24]

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Written answers

Ireland has a growing population, and it is critical that the health and social care system has the capacity to plan and deliver services that meet the health needs of its population. There are a number of reforms and initiatives underway which seek to address these demographic pressures and the health needs of patients and service users.

The ESRI has been commissioned by the Department of Health to carry out a refresh of the 2018 Capacity Review. Using the ESRI's Hippocrates projection model, the Capacity Review will project future demand and expenditure for three key service areas: 1) Public Acute Hospitals; 2) Primary & Community Care; and 3) Older Persons services. These will be projected out to 2040, at a National and Health Region level. The work on the Capacity Review is currently ongoing with outputs to be published in 2025. The results of the Capacity Review will provide an evidence basis for workforce planning and future healthcare investments.

A key reform in the move towards a population-based approach is the implementation of Health Regions. On 4 March, the HSE was reorganised into six HSE Health Regions, representing one of the most significant reforms to our health and social care services in recent years. The six Health Regions, each led by a Regional Executive Officer (REO), will have responsibility for the planning and coordinated delivery of the vast majority of health and social care services for their respective populations. The six REOs are now in place and are now driving the regional implementation of this reform.

In recognition of the fact that different regions of the country have their own unique demographic challenges and health needs, the Health Regions will take a population-based approach to how they plan, fund and deliver care. This is an approach that was championed by the Sláintecare Report. A population-based resourcing approach (PBRA) was proposed in the March 2023 Irish Government Economic and Evaluation Service (IGEES) Spending Review "Towards Population-Based Funding for Health". In line with international practice, this illustrative approach sets out a capitation funding model which takes account of demographic and non-demographic factors such as age, sex, social deprivation and rurality. Importantly, the results of this illustrative model indicated that there would be no significant change required to the existing levels of service funding in order to establish this population-based approach. The aim of PBRA is therefore to fairly distribute available healthcare funding to regions according to the relative needs of their populations and the cost of providing services to meet those needs.

The Department has established a PBRA Expert Group to further refine this approach, and a multi-year phased implementation is planned. The HSE is also progressing the development of a Health Needs Assessment Framework which will enable services to better understand the needs of their populations at a local and regional level in order to inform how services are planned and delivered.

Departmental Bodies

Questions (276)

Pádraig O'Sullivan

Question:

276. Deputy Pádraig O'Sullivan asked the Minister for Health the number of times a working group on pharmaceutical medicine (details supplied) has met in 2024; the dates of such meetings; and if he will make a statement on the matter. [30103/24]

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Written answers

In February 2023, I published the Mazars Review which examined the governance arrangements around the HSE’s Drug Pricing and Reimbursement Process. The Report found that the reimbursement process is operating in line with the legislation and that it is delivering results in line with international norms. I fully support the recommendations contained in the Mazars report around improving the process, increasing transparency, providing easier access, and supporting value for money.

An implementation group has been established between my Department and the HSE to consider and progress the various recommendations contained in the Report. The membership of the Group includes representatives of the Drugs Group, the HSE, the NCPE, and the Department of Health. The Working Group has met frequently since its establishment, to consider the involvement of patients, industry, and clinicians, in each stage of the reimbursement process.

The Group has conducted two rounds of targeted stakeholder consultation. The insights gained from stakeholders have been considered by the Group as it continues its work on progressing the various recommendations of the Review. The Group’s focus in 2024 has progressed to completion of its report. Regular meetings have concluded and collaboration on report drafting is taking place remotely. The Group’s work is now nearing completion and its report will be submitted to me in the coming weeks.

Medicinal Products

Questions (277)

Pádraig O'Sullivan

Question:

277. Deputy Pádraig O'Sullivan asked the Minister for Health how his Department measures timeliness when it comes to accessing medicines; the evidence he has that the HSE is processing pharmaceutical applications in a timely manner, as per the commitment to timely access; and if he will make a statement on the matter. [30104/24]

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Written answers

The HSE is the national authority with responsibility for the pricing and reimbursement of new medicines or new uses of existing medicines. The legislation underpinning the National Application, Assessment & Decision Process for new medicines is the Health (Pricing and Supply of Medical Goods) Act 2013 and the design of the 2013 Act complies with the requirements of the EU Transparency Directive (89/105/EEC). In line with the 2013 Act, and the national framework agreed with industry, a company must first submit an application to the HSE to have a new medicine added to the reimbursement list.

The timing of company applications for reimbursement in different countries can vary for a number of reasons, not least the available market share in each country. Once a company responsible for the commercialisation of a new medicine receives market authorisation, it can apply for reimbursement in the country (or countries) of its choice. Ireland, by virtue of its size and market share, may not always be prioritised by a company in the first stages of marketing a new product. Describing timelines for reimbursement from EMA approval to HSE reimbursement approval does not consider this important factor and misrepresents the process, as statutorily the HSE cannot add a medicine to the reimbursement list until an application is received from the company holding the market authorisation.

When an application is made to have a product added to the reimbursement list in Ireland, the HSE is required, under the 2013 Act, to decide within 180 days of receiving the application, to either add the medicine to the reimbursement list or refuse to reimburse the medicine. In assessing the application, the HSE is required by statute to consider a range of criteria including the magnitude of the clinical effect, cost effectiveness, budget impact, opportunity cost and unmet need.

The 2013 Act transparently sets out details of the criteria that the HSE must consider when making decisions in relation to pricing and reimbursement.

Prior to making any decision regarding funding / reimbursement of a medicine, the HSE must have regard to the following criteria as set out in Schedule 3 (Part 3) of the 2013 Act:

(a) The health needs of the public,

(b) The cost-effectiveness of meeting health needs by supplying the item concerned rather than providing other health services,

(c) The availability and suitability of items for supply or reimbursement,

(d) The proposed costs, benefits, and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks,

(e) The potential or actual budget impact of the item or listed item,

(f) The clinical need for the item or listed item,

(g) The appropriate level of clinical supervision required in relation to the item to ensure patient safety,

(h) The efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies) and

(i) The resources available to the HSE.

The HSE is required to consider the following criteria when it is making decisions in relation to pricing of Medicines:

(a ) the equivalent relevant prices (if practicably available) of the item in all other Member States where the item is marketed,

(b ) the relevant prices of therapeutically similar listed items,

(c ) the potential therapeutic benefits of the item for patients likely to use the item if it were to become a listed item,

(d ) the potential budget impact of the item if it were to become a listed item,

(e ) the ability of suppliers of the item to meet patient demand for the item if it were to become a listed item,

(f ) the resources available to the Executive, and

(g ) the terms of any agreement in place (whether entered into before, on or after the commencement of this section) between the Executive and any representative body of the suppliers of drugs, medicines or medicinal or surgical appliances where the agreement relates, whether directly or indirectly, to the price of the item.

The 2013 Act and the IPHA Agreements (which are published) provide the necessary transparency in relation to the design of the pricing and reimbursement processes, which are set out below.

An application to have a medicine added to the Reimbursement List or to be priced as a hospital medicine, together with any relevant fees and a Rapid Review Assessment dossier and HTA dossier (as appropriate), can be submitted to the HSE as soon as the market authorisation has been granted. In fact, the HSE enables companies to commence part of the application process (i.e. the assessment processes), provided the companies have formulated a decision in relation to the price for which they intend to apply, on receipt of a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), which generally is 2 to 3 months prior to when a market authorisation is granted.

The 2013 Act (in compliance with the Directive) allows for the operation of stop clocks during the application process whilst the HSE is awaiting information from the applicant company.

The National Centre for Pharmacoeconomics (NCPE) plays a pivotal role in assisting the HSE with the assessment of all new medicines. Since September 2009 following receipt of an application for reimbursement the cost-effectiveness of all new medicines are considered prior to a decision being made by the HSE. All applications will be subjected to a preliminary rapid review. High cost products and those with an associated significant budget impact will be subjected to formal pharmacoeconomic assessment.

The NCPE endeavours to issue a Rapid Review Assessment report within four weeks of receipt and issue the formal pharmacoeconomic assessment (i.e. HTA report) within 90 days (allowing for the ‘stop-clocks’ process). When the HSE receives a Rapid Review Assessment report or HTA report it endeavours to consider that report within 14 days in conjunction with the criteria set out in the 2013 Act. A final decision can thereafter be reached for certain medicines and will be duly notified to the Company. In the event that additional information is required to enable a decision to be made the HSE engages with the relevant company to seek same.

Following engagements with a Company, a medicine may be required to be submitted for consideration by the HSE Drugs Group (the “Drugs Group”). The HSE endeavours to advise the Company in writing of the recommendation of the Drugs Group within 14 days of the making of that recommendation. This recommendation will be commercially confidential between the HSE and the relevant Company to enable appropriate due process to be completed.

Recommendations from the Drugs Group are considered at the next HSE Executive Management Team meeting and the HSE endeavours to make a decision on the application within 45 days of the Drugs Group recommendation. The output of the consideration by the HSE Executive Management Team may result in:

a decision to reimburse at the applied terms,

a decision not to reimburse at the applied terms, or,

a requirement to meet with the applicant Company to address any issues arising or to seek clarifications.

Where the HSE approves an application to reimburse a medicine, reimbursement will be implemented within 45 days. On such approval, and where the application for reimbursement was made pursuant to the 2013 Act, the medicine will be added to the Reimbursement List and will specify the price at which the medicine will be eligible for reimbursement. The HSE publishes updates to the list of reimbursable items on its website monthly. The Reimbursement List is publicly accessible at: www.hse.ie/eng/staff/PCRS/items/

In compliance with the Directive, where the HSE is minded to make a decision to not accept a price or to not approve reimbursement the 2013 Act requires the HSE to issue a formal notice of proposal of same, setting out the proposed decision, the reasons for the proposed decision and to make clear that the applicant has the right to make representations in writing in relation to this proposal and the time frame for such representations (which must be at least 28 days). The HSE is obliged to consider any representations received before making a decision. In the event that the HSE does make a decision to not reimburse it is obliged to provide notice in writing, to set out the reasons for the decision and to provide copies of all expert opinions or recommendations considered. The 2013 Act (again in compliance with the Directive) sets out that an applicant may appeal any decision of the HSE to the High Court.

The HSE endeavours to provide access to as many medicines as possible within the resources provided to it and in as timely a fashion as possible. The HSE is working on certain improvements identified during the negotiation of the Framework Agreements with Industry in 2021, including a number of enhancements in the application process and further transparency around the application process. These enhancements were committed to by the State so as to assist with the timely processing of applications for pricing and reimbursement.

In February 2023 the Mazars Review was published which examined the governance arrangements around the HSE’s Drug Pricing and Reimbursement Process. The Report found that the reimbursement process is operating in line with the legislation and that it is delivering results in line with international norms. The recommendations contained in the Mazars report included improving the process, increasing transparency, providing easier access, and supporting value for money.

On foot of the publication of the Mazars Review in February 2023 funding has been allocated for an additional 34 WTE in 2024 for the agencies involved in the HSE’s medicines pricing and reimbursement system. This will enable them to conduct timely and efficient evaluations of medicines for reimbursement. It will also maximise the use of this substantial public investment to support access to more medicines for more people. This recruitment process has commenced and is ongoing.

Investing in this capacity will support agencies to operate to the fullest of their ability, providing timely and efficient evaluation of medicines for reimbursement.

Health Service Executive

Questions (278)

Pádraig O'Sullivan

Question:

278. Deputy Pádraig O'Sullivan asked the Minister for Health to outline the details of the service level agreement between the HSE and the National Centre for Pharmacoeconomics; and if he will make a statement on the matter. [30105/24]

View answer

Written answers

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Medical Aids and Appliances

Questions (279)

Michael Ring

Question:

279. Deputy Michael Ring asked the Minister for Health if the HSE would consider the provision of equipment (details supplied) in certain circumstances; and if he will make a statement on the matter. [30106/24]

View answer

Written answers

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Covid-19 Pandemic

Questions (280)

Neasa Hourigan

Question:

280. Deputy Neasa Hourigan asked the Minister for Health the plans to reinstate free PCR testing for covid-19; and if he will make a statement on the matter. [30111/24]

View answer

Written answers

Policy relating to testing for COVID-19 is based on public health advice. The HSE has adopted a targeted approach to COVID-19 testing, based on a clinical assessment where a clinician requires the result to contribute to the diagnosis and management of an individual patient. Testing continues in hospitals in accordance with public health advice, in relation to the management of an outbreak or specific public health risk and in community settings where a GP may decide to undertake a swab in relation to the management of an individual patient.

This approach to COVID-19 testing is facilitated by the high level of vaccine-induced and naturally acquired population immunity in Ireland. We have also implemented significant enhancements to infectious disease surveillance systems, which allows on-going assessment and close monitoring of emerging SARS-CoV-2 variants and the assessment of any potential threats to population health from COVID-19. This remains under continuous review from public health experts in the HSE.

Public health advice relating to COVID-19 is available on the website of the HSE at www2.hse.ie/conditions/covid19/. Continuing to follow the public health advice is still important. People who have symptoms of COVID-19 should self-isolate until 48 hours after the symptoms are mostly or fully gone and avoid contact with other people, especially people at higher risk from COVID-19. Anybody who has concerns about an underlying condition or their level of risk in relation to COVID-19 is advised to seek advice from their GP or treating clinician.

Medicinal Products

Questions (281)

John Lahart

Question:

281. Deputy John Lahart asked the Minister for Health if there are plans to update the reimbursement criteria for heart failure patients with reduced ejection fraction to align with European cardiology guidelines (details supplied); if he is aware that this update could potentially save 2,000 to 4,000 outpatient appointments annually, cut outpatient appointment costs and ultimately reduce mortality and hospitalisation risks for patients;; and if he will make a statement on the matter. [30114/24]

View answer

Written answers

As this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.

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