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Gnáthamharc

Thursday, 2 Oct 2025

Written Answers Nos. 435-460

Disease Management

Ceisteanna (436)

Barry Ward

Ceist:

436. Deputy Barry Ward asked the Minister for Health if her attention has been drawn to requests from an organisation regarding care for persons with asthma (details supplied); and if she will make a statement on the matter. [52744/25]

Amharc ar fhreagra

Freagraí scríofa

I met with the Asthma Society of Ireland on 4 September, where we had an opportunity to discuss their 2026 Budgetary Submission, including maintenance and reliever therapy inhalers, national reviews of asthma deaths, patient registries, and advanced nurse practitioners.

As the Deputy is aware, funding for all service developments is considered in the first instance as part of the annual estimates process, in the context of overall prioritisation of available funding. This is currently ongoing for 2026. This process seeks to balance available funding across all service areas to achieve the best possible outcomes for the greatest number of service users and prioritise areas of greatest need.

General Practitioner Services

Ceisteanna (437)

Joe Neville

Ceist:

437. Deputy Joe Neville asked the Minister for Health if her Department is aware of the GP shortages in towns in Kildare North, in particular Maynooth, which has a rapidly increasing population and growing GP shortage concerns; and if she will make a statement on the matter. [52745/25]

Amharc ar fhreagra

Freagraí scríofa

GPs are self-employed practitioners and therefore may establish practices at a place of their own choosing. There is no prescribed ratio of GPs to patients, and the State does not regulate the number of GPs that can set up in a town or community.

Where a vacancy arises in a practice with a GMS contract, the HSE becomes actively involved in the recruitment process to find a replacement GP. As of August 1st, there is one GMS vacancy in Co. Kildare, in Monasterevin/Naas.

It is acknowledged that there is limited access to GP services in certain areas. Work is ongoing to increase the number of GPs practising in the State and thereby improve access to GP services for all patients across the country.

Over €340 million in additional annual investment in general practice has been provided under the 2019 and 2023 GP GMS Agreements. The 2019 Agreement provided for increased GP capitation fees, increased supports for practices and new fees for additional services such as the Chronic Disease Management (CDM) programme.

The 2023 Agreement further increased GP capitation fees, increased the existing subsidy rates for practice staff, and introduced a grant support for additional staff capacity as well a practice staff maternity leave support. It also provided for the expansion of GP visit card eligibility in 2023 to all children under 8 years of age and all those who earn up to the median household income.

The annual intake of doctors into the GP training programme has been increased by approximately 80% from 2019 to 2024, with 350 new entrant training places made available in 2024 and again in 2025. As a result, the number of GP graduates has increased in recent years and will continue to increase in the coming years.

In addition, recruitment of GPs from abroad is ongoing under the International Medical Graduate (IMG) Rural GP Programme. As of the end of Q2 2025, 122 IMG GPs are placed in GP practices, and a further 23 have competed the programme.

Lastly, a Strategic Review of General Practice is underway. The review, with input from key stakeholders, is examining the broad range of issues affecting general practice including issues related to GP capacity and will consider possible mechanisms to attract more GPs to underserved areas. Following its completion, a final report will be presented to me outlining the findings of the review and setting out recommended actions for a more sustainable general practice.

Medical Qualifications

Ceisteanna (438)

Pádraig Rice

Ceist:

438. Deputy Pádraig Rice asked the Minister for Health further to Parliamentary Question No. 721 of 27 May 2025, the status of the HSE’s review of the physician associate grade; if she will publish the terms of reference for this review; the date at which she expects this review to be completed; and if she will make a statement on the matter. [52748/25]

Amharc ar fhreagra

Freagraí scríofa

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

Hospital Facilities

Ceisteanna (439, 463)

Pádraig Rice

Ceist:

439. Deputy Pádraig Rice asked the Minister for Health if she will allocate funding in budget 2026 for post-acute inpatient neurorehabilitation beds in the south west, in line with the programme for Government commitment to develop more specialist inpatient neurorehabilitation beds; and if she will make a statement on the matter. [52749/25]

Amharc ar fhreagra

Eoghan Kenny

Ceist:

463. Deputy Eoghan Kenny asked the Minister for Health if she intends to allocate funding in budget 2026 for post-acute inpatient neurorehabilitation beds in the south west in line with the programme for Government commitment to develop more specialist inpatient neurorehabilitation beds; and if she will make a statement on the matter. [52869/25]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 439 and 463 together.

The Deputy will be aware that there are many services that the HSE needs to support each year from within its Oireachtas approved Budget. Please note that the level of funding available to each Government Department is being considered as part of the national estimates and budgetary process for 2026, which is currently underway.

Pending completion of this process, it wouldn't be appropriate for me to comment further on any proposals at this stage.

Healthcare Policy

Ceisteanna (440)

Pádraig Rice

Ceist:

440. Deputy Pádraig Rice asked the Minister for Health further to Parliamentary Question No. 610 of 23 September 2025, the conditions included in the free hormone replacement therapy scheme under ‘medically induced menopause’; and if she will make a statement on the matter. [52750/25]

Amharc ar fhreagra

Freagraí scríofa

Menopause is the permanent cessation of menstruation. Menopause occurs with the final menstrual period and thus is known with certainty only in retrospect, one year after the event.

Menopause can be natural or induced – induced menopause may be due to surgical removal of the ovaries, or may be due to medication, chemotherapy or radiotherapy.

Health Services Staff

Ceisteanna (441)

Pádraig Rice

Ceist:

441. Deputy Pádraig Rice asked the Minister for Health to respond to matters raised in correspondence (details supplied); if she will engage with the relevant authorities regarding facilitation of these clinical placements; and if she will make a statement on the matter. [52751/25]

Amharc ar fhreagra

Freagraí scríofa

Recruitment and retention of healthcare workers including physiotherapists is a key priority for the Government. Every effort will be made to assist Irish students studying Physiotherapy in the Netherlands to secure clinical placements, enabling them to register with CORU and take up positions within the Irish health service.

Officials in my department are engaging with the HSE regarding the availability of clinical placements for all HSCP students including those students who have qualified outside Ireland and who require periods of adaptation to have their qualifications recognised in Ireland. The HSE, through the National Health & Social Care Professional (HSCP) Office is working on several work-streams to support increasing capacity to deliver sustainable and scalable clinical placement opportunities for all HSCPs including physiotherapists. This work includes education resources, events, multi-pronged communications and the establishment of core teams within each region to formalise and develop regional level HSCP clinical infrastructure.

The HSE National HSCP Office is leading work to increase practice placement capacity and the availability of placements for students. Students will benefit from increased placements associated with the following developments:

Establishment of prioritised core teams within each region to formalise and develop regional level HSCP clinical placement infrastructure.

New grade codes have been introduced which will enable HSCP to be employed on a temporary basis whilst completing periods of adaptation required to enable recognition of overseas qualifications.

Targeted communications campaign highlighting the importance of clinical placements cascaded to all HSCP at all levels with the aim of increasing the number of clinical placements available.

Ongoing support for the implementation of the HSCP Quality Framework for Sustainable Practice Education.

Development of a business case for a HSCP practice placement/compensation measures database. This will enable tracking of capacity and availability of placement opportunities.

Developing a sustainable model for training HSCPs to provide practice placements/compensation measures.

In the meantime, the students may wish to send their details to the HSE National HSCP Office (email: HSCP.NationalOffice@hse.ie), who will circulate their details to physiotherapy managers to consider if any of them are in a position to facilitate clinical practice placements.

Humanitarian Aid

Ceisteanna (442, 444)

Pádraig Rice

Ceist:

442. Deputy Pádraig Rice asked the Minister for Health the reason for the discrepancy between her Department’s stated position with respect to medical evacuations of paediatric patients (details supplied); if the position has changed since 2024; if all children have been evacuated via Egypt; and if she will make a statement on the matter. [52752/25]

Amharc ar fhreagra

Pádraig Rice

Ceist:

444. Deputy Pádraig Rice asked the Minister for Health the number of medical evacuations of Palestinian children since 2023, by year and location of evacuation. [52777/25]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 442 and 444 together.

I thank the Deputy for his question in relation to medical evacuations from Gaza to Ireland.

I can advise the Deputy that Ireland continues a strong tradition of providing humanitarian assistance including through the Department of Foreign Affairs and Trade, Irish Aid humanitarian and development assistance programme, and the HSE Global Health Programme.

In September 2024, a Government decision was made that Ireland would evacuate up to 30 paediatric patients and their carers out of Egypt, in response to the World Health Organisation's (WHO) request to activate the EU Civil Protection Mechanism (UCPM) to assist in addressing the Gaza healthcare needs.

On 15 July 2025, the Government amended the scope of the Gaza Medevac Initiative to allow for family members (parents, minor siblings or adult dependent siblings) to apply for permission to enter the State, and for exploration of alternative exit routes for medical evacuation. This decision not only applies to future medical evacuation operations but also to patients already here under the Medevac Initiative who have qualifying family members still in Gaza.

The number of patients and companions medically evacuated to Ireland is set out in the table below:

-

Number of Patients

Number of Carers

Number of companions

Total

Year

8

8

11

27

2024

4

4

10

18

2025

Total

12

12

21

45

My Department remains committed to facilitating the medical evacuation of 18 further child patients and their accompanying carers and family members and officials will continue to work closely with the HSE, CHI, WHO and the Ministry of Health in Gaza regarding selection criteria and complex logistical arrangements for the next and future medical evacuations.

Department officials and the HSE are receiving ongoing support from the Department of Justice, Home Affairs and Migration and the Department of Foreign Affairs and Trade to facilitate the next medical evacuations of children from Gaza through Egypt, and through Jordan. Given the complex nature of medical evacuation operations, several Departments and agencies are working together to get the necessary arrangements in place to evacuate the paediatric patients and their accompanying family members. It is expected that this medical evacuation will take place in the coming month.

This is subject to all permissions and logistics being put in place. Such a medical evacuation is highly complex and many determining factors are subject to challenging and shifting external circumstances.

Healthcare Infrastructure Provision

Ceisteanna (443)

Pádraig Rice

Ceist:

443. Deputy Pádraig Rice asked the Minister for Health the status of the elective hospital for Cork; if she expects planning permission to be sought in 2026; and if she will give a commitment that, subject to planning approval, construction will begin in 2027 and the hospital will become operational in 2030, as set out in the Sláintecare 2025+ plan; and if she will make a statement on the matter. [52754/25]

Amharc ar fhreagra

Freagraí scríofa

The Government is actively working to increase elective care capacity in Ireland, ensuring that high-quality and timely scheduled care is available to all. New elective facilities will support the separation of scheduled (elective) and emergency care. This can lead to improved care for patients with fewer cancellations and delays for elective care caused by seasonal surges, localised outbreaks, and surges in emergency attendances.

The Programme for Government committed to building four new elective hospitals (Cork, Galway and Dublin – 2 sites), establishing six new Surgical Hubs (South Dublin, North Dublin, Galway, Cork, Limerick and Waterford), and exploring the feasibility of a hub in the northwest. I was delighted to open the first of our new surgical hubs at Mount Carmel in February this year. The surgical hubs in Swords, Galway, Cork, Waterford and Limerick are all under construction and expected to become operational in 2026. In July I also announced plans for two new surgical hubs in the North West, to be located in Sligo and Letterkenny. The HSE is now planning for these.

The recently announced NDP funding envelope (€9.25 billion for 2026 – 2030) will support the progression of key health sector priorities over the next 5 years including delivery of the surgical hub programme and progressing detailed design and statutory planning for the new elective hospitals.

The NDP review commits to progressing Programme for Government commitments on a phased basis over the course of the NDP and allows for flexibility to prioritise ‘shovel-ready’ projects that have received all necessary final statutory approvals and are under, or ready to begin, construction.

In relation to the elective hospitals, sites have been identified for development in Cork (St Stephen's), Galway (Merlin Park) and Dublin (2 sites – Connolly Hospital and Crumlin).

The HSE is currently actively undertaking significant design for Cork and Galway, with Dublin to follow in due course. An Integrated Design Team is progressing design and engagement to inform statutory planning submissions and the regulatory approvals required for the elective treatment centres. Surveys and site investigations have been conducted, and these are informing the design and planning applications for enabling works on the sites in Cork and Galway.

The HSE is also progressing Enabling Packages in advance of main construction and is engaging with statutory planning authorities to progress the necessary planning permission applications.

Timelines for the design process and subsequent programme development are closely related to engagement with planning and other regulatory authorities. It is important to ensure that these processes are rigorous and fully consider all options in developing the most appropriate solutions for the chosen sites.

Question No. 444 answered with Question No. 442.

Ambulance Service

Ceisteanna (445)

Albert Dolan

Ceist:

445. Deputy Albert Dolan asked the Minister for Health the number of calls made to the National Ambulance Service to attend a property (details supplied) in 2024 and from 1 January 2025 and to date in 2025. [52780/25]

Amharc ar fhreagra

Freagraí scríofa

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

General Practitioner Services

Ceisteanna (446)

Albert Dolan

Ceist:

446. Deputy Albert Dolan asked the Minister for Health the number of calls made to Westdoc to attend a property (details supplied) in 2024 and from 1 January 2025 to date in 2025. [52781/25]

Amharc ar fhreagra

Freagraí scríofa

As this is a service matter, I have asked the HSE to reply to the Deputy directly as soon as possible.

Official Engagements

Ceisteanna (447)

Donna McGettigan

Ceist:

447. Deputy Donna McGettigan asked the Minister for Health if she has spoken formally with the UK health secretary in the past three months; and if she will make a statement on the matter. [52801/25]

Amharc ar fhreagra

Freagraí scríofa

I can confirm that I have not spoken formally with Secretary of State for Health and Social Care in the UK, Wes Streeting, in the past three months.

Officials from my Department however continue to engage regularly with their counterparts in the Department of Health and Social Care in the UK.

Hospital Staff

Ceisteanna (448)

Donna McGettigan

Ceist:

448. Deputy Donna McGettigan asked the Minister for Health the number of vacant consultant posts, by speciality, currently at Limerick Maternity Hospital; the expected timeframe for each of those vacancies being filled, in tabular form; and if she will make a statement on the matter. [52802/25]

Amharc ar fhreagra

Freagraí scríofa

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

Cancer Services

Ceisteanna (449)

Donna McGettigan

Ceist:

449. Deputy Donna McGettigan asked the Minister for Health the current staffing complement of the National Cervical Screening Laboratory, by discipline and grade, in tabular form; the required staffing necessary to fully repatriate screening services; and if she will make a statement on the matter. [52803/25]

Amharc ar fhreagra

Freagraí scríofa

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 Waiting Lists

Ceisteanna (450)

Donna McGettigan

Ceist:

450. Deputy Donna McGettigan asked the Minister for Health the number of persons on a waiting list for audiology services via primary care systems in CHO 3; and if she will make a statement on the matter. [52804/25]

Amharc ar fhreagra

Freagraí scríofa

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

Hospital Staff

Ceisteanna (451)

Peter 'Chap' Cleere

Ceist:

451. Deputy Peter 'Chap' Cleere asked the Minister for Health whether there is a vacant position for a speech and language therapist at St. Columba's Hospital, Thomastown, County Kilkenny; how long the post has been vacant; and the plans in place to fill this vacancy. [52821/25]

Amharc ar fhreagra

Freagraí scríofa

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

Medicinal Products

Ceisteanna (452)

Ken O'Flynn

Ceist:

452. Deputy Ken O'Flynn asked the Minister for Health the number of oncology drugs approved for use by the European Medicines Agency in each of the years 2020 to 2025; and to specify which of these are currently reimbursed under the public health system, which are only available privately, and the average waiting time from EMA approval to HSE reimbursement. [52823/25]

Amharc ar fhreagra

Freagraí scríofa

My Department Officials have reached out to the relevant parties and will contact you directly with a comprehensive response on your question.

Medicinal Products

Ceisteanna (453)

Ken O'Flynn

Ceist:

453. Deputy Ken O'Flynn asked the Minister for Health whether there are cancer drugs currently accessible to private patients in Ireland which are not reimbursed for public patients; and the steps being taken to eliminate this disparity in access. [52824/25]

Amharc ar fhreagra

Freagraí scríofa

My Department Officials have reached out to the relevant parties and will contact you directly with a comprehensive response on your question.

Cancer Services

Ceisteanna (454)

Ken O'Flynn

Ceist:

454. Deputy Ken O'Flynn asked the Minister for Health the average time taken by the National Centre for Pharmacoeconomics and her Department to complete health technology assessments and reimbursement decisions on oncology drugs in the past three years; and whether target timelines exist to expedite access for public patients. [52825/25]

Amharc ar fhreagra

Freagraí scríofa

The State is committed to providing timely access to new and innovative medicines to all patients. Work is ongoing and consideration is being given to various measures to address access to medicines, including to ensure faster access. Budgets 2021 to 2025 allocated an additional €158 million for new medicines, which has facilitated the introduction of 238 new medicines, 97 of which are for the treatment of cancer.

The HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines. This arises from the Health (Pricing and Supply of Medical Goods) Act 2013. The Act provides a rigorous process for the assessment of new medicines for reimbursement. This enables taxpayers to be confident that the right medicines are chosen, at a sustainable price.

In making a reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact.

HSE decisions on which medicines are reimbursed by the State via public funds are made on objective, scientific and economic grounds, and having regard to the advice of the National Centre for Pharmacoeconomics (NCPE).

The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the NCPE for assessment. The NCPE may advise that a full Health Technology Assessment (HTA) is recommended, which would then be commissioned by the HSE as per the agreed processes. 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). The timeline for the full HTA process is variable as this is a “stop-clock process”.

The NCPE uses a decision framework to systematically assess whether a medicine is cost-effective. This includes clinical effectiveness and health-related quality-of-life benefits, which the new treatment may provide and whether the cost requested by the pharmaceutical company is justified. The potential budget impact of a medicine is also assessed.

Following the recommendation from the NCPE, the HSE examines all the evidence which may be relevant for the decision; the final decision on reimbursement is made by the HSE. In the case of cancer drugs, the NCPE recommendation is also considered by the National Cancer Control Programme (NCCP) Technology Review Group. The time from HTA completion to reimbursement decision is variable as it depends on the outcome of price negotiations with pharmaceutical companies.

Reimbursement is for licensed indications which have been granted marketing authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA). Pharmaceutical companies must apply to the HSE for reimbursement.

Cancer Services

Ceisteanna (455)

Ken O'Flynn

Ceist:

455. Deputy Ken O'Flynn asked the Minister for Health if her Department has entered into outcomes-based or risk-sharing agreements with pharmaceutical companies in respect of new cancer drugs; and if so, to provide details of the drugs concerned, the duration of the agreements, and the outcomes being measured. [52826/25]

Amharc ar fhreagra

Freagraí scríofa

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

Cancer Services

Ceisteanna (456)

Ken O'Flynn

Ceist:

456. Deputy Ken O'Flynn asked the Minister for Health the projected level of additional annual funding required over the next five years to ensure that all newly approved cancer drugs are made available to public patients in a timely manner; and whether ring-fenced oncology funding is being considered within her Department. [52827/25]

Amharc ar fhreagra

Freagraí scríofa

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for pricing and reimbursement of new medicines.

The State has committed very substantial amounts of funds to the HSE to support new medicines (and new use of medicines) and continues to do so on an ongoing basis. Budgets 2021-2025 allocated dedicated funding for new drugs totalling €158 million. This allowed the HSE to approve 238 new medicines including 97 new oncology drugs in that period. Reimbursement is for licensed indications which have been granted marketing authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).

The HSE in its decision making considers the 5-year budget impact of each new medicine notwithstanding that the budget of the HSE is set on an annual basis. The year 1 costs of most medicines represent a fraction of the overall costs of those medicines when fully introduced.

In any single year there will be substantial uncertainty around the costs that will emerge in the year in question at the time that the budget is set.

On occasion, medicines expected to reach the market in a particular year at time of budget planning will not ultimately reach the market as they may fail to demonstrate that they satisfy the safety, efficacy and / or quality standards required to receive a market authorisation from the European Medicines Agency (EMA). In addition, any application from a market authorisation holder, may not occur in the year forecast in the horizon scan.

The full cost of new medicines (or new use of medicines) approved will never emerge within the first calendar year of reimbursement approval, given some of those approvals will be effective in Q1, some in Q2 (i.e. partial year costs), some in Q3 (i.e. less than half year costs) and some in Q4 (with little or no costs in that calendar year but substantial and growing costs in the next year).

In addition, the HSE undertakes commercial negotiations for new drugs on behalf of the State to deliver substantial savings in the medicines budget, thereby creating financial headroom to maximise budget utilisation.

The HSE is committing all resources as allocated to the provision of new medicines over time, notwithstanding any inter-year variations. Given the uncertainties outlined, the estimation and allocation of required budgets is conducted on an annual basis. This ensures optimal use of State funds to provide care for patients in Ireland.

Cancer Services

Ceisteanna (457)

Ken O'Flynn

Ceist:

457. Deputy Ken O'Flynn asked the Minister for Health whether her Department has carried out any equality or impact assessment on disparities in access to oncology drugs between public and private patients; and if so, to publish those findings. [52828/25]

Amharc ar fhreagra

Freagraí scríofa

The State is committed to providing timely access to new and innovative medicines to all patients. Budgets 2021 to 2025 allocated an additional €158 million for new medicines, which has facilitated the introduction of 238 new medicines. 91 of these are for treating cancer as well as 55 for rare diseases.

In 2024, the HSE launched an application tracker to increase transparency in the medicines assessment process. In addition, the 34 staff allocated in Budget 2024, have been hired across the pricing and reimbursement process. These measures will enable the assessment of a greater number of medicines at a quicker pace and ensure patients can easily remain informed of progress.

The timing of company applications for new medicine reimbursement in different countries can vary for several reasons, not least the available market share in each country.

Once a company responsible for the commercialisation of a new medicine receives marketing authorisation from the European Medicines Agency (EMA), 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.

Reports describing timelines for reimbursement from EMA approval to HSE reimbursement approval do not consider this important factor and misrepresent the process, as statutorily the HSE are not able to add a new medicine to the reimbursement list until an application is received.

The Minister for Health regulates the community rated private health insurance market in Ireland. This is a voluntary market, which operates under principles including minimum benefits, requiring insurers to offer a minimum level of cover in every insurance policy. Health insurance companies may exclude or include certain services and providers in their policies, provided they remain in compliance with the Minimum Benefit Regulations. Beyond Minimum Benefits regulations, the Minister has no role to play in the commercial decisions of any health insurer.

Cancer Services

Ceisteanna (458)

Ken O'Flynn

Ceist:

458. Deputy Ken O'Flynn asked the Minister for Health to provide comparative data on the time from European Medicines Agency approval to reimbursement for new oncology medicines in Ireland versus other EU member states; and to indicate whether Ireland is above or below the EU average. [52829/25]

Amharc ar fhreagra

Freagraí scríofa

The HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines. This arises from the Health (Pricing and Supply of Medical Goods) Act 2013.

Reimbursement is for licensed indications which have been granted marketing authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA). Pharmaceutical companies must apply to the HSE for reimbursement.

Once a company responsible for the commercialisation of a new medicine receives marketing 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. This is an important factor affecting the timelines for reimbursement from EMA approval to HSE reimbursement approval, as statutorily, the HSE cannot add a new medicine to the reimbursement list until an application is received.

Reports describing timelines for reimbursement from EMA approval to HSE reimbursement approval do not consider this important factor and misrepresent the process, as statutorily the HSE is not able to add a new medicine to the reimbursement list until an application is received. Additionally, the initial commercial offering from manufacturers for medicines can have significant implications for the negotiation process, including its duration. In the context of a finite health budget, it is vital that the State ensures good value for money for public expenditure, and to ensure that the available budget maximises as much access as possible to medicines and other healthcare services for patients.

Ireland encourages all pharmaceutical companies to apply to the HSE to have their medicines added to the reimbursement list once granted marketing authorisation by the European Medicines Agency. Reimbursement timelines vary by country due to market size and company strategy.

An external review of the pricing and reimbursement process, the Mazars Review, was published in 2023. The Mazars Review determined that the pricing and reimbursement process operated in line with international norms and made a number of recommendations to improve the process, resulting in:

1) the implementation of an application tracker for the medicines assessment process which was launched by the HSE in 2024.

2) the hiring of 34 staff across the pricing and reimbursement system in 2024.

These measures will enable the assessment of a greater number of medicines at a quicker pace and provide transparency to all stakeholders including patients around the status of the pricing and reimbursement application of a new treatment.

Cancer Services

Ceisteanna (459)

Ken O'Flynn

Ceist:

459. Deputy Ken O'Flynn asked the Minister for Health if she will publish in full the rationale, minutes, and assessments underpinning reimbursement decisions on oncology drugs since 2020; and if not, the reason for the continued confidentiality. [52830/25]

Amharc ar fhreagra

Freagraí scríofa

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

Cancer Services

Ceisteanna (460)

Ken O'Flynn

Ceist:

460. Deputy Ken O'Flynn asked the Minister for Health whether a national registry of oncology patients treated with newer cancer therapies is maintained; and if so, to outline how this real-world data informs reimbursement and future access decisions. [52831/25]

Amharc ar fhreagra

Freagraí scríofa

There is no dedicated national registry for oncology patients receiving new cancer therapies.

The National Cancer Registry Ireland (NCRI) collects, classifies, and analyses data on cancer incidence and prevalence across the country. It tracks newly diagnosed cancer cases and related tumours, including some subsequent tumours if they meet registration criteria. However, its focus is primarily on initial diagnoses and does not comprehensively track relapses or long-term treatment outcomes, including newer therapies.

In terms of the reimbursement of medicines, the HSE has advised it is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available to it.

The HSE robustly assesses applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds. There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed.

The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the National Centre for Pharmacoeconomics (NCPE) for assessment. The NCPE may advise that a full Health Technology Assessment (HTA) is recommended, which would then be commissioned by the HSE as per the agreed processes.

The NCPE uses a decision framework to systematically assess whether a technology is cost-effective. This includes clinical effectiveness and health related quality-of-life benefits, which the new treatment may provide and whether the cost requested by the pharmaceutical company is justified.

Following the recommendation from the NCPE, the HSE examines all the evidence which may be relevant for the decision; the final decision on reimbursement is made by the HSE. In the case of cancer drugs, the NCPE recommendation is also considered by the National Cancer Control Programme (NCCP) Technology Review Group.

Roinn