Tuesday, 26 May 2026

Disease Management

Questions (1208, 1209, 1210, 1214, 1220)

Ken O'Flynn

Question:

1208. Deputy Ken O'Flynn asked the Minister for Health if the HSE maintains a dedicated referral pathway for patients presenting with suspected neurological lyme disease, lyme arthritis or lyme carditis [39052/26]

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Ken O'Flynn

Question:

1209. Deputy Ken O'Flynn asked the Minister for Health the laboratories recognised by the HSE for lyme disease testing; the testing methodologies currently utilised; and if a review of international testing standards has been undertaken since 2020. [39053/26]

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Ken O'Flynn

Question:

1210. Deputy Ken O'Flynn asked the Minister for Health if the Department or HSE has examined international approaches to lyme disease diagnosis, testing and long-term patient management; if so, which jurisdictions were examined; and if she will make a statement on the matter. [39054/26]

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Ken O'Flynn

Question:

1214. Deputy Ken O'Flynn asked the Minister for Health if her Department has assessed regional or seasonal trends in lyme disease incidence within the State; and if she will provide details of same. [39058/26]

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Ken O'Flynn

Question:

1220. Deputy Ken O'Flynn asked the Minister for Health if lyme disease is included within national communicable disease surveillance and reporting frameworks operated by the HSE and Health Protection Surveillance Centre; and if she will make a statement on the matter. [39064/26]

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Written answers

Minister for Health

I propose to take Questions Nos. 1208, 1209, 1210, 1214 and 1220 together.

Lyme disease, also known as Lyme borreliosis, is an infection transmitted to humans through the bite of infected ticks, and it can occasionally lead to serious illness. Ticks are present throughout Ireland, including both urban and rural areas. Although ticks can be active year-round, the period of highest tick activity and therefore Lyme disease is between April and October.

The HSE’s National Health Protection Office, through the Health Protection Surveillance Centre (HPSC) provides information on the surveillance of Lyme disease. The HPSC offers a wide range of resources to help people reduce their risk of tick bites, including seasonal updates for both the public and healthcare professionals.

In 2011, Ireland became one of the first EU countries to make Lyme disease a statutorily notifiable disease. The notifiable entity is Lyme neuroborreliosis, which affects the nervous system. Between 4 and 21 cases of Lyme neuroborreliosis are notified annually in Ireland. This is considerably less than the total number of cases of early Lyme infection, which is primarily a skin infection. However, the levels of Lyme neuroborreliosis are considered to serve as an indicator of overall Lyme disease activity in the country.

Each year in early May, the HSE marks Tick Awareness Day, by providing practical advice on the prevention of tick bites, which can transmit Lyme disease. This is done through website news articles, social media posts, press releases and media interviews. This initiative encourages individuals to take preventive measures during periods when tick activity is highest. Information is provided on common tick habitats, high-risk behaviours, prevention strategies, and how to safely remove and identify ticks.

To further spread public awareness, the HSE provides downloadable posters and leaflets that are intended to be distributed in community centres, schools, and recreational and other common public and private spaces, especially those with an increased risk of tick exposure. These materials are designed to inform individuals about the risks of tick bites and the importance of preventive actions.

A full suite of Lyme Disease resources, including posters and information leaflets, is available through the HPSC website. These posters are suitable for display on publicly accessible land, and the HPSC has actively promoted their availability to Government Departments and public agencies that manage such areas. Local authorities, healthcare professionals, and members of the public are encouraged to download and share these materials.

In addition to public awareness and prevention efforts, clinical pathways for diagnosis and treatment are well established. There is a National Clinical Programme in Infectious Diseases reporting to the office of the Chief Clinical Officer. There has been a significant expansion in the number of Infectious Diseases consultants appointed throughout the country. These Consultants see patients with Infectious Diseases, including patients with Lyme Disease.

GPs are familiar with the most typical presentation, often a rash with a bull’s eye appearance. Most cases can be treated with a brief course of antibiotics, while more complicated cases are referred to infectious disease clinics. Patients with post-Lyme syndrome can be referred by their GP to a public hospital infectious disease clinic in Ireland.

Diagnosis and treatment in clinics operating in the public hospital system is in line with national and international best practice guidelines, as outlined in Infectious Diseases Society of America guidelines that have been endorsed by the Infectious Diseases Society of Ireland.

Lyme testing in Ireland is available to all clinical sites, either onsite or via the National Virus Reference Laboratory (NVRL). Confirmatory testing (western blot - an analytical technique in molecular biology and immunogenetics to detect specific proteins in a sample of tissue) is referred to the UK Lyme Reference Service.

There are a number of laboratories outside of Ireland using tests based on other methods that report positive results in a very high number of people who do not have antibodies. As with all diagnostic tests, it is essential to ensure that testing for Lyme disease should only be performed by an accredited laboratory that use validated tests and participate in a formal external quality assurance programme. Non-validated tests pose a clinical risk of misdiagnosis, exposing patients to inappropriate treatment as well as a delay in correctly diagnosing their symptoms.

Question No. 1209 answered with Question No. 1208.

Question No. 1210 answered with Question No. 1208.

Question No. 1211 answered with Question No. 1204.

Disease Management

Questions (1212)

Ken O'Flynn

Question:

1212. Deputy Ken O'Flynn asked the Minister for Health the estimated annual expenditure incurred by the HSE in relation to lyme disease diagnosis, treatment and management from 2020 to 2026, in tabular form. [39056/26]

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Written answers

Minister for Health

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

Disease Management

Questions (1213)

Ken O'Flynn

Question:

1213. Deputy Ken O'Flynn asked the Minister for Health if a national public awareness campaign relating to tick-borne illnesses and lyme disease has been undertaken since 2020; the associated annual expenditure; and if she will make a statement on the matter. [39057/26]

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Written answers

Minister for Health

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

Question No. 1214 answered with Question No. 1208.

Disease Management

Questions (1215)

Ken O'Flynn

Question:

1215. Deputy Ken O'Flynn asked the Minister for Health if her Department or HSE has engaged with patient advocacy organisations representing persons living with lyme disease since 2020; the groups involved; the dates of engagement; and the outcomes arising from such engagement. [39059/26]

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Written answers

Minister for Health

Since 2020, the Department of Health and the HSE have engaged on an ongoing basis with a range of stakeholders in relation to infectious diseases policy, including through public health awareness initiatives, clinical guidance development and wider policy work.

In relation to meetings with Lyme disease patient advocacy organisations since 2020 specifically, on 22 April 2026, I met with members of both Houses of the Oireachtas and patient representatives, including a representative of Tick Talk Ireland.

Officials in my Department have since engaged with the HSE regarding the matters discussed at that meeting. This engagement informed additional public health awareness measures to coincide with Tick Awareness Day 2026.

As matters relating to service delivery and operational engagement with patient groups are the responsibility of the HSE, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Question No. 1216 answered with Question No. 1204.

Question No. 1217 answered with Question No. 1204.

Question No. 1218 answered with Question No. 1204.

Disease Management

Questions (1219)

Ken O'Flynn

Question:

1219. Deputy Ken O'Flynn asked the Minister for Health if her Department funds or supports any Irish research projects relating to lyme disease, tick-borne illnesses, or long-term post-infectious complications; the funding allocated annually since 2020; and if she will make a statement on the matter. [39063/26]

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Written answers

Minister for Health

As an aegis body of the Department and the lead funding agency for health and social care research in Ireland, the Health Research Board (HRB) operates through a combination of project and programme grants, capacity building initiatives, collaborative research networks and infrastructure investment.

The HRB awards funding following international peer review and open competitive calls. Only those grant applications deemed excellent are considered for funding.

No research applications in the area of Lyme disease, tick-borne illnesses and related long term post-infectious complications have been submitted to the HRB between 2023 and 2026 and no research application in these areas were successfully funded in the last 10 years.

Question No. 1220 answered with Question No. 1208.

Question No. 1221 answered with Question No. 1204.

Disease Management

Questions (1222)

Ken O'Flynn

Question:

1222. Deputy Ken O'Flynn asked the Minister for Health if her Department has assessed the economic and workforce impact associated with long-term lyme disease illness, including inability to work and disability-related impacts; and if she will make a statement on the matter. [39066/26]

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Written answers

Minister for Health

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 (1223)

Ken O'Flynn

Question:

1223. Deputy Ken O'Flynn asked the Minister for Health if the HSE has assessed the clinical impact of reimbursement delays for patients with progressive neurological conditions where irreversible deterioration may occur during the assessment process. [39068/26]

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Written answers

Minister for Health

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.

Health Services

Questions (1224)

Ken O'Flynn

Question:

1224. Deputy Ken O'Flynn asked the Minister for Health if the HSE maintains any target timeframe for completion of reimbursement assessments relating to treatments for progressive neurodegenerative diseases. [39069/26]

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Written answers

Minister for Health

The Government is committed to investing in new medicines.

Budgets 2021-2025 allocated an additional €158 million for new drugs, which has facilitated the introduction of 263 new medicines, to date. Budget 2026 allocated €30 million of funding available for new drugs to be allocated from the overall additional €217 million in funding allocated for medicines.

The Year 1 cost of a new drug comes from the allocation for new medicines, but it should be noted that once these medicines are approved for reimbursement the full cost of providing them can reach multiples of this initial cost as their uptake increases.

Ireland is among the highest spenders on health across the EU (OECD), with the third-highest rate of State coverage of pharmaceutical expenditure in Europe.

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. The Minister has no role in decisions on pricing and reimbursement.

There is no hierarchy of disease and pricing and reimbursement applications are considered in order of application.

To commence the pricing and reimbursement process, a pharmaceutical company must submit an application for a new medicine or a new use of an existing medicine to the HSE’s Corporate Pharmaceutical Unit. European Medicines Agency (EMA) or Health Products Regulatory Authority (HPRA) authorisation is required for the medicine prior to submission to the HSE for reimbursement as reimbursement only applies to licensed uses (indications) of the medicine.

Applicants must continue to engage through-out the process to ensure that the necessary evidence is available for the HSE to carry out its statutory role as a decision-maker with respect to the reimbursement of new medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

As well as the health needs of the public, legislation requires the HSE to consider a medicine’s cost-effectiveness and budget impact when deciding if it will reimburse it. Objective, scientific methods are used to assess these factors alongside input from patients.

The HSE’s Drugs Group—its national expert committee, including public interest members—will consider all evidence and issue a recommendation to the HSE Senior Leadership Team, which holds final decision-making authority on the reimbursement of a medicine.

There is a suite of measures, that have been implemented and are to be implemented to shorten the timeframe from the issue of a Marketing Authorisation on foot of a positive opinion by the European Medicines Agency to a decision on whether to reimburse the medicine by the HSE's Senior Leadership Team.

Included among these measures are new Framework Agreements on the Supply and Pricing of Medicines with Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA) which provide commitments towards achieving a 180-day timeline for completing health technology assessments (HTA) and reimbursement decisions following application by the Marketing Authorisation Holder. The Agreements outline a structured process towards achieving the 180-day timeline for reimbursement decisions by Q1 2029, accelerating patient access to new treatments

Question No. 1225 answered with Question No. 1140.

Medicinal Products

Questions (1226)

Ken O'Flynn

Question:

1226. Deputy Ken O'Flynn asked the Minister for Health the average duration of the pricing and reimbursement process for orphan medicines since 2020, from initial application to final decision. [39071/26]

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Written answers

Minister for Health

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.

Medicinal Products

Questions (1227)

Ken O'Flynn

Question:

1227. Deputy Ken O'Flynn asked the Minister for Health if a review has been undertaken into the patient impact of delays in reimbursement decisions for orphan or rare disease medicines. [39072/26]

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Written answers

Minister for Health

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.