Dáil Éireann Debate, Thursday - 25 September 2025
345. Deputy Claire Kerrane asked the Minister for Health to consider adding Ehlers–Danlos syndrome to the long-term illness card as the drugs payment scheme will not cover the drug Ozempic, which is reputed to improve the condition of sufferers. [50993/25]
Amharc ar fhreagraThe Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).
In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list. In making a relevant 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.
In terms of the specific details of the pricing and reimbursement of semaglutide (Ozempic®):
Reimbursement approval is in place for semaglutide (Ozempic®) for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications and in addition to other medicinal products for the treatment of diabetes under the General Medical Services and Long Term Illness Scheme from 1st September 2018.
Pharmaceutical companies are required to submit formal applications to the HSE if they wish their medicines to be added to the list of reimbursable items covered under community drugs schemes and arrangements / funded via hospitals. In order to submit a formal application, the medicine must hold a marketing authorisation.
The European Medicines Agency (EMA) is a centralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. The EMA plays an integral role in the authorisation of medicines in the EU via the centralised procedure. The Health Products Regulatory Authority (HPRA) is the competent authority responsible for the regulation of human medicines in Ireland.
To date neither the EMA nor the HPRA have granted marketing authorisation for semaglutide (Ozempic®) for the indication of treating symptoms of Ehler-Danlos syndrome.
As outlined above, the national assessment and decision process cannot commence in the absence of a marketing authorisation in this indication.
The Long-Term Illness (LTI) Scheme was established under Section 59(3) of the Health Act 1970 (as amended). Regulations were made in 1971, 1973 and 1975, prescribing 16 conditions to be covered by the Scheme. These are: acute leukaemia; mental handicap; cerebral palsy; mental illness (in a person under 16); cystic fibrosis; multiple sclerosis; diabetes insipidus; muscular dystrophies; diabetes mellitus; parkinsonism; epilepsy; phenylketonuria; haemophilia; spina bifida; hydrocephalus; and conditions arising from the use of Thalidomide.
Under the LTI Scheme, patients receive drugs, medicines, and medical and surgical appliances directly related to the treatment of their illness, free of charge. While there are currently no plans to extend the list of conditions, it is important to remember that the LTI Scheme exists within a wider eligibility framework.
People who cannot, without undue hardship, arrange for the provision of medical services for themselves and their dependants may be eligible for a medical card under the General Medical Services (GMS) Scheme. In accordance with the provisions of the Health Act 1970 (as amended), eligibility for a medical card is determined by the HSE.
In certain circumstances the HSE may exercise discretion and grant a medical card, even though an applicant exceeds the income guidelines, where he or she faces difficult financial circumstances, such as extra costs arising from illness. The HSE afford applicants the opportunity to furnish supporting documentation to determine whether undue hardship exists and to fully take account of all relevant circumstances that may benefit them in assessment. In circumstances where an applicant is still over the income limit for a medical card, they are then assessed for a GP visit card, which entitles the applicant to GP visits without charge.
The issue of granting medical card eligibility based on having a particular disability or illness was previously examined in 2014 by the HSE Expert Panel on Medical Need and Medical Card Eligibility. The Group concluded that it was not feasible, desirable, nor ethically justifiable to list medical conditions in priority order for medical card eligibility. In following the Expert Group’s advice, a person’s means remains the main qualifier for a medical card.
Under the Drugs Payment Scheme (DPS), no individual or family pays more than €80 a month towards the cost of approved prescribed medicines. The DPS is not means tested and is available to anyone ordinarily resident in Ireland. The DPS significantly reduces the cost burden for families and individuals with ongoing expenditure on medicines.
There has been a significant focus on improving access to and the affordability of healthcare services over the last few years. This includes reductions in the DPS threshold, expansion of access to free GP care, and the abolition of all public in-patient hospital charges for children and adults. These measures continue to create a health and social care service that offers affordable access to quality healthcare.
Individuals may also be entitled to claim tax relief on the cost of their medical expenses, including medicines prescribed by a doctor, dentist, or consultant. Relief is at the standard tax rate of 20%.
