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. 72 of these new medicines were for rare diseases. 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.
There are a suite of measures in place 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 including the Framework Agreements on the Supply and Pricing of Medicines with Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA). These 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
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has sole statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes. HSE decisions on which medicines, including GLP-1 medicines, are reimbursed by the taxpayer are made on objective, scientific and economic grounds, outlined in the Health (Pricing and Supply of Medical Goods) Act 2013.
Reimbursement is for licenced indications which have been granted market authorisation either by the European Medicines Agency (EMA) or by the Health Products Regulatory Authority (HPRA).
Controls are in place within the HSE on claiming processes to ensure that only HSE approved indications are reimbursed across a range of medicines. Controls are currently in place for the Glucagon-like peptide-1 (GLP-1) receptor agonists to restrict reimbursement support to the HSE approved indication of Diabetes. This includes Ozempic® (semaglutide) and Trulicity® (Dulaglutide). Therefore, these products are not reimbursed under the Drugs Payment Scheme (DPS) and are confined to those persons with full General Medical Services (GMS/Medical Card) and Long-Term Illness (Diabetes Mellitus) eligibility.
Ozempic® does not have a licence in the EU for weight loss.
Liraglutide (Saxenda®) 6 mg/ml solution for injection in pre-filled pen is the only product currently approved under Community Drug Schemes (GMS/Drugs Payment Scheme (DPS)) for weight management with a managed access system in place.
In line with the HSE reimbursement approval above, the HSE Medicines Management Programme (MMP) developed a Managed Access Protocol (MAP) for liraglutide (Saxenda®). This MAP outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of liraglutide (Saxenda®); further information is available on the MMP website https://healthservice.hse.ie/staff/information-healthcare-workers/medicines-management-programme-mmp/managed-access-protocols/ .
Mounjaro® (tirzepatide) and Wegovy® (semaglutide) are not reimbursable under Community Drug Schemes as they are currently undergoing formal pricing and reimbursement assessments by the HSE.
The Health Products Regulatory Authority (HPRA) is the agency with responsibility for the regulation of medicines in Ireland and have an enforcement role with regard to illegal medicines.
The HPRA plays an active role in protecting public health by raising awareness of the risks associated with buying prescription medicines online and has repeatedly warned of the health risks associated with the use of GLP-1 medicines that have been obtained outside of the legitimate pharmacy setting and without a prescription supplied by a doctor providing professional oversight.
In relation to accessing medicines other than through the prescribed statutory routes, the HPRA advise that medicines purchased online may not contain the correct ingredients, may be unsafe, and are not subject to the safeguards that apply when medicines are supplied through recognised and regulated sources such as pharmacies.
In Ireland, it is against the law to supply prescription medicines by mail order (including through the internet). Manufacturing fake or counterfeit medicines – known as falsified medicines – is also a criminal offence.
