Dáil Éireann Debate, Thursday - 19 February 2026
605. Deputy Ken O'Flynn asked the Minister for Health to set out the statutory, regulatory, or administrative basis under which Exempt Medicinal Products are supported under Discretionary Hardship Arrangements during medicine shortages; whether these arrangements are governed by published criteria; and whether her Department intends to place such arrangements on a formalised national footing. [13654/26]
View answerUnder 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.
In situations where no suitable authorised medicine is available, there is legislative provision for the supply of what are known as ‘exempt medicinal products’ (EMPs). EMPs are medicines that are not nationally authorised by the HPRA or centrally authorised by the European Commission, however, they can be supplied by pharmacists in certain circumstances.
Specifically, EMPs can be supplied in response to a bona fideunsolicited order, formulated in accordance with the specifications of a practitioner for use by their individual patients on their direct personal responsibility to fulfil the special needs of those patients. If there is no suitable authorised medicine available in Ireland and a valid prescription is issued for an EMP in line with legislative requirements, an appropriately authorised wholesaler can source that product from another market for supply to the patient via their pharmacy in line with that prescription.
The legal basis for the supply of EMPs is set out in:
• Schedule 1 of the Medicinal Products (Control of Placing on the Market) Regulations 2007, as amended, and
• Medicinal Products (Control of Wholesale Distribution) Regulations 2007, as amended.
EMPs are also considered under Discretionary Hardship Arrangements (DHAs) on an exceptional, case-by-case basis where no suitable licensed alternative is available. This is in accordance with Section 23 of the 2013 Act, which provides for the supply of items not on the reimbursement List. All applications under these arrangements are reviewed on an individual patient basis. The HSE must be satisfied that the patient requires the item for clinical reasons, and that there is no item on the reimbursement list which is a suitable alternative for that patient.
These arrangements are also governed by published HSE guidance, notably HSE Pharmacy Circular 012/23, which confirms that EMP reimbursement is based on unmet clinical need and should only occur where no appropriate licensed option exists.
Medicines not on the formal Reimbursement List are considered on an individual patient basis. Community pharmacy contractors can contact PCRS Pharmacy Function Unit regarding reimbursement support. Individual applications can also be submitted by the dispensing pharmacy to: PCRS.IndividualRequest@hse.ie
Community pharmacy contractors can also submit queries relating to reimbursement of Exempt Medicinal Products (EMPs) to: PCRS.ExemptMed@hse.ie
