Cian O'Callaghan (Dublin Bay North, Social Democrats)
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321. To ask the Minister for Health if she will address the medicine shortages that are forcing pharmacists to source expensive unlicensed medicines for patients with medical cards (details supplied); and if she will make a statement on the matter. [16461/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Thank you for your question on the important issue of medicine shortages.

The Department is aware of the stress that shortages of medicines can cause for patients and healthcare professionals alike, thusly managing and mitigating medicine shortages is the subject of several workstreams across the Department and wider health service.

Ireland has a multi-stakeholder Medicines Shortages Framework in place, operated by our medicines regulator, the Health Products Regulatory Authority (HPRA) on behalf of the Department of Health. The framework aims to help prevent potential shortages from occurring and to reduce the impact of shortages on patients by coordinating the management of potential or actual shortages as they arise. Stakeholders in this framework include the HPRA, the Department, the HSE, healthcare professionals, manufacturers, wholesalers, patient representative groups and marketing authorisation holders.

There is a mechanism in Ireland that allows for the supply of unlicensed or unauthorised medicines: the Exempt Medicinal Product (EMP) route. EMPs can be supplied in response to a bona fide unsolicited 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.

As EMPs have not been granted a marketing authorisation in Ireland by the HPRA, they would not be assessed by the HPRA for quality, safety or efficacy. If sourced in response to a bona fide unsolicited order as a licensed product from another market, these medicines will have undergone an evaluation of their safety, quality, and efficacy for the granting of their marketing authorisation in that country, carried out by the respective competent authority for medicines in that state.

The legislation underpinning EMPs is set out in Schedule 1 of the Medicinal Products (Control of Placing on the Market) Regulations, 2007, as amended, and also in the Medicinal Products (Control of Wholesale Distribution) Regulations, 2007, as amended. If a valid prescription is issued for an EMP in line with the above Regulations, an appropriately authorised wholesaler can source that product from another market for supply to the patient via their pharmacy in line with that prescription. Paragraph 2 of Schedule 1 of the Control of Placing on the Market regulations refers to a personal responsibility undertaken by the prescriber when prescribing an EMP.

The supply of EMPs in Ireland must be notified to the HPRA. The availability of this information is used for the purpose of allowing the HPRA to react very quickly to reports of quality defects received about medicines from other competent authorities and to identify whether the batch of concern has come to Ireland as an EMP. The HPRA then ensures that the necessary risk-mitigating actions, such as product recall actions, are undertaken in Ireland promptly to protect patients from the risks presented by such quality defects.

An exempt product may not be prescribed or supplied in situations where an authorised equivalent (i.e. same active substance(s), strength and dosage form) is available in Ireland.

Where this query relates to reimbursement of exempt medicinal products, the query has been referred to the HSE’s Primary Care Reimbursement Service (PCRS) for direct reply to the Deputy.