3199. Deputy Denise Mitchell asked the Minister for Health if she is aware of reports (details supplied); the policy governing such circumstances; whether patients should incur additional costs arising solely from medicine shortages outside of their control; whether her Department and the HSE will review these arrangements to ensure that equivalent medicines supplied are covered under the drugs payment scheme; and if she will make a statement on the matter. [60398/26]

My Department is aware of the stress that shortages of medicines can cause for patients and healthcare professionals alike, therefore mitigating medicine shortages and strengthening security of supply is the subject of several workstreams in my Department, the wider health service and across Europe.

Unfortunately, medicine shortages are a feature of modern health systems worldwide. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; or product recalls due to potential quality issues.

To address these challenges in Ireland, a Medicines Shortages Framework, operated by the Health Products Regulatory Authority (HPRA) on behalf of the Department of Health has been established. This aims to help prevent potential shortages from occurring and to reduce the impact of shortages on patients by co-ordinating the management of potential or actual shortages across the health service as they arise. The HPRA maintains a list of current and resolved shortages on its website. The webpage is updated daily as the HPRA receives new information.

In European law, pharmaceutical companies and wholesalers should ensure an appropriate and continuous supply of the medicines they market. Companies are required to notify the HPRA of medicines shortages or potential shortages impacting the Irish market.

The HSE has advised that 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.