The Department has not conducted a formal risk assessment specific to the requirement for dispensing pharmacies to contact the Primary Care Reimbursement Service (PCRS) on a case-by-case basis to secure reimbursement approval for clinically equivalent substitute medicines during periods of formally declared shortages.
The reimbursement and substitution processes operate within the statutory framework established by the Health (Pricing and Supply of Medical Goods) Act 2013. This Act provides for the establishment and maintenance of the List of Interchangeable Medicinal Products and sets out the duties of pharmacists in relation to substitution, including provisions on clinical exemptions and reimbursement arrangements.
The Department keeps the overall medicines-shortage and reimbursement processes under ongoing review and continues to engage with stakeholders—including the HSE, HPRA, community pharmacy contractors, and industry representatives—to ensure that the regulatory and reimbursement framework remains proportionate, clinically appropriate, and responsive to patient needs.
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.
Ireland has a multi-stakeholder Medicines Shortages Framework in place operated by the Health Products Regulatory Authority (HPRA) on behalf of the Department of Health. This framework aims to help prevent potential shortages from occurring and to reduce the impact of shortages. Stakeholders include the HPRA, the Department, the HSE, healthcare professionals, manufacturers, wholesalers, patient representative groups and marketing authorisation holders.
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. No dedicated patient-safety analysis has been undertaken regarding any potential delays in access to time-sensitive medicines—including respiratory medicines—that may arise from the discretionary approval process. However, the Department and the HSE monitor system performance through existing governance structures, and the HPRA framework is specifically designed to reduce the impact of shortages on patients.
The Department keeps the overall medicines-shortage and reimbursement processes under ongoing review and continues to engage with stakeholders—including the HSE, HPRA, community pharmacy contractors, and industry representatives—to ensure that the regulatory and reimbursement framework remains proportionate, clinically appropriate, and responsive to patient needs.
