Michael Cahill (Kerry, Fianna Fail)
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194. To ask the Minister for Health the strategies in place to ensure the continuous supply of prescription drugs to pharmacies throughout the country (details supplied); and if she will make a statement on the matter. [24664/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Medicine shortages are, unfortunately, a feature of modern health systems worldwide and a global health problem. Issues surrounding security of medicines supply have been increasingly well characterised, both nationally and internationally, in recent years. The causes of such supply issues are multifaceted, ranging from pandemics, geopolitical events, perennial shortages of raw materials, manufacturing issues, quality issues, unexpected increased demand, commercial reasons, and distribution issues, such as those caused by geopolitical uncertainties. Currently, numerous shortage notifications lack specificity regarding the root cause.

In European legislation, marketing authorisation holders (the companies responsible for placing medicines on the market) are mandated to

1. provide continuous supply to a market that they serve and
2. to notify national competent authorities where they expect there to be an interruption in supply

1. Medicines Shortages Framework, operated by the Health Products Regulatory Authority (HPRA) on behalf of the Department of Health, which 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.
2. Medicines Criticality Assessment Group, convened by the Department of Health and chaired by the Health Service Executive
3. Clinical guidance, where appropriate, issued by the HSE
4. Legislative initiatives in development, via the Health (Miscellaneous Provisions) Act 2024, including Medicine Substitution Protocols, and reporting requirements for actors in the medicines supply chain