Written answers

Tuesday, 18 February 2025

Department of Health

Medicinal Products

Photo of John LahartJohn Lahart (Dublin South West, Fianna Fail)
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788. To ask the Minister for Health if she will streamline HSE reimbursement processes and reduce administrative burdens to provide for a nationwide programme for safe and appropriate medicine disposal. [5998/25]

Photo of Kieran O'DonnellKieran O'Donnell (Limerick City, Fine Gael)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Photo of John LahartJohn Lahart (Dublin South West, Fianna Fail)
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789. To ask the Minister for Health if she will adopt a more proactive approach to managing medicine shortages. [5999/25]

Photo of Kieran O'DonnellKieran O'Donnell (Limerick City, Fine Gael)
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Dear Deputy,

Thank you for your question on the important issue of medicine shortages.

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

However, 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 supply chain issues, perennial shortages of raw materials, increases in demand and manufacturing delays.

To give an overview of national initiatives for the management of shortages:

  • 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.
  • The Medicines Criticality Assessment Group (MCAG) is convened by the Department of Health and chaired by the Health Service Executive (HSE) to facilitate rapid assembly of relevant government and agency bodies to assess, address and resolve emerging medicinal product supply issues. Consequent to its deliberations, and where the MCAG deems it necessary, the MCAG membership issue communication(s), to healthcare professionals and patients, among other actions.
  • Officials in my Department are also progressing secondary legislation to underpin shortages management initiatives introduced via the Health (Miscellaneous Provisions) Act 2024, including Medicine Substitution Protocols and reporting requirements for actors in the medicine supply chain.
  • The HPRA maintains a list of current and resolved shortages on its . The webpage is updated daily as the HPRA receives new information.
My Officials are also engaged with a variety of work at a European level, including via membership of the Critical Medicines Alliance. The work of this Critical Medicines Alliance will inform the content of a European Critical Medicines Act, which aims to address shortages of medicines seen across Europe.

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