Holly Cairns (Cork South West, Social Democrats)
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594. To ask the Minister for Health if he will meet with an organisation (details supplied) to address the ongoing risk of medicine shortages. [3127/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Department of Health has recently received a request for a meeting with this organisation which is now under consideration.

Medicine shortages are increasingly prevalent worldwide over the past decade. The causes of such shortages are multi-factorial, including shortages of raw materials, manufacturing difficulties, increased demand, product recalls due to potential quality defects, and industry consolidations. Medicine shortages can originate at any point in the supply chain. They can involve and impact many stakeholders in different ways, as the supply models and clinical use of therapies can vary across national health systems.

Medicine shortages and their prevention are not unique to Ireland. Similar increases in demand and medicines shortages have been observed in the UK, throughout the EU and across the world at present. In the case of medicines used most often in Ireland, there are typically multiple alternatives available from various sources that remain available to ensure continuity of treatment. Of the products currently in short supply, alternative treatments are available for every single product.

Management of medicines shortages necessitates a multi-faceted, multi-stakeholder response to ensure patient safety, continuity of care and protection of public health. To that end, at the request of the Department of Health, the Health Products Regulatory Authority (HPRA) has assumed a coordinating function in Ireland’s response to managing medicine shortages when they occur. The HPRA is generally informed of a medicine shortage by the relevant pharmaceutical company. Shortages can also be notified to the HPRA by other stakeholders across the health system. In each case, the HPRA will work with relevant stakeholders as necessary, including the HSE, to coordinate an effective approach to the management of a confirmed product shortage. The HPRA engages with stakeholders to coordinate actions and share information to prevent or mitigate the impact of medicine shortages when they occur.

The HPRA publishes a list of medicines currently in short supply on its website with the reason for the shortage and expected dates for the return of supply. The information is available to assist healthcare professionals in managing medicine shortages when they arise and reduce their impact on patients. The information relating to shortages on the HPRA website is dynamic and changes depending on the current information the HPRA has to hand, including removal from the list when a shortage has been resolved.

The HPRA continues to work with all marketing authorisation holders to increase supply to the market. They also continue to offer regulatory flexibility where possible to suppliers. Through this close engagement the HPRA has secured additional stock of many products currently in short supply for the Irish market.

Patients or their carers who have any concerns in relation to temporary alternative products provided because of medicine shortages are advised to speak with their pharmacist or other healthcare professional involved in their care.