Fergus O'Dowd (Louth, Fine Gael)
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998. To ask the Minister for Health if the concerns detailed in correspondence by a union (details supplied) on medicine shortages will be addressed; and if he will make a statement on the matter. [21123/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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Medicine shortages have become increasingly prevalent worldwide over the past decade and are a feature of modern health systems around the world. There are many reasons for such shortages including shortages of raw materials, manufacturing difficulties, logistical/transport issues or product recalls due to potential quality defects.

The Health Products Regulatory Authority (HPRA) lead in the coordination of efforts by national agencies to manage medicine shortages. The Authority has developed a now well-established, multi-stakeholder Medicine Shortages Framework and coordinates all stakeholders to share information in order to prevent or mitigate the impact of medicine shortages when they occur.

Over the last two years, the HPRA received, on average, 66 notifications per month of potential or actual medicines shortages. In many of these cases, an impact on patients was avoided or if the shortage could not be avoided its impact or duration was reduced. This Framework was successful in ultimately preventing potential shortages in 20% of cases. Of the remaining shortages notified to the HPRA, 78% of the shortages were resolved, with 60% of those resolved earlier than initially anticipated or as expected due to the coordinated strategies of the stakeholders.

The HPRA also hosts a list of medicines currently in short supply on its website () with expected dates for return of supply. The information is made available to assist healthcare professionals in managing medicine shortages when they do arise and lessening the impact that they have on their patients.

In the case of medicines used most often in Ireland, there are typically multiple forms, brands, and generic medicines available from a range of sources. In the event that there are some supply issues for individual medicines, it is expected that alternative options such as alternative brands and generic medicines will be available to ensure continuity of treatment.

As a result of the increasing prevalence of medicines shortages globally, there has been significant interest at European level in this area, including a task force on medicines availability to identify and address issues linked to the disruption of supplies of medicines. Ireland, through the Department of Health and the HPRA, continues to contribute to these efforts at a European level to consider initiatives to minimise the risk and disruption to patient safety and care, and the impact on healthcare professionals, caused by medicine shortages.

In addition, the European Commission is currently developing a new Pharmaceutical Strategy, and the recently published roadmap for this strategy places a significant emphasis on actions to address medicines shortages and ensure access to medicines across the EU.

Any patient who is affected by a shortage of a medicine is encouraged to speak with their pharmacist or doctor.