Dáil Éireann Debate, Tuesday - 28 April 2026
1276. Deputy Pádraig O'Sullivan asked the Minister for Health whether her Department has identified which of the medicines currently in shortage across the European Union may pose a risk of shortage in Ireland; the measures in place to ensure continuity of supply and minimise patient impact; and if she will make a statement on the matter. [30904/26]
View answerMy Department is aware of the stress that shortages of medicines can cause for patients and healthcare professionals alike, and mitigating medicine shortages and strengthening security of supply is the subject of several workstreams in my Department, the wider health service and across Europe.
Medicines shortages that initially occur in other markets can also impact on supply in Ireland due to increased demand for limited available stock or related manufacturing capacity e.g. treatments for ADHD, with ongoing risk of shortages due to global increases in demand and reported manufacturing capacity limitations. The European Medicines Agency (EMA) publishes information on critical shortages monitored at EU level by the Medicine Shortages Single Point of Contact (SPOC) Working Party. As of 27th April 2026 there are 30 entries published in an online shortages catalogue, which contains information on ongoing supply shortages that have been assessed by EMA. This catalogue includes information on product discontinuations, where the marketing authorisation holder (MAH) intends to cease placing its medicines on relevant European markets on a permanent basis. Importantly any potential shortage, or current shortages ongoing nationally that are also published in this EMA catalogue can be managed under the national Medicine Shortages Framework, with support from the EMA in specific instances e.g. coordinated shortage communications that are issued to healthcare providers directly. National competent authorities including the Health Products Regulatory Authority (HPRA) will handle all notified shortages of human medicines, particularly if they do not affect other countries. The current number of shortages published by the HPRA and the EMA therefore reflect the differences in function between the HPRA and the EMA in the coordination and management of shortages.
Several initiatives have been taken over recent years at a European level to improve security of supply and address supply chain vulnerabilities that are common to multiple markets. These include an expansion of the mandate of the EMA to optimise the management and prevention of shortages at European level. In the proposed revision of the EU Pharmaceutical legislation, the European Commission has proposed further strengthening measures and specific initiatives, such as the introduction of the Union list of critical medicines and the requirement for medicine suppliers to have in place shortage prevention plans (‘SPP’). Such measures are anticipated to further improve supply chain resilience and promote continuity of supply. The HPRA is committed to continuing its active involvement at European level, including through their representative on the Medicine Shortages SPOC Working Party and the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), to maximise the effectiveness of this work.
In European law, pharmaceutical companies and wholesalers should ensure an appropriate and continuous supply of the medicines they market. Companies should notify the HPRA of medicines shortages or potential shortages impacting the Irish market. Addressing medicine shortages is complex and requires input from multiple stakeholders. A national Medicine Shortages Framework (MSF) has been in place since 2018 when the Department requested that the HPRA assume responsibility for its coordination. Since its inception, the framework has been of enormous benefit nationally. It has served to avoid the occurrence of potential medicine shortages and, where they have occurred, ensured appropriate mitigation is in place. As part of this framework the HPRA maintains a list of current shortages on its website and is in regular contact with suppliers in relation to these shortages, with a view to minimising their duration and impact on patients. The webpage of the HPRA is updated daily as the HPRA receives new information related to ongoing and newly notified shortages. Shortages when published remain active until supply returns to an acceptable level to meet demand, irrespective of whether there is a suitable alternative supply available that is meeting that demand.
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 shall issue communication(s), to healthcare professionals and patients, among other actions. The Terms of Reference for MCAG is available on gov.ie.
It is acknowledged that medicine shortages, when they occur, can be a challenge for patients and healthcare professionals. In the event that patients are unable to source a medicine, they are advised to discuss possible alternatives with their doctor pending the resumption of normal supply.
