Dáil Éireann Debate, Wednesday - 15 July 2026
368. Deputy Pádraig O'Sullivan asked the Minister for Health the steps being taken to address the shortage of bumetanide, which has been in short supply since early May 2026 with an expected return date of the end of the year; the interim arrangements in place to protect patients with heart failure who depend on this medicine; and if she will make a statement on the matter. [53753/26]
Amharc ar fhreagraMy 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.
In European law, pharmaceutical companies and wholesalers should ensure an appropriate and continuous supply of the medicines they market. Companies are required to notify the HPRA of medicines shortages or potential shortages impacting the Irish market. The HPRA maintains a list of current and resolved 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 is updated daily as the HPRA receives new information.
Karo Pharma AB the company responsible for supplying Burinex 1 mg Tablets, has notified the HPRA of a shortage of Burinex 1 mg Tablets due to a manufacturing delay impacting multiple countries.
Karo Pharma AB has informed the HPRA that this shortage will be resolved by the 1st October 2026.
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.
In addition, 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.
In many instances a shortage of a particular medicine is effectively addressed to ensure continuity of care for a patient including through the substitution for a generic version (in the case of a branded medicine short supply) or a generic version from a different manufacturer (in the case of a generic medicine in short supply). Under the Health (Pricing and Supply of Medical Goods) Act 2013 medicines which are deemed to be interchangeable can be directly substituted for one another by a pharmacist.
Where an interchangeable product is not available in Ireland, a pharmacist, in consultation with the prescriber, can source a medicine containing the same active ingredient in order to ensure that continuity of patient care is maintained, wherever possible. Such medicines may be sourced in another European Member State, or by a specialist wholesaler in a third country, and are known as exempt medicinal products (EMPs). EMPs have not been granted a marketing authorisation in Ireland by the HPRA but are sourced in response to a bona fide unsolicited order in order to fulfil the special needs of a patient. These medicines will however have undergone an evaluation of their safety, quality, and efficacy for the granting of their marketing authorisation in another EU Member State or third country by the respective competent authority for medicines.
In other instances, where a medicine shortage occurs due to a more global issue affecting multiple countries, a patient may be directed to return to their clinician to consider prescribing an alternative medicine for the treatment of their condition.
