Pearse Doherty (Donegal, Sinn Fein)
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572. To ask the Minister for Health the reason for the delay in providing prescribed solpadine for holders of a medical card; and if he will make a statement on the matter. [32116/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the Community Drug Schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013.

Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).

In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

The HSE advise that Solpadeine capsules in packs of 32 and Solpadeine Soluble tablets in packs of 60 are currently on the reimbursement list.

Chefaro Ireland DAC, the company responsible for supplying Solpadeine, has notified of a shortage of Solpadeine Soluble Tablets (12 and 60 pack) and Solpadeine Capsules (12, 24 and 32 pack). These shortages are affecting multiple countries and the company has stated that the shortages of the soluble tablets are due to manufacturing delays. The company anticipates Solpadeine Soluble Tablets 60 pack to return in October 2023 and the 12 pack to return in November 2023. Solpadeine Capsules 12 pack is expected to return in August 2023, the 24 pack in September 2023 and the 32 pack in July 2023.

The company has confirmed that stock of Solpadeine Soluble Tablets (24 pack) remains available in the interim.

Under the Drugs Payment Scheme (DPS), no individual or family pays more than €80 a month towards the cost of approved prescribed medicines. The DPS is not means tested and is available to anyone ordinarily resident in Ireland. The DPS significantly reduces the cost burden for families and individuals with ongoing expenditure on medicines.

DPS card holders should be able to access Solpadeine capsules in packs of 32 and Solpadeine Soluble tablets in packs of 60 as soon as they become available, provided that these have been prescribed by a clinician. To access other Solpadeine products which are in stock but not on the reimbursement list, they would have to pay.

Unfortunately, medicine shortages are a feature of modern health systems worldwide which have been exacerbated by recent worldwide events. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; sudden unexpected increase in demand; or product recalls due to potential quality issues.

Ireland has a multi-stakeholder medicine shortage framework in place, coordinated by the Health Products Regulatory Authority (HPRA), to prevent, wherever possible, and to manage medicine shortages when they occur. The HPRA maintains regular contact with the Department of Health regarding medicines shortages.

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. See www.hpra.ie/homepage/medicines/medicines-information/medicines-shortages .

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.