Paul McAuliffe (Dublin North West, Fianna Fail)
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649. To ask the Minister for Health his views on reports received by this Deputy that medical card holders are being denied the dispensing of prescribed solphedine due to shortages, despite the product being readily available for sale off the scheme in the same pharmacy store. [21713/23]

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 (60 and 12 pack) impacting multiple countries, not just Ireland. The company anticipates that Solpadeine Soluble (60 pack) will return in October 2023. They have not yet provided an update regarding the expected resupply of Solpadeine Soluble (12 pack).

However, several alternatives are available. The company has confirmed there is stock of Solpadeine Capsules (12, 24 and 32 packs) and also Solpadeine Soluble (24 pack).

Medical card holders should be able to access Solpadeine Capsules (32 pack), subject to the payment of the statutory prescription charge. To access other Solpadeine products that 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.