Written answers

Wednesday, 13 December 2023

Department of Health

Medicinal Products

Photo of Aengus Ó SnodaighAengus Ó Snodaigh (Dublin South Central, Sinn Fein)
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241. To ask the Minister for Health what, if anything, can be done to assist those on Saxenda weight reduction mediation who can no longer obtain their prescription due to non-availability. [55680/23]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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Novo Nordisk, the company responsible for supplying Saxenda, has notified the Health Products Regulatory Authority (HPRA) of a shortage of the product from early November until mid-February. Multiple countries, not just Ireland, are affected by this shortage. The company has informed the HPRA that the shortage is due to an unexpected increase in demand for the product and that this issue has affected supply globally. The company has adopted regulatory flexibility and has supplied products initially authorised for another country. The HPRA has no objection to this stock's continued supply until the Irish-authorised packs has resumed. The HSE is aware of the shortage and has provided a temporary reimbursement code for the stock sourced from a different country.

Novo Nordisk has also issued a communication to healthcare professionals regarding the situation and its management, which is also available on the HPRA’s shortages webpage.

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. Pharmaceutical companies and wholesalers in Europe are responsible for ensuring a consistent supply of the medicines they sell.

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 Department of Health maintains regular contact with the HPRA regarding medicines shortages.

Patients who have any concerns about availability of their medication are encouraged to speak to their GP or pharmacist.

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