Michael Ring
Question:570. Deputy Michael Ring asked the Minister for Health the reason that a person (details supplied) has been refused a drug prescribed by their GP; and if he will make a statement on the matter. [41384/23]
View answerTuesday, 26 September 2023
Questions (570)
Written answers
Ozempic (Semaglutide); this medication is licensed by the Health Products Regulatory Authority (HPRA) in Ireland and indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. Novo Nordisk markets Ozempic in Ireland.
To date, there have been particular challenges in the supply of Ozempic to all markets, including to the Irish market.
According to Novo Nordisk, production issues in August 2023 at a manufacturing site will lead to a reduction in the overall supply of the 1mg strength of Ozempic to Ireland and other EU markets during the month of September 2023. A potential further brief (approximately one week) constraint of the 0.5mg strength is anticipated in early October 2023.
Novo Nordisk has confirmed that these production issues are now resolved and it is expected that supply of the 1mg strength to Ireland will return to standard 2023 levels from October.
The pre-existing supply issues due to increased global demand, will continue into 2024. These supply issues are not unique to Ireland, increases in demand for these medications and supply constraints have been observed in the UK, throughout the EU and across the world in recent months. Shortages of Ozempic are linked to the increased demand which has been attributed to the off-label use of the product to treat obesity.
Novo Nordisk has implemented monthly allocation to pharmacies to help ensure continuity of supply and equitable distribution of Ozempic stock to Irish patients. The company has issued advisory letters to healthcare professionals to ensure they are aware of these supply issues and how to manage them. In one such recent communication to healthcare professionals, the company stated that Ozempic is only indicated for treating adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. Any other use, including for weight management, represents off-label use and currently places the availability of Ozempic for the indicated population at risk. Reimbursement support from the HSE is available for the licensed indication and approved dosage only.
The Department of Health, along with relevant experts from the HSE, HPRA, Pharmaceutical Society of Ireland and the Medical Council are continuing to work together during times of limited supply to mitigate the impact of the shortages on patients.
The Minister for Health has no role in the clinical decision-making process of a medical practitioner and patients that have been prescribed Ozempic by their doctor and are struggling to source it, are encouraged to speak to their doctor and to the pharmacies in their area as early as possible, in order to seek support in accessing appropriate treatment for their medical condition.