Stephen Donnelly (Wicklow, Fianna Fail)
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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.

Novo Nordisk, has advised of supply issues with its GLP-1 receptor agonist products including Ozempic and Saxenda. The pre-existing supply issues due to increased global demand, will continue throughout 2023 and into 2024. These supply issues are not unique to Ireland and 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 prescribing and dispensing of Ozempic should be prioritised for the licensed indication and restricted to a one-month supply.

Novo Nordisk is continuing to work on increasing its capacity to produce more of this medication. The HPRA is engaging closely with the company and the wholesalers involved in the supply of this product. This is to closely monitor available stock and to keep the health system and the public informed.

There are a number of authorised alternative medicines indicated for treating adults with insufficiently controlled type 2 diabetes mellitus are available at this time, including other glucagon-like peptide (GLP-1) receptor agonists. Where this shortage impacts ongoing treatment for a patient, prescribers and pharmacists, in conjunction with patients, should discuss the most appropriate course of action, based on suitable alternative treatment options available.

Reimbursement support for Ozempic from the HSE is available for the licensed indication and approved dosage only. Reimbursement support for the 0.25 mg and 0.5 mg pen presentations of Ozempic to make up a 1mg dose is not approved under Community Drug Schemes or any other HSE arrangement. National supply at wholesale level for all medicines in this class will continue to be monitored closely

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 this time 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.