Dáil Éireann Debate, Tuesday - 23 May 2023
793. Deputy Mary Lou McDonald asked the Minister for Health to set out the short-term measures in place to address the shortages of Ozempic; the reason for the ongoing shortages; the long-term solutions being put in place to prevent these shortages recurring in the future; and if he will make a statement on the matter. [24437/23]
View answer930. Deputy Cormac Devlin asked the Minister for Health if he will provide an update on the supply of a medication (details supplied); and if he will make a statement on the matter. [24991/23]
View answerI propose to take Questions Nos. 793 and 930 together.
Novo Nordisk, the marketing authorisation holder for Ozempic, has notified the Health Products Regulatory Authority (HPRA) of intermittent supply issues with Ozempic products due to increased global demand. The company anticipates that intermittent supply will continue throughout 2023. Similar supply constraints are being experienced in other EU countries.
Novo Nordisk has implemented monthly allocations to help ensure continuity of supply and equitable distribution of Ozempic stock to Irish patients. The company has issued letters to relevant stakeholders, including healthcare professionals, to ensure they are aware of this supply issue and its management.
In one such communication to healthcare professionals (dated 24 March 2023), 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 (PSI) and the Medical Council met recently to review supply issues relating to the GLP-1 agonist, Ozempic. In addition to continuation of efforts to work together during time of limited supply, the group agreed to issue a joint communication to the health system on this situation. This letter issued on 19th May.
