Fergus O'Dowd (Louth, Fine Gael)
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1580. To ask the Minister for Health if he expects ozempic to be added to the GMS list for weight loss; the reason the drug is not available under the drug payments, considering the considerable impact it is having on weight and the associated positive effect it is having on health, thus reducing the long term requirement for other services linked to obesity and weight problems; and if he will make a statement on the matter. [57047/23]

Brian Stanley (Laois-Offaly, Sinn Fein)
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1624. To ask the Minister for Health the reason and on what clinical basis the ozempic injection was removed from GMS cards; if he has plans to reinstate it; and if he will make a statement on the matter. [57374/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 1580 and 1624 together.

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. In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact.

Ozempic® (Semaglutide) is indicated for the treatment of adults with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise. Ozempic® (Semaglutide) is not licensed or reimbursed for the treatment of weight management in a non-diabetic population.

Therefore, reimbursement support for Ozempic® (Semaglutide) for the licensed indication only is available to those with eligibility under the General Medical Services (GMS) Scheme or the Long-Term Illness (LTI) Scheme. Ozempic® (Semaglutide) is not available on the Drugs Payment Scheme.

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 1581, 1582, 1583, 1584, 1585, 1586 and 1587 together.

Nicotine pouches are currently not covered by domestic or EU tobacco control legislation, with some Member States classifying them as either a foodstuff or medicine. The regulation of nicotine pouches is being discussed at EU level, both in terms of how these products are categorised and in the context of the review of the Tobacco Products Directive. An EU public consultation was carried out in 2023 to gain views on further regulation of novel products such as nicotine pouches, and a proposal from the EU Commission is expected this year.

It is understood that prevalence of nicotine pouch use remains extremely low in the adult population across the EU. Data on adolescent use of nicotine pouches in Ireland will be collected as part of the European School Survey Project on Alcohol and Other Drugs (ESPAD) in 2024. There is very little independent evidence available regarding any health harms from nicotine pouches, though they contain nicotine which is an addictive substance. My Department continues to monitor any emerging evidence regarding these products.