Pádraig Rice (Cork South-Central, Social Democrats)
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350. To ask the Minister for Health the position in relation to a drug (details supplied); if it will be available through the HSE; and if she will make a statement on the matter. [55951/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, I have asked the HSE for an update in this matter.

The HSE has advised that there is a National Application, Assessment & Decision Process for new medicines which is underpinned by Primary Legislation (Health (Pricing and Supply of Medical Goods) Act 2013) put in place by the Oireachtas. The HSE must comply with the relevant legislation when considering investment decisions around new medicines.

The HSE must robustly assess applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.

There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed.

Pharmaceutical companies are required to submit formal applications to the HSE if they wish for their medicines to be added to the list of reimbursable items / funded via hospitals.

On the 29th May 2024 the European Commission granted EU marketing authorisation for tofersen (Qalsody®) indicated for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.

As of the 10th October 2025, a pricing and reimbursement application has not been received by the HSE for tofersen (Qalsody®).

As per the processes outlined above, the HSE will process and assess any pricing and reimbursement application received from a company as efficiently as possible within the resources available to the HSE.

Marie Sherlock (Dublin Central, Labour)
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351. To ask the Minister for Health the measures her Department is taking to stop novel nicotine products, such as nicotine pearls, from entering and being sold on the marketplace; and if she will make a statement on the matter. [55963/25]

Marie Sherlock (Dublin Central, Labour)
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352. To ask the Minister for Health the powers she has to prevent novel nicotine products being sold on the market before they have been regulated as genuine tobacco cessation products; and if she will make a statement on the matter. [55964/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 351 and 352 together.

The EU Tobacco Products Directive regulates all tobacco products, including novel tobacco products, as well as electronic cigarettes containing nicotine and herbal products for smoking. It does not currently apply to novel nicotine products, and as such these products are not regulated by EU or domestic tobacco control legislation.

This is a separate regulatory framework to medical products which are licensed for smoking cessation, such as Nicotine Replacement Therapies.

It is recognised that EU-wide regulation on novel nicotine products would be more effective than individual Member States taking action as it ensures that measures cannot be avoided through cross-border purchases. As a revision of the EU Tobacco Products Directive has been long awaited, I have, on behalf of Ireland and several other Member States, recently called on the European Commission to bring forward the revised Directive as soon as possible. I have called for that proposal to include all novel nicotine products and for this measure to include a ban on cross-border distance sales so that national measures cannot be avoided through purchases from other jurisdictions.

My current legislative priority is the comprehensive regulation of nicotine inhaling products such as e-cigarettes, addressing point of sale display, the appearance of these devices, packaging, flavours and a ban on disposable vapes. Drafting is significantly advanced and this legislation is prioritised for publication in the Autumn Legislative Programme.

The broader focus of policy in this area continues to be ending the immense harms caused by tobacco, which continues to be the most widely used and most harmful nicotine product in Ireland, causing almost 100 deaths and 1000 hospitalisations every single week. The Tobacco Free Ireland policy is currently being revised, in order to set out clear steps to bring us to the tobacco-free goal, and effectively protect young people from nicotine products and potential harm.