Louise O'Reilly (Dublin Fingal West, Sinn Fein)
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1243. To ask the Minister for Health if a regulatory impact assessment and/or the SME test were carried out in advance of the signing of Statutory Instrument No. 736 of 2024; if she intends to publish these documents; and if she will make a statement on the matter. [3086/25]

Louise O'Reilly (Dublin Fingal West, Sinn Fein)
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1244. To ask the Minister for Health to detail the consultation that took place with retailers and/or their representative groups in advance of signing SI No. 736 of 2024, in line with commitments to consult that were given in Dáil and Seanad Éireann by the then-Minister; and if she will make a statement on the matter. [3087/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 1243 and 1244 together.

Tobacco use is the leading cause of preventable disease, disability and death in Ireland, with 4,500 people dying each year from tobacco-related diseases. Smoking related deaths are mainly due to cancers, chronic obstructive pulmonary diseases (COPD) and heart disease. The cost to society from smoking due to healthcare costs, welfare and loss of productivity is estimated to be in excess of €10 billion per year. It is therefore the Government’s objective under the 2013 Tobacco Free Irelandpolicy to effectively eliminate smoking.

The Public Health (Tobacco Products and Nicotine Inhaling Products) Act 2023 fulfils the legislative commitments made in Tobacco Free Ireland, including introducing a licensing system for retailers with the specific intention of denormalising tobacco retailing and reflecting the seriousness of the harms caused by tobacco compared to other products. It is also a pre-requisite for Ireland to ratify the Protocol to the Framework Convention on Tobacco Control which is designed to eliminate the illicit trade in tobacco products.

Consultation on this 2023 legislation took place in 2014 and 2015 with interested stakeholders, including retailers. Retailer submissions to the consultation proposed that the fee be proportionate by either number of outlets or volume of sales. Following consideration of all suggestions, the General Scheme of the Bill and accompanying Regulatory Impact Analysis were published in 2019 with a proposal to set an annual fee per outlet.

Pre-legislative scrutiny from 2021 to 2022 was conducted by the Oireachtas Health Committee, who held sessions with stakeholders from public health, retail and industry, and received further written submissions from stakeholders such as retail organisations before issuing their recommendations for the legislation.

The final Bill was debated and passed in the Oireachtas in 2023. The Act provides for an annual licence per outlet for those wishing to sell:

a) tobacco

b) nicotine inhaling products, or

c) tobacco and nicotine inhaling products.

The Act provides that the Minister for Health may set the fee for each of the three licence categories by Regulation. Those fees were set in the Public Health (Tobacco Products and Nicotine Inhaling Products) Act 2023 (Fees) Regulations 2024. As with alcohol licensing, which carries a similar fee and structure, it is a matter for each individual retailer to decide whether or not to sell these products, and to apply for the relevant licence if so.

SME Tests were completed where required for the primary legislation and the subsequent secondary legislation.

During the passage of the Public Health (Tobacco Products and Nicotine Inhaling Products) Act 2023, the Minister for Health acknowledged the need to work with retailers on the implementation of the licensing system. This will be done by the National Environmental Health Service of the HSE which will engage with retailers prior to the system coming into operation on 2 February 2026 as it has previously done on tobacco control and other public health law.