Stephen Donnelly (Wicklow, Fianna Fail)
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Botulinum toxin-containing products are prescription-only medicines in Ireland, with their authorised indications and conditions for use outlined in marketing authorisations issued by the Health Products Regulatory Authority (HPRA) or the European Commission (assessed by the EMA). These details are accessible in the product information, which includes the Summary of Product Characteristics and Package Leaflet, on the HPRA and EMA websites.

Typically, these products are authorised for administration by a physician with appropriate qualifications. However, the specifics of authorisation conditions may vary. Legislation concerning the administration of prescription medicines states that such products can be administered by, or in accordance with the directions of a registered medical practitioner or registered dentist in Ireland. To note, in Ireland, administration of prescription-only medicines is covered by the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2021 (S.I. No. 540 of 2003, as amended).

The sale or supply of medicines, including botulinum toxin, to entities or individuals can only be done within the regulated framework of medicines supply. This includes appropriately authorised medicine manufacturers, wholesalers, registered practitioners, and registered pharmacies for prescription medicines.

In respect of the wider reform of the Dental regulatory framework, my Department is committed to reviewing the Dentists Act 1985 and progressing the development of a modern legislative framework. The protection of the public and ensuring high oral healthcare standards will continue to be the central focus of this work. The review and updating of the legislation also, necessarily, is directly related to the wider implementation of the National Oral Health Policy which envisages a fundamental reform of oral health services. As such, new legislation must be fully informed by this work, which is ongoing.

I met with the Dental Council in January to discuss the regulatory powers available to them under the Dentists Act 1985, and the potential advancement of interim amendments. A series of thematic engagements between the Department and the Dental Council to discuss legislative matters in more depth, have taken place. These are important inputs to the overall regulatory reform programme that the Department is developing, and this will be a fundamental legislative reform programme with the objective of introducing a new modern regulatory framework for all relevant aspects of dentistry.