Conor Sheehan (Limerick City, Labour)
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3023. To ask the Minister for Health the action she proposes to take to deal with the unregulated operators in the cosmetics industry; and if she will make a statement on the matter. [42870/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Cosmetic procedures, ranging from surgery to non-surgical aesthetic procedures, are currently regulated through a combination of:

1) professional regulation (ie regulation of doctors and dentists who engage in cosmetic procedures). Where there are concerns regarding the practice of a regulated health professional, a complaint can be made to the relevant regulator.

and;

2) product regulation, which can be:

• products placed on the market as cosmetic products,
• products which are authorised medicines, or would be classified as such, and thereby possibly restricted to prescription control e.g. medicines containing botulinum toxin,
• medical devices - The EU Medical Device Regulation (MDR) now includes certain specified implanted or surgically invasive products that are used for non-medical purposes, such as for aesthetic purposes. The most common example are dermal fillers. This means that dermal filler products must be CE marked in accordance with the EU MDR. Note, the MDR outlines requirements for manufacturers of dermal fillers with respect to them placing dermal fillers on the market.

• 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.

Conor Sheehan (Limerick City, Labour)
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3024. To ask the Minister for Health if she intends to introduce licensing for non-surgical cosmetic procedures; the form that licensing would take; and if she will make a statement on the matter. [42871/25]

Conor Sheehan (Limerick City, Labour)
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3025. To ask the Minister for Health for an update on The Patient Safety (Licensing) Bill 2017, including when the legislation will be referred back to her from the Attorney General’s office; a timeline for enactment; and if she will make a statement on the matter. [42872/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 3024 and 3025 together.

On the 24 June 2025, I brought a Memorandum to Government seeking approval to recommence drafting of the Patient Safety (Licensing) Bill 2025. Approval was granted.

Legislative priority had previously been given to the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 which was commenced in September 2024 (other than Section 68). The Patient Safety (Licensing) Bill is part of a suite of measures to improve patient safety. The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 provides the legislative framework for the extension of the Health Information Quality Authority's regulatory remit to private hospitals. This Act also includes provisions for the establishment of a legislative framework for mandatory open disclosure and reporting of designated serious patient safety incidents and, the provision of certain legislative protections for the conduct of clinical audit against explicit clinical standards on a national basis. The Patient Safety (Licensing) Bill is the next important step in this suite of legislation.

My Office has been engaging with the Office of the Attorney General and a drafter has now been allocated to the Patient Safety (Licensing) Bill. This Bill has been placed on the Department of Health’s legislative agenda as priority legislation for drafting during the Autumn session.

The Patient Safety (Licensing) Bill will, for the first time, introduce a licensing requirement for all acute hospitals, public and private, and certain designated high-risk activities.

The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 provides the legislative framework for the extension of the Health Information Quality Authority’s regulatory remit to private hospitals. However, this needs further extension through licensing legislation to provide for sanction if hospitals do not meet the appropriate standards.

Licensing legislation is being developed to facilitate the creation of a comprehensive system of regulation to oversee all hospitals in the State, both public and private. It will also provide me, as Minister for Health, with the authority to designate certain activities as carrying a sufficiently high risk to warrant their providers to also come within the scope of the new regime.

There is a lacuna at present, whereby there is no specific legislation in place in relation to the sanctioning of hospitals if they fail to operate to minimum standards of clinical governance. The proposed Patient Safety (Licensing) Bill seeks to rectify this situation.

While acute public hospitals, private hospitals and prescribed private health services are currently subject to monitoring by HIQA, the powers of HIQA are somewhat limited. The introduction of a system of licensing will ensure that all hospitals, public and private, are operating to appropriate standards and have the requisite governance arrangements in place, to enable the delivery of the safest possible service. This will be done by giving HIQA the power of sanction when conditions of a license are not met, up to or including the cancellation of a license which may result in closure as under the Licensing Bill, it will be an offence to operate a hospital without a license.

As outlined above, the Bill will also apply to high-risk activities, which will be set out in this legislation as ‘designated’ activities, and which are conducted in other settings, such as private clinics. Such activities may, for example, include the use of anaesthesia. The Patient Safety (Licensing) Bill will also make provision for me, as Minister for Health, to make regulations to designate certain high-risk activities which may take place outside a hospital setting as requiring the provider to be in possession of an appropriate licence from HIQA. Stakeholder engagement with those with the relevant clinical expertise will take place in order to identify what will qualify as a ‘designated activity'. Stakeholder consultation on the relevant policy proposals will be undertaken in parallel with the drafting of the Bill.

It is important to note that licensing legislation is intended to add to current regulation of health services and will not duplicate existing controls. Services already regulated under other legislation are therefore excluded from the definitions of hospital and health service.

Cosmetic procedures, ranging from surgery to non-surgical aesthetic procedures, are currently regulated through a combination of:

1) professional regulation (ie regulation of doctors and dentists who engage in cosmetic procedures). Where there are concerns regarding the practice of a regulated health professional, a complaint can be made to the relevant regulator.

and;

2) product regulation, which can be:

• products placed on the market as cosmetic products,
• products which are authorised medicines, or would be classified as such, and thereby possibly restricted to prescription control e.g. medicines containing botulinum toxin,
• medical devices i.e. from 2020 certain products used for aesthetic purposes that currently do not fall within the definition of a cosmetic product or a medicine may be classified as medical devices under the new EU Medical Devices legislation, e.g. dermal fillers.

Conor Sheehan (Limerick City, Labour)
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3026. To ask the Minister for Health if she will update the licensing for the administration of a treatment (details supplied) to allow nurses to administer; and if she will make a statement on the matter. [42873/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Botulinum toxin A products, as prescription-only medicines, specifies that administration of prescription medicines shall be in accordance with the directions of a registered medical practitioner or registered dentist, acting in the course of his or her practice as a dentist or by others when in accordance with the directions of a registered medical practitioner or registered dentist, acting within the practice of dentistry.

Generally, botulinum toxin medicines are authorised for administration by healthcare professionals with appropriate qualifications and expertise in the treatment and using the required equipment.

This means that medicines containing botulinum toxin A may be legally independently administered within this State by an appropriately qualified and trained registered medical practitioner (registered in this State) or registered dentist (registered in this State). These details are accessible in the product information, which includes the Summary of Product Characteristics and Package Leaflet, on the Health Products Regulatory Authority (HPRA) and European Medicines Agency (EMA) websites.

In Ireland, administration of prescription-only medicines is covered by the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2024 (S.I. No. 540 of 2003, as amended). These provisions should be read in conjunction with the marketing authorisation for the product which specifies who may administer it.

A registered medical practitioner or registered dentist (registered in this State) may direct a registered nurse (registered in this State) to administer a prescription medicine to a patient, in accordance with the directions of that registered medical practitioner or registered dentist (registered in this State) who is responsible for the care of the patient.

The medicine administered must be one that is authorised by the Health Products Regulatory Authority (HPRA) or by the European Commission.