Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 1378 to 1380, inclusive, together.

Deputy I would like to thank you for raising these important matters and as such I have decided to answer these questions together.

To answer your questions regarding Botulinum toxin.

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.

A medicinal product which is not authorised for the Irish market can be supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of a practitioner (e.g. a registered dentist or medical practitioner) for use by their individual patients on their direct personal responsibility.. Medicines supplied in this manner are referred to as Exempt Medicinal Products (EMPs). The legislation underpinning EMPs is set out in Schedule 1 of the Medicinal Products (Control of Placing on the Market) Regulations, 2007, as amended, and also in the Medicinal Products (Control of Wholesale Distribution) Regulations, 2007, as amended. The HPRA does not assess such products' quality, safety or efficacy, as they are exempt from the requirement for marketing authorisation.

It is important to note that the clinical use of medicines in Ireland is a clinical decision a prescriber takes; the HPRA has no role in the clinical decision regarding patient treatment. The EMP route serves only to facilitate supply in response to a bona fide unsolicited order, formulated in accordance with the specifications of a practitioner for use by their individual patients on their direct personal responsibility.

Appropriately authorised wholesalers or manufacturers can import and supply EMPs and should notify the HPRA to ensure traceability in the event of a recall. Healthcare professionals typically cannot import EMPs from third countries and must involve an appropriately authorised wholesaler or manufacturer.

To answer your specific questions regarding Dermal Filler.

Dermal fillers are classified as medical devices under the EU medical device legislation and the HPRA is the competent authority for medical devices in Ireland. The Department of Health is working with the Health Products Regulatory Authority (HPRA) in considering the current regulation of dermal fillers in Ireland. Further consideration by the Department may be required in relation to the regulation of dermal fillers in the future, on foot of this work with the HPRA. There are a number of factors to consider such as training requirements, raising awareness, considerations of administration etc

In the European Union (EU), medical devices are regulated by way of an EU-wide framework which aims to ensure that all devices available for use on the EU market are safe and perform as intended. A valid medical device bears a ‘CE’ mark, which indicates that it meets the basic requirements for safety and effectiveness under European law and can be placed on the EU market. Dermal fillers are classified as medical devices and are typically regulated under the Regulation for Medical Devices (MDR) as Class III medical devices (the highest risk class). Commission Implementing Regulation (EU) 2022/2346 requires all dermal fillers to be CE-marked subject to transitional timeframes. This Implementing Regulation also includes additional requirements in the instructions for use stating that dermal fillers ‘are not to be used in persons who are less than 18 years old’ and that they should only be administered by appropriately trained healthcare professionals.

There are mandatory obligations for manufacturers to report incidents that occur with medical devices, including dermal fillers, to the HPRA. The HPRA asks individuals who have experienced any complications with the use of a dermal filler to report these to the HPRA. Reports can be submitted to the HPRA through their online reporting system available at the following link. The HPRA advises anyone who has health concerns relating to dermal fillers to contact their GP.

The Department of Health advises members of the public to refer to the HPRA website for information in relation to buying medical devices online.