Dáil Éireann Debate, Monday - 11 September 2023
1637. Deputy Mick Barry asked the Minister for Health given the complications and risks of aesthetic medicine, the steps he will take to establish a regulatory framework for aesthetic medicine practitioners that can establish licensing and qualification requirements, oversight of practitioners and promote public awareness; and if he will make a statement on the matter. [37812/23]
View answer1805. Deputy Brendan Smith asked the Minister for Health the measures he will implement to regulate aesthetic medicine and have proper regulatory controls in place, in view of the concerns by healthcare professionals outlined in correspondence (details supplied); and if he will make a statement on the matter. [38697/23]
View answer1937. Deputy Róisín Shortall asked the Minister for Health his views on matters raised by doctors practising aesthetic medicine (details supplied); the steps he is taking to establish a more robust regulatory environment; and if he will make a statement on the matter. [39248/23]
View answerI propose to take Questions Nos. 1637, 1805 and 1937 together.
Thank you for raising this important issue, Deputy. The matters outlined in the letter received from healthcare professionals working in the field of aesthetics, are broad in nature and cross-cutting. In providing this response, I have outlined the current regulation of this sector, through professional and product regulation.
Regulation of botulinum toxin
Botulinum toxin (‘Botox’) products are prescription-only medicines and as such, their administration is regulated. The regulations concern, among other aspects, who can source and administer the medicine.
The authorised indications and conditions for use are specified in the marketing authorisations (MA) granted by the Health Products Regulatory Authority (HPRA), or, European Medicines Agency (EMA), for each product. The relevant product information for each product is available from the HPRA website.
In Ireland, administration of prescription-only medicines is covered, inter alia, by the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2021. These provisions should be read in conjunction with the marketing authorisation for the product, which specifies who may administer it.
The HPRA has ongoing concerns about the illegal offering for supply or administration of medicines containing botulinum toxin by people who are not authorised/qualified to do so. The HPRA urges the public to report any suspicions in this regard to it at enforcement@hpra.ie, reportacase@hpra.ie or by phone on (01) 634 3436. The HPRA monitors for illegal supply, both in the physical and digital sphere, including administration, of medicines containing botulinum toxin. The HPRA has taken action in a number of cases, including in some cases prosecutions in the District Court in relation to illegal supply/administration/advertising of botulinum toxin containing medicines and continues to engage in enforcement of the regulations.
Regulation of dermal fillers
Dermal fillers are classified as medical devices. The manufacture and placing on the market of medical devices is regulated by way of the EU Medical Devices Regulation, 2017/745 (MDR).
The MDR, which became fully applicable in May 2021, has an expanded scope, and specifically includes all dermal fillers, including those without a medical purpose. Under the previous framework, only dermal fillers which claimed a medical purpose were required to be ‘CE’ marked as a medical device, however, since the adoption of new technical requirements for these products, known as ‘common specifications’, by way of Implementing Regulation (EU) 2022/2346 of 1 December 2022, all dermal fillers must be certified as medical devices and undergo a premarket assessment by an independent conformity assessment body (a ‘Notified Body’) before they can be CE marked and placed on the market. This implementing regulation also includes additional requirements in the instructions for use to state 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. This implementing regulation became applicable in June 2023 and is, along with the MDR in its entirety, subject to a transition period for existing products on the market.
The MDR relates to the regulation of the product itself and requirements for manufacturers of those products. It does not include provisions relating to the use of the product after it is placed on the market and does not explicitly regulate aspects relating to the use in practice or administration of the product. However, as per the provisions of the MDR, it is incumbent on the manufacturer of the medical device to ensure that their device can be used safely. A risk assessment relating to such matters, must be conducted as part of the manufacturer’s overall risk assessment for the device, with appropriate risk control measures adopted on foot of same, which may include measures relating to the use of the device in practice. A medical device should always be used in accordance with the manufacturer’s instructions for use, which may include instructions on matters pertaining to the administration of the device.
The HPRA monitors the safety and compliance of medical devices in Ireland after they are placed on the market. The HPRA operates a national reporting system for medical devices and encourages users of devices to report incidents or problems associated with their use to the HPRA through its website or by contacting HPRA, or the manufacturer, directly. There are mandatory obligations for manufacturers to report incidents that occur with medical devices, in Ireland to the HPRA. While healthcare professionals and patients are not required by law to report incidents they experience, there is a voluntary reporting scheme in place at the HPRA. Individuals and healthcare professionals are actively encouraged to report any adverse incidents to the HPRA. Reports can be submitted to the HPRA through its online reporting system available here[1] .
The HPRA advises anyone who has health concerns relating to dermal fillers to contact their GP or consultant. The HPRA encourages anyone who has information about dermal fillers which do not bear the CE mark, or which do not appear to meet the requirements of the medical devices legislation to provide details of the device in question to the HPRA.
The Department of Health (DoH) is working with the HPRA in considering the current regulation of dermal fillers in Ireland and further consideration by the Department of Health may be required in relation to the regulation of dermal fillers in the future, on foot of this work with the HPRA.
Patient Safety (Licensing) Bill
DoH continues to work on the Patient Safety (Licensing) Bill which will, for the first time, introduce a licensing requirement for all hospitals, public and private, and certain designated high-risk activities in the community. The general scheme of the Bill was approved by Government on 12th December 2017. It underwent Pre-Legislative Scrutiny at the Oireachtas Joint Committee of Health on 13 June 2018, and it is currently with the Attorney General’s Office in order for drafting to be undertaken.
In advance of the Patient Safety (Licensing) Bill, the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 will provide the legislative framework for the extension of the Health Information Quality Authority’s (HIQA) regulatory remit to private hospitals.
The DoH advises any member of the public considering treatments such as these to ensure that they are being performed and administered by an appropriately trained and qualified professional and that the products used comply with the requirements of the relevant legislation. In addition, the DoH would refer anyone seeking surgical or non-surgical procedures to the published guidance of the e Chief Medical Officer, accessible here. [2]
Irish Medical Council
The Irish Medical Council is the independent statutory body which regulates medical practitioners in Ireland. Its primary purpose is to protect the public by promoting high standards of professional conduct, education, training, and competence among doctors. One of the Council’s functions is to investigate complaints against registered medical practitioners. Any person or organisation may make a complaint to the Medical Council about a medical practitioner.
If an individual has information relating to a doctor, or doctors, and wishes to make a complaint to the Medical Council this will be investigated in line with Council procedures and legislation as per the Medical Practitioners Act 2007.
It is important to note that the Minister does not have a role in relation to individual complaints received by the Medical Council. Under the Medical Practitioners Act 2007, the Council has sole responsibility in arriving at its decisions in relation to complaints and under section 9 of the Act the Minister is specifically precluded from giving policy directions to the Council relating to its complaints function.
The Medical Council handles complaints relating to a doctor's fitness to practise medicine. Anyone can make a complaint about a doctor who is registered in Ireland. This includes members of the public, employers, and other healthcare professionals. For further information please see the Medical Council’s website Medical Council - Making a Complaint[3] .
Under the Medical Practitioners Act 2007 medical practitioners who practise medicine in the State must be registered with the Medical Council. The Medical Council is empowered to investigate cases where an individual who is not a registered medical practitioner is suspected of claiming to be a registered medical practitioner or of practising medicine in contravention of the 2007 Act. The Council can take action arising from such an investigation, including seeking an injunction from the High Court requiring the person to cease the illegal activities.
Irish Dental Council
The Irish Dental Council, established under the Dentists Act 1985, is the regulatory body for the dental profession. Its general concern is to promote high standards of professional education and conduct among dentists in Ireland.
One of the Council’s functions is to investigate complaints against registered dentists under its Fitness to Practice procedures. Any person may apply to the Fitness to Practice Committee for an inquiry into the fitness of a registered dentist to practice dentistry.
By law, the Dental Council must guide the dental profession on all aspects of ethical conduct and behaviour (Section 66 of the Dentists Act 1985). In May 2023 the Dental Council published a revised Code of Practice regarding Non-Surgical Cosmetic Procedures on its website (dentalcouncil.ie) setting out the obligations on registered dentists in relation to administering anti-wrinkle (botulinum toxins) or dermal fillers as cosmetic treatments. Failure to comply with this guidance may result in Fitness to Practice proceedings under The Dentists Act 1985.
Nursing and Midwifery Board of Ireland
The Nursing and Midwifery Board of Ireland (NMBI) is the independent, statutory organisation which regulates the nursing and midwifery professions in Ireland. Their mission is to protect the public and the integrity of the professions of nursing and midwifery through the promotion of high standards of education, training, and professional conduct.
As part of its aim of protecting the public, NMBI is legally responsible for considering complaints against nurses and midwives who practise in Ireland. If an individual is aware of an incident or incidents involving a nurse or midwife that may have compromised a patient’s safety or the protection of the public, they can make a complaint to NMBI. NMBI’s Fitness to Practise department handles all complaints fully, fairly and in accordance with the legislation. Further information is available on the NMBI website.
The Medicinal Products (Prescription and Control of Supply (Amendment) Regulations 2003 -2021 (S.I no 540 of 2003, as amended) outlines the conditions for registered nurse or midwifery prescribers to prescribe and registered nurses or midwives to administer Botulinum Toxins based on a prescription. Any administration must to be in accordance with the relevant conditions regarding prescription control medication.
[1] www.hpra.ie/homepage/about-us/report-an-issue/mdiur
[2] assets.gov.ie/11438/432380d40dbf4e0ea063ccb1485e30ef.pdf
[3] www.medicalcouncil.ie/public-information/making-a-complaint-/
