The General Scheme of the Patient Safety (Licensing) Bill was approved by Government in December 2017, and underwent pre legislative scrutiny at the Oireachtas Health Committee in July 2018. It is currently with the Attorney General’s Office in order for drafting to be undertaken. I hope to be in a position to publish this Bill in 2020.
It should be noted that the primary focus of this Bill will be on the introduction of a regulatory framework for public and private hospitals, as well as enabling for certain high risk activities that take place outside a hospital setting to be designated as also requiring a licence.
With regard to the particular cases which the Deputy refers to, I would firstly note that I am not familiar with the individual circumstances but I of course share with him the utmost concern with regard to such matters. In addition to the Patient Safety (Licensing) Bill, I have previously instructed my Department to undertake work examining whether further regulations are required in order to ensure that appropriate protections are in place for the supply and administration of dermatological fillers. This work, including consultations with relevant state agencies, seeks to identify risks in this area and any tools that may be available to alleviate issues identified.
It should be noted that there are already a number of legal frameworks in place that provide regulation in this area, including with regard to the work of the Health Products Regulatory Authority (HPRA). The HPRA have a role in protecting public health by regulating medicines, medical devices and other health products. This includes a national reporting system for medical devices where users of devices are encouraged to report incidents or problems associated with their use to the HPRA. Where a significant safety or quality concern is identified with the actual device, there are a range of regulatory actions the HPRA can take to protect public health. These include changes to labelling, information and safety notices to users and recalling the product from the market. They can also request changes or modifications to the device itself.
Aesthetic’ procedures are currently regulated through a combination of professional regulation (I.e. regulation of doctors and dentists who engage in ‘aesthetic’ procedures) and product regulation. Product regulation covers products placed on the market as cosmetic products, products which are authorised medicines or would be classified as such and are thereby possibly restricted to prescription-control e.g. medicines containing botulinum toxin (such products are also restricted to administration by physicians only), and medical devices.
From 2020 certain products used for aesthetic purposes that currently do not fall within the definition of a cosmetic product or a medicine, which includes dermal fillers, may be classified as medical devices under the new EU Medical Devices legislation - Regulation (EU) 2017/745. The Regulation, which becomes fully applicable in May 2020, specifically includes dermal fillers within the remit of the regulatory framework for medical devices.
The medical device regulations do not specifically address the administration of dermal fillers, however, under the new Regulations Member States may make provision for certain devices to be eligible for prescription control. This may represent an opportunity to introduce national legislation restricting the supply or use of dermal fillers. The Department of Health is working with the HPRA to identify the correct use of this provision and how it may be applied to the administration of dermal fillers in Ireland. Work on developing this requirement is ongoing.
Ahead of possible further regulatory changes, my Department continues to recommend that anyone seeking to have a cosmetic surgery procedure , seek advice from their General Practitioner (GP) to ensure that they are a suitable candidate for the procedure in question. GP’s can then recommend a reputable specialist practitioner in this area.
The Department further recommends a consultation with an appropriately registered plastic surgeon. In Ireland, such surgeons can be found by examining the online register of medical practitioners found at the website of the Medical Council. A patient can also establish if a surgeon is a full member of the Irish Association of Plastic Surgeons at the website of that organisation; all of its members have had full specialist training and are on the Specialist Register in Plastic And Reconstructive Surgery of the Medical Council. Specific advice, which has been prepared by the Chief Medical Officer and the Irish Association of Plastic Surgeons, is also available on the website of my Department.