Tuesday, 9 April 2019

Questions (376)

Tony McLoughlin

Question:

376. Deputy Tony McLoughlin asked the Minister for Health his plans to ensure that the lack of regulations within the medical aesthetic and cosmetic surgery sector is addressed in order to protect public health; if his attention has been drawn to the dangers posed by botched procedures and unskilled and untrained persons conducting medical aesthetics; his further plans to combat this growing trend; and if he will make a statement on the matter. [16285/19]

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Written answers (Question to Health)

Cosmetic surgery is currently controlled through the regulation of cosmetic surgeons in accordance with the Medical Practitioners Act 2007.   Under that Act, medical practitioners,  including cosmetic surgeons, who practise medicine in Ireland must be registered with the Medical Council, which has responsibility for the registration of medical practitioners and the regulation of their activities.

Certain medical devices used in cosmetic and aesthetic treatments are captured under medicines legislation and must have a product authorisation from the Health Products Regulatory Authority (HPRA) or the European Medicines Agency (EMA) before being placed on the market. There are also restrictions on who can prescribe and administer such devices as some such products are subject to prescription requirements and may only be administered by registered medical doctors or registered dentists.

Under legislation medical devices must also be CE marked before being placed on the market. The CE mark follows assessment of conformity to the relevant legislative requirements relating to benefit, risk, composition, safety and labelling and also of the manufacturer’s production standards. It does not regulate who can use the medical device or practice relating to the use of the device. The new EU Medical Devices Regulation (EU 2017/745), due to be commenced in May 2020, formally includes dermal fillers in Annex XVI within the scope of medical device regulation as devices without a medical purpose (cosmetic).

The HPRA's regulatory role involves monitoring the safety of medical devices in Ireland after they are placed on the market. The HPRA also operates 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.

Further regulation in this area will be seen following the introduction of The Patient Safety Licensing Bill. The General Scheme of the Bill was approved by Government on 12 December 2017, has completed pre legislative scrutiny, and is currently with the Attorney Generals Office for drafting. The aim of this Bill is to improve patient safety by ensuring that providers of health services do not operate below core standards, which are applied in a consistent and systematic way. Public and private hospitals and providers of high risk healthcare activities taking place outside a hospital setting will require a license to operate. HIQA will be the licensing authority. The non-hospital high risk designated activities will be prescribed by the Minister and the Department is currently working to identify those activities which should be so designated.

The Department of Health has previously recommended that anyone seeking to have a cosmetic  surgery procedure  should 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 recommended 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.