Olivia Mitchell (Dublin South, Fine Gael)
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Question 530: To ask the Minister for Health how cosmetic surgery clinics are currently regulated and if, in view of the recent defective breast augmentation procedures, he plans to update the current regulation regime; and if he will make a statement on the matter. [13722/12]

Olivia Mitchell (Dublin South, Fine Gael)
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Question 573: To ask the Minister for Health how cosmetic surgery clinics are currently regulated; in view of the recent defective breast augmentation procedures, his plans to update the current regulation regime; and if he will make a statement on the matter. [13728/12]

James Reilly (Dublin North, Fine Gael)
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I propose to take Questions Nos. 530 and 573 together.

The Madden Commission on Patient Safety identified cosmetic surgery as one of the priority areas that should be addressed by a new system of licensing. My officials are currently working on the Licensing of Health Facilities Bill which will provide for a mandatory system of licensing for public and private health service providers. The legislative proposals are being prepared broadly in line with recommendations made by the Madden Commission and are designed to improve patient safety by ensuring that health care providers do not operate below core standards which are applied in a consistent and systematic way. The intention is to have a proportionate system which has the confidence of the public. Standards and other requirements will be enforceable through inspection and imposition of sanctions as necessary. Licensing will be targeted at areas which are not currently subject to regulation. I expect to receive outline proposals for the new system of licensing shortly.

Regulation of medical devices, including the PIP breast implants at the centre of current concern, is governed by EU legislation which has been transposed into Irish law. Under the regulatory system in place, the Irish Medicines Board is the competent authority for medical devices in Ireland and is responsible for post market surveillance of medical devices and sale. Medical devices may be placed on the market anywhere in the EU, including Ireland, following certification by a notified body which awards the medical device a CE Mark. The IMB has no direct role in the authorisation of any medical device before it comes to market.

The EU Commission is in the process of revising the Medical Devices Directives and hopes to have proposals later this year. In January 2012 the Commission announced their plans to "stress test" the proposals to ensure that they are suitable to detect and resolve the issues highlighted by the PIP implants case. In addition the Commission announced a number of immediate actions to strengthen the system in the short term.

In the interim the IMB continues to liaise with EU and International colleagues (including Australia, the UK and other EU and non-EU countries) regarding the testing of PIP breast implants which is currently ongoing and any issues of concern will be communicated immediately. Women with these implants are advised that if they have any concerns about their breasts or implants they should seek clinical advice from their implanting surgeon.

All health care professionals are required to be registered with their relevant professional regulatory body. The regulation of all medical practitioners is provided for under the Medical Practitioners Act 2007. Under this Act, medical practitioners, including cosmetic surgeons, who practice medicine in Ireland must be registered in the Register of Medical Practitioners which is maintained by the Medical Council. Furthermore, since May 2011 in accordance with Part 11 of the Act, all registered medical practitioners are required to maintain their professional competence on an ongoing basis. My Department is in the process of preparing legislation to make it mandatory for all medical practitioners engaged in clinical practice to have adequate clinical indemnity insurance. It is proposed to have this legislation in place in 2012.

It is also recommended that people who avail of the services of doctors performing cosmetic surgery should ideally discuss this decision in advance with their general practitioners and should endeavour to seek the services of reputable providers. When invasive procedures are being arranged, people are strongly advised to check that the services are provided by a medical practitioner who is registered in the appropriate division of the Register of Medical Practitioners with the Medical Council. Before agreeing to undergo any procedure, people should also ascertain the level of follow-up medical support which will be available to them after surgery.