Jerry Buttimer (Cork South Central, Fine Gael) | Oireachtas source

We have received apologies from Deputies Catherine Byrne and Regina Doherty and Senators Imelda Henry and Jillian van Turnhout.

I remind members, witnesses and those in the Visitors Gallery to leave their mobile phones in the off position or airplane mode, rather than in silent mode, as they interrupt the broadcasting of the proceedings and interfere with the quality of the broadcast. They also cause angst to members of staff who must wear headsets.

The purpose of the meeting is to consider some European Union legislative proposals regarding the regulation of medical devices - COM (2012) 541 and COM (2012) 542 - and the pricing of medicinal products for human use - COM (2013) 168. We considered this issue earlier in the year and will now receive an update and clarification on same. We also requested an update on the position on De Puy hips and PIP breast implants, information on which was circulated to members in advance of the meeting.

I welcome from the Department of Health Mr. Paul Barron, assistant secretary; Ms Teresa Cody and Mr. Patrick Creedon, primary care unit; and Mr. Hugh Drumm, medicines unit; from the Health Service Executive Dr. Ian Carter, national director for acute services; from the Irish Medicines Board Mr. Pat O’Mahony, chief executive; Dr. Joan Gilvarry, director of human products monitoring; and Dr. Niall MacAleenan, clinical assessment manager and medical devices lead. They are all very welcome and I thank them for being here.

Witnesses are protected by absolute privilege in respect of their evidence to the joint committee. However, if they are directed by it to cease giving evidence on a particular matter and continue to do so, they are entitled thereafter only to qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against a person or an entity by name or in such a way as to make him, her or it identifiable. Members are reminded of the long-standing parliamentary practice and ruling of the Chair to the effect that they should not comment on, criticise or make charges against a person outside the Houses or an official by name or in such a way as to make him or her identifiable.

I thank the delegates for their attendance and invite Mr. Barron to make his opening statement.