Mr. Peter Barron:

Our concern about that particular proposal was around the timeframes. Very tight timeframes are being proposed for - in our case - the HSE to come to a decision on whether a product should be placed on the reimbursement list. Our view was that the timescales originally proposed would be too onerous on our system. Thankfully, the proposed timeframes have been changed to give us some more time.

The timeframes now proposed under the legislation marry up with the timeframes in the Health (Pricing and Supply of Medical Goods) Act that was enacted during the summer. Our concerns on that score have been addressed.

A question was asked about what I said towards the end of my statement on the environment, public health and food safety, ENVI, committee. There was one error in my statement, which I dealt with when I delivered it. I said the proposals were examined by the ENVI committee in the European Parliament, and I then said the ENVI committee had voted in favour of pre-market authorisation, but that is a mistake. When I delivered the statement I said the ENVI committee had spoken in favour of pre-market scrutiny. The difference between the two is that pre-market authorisation would mean it would have to be authorised by a third party before it could be placed on the market. That is not where the committee is at. The committee is looking for pre-market scrutiny, which would fall somewhere short of authorisation. Again, I apologise for that.

Some of the other points might be more relevant to the IMB. Deputy Healy asked what was the current position with regard to unannounced inspections. The IMB might be in a better position to deal with that. In response to Senator Burke, my understanding is that there is a RAPEX alert system, but my colleagues from the IMB might address that. He also asked about the views of industry. It is fair to say that the industry, both at Irish level and at European level, is quite exercised about the proposals. There is an intensive lobbying campaign under way, particularly at European level. There are concerns among those in the industry that the proposals, if adopted in their current form, could give rise to delays in products coming on the market and additional costs. I could go into more detail but that is a good summary of the position.

Senator Burke also asked about plastic surgery. He is aware there are concerns about plastic surgery and cosmetic clinics. The Department intends to address that through legislation on the licensing of hospitals and health facilities generally. The intention is that the legislation would be broad enough to cover the activities of the cosmetic surgery operators to which the Senator referred. The proposals on that are at a very advanced stage in the Department. We would hope to go to the Government in the new year. In the meantime our chief medical officer has agreed some advice for people considering cosmetic surgery. The advice has been agreed with the Irish Association of Plastic Surgeons and it is on the Department’s website.