Kate O'Connell (Dublin Bay South, Fine Gael) | Oireachtas source

Mr. Hennessy referred to the possibility of legislation for biosimilars similar to that for generics 15 years ago. That needs to be examined further than at a meeting of a health committee. That is not substitutable and I cannot imagine a situation where we would introduce legislation to force a consultant dealing with a complex condition to change medication based on a direction by the Oireachtas.

In his opening statement, Mr. Judge said there would be a governance review. Has this been sparked by anything?

I am very much on the same side as the witnesses. I understand the challenge of a pharmacist or a medic trying to balance budgetary constraints.

Following Deputy Brassil's contribution, it is of great concern, particularly in the case of Orkambi, that when there is a well-organised group, it can result in a situation where he who shouts the loudest gets what he wants. That makes me uncomfortable, both as a legislator and a healthcare professional. In light of Deputy Kelly's comments, while acknowledging the autonomy of prescribers to make decisions as they always have, it is not fair to say that a decision to jump over certain regulations can be equated to the use of exempt medicines in the normal scheme of things. There is much talk about conscience these days, but some of us might want to examine our consciences if we were answering those who shout loudest over those with no voice.

When pharma and economics blend, some of the language might come across as crass. However, ultimately, if €500,000 is being spent annually on a patient, someone else is not receiving something and that must be remembered. If we have given something to a particular group, does this committee suggest that we should give it do everybody or we take it away from those we did have given it to? It is easy for members to come here and throw out loose statements but, ultimately, it is a question of whether we take a medication away from somebody or whether we have a free for all.

I must leave now. I am in favour of there always being a level playing field, where if there must be a decision that goes outside the parameters, it should not be made in these Houses or by a Minister for Health but by a professional at the top of his or her game, namely a consultant operating in his or her specialism. Members who make representations have a responsibility when throwing out terms such as "life-saving" and "people are being denied a chance". Leaving aside QALY and health technology assessment, the reason many of these drugs are not mainstream is because the evidence base is not there.

People in these rooms and elsewhere talk about money for this and money for that, but there is a limited pot. This is difficult for the families affected and they are entitled to fight for themselves and what they want, but we have a responsibility and we must be reminded of it every so often.

I must leave as I have an engagement at 1 p.m. but I will read the replies if the witnesses wish to comment. I apologise for leaving.