Bernard Durkan (Kildare North, Fine Gael) | Oireachtas source

It is a race against time every morning. I thank our witnesses for coming before the committee and for the detail given in their submissions. It is hugely important in respect of an issue of this nature that adequate information is made available and that the integrity of the treatment is protected.

The benefit-risk assessment carried out has been fairly thorough. Are the witnesses satisfied that it is sufficiently firewalled and that the products are sufficiently firewalled within the system to ensure they do not fall into the wrong hands or that access is not given to those who should not have them - in other words, that they are strictly for medicinal purposes by the authorised people? That is the first question.

The next question is in regard to reimbursement. Are we satisfied that the reimbursement system is sufficiently responsive and active in its dealings with the patients?

My third question is in regard to the patients deemed to be in need. I know there were 34 applications and I got the information in regard to the volumes so far. Are the witnesses satisfied that the patients who are deemed to be in need, and who will benefit from access to the treatment, are getting access in sufficient time? In other words, is there sufficient access without there being a danger of damaging the integrity of the whole process? Those are my three questions.