Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein) | Oireachtas source

-----under section 5 on the issue of anti-epileptic drugs, AEDs. I again record the fact that it is deeply regrettable that we were not able to pursue the amendments we have validly tabled. I would like to share with the committee a case of which I have become aware. The person has epilepsy but it was controlled by the medication he or she was using. It takes some time to get to that point, as it is a matter a trial and error. However, at end of last year a substitute was introduced which had very clear adverse consequences for the person. Such situations are real. It is not a matter of an alleged fear; rather, it is a reality that will present not for all of those concerned but for some of them. It is out of concern for that particular cohort of people who suffer from epilepsy that we had sought to deal with this point.

I am not surprised that the Irish Medicines Board has presented this document to us. It was here when we walked into the room and we did not have prior sight of it. The position was explained by the Chairman; it was not his fault or the fault of the secretariat. This is very much what the Irish Medicines Board would say - namely, that these people are adequately protected and the matter is catered for within the legislation - but I am not buying that. International practice shows us that five member states of the European Union, including our nearest neighbour, already accept and provide for the exclusion of AEDs from such provisions, given the experience and knowledge they have regarding the particular need of those with epilepsy for very refined medication. Make no mistake about it; that should not be a surprise to any of us. The issue of the address of epilepsy is not only for the body but is very much of the mind. This is an area of very particular and specific address and science; it is something not to be played with.

The consequences for people of a resumed attack, an epileptic episode or a seizure are huge. A person who has been seizure-free for a number of years would be able to drive and, hopefully, hold down a job if he or she was fortunate enough to have one. A range of things are immediately turned on their heads if a further event takes place. We need to be cognisant of all of that in our deliberations on this matter.

I again ask the Minister of State to refer to the points I have made in terms of notification. We are talking about five amendments which deal with the ongoing maintenance of the list, etc., and the timeframes with regard to pharmacists, prescribers and the general public. Can the Minister of State elaborate on any or all of that? What about the point in regard to the do-not-substitute requirement, under which the GP is obliged to write in his or her own handwriting a "Do not substitute" message to the pharmacist? Will the Minister of State address that point and the consequences for the pharmacist in that situation? What should the pharmacist do in such a situation as it presents?

With regard to the prescribing of ingredients rather than named products - this applies to those who suffer from epilepsy but also to others - that was something the troika had argued for, and it needs to be addressed. Will the Minister of State advise what his notes in preparation for today's exchange indicate on these matters?