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

As the Minister of State is aware, the Moran report - he probably has a copy of it in front of him - contains a recommendation to the effect that AEDs should be excluded from the terms of the promised legislation on generic substitution. That is my clear recall of what is contained in the report which was produced by a joint working group involving the Department of Health and the HSE. The line taken in the report should be both followed and adhered to. As other members and I have stated, the practice in many other jurisdictions - not only in Europe but elsewhere - must give rise to concerns in our proceeding along the course suggested. It is not the case that we should be using trial and error in respect of those who have found stability in their lives in the aftermath of a process of trial and error. The consequences of a misfit for those on anti-epileptic drugs could be absolutely life-changing. That is the real concern.

I am sure that, like me, other members have been advised of specific cases in the not too distant past in which substitution has occurred, perhaps in pharmacies, in the filling of prescriptions. I am not completely clear on whether substitution took place at that point or at the point where such prescriptions were actually written. However, that would be my guess. When substitution occurred, it gave rise to serious consequences. In one instance about which I am very clear, the patient was obliged to return to both their GP and their specialist and put back on the original branded product. In that case, it was not another generic substitute but a branded product. The incident to which I refer occurred at Christmas time. As the Minister of State is aware, when such an incident occurs, a patient must not have a seizure for a full 12 months before he or she can resume driving and a number of other activities. It is extremely important that those with epilepsy and who drive do not have occurrences or events which can significantly impact on the quality of their lives. The risk is too great. We should, therefore, adhere to what is recommended in the Moran report.

It is my view that we should press the amendment, but I do not want a division to occur. I intend no personal criticism of the Minister of State, but there is obstinacy in this matter. I support the Bill and also what it is intended to achieve.