Róisín Shortall (Dublin North West, Independent) | Oireachtas source

I have not heard that. The Moran report has made it clear that the generic substitutes for drugs for persons with epilepsy that are listed among the categories for use and for prescribing for people with epilepsy are currently not safe. If the Minister accepts that, action must be taken to avoid the potential risk for people in the event - and it is not an unlikely event - that somewhere along the line they would be given a generic substitute for their epilepsy drugs, either by a prescribing doctor, consultant or nurse or by a pharmacist. As far as I can see, the Minister of State is not in a position to give a guarantee that that will not happen and therefore there is a real and substantial risk that it could happen in certain cases. The impact of that is potentially very serious for the person concerned and it could be catastrophic.

A case was brought to my attention recently of a young woman who has epilepsy that is very well controlled by the medication she is on. She is living a full and independent life as a result of that medication, but recently she changed consultant and her new consultant decided to change her medication. That has had a hugely negative impact on her life because the change in medication, which was done professionally and so on, has resulted in daily fits, so that she is unable to go to work or drive and is highly dependent on her parents to manage from day to day. This illustrates the delicate balance involved in proper prescribing for an individual with epilepsy. Getting that balance of medication right for a person with epilepsy is a huge challenge. In switching a person to a substitute drug, the potential for hugely life-limiting implications is very real. I cannot see how, under these arrangements, we can avoid a situation in which a person with epilepsy may be prescribed or given a generic substitute for their epilepsy drug. I cannot see how we can prevent that from happening. This point is not being made regarding all epilepsy drugs per se but in respect of epilepsy drugs prescribed for people with epilepsy. There are real risks in this regard. I am not in any way reassured by the points that have been made so far that the system being proposed under this legislation is sufficiently robust to avoid that kind of risk.

As I said earlier, there is evidence that generic substitution is already taking place in the case of antiepileptic drugs, AEDs, for people with epilepsy in the hospital setting. It is all very well to give an assurance in the House that this will not happen, but it is already happening in certain circumstances. Nothing that has been said here today gives any kind of reassurance that those issues will not continue to arise and that mistakes will not be made, irrespective of the kind of guidelines given.

If the Minister of State is not prepared to accept these amendments, which provide for a reasonable approach to the issue could he, even at this late stage, give a firm assurance to people with epilepsy and state clearly that no person who suffers from epilepsy will be subject to generic substitution on those medications where it is unsafe to do so? Will he give a clear and categorical assurance in the House today that this will not be the case where AEDs are substituted in the case of people with epilepsy?

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