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

The Minister of State's response is disappointing. These concerns are not vexatious or frivolous in any way. As other Members have stated, there is not a queue of people objecting to generic substitution. The group to whom we refer is the only group objecting. It is doing so on very good grounds.

Does the Minister of State accept that it is not currently safe to substitute generic drugs for AEDs? If so, does the Department not have an onus to put in place the kinds of safeguards that are required? In the absence of those safeguards, one is depending on the individual patient's full awareness of his or her condition and the dangers associated with generic substitution. The patient would have to be very alert to the dangers associated with prescribed medications. One is also depending on all general practitioners being fully aware of the circumstances. That is not necessarily the case. We should also bear in mind locums, hospital prescribers and pharmacists. Everybody along the chain needs to be fully aware of the inherent or very real dangers of generic substitution of AEDs for people with epilepsy. That is a big ask. I do not have confidence that there is sufficient awareness throughout the prescribing chain.

Why is the Minister of State not prepared to include in the legislation the requested safeguards? He has not provided an explanation for that. While in the majority of cases generic medicines are absolutely safe, they are not in the case of AEDs. While medications may be perfectly safe for people with certain conditions, it does not follow that they are safe for people with every condition for which they are prescribed. Does the Minister of State accept the basic point that it is not currently safe to substitute generic medicines for AEDs? If he accepts this, why is he not prepared to provide the safeguards?

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