Denis Naughten (Roscommon-South Leitrim, Independent) | Oireachtas source

I will return to the point I made earlier. A young lady from Roscommon who contacted me in the past 24 hours is very fearful that her medicine may be substituted. Based on the criteria of the Irish Medicines Board – the Minister is correct that there are many checks and balances – and the recommendations in the Moran report, which states AEDs and a number of other medicines should not be substituted based on current medical evidence, there will not be any deliberate intention to introduce generic substitution for AEDs. If that is the case – I genuinely believe it is – why are we exposing individuals who require AEDs to the risks associated with the prescribing change?

The debate on the Moran report concerns whether there should be a statutory footing. The argument has been made by Epilepsy Ireland that placement on a statutory footing would ensure there will be no risks along the prescribing chain. Not only would there be the checks and balances, there also would be provision for the general practitioner to stipulate that there should be no substitution in regard to the prescription. The pharmacist, under section 50, has discretion not to dispense. Surely, therefore, rather than allowing a mistake to happen somewhere along the prescribing chain, would it not be far more advantageous to make a statutory provision specifically in regard to AEDs prescribed for the purpose of treating epilepsy? This would provide the clarity that is required and get rid of the unnecessary fear that is currently hanging over people who rely on AEDs to manage their epilepsy daily. The Government should deal with this issue once and for all. It should provide certainty and confidence in the legislation so we can all endorse its passage.

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