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

I support the comments made by Deputy Murphy regarding the research in Canada and the fall-out from the introduction of interchangeability of AEDs in Canada. The Canadians have seen the errors of their way and there has been a knock-on fall-out as a result in the context of additional costs for the health service for people with epilepsy presenting with conditions associated, directly and indirectly, with the substitution of their branded AED. It is important to reiterate that we are not against using generic medicines for people with epilepsy. What we are against is the interchangeability of a particular medicine.

I am sure the Minister of State has spoken with the Irish Medicines Board, IMB, on this issue and I am sure the board has indicated to him that it is very unlikely AEDs will ever fall into the interchangeability category. However, in light of the consistent research that has been conducted across the world on the interchangeability of AEDs, it surely makes sense to provide legal certainty to people with epilepsy by ensuring AEDs are removed from the list of medicines possible for interchange at some date. I realise there are issues with including this in primary legislation, but an alternative would be to make provision for a statutory instrument to be published in tandem with the legislation.

This secondary legislation could specifically state that AEDs will not fall into this category. The secondary legislation could also deal with the list published in the Moran report and provide for it to be altered at a future date as medical research changes. A statutory instrument provision would, at least, give statutory reassurance to people with epilepsy, something they do not have currently. It would also send out a clear message to them. The fear is that once this legislation is enacted, a carte blanche approach will be taken in regard to drug substitution. We know that is not the case and that each case will be dealt with by the IMB. However, all we need is for one mistake to be made somewhere along the prescription line for an individual and this could have long-term consequences for that individual.

If the Minister of State is not prepared to amend the legislation in order to make a specific provision in regard to AEDs, will he at least give a commitment to making a provision that will allow him introduce secondary legislation that will make specific reference to AEDs where they are being prescribed for people with epilepsy so that they will not be prescribed on an interchangeability basis.

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