Catherine Murphy (Kildare North, Independent) | Oireachtas source

I missed some of the debate and hope I will not repeat what somebody else has said. One thing we are pretty good at in this country is looking at something that has not worked elsewhere and then trying it out here to see whether it works here. Volume 9, issue 3 of The Lancet in 2010 referenced a Canadian study on the issue of generic drugs. The article stated that doctors, patients and advocacy groups in England and elsewhere are concerned that generic anti-epileptic drugs might not be therapeutically equivalent to branded drugs, which could put patients at risk of break-through seizures or adverse events. It went on to say that according to retrospective review - which is as conclusive as one can get because one can see how something played out - of medical and pharmacy claims in Canada, the rates of switch-back to a branded drug after generic substitution were greater for AEDs than for non-AEDs. Also, health care costs were greater in patients who received generic medication compared to the branded version.

The Canadian study appeared in the Neurology academic journal in June 2009, Volume 72, No. 24. The conclusion stated that multiple generic substitution was significantly associated with negative outcomes, such as hospitalisations, injuries and increased health care costs. Furthermore, the risk of head injury or fracture was almost three times greater in patients who switched from one generic version to another compared with patients who continued on a branded version. This is quite conclusive and comes from a very reputable source. Generic substitution has been tried, but has had to be reversed. Why do we ignore this kind of evidence as we are doing here?

Deputy Shortall suggested that if the Minister of State was not willing to accept these amendments, he could use some other mechanism to deal with the issue. For example, he could insert a section that would allow for a ministerial order at some stage so that we do not have to come back with primary legislation in order to change a provision if we discover it is necessary. We may discover that what has happened elsewhere happens here also. We are not of a hugely different genetic make-up to the rest of the world and if something has happened elsewhere, it is likely the same experience will occur here if drugs are interchanged and outcomes are poorer as a consequence.

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