Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein) | Oireachtas source

I move amendment No. 4:

In page 14, between lines 23 and 24, to insert the following:

"(3) The Board shall, in determining an application under subsection (2), have regard to the desirability with respect to efficacy and safety of refusing to add medicinal product in the anti-epileptic drug class, used in the treatment of persons with epilepsy for the purpose of preventing seizures, to the List of Interchangeable Medicinal Products.".

I am joined in presenting that amendment by Deputies Catherine Murphy and Billy Kelleher. As I indicated in the earlier engagement in respect of amendments Nos. 1 to 3, inclusive, this is the meat of what we are about in the Health (Pricing and Supply of Medical Goods) Bill 2012. Amendments Nos. 4 and 18 get to the nub of the issue. These amendments arise from the concerns of people with epilepsy. Concerns about the need to ensure that there is no inappropriate substitution of their medication is not a small matter: it is a hugely important issue. As he has indicated, the Minister is well aware of the concerns of people with epilepsy in this regard and has confirmed that today. There is a particular issue with regard to the precise formulation of anti-epileptic drugs, AEDs, and the concern that generic substitutions are not exact replicas and with possibly very negative consequences.

Other Deputies and I have received direct testimony during the course of hearings at the health committee, as well as through meeting individual sufferers of epilepsy and their representative voices in Epilepsy Ireland. That direct testimony from those who have suffered negative effects from unsuitable generic substitutes tells us this is a real issue. It is not a case that it might happen. The fact of the matter is that it has happened and the evidence is available to support this. People who moved to unsuitable generic substitutes have had to revert back to their original prescriptions to re-stabilise their circumstances. I know people with epilepsy and can assure the Minister and the House of the genuineness of their concerns in this matter. It is not about Opposition Members seeking some minor note that we have managed to amend a government Bill - far from it. It must be acknowledged, too, that each and every one of us on these benches indicated on Second Stage that we absolutely supported the Bill’s thrust and that we would be a party to its final passage.

Amendment No. 1 sought to include the definition of non-interchangeable medicinal products, but the Minister would not accept it, which is reflective of the Government’s general disposition to Committee and Report Stages amendments from the Opposition. The section covering definitions defines everything, including "the Minister", except non-interchangeable medicinal products. Including that definition would not have altered the Bill one iota, yet the Government voted down the amendment. Earlier, as indicated by a nod from the Minister of State, he accepted we were into the real core issue. I am deeply concerned that the Government is demonstrating that it is not willing to accept any change, that it knows best, that we are wasting our time going through a long examination of the minutiae of legislation, while offering, in good spirit, important, relevant and necessary amendments.

Those who have campaigned for the exclusion of AEDs, anti-epileptic drugs, from the terms of the legislation want to have their concerns recognised in the Bill. It is important that they have certainty. They have asked us, as legislators, to provide that certainty. Epilepsy Ireland has spent considerable time and, unquestionably, a significant part of its limited resources in a stoical effort to avert the problems that could present and which have already done so. I commend its efforts and record my disappointment that despite its sincere efforts, the necessary protections will not be built into the Bill. I am also disappointed that the stance being taken by the Government will see the rejection of amendments Nos. 4 and 18. As I put it to the Minister of State last week, I hope he will prove me wrong. I urge the Minister to accept these amendments in the spirit in which I and others have brought them forward. It is not an exercise to get one over on the Government; rather, it is an exercise to give proper and due service to the concerns of a cohort of citizens, concerns which the Minister of State has acknowledged and accepted. I cannot understand why the Government will not accept the validity of the amendments and act accordingly. I, therefore, urge the Minister of State to accept amendments Nos. 4 and 18.

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