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

I had hoped that with the passage of a couple of weeks since we last debated the issue on Report Stage the Minister of State might take a different view. I regret, however, that he remains solid in his opposition to the proposed amendments from me and my colleagues in this regard. I draw to his attention what amendment No. 4 states. It proposes to insert the phrase, "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...". The phrase is "shall ... have regard to". This was a compromise draft following what I had argued for on Committee Stage. What I presented on that Stage was far more specific and firm in its intent. I cannot understand why there is no inclusion of an acknowledgement of the special concerns that are particular and, I believe, unique to people with epilepsy. In this instance, the amendment only affirms that the need for due regard in terms of efficacy and safety would be incorporated in the legislation. It is not a lot to ask. It would not, of itself, lock those responsible into specific actions. However, it would require due regard in terms of efficacy and safety. These are at the core of the concerns of people with epilepsy and at the heart of the campaign of the Irish Epilepsy Ireland with regard to this legislation. It supports the legislation, but, as we do, it wishes to have it fit for purpose and applicable in all situations. It is not as if we are looking at a case of "what if?" As I told the Minister of State previously, there is ample evidence that substitution or the provision of interchangeable medicines has led to adverse consequences, not only in the international experience, which has been cited to us, but also domestically in relatively recent times. It is incumbent on us, as legislators, to ensure the legislation properly reflects the combined knowledge and wishes of Members of the House. The Bill without a reference to this very important concern gives no such indication in this regard to those who will be responsible for implementing its provisions.

I appeal to the Minister of State to reconsider amendment No. 4. Its wording would not place anybody in an uncomfortable or unreasonable position but would properly recognise the special case real concerns of epilepsy sufferers and their families regarding AEDs and their substitution and interchangeability.

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