Alex White (Dublin South, Labour) | Oireachtas source

As Deputy Caoimhghín Ó Caoláin identified, the amendments in the next group deal more specifically with AEDs but we have started the debate in this group. The specifics of AEDs is more germane to the next group but I will deal with the issues raised in this group of amendments and again when dealing with the next group. We are dealing with amendments Nos. 1 to 3 and they seek to introduce a new definition of a non-interchangeable medicinal product in the Bill. A non-interchangeable medicinal product is defined in the amendments as a medicinal product that is not interchangeable with any other medicinal product as provided for under section 5 of the Bill. The framework of the Bill provides that the IMB establishes and maintains a positive list of interchangeable medicinal products under the provisions of sections 4 and 5 of the Bill.

This approach is consistent with the recommendations set out in the Department of Health-HSE report entitled, Proposed Model of Reference Pricing and Generic Substitution, or the so-called Moran report of 2010.

While some countries maintain a negative list of interchangeable medicinal products, I do not consider it appropriate to maintain both a positive and a negative list in this Bill, which is what is proposed here. A positive list means that only products on this list may be substituted. Some countries have negative lists, that is, the substitution of all medicinal products permitted with the exception of specified medicinal products. A positive list of interchangeable medicinal products is considered more desirable from a patient safety perspective and in those circumstances, I do not propose to accept these amendments.

I thank Deputies Murphy and Shortall for their overall support for what this Bill seeks to achieve and I very carefully note it. I agree with what Deputy Murphy and others have said about the concerns people with epilepsy have in regard to their medicines. As politicians, we have all received representations and I have met members of the Irish Epilepsy Association. I have a personal knowledge of this area as people close to me have had epilepsy. I have an appreciation of what has been said about the implications for people and their medicines and the necessity for and importance of stability, which Deputy Murphy rightly pointed out.

Deputy Naughten and others asked me to genuinely consider this issue, which I have done. I have thought very carefully about it, as a Minister should, have met representatives of the Irish Epilepsy Association and have discussed it on a number of occasions with officials. I have gone through it very carefully and assiduously.

I emphasise the point, as I did on the last occasion, that we are not substituting medicines in this exercise. What I am asking the House to do is to agree to a statutory regime to be put in place to enable the responsible body to consider whether it should substitute medicines in particular circumstances. It is very important we remember that distinction. I do not have to remind Members of this House of that, and I do not want anybody to be offended that I make the point in those blunt terms. We are not being asked to substitute or otherwise anything in regard to particular medicines; we are being asked to put in place a statutory regime.

The expert body, the Irish Medicines Board in this instance, should have the level of trust not just from this House but publicly to do what it is required to do. It must follow - I refer to Deputy Shortall's question about guarantees - the very rigorous requirements set out in the Bill which it must honour, apply and have regard to if it is to consider the substituting of any medicine. The answer to the question about guarantees is what the House is doing in this legislation - that is, it is putting in place these rigorous requirements on the Irish Medicines Board, to which it must have regard. It is not a question that it may or it might have regard to them; it must have regard to these criteria which are quite clear and rigorous. I am asking the House to agree that they will be set out in legislation.

Deputy Naughten said that will not happen. It may not happen but it is a matter for the Irish Medicines Board - the people who are expert and who must carry out this work in the context of the requirements set out in the Bill - to make that decision. That is what I respectfully ask the House to acknowledge and agree to, that is, that it should be a matter for the Irish Medicines Board to consider this. All we are being asked to do is to put in place a statutory regime. The guarantee of and the requirement for safety are adequately dealt with in what we are asking the House to agree to in the Bill in terms of the various standards and criteria which have to be applied.

I think Deputy Murphy raised the question of the UK. I can advise the House that there is no official list of medicines considered unsuitable for generic prescribing in the UK but the national prescribing centre there makes the following comments regarding anti-epileptic medication. It states that loss of seizure control has been reported in patients after switching brands of epileptic medicines and that continuity of the same brand or the same generic preparation is recommended. Deputy Murphy mentioned that continuity is extremely important.

I mentioned the Moran report about which we should be absolutely clear. That report referred to medicines and types of medicines which, in general, would not be regarded as interchangeable. Appendix D to the report states: "General circumstances where medicines will not be regarded as interchangeable (on the basis of current evidence and manufacturing standards) include the following". It provides an extensive list, which I will not go through but which includes anti-epileptic medicines. The report refers to medicines and the types of medicines which, in general, will not be regarded as interchangeable. The report does not a call for a statutory exclusion of a medicine or group of medicines.

I fully appreciate the points Deputies raised and the concerns they have but the job we are being asked to do is to set out a statutory framework. Let us put in place a statutory framework and rely on the Irish Medicines Board to carry out the task required of it within the context of the rigorous criteria set out in the Bill.

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