Alex White (Dublin South, Labour) | Oireachtas source

I will try to make my original point in slightly different terms. The Irish Medicines Board will have a central role to play in what is contemplated in the legislation. I do not want any of those present - members, the Chairman and everyone else involved in the legislative process - to react to what I am about to say because it is not intended in a critical way. The point is that we cannot substitute ourselves for the Irish Medicines Board. The board has the relevant expertise in this area; not only that, it will also be required to carry out very robust tests under section 5. No one has said this; in fact, the opposite has been said. I appeal to colleagues not to, as it were, imagine that the Irish Medicines Board cannot be trusted in some way or that we have to keep certain elements of what is proposed away from its control. That would be the effect of providing for a statutory exclusion of a particular drug or class of drugs. We should proceed with the Bill in accordance with the scheme we have put in place and trust and have confidence in the Irish Medicines Board in what we are calling on it to do with regard to AEDs or other drugs.

I wish to make matters absolutely clear in respect of the Moran report. I understand why it might be interpreted as having recommended that AEDs be excluded.

It does not recommend the exclusion of AEDs. The Moran report sets out ten criteria in terms of interchangeability which the Bill reflects. It then states:

General circumstances where medicines will not be regarded as interchangeable (on the basis of current evidence and manufacturing standards) include the following:1. Where there is a difference in bioavailability between brands of the same medicines, particularly if the medicine has a narrow therapeutic index. Changing preparations may result in sub-therapeutic or toxic doses. Products in this group include the following anti-epileptic medicines ... CFC-free Beclomethasone metered dose inhalers, etc.

The report is essentially stating anti-epileptic drugs are examples of the types of drugs that should not be considered for interchangeability. If they are not interchangeable and the report is correct, they would not pass the test as set out in section 5. We are setting out the test which the Irish Medicines Board must observe. I appeal to colleagues to communicate trust and confidence in the board, as Deputy Peter Fitzpatrick said. The legislation sets the statutory basis and it is up to the board to carry out this important work.