Alex White (Dublin South, Labour) | Oireachtas source

The fear that Deputy Naughten talked about is the fear of something that may happen in the future. The fact is that we are giving direction. Deputy Ó Caoláin should note that we will be giving direction in the legislation, if it is passed, because we are setting out the criteria that the Irish Medicines Board will be required to follow.

We are giving a direction in that regard.

On the question of safety, interchangeability and the experience overseas, there are six main classes of anti-epileptic drugs, AEDs, and a number of medicines in each of these classes. The Irish Medicines Board has reviewed the policy on interchangeability of AEDs in a number of countries, including Denmark, Sweden, the United Kingdom and the Netherlands. Some AEDs are listed as interchangeable in some of these countries but not in others. The board points out that where a medicine is not listed on a country's website, it has no further information on it. However, there may be a number of reasons for a medicine not being listed, including that it is not authorised in the country or that the list only contains medicines which are subject to reimbursement. In addition, there may be practise guidelines in operation in the country of which the board is unaware. For example, in the case of the Netherlands the board advises that there is automatic substitution for an AED.

The Moran report was mentioned a number of times. It is important to point out again that the report does not contain a recommendation that there be a statutory exception made for AEDs. That is not so. The Irish Medicine Board's commentary in the report which I have read and will read again if I have the time, although I probably will not, is on the propriety or otherwise of medicines being interchanged, which is the type of issue with which the board will have to deal when it arises. 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:

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 anti-epileptic and other drugs.]

2. Where modified release preparations are not interchangeable...

In its commentary the Irish Medicines Board lists the types of drugs which in its view will not generally be regarded as interchangeable. I have no doubt that the board will have regard to the literature, experience and expertise available in this area, as well as to the criteria set out in the Bill, which also draws from expert opinion.

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