Alex White (Dublin South, Labour) | Oireachtas source

Deputy Denis Naughten was not here when I made the point about listening to and respecting people, which I do. I have listened carefully to every word stated about this issue. I am not persuaded by the Deputy and other colleagues that the way to proceed is to provide for a hollowed out statutory exemption.

On the point made by the Deputy about human error always being a possibility in these cases, what is proposed does not arise in circumstances other than where the generic product is already on the list. The question of the consultant also does not arise, although that is an additional safeguard in circumstances where a decision has been made to substitute a medicine. There is no requirement for the protection of the "do not substitute" clause, unless the medicinal product concerned is on the list in the first instance. The safeguards are set out clearly in the legislation.

Deputy Caoimhghín Ó Caoláin has asked why I cannot accept amendment No. 4 because all it does it seek that the board have regard to the desirability with respect to efficacy and safety. With respect to the Deputy - I say this with some force, justifiably so - the criteria set out in section 5 are stronger than what is proposed in amendment No. 4, which seeks that the board have regard to the desirability with respect to efficacy and safety. Section 5(7) states:

The Board shall not under subsection (2)(a) or (4)(a) add a medicinal product to a group of interchangeable medicinal products if the Board is satisfied that--(a) there is a difference in bioavailability between the medicinal product and the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products which may lead to a clinically significant difference in efficacy between them,

(b) the medicinal product contains more than 2 active substances...

Subsection (7)(e) states:

...the medicinal product cannot be safely substituted for each of the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products.

The precise reference to "efficacy" also occurs in the course of the section. The concern which the Deputy's amendment seeks to address is, with respect, better dealt with in the body of the Bill than, perhaps, he accepts.

Deputies Billy Kelleher and Catherine Murphy spoke about fear. Fear is real in the sense that people have reason to be fearful in respect of their own health and well-being and they look to politicians and the Government to allay these fears. I accept this. We do this not by shying away from legislation because it might be better not to address an issue in an Act but by putting in place systems which ensure trust in public institutions, particularly regulatory bodies, established by the House. Fear should be addressed by having in place robust, expert public institutions such as regulatory bodies such as the Irish Medicines Board. I sympathise with Deputy Catherine Murphy in having assiduously researched this issue. While we have a great deal of expertise - or at least claim to have - we are not scientists. We are giving responsibility for this matter to the Irish Medicines Board and should join together and trust it, as an institution, to do what is required. In that way, we will allay people's fears.

It would not be appropriate to include an authority in respect of a ministerial order. What would that achieve? It would mean we would be contemplating a situation where the Minister should step in to overrule the IMB. In other words, the IMB would do something which the Minister thought was wrong and would have to overrule. That is the wrong way to go about processing legislation. We must trust institutions but set down in legislation onerous criteria to ensure they do the job we want them to do.

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