Róisín Shortall (Dublin North West, Independent) | Oireachtas source

I support the Bill fully and commend the officials who have done so much work on it over so many years. It is finally wending its way slowly through the Houses of the Oireachtas. I am very aware of the many obstacles which have been put in its way over a number of years. It would be worthwhile to examine those obstacles more closely. The legislation is a welcome contribution to tackling the unacceptably high drugs bill in the State and should benefit the taxpayer and consumers. While I support the Bill generally, I also support the amendments proposed to safeguard the interests of people who suffer from epilepsy.

Like other Members, I have been contacted by representatives of people who have epilepsy to express their concern about the legislation. While there are certain safeguards in place and it will be open to a general practitioner to write "do not substitute" on a prescription, the Bill is not safe enough as far as people who suffer from epilepsy are concerned. It has been brought to my attention that some groups involved are aware of cases - mainly in the context of hospital prescribing - where unsafe generic substitution is already happening. I recognise the efforts the Irish Medicines Board has made to provide an assurance. Nobody doubts its bona fides and good work and there is no question of the board sanctioning deliberately an unsafe practice. However, the concern is that the legislation as drafted leaves open the possibility of unsafe substitute medicines being prescribed for people who suffer from epilepsy. That has very serious implications.

For the IMB to say it does not intend to do that is inadequate in the circumstances. There have already been unsafe prescribing patterns within hospitals. It is quite possible it could be repeated in GP surgeries. GPs operate as independent practitioners and the Department or the HSE does not have much of a handle on detailed prescribing patterns by GPs. It is reasonable to seek the safeguards requested and provided for in these amendments. I note the comments of the Minister of State on Committee Stage but it is necessary to go further. I ask him to reconsider his position in respect of the amendments. It is not currently safe to substitute generic drugs for AEDs for people with epilepsy. That is the bottom line and it is a legitimate fear people have. Unless the practice is specifically exempted in the legislation, it is quite possible it could happen in certain circumstances. I urge the Minister of State to rethink this.

He could go much further and give an assurance to people with epilepsy by stating clearly that no person suffering from epilepsy will be subject to generic substitution of the medications where it is unsafe to do so. That is the least the Minister of State should do. It will also be helpful, from the point of view of giving public reassurance, if the Minister of State outlined the implications for the IMB should it sanction any unsafe practice. That would be an important contribution to the debate. The only real safeguard that can be put in place is adopting the approach proposed in the amendments. I urge the Minister of State to consider them.

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