Denis Naughten (Roscommon-South Leitrim, Independent) | Oireachtas source

This is an important issue and we have received many representations on this. We have also had hearings and I want clarification. I thank the Minister of State for his response. I again refer to the shoe analogy. If he goes into a shoe shop tomorrow morning to buy a pair of shoes and picks a pair out and the retailer says he has another pair in the same size that look the same but are €20 cheaper, he would not buy them without first trying them on and that is the difficulty for someone with epilepsy. It might say the same thing on the tin and that will be the case because if it is a generic medicine, it will be a substitute for whatever is the market leader. There is a niche in the market and some of the largest players in generic medicine in Europe are based in this country. They are successful and they can see a market leading drug that is coming out of licence. They will manufacture this product, which is supposed to be the same as the product on the market. It would not be a generic medicine if that was not the case. That is grand for 99.5% of the population but there are people who, for one reason or another, will have a reaction to the medicine, possibly because of the way it is formulated and so on. We can identify a cohort of the population who have a problem with generic substitution, that is, epilepsy sufferers.

The Minister of State said section 7(1) provides reassurance that substitution cannot happen if there is a clinically significant difference in the efficacy of the drug. I fully accept that but the difficulty is there is not in many cases a clinically significant difference between the two groups but, on an individual basis, people react differently because of the type of condition epilepsy is and the legislation cannot make provision for this because of the way it is worded and because of its purpose.

The other issue is a greater concern, which we will deal with later under section 13, but it was referenced by the Minister of State in arguing his case. He said in regard to substitution that the IMB will progressively go through a number of different medications and it could be a while before it gets to AEDs or other substitute drugs for epilepsy sufferers. The difficulty is pharmacists are substituting medicines at the moment and they are not even telling the patient that they are substituting the particular medicine.

As stated, we will return to this matter when we come to section 13. However, what I have described is happening. If that is the case and statutory provision has not been made, how can the Minister of State assure us that it will only apply to the 20 target groups in question once the legislation has been enacted? It is already happening, which runs contrary to the provisions in the existing legislation.