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

I support the amendments tabled. We debated this in detail on Committee Stage. The Minister of State knows we have received much representation across our constituencies and across the country. This comes from people with epilepsy or their families and concerns generic substitution. For 95.5% of the population, generic substitution is not an issue. It concerns only a small cohort of people, as has been articulated earlier. This is the only group that has articulated specific concerns regarding generic substitution. There is a genuine fear among people with epilepsy regarding substitution of AEDs. On Committee Stage I pointed out that a substantial amount of money is spent on AEDs on an annual basis. It amounts to some €75 million, of which €40 million is prescribed almost exclusively to treat neuropathic pain. Those with epilepsy and their advocates have no disagreement with generic substitution being used for that purpose. The issue concerns medicine specifically prescribed to prevent seizures. The Minister of State is putting the onus on the individual suffering from epilepsy.

The vast majority of people with epilepsy can function fully in society. An example is the late Joe Doyle, who was a Member of this House and the Upper House. However, a certain cohort have other illnesses or disabilities. They may have learning difficulties and may be reliant on elderly parents to collect their prescriptions and ensure they take it. We are now relying on GPs to make sure they put the "do not substitute" instruction on the prescription. In 99.9% of cases that will happen but anyone who works in the medical profession knows that GPs sometimes make errors, usually on repeat prescriptions. Who is responsible if a GP does not specifically include the "do not substitute" instruction on a repeat prescription and the person with epilepsy does not realise that the medicine has been substituted and it leads to an adverse reaction?

We should not introduce legislation that will cause unnecessary concern. The view of the Minister of State is that we will not see generic substitution of AEDs for people being treated for epilepsy. I do not think the IMB will introduce such a measure. In practical terms, GPs will include the "do not substitute" instruction in case there is a possibility that it will be substituted. We seek a safety net to ensure that anyone with epilepsy can go in with confidence, have the prescription refilled and ensure they receive the exact same medicine.

In correspondence with the committee, the IMB made the point that interchangeable medicines are those that have the same quality of and quantitative composition in terms of active substances. The difficulty with AEDs is that, even when these criteria have been met, there can still be a problem for someone with epilepsy. I was at the Science Gallery in Trinity College in the past couple of weeks, since our discussion on Committee Stage. I heard a presentation on thalidomide and it referred to the wrong stereoisomers included in the medicine. If its mirror image had been used, there would not have been the huge adverse reaction to it. In that case, quantitatively and qualitatively, it was the exact same medicine at the time. Thankfully, medicine has progressed significantly since that and we would hope not to see a replication of it. However, we want to ensure that all the checks and balances are in place and we look to dispel the fear in the community of people with epilepsy and their advocates.

I ask the Minister of State to examine the amendment. In practical terms, I do not think it will happen anyway. Why not put a belt and braces approach to ensure the legislation is watertight so that people with epilepsy have the confidence to pick up a prescription and ensure the prescription is filled at the pharmacy with the exact same medicine as heretofore? People can then take the medicine and be sure they will not have an adverse reaction.

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