Dr. Joan Gilvarry:

I will come in on that. Somebody said there was a rush to approval of products. There is never a rush to approval of products. They must meet pre-specified quality, safety and efficacy data and that is continually monitored throughout the life cycle of that product. We get periodic safety update reports from the company. We continually monitor adverse reaction reports and detect signals through the European database. If there is a red alert, as the Senator calls it, it can be referred immediately by us or any other member state to the European committee for a full scientific review. That is what happened here.

As Mr. Murphy said, we have extensively and repeatedly communicated on the product to healthcare professionals in recent years and the problem is that the message is not getting through. We regulate the product. We recently asked the HSE, the clinical leads and the lead in primary care to come in to us to see how they can help us get the message through to the GPs via the neurologists, to the prescribers via the psychiatrists, and also to the pharmacists via the Pharmaceutical Society of Ireland, PSI, which was represented at that meeting. We are not in the doctor's surgery when the doctor is prescribing and talking to the patient. We are not in the pharmacists when the medicine is being dispensed, but all of these are trying to assist us now. The PSI recently sent communications to other pharmacists to make sure the package leaflet and the patient alert card is given at the time of dispensing, and the head of primary care has written to all the GPs to tell them they need to identify the patients who are on this treatment at this time. They are following up, which is very good and I appreciate it, with the GPs in terms of identifying the patients who are women of childbearing age whom they have on this medicine.

We need help to implement all our recommendations. We cannot do them alone. We need the pharmacists, the HSE, the neurologists, the GPs, the psychiatrists and everybody in the healthcare system to listen and implement what we have been saying for years.