Dr. Almath Spooner:

I thank members for their thoughtful questions, which I will try to answer as sequentially as possible. Deputy O'Reilly asked how we will monitor impact, which is a critical question because as well as looking back and learning lessons, we need to work together to ensure that future generations are protected. It is important to emphasise that at this point, we have taken the most definitive regulatory step possible. We have contraindicated the use of sodium valproate - Epilim - in women of childbearing potential unless the requirements of the pregnancy prevention plan are followed. Following amendment of the licence, it is now a requirement of the licence that the pregnancy prevention plan is implemented, which is an important change. We have tried communication. We are moving from process to impact. The objectives and the goal of risk minimisation is that women of childbearing potential will have full information on the risks, with the overall goal being that exposures and pregnancy are avoided. We do not want to see future children harmed by this medicine.