I propose to take Questions Nos. 469 to 472, inclusive, together.
Sanofi is the current marketing authorisation holder for Epilim (sodium valproate) in Ireland. Sodium valproate was first authorised for use in Ireland in 1975 by the Health Products Regulatory Authority's predecessor organisation, the National Drugs Advisory Board.
Foetal Anticonvulsant Syndrome (FACS) is an umbrella term for a group of conditions that can affect some babies if they are exposed to certain anti-epileptic drugs (AEDs) in pregnancy. As the Deputy is aware, there is evidence that certain AEDs, including valproate medicines, are associated with an increased risk of birth defects, including congenital malformations and developmental delays. There are no plans at present to establish a compensation fund for people affected by FACS in Ireland.
The Deputy's statements concerning the information and recommendations on sodium valproate use provided in Ireland since 2001 are factually inaccurate. Following the Joint Committee on Health debate on sodium valproate in April 2018, both the Health Products Regulatory Authority and Epilepsy Ireland wrote to the committee's chairman to correct certain inaccurate statements made during the Joint Committee debate.