Tuesday, 18 June 2019

Ceisteanna (469, 470, 471, 472)

Mattie McGrath

Ceist:

469. Deputy Mattie McGrath asked the Minister for Health the person or company that is the marketing authorisation holder for sodium valproate marketed here as Epilim; if the Health Products Regulatory Authority is the body that granted the marketing authorisation here; and if he will make a statement on the matter. [25476/19]

Amharc ar fhreagra

Mattie McGrath

Ceist:

470. Deputy Mattie McGrath asked the Minister for Health if liability has been established as to the person or body responsible for the failure to prevent pregnant women and their unborn children contracting foetal anti-convulsant syndrome as outlined in the report by the Joint Oireachtas Committee on Health on this matter; and if he will make a statement on the matter. [25477/19]

Amharc ar fhreagra

Mattie McGrath

Ceist:

471. Deputy Mattie McGrath asked the Minister for Health if a compensation fund is being made available to those affected by foetal anti-convulsant syndrome; and if he will make a statement on the matter. [25478/19]

Amharc ar fhreagra

Mattie McGrath

Ceist:

472. Deputy Mattie McGrath asked the Minister for Health if a reason has been established as to the reason there was a delay in notifying Irish users of sodium valproate, known as Epilim, regarding risks associated with its use; the reason information on the risks to pregnant women was first included in UK in 2002 but the same information did not appear here until 2008 (details supplied); and if he will make a statement on the matter. [25479/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

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.