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Parties support investigation into sodium valproate prescription

Sinn Féin has committed in its election manifesto to investigating the prescription of sodium valproate (Epilim), an anti-epileptic medication that can cause serious harm to the foetus in pregnancy.

The party’s general election manifesto, launched yesterday, commits to “investigating use of sodium valproate” and creating “dedicated healthcare pathways for those affected”.

A HSE-commissioned study has estimated that up to 1,250 children have experienced some form of neurodevelopmental delay and between 153 and 341 children a major congenital malformation, arising from sodium valproate exposure in utero from 1975 to 2015.

In 2018 the Oireachtas Health Committee recommended an independent inquiry and further consideration of the issue of compensation for families affected by foetal anticonvulsant syndrome (FACs).

However, outgoing Minister for Health Simon Harris had yet to decide on an independent investigation, and campaigners were due back before the Health Committee prior to the general election being called.

This week, Fianna Fáil’s health spokesperson Stephen Donnelly confirmed to the Medical Independent (MI) that he is “100 per cent” in favour of an independent inquiry “and I don’t understand how it hasn’t happened”.



On the issue of compensation, including whether the State or the pharmaceutical company may be liable, Mr Donnelly said “you can’t pre-empt a report”.

As matters stood, he said, the people affected were not getting the support they required from the State.

“These people have been treated very, very badly, and they have had to fight for every single support they get,” according to Mr Donnelly. “So regardless of any report, in my view they have been failed by the State, and they need a comprehensive package of supports in place for the rest of their lives. That has to happen anyway, but then we need a report, and if liability is established, if people knew things or if information was suppressed or anything like that, then that has to be looked at very seriously.”

The HSE has developed a report outlining a care pathway for affected families, but MI understands this has yet to be funded or implemented.

The Executive has said access to the pathway will only be open to those families with a diagnosis of FACS, a position criticised by Organisation for Anti-Convulsant Syndrome (OACS) Ireland, which has cited continuing delays obtaining a diagnosis through the pressurised clinical genetics service.

OACS Ireland and Epilepsy Ireland have continued to call for an independent investigation into prescription of valproate medicines.

The French Government has opened a compensation scheme for affected families, while a UK government-commissioned report examining how its healthcare system responded to concerns about sodium valproate (and two other medical interventions) is expected to be published in late February or March.

In 2018 the European Medicines Agency (EMA) announced new Europe-wide safety measures on sodium valproate as women were “still not always receiving the right information in a timely manner”, following previous measures announced in 2014.

Sodium valproate was licenced in Ireland in 1975, for treatment of epilepsy, and the licence was extended to bipolar disorder in 2008.

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