07-06-2018 | FACS Forum welcomes Oireachtas committee report on Sodium Valproate

07 June 2018
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The FACS Forum has welcomed the findings of the Oireachtas Health Committee report on Foetal Anti-Convulsant Syndrome (FACS) and is pleased that it agrees with the key points made by the Forum at last month's hearing. The FACS Forum now urges Minister for Health Simon Harris TD to act swiftly upon the report's recommendations.

The Committee, chaired by Dr Michael Harty TD, emphasised their support for those affected by FACS and makes a number of recommendations which are intended to address the concerns raised by Epilepsy Ireland, OACS Ireland and other member organisations of the Forum.

Deputy Harty states: "The Committee urges that prompt access to adequate services is made available to families affected by FACS. The Committee also recommends that all stakeholders collaborate to ensure these families receive this support. It is noted that individuals with FACS are not affected by chance but by the failure to adequately inform and counsel women who were prescribed valproate medicines.

He adds: "Further examination is required to establish liability but regardless of the causes, the Committee is of the opinion that the State has responsibility to assist all those affected by FACS."

The report includes 12 recommendations:

  1. Full and immediate implementation of all of the European Medicines Agency measures announced in February.
  2. Continued close collaboration between the HSE, HRPA and the FACS Forum to achieve implementation.
  3. All risk reduction measures to be reviewed regularly to ensure effectiveness.
  4. Establish a register to record individuals who were prescribed valproate during pregnancy and all individuals affected by FACS. 
  5. This register should be supported and resourced by the HSE or HPRA
  6. A high priority to be given to the establishment of a central point of reference for those affected by FACS. 
  7. Responsibility for this central point of reference be delegated to either the HSE Valproate Response team or the HPRA-led stakeholder group. 
  8. Children exposed to valproate to be assessed and diagnosed as appropriate 
  9. A HSE liaison officer to engage with families affected by FACS and a full suite of services to be agreed with families within 8 weeks of the publication of the report. 
  10. The HSE to report back to the Committee on progress in establishing support services within 12 weeks of the publication of the report. 
  11. The establishment of an independent investigation to examine the historical use of valproate in Ireland and into its ongoing effects
  12. Further consideration and examination to be undertaken with regard to compensating FACS patients. 

The report also emphasises that collaboration is vital and with Government support, it is necessary to respond accordingly in the following areas:

  • To provide adequate support to those affected by FACS;
  • To ensure measures are implemented to avoid future cases of FACS;
  • To investigate the historical use of valproate and how inaction resulted in cases of FACS.

The committee states that in order to address the matter comprehensively, time and resources will be required. However, the report also notes that some of the outstanding concerns require immediate action and "should be considered as a high priority". 

The full report can be downloaded below.

Attached Documents

PDF icon Oireachtas Committee Report on Valproate & FACS (Joint_Committee_on_Health_Report_on_Foetal_Anti-Convulsant_Syndrome_310518.pdf | 700 kB)
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