Finian McGrath (Dublin Bay North, Independent) | Oireachtas source

I thank the Senator for raising this important issue. I accept it is a hugely important issue which criss-crosses my own portfolio relating to children with disabilities. As she noted, the Oireachtas Joint Committee on Health recently published a report on sodium valproate and the foetal anticonvulsant syndrome, FACS, following a meeting with FACS Forum Ireland, the Health Products Regulatory Authority, HPRA, and the HSE. The joint committee's report includes a number of recommendations, all of which are being considered and are being implemented by the HSE, the HPRA and my own Department. The first three recommendations made by the joint committee relate to measures recommended by the European Medicines Agency, EMA, on foot of a review of valproate medicines which took place in 2017 and early 2018. Following the European Commission's decision to endorse EMA recommendations, valproate medicines are now contraindicated in women who are able to have children, unless the terms of special pregnancy prevention programme are met. This programme includes measures to ensure patients taking Valproate are fully aware of the risk and the need to avoid becoming pregnant while taking it.

I am happy to report the HPRA has made significant progress in implementing the EMA's recommendations that fall under its remit. In March, for example, the HPRA approved an application to include a warning on the outer carton of the drug packaging in the form of a visual symbol and box warning. The HPRA also approved an application to include a visual warning symbol on the drug's blister pack. In early June, the marketing authorisation holder distributed the new Valproate educational materials approved by the HPRA to all relevant healthcare professionals and patient groups. These educational materials include a patient guide, a healthcare professional guide, a patient card and an annual risk acknowledgement form, as recommended by the EMA. Several of the recommendations made by the joint committee relate to providing a clear diagnostic pathway for children suspected of having FACS, and establishing support services for children and families affected. This ties into the work of the HSE Valproate response team which developed a draft plan to address these particular issues. Officials in my Department and the HSE are working together to identify the requirements for infrastructure and resources. The joint committee also made recommendations concerning an investigation into the historical use of Valproate, as well as a consideration of the issue of compensation.

There are several projects planned or early in progress that will give us a much clearer picture of the numbers affected by FACS., and of the information provided to patients and doctors at different points since the drug was fully licensed. It is appropriate to allow these projects to conclude in the first instance.

Finally, I will need to give the issue of compensation further consideration, as recommended by the committee. This issue is particularly complex given the number of different parties involved to one degree or other, where a woman is prescribed and dispensed sodium valproate.