Kate O'Connell (Dublin Bay South, Fine Gael) | Oireachtas source

I thank all present for attending, particularly the witnesses and the parents of affected families. My view is that, regardless of the causes of the conditions the children have, the State has responsibility to assist those children and their families. I am a community pharmacist. I have dispensed valproate for years and have long been aware of the congenital issues with the prescribing of the drug. In many cases women have been stabilised on the drug since their teenage years and then start a family. My understanding is that there was a failure in the counselling of women who were taking valproate as to the appropriate treatment for them in regard to a transition from not wanting a baby to starting a family. Are the HPRA and the HSE happy that that failure has been rectified and there is no chance that any woman who has been long stabilised on valproate will slip through the net and not receive the appropriate counselling? For some patients, it is the only product that will keep their epilepsy under control. That causes a serious problem when such people want to start a family. Decisions must be made in such a situation. Changing the medication of a woman who is stabilised on epileptic medication while pregnant could be very dangerous to the mother and the developing life in her womb.

As regards the EU-wide response, are the Department and the other witnesses happy that the response in Ireland was as fast and robust as that of our European counterparts? Are we at the same level as other countries in that regard? Much information and many bulletins, stickers, leaflets and so on have been sent to community pharmacists and I am very happy to see that happening. However, it is clear that did not work in the initial phases. The HPRA statement indicates that the first interventions to get this information out did not have the desired effect. However, it was done again and seemed to have a better response. Has there been an assessment of what might be a better response were this ever to arise again? Is the dissemination of information to patients on this medication best achieved by sending stickers, leaflets and cards and educating pharmacists and GPs? I suspect that, in this day and age, that is not the best way to make an impact.

As regards the continued review of the product, it is now clearly linked to congenital disorders. It is very important to point out that it has been so linked since it came on the market. However, there has been a marked rise from over 10% to 40% in the number of people who have developed mental issues. What is being done? In the case of drugs such as isotretinoin, also known as roaccutane, the initial recommendation was that they should not be used by women of child-bearing age, followed by a recommendation that prospective fathers should not use them. Are the witnesses considering the effect of valproate on sperm generation? Many girls on the medication were exposed to it in utero. Are such girls now grown up and have any studies been carried out on the effect on their reproductive systems? Is there any information on the effects on the offspring of mothers who were on the medication?