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

The evidence of today is that there have been deficiencies in how this was handled, whether in Ireland or in the EU. It seems to have accelerated in recent years, ending up with a contraindication of the product in pregnancy. It is clear that there has been an issue with the dissemination of information, from EMA level down to real-life people, meaning people on the medication were not aware of the issue. I refer to the recent 20% figure to that effect coming from the UK. What are the HPRA and the Department going to do to ensure it does not happen again that such a thing takes so long to be felt on the ground? Many community pharmacists have an area for information and it is their responsibility, along with prescribing doctors, to get the information to people. There seems to be a deficit in the information getting to people who were on the medication and about to get pregnant or who had already had children.

The link with neural tube defects is quite interesting and my understanding is that the rate of neural tube defects is rising here more quickly than in any other European country, partially due to the lack of folic acid supplements in foods. Can the Department say what we are doing about that? We have brought it up many times in this committee, both in connection with the eighth amendment and the national maternity strategy.

I am not making any correlation between thalidomide and this product but after the thalidomide cases there was an overhaul in how we assessed medication. Can the HPRA comment on the risks associated with not continually reassessing the safety of drugs and with licensing a drug for use without sufficient evidence to support its clinical safety? What are the risks of a rush to approval of a particular medication without knowledge of its long-term effects on pregnancy and babies? We might think a central nervous system, CNS, drug would not have an effect on developing life but clearly it does. This committee has recently heard of moves to license drugs without the appropriate safety information.

Where does the responsibility of the drug company lie in respect of this? This drug is off patent and it is very cheap now but it was very expensive 15 years ago. Time passes quickly.

Where does the drug company's responsibility lie? What if Sanofi just decided for market reasons or because it was too much hassle to withdraw the drug from the market? How can the State encourage it to live up to its responsibilities?