Mr. Peter Murphy:

On Deputy Donnelly's question regarding the State and its responsibility, it is important to reiterate that these disabilities are not bad luck or random incidents, they have been caused for reasons other than chance such as exists in the general population. Our overall position is there is a huge public interest reason as to why this issue should be investigated. Rather than us coming here today and saying X or Y is responsible, what we need is an independent inquiry to look into these questions and come up with answers. There are a lot of parties that would need to be involved in that discussion.

As for what is happening in other countries, the UK recently announced a review of this drug and a number of other products and drugs with a view to determining whether the State has responded adequately over the years to safety issues. As part of this review, the issue of a compensation scheme is being examined. France has gone a step further in that the state there has accepted its responsibility and established a compensation fund of approximately €10 million. The French Minister for Health has acknowledged that this is merely a starting point. Crucially, in France there have been moves to involve pharmaceutical companies in the process. As I understand it, if the pharmaceutical companies do not make an offer of compensation to an individual then the state will cover it. Obviously, the legal system in France is different to ours.

Deputy O'Reilly asked when the risks were known. I am sure the Health Products Regulatory Authority, HPRA, will have more information on this but from our point of view foetal valproate syndrome was first reported in the early 1980s and it was well established and accepted by the mid-1990s. There was a key paper on this in 1995, which outlined the many different symptoms that could have been experienced. It was in the early 2000s that the link with developmental delay, autism and ADHD became known. We have reviewed the information that was provided on the summaries of product characteristics, SPCs, which are the documents provided to pharmacists and health care professionals about drugs and we have found discrepancies in terms of reporting of risks on those materials compared to the data that would have been known at the time, as well as some variances between what was on the UK data sheets and what was on the Irish data sheets at the same time. These are all issues that could be looked at as part of an inquiry to establish what may have happened over the years.