Oireachtas Joint and Select Committees

Wednesday, 25 April 2018

Joint Oireachtas Committee on Health

Business of Joint Committee
Foetal Anti-Convulsant Syndrome: Discussion

9:00 am

Photo of Bernard DurkanBernard Durkan (Kildare North, Fine Gael) | Oireachtas source

I thank the Chairman. I welcome all of the delegates. We are all concerned about the tragic consequences and the effect this matter has had on individuals and their families. Which country first identified the seriousness of the risks involved? There appears to have been strong support for the drug in Scandinavian countries, but I am not sure whether that remains the case. The drug is still recommended and used in Iceland. I know that it was used or used in combination with something else in the 1960s. Some body somewhere first detected its negative aspects and I would like to know more about the matter.

Why, when it was first discovered, was no Government health warning issued? I am not necessarily referring to the Irish Government. The international community should have recognised the potential risk and applied a health warning to protect both patients and the professionals who might have found themselves in the position of prescribing the drug in certain circumstances.

Is the drug permitted for use in all European Union member states? Do containers containing capsules or tablets display warnings? If so, when did that take place? Is the matter in hand?

Negative side effects have been identified. How long did it take for a warning to be issued to all member states and practitioners throughout the European Union? It is important that we know such information.

There are alternatives. What are they and how effective are they? Have they been prescribed and recommended for use throughout the European Union? Have they been prescribed and recommended for use in this country? Have GPs and consultants been advised of their potential use and to what extent have they been so advised?

On the HPRA's response, it appears on the face of it that matters were beefed up to European speeds. However, I do not know and would like it to be confirmed.

With reference to European agencies, on many occasions we have discussed the effectiveness of the Irish system versus the European system and the need to have one overall system to provide for the Rolls-Royce tests.

Has that taken place in this instance? In the European system, tests should be well ahead of everybody else and should be on a par with the best internationally.

It was 2009 when some concern arose at European level. Were warnings issued throughout the system to all European countries? If not, why not? Were there any discoveries by the HPRA in Ireland?

In October 2013, when the concerns were obvious to everyone, how effective a warning was issued throughout the system, to doctors and patients who might have been recipients of this treatment? How quickly was the warning issued and how effective was it and was it sufficient to alert people to the seriousness of the situation? Herd protection is one thing but individuals have rights in all systems. It is not true to say that it was tragic - which it is - but necessary. There are alternatives, and they need to be examined and treated as equally effective treatments.

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