Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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Question 2: To ask the Minister for Health the action he is taking in response to the findings that the swine flu vaccine Pandemrix may be linked to narcolepsy; and if he will make a statement on the matter. [26439/11]

James Reilly (Dublin North, Fine Gael)
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It is estimated that approximately 250,000 Irish children and adolescents aged five to 19 received Pandemrix vaccine to protect them against pandemic, H1N1, swine flu. Thirty potential cases of narcolepsy have been identified, 16 of which have been confirmed by the Irish Medicines Board as having been vaccinated with Pandemrix. Of the 16 cases, 15 were under 18 years of age. The remainder of the cases include those who have not had a final clinical diagnosis of narcolepsy and also includes a small number of patients who have been diagnosed but who may not have had Pandemrix vaccine.

The Department of Health and the Health Protection Surveillance Centre, HPSC, of the HSE are working with the Irish Medicines Board and clinical experts in narcolepsy to examine the Irish data. However, the number of cases in Ireland is relatively small and may not allow causality to be determined. The results of this study are expected before the end of the year. Further studies are also ongoing in several European countries.

Relevant health care professionals, that is, GPs, paediatricians, psychiatrists, clinical psychologists and public health nurses have been advised on the possible association between Pandemrix vaccination and narcolepsy and on the referral of suspect cases for diagnosis. The HSE has agreed to provide discretionary medical cards to children affected on an interim basis pending the outcome of decisions to be made around supports necessary on an ongoing basis.

A group called Sufferers Of Unique Narcolepsy Disorder, SOUND, has been set up by parents. This group is actively engaged with the HSE and has two representatives on the HSE incident management team that is managing this issue.

The Department of Education and Skills together with the National Council for Special Education is also considering what further supports are required for the education of the young people affected.

Later today I will meet with representatives from SOUND and I understand that a meeting is being arranged with the Minister for Education and Skills also.

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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The Minister has indicated that some 30 cases of narcolepsy with a direct link to Pandemrix have been identified by the HSE. What assistance does the State intend to provide for these children and their families, given that it is a direct result of the administration of the swine flu vaccine? The Minister said that discretionary medical cards will be provided on a temporary basis, but will he elaborate on that? Will all children in whom narcolepsy presents and where there is a clear link with Pandemrix receive a medical card irrespective of the circumstances of the families concerned? Does he share the concern of parents and the wider community that new cases are still presenting and we do not know the full extent of the problem? With the recent publicity around the launch of the SOUND group, which the Minister mentioned, several new cases have come to light, and that is likely to continue for some time to come.

When the Joint Committee on Health and Children met on 8 September 2009 to address the swine flu issue, I and other members, including the Minister, expressed concern about the indemnity granted to vaccine manufacturers, including GlaxoSmithKline, the maker of Pandemrix. Is the nature of that indemnity such that GlaxoSmithKline will be legally absolved from any accountability for the drug causing narcolepsy in Irish children? That needs to be clarified. Is the State now finding itself in the dock in this connection?

James Reilly (Dublin North, Fine Gael)
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First, I reiterate that no link has been established as yet. It is interesting that some of the Nordic countries such as Finland and Sweden are concerned about large numbers of cases there, but other countries such as the UK and the US do not seem to have an issue. Like Deputy Ó Caoláin, I remain concerned about the matter. As a parent, I am concerned about the possible damage the vaccine could have caused, but I will not prejudge the situation until all the facts are before us.

In defence of my predecessor, I have to say that she acted in good faith. It was an emergency because the country's health was at risk. We can never know how many people would have died had there not been a vaccination programme. That is always the problem with these situations. We will do the most important thing, which is to support all our citizens who suffer from narcolepsy, including children in particular, and give them the medical and social supports they require. The broader issue of the causality can be pursued in a more orderly fashion. What is important is that people who have a problem have it addressed from both the medical and social perspectives.

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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At the committee meeting I mentioned, an HSE representative said that the HSE and the World Health Organisation expected "adverse events to be at a minimum". The Minister compared the number of people presenting with narcolepsy and the number of those who received the Pandemrix vaccine, but this is a serious matter for the children and families concerned, and such assurances have proved hollow to them. Does the Minister accept that, with hindsight, granting an absolute indemnity to a multi-billion-euro international drugs company in relation to an untested vaccine was not the correct way to go? Does he agree that we need to ensure we do not make the mistake of administering such a vaccine in future without all the proper checks being in place?

Finally, on the assistance to be offered to the children, we should be clear that they are in their early years of school attendance and this matter will significantly impact on their potential development through the education process. The Minister said he is speaking to the Minister for Education and Skills, but will the Government ensure that the necessary supports are provided for these children so that they do not fall behind? Let there be no mistake - the issue is not about attentiveness in the classroom. These children fall asleep and they will miss out on critical hours of education in the years ahead. Will the Minister ensure supports for them?

James Reilly (Dublin North, Fine Gael)
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It is easy to forget the situation that pertained. The reality is that we were facing a swine flu epidemic.

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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We have to deal with the situation here and now.

James Reilly (Dublin North, Fine Gael)
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Excuse me. I did not interrupt the Deputy. We were dealing with an epidemic. I was not in charge at the time, but nonetheless I believe in fairness, and the Minister of the day was faced with this enormous threat to the wellbeing of the people, and to younger people in particular. Given the genetic make-up of the flu and the fact that it related somewhat to an epidemic that occurred years ago, people over 55 perhaps had some degree of immunity. Younger people were at more serious risk. Vaccine manufacturers go through a range of safety checks, but when they are put to the pin of their collar in relation to producing enough vaccine around the world to protect people from a looming crisis, perhaps not all the research that would usually be done can take place, because some of it is time related. No doubt that is why they sought the undertaking from the Government in relation to indemnity. I will revert to the Deputy in writing on the exact nature of the indemnity, but we have to be fair. It is easy enough to give out, and there is plenty to give out about without giving out about those things, which were not under the Government's control and had to be done in the way they were done.

To return to what I believe is the substantive issue, the Government will endeavour to ensure that all the social, educational and medical supports are there for people who might have suffered as a consequence of the vaccine. However, the Deputy should bear it in mind that the individuals in nearly half of the cases that have been identified, or certainly a large minority, never had the flu jab. They are owed a duty of care, too.