Marc MacSharry (Sligo-Leitrim, Fianna Fail) | Oireachtas source

I thank the Ceann Comhairle for selecting this matter for discussion and I welcome the Minister of State at the Department of Health, Deputy Daly, to the House. This matter relates to issues arising in regard to the Pandemrix vaccination for swine flu some years ago, but I want to put on record my unequivocal support for vaccination when vaccines are available. That said, my ambition is to ensure that when known side effects or issues arise with a small number of patients who have been vaccinated appropriate care pathways are put in place for them and that a compensation scheme is put in place for these people in line with the recommendation of the vaccination steering group several years ago and committed to in the programme for Government.

On 18 May 2009, Dr. Brendan Corcoran signed a contract with GSK for 8 million Pandemrix vaccines manufactured with the benefit of an adjuvant known as AS03, manufactured in Dresden in Germany. An adjuvant is a stimulant to the immune system which means less core vaccine is put into the vaccination, which is a cost saving measure to the company. It is within this adjuvant that a problem may have arisen. When this contract was signed Pandemrix had not been clinically tested and no risk analysis of it had been done, and this was known. As a result the HSE had to provide an indemnity to GSK before it would agree to provide it to Ireland. The European Medicines Agency, as part of the licensing, demanded that GSK keep all details of any adverse impacts of this particular vaccine.

In October-November 2009, just before the vaccination programme commenced, leaflets were distributed to patients that promoted false and incorrect information. Patients were told that Pandemrix is as safe as the ordinary flu vaccine but this was not known to be true at that time, and in fact is false. They were also told that Pandemrix was clinically tested. This was known to be not true and false yet it was produced by the HSE in our name as a State. The office of the Chief Medical Officer was informed by the Irish Medicines Board of its concern in the absence of clinical testing and a risk analysis regarding the dosage, if any, that could be administered to children or pregnant women.

Why was the public told lies in this way while health professionals were given different information? The incidence of swine flu began to decline in week 42 of 2009. In other words, one week prior to commencement of the vaccination programme on 25 October 2009. Four days later on 29 October 2009 GSK informed the HSE of significant adverse outcomes but the vaccination programme continued. By week three of 2010 incidents of swine flue was down to one case per week but still the vaccination programme continued. Why? Was it really necessary or was it the case that having purchased 8 million vaccines at an alleged cost of €80 million we needed to save face? This 8 million vaccines amounts to two for every person in the State, with a prescribed lifespan. Rather than have a voting machines type debacle we continued to prescribe regardless.

As this vaccine had not been clinically tested and no risk analysis of it had been undertaken general practitioners, GPs, had to be fully indemnified by the State Claims Agency before they agreed to vaccinate people. Was the State Claims Agency provided with the information that GSK was sending in regularly in regard to adverse outcomes? Where are we now? In 2012, Dr. Darina O'Flanagan on behalf of the State, along with others in Norway and Sweden where the same vaccine had been administered, reported a proven link between narcolepsy and the Pandemrix vaccination. This is now established. A number of children and young adults have experienced life altering illnesses. Some have taken cases to the courts and others are desperately awaiting State assistance and compensation commensurate with those life altering illnesses. I ask the Minister of State, Deputy Daly, to outline his proposals to compensate these people who are suffering.

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