Wednesday, 11 July 2018
Topical Issue Debate
Vaccine Damage Compensation Scheme
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.
I thank Deputy MacSharry for the opportunity to update the House on this issue. I acknowledge the impact on all people who have been diagnosed with narcolepsy. In particular, I am aware of a specific group of individuals who claim to have developed narcolepsy after they received the Pandemrix vaccine during the 2009 influenza pandemic.
The Deputy raises issues concerning when knowledge of potential side effects become known. I take this opportunity to update the House of what was known at that time. In August 2010, the Swedish pharmacovigilance authority reported that it was investigating six cases of narcolepsy reported by health care professionals as a possible adverse event following the use of the Pandemrix vaccine during the pandemic. This was followed later that month by reports from the Finnish National Institute for Health and Welfare noting there had been a more than expected number of cases of narcolepsy in children and adolescents that year. On 23 September 2010, the Committee on Human Medicinal Products of the European Medicines Agency concluded in its initial review of available data that the available evidence did not confirm a link but that more research was needed.
By the end of March 2011, the Irish Medicines Board - now the Health Products Regulatory Agency - had received reports of two confirmed cases of narcolepsy following vaccination with Pandemrix vaccines. The Department of Health and the HSE agreed that the HSE Health Protection Surveillance Centre would work with the Irish Medicines Board and Irish clinical experts in narcolepsy to examine the Irish data and report on the findings. The information I have just given is included in the final report of national narcolepsy study steering committee entitled, Investigation of an increase in the incidence of narcolepsy in children and adolescents in 2009 and 2010, published on 19 April 2012. As Deputies are aware, I cannot comment on individual cases or matters that are the subject of litigation. However, I can provide background information and clarify matters that are already in the public domain.
The management of these cases transferred to the State Claims Agency on 15 October 2013 when the Taoiseach signed the National Treasury Management Agency (Delegation of Claims Management Functions) (Amendment) Order 2013. It is not appropriate for a Minister to interfere in the court’s case management of these claims or in the management of these claims by the agency. The Minister, Deputy Harris, continues to engage with the Minister for Justice and Equality, Deputy Flanagan, and the Minister for Finance, Deputy Donohoe, on what further improvements can be made to the legal framework governing the management of product liability cases. Like the Minister, Deputy Harris, and the HSE, my priority is to ensure that the individuals and families affected receive appropriate health and social care supports. The Department has engaged with the HSE and the Departments of Education and Skills and Employment Affairs and Social Protection to ensure the provision of a range of services and supports on an ex gratiabasis. The HSE's advocacy unit acts as a liaison with other service providers and Departments to facilitate access to required services. It is in regular contact with the individuals affected and their families and regional co-ordinators have been appointed to assist by providing advice, information and access to local services.
I thank the Minister of State for his reply but it does not answer the questions. I am informed that the State Claims Agency has spent €2 million rigorously defending discovery alone in cases. Have we learned nothing from more recent crises involving people who have lost their lives or will lose their lives? Ministers need to take a much more hands-on role in regard to how the State Claims Agency handles cases.
Last year the Minister, Deputy Harris, was quoted in the media as saying that the Department was considering a compensation scheme for side effects of important vaccines in line with the steering group on vaccines which had gone back over several years. That is over a year ago: what has happened? It is six years since our own Dr. Darina O'Flanagan established and proved the link with narcolepsy which concurs with the Swedes and Norwegians who also used the same one, and yet we have done nothing. I accept there is discretion in medical cards and there are a few bits and pieces to help people out, but no compensation commensurate with the level of suffering they have with lifelong and life-altering illnesses such as narcolepsy.
I am unequivocally in favour of vaccination. I have been vaccinated with Pandemrix as have my children. Luckily for us we have no side effects. Some do and they are entitled to be compensated as such. We need to bear in mind that Dr. Brendan Corcoran on behalf of the State signed a contract for 8 million vaccines in 2009 in the knowledge that it was not clinically tested and had no risk analysis. I am putting it in the public record, if the Minister of State feels it needs to be on the public record before he can comment. The Irish Medicines Board expressed its concerns about this to the office of Dr. Tony Holohan, the Chief Medical Officer, and nothing happened. The State intentionally lied to patients in three patient-information leaflets telling people it was tested when it had not been, that it was as safe as the ordinary flu vaccine when it was not, and that it was exactly the same as Celvapan and other vaccines when it was not.
I ask that the Minister of State seek with the Department of Finance, through the NTMA and the SCA, to desist from costly defences in these cases, engage and offer immediate mediation, and put in place an appropriate compensation scheme for the girls and boys, young women and young men-----
The development of a national narcolepsy service continues to progress. The paediatric service is currently fully operational with all staffing in place. The Department gave approval for the adult services in January 2018. The clinical nurse specialist is already in place and the recruitment of a consultant neurologist is under way. A range of equipment needed for the centre is being procured. St. James's Hospital expects to have a formal service for adults in place by the fourth quarter of this year and referrals are currently being accepted.
It is acknowledged that treatment and individual medical needs may need to be reassessed over time. Consequently the services and supports provided are reassessed on an ongoing basis to take account of any changes in the individual's condition and circumstances. I again acknowledge the impact on the lives of these people and families affected by narcolepsy and reiterate my commitment to the ongoing provision of appropriate services and supports for these people.
I will relay the Deputy's comments and concerns back to the senior Minister in my Department and to the Department of Finance on his behalf.