Dáil debates

Wednesday, 11 July 2018

Topical Issue Debate

Vaccine Damage Compensation Scheme

2:55 pm

Photo of Jim DalyJim Daly (Cork South West, Fine Gael) | Oireachtas source

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.

Comments

No comments

Log in or join to post a public comment.