Written answers

Wednesday, 13 June 2012

Department of Health

Vaccination Programme

9:00 pm

Photo of Catherine MurphyCatherine Murphy (Kildare North, Independent)
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Question 221: To ask the Minister for Health if he will confirm the veracity of the claim by a company (details supplied) that have received indemnity from the State in 2009 relating to the use of the Pandemrix influenza vaccine; if so confirmed, if he will release a copy of this indemnity to members of the Oireachtas; if he is satisfied that the company disclosed all relevant information on Pandemrix to the State in advance of the indemnity being agreed; if he will confirm if the indemnity is now legally unenforceable in view of the present circumstances; and if he will make a statement on the matter. [28588/12]

Photo of Catherine MurphyCatherine Murphy (Kildare North, Independent)
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Question 222: To ask the Minister for Health his views on the conclusions of the National Narcolepsy Steering Committee report Investigation of an increase in the incidence of narcolepsy in children and adolescents in 2009 and 2010; his views on whether the State and a company (details supplied) are liable in respect of the cases of narcolepsy developed by several young persons following vaccination with Pandemrix in 2009; and if he will make a statement on the matter. [28593/12]

Photo of James ReillyJames Reilly (Dublin North, Fine Gael)
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I propose to take Questions Nos. 221 and 222 together.

In response to the 2009 H1N1 influenza pandemic, the HSE procured two vaccines. The HSE, with the approval of my Department and the Department of Finance, indemnified the suppliers from and against loss and damage in respect of any claim against the supplier arising from or in connection with the use and administration of licensed or unlicensed vaccine supplied. The indemnity clause in relation to the supplier in question is attached.

This was a necessary response in order to ensure that Ireland could access the vaccine as early as possible during the pandemic. All European countries who accessed pandemic vaccines indemnified the companies who supplied them. The report of the National Narcolepsy Steering Committee was published on 19 April and is available on my Department's website. My Department is working closely with the Health Service Executive (HSE) and the Department of Education and Skills to address the needs of those affected by narcolepsy. The HSE has provided a range of services and supports to those affected including access to rapid diagnosis, clear care pathways, temporary medical cards and reimbursement of expenses incurred.

Multi-disciplinary assessments which will allow for the appropriate individualised health and educational supports to be put in place have commenced. The National Educational Psychological Service (NEPS) is currently engaging with the HSE and with the individual schools and parents of children concerned to identify and provide educational supports for the children and adolescents affected. In addition, reasonable accommodations have been put in place for students with narcolepsy starting state exams today. My Department is considering all other possible supports which may need to be put in place for those affected. A Memorandum for Government setting out the full response to this issue is being prepared for submission in the coming weeks. I would like to assure the Deputy that this matter continues to be a priority for my Department.

Agreement between Glaxo Group Limited Glaxo Wellcome House Berkley Avenue Greenford UB60NN UK ("GGL") GlaxoSmithKIine (Ireland) Limited Stonemason's Way Rathfarnham Dublin 16 Ireland ("GSK Ireland") (and together "GSK")

and

Health Service Executive

Head Office,

Oak House,

Limetree Avenue

Millenium Park,

Naas Co Kildare

Ireland

("HSE")

regarding Reservation and Supply of Pandemic Influenza Vaccines

Page 2 of2

11. PRODUCT LIABILITY AND INDEMNITY

Product Liability Indemnity

HSE shall indemnify and hold harmless each GSK Indemnified Party against any and all liability, damages, penalties, fines, costs, expenses (including reasonable legal expenses and reasonable expenses of other professionals) and other losses suffered or incurred by any GSK Indemnified Party resulting from or arising out of any Claim against any of them by any person directly or indirectly arising from or in connection with the use and administration of the Pandemic Vaccine supplied under this Agreement, including Claims for lack of safety, quality or efficacy and for death or personal injury PROVIDED that there shall be no obligation on the part of HSE to indemnify and hold harmless any GSK Indemnified Party in connection with any Claims for death or serious personal injury where it is demonstrated that such death or serious personal injury is directly caused by defects in the manufacturing of the Pandemic Vaccine that are: (1) the result of either (a) Wilful Misconduct, on the part of GSK and its Affiliates or (b) the Pandemic Vaccine not being manufactured by GSK or Affiliate in compliance with GMP, to the extent that each standard of GMP is applicable and subject to GMP deviations as per Section 10.3, including in circumstances where there is no Regulatory Authorisation and (2) the actual cause of any alleged death and/ or serious personal injury that is the subject of the Claim.

Regulatory Indemnity

HSE shall indemnify and hold harmless each GSK Indemnified Party against any and all liability, damages, penalties, fines, costs, expenses (including reasonable legal expenses and reasonable expenses of other professionals) and other losses suffered or incurred by any GSK Indemnified Party resulting from or arising out of Claims by the Competent Regulatory Authority, other authorities of Ireland and/or other third parties to the extent such liability, damages, penalties, fines, costs, losses and/or expenses relate to GSK and/or any Affiliate supplying the Pandemic Vaccine (or Components) to HSE either (i) without Regulatory Authorisation or without approval of necessary Variations in the circumstances set out in section X.

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