Sodium oxybate (Xyrem) – Ex gratia provision to victims of Pandemrix

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Background - Pandemrix

The Pandemrix vaccine was was developed by GlaxoSmithKline (GSK)and given to 6 million people during the global H1N1 ”swine flu” pandemic in 2009 and 2010. Owing to the nature of that pandemic, the European Commission, on the advice of the European Medicines Agency, fast-tracked the vaccine's licensing. The UK Government then undertook a vaccination programme, based on advice from the Joint Committee on Vaccination and Immunisation. In short, Pandemrix was licensed for use in the EU, including the UK, without the usual clinical trials having been completed. GSK was given an indemnity from any liability by the UK Government. Pandemrix was also administered on a smaller scale during the 2010/2011 flu season.

Concerns were raised in Finland and Sweden about the association between the Pandemrix vaccine and narcolepsy. Following that, a study by the UK Health Protection Agency and others, which was funded by the Department of Health and the HPA, found that around one in every 52,000 to 52,750 Pandemrix jabs led to narcolepsy. Consequently, the Government has recognised the link between Pandemrix and narcolepsy.

Background – Xyrem

Xyrem (sodium oxybate) is widely regarded as one of the most effective treatments for narcolepsy and cataplexy. However, Xyrem is expensive and not licensed for use in children. As a result, many patients are denied access to this medication.

Claims for compensation

Anyone who developed narcolepsy as a result of vaccination with Pandemrix may bring a claim for personal injury compensation against the manufacturer, GSK. As a result of the indemnity given to GSK, any compensation that is awarded will be funded by the Government.

Ex gratia provision of Xyrem

The Government operates a scheme under which the Department of Health will fund, on an ex gratia and time-limited basis, provision of Xyrem to personal injury claimants suffering from narcolepsy with cataplexy, who have made claims against GSK that they developed the condition after immunisation with Pandemrix vaccine. The Government has recently confirmed in Parliament that this scheme will remain in place until all the personal injury claims have been settled. The health departments in Scotland, Wales and Northern Ireland are also participating in the Scheme.

Details of this scheme, including an application form for funding under the scheme, can be found here.

 

IMPORTANT NOTE: Whilst we have endeavoured to ensure its accuracy, this resource article is provided for information purposes only. It does not constitute legal or medical advice. Before any action is taken in reliance on information in this article, advice should be sought from an appropriately qualified professional.