By Niamh McKeever & Laurence Mulligan

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Published 15 July 2021

Overview

It is not that long ago since the last official pandemic. In 2009, just 12 years ago, the World Health Organization declared a swine flu (H1N1) pandemic. The predominant vaccines used to combat that virus were Pandemrix and Celvapan. Health Service Executive (“HSE”) clinics and GPs administered over 900,000 doses of Pandemrix in Ireland.

It is estimated that as many as 575,400 people died as a result of the swine flu pandemic around the world. 27 people died in Ireland and more than 1,000 people needed to be hospitalised. Within the first week of the vaccine programme rollout, swine flu cases in Ireland began to fall and within a little over two months, dropped to single figures per week. In August 2010, the World Health Organization declared the swine flu pandemic was over.

However, vaccines and indeed any medication are not without side effects. Studies by the British Medical Journal, the European Medicines Agency and Finland's National Institute for Health and Welfare found that children vaccinated with Pandemrix had a risk of narcolepsy that was 13.9 times higher than that of unvaccinated children. Narcolepsy is the sudden and unpredictable outbreak of sleeping, which can affect an individual at any time during the day. Narcolepsy is an auto immune disease and the vaccine affected children and teenagers in a different way because their immune systems were not fully developed when the vaccines were administered. On March 28 2011, the HSE ordered a halt to all use of the vaccine and the vaccine is no longer used in Ireland.

A number of claims in Ireland, estimated to be in the region of 100, have been taken by children and young adults who claim to have suffered ill effects as a result of receiving the Pandemrix vaccine. Two such cases, seen as test cases, were concluded over the last 18 months. Both cases settled and therefore there is little known about them. Reports indicate that in both of these cases, the Plaintiffs were administered the Pandemrix vaccine when they were children and claim that they developed narcolepsy and associated cataplexy as a result. It is understood that both of these cases settled with the Plaintiffs receiving compensation. It is further understood that the terms of settlement of one of the test cases will apply to all other swine flu vaccine cases in Ireland, and indeed a further case has settled by way of mediation since that case.

These cases highlighted the lack of a vaccine compensation scheme in Ireland and the highly adversarial and costly process that continues to exists where claims such as these are taken in this jurisdiction.

 

Covid-19 Vaccination Programme

Ireland, as an EU member state, indemnified Covid-19 vaccine manufacturers as part of the advanced purchase agreements. Access to vaccines necessitated this agreement. The result is that the State, rather than the manufacturer, will be liable for the cost of redressing injuries caused by these vaccines.

Following the above mentioned cases, and particularly in light of the fact that the State indemnifies the vaccine manufacturers and encourages the public to be vaccinated, there have been further calls for a vaccine compensation scheme to be set up. In December 2020, an expert group chaired by Mr Justice Charles Meenan to review the Law of Torts and the current systems for the management of clinical negligence claims published its report (the “Meenan Report”). The Meenan Report recommended that a vaccination compensation scheme be put in place as a matter of urgency, acknowledging the “strong moral argument that the State, which actively encourages vaccination, should accept responsibility for those who suffer harm as a result”.

Reports suggest that other countries who grant indemnity to vaccine manufacturers, including England, have in place state compensation schemes. According to the expert group, if such a compensation scheme was to be set up, it should have the following features:

  • Cover specific vaccines e.g. MMR, HPV, DTP, and such other vaccines as may be recommended;
  • Medical evidence would be required establishing that the vaccine caused or contributed to the injury;
  • The scheme would be administered by a panel who would be entitled to instruct their own medical and other experts to consider and advise upon issues of causation, injury and the effects of these injuries on the person making the claim;
  • Claims would be considered in private but decisions would be published in an anonymised form;
  • Making a claim or receiving an award under the scheme would not be a bar to bringing legal proceedings, but any damages awarded would be reduced by the amount awarded under the scheme;
  • Time limits would be fixed within which claims under the scheme could be made; and
  • The reasonable costs and expenses of claimants (including legal expenses) would be covered.

 

Conclusion

Subsequent to the publication of the Meenan Report, it was confirmed that the Government had agreed that a compensation scheme would be established and managed by the State Claims Agency, but this has not yet transpired. Further developments are awaited in that regard as the rollout of the Covid-19 vaccination programme continues.

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