Call for no-fault compensation for adverse vaccine events

In an article in the June issue of the Medical Journal of Australia, three medical specialists have called for the introduction of a no-fault compensation scheme for serious adverse events which can be confidently attributed to vaccination.

The authors of the article are Heath A Kelly, head of the Epidemiology Unit at the Victorian Infectious Diseases Reference Laboratory, Clare Looker, an epidemiologist at the same laboratory, and David Isaacs, Clinical Professor in Paediatric Infectious Diseases at the Children’s Hospital at Westmead.

They have also called for an improvement in the monitoring of adverse events following immunisation (AEFI).

“An investigation into the unexpectedly high number of febrile convulsions in children aged less than 5 years after they had received the influenza vaccine in 2010 – in some cases, with devastating consequences – provided a forceful reminder that timely vaccine safety monitoring is needed in Australia.

“More active adverse event surveillance is certain to uncover more AEFI but many of these will only be coincidental, while others will be of a transient or relatively trivial nature. On rare occasions, a serious AEFI with long-term sequelae will be recognised. A decision will then need to be made on whether the vaccine was responsible for that serious event.”

The World Health Organisation defines four categories of serious AEFI: hospital admission or prolongation of an existing hospital admission; permanent disability; any event that is life threatening; or death. Using these criteria, 8% (193/2396) of the AEFI reported by passive surveillance in Australia in 2009 were judged to be serious.

“However, unlike many countries where compensation schemes exist for adverse events attributed to a vaccine, Australia has no routine approach to making the assessment of attribution. Parents of children or adults who believe they deserve compensation for a serious adverse event that they attribute to a vaccine are therefore required to make their case through the adversarial legal system. This requires the demonstration that an individual or an organisation was at fault. However, fault is often difficult to demonstrate and an adverse event may be caused by vaccination through no fault of the vaccine manufacturer, the regulator or the person who administered the vaccine.”

No-fault vaccine-injury compensation programs are based on the premise that any adverse event attributable to vaccination is not due to the fault of a specific individual or organisation, but due to an unavoidable risk that is acknowledged as being associated with vaccines.

The proposal was in part inspired by the case of a Queensland child who developed transverse myelitis after receiving oral polio vaccine. “This was an example of an adverse event following vaccination where no fault was attributable to any party.”

As causality had not been accepted, the child has received no compensation.

“The general principles associated with this case raise a number of pertinent questions for Australia. First, should a child who may have been injured by a vaccine, which was endorsed and paid for by the community, be compensated by the community when the serious adverse event may be attributed to the vaccine? Second, what are the criteria for accepting an attributable relationship between receipt of the vaccine and a subsequent adverse event? Third, what is the best method for financing a compensation scheme? Each question may highlight a potential barrier to the implementation of a no-fault AEFI compensation scheme in Australia.

By 2010, 19 countries around the world had implemented no-fault AEFI compensation, implicitly answering “yes” to the question of whether the community owes a duty of care to an individual injured by a vaccine.

“There is a strong ethical argument for this position, based on the concept of redistributive justice. Any person who is injured while helping to protect the community – for instance, by contributing to herd immunity, such that there are sufficiently many people immunised to prevent widespread disease transmission within the community – should not bear the consequences of injury alone. In essence, the community owes a debt of gratitude to that person.”