Who pays if you suffer side-effects from Covid-19 vaccine?

Promised vaccine compensation scheme must be set up to maintain public confidence

The absence of a vaccine compensation scheme in Ireland is concerning amid the continued rollout of the Covid-19 vaccination programme. In December 2020, an expert group chaired by Mr Justice Meenan recommended that a scheme be put in place, noting the added urgency for a vaccine compensation scheme given the “recent publicity and public commentary concerning certain vaccinations”.

Subsequent to the report, the Taoiseach Micheál Martin confirmed in December that the Cabinet agreed that a scheme would be established and managed by the State claims agency, but this has not yet transpired.

Ireland, as an EU member state, indemnified Covid-19 vaccine manufacturers as part of the advanced purchase agreements. This was necessary in order to obtain access to the vaccines. The result is that the State, rather than the manufacturer, is liable for the cost of redressing injuries caused by these vaccinations.

The expert group recommended a vaccine compensation scheme acknowledging the “strong moral argument that the State, which actively encourages vaccination, should accept responsibility for those who suffer harm as a result”. Motivation for these schemes is about inspiring and maintaining public confidence in vaccines, as noted by a 2019 report by the Health Research Board into vaccine redress programmes.

Other countries who grant indemnity to vaccine manufacturers, including England, have in place state compensation schemes. The structure of schemes vary across jurisdictions. Some are “no-fault”, meaning the first hurdle in proving the state was negligent in providing the vaccine is removed. In Ireland, constitutional protection of equality, right of access to the courts, and bodily integrity led the expert group to recommend against a no-fault system for certain clinical negligence claims. But the group was in favour of an ex-gratia payment scheme for vaccines. Under that scheme, liability would not need to be proven.

Demonstrating negligence

This would be welcomed; demonstrating negligence in relation to the delivery of vaccines has proven difficult. Though involving different facts to Covid-19 vaccines, more than 80 cases were listed for the High Court involving claims that the Pandemrix swine-flu vaccine caused narcolepsy, among other sleep disorders. Two claims were settled, and in February 2021 a liability settlement was negotiated that would apply to all of the other cases. Mr Justice Kevin Cross in the High Court “warmly welcomed” the group settlement, noting the significant litigation hurdles for the plaintiffs.

In the absence of a compensation scheme for the vaccines – that would remove the burden of proving negligence liability – two challenges could arise for a person who suffers injuries as result of the vaccines.

The vaccine recipient must first demonstrate that the HSE was negligent in failing to warn of risks inherent in the vaccine, thereby failing to obtain informed consent. This involves a judicial determination whether the risks were known by a responsible body of medical opinion at the time that the vaccine was given.

Proving negligence might be difficult for people who receive the vaccine before the risks could reasonably be known by the medical profession

If the risks were known, the court must determine whether the recipient was sufficiently warned of the risks by the HSE. The recipient must then prove that the failure to warn caused her injuries. So the court would ask another question: would a reasonable person in the recipient’s position have wanted to be warned about those risk?. If the answer is yes, then the court must decide whether the recipient would still have proceeded with the vaccination in light of knowing the risks. If the recipient would have proceeded anyway, then the negligence claim would fail as her injuries would not be deemed to be caused by the State’s negligence. Medical experts across the world are endorsing that the benefits outweigh remote risks of Covid-19 vaccines; this might become a background factor for the court in deciding how the recipient would have acted had she known about the risks.

Product liability

If the risks were not known at the time the vaccine was given, the HSE may not be liable. The rapid pace of vaccine development means that some risks, or their rate of occurrence or severity, may only come to light after vaccination programmes have begun. We are witnessing this with the AstraZeneca and Johnson & Johnson vaccines. Proving negligence might be difficult for people who receive the vaccine before the risks could reasonably be known by the medical profession. Similar challenges might arise under product liability: if scientific knowledge was not capable of discovering a defect at the time the vaccine was put into circulation, the manufacturer may not be liable, and therefore the State might not be responsible for paying damages under this route either.

Manufacturer indemnity

Yet the State, in granting manufacturer indemnity before the vaccination programme began, in effect assumed responsibility for redressing injuries caused by the vaccines.

Even within the expert group’s recommended ex-gratia payment scheme, it would still be necessary to prove that the vaccine caused the injuries. This may be difficult in some cases. For example, a causal link has not yet been established between the extremely rare blood clots that have been reported and the AstraZeneca or Johnson & Johnson vaccines. Inability to prove causation was identified by the Health Research Board as a reason for the significant decline in awards under the vaccine damages payments scheme in England.

It is imperative that a compensation scheme that removes a potential liability lacuna be established sooner rather than later

Proving causation may be a necessary check on State liability, but whether that is a justified counterbalance to maintaining public confidence in certain vaccines is something to be considered by the Government. If the correlation between risks and vaccines is sufficient to pause particular vaccines for certain groups, as has occurred with the AstraZeneca vaccine in Ireland and other countries, State responsibility for injuries caused by these vaccines comes into question. A relaxed standard of causation has been adopted in some countries for vaccine compensation schemes and could be a potential compromise here. This could be offset by the expert group’s recommendation that ex-gratia payments be reasonable and based on proven loss.

Public confidence

It is imperative that a compensation scheme that removes a potential liability lacuna be established sooner rather than later. Though evolving scientific knowledge about the serious but extremely rare side effects of some Covid-19 vaccines demonstrates confidence in their continued use, maintaining public confidence is crucial. After Tánaiste Leo Varadkar’s statement on Thursday that those who refuse the AstraZeneca vaccine will be placed at the end of the list, a State compensation scheme that reassures the public of monetary damages in the rare event of a serious injury caused by these vaccines is more important now than ever before.

Sarah Fulham-McQuillan is deputy director of the UCD Centre for Constitutional Studies