The vaccine will be safe. But this legal contingency plan is necessary nonetheless

We should be looking now at the system to compensate anyone who is harmed, however unlikely that harm may be

November 27, 2020
SOPA Images/SIPA USA/PA Images
SOPA Images/SIPA USA/PA Images

The development of what appear to be three effective vaccines against Covid-19 is excellent news. But every silver lining has a cloud, and there is no news so good that it does not cause lawyers to ask themselves about what happens if things go wrong.

Vaccines are overwhelmingly safe. And before any vaccine is released in the UK it will have to be approved by the Medicines and Healthcare Products Regulatory Agency (MHRA)—the very well-respected UK authority responsible for approving all medicines, including vaccines. The best advice for those who are recommended to have an approved vaccine will be to have it, both in their own interests and, importantly, in the interests of everyone else around them.

Lawyers, though, are paid to be pessimists. Vaccines can go wrong, for some people. A recent example is the H1N1 vaccine (Pandemrix) developed by GSK in the late noughties. Because of concerns about the H1N1 pandemic, approval of Pandemrix by the European Commission and European Medicines Agency (EMA) was fast-tracked without all the usual clinical trials having been completed. Six million people were vaccinated. In almost all cases there were no problems. But in a very small number of cases—around one in 52,000—children given Pandemrix developed narcolepsy and cataplexy (in broad terms, neurological conditions that made them prone to sudden attacks of day-time sleepiness, and to a sudden loss of muscle tone which could lead them to collapse to the ground as a result of temporary muscle paralysis). Those conditions have had a very serious impact on their daily lives both as children and as they grow up—for example, they are unable to drive, their social lives and relationships have suffered, and many jobs are closed to them. There is a general consensus—accepted by the UK government—that Pandemrix caused that reaction in those children, though the science behind that causative link is still not entirely clear.

The Covid-19 vaccines are likely to be approved by the MHRA under a special regime that allows it to approve on a temporary basis the use of unlicensed medicinal products in response to threats such as infectious pathogens (unless the EMA and Commission manage to license those vaccines by the end of the year, in which case the licence will “roll over” into the UK after the end of Brexit transition—otherwise, post-transition licensing decisions will be for the MHRA). The MHRA will have to be satisfied that there is enough evidence that the vaccines are safe, effective and of good quality to justify that temporary approval. But it will not have gone through the full rigorous process needed to secure a full licence for those vaccines. So what is the legal position if, God forbid, something goes wrong, as it did for a tiny minority of those vaccinated with Pandemrix? What rights would that tiny minority have?

One possibility is to sue the producer for damages under the Consumer Protection Act 1987. In the Pandemrix case, the UK government—along with some other governments such as Ireland’s—gave GSK an indemnity against such claims: since settlements are typically confidential, it is not known what success those claims have had, though it is public knowledge that there has been at least one settlement of such a claim in Ireland. But the key legal issue under the CPA is whether the producer can show that it could not have been expected to discover the problem given scientific and technical knowledge at the time that the vaccine was supplied, a test that provides fertile ground for scientific and legal argument. If the producer satisfies that test—which is entirely possible—there will be no liability to pay damages.

Another possibility is the Vaccine Damages Payments 1979 (VDPA). The VDPA requires the Department for Work and Pensions to make a fixed cash payment (currently set at £120,000, but changeable by ministers) to anyone who can show that they have been “severely” disabled as the result of being vaccinated against diseases listed in the act (a list that can be added to by ministers), whether or not that is something that could possibly have been predicted. It should though be noted that the VDPA does not attempt fully to compensate those who suffer vaccine damage against loss of earnings or the cost of care—it is simply a fixed sum payment that is unlikely in most cases of serious disablement to come near an award that could be made under the CPA (where an action under the CPA is available). Further, the claimant has to show causation—a matter that is often in dispute and hard and expensive to prove, though accepted by the DWP in the case of Pandemrix.

Moreover, if the disablement is not “severe” then no payment can be made under the VDPA: entitlement is either to the full amount or nothing. Rather oddly, “severe” is defined as being “60 per cent disabled” by reference to a scale of industrial injuries: that scale lists all sorts of industrial injuries (loss of limbs, sight, or hearing) but is not of much obvious use in assessing the severity of a neurological condition such as narcolepsy. That said, in 2017, the Court of Appeal held, in a test case in which I represented the claimant, that you could deduce something about whether narcolepsy and catalepsy were “severe” from the fact that industrial injury scale regards a double below-the-knee amputee as 100 per cent disabled (recording my observation that on that basis Oscar Pistorius is 100 per cent disabled).

That is where the law currently stands: but what should the government do? The starting point, in my view, should be that vaccination is unique among medical procedures in being given not just for the benefit of the person being vaccinated but for the benefit of the community as a whole. That gives rise to a powerful moral case that, if that risk occurs, the victim should be (as far as possible) fully compensated by the community as a whole.

In policy terms, that points firmly towards the government adding vaccination against Covid-19 to the list covered by the VDPA, something which is in its immediate power to do. But it also points to a review of the structure of the VDPA itself: in particular, the crude scheme under which you get £120,000 if “severely” disabled but nothing otherwise should be replaced by a scheme that compensates for any disablement and covers financial loss (perhaps excluding relatively trivial side effects).

One objection to that proposal might be that persuading the public to get vaccinated will be hard enough without there being a discussion about what happens if something goes wrong. But what really damages public trust is a pretence that there is no risk when there is (no matter how small): and part of the way of addressing public concern about risk is a promise that if the worst does happen as result of doing what the state recommends, then the state will pick up the financial consequences. That message fits in with what I believe should be the clear message that getting vaccinated is, save in cases where it would be against medical advice, a public duty carried out for the benefit of all, and that anti-vaxxers are not just scientifically but morally wrong. But duty cuts both ways—and if we as citizens are going to be asked by to do our duty, then our government has a corresponding duty to take care of us if things go wrong.