Can the UK’s decade old vaccine damage payment scheme handle COVID-19?

It is anticipated that by the end of 26 January 2021, at least 10% of individuals in the UK will have received one dose of COVID-19 vaccine. In order to encourage vaccine confidence, the UK Government has announced that anyone who experiences adverse side effects, and is eligible, can apply to receive compensation under a Government funded program that has existed since 1979, the Vaccine Damage Payment Scheme (the VDPS).

Will this Scheme be adequate to the task of encouraging vaccine take-up asks reporter David Cox from Payment Source in January 2021. Partner Sarah Moore shared the following detailed observations:

The Vaccine Damage Payment Scheme was first introduced to encourage families to access vaccines for their children in the context of DPT. Whooping cough rates were on the increase and there were widespread anxieties regarding the safety of vaccines which served to increase vaccine hesitancy and reduce take-up. The Scheme was set up to respond to those concerns. As I understand it, the Scheme was only ever supposed to be a temporary measure, pending the outcome of the Loveday v Renton legal case in 1988. However, it appears to have become stuck as statute, and despite the tireless efforts of campaigners over the years, including most notably the VVSG and Olivia Price, there seems to be a lack of political will to reshape it and make it fit for purpose. Against that backdrop, and in the context of an unprecedented mass-population vaccine roll out campaign, it is surprising that the Government has decided to extend, rather than re-design the VDPS.

About the high bar for acceptance:

The Vaccine Damage Payment Scheme in the UK is unusual in that, unlike other countries – including the US and the Nordic countries - it requires applicants to prove causation on the 'balance of probabilities,' that is to show that it is more likely than not that the vaccination caused the injury reported. That means that applicants have to effectively discharge the same civil law burden of proof that any Claimant must in the course of litigation. There is always a balance to strike between ensuring that compensation is paid where there is just cause, and setting the bar so high that families, often acting without lawyers, can meet the test. In the case of the VDPS, the data indicates that very few applicants are successful: If you put that data alongside the longstanding work done by campaigners and politicians over the years to push for amendments to the scheme; and the fact that making the scheme more accessible has wider social policy benefits, not least in countering 'vaccine hesitancy,' then you might fairly reach the conclusion that the 'bar is set so high' for applicants on purpose – to restrict access and restrict the payments that need to be made by the DWP.

The advantages of reforming the VDPS are well known to the Government, and have been for years, see for example the HoC debate in Hansard in March 2015. I have seen no robust justification for why the 'bar is set so high' and why the scheme has not been reformed. In the 2015 debate you'll see that the Minister at the time Jane Ellison concludes, 'my sense is that the scheme, which aims to provide proportionate help, has got the balance about right'. She doesn't elaborate further – but you have to wonder whether there is really the political will to make the scheme accessible.

About pharma taking more responsibility for vaccine issues:

No vaccine manufacturer intentionally sets out to make a 'bad' vaccine – that wouldn't make any commercial sense. However, I do think that in the UK more broadly, we have a legal culture in which it is very difficult for a Claimant to hold Big Pharma to account. The Cumberlege Review, which reported last year, concluded that in the UK it is very difficult for those injured by medical products to access justice and compensation for the harms suffered, and recommended a bespoke Redress Scheme that would compensate individuals affected by a range of Big Pharma products.

That 'access to justice' issue is also evident if you look at the cases won by Claimants against Big Pharma in the UK in the last 20 years i.e. zero. Whether or not that 'justice gap' affects the way in which Big Pharma approaches the UK market, in contrast with how it approaches other jurisdictions, such as the US – where litigation vs Big Pharma is very often won by Claimants, is difficult to know. However, it is often the case that Big Pharma gets products approved much more swiftly in the EU than it does in the US. That is partly a function of the different approaches to pre-marketing clearance taken by the FDA vs the MHRA – with the FDA often withholding approval in the US, whilst the same product is cleared swiftly in the UK (the classic example here is Thalidomide – launched in the UK, prevented from reaching the US market by the FDA). However, logically, if you have a choice of 2 jurisdictions in which to launch a product first – it makes commercial sense to opt for the jurisdiction in which the Government offers you an indemnity, where the prospects of successful Claimant litigation are relatively slim, and where manufacturer is able to get its product to market more quickly.

About the scheme's £120,000 payment cap:

The maximum award under the VDPS is currently £120,000. That is made on an 'ex gratia' lump sum basis, i.e. it is not assessed in line with the levels of damages recommended by the Courts in personal injury compensation claims, in that sense these awards are not 'compensatory' at all. Taking an extreme case, a child might suffer significant neurological damage – in a court case they might receive millions of pounds under the scheme they would receive £120,000, which – depending upon their needs might fail to afford the care that they need for a single year, let alone a life time of high dependency.

About expensive, lengthy litigation versus using the scheme?

The odds are stacked against Claimants seeking to hold Big Pharma to account in the UK, for a number of reasons:

  1. expense – there is no longer Legal Aid available for Claimants to bring this kind of case in the UK
  2. these cases are hugely expensive, such a claim taken all the way to trial would likely cost many millions of £s
  3. it is difficult to get third party/external funding for a case of this nature because Claimants so rarely win in the UK.

Why don't they win? Difficult to say in succinct terms but it is interesting to note the different approaches of the US Courts and the UK Courts to these types of cases – in terms of the way in which the scientific evidence is assessed, and also the role of the jury. In the US these claims would be heard in front of a jury; in the UK these claims come before a single judge with no jury.

About the difficulty of proving a causal link to the vaccine?

This remains very difficult indeed. The 1988 case of Loveday v Renton, is really the last time the issue of vaccine damage was before the UK courts in the context of the DPT vaccine. Fortunately, whilst vaccine injury does occur – it is a very rare occurrence. That rarity can make it difficult for Claimants to demonstrate a causal connection in their case, particularly as historically the Courts have required a Claimant to show that the vaccine doubled their risk of developing the particular harm suffered. To meet that test a Claimant will need access to extensive data, and expensive expert analysis. As such, the very high burdens of proof and cost imposed within the UK system as it stands, means that very few Claimants will advance a case through the Courts for vaccine harm.

Effect of the disablement of 60% specification:

In the absence of more recent data, looking at data from 2017 (in response to an FOIA): there were 6196 claims, of which 936 were successful. Of the 6196, 125 of the failures were cases in which 'causation is accepted but resulting disablement is not severe' (less than 60%). In theory those people could still access justice through a civil claim but for the reasons outlined above, they are unlikely to be able to do so in practice. It seems extraordinary that the scheme will 'compensate' for 'severe' harm but nothing else. What if you are 59% disabled? What does 60% disabled actually mean? The assessment is based on medical evidence, but again seems to aim at narrowing the people whom the scheme will assist.

About a revamp of VDPS:

The sceptic in me says, not likely, the optimist in me, says – actually if there is ever a time and momentum to force reform – it is now, in the unprecedented context of a global pandemic, and the government urging population wide take up of a 'voluntary' vaccination programme. I remain hopeful.” As at the end of January 2021, data indicates that vaccine take up remains high across the UK, but there are early indications that some communities, including BME groups, might be more reluctant to receive the vaccine. In this context, the Government needs to ensure that its messaging around the safety of the vaccine is clear and reassuring. Ensuring that a re-vamped compensation scheme is in place, in the unlikely event that something goes wrong, might provide further reassurance to those who remain concerned.

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