Science and medicine have played a fundamental role in getting us to this point. In this blog we set out how the law has a potentially transformative contribution to make in countering trends of vaccine hesitancy, thereby supporting the successful delivery of the UK’s Covid-19 vaccine programme.
Herd immunity and vaccine hesitancy
A key term in the virology lexicon is the concept of ‘herd immunity’. The WHO defines this as : ‘a concept used for vaccination, in which a population can be protected from a certain virus if a threshold of vaccination is reached’. With a UK vaccination programme now underway, there is every reason to hope that herd immunity can be achieved through mass vaccination - providing it can overcome vaccine hesitancy.
In September 2019 the Government published research indicating that ‘the delay in acceptance or refusal of vaccines despite the availability of vaccination services’, was rising globally.
Targeted disinformation campaigns during 2020; confusion around less well-studied vaccines being launched and memories of other rapid vaccine rollouts, such as the 1972 US swine flu vaccination - linked to reports of the Guillain-Barre syndrome - have been cited as exacerbating vaccine hesitancy in the UK.
Ironically, the speed with which the UK’s Medicines and Healthcare Regulatory Authority (the MHRA) has been able to procure, license and roll-out use of the Pfizer/BioNTech vaccine may further feed this hesitancy.
To secure the MHRA’s more rapid licensing of the Pfizer/BioNTech vaccine, the regulator approved supply under the emergency provisions of section 174 of the Human Medicines Regulations 2012, permitting the disapplication of the conventional route to drug licensing (section 46) in specific circumstances. The MHRA rapidly countered suggestions that speed has been prioritised over safety in their press release of 2 December 2020.
No longer bound by EU rules, the UK’s rapid approval of the COVID-19 vaccine, constitutes the UK’s most significant unilateral decision, outside of the network of established EU institutions, in almost 50 years. European Health Ministers have contrasted the UK’s rapid approach with what they deem the more robust approach of the European Medicines Agency.
At the date of writing all reports indicate that there are no significant safety concerns with the Pfizer/BioNTech vaccine.
Where the law comes in
A paper published by the British Institute of International and Comparative Law (BIICL) in November, highlights the vital role that the law can play. Providing recipients of new COVID-19 vaccines with recourse to compensation covering healthcare costs, any loss of livelihood and long term complications, can form an ‘important foundation on which to build and maintain public vaccine acceptance’. Previous Perspectives piece exploring the briefing paper.
The BIICL paper recommended that the financial scheme should be based on a no-fault model, enabling swift and simple claimant access, and that the compensation available should be at a level which will incentivise individuals to use the scheme as opposed to more expensive and protracted litigation.
COVID-19 and the Vaccine Damage Payments Scheme (VDPS)
Just a day after the MHRA announced licensing of the Pfizer/BioNTech vaccine, the Government moved quickly to announce that it was taking the ‘precautionary step’ of adding the COVID-19 vaccine to the existing Vaccine Damage Payments Scheme (VDPS).
The Vaccine Damage Payments Act 1979 (VDPA) is a national compensation scheme for those injured as a result of government recommended vaccination programs.
The scheme has received criticism over the years, because: (1) an applicant must demonstrate 60% disablement as a direct result of the vaccine; (2) the maximum award is limited to a single tax free payment of £120,000; (3) the scheme is government funded, effectively indemnifying the manufacturer; and (4) the success rate for applicants is very low. Current data indicates that the success rate is less than 2%.
Traditionally the VDPS does not prejudice the ability for a claimant to pursue a manufacturer in the courts in respect of alleged vaccine damage. However, by clearing the vaccine through section 174 of the Human Medicine Regulations 2012 the Government has granted the manufacturer immunity from civil litigation.
Providing a safety net fit for purpose
As recently as July 2020, a government ordered review chaired by Baroness Cumberlege, recommended specific no-fault Redress Schemes for persons exposed to harm as a result of medical devices and medicines approved for use by the MHRA.
Such no-fault compensation schemes already exist in the UK, in the context of Thalidomide and vCJD (BSE), for example. The existence of such schemes demonstrates the viability and value of providing substantive bespoke support to those injured by government approved products, whether they be medicines, medical devices or vaccinations.
By adding COVID-19 to the VDPS within a week of the MHRA’s approval of the Pfizer/BioNTech vaccine, the Government has acknowledged the vital interplay between the law, public confidence and the success of a mass vaccination programme. The question remains, does the government’s chosen policy of utilising the VDPS in this way, provide the safety-net that some vaccine recipients will need, given the febrile global debate about vaccination safety?
If we are to have any hope of looking back on 2020, this time next year, as an aberration – rather than the beginning of a ‘new normal’, the Government will need to keep this issue under close review.