The COVID-19 vaccination programme continues its roll-out across the UK, with more than 24 million people having received their first dose as at 15 March 2021 – a significant milestone in the fight against coronavirus. At the time of writing, three different forms of the vaccine have been approved for use in the UK: the Pfizer/BioNTech vaccine; Oxford/AstraZeneca; and, most recently, the Moderna vaccine.
These vaccines have been developed and approved rapidly, to deal with the global pandemic and protect vulnerable people as soon as possible. With recent reports about the AstraZeneca vaccine, Dr Phil Bryan, MHRA Vaccines Safety Lead, said on 11 March 2021 that: "Vaccine safety is of paramount importance and we continually monitor the safety of vaccines to ensure that the benefits outweigh any potential risks… People should still go and get their COVID-19 vaccine when asked to do so". At the time of writing, the World Health Organisation (WHO) has urged countries not to pause COVID vaccinations and said there was no evidence of a link between the vaccine and blood clots.
In the context of the rapid development and employment of the COVID-19 vaccines, how do controls on potential civil liability for injuries arising from vaccine use or delivery operate?
Approving new vaccines
In the UK, all vaccines need to be approved for use by the MHRA. In considering new medicines, the MHRA works within the Human Medicines Regulations 2012 (the "2012 Regulations"), which set out the procedure for authorising and producing medical products.
Authorised medicinal products
Regulation 46 of the 2012 Regulations prohibits the sale or supply of "unauthorised" medicinal products, protecting patients from receiving untested or unsafe treatment. In this context, "unauthorised" is defined as a medicinal product which does not have a UK marketing authorisation (that is, the normal MHRA authorisation under the 2012 Regulations), or another authorisation such as an EU marketing authorisation. Ordinarily, this means that products which have not been through the marketing authorisation process cannot be sold or supplied in the UK.
However, even before the coronavirus pandemic took hold, the 2012 Regulations included provision for the rapid rollout of medicines if needed, without going through the marketing authorisation procedure. Regulation 174 provides that a medicinal product can be sold or supplied if it has been authorised on a temporary basis by the MHRA. A temporary authorisation can be made in response to the suspected or confirmed spread of nuclear radiation, chemical agents, toxins, or "pathogenic agents" which "may cause harm to human beings".
Unlike most other existing vaccines the COVID-19 vaccines have been given this temporary authorisation by the MHRA, rather than a normal marketing authorisation. The reliance on Regulation 174 enabled the MHRA to authorise the sale and supply of the vaccines in a shortened time-frame.
Conditions of temporary authorisation
The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 amended the 2012 Regulations by inserting a new Regulation 174A. This new section adds some structure to the bones of Regulation 174, and allows the MHRA to attach conditions to any temporary authorisation.
Detailed conditions have been applied to the temporary authorisation of the COVID-19 vaccines including in relation to quality, product information, clinical and pharmacovigilance, deployment, and supply chain/distribution. Copies of the conditions placed on each vaccine are available on the Government website.
Regulation 345 of the 2012 Regulations applies where the MHRA has made a "recommendation or requirement" for the use of a medicinal product in response to nuclear radiation, chemical agents, toxins, or "pathogenic agents" (a virus), either:
- without an existing marketing authorisation; or
- where there is a marketing authorisation, but for a therapeutic indication not permitted under the authorisation.
Under Regulation 345 of the 2012 Regulations, there is no civil liability for any loss or damage resulting from the use of a product in accordance with the recommendation or requirement applied to: (i) the holder of an authorisation for the product, (ii) the manufacturer of the product, or (iii) their officers, agents or employees.
This regulation was in place prior to the pandemic; but, has been expanded to also include "the person responsible for placing the product on the market in the United Kingdom" where the product has received the temporary authorisation under Regulation 174.
This means that where the MHRA have made a recommendation or requirement in respect of a product which has received MHRA temporary authorisation under Regulation 174 (so that there is no holder of a marketing authorisation, but only a temporary authorisation), then the person responsible for placing the product on the market in the UK will have no civil liability for loss or damage resulting from the use of the product – if it is in accordance with the MHRA recommendation or requirement.
This new provision does extend the scope of the protection from civil liability provided by the legislation. However, it is limited by the terms of Regulation 174A(3). Where a temporary authorisation is made, then the sale or supply of a product in breach of any condition attached to that temporary authorisation, can result in the loss of the protection from civil liability provided by Regulation 345. The protection will be lost where the breach creates a risk of death or personal injury such that a reasonable person with relevant expertise would regard the breach of the condition as being "sufficiently serious" as would justify the MHRA setting aside the recommendation or requirement which allows use of the product. Effectively, the sale or supply of a product in breach of the condition is deemed to be a use of the product outwith MHRA recommendations or requirements; so, the protection from civil liability in Regulation 345 no longer applies.
This piece of legislation is complex and it can be difficult to navigate. The MHRA, as the relevant regulator, has a key role in determining the conditions of a temporary authorisation; and, when assessing what would be justified as a "sufficiently serious" breach to merit setting aside a recommendation or requirement (and therefore, removing the protection from civil liability).
Medical staff & vaccinators
Regulation 345 of the 2012 Regulations also provides protection from civil liability for use of the product to "any healthcare professional". This is broadly defined but includes doctors, dentists, pharmacists, registered nurses and other healthcare workers.
In addition, the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 added a further classification so that protection from civil liability under Regulation 345 also applies to "any person, not being a healthcare professional, who administers the product in accordance with a protocol" approved by the Secretary of State, or his equivalents in the devolved administrations.
In this way, the Regulations provide protection for the individuals who are actually administering the vaccine, when it is used in accordance with the MHRA's recommendations or requirements. The original wording in the 2012 Regulations protects against any fears that medical staff could be held responsible for the product they are using to treat patients; while the additional wording added by the 2020 Regulations gives the same reassurance to, for example, vaccinators trained specifically to deliver vaccines during the COVID-19 pandemic.
Could claims be made another way?
This depends on exactly what the injury is, and how it has been caused.
Consumer Protection Act 1987
In the first instance, if the injury was alleged to be caused by the vaccine itself, patients could seek to claim under the Consumer Protection Act 1987. Section 2 of that Act provides that where any damage is caused "wholly or partly by a defect in a product", the producer (or anyone holding themselves out to be the producer), or importer of the product shall be liable for the damage; or, the supplier of that product if the supplier fails to identify the producer to the person who suffered the damage. The protection from civil liability provisions in Regulation 345 of the 2012 Regulations explicitly do not apply to liability under Section 2 of the 1987 Act.
This means that if a defect in the product could be proved, a consumer protection claim could be made. It's important to note however, that this is distinct from a harm caused by the vaccine itself. So, for example, a claim could be made where there was a defect in the vaccine (perhaps a "bad batch" of vaccine which had been compromised during production); but not if the vaccine has been made correctly.
Vaccine damage payments
In circumstances where an injury has been caused by the vaccine, rather than a defect in the vaccine, a patient may be entitled to a Vaccine Damage Payment under the Vaccine Damage Payments Act 1979. This is a one-off payment of £120,000, paid by the Government if a patient receiving a vaccine suffers a "severe" mental or physical disability as a result (defined by the Government as "at least 60% disabled"). COVID-19 was added to the list of vaccinations falling within the scheme in December 2020.
The question of whether any harm allegedly caused by a vaccine is due to a "defect" or due to the vaccine itself will depend on each individual case, and would ultimately have to be decided based on the evidence.
Medical negligence and consent
Finally, any injuries which are caused by negligence in the delivery of the vaccine may still be the subject of a claim if they are not covered by the civil liability protection for "use" of a product provided under Regulation 345 - that is, not consistent with the recommendation or requirement of the MHRA. In these cases, it may be possible to make a personal injury claim, in the same way as for any other medical treatment but again, would ultimately have to be decided based on the evidence.
It is important that medical staff providing vaccines remember that despite the nationwide programme, the vaccine is essentially an individual treatment for each patient – and that ultimately, it is a voluntary treatment under the current law. Relevant medical histories and informed consent should be taken into account as with any other treatment, and if there are potential contra-indicators or side effects from a vaccine – or, from a specific brand of vaccine – healthcare professionals will need to ensure that they have taken these into account.
The arrival of COVID-19 vaccines has been a welcome development in the battle against the ongoing pandemic. Given the speed and urgency with which vaccines have had to be developed and authorised for use, developers, producers and suppliers of the vaccines have been given a considerable degree of protection against vaccine-related personal injury claims; but, this is balanced by the fact that this protection is only provided they adhere to conditions, recommendations and requirements imposed by the MHRA. Similarly, those working with patients, will know that the nature of the vaccines and the circumstances in which it has been developed and authorised will not expose them to increased risk of civil liability.
For patients, although there is legal protection in place for manufacturers developing these essential vaccines, this is not absolute and there are also other means to make a claim if a vaccine is defective or not produced in line with its authorisation.