The Medicines and Healthcare Regulatory Agency (“MHRA”) has given Pfizer-BioNTech’s COVID-19 mRNA Vaccine BNT162b2 temporary authorisation under regulation 174 of the Human Medicines Regulations 2012, which enables temporary authorisation to be granted in response to situations such as pandemics.
In this blog, which is the first of a two-part series, Cressida Mawdesley-Thomas considers when there could be civil liability for an unlicensed vaccine. It also considers the conditions imposed by the MHRA for the granting of the temporary authorisation to Pfizer-BioNTech’s COVID-19 vaccine.
The second instalment of the two-part series will consider:
- No-fault compensation under the Vaccine Damage Payment Scheme.
- Why the recommendations made by the Cumberlege review / First Do No Harm Report must be heeded to foster public trust in new vaccines (see our previous blog and webinar on the Report).
COVID-19 vaccines are likely to be the only way to restore life back to how it was pre-pandemic. Accordingly, the development and testing of COVID-19 vaccines has been accelerated and the UK has become the first country in the world to grant temporary authorisation for widespread use of the Pfizer-BioNTech vaccine. The Pfizer-BioNTech vaccine has been developed and approved within 10 months, far faster than any vaccine before. Most previous vaccines have taken around 10-15 years to develop, although the Ebola vaccine was developed and produced within 5 years.
The stages of vaccine development are as follows:
- Pre-clinical analysis (such as testing on mice);
- Stage 1 clinical trials which involve testing the vaccine on small numbers of people;
- Stage 2 clinical trials which involve testing the vaccine on hundreds of people;
- Stage 3 clinical trials which involve testing the vaccine on thousands of people (e.g. the Pfizer-BioNTech vaccine was tested on 43,500 people in six countries in stage 3 trials).
A vaccine will only pass to the next stage of clinical development once it is shown to be safe and efficacious at the prior stage. After all three stages of clinical trials have been passed, the vaccine is taken to the regulators to review (which includes peer-review by academics and experts) before it is approved, manufactured and administered. An overview of how some of the vaccines compare in stage 3 clinical trials (results not yet peer reviewed, except for Pfizer-BioNTech) is set out in tabular form below:
|Oxford / AstraZeneca||Viral vector (genetically modified virus)||x2||62-90%||Regular fridge temperature|
|Moderna||RNA (part of virus genetic code)||x2||95%||-20C up to 6 months|
|Gamaleya (Sputnik V)||Viral vector||x2||92%||Regular fridge temperature|
The Pfizer-BioNTech vaccine: tested but unlicensed
The independent Joint Committee on Vaccination and Immunisation (“JCVI”) will advise the UK government on which COVID-19 vaccine(s) the UK should use. The government has said in the conclusion to its consultation earlier this year on distributing treatments and vaccines for COVID-19:
…given the nature of the threat we face, the JCVI may take the very unusual step of advising the UK government to use a tested, unlicensed vaccine against COVID-19…
This is legally possible pursuant to r.174 of the Human Medicine Regulations 2012 (“the Regulations”) which disapplies the requirements of authorisation in response to situations such as pandemics. The MHRA have used the power under r.174 to grant the Pfizer-BioNTech vaccine temporary authorisation.
Civil liability for a tested but unlicensed vaccine
Pursuant to r. 345 of the Regulations, there is generally no civil liability against marketing authorisation holders, manufacturers and health professionals for any consequences resulting from the use of an unauthorised (i.e. unlicensed) medicinal product, such as the Pfizer-BioNTech COVID-19 vaccine. The UK Government proposes to expand this protection to pharmaceutical companies, so they are no worse off than the manufacturer who is producing the product on their behalf.
This is not an unduly concerning development (the policy merits of which are beyond the scope of this blog) as consumers can still bring a claim for damage caused by an unlicensed product if it is defective. This is because the right to bring a claim for defective products under the Consumer Protection Act 1987 (“CPA 1987”) is preserved by r. 345(4) of the Regulations. What is more concerning is that there is no general civil liability against health professionals / those who might administer an unlicensed vaccine if they failed to warn a patient of the risks of the vaccine or incorrectly administer / store the vaccine. A product will not be defective because it was administered without a proper warning being given. It is essential that all patients are told, in terms they understand, about the benefits, risks, alternatives and doing nothing when they are offered this unlicensed vaccine.
Defective products – Consumer Protection Act 1987
Section 2(1) of the CPA 1987 imposes strict liability “where any damage is caused wholly or partly by a defect in a product” on producers of products, as well as those who import such products and those who put their label on them.
A product is defective for the purposes of the CPA 1987 “…if the safety of the product is not such as persons generally are entitled to expect…”, taking all the circumstances into account, including, as per section 3(2) of the act:
(a) the manner in which, and purposes for which, the product has been marketed, its get up, the use of any mark in relation to the product and any instructions for, or warnings with respect to, doing or refraining from doing anything with or in relation to the product;
(b) what might reasonably be expected to be done with or in relation to the product; and
(c) the time when the product was supplied by its producer to another.
Meaning of “defective”
The CPA 1987 implements the Defective Products Directive 85/374/EEC of 25 July 1985 (“the Directive”). Since that time there have not been any domestic or European decisions which have dealt directly with when a vaccine would be considered defective for the purposes of CPA 1987 or the Directive. However, Mrs Justice Andrews DBE sitting in the High Court considered in detail whether a product was defective in The Pinnacle Metal on Metal Hips Group Litigation  EWHC 1208 (QB) at 84. The key points from this decision can be summarised as follows:
- The Court’s focus should be on whether the product is safe, and safety is an inherently relative concept – effective medical products rarely carry no risks whatsoever.
- The approach of Hickinbottom J’s in Wilkes v DePuy  EWHC 3096 (QB) (another case concerning hip replacements) was preferred to that of Burton J in A v National Blood Authority  3 All ER 289 (a case involving contaminated blood). It was held by Mrs Justice Andrews that: “the court must maintain a flexible approach to the assessment of the appropriate level of safety….”. Burton J’s comments that certain factors, such as the benefits a product could bring, should be disregarded because the CPA 1987 imposed strict liability, were rejected.
- Accordingly, a product’s benefits, cost and avoidability were features which could, in appropriate cases, be taken into consideration when assessing whether a product is defective.
- Information and warnings provided to healthcare professionals are plainly relevant circumstances.
- A product will not be defective because a known risk manifests itself, or one that is inherent in all products which have the same characteristics. This is because the product will not have fallen below the standard people are generally entitled to expect.
In the current context, it is therefore suggested that, if there is choice from a selection of vaccines, and a patient sustains harm from one vaccine due to an abnormal risk that no other vaccine carried, then there would be a good case to say that the vaccine was defective. However, if the patient was warned beforehand that the vaccine they were due to take could cause such a side-effect in a very small number of cases, then it is unlikely that the vaccine would be found to be defective.
Proving that the harm was caused by the vaccine
In Sanofi Pasteur Case C‑621/15, the CJEU considered how a person who had received a vaccine and subsequently contracted a disease might be able to discharge the burden of proving that the disease was due to a defect in the vaccine.
The decision in Sanofi Pasteur allows courts to find that causation has been established “notwithstanding the finding that medical research neither establishes nor rules out the existence of a link between the administering of the vaccine and the occurrence of the victim’s disease” provided that the evidence adduced is “sufficiently serious, specific and consistent”. The CJEU also made clear that causation cannot be established by the operation of a legal presumption causation will be made out where the scientific evidence neither confirms nor refutes a causal link between the vaccine and the damage.
Further safety measures: conditions of temporary authorisation for an unlicensed vaccine
The government has amended the Regulations such that the MHRA can make, and indeed has made, the recommendation for the unlicensed vaccine subject to a number of conditions. The conditions imposed by the MHRA for the grant of temporary authorisation for the Pfizer-BioNTech Vaccine’s relate to: (i) quality, (ii) product information and instructions for Use, (iii) clinical and Pharmacovigilance, (iv) deployment, (v) supply chain and distribution.
Those in the supply chain who are wholly or partly responsible for a sufficiently serious breach of the conditions lose the general immunity from civil liability under regulation 345 (which implements article 5(3) of Directive 2001/83/EC). What constitutes a “sufficiently serious” breach will be judged by the standards of an objective (specialist) bystander, who in the context of a COVID-19 vaccine would be a reasonable pharmaceutical company. The government consultation suggests that such a term has only been included to ensure that claims are not made for minor technical breaches of conditions of unlicensed supply. However, it is submitted that the final decision on what the “objective bystander” would think – whether it be the ordinary man or woman in the street or the specialist bystander – would of course be for the courts.
COVID-19 vaccines are a cause for optimism: in clinical trials they have been more effective than first hoped, and they are likely to be the path back to better health and prosperity. Such vaccines could be rolled out to the very vulnerable soon, with older adults resident in care homes and care home workers first on the list. However, as with other medical interventions, it remains important that all individuals are empowered to make an informed choice, and that communications regarding the risks and benefits are tailored to each individual patient’s needs. If information is communicated clearly, this is likely to generate increased public trust in any vaccines available.
Patients can also take comfort that even if an unlicensed vaccine is distributed, which could well be before Christmas, there will still be civil liability for a vaccine which causes harm as a result of a defect. Further, the Pfizer-BioNTech vaccine is subject to conditions, a sufficiently serious breach of which would lead to civil liability for those in the supply chain responsible for the breach. What is not yet clear is just how egregious a breach will have to be in order to be deemed “sufficiently serious”, although there is bound to be the argument that this is a higher test to meet than the ordinary test for negligence.
 This reads, so far as is relevant as follows: “…Member States shall lay down provisions in order to ensure that marketing authorisation holders, manufacturers and health professionals are not subject to civil or administrative liability for any consequences resulting from the use of a medicinal product otherwise than for the authorised indications or from the use of an unauthorised medicinal product…”
 Vaccine BNT162b2 – MHRA Conditions of Authorization under Regulation 174, 2 December 2020, available here: Conditions_of_Authorisation_for_Pfizer_BioNTech_COVID-19_vaccine.pdf (publishing.service.gov.uk)