Authorising an unlicensed vaccine: The Medicines and Healthcare Products Regulatory Agency has the power

23rd October 2020

The Medicines and Healthcare Products Regulatory Agency ("MHRA") has the power under reg.174 of the Human Medicines Regulations 2012 ("HMRs"), to temporarily authorise use of an unlicensed vaccine in response to a specific health threat such as COVID-19.

In circumstances where it exercises this power, key stakeholders such as manufacturers and healthcare professionals have immunity from civil action under reg.345 of the HMRs.

The immunity granted under reg.345 is not complete, however, and does not apply in relation to liability for defective products under s.2 of the Consumer Protection Act 1987 (“CPA”). If the safety of the product, “is not such as persons are generally entitled to expect,” taking all circumstances into account, manufacturers are not protected from civil liability. Those circumstances will include consideration of the scientific and technical knowledge at the time the product was put on the market, which means that no liability will attach if the producer can show that knowledge was not such as to enable the defect to be discovered.

Notwithstanding the above, immunity can be lost in certain circumstances. In order to benefit from immunity, it is imperative that the medicinal product supplied is that which the MHRA has recommended. If the supply is materially inconsistent with the MHRA’s recommendation, civil liability will still attach.

The paper makes it clear, however, that it would be unfair for immunity to be lost automatically after breach of a condition included in MHRA’s approval; and refers, as an example, to breach of a technical requirement with a relatively ‘inconsequential effect’ having a disproportionate impact.

It is anticipated that there will be a need to establish an objective test, to determine whether there has been a sufficiently serious breach so as to lead to the loss of immunity. The paper suggests the following test be applied:

…any risk of death or personal injury that is wholly or partly attributable to that breach is such that a reasonable person [with an interest in placing medicinal products on the market] would regard the breach as sufficiently serious to justify the licensing authority setting aside the recommendation…

Objective bystander

This test comes with two options that determine who the ‘objective bystander’ is. If the words in square brackets remain, the ‘objective bystander’ is a ‘reasonable’ pharmaceutical company. Without those words, the ‘objective bystander’ becomes any reasonable person.

In the case of the former, the objective bystander would have detailed knowledge of every aspect of the supply chain, which would mean a determination on whether immunity should be lost would require detailed technical evidence on the relevant standards of a reasonable pharmaceutical company. The burden of proof is much higher. In the latter, the burden of proof is much lower as it is only necessary to consider the standards of the reasonable person, which will involve less technical knowledge.

Once the status of the ‘objective bystander’ is agreed, it will then be for the Courts to determine what they would think in any given circumstances.

Finally, the paper considers the importance of separating the liabilities of different actors in the supply chain, by clarifying that only those persons or entities who are ‘wholly or partly responsible’ for a breach of the conditions lose immunity, rather than every actor in the supply chain.

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