Departmental Contingent Liability Notification: Human Challenge Project

Lord Sharma Excerpts

Thursday 26th November 2020 Written Statements

[The Secretary of State for Business, Energy and Industrial Strategy (Alok Sharma)]

I am tabling this statement for the benefit of right hon. and hon. Members to bring to their attention the contingent liabilities relating to the contract signed between the Government and Imperial College London for the human challenge project.

This project was announced on 20 October and is aimed at supporting the search for a covid-19 vaccine. A £33.6 million Government investment will back the project in partnership with Imperial College London, hVIVO and the Royal Free London NHS Foundation Trust.

In human challenge studies, a vaccine candidate that has proven to be safe in initial trials is given to a small number of carefully selected healthy, young adult volunteers who are then exposed to the virus in a safe and controlled environment. These studies offer the chance to accelerate development of promising vaccines against covid-19, bringing them to people more quickly and potentially saving thousands of lives.

The first step of the project is the virus characterisation study. This will begin in January 2021 and establish the smallest amount of virus needed to cause covid-19 infection in the volunteers. Robust safety, ethics, and regulatory approvals will be put in place before the study begins. Imperial College is the academic study sponsor for the characterisation study. As study sponsor, Imperial will be liable for any negative side-effects volunteers may experience in this study. Imperial has therefore taken out its own insurance, up to the sum of £10 million and for up to 36 months after completion of the study.

My Department has agreed to provide the excess for a relief claim that Imperial may make for a maximum of £15,000 per volunteer (to a maximum of the 90 volunteers involved in this study). This is only applicable where the claim arises as the result of the study but not as the result of one of the parties’ negligence. In addition to the agreed excess, my Department has agreed to provide unlimited indemnity beyond the £10 million.

My Department believes that this is a justifiable position given the very low risk of exceeding the maximum liability. In a reasonable worst-case scenario, our analysis estimates that liability would be under £1.5 million. Therefore, we do not expect the maximum liability to be exceeded.

A full departmental minute will be laid in the House of Commons providing more detail on this contingent liability.

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