Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether the grant of the Marketing Authorisations for Cominarty products on 9 November 2022 will affect (a) immunity against civil liability, (b) indemnities against product liability and (c) other indemnities given by his Department.

Regulation 345 of the Human Medicines Regulations 2012 provides partial immunity from civil liability for suppliers where a temporary authorisation is in place to supply a product under regulation 174. Supply of the vaccine was authorised under regulation 174 as a temporary measure before the Medicines and Healthcare products Regulatory Agency granted a Conditional Marketing Authorisation (CMA). Once the CMA is in place, this partial immunity no longer applies.

We are unable to provide information relating to any indemnities provided by the Department as this is commercially sensitive. However, indemnities do not affect the routes available to an individual to pursue a legal claim against the manufacturer, including for product liability. These indemnities establish that, in certain circumstances, a party to the agreement will pay the other party’s losses arising from a claim.