Chris Seeks Assessment Of Authorisation For The Comirnaty Covid-19 Vaccine
Christopher Chope Conservative, Christchurch
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 7 November 2022 to Question 77274 on Coronavirus: Vaccination, if he has made an assessment of the potential impact of full marketing authorisation being granted to the Comirnaty covid-19 vaccine on Comirnaty's (a) indemnity against product liability and (b) partial immunity against civil liability; and if he will make a statement on the expected timeframes for meeting the post-authorisation conditions of the GB Conditional Marketing Authorisation for that vaccine.
Will Quince Minister of State (Department of Health and Social Care)
Indemnities do not affect the routes available to an individual to pursue a legal claim against the manufacturer. It establishes that in certain circumstances, one party to the agreement will pay the other party’s losses arising from a claim.
Regulation 345 of the Human Medicines Regulations 2012 provides partial immunity from civil liability for suppliers when there is a temporary authorisation 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 the conditional marketing authorisation. This partial immunity would only have applied in relation to the product supplied under the regulation 174 authorisation. It would not have applied in relation to the product that was authorised by the Conditional Marketing Authorisation. And the grant of a full Marketing Authorisation would not affect any partial immunity under the Regulations.
There are still conditions to be met for the bivalent Comirnaty products, where currently the target resolution dates are before the end of 2023. There are also post-approval measures relating to drug safety monitoring through the pharmacovigilance process, as for all licensed products on the market.
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To read the previous Written Question please CLICK HERE
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