2020-09-18 16:56:27
The Department of Health and Social Care has just completed a consultation (conducted over only three weeks) on amending the Human Medicines Regulations (HMR). The aim of the proposed amendments is to enable COVID-19 vaccines (when available) to be used before there has been time to grant a marketing authorisation “if there is a compelling case, on public health grounds, for using a vaccine before it is given a product licence”.
Currently, regulation 345 of the HMR gives immunity from liability for loss and damage where the MHRA recommends or requires the use of a product without a marketing authorisation. Regulation 345 currently extends immunity to manufacturers, marketing authorisation holders, their employees and health care professionals. The amendments proposed to the HMR include extending immunity from liability for loss and damage to pharmaceutical companies that place unlicensed products on the market; and also to extend immunity to other health care workers.