Review of temporary provisions in the Human Medicines Regulations 2012 to support influenza and COVID-19 vaccination campaigns

The Human Medicines Regulations 2012 (HMRs) were amended in the final quarter of 2020 to add flexibility to some of the normal rules that would ordinarily govern vaccines and their supply to patients, in light of COVID-19. The changes were to facilitate the mass vaccination campaigns that have been taking place against both COVID-19 and seasonal influenza in the UK. These provisions remain in force until 1 April 2022 to support COVID-19 and seasonal influenza vaccinations.

Action is needed to determine if the provisions should be made permanent, extended for a further limited period or allowed to lapse. The Secretary of State, in conjunction with the Minister of Health in Northern Ireland, is seeking views on these proposals. The suggested changes to the HMRs will help to ensure the NHS continues to have the added flexibility it requires to operate any necessary mass vaccination programmes for COVID-19 and influenza.

We understand that the NHS has already used the full range of options available to them as provided by the HMRs to deliver vaccines safely and effectively at the pace and scale required.

In the interests of pandemic preparedness, we are also seeking views on whether to retain these provisions so that they may apply to any future pandemic.