Changes to Human Medicines Regulation to go ahead amid coronavirus (COVID-19)

Changes to Human Medicines Regulation to go ahead amid coronavirus (COVID-19)

The Department of Health and Social Care has published the government’s response to the consultation on proposed changes to the Human Medicines Regulations 2012 (HMR 2012), SI 2012/1916 and announced new measures to support the rollout of coronavirus (COVID-19) vaccines. The proposed changes relate to authorising temporary supply of an unlicensed product, civil liability and immunity, expanding the workforce eligible to administer vaccinations, promoting vaccines and making provisions for wholesale dealing of vaccines. The government has proceeded with the changes to the HMR 2012, SI 2012/1916 proposed in the consultation with new legislation introduced on 16 October 2020 which came into force on the same day.

The government has, in large part, proceeded with the proposed changes to the HMR, however, it has modified some of the proposals to:

• ‘ensure robust scrutiny of the impact of regulation 174 takes place by making it a requirement that the impact of this regulation will be formally reviewed within a year of any first use. Regulation 174 is the existing mechanism which allows for the temporary authorisation of an unlicensed medicine or vaccine'

• promote objectivity by changing the 'objective bystander' test that relates to loss of immunity from civil liability where conditions are breached to make this a person who has 'relevant expertise in the subject matter of the breach', in place of the original reference to pharmaceutical companies

• create an additional level of reassurance in relation to the expanded workforce by making it clear that the new national protocol should include, where appropriate, the requirements for the supervision of an additional experienced vaccinator'

The government’s response can be read in full here.


• Distributing vaccines and treatments for COVID-19 and flu

• New measures to support roll-out of vaccines in the UK

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