The government has now approved the supply of the Pfizer-BioNTech COVID-19 vaccine. The reason they have been able to do this so quickly is because they have taken advantage of the temporary authorisation regime laid out by the Human Medicine Regulations of 2012 and 2020. The 2012 Regulations were updated in 2020 specifically to facilitate the smooth rollout of the COVID-19 vaccine. In the public consultation preceding the introduction of these updated regulations, several respondents raised concerns regarding unlicensed vaccines and immunity from civil liability. In practice, very little is known about these regulations and their application. This article seeks to shed some light on the temporary authorisation regime and suggest a means of alleviating concerns in the context of “vaccine hesitancy”.
Human Medicine Regulations of 2012
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On 16 October, the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (SI 2020/1125) entered into force. The Regulations cover temporary authorisations for vaccines, civil liability and immunity for participants in vaccination programmes, expansion of the healthcare workforce who can administer vaccines, promotion of vaccines and an exemption to wholesale licensing requirement.