Response to DHSC Open Consultation: Changes to Human Medicine Regulations to support the rollout of COVID-19 Vaccines

Files in This Item:
File Description SizeFormat 
Response to HMR consultation - final version - 18 Sep 20.pdf190.74 kBAdobe PDFDownload
Title: Response to DHSC Open Consultation: Changes to Human Medicine Regulations to support the rollout of COVID-19 Vaccines
Authors: Kirchhelle, Claas
Permanent link:
Date: 18-Sep-2020
Online since: 2021-01-15T09:42:53Z
Abstract: We are writing in response to the UK Government consultation in respect of the proposals to modify the Human Medicine Regulations 2012 (“the Regulations”) in order to support the rollout of a COVID-19 vaccine. This is a submission to the consultation on behalf of a group of specialists drawn from different disciplines setting out our views on the proposed changes. Under the proposed modification of the Regulations, the envisaged scenario is that if there is a compelling case on public health grounds for using a vaccine before it is given a product licence, the Joint Committee on Vaccination and Immunisation may take the step of advising the UK government to use a tested, unlicensed vaccine/s against COVID-19. This would be a highly unusual step to take, and we have concerns about any UK Government decision to resort to the supply of an unlicensed medicinal product in this manner and the public health messaging that is thereby relayed. This is particularly the case in respect of one or several vaccines which have been developed under a fast-track procedure, potentially based on innovative technology, and which is to be used on such a wide scale to the general population.
Funding Details: Wellcome Trust
Type of material: Technical Report
Keywords: COVID-19CoronavirusMedicinal producsRegulationsVaccines
Other versions:
Language: en
Status of Item: Not peer reviewed
This item is made available under a Creative Commons License:
Appears in Collections:History Research Collection

Show full item record

Page view(s)

Last Week
Last month
checked on Feb 25, 2021


checked on Feb 25, 2021

Google ScholarTM


If you are a publisher or author and have copyright concerns for any item, please email and the item will be withdrawn immediately. The author or person responsible for depositing the article will be contacted within one business day.