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From January 2021, the UK’s licensing authority will have new powers to license all medicines, including vaccines. However, if there is a compelling case, on public health grounds, for using a vaccine before it is given a product licence, given the nature of the threat we face, the JCVI may take the very unusual step of advising the UK government to use a tested, unlicensed vaccine against COVID-19, and we need to make sure that the right legislative measures are in place to deal with that scenario.
Clarify the scope of immunity from civil liability which regulation 345 of the HMRs puts in place for certain products whose unlicensed use is recommended by the licensing authority in response to certain specific types of public health threat, so that it clearly applies not just to manufacturers and healthcare professionals but also to the company placing an unlicensed medicine such as a vaccine on the market with the approval of the licensing authority
I didn’t read it like that, especially the conclusion. 'This consultation document has laid out the proposals for changes to the Human Medicine Regulations 2012'
I thought use of the conditional or future tense throughout, (except when explaining the background) and use of phrases such as 'is seeking views on proposals', 'Policy Objectives' and 'Nature of the Consultation' makes it clear that it isn’t a done and dusted piece of legislation.
Edit: Oh, I’ve just reread the text of your post, and I think you are talking about the main framework legislation, which is to replace the EU legislation when we Brexit in january. Yes, we will have to have 'new powers' because the EU law will no longer be valid in the U.K.
I thought you were talking solely about the unlicensed vaccines bit, which is still under consulatation, because that’s the bit that you picked out in your Thread title, 'Government proposed changes to allow unlicensed vaccines from Jan 2021'
True, they passed legislation at the start of the pandemic, with agreement from opposition parties, to allow them to bring in quick legislation where needed, (for example, lockdowns and closures and restrictions on movement) without having to debate it in Parliament every time.
