growstuff I'm still not clear why new legislation is needed if unlicensed drugs can already be prescribed. Does anybody know what's new?
These extracts from the consultation document might clarify this a bit:
Regulation 174 of the HMRs allows the licensing authority to permit a temporary authorisation for the supply of an unlicensed medicinal product for use in response to certain specific types of public health threat – the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation.
A COVID-19 vaccine would only be authorised in this way if the licensing authority was satisfied that there was sufficient evidence to demonstrate the safety, quality and efficacy of the vaccine, in the particular context in which the licensing authority was asked to take that decision.
The proposed amendments build on and add to the existing text for regulation 174, which we are not proposing to alter. While it is implicit that under regulation 174, as currently drafted, a decision to authorise the supply an unlicensed medicinal product could carry certain conditions, this is not expressly articulated.
To provide transparency, we propose to amend the HMRs to make it explicit that the supply of products, including COVID-19 vaccines, which is temporarily authorised under regulation 174 may be subject to conditions. The imposition of conditions enables the licensing authority to define the safeguards that are a pre-requisite for the safe supply and use of the product and without which authorisation would not be valid. This can range from specifying whom the product is suitable for, setting batch testing and quality assurance standards, and ensuring that appropriate storage is in place throughout the supply chain. Given its importance, it is appropriate to articulate this element of the licensing authority’s decision-making more fully in the legislation.
There is a lot more there but I don't want to copy everything. What I note from the document is that it is still the licencing authority which would decide if a vaccine should be distributed. Having read part of the document, I actually feel better about the whole thing. I'll probably have a go at the rest of the document this afternoon. Of course I am not a specialist in this area.