Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022

Viscount Stansgate Excerpts

Monday 14th March 2022 Grand Committee

Why now? There is a possibility—this year and next—for the industry, the Accelerated Access Collaborative and all the organisations that participate in it to work together and devise a scheme that is about not only streamlining regulation but using real-world data to trigger reimbursement. That reimbursement structure can then be put into the negotiation for the new voluntary pricing and access scheme, which starts from the beginning of 2024. My pitch to noble Lords and my noble friend is this: let us see that happen this year. I am taking this opportunity to ask if the Government will make it happen, through the AAC, during the course of this year.

[Viscount Stansgate (Lab)]

Am I allowed to ask a question before the Minister replies? I notice that one of the SIs has an impact assessment attached to it and the other, related to early access to medicines, does not. When I looked at the explanation, it said that it does not reach the threshold required to undertake a full impact assessment. What is the threshold above which you are required to provide a full impact assessment?

[The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)]

My Lords, the noble Baroness, Lady Brinton, is taking part remotely. I invite her to speak.