Dear Department of Health and Social Care (DHSC),

I am writing to make a request for information under section 1 of the Freedom of Information Act (FOIA) 2000.

In the House of Commons today (14 September 2021), the Secretary of State for Health and Social Care, speaking about the COVID-19 vaccine currently being developed by Valneva SE, said, and I quote:

"...it was also clear to us that the vaccine in question that the company was developing would not get approval by the Medicines and Healthcare Products Regulatory Agency here in the UK".

In light of the above, please can you confirm:
a) To what extent ministers are formally involved in the regulatory affairs of the Medicines and Healthcare products Regulatory Agency (MHRA), including, but not limited to, in the affairs of the Commission on Human Medicines (CHM).
b) To what extent ministers are involved otherwise than formally in the regulatory affairs of the Medicines and Healthcare products Regulatory Agency (MHRA), including, but not limited to, in the affairs of the Commission on Human Medicines (CHM).
c) Whether it is standard practice for ministers to be involved in applications for the authorisation of, or for a variation to the authorisation of, a particular pharmaceutical product, including, but not limited to, applications conducted by means of a so-called rolling review, before such applications are decided, and, if it is not standard practice, in which exceptional circumstances ministers would be involved.
d) Whether ministerial input is ever taken into account in deciding whether to authorise, or to vary the authorisation of, a particular pharmaceutical product.

Yours faithfully,

Kenneth MacArthur

Dear Department of Health and Social Care (DHSC),

Thank you for your response.

Based on your response, I am happy to revise the substantive part of my request to the following:

Please can you confirm whether recorded information exists which describes any or all of the following:
a) To what extent ministers can or should be formally involved in the regulatory affairs of the Medicines and Healthcare products Regulatory Agency (MHRA), including, but not limited to, in the affairs of the Commission on Human Medicines (CHM).
b) To what extent ministers can or should be involved otherwise than formally in the regulatory affairs of the Medicines and Healthcare products Regulatory Agency (MHRA), including, but not limited to, in the affairs of the Commission on Human Medicines (CHM).
c) Whether ministers can or should be involved in applications for the authorisation of, or for a variation to the authorisation of, a particular pharmaceutical product, including, but not limited to, applications conducted by means of a so-called rolling review, before such applications are decided.
d) Whether ministerial input can or should be sought and/or taken into account in deciding whether to authorise, or to vary the authorisation of, a particular pharmaceutical product.

If any such information exists, please can you provide it to me.

I am happy for the above to be considered a revision to my original request, or a new request, as you see fit.

Yours faithfully,

Kenneth MacArthur