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Slave1

08/12/25 10:17 PM

#781072 RE: muee88 #781067

Why Section 22(1) Means More Than Just “Having the Summaries”

Section 22(1) of the UK Freedom of Information Act is not a generic placeholder and it is not used to say “we have meeting summaries” in the ordinary sense. It is a specific exemption that can only be applied when three strict conditions are met.

1. The information already exists in recorded form and is held by the authority.

2. The authority intends to publish it at a future date in a form and at a time of its choosing.

3. A public interest test has been carried out, weighing immediate transparency against the orderly publication process.

If the requested information did not exist, was speculative, or did not match the request, the MHRA could not lawfully apply Section 22(1). In that case they would have to respond under Section 1(1)(a) by stating they do not hold the information, or they would have to use a different exemption, such as Section 12 for excessive cost or Section 41 for confidential information.

In this FOI request, the question was narrowly framed. It asked whether any discussions during the May or June 2025 CHM meetings involved a medicine for the treatment of brain cancer. The MHRA’s reply did not use Section 1(1)(a) or any other exemption. Instead, they stated, “We can confirm that the Agency holds the information you are seeking.”

That statement is not generic. It is an explicit acknowledgment that the CHM minutes for May or June 2025 contain exactly the type of discussion the FOI request asked about — a brain cancer medicine. The reason they are not disclosing it now is because CHM minutes go through a formal process before release, which includes accuracy checks, redaction of any commercially confidential details, and then publication in the normal course.

It is important to understand what CHM is doing at this stage. The Commission on Human Medicines is the statutory expert body that advises the MHRA on the benefit–risk balance and the content of the Summary of Product Characteristics, the legal label defining what the medicine is approved for, who it is for, how it should be used, and what warnings must accompany it. CHM does not meet at this point for early scientific advice or speculative discussion. By the time a medicine appears on their agenda, it has already completed the MHRA’s scientific assessment and is in the label finalisation and decision-preparation phase.

The timing of this FOI reply fits DCVax-L’s regulatory path. The MAA was validated in March 2025. In most cases, there is a 60 to 120 day window from validation to CHM review, which puts a May or June meeting exactly in the expected timeframe.

The idea that this is “just the summaries” misses the point of Section 22(1). This exemption is applied to specific content within the summaries that directly matches the FOI request. If there were no relevant content — in this case, no brain cancer medicine discussion, the MHRA would have responded that they do not hold any such information. They would not use Section 22(1) for unrelated material.

Because Section 22(1) has been invoked here, we know the following. A discussion on a brain cancer medicine took place. It was specific enough to be recorded in the CHM minutes. It is scheduled for publication once the standard clearance process is complete. The product is not named in the FOI response because regulators will not do that before official publication, but given the rarity of adult glioblastoma marketing authorisations in the UK and the public record of NWBO’s submission, the probability strongly points toward DCVax-L.

The FOI reply is therefore not a casual acknowledgment that the MHRA possesses meeting summaries. It is a formal confirmation that they hold the exact information requested, that a CHM discussion took place in May or June 2025 on a brain cancer medicine, and that it will be made public in the CHM summary minutes when the formal publication process is complete.
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