FOI 2026/1751

I am writing to make a request under the Freedom of Information Act 2000. Please also apply this to any information held by your ICB following the ICB restructuring on April 1^st 2026.

1. Please provide a copy of the Action and Improvement Plan produced pursuant to Action 2 of the NatPSA by the 31 January 2024 deadline, or the nearest equivalent document your organisation holds.
2. Please provide any entry or entries on your corporate risk register relating to valproate-containing medicines (including those recorded as sodium valproate, valproic acid, valproate semisodium, Epilim, or Depakote), added or active at any point between 1 October 2023 and the date of this request. For each entry, please provide the risk title and description, date first added, inherent and residual risk scores, recorded controls and mitigating actions, and current status, if closed, the date of closure and reason recorded. If no such entry exists or has existed in this period, please confirm this in your response.
3. Please provide copies of any papers, reports or minutes from your Medicines Optimisation Committee or equivalent, or any sub-group or working group established to co-ordinate valproate safety, concerning valproate prescribing or patient outcomes, to address cost concerns you can simplify by identifying documents by keyword searches for “valproate”, “VPA”, “Epilim” and “valproic acid” from October 2023 to March 2026.

If complying with all three parts of this request would exceed the appropriate cost limit, please prioritise parts 1 and 2 and respond to part 3 only to the extent that cost permits. I would appreciate confirmation of receipt of this request.

1. The release of this information is considered exempt from disclosure by virtue of section 36(2)(b)(i) and (ii) of the Freedom of Information Act, as disclosure would be likely to inhibit the free and frank provision of advice and the free and frank exchange of views for the purposes of deliberation.

Section 36 – Prejudice to the effective conduct of public affairs

The Minister responsible for the Freedom of Information in the Department of Health has authorised the senior person in charge of the National Health Service bodies to act as ‘Qualified Persons’ and under Section 5 of the National Health Service Act 1977 this is the Chief Executive. Under the Section 36 exemption, the ‘qualified person’ for NHS Greater Manchester (NHS GM) is Professor Colin Scales, Acting Chief Executive.

Professor Scales is of the opinion that the information should be withheld as he considers that it would, or would be likely to prejudice, the effective conduct of public affairs.

Disclosure of the Action and Improvement Plan, would, or would be likely to:

• inhibit the free and frank provision of advice, and
• inhibit the free and frank exchange of views for the purposes of deliberation.

The document is an internal working document which contains sensitive information including patient specific cases. To share this information would also be likely to negatively impact stakeholder engagement and cause a “chilling effect” relating to very important issues and concerns that would be likely to impact quality of patient care.

In addition, disclosure would be likely to prejudice the effective conduct of public affairs by undermining the ICB’s ability to manage system performance and improvement through frank internal dialogue prior to formal decisions being reached.

Public Interest Test

Factors favouring disclosure.

Openness and transparency: It is important that NHS GM acknowledges their responsibility to be open, transparent and accountable in relation to patient care and patient safety.

Factors favouring non-disclosure.

NHS GM consider sharing the information requested would inhibit advice, views and openness between decision makers, necessary to agree appropriate service provision for the patients it serves.

Disclosure of such sensitive material would be likely to lead to self-censorship by officers and system partners in future, particularly where discussions involve sensitive performance issues or emerging concerns which are currently informing the NHS GM plans to improve patient safety when looking at the National Patient Safety Alert (NatPSA). This would reduce the candour and quality of internal advice available to decision-makers.

Balancing Test.

NHS GM has carefully considered whether the requested information could be disclosed in a redacted or partial form. However, meaningful disclosure would not be possible without undermining the protected interests. Redaction would leave the remaining material fragmentary and misleading.

It is the decision of NHS GM that the public interest at this time lies in non-disclosure of the information for the reasons outlined above. NHS GM consider that the public interest in withholding the information outweighs the public interest in disclosure.

2. There are no entries active, nor closed, which relate to valproate-containing medicines recorded within the NHS GM corporate risk register.
3. The release of this information is considered exempt from disclosure by virtue of section 36(2)(b)(i) and (ii) of the Freedom of Information Act, as disclosure would be likely to inhibit the free and frank provision of advice and the free and frank exchange of views for the purposes of deliberation.

Section 36 – Prejudice to the effective conduct of public affairs

The Minister responsible for the Freedom of Information in the Department of Health has authorised the senior person in charge of the National Health Service bodies to act as ‘Qualified Persons’ and under Section 5 of the National Health Service Act 1977 this is the Chief Executive. Under the Section 36 exemption, the ‘qualified person’ for NHS Greater Manchester (NHS GM) is Professor Colin Scales, Acting Chief Executive.

Professor Scales is of the opinion that the information should be withheld as he considers that it would, or would be likely to prejudice, the effective conduct of public affairs.

Disclosure of the copies of any internal papers, reports or minutes in scope of the request would, or would be likely to:

• inhibit the free and frank provision of advice, and
• inhibit the free and frank exchange of views for the purposes of deliberation.

The documents contain sensitive information including patient specific cases. To share this information would be likely to negatively impact stakeholder engagement and cause a “chilling effect” relating to very important issues and concerns that would be likely to impact quality of patient care.

In addition, disclosure would be likely to prejudice the effective conduct of public affairs by undermining the ICB’s ability to manage system performance and improvement through frank internal dialogue prior to formal decisions being reached.

Public Interest Test

Factors favouring disclosure.

Openness and transparency: It is important that NHS GM acknowledges their responsibility to be open, transparent and accountable in relation to patient care and patient safety.

Factors favouring non-disclosure.

NHS GM consider sharing the information requested would inhibit advice, views and openness between decision makers, necessary to agree appropriate service provision for the patients it serves.

Disclosure of such material would be likely to lead to self-censorship by officers and system partners in future, particularly where discussions involve sensitive performance issues or emerging concerns which are currently informing the NHS GM plans to improve patient safety when looking at the National Patient Safety Alert (NatPSA). This would reduce the candour and quality of internal advice available to decision-makers.

Balancing Test.

NHS GM has carefully considered whether the requested information could be disclosed in a redacted or partial form. However, meaningful disclosure would not be possible without undermining the protected interests. Redaction would leave the remaining material fragmentary and misleading.

It is the decision of NHS GM that the public interest at this time lies in non-disclosure of the information for the reasons outlined above. NHS GM consider that the public interest in withholding the information outweighs the public interest in disclosure.

It is critical that NHS GM maintain the greatest possible confidence without any concern that confidential or sensitive information provided, consulted, or relied on may be compromised.

However, there have been some discussions relating to the information requested in Greater Manchester Medicines Management Group (GMMMG) meetings. In line with Section 16 (advise and assist) of the FOI Act 2000 please find a link below to the GMMMG website and the published meeting papers: https://gmmmg.nhs.uk/meetings/gmmmg-meetings/

Furthermore, NHS GM are also in the final stages of developing a Valproate Guide for the system which is due to progress for GMMMG consultation in the coming weeks which will also be available via this website.