Recommendations

Recommendations made on the 20th of October, 2023

We must implement a structured approach to obtain information relating to a patient’s conditions directly from patients and their families at least on a daily basis.  In the first instance this will cover all in-patients in acute and specialist Trusts.

All staff in those Trusts must have 24/7 access to a rapid review from a critical care outreach team who they can contact should they have concerns about a patient.

All patients, their families, carers and advocates must also have access to the same 24/7 rapid review from a critical care outreach team which they can contact via mechanisms advertised around the hospital and more widely if they are worried about the patient’s condition.

The Government has accepted these recommendations, and has trialled Martha’s Rule in 143 sites across England. See the NHS England page on Martha’s Rule by clicking the button below:

Recommendation made on the 2nd of November, 2023

The Patient Safety Commissioner recommends for NHS England to have a fully funded and resourced system for improving the safe use of the most potent teratogenic medications, through a National Quality Improvement Programme for Integrated Care Systems, starting with the safe use of sodium valproate. The Commissioner believes that this should be implemented by September 2024 for sodium valproate, before expanding to cover any medication with a Pregnancy Prevention Programme by September 2025.

In January 2024 NHS England accepted this recommendation.  See the full response by clicking the button below:

Recommendations made on the 7th of February, 2024

All of Sir Robert Francis’ KC’s principles should be applied to any redress scheme for valproate and pelvic mesh.

Government must work across Whitehall and industry to bring a focus on addressing the needs of harmed patients in accessing support, educational resources, and public services. We define this as ‘non-financial’ redress.

The government should create a two-stage redress scheme – formed of (1) an Interim Scheme and (2) a Main Scheme. This Interim Scheme will, importantly, enable government to identify the size of the harmed populations.

All directly harmed patients of pelvic mesh and valproate are provided with an interim payment – of a fixed sum – through an Interim Scheme in recognition of the regulatory failures that led to their avoidable harm.

The Interim Scheme should be followed by the creation of a Main Scheme which would offer more tailored bespoke financial support to those directly harmed and – after further consultation with patients to finalise the definition – those indirectly harmed.

Treatment provided by both the NHS and independent sectors should be in scope of the redress scheme – as the regulatory failures uncovered by the First Do No Harm review span both.

Patients should find the application process for both the Interim and Main Scheme straight-forward, accessible, and non-adversarial. To support this outcome, a presumption of truth should be embedded within each scheme.

Both the Interim and Main Schemes should be administered by a body which patients have confidence in.

Both the Interim and Main Schemes should provide all harmed patients (not just those eligible or who wish to apply) with free emotional support.

The administrators of any redress scheme must be accountable to Parliament via the Public Accounts Select Committee.

The Patient Safety Commissioner has not yet received a response from the Government.

Recommendations made on the 31st of March, 2025

The MHRA needs to review – working alongside patients – whether their current guidance and regulations for the licencing and packaging of medicines goes as far as is possible to enable their safe use by those with sensory impairment.

The ABPI, MHRA and DHSC should work together to restart work – alongside published milestones – to digitise paper-based patient information leaflets via the existing UK Electronic Patient Information Task Force (ePIL). As part of this restart, ePIL, working with patients, should examine how to maximise the benefits of this work for patients with sensory impairment.

NHS England’s Diabetes Programme Team should launch a patient reference group to assess, understand and mitigate the barriers and enablers to the safe and effective roll-out of medical devices and other education programmes for the management of diabetes (such as DAFNE) for those with sensory impairments.

DHSC and NHS England need to ensure the work announced to improve and expand the NHS App in ‘Reforming elective care for patients’ includes an assessment – conducted with the input of patients – to determine whether further accessibility improvements are required, especially for people with visual impairment.

In May 2025, the MHRA responded to Recommendations One and Two. The MHRA includes Recommendation One in their current Agency Business Plan, and, in line with Recommendation Two, their refreshed Business Plan (2025-2026) includes a commitment to scope and engage with healthcare partners to identify opportunities to enable better patient access to healthcare information.

See their full response by clicking the button below: