In this blog Patient Safety Learning outlines the key points included in its response to the consultation on establishing a Patient Safety Commissioner for England. This sets out their feedback to this consultation and describes the powers and resources this role will require if it is to effectively influence change and improve patient safety.
As part of the Medicines and Medical Devices Act 2021, the UK Government formally committed to establishing the new role of a Patient Safety Commissioner for England. This was a key recommendation set out in the First Do No Harm report, published in July 2020 by the Independent Medicines and Medical Devices Safety Review (also known as the Cumberlege Review).
Here we will briefly provide the background to the creation of this role, before then outlining the key elements of our response to the Department of Health and Social Care consultation on this under the following headings:
- Term length
- Role of the Secretary of State
- Funding and functions
- Advisory board and working with patients
- Missed opportunity for feedback
The Cumberlege Review examined how the healthcare system in England responded to reports about harmful side effects of medicines and medical devices, focusing on three specific interventions: Hormone pregnancy tests, Sodium valproate and Pelvic mesh implants.
These interventions had resulted in a truly shocking degree of avoidable harm to patients over a period of decades and the Review described the healthcare system’s response to this as ‘disjointed, siloed, unresponsive and defensive’. You can read more about our assessment of the Review’s findings here and our thoughts on the Government’s recent response to its recommendations here. 
A key issue identified by the Cumberlege Review was the failure of the healthcare system to listen to patient concerns and a pressing need for ‘the patient voice and influence within the NHS’ to be strengthened. It recommended the appointment of a Patient Safety Commissioner to represent the views and interests of patients in relation to the safety of medicines and medical devices.
Nadine Dorries MP, Minister for Mental Health, Suicide Prevention and Patient Safety, confirmed that the Government would accept this recommendation in December 2020, with this being subsequently included in the Medicines and Medical Devices Act. This set out that the Commissioner would:
- Be an independent statutory office holder, funded by the Department of Health and Social Care and appointed by the Secretary of State.
- Have powers to make reports or recommendations and request and share information from relevant persons.
The public consultation on this role, published on the 10 June 2021, posed specific questions asking for comment on the proposed arrangements for the appointment and operation of this Commissioner. In the following sections of this blog we will outline the key elements of our response to this.
The consultation suggests that the new Patient Safety Commissioner for England should serve a term of three years, eligible for one reappointment. In our response we said that this term length was a little too short, suggesting that this should be expanded to four years, eligible for one reappointment. We believe that to enable the new Commissioner to investigate and monitor serious patient safety issues this greater length of time may be advantageous.
Taking the patient safety issues relating to the Cumberlege Review as an example, it took over three and a half years from the Review being commissioned by the Secretary of State to its recommendations receiving a full response from the Department of Health and Social Care - greater than the length of a proposed single term for the new Commissioner. Further to this, monitoring the initial implementation and effectiveness of these recommendations is likely to need at least another two to three years. This is an illustration of where a maximum length in office of six years for the Patient Safety Commissioner may prove to be unhelpful in overseeing similar work.
We also suggested that the Government should consider whether the term length for the inaugural Commissioner should be slightly extended as a one-off measure. This would account for the significant one-off task they will have at the start of their term in setting up the role, forging initial links with key stakeholders and recruiting staff to support their activities. We would estimate that this may require an additional 12 to 18 months.
Role of the Secretary of State
We disagreed with a proposal in this consultation that the Patient Safety Commissioner could be removed from their post by the Secretary of State for Health and Social Care if they deemed it appropriate.
As stated in our response to the Scottish Government’s consultation on creating a Patient Safety Commissioner, we believe that this type of role needs to be independent from those funding and delivering healthcare. In our view this requires a formal separation in accountability arrangements from the Secretary of State, so that they are not able to remove the role holder at their discretion.
If the Government is not willing to formally remove this line of accountability from the Secretary of State to the Commissioner, we would concur with the view set out by the Patients Association in their response to this consultation. They noted the importance of putting in place processes for appointing or dismissing a Commissioner, stating that:
“These should be developed, using a further public consultation, to provide a safeguard against a Secretary of State appointing a politically pliant Commissioner, using the role to channel public funds to an individual with whom they have a political or personal relationship, or dismissing a Commissioner who has raised legitimate but politically inconvenient concerns”
Funding and functions
The consultation suggests that the Patient Safety Commissioner should:
- Receive renumeration
- Be funded by the Secretary of State regarding staff and facilities
- Publish an annual business plan, accounts, and an annual report
In our response we agreed that the Commissioner should receive renumeration. Patient Safety Learning believes this role should afforded a competitive salary to attract an appropriate candidate, as is the case for similar roles such as the Children’s Commissioner for England.
On the issue of funding, as with the role of the Secretary of State mentioned in the previous section, we expressed concerns about financial support coming directly from the Department of Health and Social Care. We believe that it is vital that there is a degree of separation here to make clear the Commissioner’s independence from those funding healthcare. Given the complexity of the health and social care system, we believe the role will need to be funded to support a small office of staff to assist them in carrying out their functions effectively.
We agreed with proposals for the Patient Safety Commissioner to publish an annual business plan, accounts, and an annual report. We suggested that their annual business plan should include:
- Their reflections on key patient safety findings from the previous year and an indication of how these will inform their work in the forthcoming year
- Proposals for reviews and inquiries over the coming year. These may involve looking at a specific patient safety concern, patient safety performance or an issue of wider systemic reviews
- Plans for engagement with patients and patient groups over the forthcoming year
The consultation set out that in their annual report the Commissioner should summarise their activities, describe steps they taken to consult with patients and outline the actions resulting from this. Further to this, we suggest that this should:
- Provide an overview of how the Patient Safety Commissioner has engaged with regulators, providers, commissioners, policy makers and a range of stakeholders in health and social care
- Outline their work establishing networks across the UK and internationally to better understand and contribute to good practice in patient engagement and empowerment for patient safety
- Share examples of patient safety good practice identified and promoted through their work
Advisory board and working with patients
We strongly agreed with a proposal in this consultation that the Patient Safety Commissioner may appoint an advisory board. We would go further and suggest that they should appoint an advisory board.
There are significant sources of professional and patient knowledge, expertise and lived experience on patient safety issues in both the UK and globally. We believe that there would be value in seeking this out from others, in particular:
- Patients with lived experience of patient safety incidents and avoidable harm
- Patient campaigning groups
- Human factors and ergonomics experts
- Patient safety charities, organisations and health systems from the UK and other parts of the world
- Health and social care charities
Concerning the second group listed above, the Cumberlege Review clearly demonstrated the vital role that patient groups can play in highlighting systemic safety failings. At Patient Safety Learning we are currently working closely with patient groups to highlight patient safety concerns impacting people living with Long Covid and women who have experienced painful hysteroscopy procedures in the NHS. We believe there is a significant opportunity for insights from such groups to help inform the Commissioner’s work and that such groups would be key stakeholders and partners in striving to reduce avoidable harm.
Missed opportunity for feedback
In our consultation response we noted that this process could have been significantly improved by a less restrictive format. The online form provided lacked a meaningful option for participants to share their views on issues beyond the rather narrow selection of questions included in the consultation.
A particular area of concern from our perspective that this consultation did not provide scope for commenting on was the remit of the Patient Safety Commissioner and its limit to patient safety issues relating to medicines and medical devices. For the new Commissioner to be an effective champion for patients, encouraging health care organisations and the system to respond more effectively patient safety concerns, we believe they need a wider remit than this and from the outset.
As in our response to the consultation on establishing a Patient Safety Commissioner for Scotland, we suggested that a broader remit could be modelled on the Healthcare Safety Investigation Branch (HSIB) in England. Its rationale for looking into patient safety issues is to consider where something dangerous has happened, whether this resulted in harm or not, and investigate unsafe conditions that could cause harm. They then decide whether to look at an issue further based on the following criteria:
- Scale of risk or harm
- Impact on individuals involved and public confidence in the healthcare system
- Potential for learning to prevent future harm
A wider remit such as this would allow the Commissioner to investigate and make recommendations on a range of patient safety issues, such as unsafe surgical procedures, healthcare-associated infections, and diagnostic errors. This could also present more opportunities for insights and learning that could also applied to the safety of medicines and medical devices.
A Patient Safety Commissioner with a remit limited medicines and medical devices may create some confusion where patients want to highlight a clear patient safety issue that does not qualify under these terms. If the new Commissioner is not listening to these patients or patient groups concerns, who will?
The need for step change in patient safety
With the right remit and responsibilities, Patient Safety Learning believes that a Patient Safety Commissioner can play an important role in improving patient safety in England. However, they alone cannot bring about the fundamental change required to tackle unsafe care and empower patients.
We believe that there needs to be a step change in how we support and engage patients in patient safety and for the health care system to transform itself, putting patient safety at its core. Key to this is patient safety being seen as a core purpose of health and social care, not one of several competing priorities to be traded off against each other. In our report, A Blueprint for Action, we set out an evidence-based analysis of why harm is so persistent and what is needed to deliver a patient-safe future, identifying six foundations of safer care. We believe that the role of the new Patient Safety Commissioner for England must be considered in this wider context of the need to transform our approach to patient safety.
- UK Government, Medicines and Medical Devices Act 2021, 11 February 2021.
- The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020.
- Patient Safety Learning, Analysing the Cumberlege Review: Who should join the dots for patient safety? 16 July 2020.
- Patient Safety Learning, A year on from the Cumberlege Review: Initial reflections on the Government’s response, 23 July 2021.
- Department of Health and Social Care, The appointment and operation of the Patient Safety Commissioner, 10 June 2021.
- Patient Safety Learning, Patient Safety Commissioner for Scotland: Consultation Response, 9 June 2021.
- Patients Association, Response to the consultation on the appointment and operation of the Patient Safety Commissioner for England, August 2021.
- HSIB, Tell us about a patient safety concern, Last Accessed 27 May 2021.
- Patient Safety Learning, The Patient-Safe Future: A Blueprint for Action, 2019.