Last week the UK Government confirmed that it would accept one of the key recommendations in the First Do No Harm report, published earlier this year by the Independent Medicines and Medical Devices Safety Review (more commonly known as the Cumberlege Review). Nadine Dorries MP, Minister for Mental Health, Suicide Prevention and Patient Safety, was quoted as saying that this would be tabled as an amendment to the Medicines and Medical Devices Bill.
This announcement has been welcomed by the Review’s Chair, Baroness Julia Cumberlege, and members of the newly formed All-Party Parliamentary Group for First Do No Harm, which has recently been set up to raise awareness and build support for the implementation of the Review’s recommendations. But what this role will look like in practice, and what impact will it have on patient safety?
The Cumberlege Review examined how the healthcare system in England responds to reports about the harmful side effects from medicines and medical devices. It focused on three specific medical interventions: Hormone pregnancy tests, Sodium valproate and Pelvic mesh implants.
Its report, published in July this year, set out the shocking scale of avoidable harm that resulted from these three interventions over a period of decades. It made a series of recommendations and actions for improvement, the second of which was:
“The appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. The Commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices.”
The Review envisioned this role as sitting outside of the existing healthcare system with “a direct line of accountability to Parliament through the Health and Social Care Select Committee”. It explained that the Commissioner should focus on two aims:
The Cumberlege Review includes in an appendix with further information about how a Patient Safety Commissioner for England would work in practice, providing suggestions on its powers, appointment, accountability, and organisational structure. Until we see more details following the passing of the Medicines and Medical Devices Bill into law, the extent to which these suggestions will be adopted remains an unclear. Some elements that we think are essential are:
The Patient Safety Commissioner must be independent of those funding and delivering healthcare and free to speak their mind without fear or favour.
The Review suggests the Commissioner should be appointed by the Privy Council and funded by the Cabinet Office, maintaining a level of separation from the healthcare system. This is to be welcomed, especially as other Commissioners do not always that degree of independence. For example, this is not the case in the role that this proposal draws much inspiration from, the Children’s Commissioner, who is directly appointed by the Secretary of State for Education and funded by their Department.
The First Do No Harm report states that the Patient Safety Commissioner should aim:
“… to improve identification of systemic safety issues and to improve the system’s coordinated response. Through a renewed focus on patients’ needs and a drive for cooperation and coordination, the Commissioner will help to release the wider benefits for the healthcare system from individual organisations’ safety improvements.”
This is a welcome ambition, but is it achievable? The Commissioner’s main role is promoting the rights of patients. This must be more than just listening and promoting. The Commissioner should be able to recommend and/or lead inquiries and reviews. This is a recommendation that we believe is essential to turn words into action and we would strongly commend the Government to agree to this in its response.
The healthcare system, or broader health and social care systems depending on the Commissioner’s final remit, is incredibly complex. The Commissioner’s Office will need to be properly resourced to enable it to:
Resources must be made available to the Commissioner to support their remit. This will prove to be instrumental as to whether they are able to achieve their objectives.
4) Collaboration with patient safety groups and networks
While the role of the Patient Safety Commissioner will be a new one, there are already a diverse range of groups outside of the NHS that can provide a helpful source of knowledge, insight, information, and support.
By bringing these organisations into a network, the Commissioner could amplify the voices of many already actively promoting patient safety. By no means an exhaustive list, but this could include: AvMA, The Patients Association, Healthwatch, Care Opinion, patient campaigning groups and of course, Patient Safety Learning. Our free knowledge sharing platform for patient safety, the hub, could provide valuable resources and a community forum for listening to patients’ voices.
We believe that a well-resourced Patient Safety Commissioner could play a vital part in improving patient safety in England. The Commissioner must have the resources and powers to influence change. It will not be sufficient for the Commissioner to raise patients’ concerns if the healthcare system is not compelled to listen and respond.
We consider that the Commissioner alone will not be able to bring about the fundamental change that is required to tackle unsafe care and empower patients. What is required is a step change in how we support and engage patients in patient safety and how the health care system transforms itself to put patient safety at its core. Many of these changes are needed throughout the health and social care system, from the bottom up. We describe the action that is needed in our report A Blueprint for Action and highlight 6 foundations for safer care that are urgently needed.
Another one of the recommendations of the Cumberlege Review was to establish a task force to implement its findings. If we are to make the wide-ranging changes needed for safe care, we believe that any such task force needs to look at patient safety issues beyond this report. Such a task force should include recommendations made by other major patient safety reports, such as:
One final notable issue posed by the commitment of the Government to establish a Patient Safety Commissioner for England is how this will work within the devolved health and social care system across the UK. The Scottish Government announced in September that they would be seeking to establish such as role, confirming this in a subsequent parliamentary debate.  However at this time it is unclear whether these arrangements will be replicated across each of the four nations.
In Wales, the Government is yet to issue a formal response on the Cumberlege Review’s recommendations, indicating in a recent response to a parliamentary question that they were still considering this. Meanwhile in Northern Ireland, at the end of November the Minister for Health Robin Swann MLA stated in a Assembly debate that this was one of a number of issues being considered by a working group looking at the Cumberlege Review’s recommendations.
This was not an issue for the Cumberlege Review to consider, with its remit specifically concerning England. However, thought needs to be given as to how multiple Patient Safety Commissioners may interact and work together, or how this might work in practice if some parts of the UK are covered by such a Commissioner and others are not.
There would be likely be significant common ground between the different Commissioners, resulting from similarities in healthcare provision across the UK. If significant patient safety issues who identified by one nation, there would be a value in ensuring a significant degree of coordination is in place to ensure that similar issues are not missed in other parts of the country.
 Health Service Journal, Government finally accepts need for ‘independent’ national patient safety commissioner, 17 December 2020. https://www.hsj.co.uk/patient-safety/government-finally-accepts-need-for-independent-national-patient-safety-commissioner/7029191.article
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 Patient Safety Learning, The Patient-Safe Future: A Blueprint For Action, 2019. https://s3-eu-west-1.amazonaws.com/ddme-psl/content/A-Blueprint-for-Action-240619.pdf?mtime=20190701143409.
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 Independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust, Ockenden Report: Emerging findings and recommendations form the independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust, 10 December 2020. https://www.ockendenmaternityreview.org.uk/wp-content/uploads/2020/12/ockenden-report.pdf
 Dr Bill Kirkup CBE, The Life and Death of Elizabeth Dixon: A Catalyst for Change, November 2020. The Life and Death of Elizabeth Dixon: A Catalyst for Change - November 2020 (publishing.service.gov.uk)
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 Senedd Cymru – Welsh Parliament, Written Question 81592, 26 November 2020. https://record.assembly.wales/WrittenQuestion/81592
 Northern Ireland Assembly, Official Report, 30 November 2020. http://aims.niassembly.gov.uk/officialreport/report.aspx?&eveDate=2020/11/30&docID=317938