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Written on 16th July 2020 by Susan Brown

The IMMDS Review, which recently reported on the healthcare system’s response to safety concerns about valproate, vaginal mesh and Primodos, has called for a Patient Safety Commissioner to ‘champion the patient’s voice’ in reducing avoidable harm by improving patient safety.

The Patient Safety Commissioner would work outside the current network of patient safety organisations and be directly accountable to Parliament through the Health and Social Care Select Committee. The Commissioner would identify and encourage action that is needed to improve patient safety around the use of medicines and medical devices. In doing so, they would ‘hold the healthcare system to account’, on behalf of patients, for delivering improvements in patient safety.

IMMDS Review condemns healthcare system’s failure to listen to patients’ safety concerns

The recommendation for a new, independent, statutory Patient Safety Commissioner follows the IMMDS review’s condemnation of the way patients’ concerns around the safety of valproate and other treatments were ignored for so long. The system’s delays in taking action resulted in avoidable harm to thousands of women and children. 

In her letter to the Secretary of State which opens the IMMDS’s report, ‘First Do No Harm’, Baroness Julia Cumberlege says:

"We have found that the healthcare system – in which I include the NHS, private providers, the regulators and professional bodies, pharmaceutical and device manufacturers, and policymakers – is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre [the reason for its existence]. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially."

Why do we need a Patient Safety Commissioner? 

The IMMDS review and other healthcare inquiries have repeatedly found that patients’ and their families’ reports of harm are not acted upon until media or other public campaigns force the healthcare system to take action. Patients have a valuable role in identifying harm and promoting safety but their voices are often ignored by NHS and other health professionals. This leads to unacceptable levels of avoidable harm. 

"In our view serious harm is being done to patients and their families as a result of failure to identify risks in a timely manner or to respond to identified risks with appropriate action."

The review called for a solution which promotes the patient and the public’s point of view and actively seeks improvements in patient safety, without duplicating the work of the 126 organisations and additional 211 NHS commissioning bodies which already have ‘some regulatory influence’ on NHS providers in England.

Regulation of patient safety for medicines and medical devices involves:

  • monitoring services and professionals by systematic collection of information to assess and maintain standards of care
  • research 
  • investigation of incidents 
  • inspections 
  • analysis and sharing of data with other regulatory organisations
  • professional and legal advice and support for healthcare providers or other regulators 
  • advice and support for the public, publishing performance evaluations and information on standards
  • setting standards 
  • policy making, setting formal rules and guidelines.

With so many organisations working towards improving patient safety in so many different but isolated ways, the system as a whole is disjointed and cannot react as quickly as is needed to protect patients from further avoidable injury.  

What needs to change?

The review identified that the healthcare system’s management of patient safety concerns needs to change in three key areas: 

  • faster and wider recognition of issues identified by patients and the public
  • becoming better at listening to and acting on patients’ experiences of avoidable harm
  • faster and better coordination between different agencies when improvements and solutions are identified, to protect future patients and members of the public.

Putting  patients’ experience at the centre of the patient safety system and formally recognising the value of patients’ reports about safety concerns is fundamental if avoidable harm is to be reduced. 

What would be the role of a Patient Safety Commissioner?

The Patient Safety Commissioner would champion the patient’s voice and experiences. Their aim would be to improve identification and a coordinated response to systemic safety issues. Their primary statutory function would be to promote and improve patient safety, and to promote the views and interests of patients and the public in relation to the safety of medicines and medical devices. 

The review suggested that, ideally, to maintain their independence from the healthcare system, the Patient Safety Commissioner would be appointed by the Privy Council and funded by the government through the Cabinet Office rather than the Department of Health and Social Care.

Their remit would be defined by legislation but they would have power to do anything necessary to achieve their aims. Everything they do would be based on a set of Principles of Better Patient Safety, which would be written in consultation with patients, their representatives and the public. The Commissioner would appoint an advisory board to advise and support them in complying with their aims and patient safety principles.

They would report directly to Parliament via the Health and Social Care Select Committee, to the Secretary of State for Health, and to other agencies and organisations. In setting their own work agenda they would avoid duplicating what is being done elsewhere. They would advise on system-wide safety concerns, and make recommendations such as for reviews, in-depth inquiries, performance evaluations and other actions where needed. 

Above all, the Patient Safety Commissioner would have a duty to involve and inform patients and the public, and would be accountable to them in various ways, including by publishing reports,  carrying out research and consultations. Patients, individual members of the public and whistle-blowers could report their concerns to the Patient Safety Commissioner directly, but the Commissioner would investigate broader safety concerns rather than individual cases. 

Is the healthcare system willing and able to learn, to change, and to compensate fully those who have been harmed?

As is so often the case with independent reviews and inquiries, Baroness Cumberlege and her dedicated team have shone a much needed light on the dangers of a healthcare system which ignores patients’ concerns.

The shocking extent of the harm that systemic negligence has caused so many women and children to suffer is totally unacceptable and cannot be allowed to continue. Faced with the truth of the healthcare system’s failings and the suffering that it has caused in just three areas of women’s care, the healthcare system must now prove that it is willing and able to learn, to change and to compensate fully those whom it has injured.

Boyes Turner’s clinical negligence team welcome all genuine efforts to strengthen and protect patients’ safety, including the proposed appointment of a Patient Safety Commissioner. Meanwhile, we remain committed to achieving full compensation for patients who have been harmed.   

If you or a member of your family have suffered serious disability as a result of medical negligence and would like to find out more about making a claim, contact us by email at