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Regulatory reform - a perspective from the Patients Association

Where is the patient voice in the reform proposals?

The Department of Health and Social Care’s new proposals for regulating healthcare professionals share certain characteristics with its white paper for reorganising the NHS. Both offer promising solutions for problems that have been identified within the system, and should ultimately make the operation of the system much smoother for those who work in it. There is also a case for saying that these process improvements will also bring benefits for patients. But in both cases, the question has fundamentally not been considered from the perspective of patients, and patients themselves are largely absent from the proposals: neither set of plans offers a meaningful role for patients, and in different ways this threatens to undermine the effectiveness of both.

Throughout the proposed new regulatory structures, opportunities have been missed to guarantee a role for patients in setting the standards that registrants will have to be able to meet. Regulation is supposed to be done in the interests of patients, but there are no fixed systems or structures to ensure that regulators get patients’ views on-board when setting standards for education and training, for instance.

More serious still, however, is the absence of patients from the proposed new processes around fitness to practise. This deficit is so serious that we worry whether the new proposals are truly fit for purpose: it is possible to imagine ways in which the new system will be ineffective in ensuring patients’ safety.

Patient perspective on proposals to reform fitness to practise

Under the new three-step fitness to practise process proposed for all regulators, the aim is for as many cases as possible to be dealt with by case examiners, through agreed outcomes with registrants. While this process may well be effective in reaching outcomes more quickly for practitioners, it shuts patients out almost entirely: beyond their initial raising of a concern, the patient could play no role in the process at all. In our consultation response, we will be calling for an obligation for regulators to engage with patients meaningfully at this stage, and making clear that the proposed requirement to keep patients informed will not suffice.

The lack of an effective appeal process at this and the other stages is also troubling. The proposed Registrar review power will allow some decisions to be challenged but it is unclear how effective this will be or easy it will be for patients to challenge wrong outcomes. In addition, the process places a significant burden on patients to request a review at an already potentially difficult time for them. Patients could well be left helpless while regulator and registrant agree what might seem to the patient to be an unduly lenient arrangement that does not address their concern – in other words, the process risks looking like it pays no regard to patients’ views. Indeed, things might not even get this far if the initial assessment leads to a case not being forwarded to a case examiner at all. It is hard to see how patients will feel confident in this process.

Is it a step backwards?

The lack of any remit for an independent organisation to review and if necessary challenge decisions is also a concern, and a key reason why any unease felt by patients may well be justified: without such a safeguard, which was previously introduced following the Bristol Royal Infirmary Inquiry, the system is entirely reliant on regulators remaining ultra-vigilant in maintaining rigorous standards. The power for Registrars to review the decisions of case examiners puts the regulator in complete control, with no checks or balances on its performance. Isolated slips, or the development of an unhealthy culture where due rigour is not applied, could simply go undetected. This leaves the door open for future patient safety scandals.

Standing back, it can be observed that the role of regulators is not well known. For patients and the public, regulation is not open and transparent, although information is there to be found if people do some digging. More therefore needs to be done to engage with patients and promote the role of public protection. In this context, it is concerning that the changes proposed here are likely to result in less engagement and involvement of patients in the regulatory system.

Patients need to be heard for these reforms to inspire confidence in regulation

While there may be many sensible provisions here to enable the regulatory system to adapt to changing circumstances without having to alter primary legislation every time, at crucial points the proposed processes exclude patients and silence the patient voice – the exact opposite of what a process to protect the public and patients should be doing. With so few rights and so little say, it’s impossible to believe that this system will enjoy patients’ confidence, or meaningfully protect them. Without changes to give patients a voice, we will be unable to support these proposals.


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Please note the views expressed in these blogs are those of the individual bloggers and do not necessarily reflect those of the Professional Standards Authority.