Our thoughts on the PSA Report ‘Reshaping regulation for public protection’

  • 4th November 2021

Last week the Professional Standards Authority for Health and Social Care published a new report, Reshaping regulation for public protection, outlining their view on the implications of the Health and Care Bill for professional regulation.[1] In this blog, Patient Safety Learning looks at this report in more detail and explores the key patient safety aspects of this.

Health and Care Bill

On 6 July 2021 the UK Government published the Health and Care Bill, which sets out proposals to change to the delivery and organisation of health care services in England.[2] [3] This Bill includes:

  • Plans to formally merge NHS England and NHS Improvement.
  • Provisions to establish Integrated Care Systems on a statutory footing.
  • New powers for the Secretary of State for Health and Social Care over the system.

The Professional Standards Authority for Health and Social Care (PSA) report, Reshaping regulation for public protection, focuses on the proposed new powers for the Secretary of State.[4] Specifically, that the Secretary of State would be able to abolish an individual health and care regulator, and remove a professional from regulation if regulation is not required for protection of the public. This would mean that the Secretary of State could change the number of regulators, or who is regulated, without an Act of Parliament.[5]

Problems with the current system

Before the PSA set out their view in their report on how these new powers could be used to reform professional regulation, they outline several important problems concerning how the existing system operates, stating:

  • Investigations into serious patient safety scandals over the past twenty years, from the Kennedy Inquiry to Cumberlege Review, highlight how a lack of coordination between different parts of the patient safety landscape has contributed to when things have gone wrong or prevented problems from being detected.[6] [7]
  • There are gaps in the existing system of professional regulation, with “up to two million unregulated roles within the wider workforce”.[8]
  • The regulatory environment is complex, with multiple bodies having a role overseeing the safety and quality of services, with these arrangements differing across England, Northern Ireland, Scotland, and Wales.
  • Boundaries between regulators can create barriers which “can increase the risk of public protection failures” and result in the system being unable to adapt to new changes quickly.[9]

Patient Safety Learning agrees with this assessment by the PSA. The notion that there are gaps in leadership for patient safety at a system level is not a new one. In their 2018 report, Opening the door to change, the Care Quality Commission also acknowledged this, describing the system as “confused and complex, with no clear understanding of how it is organised and who is responsible for what”.[10]

We believe when developing any plans to reform professional regulation in health and social care, patient safety must be at the core of this, designed into the heart of the new system. This includes overarching leadership for patient safety across professional regulators and the wider health and care system, standards for patient safety and published organisation and system goals for safe care.

Whatever changes that may be subsequently proposed by the Government, it is vital that there are proper safeguards in place and that reforms are focused on protecting patients and service users.

Creating a simpler and more coherent system of regulation

Having outlined where it perceives some of the key problems to be in the current system of regulation, in their report the PSA goes on to suggest how new powers for the Secretary of State in the Health and Care Bill could be used to reform this. They suggest that:

  • The Government uses these new powers to create a single regulator, removing the boundaries which prevent regulation working as a coherent whole and allow for the development of a common code of practice.
  • They develop a risk-based approach to regulation to consider which currently unregulated roles may need to be brought into this. The PSA state that this should be based on “a robust, independent process to ensure that any decisions are based on a clear assessment of the risk of harm arising from practice”.[11]
  • That the Accredited Registers (AR) programme, which lets the public have access to qualified practitioners wherever and whenever they access care, is retained in these reforms.

Patient Safety Learning recognises the potential advantages of aligning the regulation of healthcare professionals from a patient safety perspective. We see the benefits of developing a common statement of professional practice across a range of different roles, to make clearer what the public can expect from health and care workers and when to report a concern to the regulator.

We also note that to meet this aim of aligning regulation, the creation of a single regulator is not the sole approach to this. The PSA itself in their report indicates that a simple reduction of the existing number of regulators would have potential benefits in this regard, as well as providing a simpler structure for patients and the public to navigate.

We strongly support the PSA’s proposal to develop a risk-based approach to regulation. Patient Safety Learning believes that it is vital that we understand where there are currently unregulated roles with a significant responsibility for patient safety and address these gaps where appropriate with a consistent and transparent process. We also believe there is value in the existing Accredited Registers programme and support the PSA’s proposal that this is retained as part of any future reforms.

Looking to the future

The PSA report also acknowledges the important issue of when any significant regulatory reforms should be implemented, given the continued pressures of the Covid-19 pandemic and the backlog of non-Covid care and treatment. They state:

“The existence of effective regulatory arrangements, focused on risk, safety and public protection, will be central to the delivery of care whatever challenges the sector faces in the years ahead.
While some might argue that the timing is wrong for change on this scale, there is already a busy and ongoing programme of regulatory reform with the sector invested in improvement and change. Although further structural and organisational mergers may be challenging, we think that with appropriate oversight and governance, the sector is well-placed to respond.”[12]

Patient Safety Learning agrees that reforms to the system of professional regulation that can deliver improvements to patient safety should be prioritised. Considering the current pressures faced by health and social care services, we believe that any future Government plan to reform or significantly change professional regulation needs to assess the patient safety impact of any proposed changes and put in place safeguards to minimise any regulatory disruption in the process of this.

We also concur with one of the PSA’s closing statements in their report, that:

“Without a clear plan there is a risk that a piecemeal approach could make things more, rather than less, complicated or prioritise short-term reduction in costs and improved flexibility over public protection.” [13]


[1] Professional Standards Authority for Health and Social Care, Reshaping regulation for public protection: Our view on the implications of the Health and Care Bill for professional regulation, 28 October 2021. https://www.professionalstandards.org.uk/docs/default-source/publications/thought-paper/reshaping-regulation-for-public-protection.pdf?sfvrsn=94d74820_7

[2] UK Parliament, Health and Social Care Bill, Last accessed 1 November 2021. https://bills.parliament.uk/bills/3022

[3] The Kings Fund, The Health and Care Bill: six key questions, 6 September 2011. https://www.kingsfund.org.uk/publications/health-and-care-bill-key-questions

[4] The PSA oversees the ten statutory bodies that regulate health professionals in the United Kingdom and social care in England. It is an independent body, which is accountable to Parliament.

[5] In their report the PSA set out the significance of this change as follows: “They (the Government) could instead make changes using secondary legislation or ‘regulations’ sometimes referred to as ‘Henry VIII’ powers. Changes made in this way are not subject to the same level of Parliamentary scrutiny as a Bill so let the Government make changes more quickly. They are still required to consult for 12 weeks and the legislation must be approved by both Houses of Parliament”.

[6] Ian Kennedy, Learning from Bristol: The Report of the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary 1984- 1995, 2002. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/273320/5363.pdf

[7] The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf

[8] PSA, Reshaping regulation for public protection, 28 October 2021. https://www.professionalstandards.org.uk/docs/default-source/publications/thought-paper/reshaping-regulation-for-public-protection.pdf?sfvrsn=94d74820_7

[9] Ibid.

[10] Care Quality Commission, Opening the door to change: NHS safety culture and the need for transformation, 2019. https://www.cqc.org.uk/sites/default/files/20181224_openingthedoor_report.pdf

[11] PSA, Reshaping regulation for public protection, 28 October 2021. https://www.professionalstandards.org.uk/docs/default-source/publications/thought-paper/reshaping-regulation-for-public-protection.pdf?sfvrsn=94d74820_7

[12] Ibid.

[13] Ibid.

Response to HSIB investigation


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