The Extending Professional Regulation Working Group was established, following the White Paper on Trust, Assurance and Safety - The Regulation of Health Professionals in the 21st Century, to take forward the work on the scope of regulation for the healthcare sector.

Its terms of reference were to consider the recommendations in the White Paper and to create a framework for extending professional regulation.

Following extensive engagement with stakeholders and other interested parties which helped to shape and inform its work, the group published its report on 16 July 2009. The report can be found on the Department of Health's website.

The report discusses the five key areas which the group considers play (or will need to play) a major part in informing the landscape of professional regulation and makes recommendations in relation to each of them. These are discussed further below.

Risk assessment

The report notes that decisions to extend regulation need to be informed by a judgement about how much and what type of regulation is proportionate - having first identified the type and level of risks associated with provision of the relevant healthcare services and the costs involved in mitigating those risks through regulation.

It also outlines factors that will help to inform the quantification of risk, including for example an assessment of priorities, the degree of assurance required for any particular activity etc.

Further work is presently being undertaken by independent consultants on developing a risk assessment tool with the aim of helping to assess risk on a more scientific, robust and rigorous basis.

Given this ongoing work the group recommends that ministers should continue to refine the risk-based approach as it will be an invaluable tool in informing future decisions on the extension of regulation.

Cost/benefit analysis

The report signals the group's view that, while costs associated with the current system of regulation are significant, they have also secured significant benefits, including for example trust in healthcare services and in professionals and higher standards of care.

It also recognises that while the risks, benefits and costs of regulation are diverse and complex, and therefore will inevitably involve a fine balancing exercise, decisions to extend the regulatory system and/or the scope of any such extension must be informed by the associated costs and benefits of doing so.

Examples of the type of costs and benefits that may need to be considered in the decision-making process are provided. In terms of costs, these range from easily identifiable costs such professional fees to more intangible costs such as those associated with time incurred in compliance activities. Some benefits noted include fostering a sense of belonging and identity which in turn can lead to benefits gained from defined behaviour and strengthened values.

The group recommends therefore that even where benefits are unproven or controversial there may nevertheless be a need for more formal regulation and/or registration of certain professions or practices where the nature of the treatment poses a significant risk to patients and the public.

Proportionate methods of regulation

The observation here is that different health professions may need different levels of regulation. This means that a proportionate response is required to the scope and extension of the regulatory regime as informed by the needs of both the individuals and professions providing the services and the patients/public receiving them.

A number of alternative models (to the current statutory conventional model) are discussed including light touch regulation, voluntary self-regulation, employer-led regulation, and a licensing regime.

This latter alternative is explored further by way of a more radical approach which would involve the licensing of everybody working in the NHS. To consider the feasibility of such a radical approach the group recommends the introduction of pilot schemes for healthcare support workers employed in secondary care services (which could for example include managers, porters, healthcare assistants etc.).

Additionally in order to enable consumers to make a clear and informed choice about healthcare services, greater public awareness of the regulatory framework, for example through GP surgeries and other NHS facilities and services, is also recommended.

The suggestion is for public awareness to be facilitated through an easy-to-use public guide which explains the different roles and professions, describes the extent to which they are regulated and provides advice on how the consumer can procure and expect safe, effective, high-quality and respectful care.

Modernising routes to regulation and registration

Concerns are highlighted about an extension of regulation potentially leading to more professionals wanting to be regulated not only for reasons of public protection and patient safety but also to secure their positions within the profession for reason of status and market position.

The group agrees that is not a sustainable approach and proposes a new 'gatekeeper' role which would provide a single point of access for all decisions on whether regulation is warranted for any particular profession or practice and, if so, the type of proportionate regulation that will offer the necessary protection for the public. The recommendation is for the 'gatekeeper' role to be undertaken by an appropriate body as determined by ministers.

The proposal further recommends that the 'gatekeeper' should conduct an initial overview of unregulated health workers and draws up a shortlist of groups which might need to be considered for more formal regulation, registration or licensing.

The shortlist would then be considered by an Independent Advisory Panel - to be established by the 'gatekeeper' and comprising of representatives from different stakeholders - for the purposes of agreeing a prioritised list of groups needing further regulation. The panel would also be responsible for considering other recommendations to ministers.

Stakeholder involvement

The report highlights the importance of the effective engagement of the public, patients, users of healthcare, employers and other affected parties in decisions about extending professional regulation and in determining the design and delivery of proportionate regulation.

Given that the remit of Council for Healthcare Regulatory Excellence (CHRE) includes it being an independent and expert voice of the patient and the public, the group recommends that it should be given appropriate powers and capabilities (including resources) to lead and inform public and media discussions about professional regulation.

A further recommendation is for the Government to commission advice from the CHRE on implementing a more effective mechanism for engaging stakeholders in policy development with regard to the scope and extent of professional regulation.

In terms of involving those who need to apply the new regulatory arrangements, for example, employers and others responsible for the work of health professionals, the recommendation is that responsibility should be given to the 'gatekeeper' (discussed above) who should develop and implement formal and effective arrangements to facilitate such involvement.

Next steps

Although the work of the group is complete - at least for present purposes - there is much further work to be done by the Department of Health (and ministers in devolved administrations) in developing and implementing the future regulation of a broader range of professional and occupational groups working in the healthcare sector.