The Professional Standards Authority has published a substantive and wide-ranging report concerning the present and future of healthcare regulation. Its "Rethinking Regulation" paper draws on a range of evidence, expert commentary and academic research on the structure and function of regulation, and delivers thought provoking opinions on the strengths and weaknesses of the sector across four main topics: risk and regulation of people; the relationship between professional and systems regulations; supporting professional conduct and behaviour; and regulatory governance and purpose.
The PSA makes clear that its critique should be seen in the context of a legislative straitjacket. Against a backdrop of an ageing population, increased long-term health conditions and a shortage of health and care workers, it is essential – the paper argues – for health and care regulation to be reformed, "re-engineered" and, particularly, for regulators to be afforded more flexibility if they are to adapt to fast-moving changes and remain fit for purpose.
Reaction to the paper has been understandably mixed. The absence of a strong evidence base to justify the value or benefits of regulation is a recognised, but often unspoken, challenge to all working in regulation. The paper ends "if regulation was going to improve care, it would have done it by now. So it is time to improve regulation." One cannot help but conclude that, despite the enormous amount of work that went into the Law Commission's draft bill to harmonise the regulation of healthcare professionals and the government's response, the PSA is seeking to throw down a gauntlet to legislators and those in the sector, that a more fundamental rethink is required. The implied re-engineering task is vast and potentially overwhelming. Many might doubt that such re-structuring would ever realistically be undertaken by governments facing more pressing and political imperatives, and some may be left downcast that their strenuous efforts to improve regulatory frameworks are devalued.
However, the paper does reflect international debate as to the hows and whys of regulation and it can only be a good thing that we are challenged to "focus on doing what works, and a readiness to stop doing what does not" when working in this field and particularly when there are opportunities to change. We have summarised the report's further opinions below, loosely accordingly to the topics it addressed.
Risk and the regulation of people:
- The aspiration of certain professional groups for statutory regulation as a "badge of professional status" is "out of date"; statutory regulation should, the report suggests, only intervene where the risks to the public arising from the would-be regulated professionals' activity justify such relatively high "regulatory force". At the other end of the spectrum, the report praised voluntary registration and accreditation as an appropriate alternative where risk to the public is lower/ less frequent.
- The absence of a consistent means of assessing the risk posed by a profession (or system) has created a "vacuum", resulting in decisions to regulate being made "without any serious reference to public protection". The PSA stated that it will continue to work on a "risk matrix" in this respect.
Professional and system regulation:
- The disconnect between individual/ professional and systems regulation is counter-intuitive given the contextual importance of institutions and systems to professionals' behaviour and competence. Professional and systems regulators should share objectives, data and intelligence.
- Systems regulation may have distorted or obstructed regulated organisations' priorities; by way of example, the report cited a comment by a senior leader at the Mid Staffordshire NHS Trust that managers there had come to think that "they were working for the regulator and forgot they were working for patients".
- Healthcare organisations need to embark on a cultural shift, away from a "blame" culture to one of "constructive mistrust" in which individuals take responsibility, as part of a team, for being vigilant about each other's work and for "speaking out in time to avert harm". Individuals and teams should be motivated to improve and achieve, and not be frightened into "resentful compliance".
Supporting professional conduct and behaviour:
- Existing regulatory frameworks risk overburdening registrants by rules and guidance "to the detriment of their performance". Regulation cannot eliminate risks in health and social care and should not seek to do so, lest it eliminate the possibility of professionals undertaking "beneficial innovation" to patients.
- Regulation should be less process focused, and driven more by identifying and preventing specific types of harm to patients and service users on a smaller scale. This, the PSA recognises, will be challenging for regulators but may be achieved by a culture of "delivery through others" and collective responsibility. It will require the encouragement of other registrants to act as regulators' "eyes, ears and agents on the ground – taking action to prevent small problems from escalating before any regulatory involvement is required".
- Regulators have an important role in facilitating such improvement but are not responsible for driving them (described as the difference between responsibility for preventative quality control, not direct quality improvement) and should not do so at risk of losing sight of their objectives and impartial advantage, and of "marking [their] own homework". The paper commented that regulatory action is apparently perceived as more successful, and more justifiable, when judged against a benchmark rather than as a pursuit of continuous improvement Legal responsibility for the latter lies, rather, with professionals and their managers. The report added that there is little evidence to show that regulators' efforts to shape registrants' behaviour and practice have had any direct influence, at least over and above that of other influences.
Governance and purpose:
- Regulators must (re)focus on their core purposes, drawing away from what the PSA describes as "regulatory mission creep" (an over-expanding of their spheres of influence) which has confused the public and caused internal conflicts of interest. In future, regulators will need to negotiate their respective responsibilities and how these interrelate, in order to achieve "shared positive outcomes".
The PSA anticipates that, in repositioning regulation, regulators may need to adopt "radically different interventions" based on defining the public health outcomes and registrant behaviour it wishes to see.
Long held and established views about the role of regulators, particularly those in the statutory health and social care sector, will be hard to dislodge but perhaps the PSA paper will be a further step on the journey to rethinking regulation for the future.
 The Law Commission's 2014 draft bill only set out to simplify existing provisions; it was not tasked with examining whether these were actually fit for purpose. It is, the paper argues, essential to focus on the latter and to "re-engineer" healthcare regulation.