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Viewpoint - Christine Braithwaite

Time to rethink regulation

Our regulatory system is creaking and its long-term prognosis is poor. Regulators of people, places and products alike work hard to make their legislation deliver safer outcomes for patients.  But much of it is outmoded, experimental and not evidence based.  

Professional regulation is based on a model designed for doctors 150 years ago, with fitness to practise processes formed deliberately around a legal model of prosecution and defence.  Health provider regulation is on its fourth iteration (CHI, Healthcare Commission, CQC and CQC reformed). Hospital inspections are being abandoned in Denmark and they get a mixed reception here.  Major inquiries and reports have revealed gaps, overlaps and weaknesses.  

Our regulatory system has evolved more by historical and political accident than by design and yet it impacts on something as vital as our health and wellbeing.  Care is delivered by people within a system. Errors happen as a result of failures in systems. Individuals fail in poor systems and thrive in good ones. The deliberately deviant (adventurers) defy the best of them. Organisations too are supported or thwarted by the systems in which they operate.

We need a regulatory framework that is designed for the health and care delivery system we have today. Professional regulators are disappointed that a new Bill tidying up their disparate legislation has not yet been taken forward – it would have helped, but it won’t cure.

Five years ago we firmly believed that health and care professionals are the lynch-pin of patient safety. When the health professional interacting with the patient does the right thing, the patient is likely to be safe.  We still think that. But now we know so much more about the psychology of professionals and are continually learning more about the circumstances in which they fail.  If professionals are to keep patients safe they must be supported by a regulatory framework that is deliberately designed to do that.  

The Duty of Candour illustrates this inter-relationship.  NHS Trusts must comply with a legal duty of candour and will be prosecuted if they do not. They will rely on professionals to tell them when candour is needed.  Our research shows professionals will only do that if their own mind-set allows it and their organisation supports them.  Professional psychology and organisational behaviour bite at this point. The regulatory framework – which includes the possibility of no regulation – must create the climate in which organisations are excellent so that professionalism can flourish .

Christine Braithwaite
Director of Standards and Policy