What makes a successful regulatory body?

When David Prior took to the airwaves in June to address what had gone wrong at the Care Quality Commission, few listeners can have anticipated the brutal assessment he delivered.

‘What ministers wanted was a policeman. What they got was a social worker’

“I have known for the last three months that we were not fit for purpose when it came to hospital inspections,” the recently appointed CQC chair told his incredulous interviewer, after it emerged that a CQC report into its own failure to flag up poor standards at Furness General Hospital had been deliberately suppressed by the organisation itself.

“There’s an old saying: the fish rots from the head,” Mr Prior went on. “The board and the senior executive were totally dysfunctional.”

Four weeks later, health secretary Jeremy Hunt announced to MPs that 11 hospital trusts identified as poorly performing by NHS medical director Sir Bruce Keogh, were to be put into “special measures”. It is all a long way from what the Labour government hoped for back in the post-landslide days of 1997, when its white paper, The New NHS: Modern, Dependable, announced plans to create the first NHS quality monitoring organisation, the Commission for Healthcare Improvement.

“For the first time the need to ensure that high quality service is spread throughout the service will be taken seriously,” prime minister Tony Blair wrote in his foreword to the white paper. “National standards of care will be guaranteed.”

Different fates

But the CHI was not the only new body envisaged in the document; also mentioned was the government’s commitment to establish an independent National Institute for Clinical Excellence, which would “promote clinical and cost effectiveness by producing clinical guidelines and audits, for dissemination throughout the NHS”.

By 1999, both the CHI and NICE were up and running. But their fates were to be very different.

The CHI lasted for just five years before it was subsumed by the Healthcare Commission (officially the Commission for Healthcare Audit and Inspection), which was in existence for another five years until its responsibilities were taken over in 2009 by the Care Quality Commission.

Over the same period, NICE has seen an expansion of its original remit and changes to its formal title (it became the National Institute for Health and Clinical Excellence and is now the National Institute for Health and Care Excellence).

Unclear intentions

So what factors have enabled NICE to thrive and develop its now international reputation, while successive quality monitoring organisations have struggled, at best, to establish themselves as effective in improving standards and, at worst, failed to prevent the horror of Mid Staffodshire?

Ask some of those who have been closely involved with NICE or the CQC and its predecessors – as a new research project sets out to do – and common themes start to emerge.

Chief among them are the deleterious effects of political interference and frequent organisational change, as well as the difference in clarity of the respective purposes of NICE and successive healthcare regulatory bodies.

‘It looked like another kind of regulatory policy was being developed on the hoof… immediately creating a tension between regulators’

Right from the start, says University College London professor of political theory and public policy Albert Weale, “NICE had a clear intellectual paradigm [that] came from the health economists”.

The role of the CHI was based on much more nebulous criteria, says former Department of Health director of policy and planning Andy McKeon, who was instrumental in drawing up the 1997 white paper. “What ministers wanted was a policeman. What they got was a social worker,” he adds. That uncertainty appears to have dogged CHI and its successors ever since, provoking frequent internal debate over whether their core function should be to benchmark minimum standards or to improve quality across the board.

Linda Patterson, now clinical vice president of the Royal College of Physicians, was medical director of CHI from its inception until its role was swallowed by the Healthcare Commission. While she believes the CHI struggled initially to “get to the heart of what quality care [was] about”, she is also adamant the organisation was peopled by a highly committed team, which had begun to make an impact and would have gone on to achieve significant results.

Lost quality

Even when the government signalled its intention to incorporate an audit function into CHI’s remit, turning it into the CHAI, she and her colleagues fully expected to continue the work they had begun.

“It was named deliberately [to sound the same as before]. We were told ‘there’s going to be a change, it’s a legislative change, we’re going to have a slight change of name’, and we thought we were just carrying on.” Instead, she and others at the top of the team found themselves “completely chopped off”.

Tussles with the Department of Health over control of CHI played a major part in the organisation’s demise, Dr Patterson believes. “I don’t think the government understood that we really were independent…they thought they could ring us up and tell us what to do,” she recalls.

At the same time, though, she says the department made insufficient effort to facilitate the involvement of senior clinicians and managers in the CHI’s inspection work. There was also pressure for a quick fix. “They thought we were taking too long. They wanted results…They became impatient, which was a real fault of the Labour government.” Ultimately, she remains baffled by what happened.

“I still don’t know. I did go and see somebody very close to the centre of power who said that he had thought that certainly some of us at the CHI had done a really good job. But the phrase that was used was: ‘It’s like imperial Rome. You’re just the bodies on the floor’.”

The upshot was that much of the collective experience of quality monitoring gained during the CHI’s existence was lost, she says. “It’s as if nothing has happened before.”

She describes a growing sense of deja vu at recent developments. “They are reinventing the wheel. I went to a consultation meeting at the CQC in my current role and [CQC chief executive] David Behan was talking about what they were going to measure, [including] leadership and the culture of the organisation. And he was describing it all and [talking about] having more professional inspectors − how they want more people in from the service − and this guy at the table, who was from an ambulance trust, said: ‘Hang on a second, this sounds awfully like a CHI review.’”

Unwelcome change

Dr Patterson’s experience appears to be echoed in key respects by that of Sir Ian Kennedy, who was appointed to chair the newly created Health Commission. He describes being invited in 2004 to a meeting with Tony Blair and health secretary Alan Milburn.

“Tony Blair said to me: ‘What do we need to do now?’ Sir Ian recalls. “And I said to him: ‘Absolutely nothing for five years. You’ve got the architecture, just leave it and we’ll let it settle down…particularly as regards to the regulatory system.’ Less than a year after that meeting, in the budget statement in March 2005, the then chancellor Gordon Brown announced that the Healthcare Commission would be merged with two other bodies to form the CQC.

“I was flabbergasted because my ‘do nothing’ to Blair had translated as abolition within 11 months,” Sir Ian says. He also points to a lack of openness on the part of the Department of Health about developments, which affected the Healthcare Commission and his own role within it.

Specifically, Sir Ian recalls a meeting attended by “two or three people” who were unfamiliar to him. They were introduced to him as the team from Monitor, which would shortly take over the regulation of foundation trusts.

“I had, prior to that, absolutely no awareness that, in another part of the forest, the Department of Health was creating another regulatory body called Monitor,” Sir Ian says. “Now there is no reason why they should have told me, except that it looked like sleight of hand. It looked like another kind of regulatory policy was being developed on the hoof… What that did was to create immediately a tension between regulators.”

‘MPs reacted to reports by wanting to fire someone − which was perfectly pointless − rather than address what we were saying was the problem’

Sir Ian is also critical of the fact that the Healthcare Commission was expected to implement standards driven by the then chief medical officer for England, Sir Liam Donaldson.

“In part they were informed by his expertise as a distinguished health policy leader, but they were also reflective of government issues in terms of targets and so on and so forth. And that, in my view, was a dreadful mistake… modern regulation of course needs standards, but those standards should emerge from the sector you are regulating; in other words, they should emerge from the bottom up, not the top down.”

Facing resistance

Sir Ian says there was fierce resistance at the highest level within the Department of Health to the work of the Healthcare Commission, which was scrutinising data from individual trusts in an attempt to identify potential anomalies such as higher standardised mortality ratios:

“There was deep resentment at the top of the office to this notion of regulation, not least because it kept on turning over stones and the sense was ‘well, it’s a bad news story all the time’… David Nicholson in particular was a vocal opponent of the model because he was managing the NHS and things like a report we produced on Maidstone and Tunbridge Wells [which had abnormally high rates of the bacterial infection C. difficile were] deeply embarrassing.

“And, of course, MPs reacted to those reports by wanting to fire someone − which was perfectly pointless but had all the qualities of macho reaction − rather than address what we were saying was the problem. They were egged on by the managerial classes, who were saying, ‘This is embarrassing to the NHS; this is embarrassing to you, therefore, [as the] government… who will rid me of this troublesome priest?’”

Stark contrast

This level of reported conflict between the quality regulators and government appears to be in stark contrast to the relationship between the DH and NICE in its formative years.

“There was no attempt at all to interfere,” says Sir Michael Rawlins, who chaired NICE from its launch until April this year. “Actually, ministers realised the value of having us, as it were, as a fig leaf for them − the ‘blame quango’ − they found that very useful. So it genuinely was independent.”

NICE faced considerable resistance on other fronts − notably from the pharmaceutical industry and from patient groups that objected to some of its decisions about specific drug treatments. In some cases the two joined forces, says Sir Michael. For a time, some pharmaceutical companies were winding up patient organisations and giving them pro bono PR help. “When I discovered that I went very public about it and I castigated the patient organisations who were doing it.”

NICE did, however, garner helpful support from many of the royal medical colleges and from the British Medical Association at an early stage − support that Sir Michael believes was due, in part, to his own positive professional relationships with the college presidents and other senior clinicians.

‘What you got was just a succession of organisational change. And organisational change is the bane of British government’

As current NICE chair David Haslam points out, it is perhaps difficult to judge whether NICE was left alone to do its job because it was performing effectively, or performed effectively because it was left alone to do its job. Either way, he says, the message is clear: “Leave things alone and they do better.”

Professor Weale underlines the point: “There is one very obvious difference between [NICE and the quality monitoring bodies], which is continuity of organisation on one side and discontinuity on the other… What you would have ideally wanted [in quality monitoring], I think, would have been something that was intellectually quite robust at the beginning, which incrementally developed and tried to, itself, learn the lessons of where its regulation was successful or not. Instead what you got was just a succession of organisational change. And organisational change is the bane of British government.”

Levels of clinical engagement, patient and public involvement, resources and personal relationships (both good and poor) between key players have also been cited by interviewees as important factors in determining the path of NICE and the healthcare regulatory bodies.

Further interviews are planned and a full account of the research will be published at a later stage.

Peter Littlejohns is professor of public health at King’s College London and was founding clinical and public health director of NICE, 1999–2011; Polly Newton is a freelance journalist