With many years' experience as a lawyer in the healthcare regulatory sector, David Gomez talks of the significant changes he has seen: the impracticability of healthcare professionals being regulated by ten different statutory regulators when there is so much interdisciplinary care; the different rules for each of the professions who each have to face their own fitness to practise panels. He also discusses inequality of arms between the regulator and the professional, many of whom cannot afford legal representation, and the role of the Professional Standards Authority which oversees the statutory regulators. Finally, he considers whether a total rethink is necessary about the regulation of healthcare professionals.

Barry Baines: Welcome. This is Barry Baines from Baines Law, a legal miscellany, where we regularly podcast about cases and legal issues, as well as talking to professionals and others who have experience of our legal system.

Our guest in this episode is a lawyer who specialises in public and regulatory law. Whilst in the Government legal service and in private practice, he acted for a wide variety of regulators and public bodies, including most of the healthcare regulators. He has held senior legal, policy and operational in-house roles at a number of public bodies, including as General Counsel of the Human Fertilisation and Embryology Authority; Head of Regulation at the General Osteopathic Council; Assistant Director of Scrutiny and Quality at the Professional Standards Authority for Health and Social Care; and interim Director of Legal at the Equality and Human Rights Commission. His practical experience of adjudication issues extends to serving as secretary to the statutory Fitness to Practice Committee of the Royal Pharmaceutical Society of Great Britain, and he was draftsman to the committee chaired by Lord Carlisle that developed the first case management protocol for the General Medical Council.

He has drafted statutory instruments, rules, regulations, and fitness to practice and licensing procedures for many health and social care regulatory bodies. He is probably best known currently as the lead author and general editor of “The Regulation of Healthcare Professionals: Law, Principle and Practice “published by Sweet & Maxwell.

We extend a warm welcome today to David Gomez.

Well, good morning, David. Thank you very much for joining us today. And I wonder if I could start off by talking about the wide variety of roles you've held in the health sector. You must have seen significant changes and themes over the years. What can you tell us about that?

David Gomez: Thank you, Barry. It's very kind of for you to have me on.

Yes. I mean, I think over the years, Regulation has become a bit of a growth industry. If you think about it, first of all, the most obvious thing to think about is the increased volume of complaints. This is partly due to the decline of trust in professionals, documented by Baroness Neill in her seminal talk a few years ago. The move away from medical paternalism and the internet. There's so much information about redress and complaints procedures now. And patients are more assertive; they're no longer the passive recipients of medical care. They have a real interest in the outcomes. The other thing to note of course, is the increased number of professions have been brought into statutory regulation and the “takeover” of representative bodies. Think about the HCPC; that now has about 15 professions that it regulates.

Another key thing, and a driver for change, was if I put it this way, the increased professionalism of regulation in fitness to practise proceedings that was brought about the Human Rights Act and the transfer of jurisdiction from the Judicial Committee of the Privy Council, to the Admin Court. You remember in the old days, the Judicial Committee was very civilised, very kind of a sedate. But the Admin Court took no prisoners really. Suddenly regulators were losing, and losing hard. Their charges weren't drafted properly. The cases were taking too long. The committees didn't have objective guarantees. The reasons weren't sufficient. And so regulators had to up their game; they had to really kind of professionalise their fitness to practice processes.

The most significant thing, I think, is the move away from this backward looking process of professional misconduct and deficient professional performance, towards what I think of as this Janus faced concept of fitness practice which looks both backwards and forwards, and this important emphasis on the process of remediation.

And that has led in some cases to a real focus on some regulators trying to divert cases out of the fitness to practice process, if there's evidence of remediation. And at the same time, I think there's a general focus on professionalism and revalidation. And now of course, the key thing, as you know from working with the dentists, is the idea of “upstreaming”; that regulation should start right at the beginning rather than at the end, where you're almost dealing with failures of regulation. So all in all, I think what we have now is a more forward looking and preventative process; a change from the model of rear view/ barn door regulation that we have had traditionally in the UK, I think.

Barry Baines: Yes, there's great emphasis on training now, isn't there?

David Gomez: Yes.

Barry Baines: Getting the proper professional qualifications, keeping those qualifications up to date.

But you mentioned the way it's proliferated and really that brings us onto the fact that there are 10 statutory regulators, aren't there, overseeing the regulation and registration of people who work in the health and social care. I'm talking about doctors, dentists, pharmacists, social workers, etc, and each have their own rules. Perhaps that doesn't make for the best approach to regulation. There have been various attempts to change the system, but so far none has been successful.

David Gomez: I think that's absolutely right.

Barry Baines: Yes, indeed.

The reality is that healthcare is increasingly being delivered in multidisciplinary teams. There needs to be a greater convergence between systems regulators and the regulators of individual professions. There remains a live and unresolved tension between the aspirations of a “no blame” open investigation culture in the NHS, and the reality of the focus on individual accountability - and therefore blame- in the fitness to practice and misconduct proceedings of the individual regulators.

There's obviously too much regulation, too much law. We need to cull, I think, the number of regulatory actors and focus on effective and preventative regulation.

And one way to do that is to reduce the number of cases in the system. And we do that by raising the threshold of seriousness, by focusing on risk. We should be asking, I would suggest, not whether the practitioner did it, but rather whether the practitioner is dangerous.

But within the existing legislative framework, there are things we could do better. We do not need new legislation to ensure our registers are accurate and up to date, or to undertake a proper investigation or keep complainants informed of the progress of a complaint. Nor to serve the case papers and unused material promptly; to draft adequate charges; or produce sufficiently reasoned decisions. I think sometimes reform and legislation are used as a kind of a scapegoat when in reality, we can do much better within the existing processes.

Barry Baines: Indeed. Do you have anything to say about the thresholds for investigations on that tack because at present, the regulators have extremely low thresholds without any concern for the proportionality of the regulator, it seems to me. Do you have anything to say about that?

David Gomez: I do. I drafted the first threshold criteria for the Royal Pharmaceutical Society, as it then was. It was then taken on by the General Pharmaceutical Council. And when I was at the Osteopaths, one of the things that I introduced was threshold criteria.

We need to get away from all these sorts of cases of rudeness and really competition cases. Rudeness, sleeping on duty, things of that kind, and focus on risk. I feel very strongly about this. Sometimes I'd be, when I was at the PSA, I'd be reading cases and asking “ Why are we here?” This is a case for the employer. This is an issue of contract. It's not a public interest matter.

Barry Baines: And of course the cost of all this falls mainly on the regulated, doesn't it?

David Gomez: Indeed. And it's heartbreaking. If you look at the accounts of, and the public reports of these regulators; the proportion of public money being spent on lawyers' fees! I mean it's good for lawyers, but it isn't good, I think, for the public interest.

Barry Baines: Yes. Most health regulators have their own fitness to practice panels who decide contested issues and determine sanctions. The exception to that, I suppose, is the General Medical Council who send their cases to the Medical Practitioners Tribunal, which is a sort of arms length adjudicator. What do you think of the advantages and disadvantages of these slightly different systems?

David Gomez: Well, there are no advantages, it seems to me. I mean, do we need different systems? And increasingly healthcare is being delivered in multidisciplinary teams. It is not impossible to envisage a situation, in which something goes wrong with the care of a patient and the surgeon, the theatre nurse, the pharmacist, and the paramedics all face proceedings. I think in these sorts of circumstances, a single panel should be able to hear this sort of case to ensure that all appropriate evidence is before it, and to ensure consistency of outcomes. And in relation to the sanction, I mean, you remember the case of the rugby nurse and the doctor.

Barry Baines: Indeed, yes, I do.

David Gomez: And the concern about the perceived difference in outcomes. Any nurse would tell you that doctors appear to be treated more leniently in fitness to practise proceedings than nurses. I think if we are to retain these separate panels, then public confidence can only be maintained by the creation of an inter-regulatory Sanctions Advisory Panel.

This is something Dame Janet in the 5th Shipman Report kind of encouraged. I go further. I'd have a panel staffed by regulators; patient, public, and registrant representatives; and academics and experts on sentencing, who are charged specifically with creating consistent evidence-based sanctions guidance and guideline cases for use across all the professions, and which is legitimised by a process of public consultation.

The Solicitors Regulation Authority went some way to towards that. They had a conversation with the profession a few years ago saying –“what do you think the tariff should be for this sort of case?” I think we need to formalise that and role that out across the healthcare professions. There needs to be real consistency in sanctions, and the Indicative Sanctions Guidance has had its day. It's not granular enough to deal with the kind of cases that we're getting now, I think. And in a few cases, there's been adverse judicial comment about the Indicative Sanctions Guidance, particularly in relation to dishonesty.

Barry Baines: Yes. You mentioned the Solicitors Regulation Authority, of course, which I also have experience of, and you will have noticed, of course they have a proposal at the moment to increase their own fines, which they can levy internally.

David Gomez: Yes.

Barry Baines: Do you think that's a good system?

David Gomez: I think it's a useful way of dealing with administrative errors. I think the risk profile of healthcare professionals is different. In healthcare, I don't think administrative errors should be before the Fitness to Practise Committees. And I would, if we are going to take a serious grip on this and raise the threshold, I don't think administrative errors should cross the threshold of something that the regulators are looking at, in healthcare. It's about risk and about safety. And purely administrative errors should be dealt with at the Trust level or by the employer, it seems to me.

Barry Baines: Yes, I agree. They're quite different. Now, can we come onto a quality of arms and fitness to practise hearings?

David Gomez: Yes.

Barry Baines: Usually, but not always, doctors, dentists and pharmacists, for example, will be able to afford subscriptions to professional bodies who will ensure that if they face fitness to practice proceedings, they will be represented usually by an experienced junior barrister or in some cases by Queen's Counsel. I expect you've seen at the GMC, for example, they're more likely to get a consultant represented by Queens Counsel and perhaps a more junior doctor by a junior barrister. At the other end of the scale, we will see many people regulated for example, by the Health and Care Professions Council paramedics and the like, who can't afford such representation and will have to speak for themselves. Is this a fair procedure when the regulator can always choose to be represented by counsel if it wishes.

David Gomez: Now in the old days, you will remember that attempts were made to balance the scales through the good offices of the legal assessor. He or she would take a more proactive role, with an unrepresented registrant; discussing the case in detail with them beforehand, ensuring that the registrants understood the procedure, and being alert to ensure that the registrant's case was put to witnesses and the committee during the hearing.

With the advent of legal chairs, of course that's no longer possible, certainly not to the same extent. And the legal chair can hardly go into a huddle with the registrant, leaving the case presenter excluded.

To answer your question, no, it is not fair. I have read many decisions where I felt personally that a different and better result might well have been achieved if legal representation for the registrant had been available.

The rules of most regulators now are flexible enough to allow these Mackenzie friends and trade union representatives, and the Bar pro- bono unit offers some assistance, if they can be got hold of. But ultimately, I think this is a problem that the regulator doesn't have the resources to address.

Ultimately, any increase in expenditure must come out of registrants’ fees and the profession as a whole. And it would therefore require the profession as a whole to find a solution to this problem.

But I would add that equality of arms starts well before representation. Where a regulator can and should make a difference is ensuring timely and fair disclosure of the case against the registrant and particularly, in relation to service of the unused material. It is shocking that many of the healthcare regulators do not have a published disclosure policy or internal procedures to ensure fairness or indeed quality control. I think this is an area that PSA should take a real active role in enforcing.

Barry Baines: Yes. Compare it with the criminal law system …

David Gomez: Yes.

Barry Baines: ... where we've seen the injustices which have occurred there. And of course the injustices in the healthcare system can be huge, can't they?

David Gomez: Indeed. And doubly so, because sometimes cases have been referred from the criminal system.

Barry Baines: Indeed. So I wonder if we can come on for a moment to consider the role of the PSA, Professional Standards Authority, what I describe as the super regulator, which you know much about and which oversees the performance of the healthcare regulators, it regularly publishes reports on the performance of the healthcare regulators. And if it believes a registrant has been too, leniently dealt with, by a fitness to practice panel, it may itself intervene and appeal itself the decision to the high court. Now, the government's indicated it proposes to remove that right of appeal. Do you think the PSA has an effective role, and what do you think about the government's propose?

David Gomez: Gosh. Can I divide the answer into two bits? There's two bits.

Barry Baines: Oh, do indeed. Yes.

David Gomez: Yes. Effective role and the government's proposals.

So talking about effectiveness. I think that we must remember the PSA has been through many iterations. It had its genesis as a recommendation in the Kennedy Report for a body, which was envisaged to act as the patients’ voice.

I think one of the real benefits of the Council for Healthcare Regulatory Excellence, as it then was, was this process of bringing the regulators out of their silos and effectively knocking heads together; sharing best practice in adjudication, getting the regulators to adopt things like the Indicative Sanctions Guidance, for example. I think they were the heady days of what is now the PSA and they made some real achievements, some easy wins there.

In its current role, the PSA has made important contributions to thought leadership and the purpose of regulation. The concept of “Right Touch Regulation” for example is a good example. And that includes two important steps which are, I think, often overlooked. Including in relation to some of the recent consultations in the field. These are the need to identify the problem before the solution and the need to check for unintended consequences.

They've also produced very interesting work on risk profiles, justifying statutory regulation, and that all feeds into this ongoing debate about reform, and whether some professions should remain under statutory regulation. And if so, what's the level of statutory scrutiny.

One of the real benefits of course, is the idea of this overarching viewpoint; the birds eye view. And the key tool there, was the performance review of all the regulators. As part of that, the PSA used to audit the regulators’ case work, but that has long been discontinued. And the process of review, I regret, has become tired and subject to gaming by the regulators.

In the old days, the PSA would issue the annual report, which had all the regulators in a huge massive document. And you could compare like with like. Now, the reviews come out at different times of the year, and it's impossible to compare meaningful data in terms of stats or objective reporting. It's apples and pairs. There's a lot of gaming going on. The PSA have shied away from dictating best practice nowadays. There's no benchmark of what “good” looks like.

I personally do not see the value of reporting as an end in itself. The purpose should be to drive improvement, not make a report of performance. I take an obvious example. The NMC is a very different organisation nowadays. Although it is a matter of public record that there have been long periods where the NMC has been a failing organisation. I do not think the PSA or the Privy Council (which was the ultimate backstop) have been effective in holding the NMC to account or ensuring that regulatory objectives were achieved during this time. Levers could have been pulled and influence brought to bear but this was not done. I think there could have been a more concerted effort to buddy up good and less good regulators; to ensure that they could learn from each other and to drive improvements. I also think that PSA could take a more proactive role in driving up quality in fitness to practise proceedings, including sanctions as discussed, and disclosure. And in ensuring that BAME registrants are not being disadvantaged in the system in terms of representation and outcome.

Moving towards the second part- the Government proposals-, and I’m reminded of the saying that hard cases make bad law. You recall, of course the controversy of the Bawa-Garba case. That created a huge backlash and the understandable concerns about the way in which the GMC had exercised its own right of appeal.

However, if you look at the number of cases appealed by both regulators- the GMC and the PSA- and the results achieved, the GMC appears to have a better success rate than the PSA in terms of the number of successful appeals brought and over a much shorter period.

And if this is the case, it seems an odd thing to do; to take away this power from GMC, where the public interest appears to be successfully championed, in the majority of cases.

The PSA does not appear to have the same appetite for challenge as the GMC. It has to be said that the way in which the PSA has exercised its right of appeal is opaque. There are no published criteria about what sort of cases it will take, or the circumstances in which it will exercise the right of appeal. The section 29 appeal case minutes on the PSA website do not provide much illumination or provide an accurate guide to how the PSA is likely to exercise its discretion in a future case. I think this is unacceptable for an overarching regulator, which was envisaged in part as acting as a patient's champion.

What I will say, is that when you look at the cases appealed by both the GMC and the PSA, it raises concerns about whether BAME registrants are disproportionately overrepresented in the appeal process.

I put it no higher than that for now. But I would suggest that there's a real and urgent need for effective research; to determine quantitatively and qualitatively, whether or not there's a problem here.

Going back to the origins of the PSA, there is a need for a body to be able to challenge fitness to practice decisions made by the regulators, in the public interest, and in the interest of patients and their families.

In the final analysis, though, it is not so much about which body exercises the power, but rather how that power is exercised and there must be clear and transparent thresholds and criteria.

Barry Baines: Thank you for that explanation, David. It seems to make a lot of sense. So can I turn to the COVID pandemic? They have through necessity, been many remote hearings conducted by regulators in their disciplinary processes. And it's caused us to rethink a little. The Health and Care Professions Council is consulting on holding the majority of its hearings remotely in the future and Social Care England is considering holding all of its hearings remotely. What do you consider to be the advantages and disadvantages of these proposals?

David Gomez: Well, we’ve all had to learn new skills, haven’t we? Us old fogeys are here chatting on Zoom! I think the quick wins for regulators and lawyers are obvious: the hearings on the internet cut costs and travel expenses; free up hearing rooms for other uses; bundles can be shared and marked up electronically etc. Some systems allow automatic transcripts to be produced from the hearing recording. IT may be less intimidatory for certain witnesses when they're giving evidence by video link. And that might actually improve the quality of evidence before the committee.

However, those with poor access to high quality IT, or those who are unable to get to grips with the new technologies or potentially those who are disabled, I think, can be quite seriously disadvantaged.

The other concerns are about the integrity of the hearing process, Who else is in the room with a witness? Are they being coached?

And when IT goes wrong, it can go wrong spectacularly. There's always a concern about confidentiality and IT breaches. And conversely, having IT in your home is intrusive and may well add to the stress of the proceedings. Whilst there is a facility for online breakout rooms in some systems, it may be difficult to actually engage with counsel or your legal representative, or to get their attention while they're in full fight during the hearing.

I think there is a growing consensus. I mean, just anecdotally talking to people and reading the conversation in the Gazette, that assessing the credibility of a witness of a video link is not quite the same as through a screen; it's somehow curated through the screen. The committee do not have the same opportunity to see and assess the witnesses' demeanour; the mannerisms or reaction, to the same extent as with a live witness in the box before them.

I think I would say the jury's out and while the technology is fine for administrative hearings, where the registrant does not wish to attend or is not required to attend- or review hearings and the like- I would suggest that the best practice would be to offer the registrant the choice of whether to have a video hearing or not. And ideally, the opportunity to travel to a regional venue with state of the art technology available, rather than have everyone connecting from their homes. There ought to be some kind of regional hubs with state of the art video conferencing facilities that can be used. It would still cut costs; committee members don't need to attend, but at least that way, you are able to ensure that there's no one in the room with a witness and can safeguard the integrity of the process as well as safeguard the quality of the IT available.

Barry Baines: I'm interested to hear what you say about more local venues, because not so long ago, the General Medical Council, for example, had hearings in London as well as in Manchester. Whereas now, they're all in Manchester. And The Nursing and Midwifery Council used to travel around the country generally and hold local hearings.

David Gomez: Yes. Oh yes, like the Assizes! I agree. I think you can't win. Wherever you site the hearings, people have got to travel to them and it's a cost. But if you rent an office with decent IT facilities in a number of major cities and towns, I think you can still cut costs and provide a service to the registrant that you're there to serve in a way, as well as protect the public.

Barry Baines: As always, it's balancing cost with justice, isn't it?

David Gomez: Yes. Indeed.

Barry Baines: One of the principal drawbacks of fitness to practice proceedings is the inordinate length of time it takes for some cases to go through the process before they reach a panel hearing. We hear of two years, three years, four years, or even more. Is there in your view, a better way of dealing with fitness to practice cases?

David Gomez: Yes. And we've touched on this. I think it absolutely involves a radical change of mindset. I go back to this idea of the national conversation with the public and the professions and raising the threshold of seriousness; the point at which a matter is referred to a national regulator.

The reality is that we have an aging population with increasing demands on the healthcare system, at a time when the healthcare system is under siege with a perfect storm of COVID, Brexit, and chronic underfunding over a sustained period of time.

The reality is that we need our healthcare professionals like never before, and it may be time to move, I suggest, towards a more utilitarian approach. As long as healthcare professionals are safe and competent and do not pose a current risk to the public, perhaps we should be more forgiving of human frailty?

Barry Baines: I couldn't agree more, David. I mean, raising the threshold of seriousness must be important for the future in injecting some proportionality, and as you say, being more concerned about the safety of practitioners than punishing.

David Gomez: Yes, I agree. I agree. We need to move away from a model of professionalism towards a model of risk.

I think the events of the last couple of years, show just how much we need healthcare professionals and sometimes the regulatory juggernaut needs to be carefully moderated, to ensure it doesn't become oppressive.

Barry Baines: Indeed. David, thank you very much for sharing your views about the process today. I'm sure everyone concerned with healthcare regulation will be enlightened by them, and it will give plenty of food for thought and discussion in the future.

David Gomez: It's been a pleasure, thanks so much, Barry. Take care.

Barry Baines: Thank you for listening to Baines Law. Listen out for future podcasts where we will continue to discuss issues of interest to the legal community. If there is a professional perspective that you would like to share, get in touch via our website at wwwbarrybaines.com. You can also follow us on Twitter @baineslaw. We look forward to presenting to you again, very soon on Baines Law.