The seven qualities of highly effective regulators

Medical regulators, such as the General Medical Council and its international peers, face a rapidly changing environment, with heightened patient expectations, new technologies, and global hyper-mobility of health practitioners raising new and challenging issues for the safe regulation of health practitioners.

In September 2014, the International Association of Medical Regulatory Authorities brought together regulators from 50 countries to discuss the future of medical regulation. Vibrant debate covered issues ranging from registration of international graduates to revalidation, from candour after harm to the costs of criminal history checks. Gradually, consensus on seven key qualities of a modern medical regulator emerged.

1) Clear

The first, and arguably most important, quality of a regulator is clarity about its purpose and the problems it seeks to solve. It is all too easy for a regulator to become consumed with crises, programs, and processes, and lose focus on the outcomes it is trying to achieve. Harry Cayton is among those who urge regulators to “keep it simple” with a clear eye on their overarching purpose.

At the most basic level, medical regulators exist to protect patients from harms of one type or another. In the words of Malcolm Sparrow, their core task is to identify “bads” (hazards, risks, threats, problems or harms) and control them effectively within the limits of their governing law.

But at a deeper level, a number of unresolved tensions and conflicts exist. There are balances to be struck between the privacy of individual practitioners and the right of the public to know; between quality of care and access to care in the face of workforce pressures; between addressing poorly performing outliers and shifting the mean. Clarity on the best way to resolve these tensions remains elusive.

Malcolm Sparrow, The Art of Harm Reduction

2) Agile

Second, regulators must have the agility to use the right regulatory tool for the task, rather than constraining themselves to “the way it has always been done”. As Malcolm Sparrow explains, it is time to undo the dichotomy between hard and soft regulatory approaches and acknowledge that different problems need different solutions.

An agile regilatory system is one that has the capacity to respond to novel and emerging risks, such as the use of social media or the global movement of temporary medical workers. Peter Rubin notes that, historically, professions are most unhappy when they get out of step with public opinion. Regulators play an important role in helping the profession to keep step with public expectations and priorities.

In some countries, outdated legal structures restrict the regulatory options available to boards, and in this situation legislative change may be needed to support improved practice. For example, the use of mediation and other alternative dispute resolution techniques can be a timely and cost-effective alternative to formal investigation, but is not supported by some statutory frameworks. Importantly, agility does not mean throwing entire regulatory systems out each time there is a scandal, but rather having the capacity to learn, adapt and adjust.

3) Trustworthy

The third quality of an effective regulator is trustworthiness. For a regulator, the answer to the Machiavellian question whether it is “better to be loved than feared or feared than loved?” is “regulators should aim to be neither loved nor feared, but trusted and respected.”

As explained by Baroness Onora O’Neill, the three critical components of trustworthiness are competence, honesty, and reliability. For patients and practitioners, regulatory systems can be daunting to access and bewildering to navigate. The current disconnect between what regulators know internally and what they disclose externally is unlikely to be sustainable in today’s world.

Competence involves addressing risks to public safety effectively in a way that supports, rather than undermines, professionalism. Honesty requires transparency and true, clear communication about how and why decisions are made. Reliability requires timely and consistent decision-making.

4) Curious

A willingness to question, a desire to learn, and an openness to new evidence is the fourth quality of an effective regulator. Dr Joanna Flynn speaks of a shift from being “regulatory philosophers” to “regulatory scientists” – with a focus on understanding and strengthening the evidence-base for regulatory decision-making.

The kinds of questions a regulator might ask include “What impact does revalidation have on physician performance?” “What behaviours at medical school predict future problems?” and “How can impaired practitioners most effectively be supported to return to safe practice?”

As well as a curiosity about works and why, this style of decision-making requires access to high quality data and sophisticated analytical skills. In the words of Malcolm Sparrow, it’s time for regulators to start “thinking like epidemiologists”. Where the necessary skills may not always be available in-house, partnerships with researchers may offer a valuable resource, and we can expect to see an increasing focus on the “science of regulation” over coming years.

5) Humble

The fifth quality of an effective regulator is the humility to recognise that none of us operate alone, that there is much to be learnt from others, and that there are some problems that regulation alone cannot solve.

At last count, there were 2,372 medical schools across 179 countries. No individual regulator can possibly maintain an intimate knowledge of the standards of each of these schools: international collaboration and cooperation to develop standards for accreditation and mutual recognition of qualifications is critical.

Other countries and other professions can offer valuable insights into regulatory best practice. In regulation, as in healthcare, some of the most innovative solutions may come from developing countries who have been able to leapfrog over traditional constraints and have learnt to do more with less.

Assistance can also come from patients themselves. The involvement of patients in regulation has become a global, unstoppable and desirable force in regulation – from feedback on individual care experiences to lay representation on boards to the involvement of experienced consumer advisors who are highly skilled at hearing and giving voice to other patients’ concerns.

6) Unbiased

The ability to make fair, independent and unbiased decisions is the sixth quality of effective regulators. In the words of Frank Montgomery, trying to regulate in a system that is captured by professional self-interest is like “fighting with a wet paper sword”.

Strong lay representation and (a reasonable degree of) independence from government are increasingly recognised as essential prerequisites for effective regulation.

An unbiased system values the perspectives of both practitioners and the public in shaping the system.

7) Proactive

Finally, effective regulators look upstream for opportunities to prevent harm before it occurs. Regulators have traditionally been reactive – responding to harm after it has occurred. Peter Rubin is among those who argue that an ounce of prevention is worth a pound of cure: the earlier regulators can identify a problem the better the chance of remediation.

A more proactive approach favours harm-reduction over ritualistic compliance, and requires a strong focus on understanding the factors that predict a future risk of harm.

As medical practice and community expectations evolve, so too must medical regulation. A clear focus on purpose, an agility of response, a reputation for trustworthiness, the curious mind of a scientist, an attitude of humility, a commitment to unbiased decision-making, and a proactive approach to preventing harm are all qualities that will stand regulators of the future in good stead.

Baroness O’Neill’s thought-provoking presentation on “Maintaining Trust in the Medical Profession” and other keynote presentations are available on YouTube: http://www.youtube.com/watch?v=mfZAe3Qdf8I