The Challenges Facing Medical Regulation Across the Globe

The regulation of doctors — and indeed, other health professionals — is under pressure, and arguably more under pressure than at any time in its history. The model for professional regulation that emerged in many jurisdictions during the 19th and 20th centuries is being challenged from different directions, and there is a growing recognition among regulators themselves in many parts of the world that the status quo is not an option.

Partly, this arises from the simple reality that the industry in which health professionals work is itself undergoing major reform throughout the world. One of the most significant developments has been the belated recognition that health care is a safety-critical industry and that, as such, it needs systems and processes that reflect its considerable potential to do harm.

At the turn of the century, the seminal report from the United States' Institute of Medicine (IOM), To Err is Human,1 placed health care 10 years behind other safety-critical industries. It may be that the gap has not narrowed much in the last 15 years, but there is a much greater commitment to measuring quality and at least a growing awareness of the damage caused by the adverse effects of medical treatment. Estimates vary but it seems certain that the quoted figures of between 140,000 to 250,000 iatrogenic related deaths worldwide are well short of the mark given the absence of accurate data.2

Of course much of that preventable harm is not the result of individual incompetence but the product of flawed systems and processes, often where the science of “human factors” has been ignored or not even considered.3 Nevertheless, the growing awareness that doctors can do harm as well as good, that levels of competence and skill can vary enormously, and that this has a direct bearing on patient outcomes, is increasingly posing difficult questions for professional regulators. As the pediatric nephrologist Sir Cyril Chantler noted, “Medicine used to be simple, ineffective and relatively safe. It is now complex, effective and potentially dangerous.”4

THE MODEL FOR PROFESSIONAL REGULATION THAT EMERGED IN MANY JURISDICTIONS DURING THE 19TH AND 20TH CENTURIES IS BEING CHALLENGED FROM DIFFERENT DIRECTIONS.

As regulators, the challenge is obvious for many of us whose organizations have traditionally relied on a reactive, operational model that largely responds only when something goes wrong. The challenge is even greater for regulators, who concentrate on misconduct and barely look at professional competence.

Alongside these changes has been a growing consumer voice, at least in some jurisdictions. This has challenged professional hegemony in general and the medical profession in particular. In almost all countries, physicians are still held in very high regard; when it comes to trust, in the United Kingdom they constantly outrank every other professional group5 but deference has certainly diminished and there is at least the beginning of a challenge to the assumption, still held by many patients, that every physician is more or less competent.6

...DEPARTMENTS OF HEALTH AND HEALTH CARE PROVIDERS ARE INTERESTED IN CHALLENGING TRADITIONAL PROFESSIONAL BOUNDARIES AND IN EXPLORING NEWER ROLES.

The third party in the regulatory compact, or unwritten agreement between the profession and the public, is government; for the vast majority of regulators the powers they exercise, and indeed the privileges enjoyed by their registrants, are the products of legislation. In the past, many governments took a relatively laissez-faire view of health care regulation, subscribing to the general view that the professions could look after themselves and weed out any practitioners who were “letting the side down.”

But no more. It is becoming clear that governments of all varieties have developed a keen interest in professional regulation.7 The patient safety agenda is part of this, but so too are concerns about the configuration and flexibility of the health workforce, recruitment and an understandable desire to make health care more effective and efficient. Central to this is also concern about the cost of educating and training new professionals, given the almost universal crisis around funding. Unsurprisingly, departments of health and health care providers are interested in challenging traditional professional boundaries and in exploring newer roles, such as Nurse Practitioners and Physicians Associates (sometimes called Physician Assistants) and expanding existing roles.

Governments have also become increasingly interested in professional mobility, either as unwilling exporters of one of their most precious assets — the professionals that they have trained — or as importers of those health professionals. Importers may worry about quality, but are more often concerned that they may not be able to recruit enough doctors to fill shortages in remote areas or in less popular medical specialties — for example, Brazil's Programa Mais Médicos (More Doctors Programme)8 and Australia's General Practice Rural Incentives Programme (GPRIP).9 The capacity of regulators to make it easier or more difficult for physicians to move across borders arouses keen government interest. Regulators can be torn between their own commitment to maintaining standards and pressure from their government to facilitate the importation of more doctors.

As governments have become more worried about cost, and as data has become more widely available, they have also taken a much greater interest in quality and measurement. In many parts of the world, a new kid has appeared on the block — the system regulator. As ever, with widely different powers and ways of going about their business, the new arrivals on the regulatory scene are concerned not with individual professionals but with the quality, safety and effectiveness of the organizations and systems in which doctors work. Voluntary accreditation, such as that provided by the respected Joint Commission on Accreditation of Hospitals (JCAH) in the United States (founded in 1951) is long established, but government funded systems to regulate and inspect hospitals and other health care facilities have become more widespread.10

The relationship between professional and systems regulation is likely to be a significant one in the future, with demands for much greater sharing of information and intelligence. In the Kingdom of Bahrain the regulation of all health care professionals and all health care facilities (public and private) is combined into one, independent authority, which incidentally, also regulates pharmaceuticals.11

As well as adapting to these wider changes, it seems certain that medical regulators will face a number of specific challenges that reflect the dynamic and fast-changing environment in which they operate.

So what are the specific challenges that face 21st century medical regulators? For some, the greatest in recent times has been the increase in complaints about physicians; figures vary but it seems that complaints against professionals are rising and that in developed countries there have been significant increases in the numbers of patients wishing to raise a concern about their medical treatment. In the UK, the number of complaints to the GMC from patients nearly doubled between 2007 and 2012.12 Data from Ireland and France also suggest that complaints made to medical regulators have also increased in recent years.13

...IT SEEMS THAT COMPLAINTS AGAINST PROFESSIONALS ARE RISING AND THAT IN DEVELOPED COUNTRIES THERE HAVE BEEN SIGNIFICANT INCREASES IN THE NUMBERS OF PATIENTS WISHING TO RAISE A CONCERN.

The cause remains uncertain; the decline in deference, access to information resulting in rising expectations and knowledge among patients and negative portrayals of the medical profession in the media all play their part. Where the local complaints resolution is poor, the regulator is also likely to attract more business from dissatisfied patients and relatives. One further factor, which has received less attention but may be a signpost for what is to come, is the impact of the Internet, which not only makes it easier for patients and relatives to learn more about the practice of medicine and find the regulator, but often makes it much easier for them to also submit a complaint.

As patients become better informed and more digitally savvy, it is hard to imagine that this trend will do anything but increase further. On the face of it, better patient access to medical regulators must be regarded as a good thing, but a significant difficulty is the fact that very often, complaints do not reach the legal threshold of the regulator, and even when they appear quite serious at the outset, when investigated they may not justify regulatory action. This is often the case when complaints are based on a single clinical incident.

If no action is taken, this may leave a dissatisfied complainant, a damaged doctor and an irritated employer, while in some cases at least it may have been a waste of time and of regulatory resources. None of this does the reputation of the regulator any good.

Secondly, the increased mobility of doctors presents a number of regulatory challenges. It is now generally accepted that while many aspects of medical knowledge and skill are transferable from one context to another, the influence of culture and the manner in which doctors are trained and practice can have a huge impact on the ability of the doctor to function well in his or her new surroundings. There is now a wealth of evidence on the challenges facing doctors moving from one jurisdiction to another. This can be exacerbated by the fact that international medical graduates are often sent to areas where it is hard to recruit home-produced doctors, leaving them isolated and vulnerable. In the UK for example, recruiting doctors can be difficult, especially in deprived areas and more remote communities.14

For regulators, the guardians at the gateway to the medical profession within their jurisdictions, this presents a series of challenges — apart from establishing doctors' identities, the validity of their qualification, their disciplinary record and evidence of good standing in all the places where they have worked, the regulator also has to determine its own standard and how this can be applied to international applicants. In countries where the numbers are small, the resources and systems are unlikely to be available to undertake a good assessment, and in countries where more than one in three doctors15 have not been trained locally, the ability to triage and select well and fairly becomes a fundamental feature of patient protection.

THERE IS NOW A WEALTH OF EVIDENCE ON THE CHALLENGES FACING DOCTORS MOVING FROM ONE JURISDICTION TO ANOTHER.

Although not necessarily the direct responsibility of the medical regulator, for countries exporting physicians, the impact of this growing traffic in health care professionals can be disastrous. In parts of Africa and Eastern Europe there have been claims that already stressed local health systems have been left in an even more fragile state because of recruitment by richer nations.16 The charity Health Poverty Action has estimated that the investment lost by source countries from health professional migration may even exceed the monies received in health aid from destination countries.17

In 2010, the Organisation for Economic Co-operation and Development (OECD) reported that Mozambique had an expatriation rate among doctors of more than 50%.18 Within Europe, doctors and other health care professional staff often move to the UK, Germany, or Scandinavia in search of better salaries and working conditions, resulting in a similar trend. A European Commission study found that labour mobility was a major contributory factor in creating shortages of health workers in newer EU member states, such as Poland.19

Nor is the decision to relocate confined to qualified doctors; increasingly medical students are training in one country in the expectation of practicing in another. This is coinciding with an exponential growth in medical schools, fueled by the shortage of doctors in many parts of the world and by the large profits that can be made from private medical education. New medical schools are opening in countries as far apart as China, Brazil and the UK, again presenting regulators with the challenge of how to assess the quality and relevance of the education and training that is being offered. The World Directory of Medical Schools demands that criteria are met before a school is accepted in the directory, but those responsible are clear that this is a limited test and a long way from a mark of quality.20 The need to better assess standards of medical education has been recognized by the United States' Educational Commission for Foreign Medical Graduates, which is planning only to accept doctors who have qualified from schools that have been accredited by agencies approved by the Commission.21 Such an accreditation system may prove effective for countries willing to go with the American standards or develop their own, if they can afford to be choosy and reject unsuitable candidates. However, it may work less well in parts of the world where they are desperate for doctors and have no means of assessing the ever-expanding number of schools.

INCREASINGLY MEDICAL STUDENTS ARE TRAINING IN ONE COUNTRY IN THE EXPECTATION OF PRACTICING IN ANOTHER.

The third challenge is one that faces every regulator around the globe — how to harness and adapt to the impact of data. The digital revolution is affecting health care, just as it is affecting every walk of life; reducing the asymmetry of information between patient and doctor, revealing variation in performance within and between institutions and teams, and between individual professionals. It is creating greater transparency and demand for even greater openness. At the same time, like a tide receding, it exposes patterns and trends hitherto hidden from view.

MOST REGULATORS ARE AWASH WITH DATA BUT FOR THE MOST PART IT HAS BEEN IMPENETRABLE, AND THE ANALYSIS NEEDED TO MAKE SENSE OF IT HAS BEEN EXPENSIVE AND HARD TO EXECUTE.

Most regulators are awash with data but for the most part it has been impenetrable, and the analysis needed to make sense of it has been expensive and hard to execute, not least because most data has been collected for operational purposes rather than to understand what is going on. The power of the digital age gives regulators the opportunity, in many ways for the first time, to understand the impact of what they do and, sometimes, the impact of what they are not doing.

So, given this uncertain external environment and these specific challenges, what is the future for medical — and indeed, health care —professional regulation?

Health care is now center stage just about everywhere; political and media interest in the quality of doctors and other health care professionals is not going to go away. Quite the reverse, in fact. Professional regulation may not be a stated political priority but there will be ongoing and, very likely, increasing interest in how well it is being done.

The structure of regulation may change: A study for the Hong Kong government22 found pressure for reform or ongoing changes in just about every country it researched. Noted were moves towards greater lay involvement, some interest in multi-professional regulation (or at least in umbrella bodies and shared activities) and some moves from pure self-regulation by the professions to what the researchers described as “a partnership model.”

Whatever new or reformed structure or governance model of medical regulation is chosen, there will be a need not just for new legislation, but for legislation that is more flexible and can adapt to changing circumstances and demands. A system that was designed to manage a handful of complaints a month, or occasional applications from new medical schools, will simply not cope as the numbers and complexities mount.

And the way we do regulation must surely change. As Dr. Joanna Flynn, the Chair of the Medical Board of Australia, observed, we need to move from being predominantly “philosopher regulators to being scientific ones”23 — ethics and the values that underpin it will remain key to good and effective regulation, but to this must soon be added the study of data and trends that will enable regulators to identify areas of risk among different groups of physicians, at different points in their careers, and depending on what specialty, or where they work.

Malcolm Sparrow of Harvard University has articulated how this might be applied to medical regulation with more focus on identifying and reducing risks and harms, the development of “Regulatory Craftsmanship” using a broader range of tools than regulators traditionally employ, and mastering new organizational methods.24

Intelligence-led and risk-based regulation of this kind should enable regulators to be more proactive, seeking to prevent harm before it has occurred — helping to stop the bodies from falling into the river, rather than merely fishing them out downstream when it is too late.

The growing interest in ways to make sure physicians can demonstrate ongoing competence is one manifestation; where a physician struggles to do this it can trigger an intervention or initiate remediation, which can avoid harm to patients and a further deterioration in practice, which may be irreversible.

And all this will almost certainly test the compact between civil society and the medical profession, which the regulator seeks to operationalize. The traditional view that all the regulator has to do is register the physician at the start of his or her career, and only intervene when he or she commits some transgression, is already being challenged all over the world.

The future then must lie in a much closer — and in some ways, a less threatening — relationship between the regulator and the physician. A relationship which is less about discipline and more about regulators committed to preventing harm, promoting and defending standards of good practice and seeking ongoing assurance that every physician is competent to practice safely and effectively.

There was a time when regulators could more or less operate in isolation, but given the rapidly changing terrain in which we all operate and the shared challenges we face, doing our own thing makes little sense. In this regard, the Federation of State Medical Boards in the United States has identified six attributes necessary for regulators to retain their relevancy in our fast-changing world: physician engagement, public participation, communication, transparency, innovation and collaboration.25 Never have we needed to learn from each other as much as we do now. Our structures may be different and undoubtedly our history, our laws and our cultures will create and perpetuate differences, but these differences are opportunities to share experience and to learn.

THE FUTURE THEN MUST LIE IN A MUCH CLOSER — AND IN SOME WAYS, A LESS THREATENING — RELATIONSHIP BETWEEN THE REGULATOR AND THE PHYSICIAN.

That is why at the International Association of Medical Regulatory Authorities (IAMRA) we are so committed to expanding the international community of medical regulators and those who have an interest in our work. We now have 84 members from 41 countries but we need to reach out to state and provincial boards in larger countries, to middle-income countries, and to the developing world. We are clear that we should not promote any one model or structure of regulation, but we do have a shared purpose to protect the public and a shared understanding that we are not here to judge each other but to judge ourselves.

• Copyright 2015 Federation of State Medical Boards. All Rights Reserved.