Health practitioner regulation and national health goals

Abstract The role of health practitioner regulation in ensuring patient safety is well recognized. Less recognized is the role of regulation in addressing broader health system priorities. These goals include managing the costs, capacities and distribution of health professional education institutions; ensuring the competence and equitable distribution of health workers; informing workforce planning and mobilization; enabling the use of digital technologies; and addressing challenges related to the international mobility of health workers. Even where health practitioner regulation is designed to advance these goals, important gaps exist between the potential of regulatory systems and their performance. The response to the coronavirus disease 2019 (COVID-19) pandemic led many countries to introduce regulatory changes to allow more flexibility and innovations in the mobilization of health practitioners. Building on this experience, we need to critically re-examine health practitioner regulatory systems to ensure that these systems support rather than impede progress towards national health goals. We discuss the role of health practitioner regulation in contemporary health systems, highlighting recent regulatory reforms in selected countries, including during the COVID-19 pandemic. We identify the importance of dynamic, effective and flexible health practitioner regulatory systems in progress towards universal health coverage and health security.


Introduction
Occupational regulation has been defined as "the legally defined requirements or rules that govern entry into occupations and subsequent conduct within them." 1 Systems for regulation of health practitioners are designed to address the asymmetry in knowledge between patients and practitioners, and reduce the risk of harm to patients.Regulations covering health practitioners generally include: 2 (i) educational requirements for professional practice through the establishment of education standards and quality assurance of education programmes; (ii) a system of registration or licensure which may include establishment of professional codes of conduct, identification of protected titles or regulated scopes of practice and requirements for maintenance of registration; (iii) a register of those who are licensed or registered, which may be accessible to the public and include any special requirements or restrictions on registration or licensure; and (iv) processes for dealing with concerns about regulated practitioners, and systems for implementing appropriate disciplinary measures in cases of professional misconduct, sub-standard performance or addressing impairment in physical or mental capacity.
The systems for health practitioner regulation are under increasing pressure in many countries due to several factors: the growth and privatization of health professional education; the increasing prominence of previously unregulated occupations, and the emergence of new occupations and new technologies in health care; emergencies and humanitarian crises; increasing international mobility of practitioners; a growing focus on team-based and integrated networks for service delivery; and increasing consumer demand, expectations and knowledge. 3he coronavirus disease 2019 (COVID-19) pandemic has further highlighted the need for health practitioner regulation to be more readily updated, with room for flexibility and better alignment to current national health priorities.Across countries, the adaptations made to health practitioner regulation were fundamental to ensuring the rapid availability of health practitioners for the national emergency response.The lessons of the pandemic create an opportunity to examine the role of regulation in advancing health system needs and priorities, and to consider how innovations and greater flexibility in regulation can be applied without compromising patient safety. 4ealth practitioner regulation is increasingly recognized as a core mechanism to ensure the availability, accessibility, acceptability and quality of the health workforce. 5,6Through an overview of diverse health practitioner regulatory systems, we highlight the evolving role of health practitioner regulation in contemporary health systems, including in low-and middleincome countries.We describe recent regulatory reforms and the adaptions during the COVID-19 pandemic, and discuss the opportunity to strengthen the alignment of health practitioner regulations with national health goals.

Diversity of systems
Health practitioner regulation encompasses multiple aims, with substantial diversity in the structure and operation of regulations across countries with different geography, economy and socio-political history. 2 Examples include self-regulation (regulation administered exclusively by individuals who are members of the professions being regulated); independent statutory authority (an authority established by law specifically for regulatory functions); co-regulation (delegation of certain regulatory functions to the professional associations); direct government regulation (regulation administered by government entities); and combinations of the above.The regulatory approaches can range across competencies (as-sessing individual practitioners); risk of harm (assessing risk of practitioner intervention or activity); scope of practice (limiting roles, activities or authority of practitioner or occupations); and controlled acts (limiting specific procedures or tasks to authorized practitioners or occupations). 7he health occupations that are regulated and the type of regulation can vary across countries and jurisdictions.Regulation may also be non-statutory, as in the case of voluntary regulation.There may even be no regulation for certain health occupations in some cases, except for generic rules that are applicable to all occupations in a country.Depending on the type of health occupation and the country, regulation may differ across sub-national jurisdictions, and regulatory functions may be separated across different authorities.
The diversity in health practitioner regulatory systems can be explained by the context in which they are established and operate (Fig. 1).Systems for occupational regulation are influenced by the legal tradition, political economy and colonial history of a country.At the centre of the system are the interactions among government, business, professions and civil society.Historically, health professions in anglophone countries have followed the British model of self-regulation, while in other political systems, governments have more control over health practitioner regulation.The design of health practitioner regulation often follows occupational regulation models in the country, rather than the health system in which the health practi-tioners work.In fact, health practitioner regulation may be disconnected from or lag behind health system reforms. 8owever, health systems tend to have a greater reach into communities than legal systems, and pragmatic local norms can override formal regulatory provisions for health practitioners in remote and underserved geographical locations.

Low-and middle-income countries
The capacity of regulators to implement regulatory policies and perform their functions is fundamental for health practitioner regulation to be effective.There is concern, however, that the establishment of health practitioner rules and statutes in low-and middle-income countries may outpace a country's ability to implement them.
Despite established regulatory systems, wide variation exists in the quality of practitioners within and across lowand middle-income countries.These variations raise questions over the standardization of qualifications, job titles and minimum competency, and point to concerns over the sometimes low quality of health practitioners, including regulated professions. 9,10ealth practitioner registries provide information on regulated health practitioners and are the most common source of data on the health workforce.However, enforcement of registration requirements and registry maintenance has been a major challenge.Studies show that in some countries only 44% of physicians working in the public sec-tor were registered, 11 and in others only half of the registered practitioners were in active practice (10 898 out of 21 731 health practitioners in some areas, and 7719 out of 17 443 health practitioners in others). 12In countries with federated systems, health workforce data recorded by the professional councils may not account for migration, death or double-counting of practitioners who are registered in more than one state. 13perational challenges may worsen the situation.In some settings, delays in procurement of certificates have led to long suspensions in issuing licenses, 14 including during the COVID-19 pandemic.Financial resources are a key barrier to strengthening regulatory systems in low-and middle-income countries.For instance, in 2011, the administrative cost of Kenya's regulatory system on health practitioners was estimated to be 13.2 million United States dollars, equivalent to around 0.6% of the country's total health expenditure. 15nforcement of regulations for short-term international health practitioners is also a challenge in low-and middle-income countries.][18] The limited effectiveness of regulators in addressing professional and ethical misconduct of practitioners  is also a concern in some low-and middle-income countries.][21][22] In some low-and middle-income countries, the strong influence of their colonial history on the objectives and approach to health practitioner regulation has contributed to the current regulatory challenges faced.Often health practitioner regulatory systems were established by the former colonial governments following the model in their respective country of origin, with little consideration given to the local context and population needs. 11,23,24Even after independence, these systems were rarely reformed according to evolving population and health system priorities, in contrast to the periodic reforms in high-income countries.

Recent reforms
Despite the diversity of health practitioner regulatory systems, the core purpose of these systems is to serve the public.However, the definition of public interest is itself contested, as it varies across jurisdictions and has evolved over time, primarily through assuring competency and minimum standards of health practitioners.While an earlier interpretation of the public interest was viewed as synonymous with elevating the status of professions, this understanding is increasingly shifting towards defining value from the perspective of communities.Public interest is now seen as prioritizing the efficiency, value-for-money, quality and safety of health services, and the responsiveness of the regulatory system to the complex and evolving needs of health systems.Public interest also includes whether the regulatory intervention is proportional to the risks presented by the practitioner and to the benefits accrued from the intervention and the regulatory burden imposed. 25ox 1 compares the contemporary understanding of goals in the public interest of health practitioner regulation with that in the 19th and 20th centuries.
Table 1 highlights recent reforms in six countries that had traditionally fol-lowed a model of self-regulation.These reforms illustrate how the rationale for health practitioner regulation is expanding beyond patient safety to broader purposes, such as health workforce sustainability, promotion of wider health-sector goals and universal health coverage (UHC).
The objective of Australia's national registration and accreditation scheme includes ensuring "workforce mobility across Australia" and enabling the "continuous development of a flexible, responsive and sustainable Australian health workforce." 5India's National Medical Commission replaced the Medical Council of India that was established during the British colonial period.The National Medical Commission Act aims to "ensure availability of adequate and high-quality medical professionals in all parts of the country, " "promote equitable and universal health care that encourages community health perspective, " and "promote national health goals." 6 Nepal's Medical Education Commission regulates all health professional education institutions and programmes, which used to be the responsibility of various professional councils and government entities.The law on medical education is intended to develop professional education "in alignment with national needs, " and "ensure equal access to all students including the deprived." 27 New Zealand's health practitioners' competency assurance system includes elements to "promote and facilitate interdisciplinary collaboration and cooperation in the delivery of health services," and "to promote public awareness of the responsibility of authorities." 28 Common themes related to reform in these six countries in Table 1 include improving transparency about the appointment of regulators; how they operate; and their regulatory decisionmaking and social accountability.The role of communities in regulation is also growing, with greater representation of lay members on regulatory boards.
Efforts to balance power across the state, the professions and civil society include establishing oversight bodies for regulatory authorities in Kenya and the United Kingdom of Great Britain and Northern Ireland; replacing elected members of the profession within the regulatory boards with appointed members; and including public representatives on regulatory boards in Australia, India, Nepal and the United Kingdom.
Recent reforms have been triggered by a variety of factors.In some countries the public outcry over risk to patient safety from regulated professions, 30 and regulatory inefficiencies and corruption have led to reforms. 31 Health practitioner regulation and national health goals Agya Mahat et al.
other countries, reform was prompted by substantial growth of the private sector; along with increased demand for quality care and increased influence of international standards; 32,33 concerns over cost and quality of medical education in the private sector; 34 and the need to ensure that future national health workforce requirements can be met. 5he patterns of reform are not uniform, however.In several anglophone countries, regulatory models tend to be shifting from self-regulation to systems with stronger state oversight. 5,6,9However, countries with traditionally stronger government involvement, such as China and Republic of Korea, are delegating certain regulatory functions to the professions. 35,36Indonesia is considering a draft Health Omnibus law that brings together health practitioner regulation and other health laws in support of national health priorities. 37eforms in Australia created uniform national standards for regulated health practitioners, and a single agency responsible for regulatory functions. 5owever, implementation of national standards can be challenging in contexts with substantial sub-national variations in health and other socioeconomic conditions. 10Major reforms may not endure when there is a lack of consensus among stakeholders, or political instability. 38 cross-country historical review of health practitioner regulatory reforms over the last century further suggests that successful reforms, at minimum, require responsiveness to the local context; a clear understanding of regulatory goals to be addressed; and collaboration across relevant stakeholders (such as government, the public, professions, employers and businesses). 39

Regulation in health emergencies
Emergencies such as disasters, humanitarian crises and disease outbreaks place enormous stress on regulatory systems due to the heightened demand for qualified health practitioners.In such situations, regulatory flexibility enables the rapid deployment of additional health practitioners to respond to the emergency and to maintain essential health services.Box  • Protect the health and safety of the public by providing mechanisms to ensure that health practitioners are competent and fit to practise their professions.
• The 11 regulatory authorities are responsible for regulation of existing regulated health professions.It is possible for regulatory authorities to be merged and to add new health professions to be regulated at the recommendation of the health ministry.• Each authority comprises a maximum of 14 members, most of whom are elected health practitioners, but the authority includes at least two to three lay members.• Among others, the functions of each regulatory authority include: specifying the qualifications required for their scope of practice within the profession; authorizing registration of health practitioners and maintaining registers; notifying employers and other relevant authorities if the practise of health practitioners may pose a risk of harm to the public; liaising with other regulatory authorities about matters of common interest; promoting and facilitating interdisciplinary collaboration and co-operation; and promoting public awareness of the responsibilities of the authority.• A performance review of each authority must be conducted at least every 5 years through an independent person appointed by the health ministry.The pandemic also highlighted the role of regulatory bodies in supporting workforce planning.While many countries struggled with collating data on their active health workforce, Australia's regulatory authority was able to swiftly reinstate the registration of almost 40 000 practitioners who had left practice, without any application forms or fees, to support the government in planning for the surge response. 40hile most of the regulator y flexibility was temporary and enabled through executive orders, some countries have made long-term changes from lessons learned during the pandemic.These changes include developing legislation for regulating telemedicine services, 41 and in some cases permanently abolishing the final examinations of doctors to enable their early deployment into practice. 42On the other hand, following legal proceedings, the expansion of scope of practice of certain health occupations has been reversed in some cases on the grounds of patient safety. 43

Alignment with national goals
While health practitioner regulation is essential for identifying practitioners who have the minimum qualifications to provide safe care, there has been limited research on the links between health practitioner regulation and health system goals.The performance of regulatory systems is often limited to measurement of regulatory activities in isolation from patient outcomes.Evidence related to the effect of health practitioner regulation on population health outcomes is scare. 44here is also concern over regulation being used to reduce competition for patients, and to increase wages of incumbent practitioners by limiting entry into practice of newcomers to the regulated profession as well as new professions. 45,46Yet health workforce shortages and inequitable distribution of health professionals are major barriers to universal health coverage (UHC).Furthermore, regulatory systems that work in isolation and scattered across different occupations are reported to have constrained implementation of inter-professional education and teambased practice. 8icensing -with restrictions placed on who can provide specific services or perform certain tasks -is recognized as the most intensive type of occupational regulation. 47Licensing can impose significant regulatory burdens and costs for the government, regulators, practitioners and the public, and is recommended only for occupations that pose the highest patient safety risk.Yet an increasing number of professions are pursuing this route.Some researchers have argued that licensing increases the labour supply. 48Other researchers, however, find that excessive restriction on education, scopes of practice and licensing can limit the supply and mobility of health practitioners.Such restrictions also increase the cost of health services and wages of practitioners, especially those who can work independently, without necessarily improving the quality of services. 45,46,49,50ecause of the economic effects resulting from constraining the supply of health practitioners, regulation can be (mis)used to secure monopoly in the health labour market and protect the scope of practice of specific professional groups over evidence-based interven-

Box 2. Examples of emergency flexibilities and adaptations in health practitioner regulation in selected countries
Entry to practice tions to advance public welfare.There is concern that regulatory systems may be serving the interests of the professions (by constraining supply) and the regulators, rather than improving the quality of health professional education and practice. 23,49evertheless, there are important examples where health practitioner regulation has been used to strengthen health system goals.The conditional release of doctors' professional licenses or certification on completion of rural service has helped place physicians in underserved areas in both highincome and low-and middle-income countries, for example in Australia, Ecuador, Nepal and Nigeria. 51In some settings, health practitioner regulation has been used to control entry to the private sector and minimize the negative consequences of dual practice (a phenomena in which a health practitioner is simultaneously employed in the public and private sector), for example in Botswana, Kenya, Myanmar and Uganda. 51,52Regulation has also been applied to control the financial costs incurred to students in health professions, 27 inform health workforce planning and strengthen health-sector governance more broadly. 6here is need for greater research and policy attention on how to link health practitioner regulation to health system performance and patient outcomes to better serve the needs of health systems.Research on the effects of regulatory flexibility and innovations enacted in response to the COVID-19 pandemic should be considered to inform longer-term reforms.

Conclusion
Important gaps exist between the potential of health practitioner regulatory systems and their actual contribution to UHC and health security.Common challenges include fragmented and ineffective regulatory systems; rigid education models; unnecessary requirements for entry to practice; restrictive scopes of practice; and reimbursement schemes that are occupation-specific.These issues may be impeding rather than supporting efforts to optimize the workforce, establish team-based practice and achieve equitable distribution of health workers, while increasing the cost of health services without any concomitant benefit to patients.
We need to critically examine how to best to align health practitioner regulation to a contemporary understanding of the public interest in specific contexts, including the prioritization of national health goals (Box 3).Regulatory systems are not static.Improvements are necessary to address the emerging needs for patient safety, and to incorporate advances in biomedicine and in information, communication and technology.Such improvements should be informed by regular review of regulatory policies and standards, not only on patient outcomes but also on health-system results.
That said, the health practitioner regulatory reforms can only deliver results when the design is based on national needs, is appropriate to the context, balances multiple interests and has sufficient resources to operate effectively.The pandemic experience presents a unique opportunity to reflect on the priorities and objectives of health practitioner regulation, to generate evidence on health outcomes, and to prepare the health workforce and health system to be more responsive and resilient.

Fig. 1 .
Fig. 1.Factors determining for design of health practitioner regulatory systems Note: Health system and occupational regulation are the major elements that determine the design of health practitioner regulation in a jurisdiction.The influence of occupational regulation (blue solid arrow) is more than the health system (blue dashed arrow) on health practitioner regulation even though the latter reaches deeper into communities.These reaches (grey dashed arrows) are, in turn, determined by contextual factors such as political and economic models, colonial history, and legal traditions.The balance of power between the state, professions, civil society and businesses, also influence health practitioner regulation.As a result, there is substantial diversity in how health practitioners are regulated across and within countries.Bull World Health Organ 2023;101:595-604| doi: http://dx.doi.org/10.2471/BLT.21.287728

Table 1 . Contemporary reforms in health practitioner regulation in selected countries
The Nepal Medical Education Commission was established to regulate the education sector of health professions and improve its quality, replacing the function of the professional councils on education and accreditation.•The Commission is chaired by the prime minister, while the ministers for education and health are co-chairs; the vice-chair is appointed by the government.Other members include representatives from the government, academics, professional councils, professional associations, civil society, and private medical and dental colleges.• Ten years after the adoption of the National Medical Education Act, all medical education institutions will start to be not-for-profit institutions.• At least 75% of the seats in public institutions and 10%-20% of the seats in private institutions should be allotted to scholarship students, and everyone on government scholarship will have to sign a bond to work in government-deployed areas for 2 years or pay a financial penalty.• The Commission sets a limit on the education cost charged to students in the private sector, grants accreditation to education institutions and conducts a common entrance examination for entry into undergraduate and postgraduate programmes.• No new medical, dental or nursing college can be established in the Kathmandu valley for 10 years after the adoption of the Act.
• Deployment of health professional students: France, India • Early or expedited graduation of health professional students: Italy, USA • Waivers on registration or licenses or validity of out-of-state license: Canada, Peru, USA • Waivers on registration or license renewal: Netherlands (Kingdom of the), South Africa, USA • Re-employment of retired practitioners: Australia, New Zealand, Spain, USA Waivers on validation of qualifications: European Union, Peru • Supervised clinical practice for unregistered practitioners or limited permits: United Kingdom of Great Britain and Northern Ireland, USA Bull World Health Organ 2023;101:595-604| doi: http://dx.doi.org/10.2471/BLT.21.287728Health practitioner regulation and national health goals Agya Mahat et al.