We identified key themes in our evidence synthesis, clustered under a series of HPR topics organized according to our structures-processes-outcomes conceptual framework. These topics and key themes are presented in Figure 6.
INSERT Figure 6: Overview of topics and themes categorized by structures, processes, and outcomes.
(A) Structures
Scope and governance of regulatory systems
A total of 134 published articles and 203 grey literature sources addressed HPR governance systems. Published articles primarily focused on nurses, midwives and advanced practice nursing (APN) roles (n=35), followed by other health practitioners (n=23) and T&CM practitioners (n=22) (Figure 7). Most literature came from the United States (US) (n=20), Australia (n=19) and the United Kingdom (UK) (n=13). Four themes were identified from the published and grey literature on this topic.
INSERT Figure 7: Most frequent countries and health occupations in published literature addressing the scope and governance of regulatory systems
First, there is diversity in the purpose, scope and features of regulatory systems and how decisions are made about which health occupations should be regulated.
Shaped by contextual factors such as the historical division of labour and population health needs (19–21), there is jurisdictional variation between which occupational groups are regulated and how. While most jurisdictions have some form of legislated licensing scheme for one or more health occupations, the purpose, scope and features vary. More jurisdictions are using good regulatory practice to strengthen the evidence base for making these contested decisions (22–27). The evidence suggests that in jurisdictions without strong regulatory management systems, some occupational groups are being licensed through a less resource-intensive type of regulation, which might provide sufficient public protection at a lesser cost to the practitioner, the regulator and the public (5,24,28–31,31,32).
Second, the principles and tools of risk-based regulation adopted by some regulators signal a shift to more proactive strategies for harm prevention and minimization.
The literature describes how regulators use data analytics tools to refocus regulatory resources, to systematically identify concentrations or ‘hot spots’ of risk (due to registrant competence or conduct issues) and develop targeted harm reduction programs (33–38). Some literature suggests that risk-based regulatory strategies have been applied more widely during the COVID-19 pandemic – more nimble regulators have weighed the risks and benefits to the public of various regulatory actions used to facilitate a surge workforce (39–44).
Third, various generic and HPR-specific standards and tools are being used to assess HPR performance, with some adaptable for use in lower-resource environments.
The literature presents a range of frameworks and tools used by governments to improve regulatory policy and practice, from generic whole of government good regulatory practice frameworks (24–27) to HPR-specific evaluation tools (32,36,45–48). We identified an increased focus in the grey literature from high-income countries (HICs) on assessment and accountability standards that apply to regulators, including heightened scrutiny of regulatory operations by integrity agencies and other independent review bodies (2,49–53).
Fourth, there are diverse approaches to regulatory reform, with studies reporting new regulation or regulatory strengthening activities in LMICs, sometimes prompted by development aid or trade agreements.
Jurisdictional regulatory reform processes range from successive system-wide reviews and ongoing formalised reform programs (2–4,6,7,49,51,54,55) to more incremental, piecemeal or ad hoc reforms (19,30,56,57). In LMICs, studies documented the establishment of new regulators and other regulatory strengthening initiatives, sometimes associated with development funding. Six studies from sub-Saharan African countries presented results from the African Health Profession Regulatory Collaborative (58–61,61–63). They reported substantial and sustainable advances in regulating nurses and midwives in Africa, offering a framework for evaluating future progress. In Europe and South-East Asia, studies referred to the role of trade agreement mutual recognition arrangements in motivating governments to establish or reform licensing schemes (64–73).
Regulatory institutions
Our review identified 42 published articles and 64 grey literature documents addressing the institutional arrangements under which HPR functions are delivered. The published literature was primarily on nurses and midwives (n=13), followed by medical practitioners (n=12) and health practitioners in general (n=12). International (global and multi-country) studies were prominent (n=10), followed by studies from the US (n=7) and Australia (n=5) (Figure 8). Three themes were identified from the synthesis of the literature on this topic.
INSERT Figure 8: Most frequent countries and health occupations in the published literature on regulatory institutions
First, there is no widely accepted typology for describing HPR institutional and governance arrangements.
There is considerable diversity in the institutions responsible for HPR and their governance arrangements, reflecting diverse political, social, and professional contexts (19,20,74–79). Much of the published literature compared the governance arrangements of regulators across multiple jurisdictions (5,19,20,74,76,79–91) or analyzed the strengths and limitations of specific elements of governance (81,92–95). There was no widely accepted or commonly used taxonomy for describing the features of HPR institutions, and terms such as ‘independent’, ‘autonomous’, ‘profession-led’ and ‘government-led’ were used without clear or standardized operational definitions.
Second, tensions between ‘profession-led’ governance models and increasing government expectations for oversight and control of regulators reflect a long history of contestation in some jurisdictions over who controls the institutions that govern health practitioners.
Some researchers highlighted the potential for conflicts of interest where the regulator operates within a health ministry that has broader service delivery and stewardship responsibilities, calling for reforms to strengthen the independence of regulators from governments (76,81,82,96). Similarly, some international professional associations argue for ‘profession-led’ (or ‘professional self-regulation’) rather than government-led regulation (97–99). Conversely, other sources questioned governance arrangements where the regulator is constituted with elected members of the occupational group being regulated, with calls to reduce the level of control exercised by health practitioners and increase government oversight (2–4,6,54,80). A shift away from governance models that embed ‘representativeness’ (of those being regulated) and towards greater government oversight and control is evident primarily in Anglophone countries with a long history of delegating regulatory powers to ‘profession-led’ bodies. The grey literature suggests that governments are placing greater expectations on regulators to be more transparent and accountable in their operations, better manage conflicts of interest (through, for example, structural separation of investigation functions from determinative functions in disciplinary matters) and ensure registrants are afforded procedural fairness (2,3,6,49,50,91,100–102).
Third, HPR governance reforms show a trend toward use of umbrella laws and multi-profession regulators, more diverse governing board membership and increased accountability obligations.
There is evidence of trends toward use of umbrella statutes and multi-profession regulatory agencies, with studies from LMICs and HICs suggesting considerable net benefits (20,33,64,91). There is some evidence from HICs that, by achieving greater economies of scale, multi-profession regulators might be more efficient than large numbers of small profession-specific agencies (51,103). WHO publications and government reviews have encouraged multi-profession governance to address the disadvantages of profession-specific regulatory ‘silos’ for setting education and practice standards and administering disciplinary and enforcement functions (2,9,49,104). These models also enable more efficient updating of the legislative framework and facilitate international collaboration (6,105).
Regulatory system linkages
Our review examined evidence concerning the nature of the interfaces and linkages between HPR and other quality assurance mechanisms, within health systems and with other institutions and sectors beyond health. This literature included 110 published articles and 83 grey literature sources. The published articles focused primarily on nurses and midwives (n=31) and medical practitioners (n=31), followed by health practitioners generally (n=27) (Figure 9). Articles came primarily from the US (n=22), followed by studies with a global or international focus (n=18) and Europe (n=11). Two themes were identified from the published and grey literature.
INSERT Figure 9: Most frequent countries and health occupations in published literature on regulatory system linkages
First, routine collection by regulators of comprehensive workforce data is being used to improve health workforce planning, development, supply and distribution.
The literature shows how HPR can directly impact workforce supply and facilitate (or hinder) a flexible, responsive, and sustainable health workforce (1,4,6,104). The literature also reveals an increasing recognition of the role of regulators in collecting and supplying to governments registrant data for use in health workforce planning (106–108). Several reports highlighted how the COVID-19 pandemic has rapidly escalated the need for timely workforce data collection, planning and mobility (109–111). Actions taken by regulators to support a surge workforce during the pandemic were highlighted, including widespread scope of practice reforms, fast-tracked licensing and foreign credential recognition, rapid recruitment from abroad and from final year medical and nursing students, rapid retraining using online learning, incentivizing labour mobility, and setting practice standards and guidance to support the delivery of virtual care (39,42–44,110,112–114).
Second, despite continuing efforts for harmonization and mutual recognition, challenges remain with cross-border recognition of qualifications and portability of registration.
Many studies addressed the challenges faced by regulators in responding to the demand for greater mobility of health practitioners across jurisdictions, including under mutual recognition arrangements.[3] These challenges relate to factors such as the variability in requirements for registration (e.g., qualifications, examinations), the diversity of requirements for renewal of registration (e.g., CPD, revalidation), the need to assure the competency of practitioners providing virtual care, and the management of disciplinary matters that require regulators to share information or that raise cross-border jurisdictional issues (21,68,73,115–118).
Third, HPR policies impact the migration of health workers.
Studies point to the role of HPR policies (qualifications and other entry requirements for registration, types of registration) in contributing to international migratory flows of skilled health personnel. Several studies documented the adverse impacts for LMICs of health workers leaving their countries or communities to pursue better paying work opportunities elsewhere. Several studies noted the challenges with implementation of the 2010 WHO Code of Practice on International Recruitment of Health Personnel (119–124). A complex range of push and pull factors were identified, with gaps in knowledge of effectiveness of policy interventions in HICs and LMICs that might regulate positively the movement of health practitioners from LMICs. A study of implementation of the Code in four ASEAN member states found most of the out-migrating professionals leave voluntarily, that is, outside government-to-government agreements. While registration and employment regulations apply equally to domestic and foreign trained professionals, local language requirements were a barrier.
(B) Processes
Registration and monitoring of continuing competence of practitioners
We examined the literature on HPR registration processes, including setting standards for registration, processing applications, monitoring standards of practice and the continuing competence of registrants, and the operation of public registers. We identified 132 published articles and 73 grey literature documents (Figure 10). Most published articles come from the US (n=34), followed by international studies (n=16), and the UK (n=14). Articles focused primarily on medical practitioners (n=61), nurses, midwives and APN roles (n=29), and health practitioners generally (n=15). Five themes were identified from the published and grey literature.
INSERT Figure 10: Most frequent countries and health occupations in the published literature on registration and monitoring of continuing competence of practitioners.
First, while there are signs of regulatory convergence as more jurisdictions establish statutory registration schemes, some schemes lack a comprehensive set of powers, functions, and accountabilities.
There is evidence that many LMICs and HICs with differing legal traditions have enacted statutory registration schemes for key occupational groups, such as medical doctors, nurses, midwives, dentists and pharmacists.[4] However, in some cases, regulators do not have the full suite of requisite powers, functions and accountabilities (e.g., powers to grant different types of registration, impose annual registration renewals, monitor compliance with practice standards, and take enforcement action for breaches; and obligations to observe procedural fairness in regulatory decision making, collect and supply practitioner data for workforce planning and system improvement purposes, and report routinely on the performance and outcomes of regulatory activities) (9,19,74,76,77,84,85,104,125,126).
Second, the evidence on the effectiveness of the national licensing examination (NLE)[5] for assuring graduate capability is limited, and the complexities of running a robust and reliable NLE can be underestimated.
Four UK-authored systematic reviews examined whether NLEs assure practitioner competence or improve patient safety and found the evidence was weak (127–130). Several studies from LMICs highlighted factors contributing to the pressure to introduce an NLE, such as the rise in private sector education providers resulting in a surplus of graduates and uncertain standards, the need to standardize training and entry to the public service, and to improve quality of care (67,73,131–134). These studies also highlighted the complexities of introducing NLEs, including in the context of mutual recognition agreements that seek to harmonize entry requirements to promote fairness, the common market, and freedom of movement (73).
Third, statutory registration schemes can help governments address workforce shortages in rural areas and during emergencies.
The literature discussed the role of HPR processes in addressing the challenges of securing a sufficient rural workforce in LMICs (66,135–138) and HICs (139–143). Regulatory tools can be used to support the implementation of broader rural workforce recruitment, retention and development strategies. Examples include compulsory service requirements tied to registration or modified qualification requirements, scopes of practice and supervision arrangements for practitioners recruited specifically to work in areas of workforce shortage (66,135–138). In HICs, the literature focused on regulatory changes made or advocated to support advanced practice nurses serving rural communities. There is substantial evidence that jurisdictions enabling autonomous advanced nursing practice achieve higher supply of these nurses, improve patient access to health services, and better healthcare outcomes, especially in rural and underserved areas (139,140,144).
Fourth, the recruitment and integration of internationally educated health practitioners into a workforce presents particular challenges, with evidence of effective integration programs.
Studies examined how statutory registration impacts internationally educated health practitioners (IEHPs), focusing on how well they integrate into a health workforce. Studies evaluated the impact of assessment requirements (145–149), comparative rates of disciplinary or fitness to practice actions against internationally and locally educated practitioners (150,151), the implementation and effectiveness of specific transition-assistance programs (142,152), and the broader implications of IEHP mobility (153,154), mostly from the point of view of destination countries. Various international conventions, treaties and intergovernmental trade agreements were instrumental in encouraging governments to remove or reduce barriers and facilitate health practitioner mobility (155–161).
Fifth, while regulator-mandated continuing professional development (CPD) is common and can be effective, various continuing competency mechanisms are found in HICs, with limited evidence of comparative effectiveness.
Continuing competency mechanisms vary across jurisdictions and practitioner groups in the same jurisdiction. These mechanisms include mandatory CPD standards required to renew registration (162–164), certification and recertification programs run by a range of non-government bodies (118,165–167), maintenance of certification programs run by specialist colleges (168–173), and revalidation programs run in partnership between regulators and employers (127,174,175). Requiring participation in CPD is the most common mechanism used by regulators to assure the continuing competence of registrants. However, studies point to deficiencies in these requirements where insufficient attention is given to the context, the learner’s needs and the delivery methods (176–179). Evidence suggests a link between CPD requirements and improved skills and knowledge (180,181). In LMICs, mandatory CPD linked to registration can be a pivotal strategy to lift the skills of various health workers, but adequate enforcement and continued resource inputs are required (58,67,182–185).
Accreditation of health practitioner education (HPE) programs
Literature on the role of HPR in accrediting education programs for entry to practice included 35 published articles and 43 grey literature sources. The published literature on this topic focused primarily on nurses and midwives (n=14), followed by medical practitioners (n=7) and health practitioners generally (n=5) (Figure 11). The international literature was most prominent (n=11) but so too were articles on the US (n=5) and sub-Saharan Africa (n=3). Four themes were identified from the published and grey literature.
INSERT Figure 11: Most frequent countries and health occupations in published literature addressing accreditation of HPE programs
First, arrangements for delivering HPE accreditation for entry-to-practice programs vary across jurisdictions and occupation.
Responsibility for assessing and assuring the quality of HPE programs and under what governance arrangements varies across and within jurisdictions. This function may be carried out by one or more statutory regulators, the responsible education ministry, or a non-government professional body under delegation from government. Sometimes there is an oversight body that brings together key government, regulator and non-government entities. This diversity extends to the linkages between the health and education sector accreditation processes (if any), the extent of coverage of public and private sector institutions and programs, and the transparency of operation and performance of accreditation systems (5,20,21,64,78,90,91,186–190). In some jurisdictions, graduation from a program of study accredited by the regulator is sufficient to qualify for registration (102,192). In others, graduates of accredited programs must also sit an NLE (5,90,91). Several reports highlighted the interdependence of the health and education sectors in quality assuring HPE programs and the need for stronger coordination and joint standard setting (102,182,191). No studies were identified that evaluated the effectiveness of different governance models.
Second, despite the diversity in governance, core elements of HPE accreditation appear broadly consistent across jurisdictions and there appears to be a growing involvement of international accreditation agencies and standards.
While several studies noted a lack of evidence to support accreditation as a tool for quality assuring the health workforce (193–195), this review found broadly similar core elements of HPE accreditation described in the literature (195–198). Also evident is a shift to outcomes-based measures and competency-based education (46,193,196), including in documents published by international standard-setting bodies such as the International Confederation of Midwives and the World Federation of Medical Education (199,200).
Third, while there is little evidence of the effectiveness of HPE accreditation, it is considered an important tool for assuring graduate competence for entry-to-practice and progressing broader social goals.
The review found little published literature assessing the effectiveness of HPE accreditation in producing skilled and competent practitioners (193,194). No studies were found that compared jurisdictions with and without HPE accreditation or compared HPE accreditation with other quality assurance mechanisms such as national examinations. Despite the limited evidence base, some have pointed to the potential to use accreditation to achieve broader societal goals, such as increasing equity, diversity and cultural sensitivity of the workforce and removing racial discrimination from the health system (191,206).
Fourth, HPE accreditation is being used as a tool for regulatory strengthening, although implementation is often weak, especially in some LMICs.
There is evidence that establishing HPE accreditation in LMICs has been prioritized in regulatory strengthening programs, particularly for nurses and midwives. The largest group of studies was associated with regulatory strengthening programs in sub-Saharan African countries (62,131,182,187,190,201,202). There were also studies from Cambodia, India, Nepal and Vietnam (64,203,204). Initiatives to introduce or strengthen accreditation of education programs and institutions were embedded within broader HPR reform programs designed to improve the quality of the health workforce (62,64,201,205). There is, however, some evidence in the grey literature that implementation of accreditation standards in some LMICs is hampered by insufficient mechanisms to ensure compliance (88–90,188).
Regulation of scopes of practice
We examined the literature on different approaches to regulating practitioner scopes of practice and the impact on health workforce capability, flexibility and access for patients to safe, high-quality services. The 119 published articles and 57 grey literature documents on this topic predominantly focused on nurse practitioners or APN roles (n=36), nurses or midwives (n=24), followed by health practitioners generally (n=16) (Figure 12). The US was the most studied country (n=46), followed by international studies (n=17) and Canada or the UK (n=8). Four themes were identified from the published and grey literature.
INSERT Figure 12: Most frequent countries and health occupations in published literature addressing regulation of scopes of practice
First, there is evidence that restrictive and unresponsive scope of practice regulation is stifling innovation, inhibiting workforce reform and having adverse impacts on healthcare access and quality.
The literature shows how regulators in some jurisdictions are empowered to use reserved practice provisions to control which occupations or classes of registrant may carry out certain procedures and who must work under supervision or only on referral. Such blanket occupation-based and centrally administered restrictions may hamper the development of team-based care and other innovative models of care, and many studies documented the adverse impacts on access to and quality of care (140,144,207–217). Overly restrictive scopes of practice were criticized during the COVID-19 pandemic, with both published and grey literature documenting the need for more flexibility in determining local health service roles and skill mix and enabling task shifting to support the crisis response (218–221).
Second, conflicts over scopes of practice reflect the tensions and competing interests between occupations.
The literature on scope of practice reform underlines the complexities of a dynamic and evolving division of labour in the health sector, the modern context of team-based and collaborative practice, and the urgency of workforce reform to improve access to care. Comparative studies emphasize the need to use the best available evidence to inform scope of practice reform (39,222–225) and grey literature documents propose criteria and processes to strengthen evidence-informed decision-making and better manage competing interests and politics (5,226–228,228–231).
Third, using HPR to support expanded scopes of practice, such as authorization to prescribe or administer restricted medicines, is improving healthcare access and quality in both LMICs and HICs.
There is evidence that expanding health care worker scopes of practice to encompass prescribing and administering restricted medicines improves access to and quality of care, particularly for rural or other underserved populations (94,209,232–246). The role of regulators includes setting the necessary competencies, accrediting training programs, monitoring compliance with standards for safe use of medicines and dealing with registrants breaching accepted practice standards (6,247).
Fourth, with increasing reliance on health associate professionals, quality assurance of this workforce relies primarily on employer measures, although negative licensing provides an additional layer of public protection in some jurisdictions, particularly for practitioners who are self-employed.
The review found diverse literature indicating increasing reliance on and expanding scopes of practice of registered and unregistered health associate professionals[6] - in both HICs (212,248–251) and LMICs (252–255). Studies focused on the HPR processes used to support a rationalization of the skills mix and allocation of roles and responsibilities, including education, management and supervision requirements to ensure safe and quality care. The evidence was mixed. Several studies from both HICs and LMICs highlighted safety concerns where role delegation reforms, often involving the administration of medicines, occurred without adequate accompanying measures and supervision and sometimes beyond what was authorized by law. More studies reported positive outcomes, both for program efficiency and patient care. The grey literature yielded extensive evidence of the benefits of skills mix and role delegation reforms, and the ingredients of successful reform initiatives, particularly in dental care, nursing, pharmacy and allied health. There is evidence that negative licensing (where a mandatory code of conduct applies to all unregistered health workers with regulators empowered to investigate breaches and remove unfit workers from the health workforce) provides an additional layer of public protection for health service users (31,256–262).
Regulation of complaints-handling and discipline
Sixty-seven (67) published articles and 72 grey literature sources included content related to the operation of complaints and disciplinary functions under HPR regimes. The published literature focused primarily on medical practitioners (n=35), followed by health practitioners in general (n=10) and then nurses and midwives (n=9) (Figure 13). The US was the most prominent jurisdiction (n=17), followed by Australia (n=16), Canada and the UK (n=10 each). Three themes were identified from the published and grey literature.
INSERT Figure 13: Most frequent countries and health occupations in published literature on regulation of complaints-handling and discipline
First, there is considerable diversity in the regulatory powers, governance of and processes for managing complaints and discipline, but little evidence on how best to design and deliver effective systems.
Despite the importance of HPR processes for identifying and managing practitioners with conduct, competence, or capacity concerns, there is considerable diversity of arrangements for dealing with complaints and discipline: in the architecture of the disciplinary process, the triggers for regulatory action, the conduct that regulators focus on, the range of powers and penalties available, the extent of monitoring and enforcement activity, the procedural fairness safeguards and the level of transparency and reporting of the performance of these functions (5,74,76,78,91). Comparative studies (71,76,207,263–265) were primarily in HICs. Three studies addressed challenges with managing complaints and discipline in LMICs (266–268). Government or regulator commissioned reports in HICs explore some of the systemic complexities and tensions in complaints management, including whether the primary purpose of regulation is punitive or remedial, how these processes fit within broader jurisdictional civil and criminal law and malpractice compensation systems, and how to better support complainants and practitioners throughout the process (2,3,49,54,269–271). Comparative studies are rare and mainly descriptive. With a few exceptions, most systems lack transparency, with little evidence of performance reporting or focus on quality improvement.
Second, regulators in some HICs are designing risk management and prevention strategies, informed by studies of prevalence rates for disciplinary action.
The literature suggests substantial research effort in HICs directed at measuring the prevalence rates for disciplinary action in particular cohorts of practitioners and how regulators may use these data to identify and mitigate the risk of harm to the public. A shift to risk-based regulation is evident with disciplinary data analysed to identify the patterns and characteristics of registrants subject to disciplinary action (37,38,272–274). In the US, multiple studies found that physicians who failed to recertify or allowed their certification to lapse were significantly more likely to be subject to disciplinary action later (168–170,172). While several studies examined practitioner stress when subject to disciplinary action (275–277), it is primarily governments and regulators that have commissioned research on the complainant experience (48,278–282).
Third, remediation programs for impaired and poorly performing practitioners and mandatory reporting obligations may be effective public protection mechanisms, albeit with resourcing and implementation challenges.
There is growing interest from regulators and researchers in remediation (returning impaired or poorly performing practitioners to safe and competent practice) and mandatory reporting (legislated obligations on registrants and/or employers to report certain registrant misbehaviour to regulators). Studies have generally reported positive effects of HPR remediation processes, though such programs are resource-intensive (283,284). Studies also examined legislated obligations for mandatory reporting as a mechanism for alerting regulators to practitioners or students with conduct, competence or impairment concerns, finding that these obligations may strengthen public protection if carefully structured and clearly communicated (207,272,273,285–287).
Regulation of traditional and complementary medicine practitioners
There were 56 published articles and 35 grey literature sources relevant to regulating T&CM practitioners. Articles from Australia (n=12), the US (n=10) and international focus (n=7) were prominent (Figure 14). Three themes were identified from the published and grey literature.
INSERT Figure 14: Most frequent countries and health occupations in published literature addressing regulation of T&CM practitioners.
First, statutory registration is being extended to more T&CM occupations in more jurisdictions, in response to evidence of risk.
Statutory registration schemes have been enacted at an accelerating rate for T&CM occupations over the past decade, often to preserve Indigenous medicine traditions in LMICs and in response to pressure from representative bodies in HICs (20,91). Some jurisdictions have applied regulatory impact assessment processes to inform decisions about whether and how to regulate these occupations (55,288–290). These studies suggest the risk profile of some T&CM occupations warrants the level of public protection that statutory registration affords (6,20,260,288,289,291–295).
Second, statutory registration is a favored strategy of many T&CM professional bodies as a strategy to prevent entry of untrained practitioners, foster collaborative practice and promote integration into the mainstream healthcare system.
While the literature points to continuing interest in and use of T&CM in LMICs (91,296–298) and HICs (299–303), studies suggest that T&CM practitioners continue to struggle for institutional recognition of their practice and to engage conventional practitioners in collaborative practice. In LMICs, studies show efforts to better harness indigenous medicine practitioners to deliver primary care and meet public health goals, with statutory registration a vehicle to lift the status of indigenous medicine practitioners and facilitate their integration into mainstream health systems (297,298,304,305). In HICs, occupational closure is sought to lift standards, protect the public and increase institutional recognition. It may also be pursued to address restrictive regulations that limit practice or prevent access to tools of trade (herbal medicines).
Third, studies suggest that statutory registration works equally well for established and widely practised T&CM occupations, with some adjustments.
Statutory registration of T&CM occupations has been implemented in both LMICs and HICs. Where such schemes are in operation, studies suggests that this regulatory model works just as well as for other health occupations (260,288). A similar range of research concerns was found, such as the content of accreditation standards (306,307), implementing evidence-based national examinations (20,308–310), regulatory strengthening (311,312), and regulating scopes of practice (294,301,313–316). Studies note some of the policy challenges and adjustments required when applying statutory registration to the T&CM occupations, such as evaluating risk, protecting traditional knowledge, applying flexible language requirements, or delivering care to underserved populations (288,294,313–315,317–323).
(COutcomes
Impacts of regulation on health workforce and health system outcomes
To assess the evidence on the impact of HPR structures and processes in achieving the health workforce and health system outcomes desired by governments and other stakeholders, we reviewed studies that reported or measured the following health system and workforce outcomes: safety, quality, capacity/access, capability, effectiveness, quantity (of practitioners), and sustainability. We found 310 empirical studies in the published literature and 105 grey literature sources that included a discussion of one or more of these outcomes when broadly defined. Studies were primarily on nurses, midwives and APN roles (n=105), and medical practitioners (n=79), followed by health practitioners in general (n=46). Similar to other topics, the US was prominent (n=75), followed by international studies (n=48), Australia (n=29) and Canada (n=27) (Figure 15). Four themes were identified from the integrated synthesis of the published and grey literature on this topic.
INSERT Figure 15: Most frequent countries and health occupations in published literature addressing impacts of HPR on health workforce and health system outcomes.
First, few jurisdictions have institutionalized arrangements for periodic review and continuous improvement of their HPR systems.
Some literature examined the economic impacts of occupational licensing in general (56,57,324–326) and evaluated the effectiveness of a licensing law or the overall performance of a regulator or regulatory system (288,291,295,327–329). It is difficult to draw conclusions from these studies given the diversity of topics covered, though findings often included calls for stronger regulation, expansion of statutory registration to additional occupational groups, and greater accountability to operate in the public interest. In a small number of Anglophone HICs, extensive grey literature shows regulatory reform efforts over several decades to strengthen governance, transparency and government oversight and expand and codify statutory powers and functions (2,4,49,51,54,330–333). There were reports of unscheduled or one-off regulatory reviews that led to significant legislative and administrative reform, generally in response to a crisis or regulatory failure (2,334–336). The UK, New Zealand, and Ontario (Canada) were identified as having a proactive system of periodic review of the performance of regulators. An active program of continuous improvement was evident in the UK with the operation of its meta-regulator, the Professional Standards Authority, and in New Zealand, a requirement for independent performance reviews of regulatory authorities has been legislated. American bodies such as the National Council of State Boards of Nursing and the Federation of State Medical Boards also featured in the grey literature on regulatory system improvement, as did international organizations including the OECD and the WHO (9,25,104,311,337–343).
Second, further evaluation is needed of alternative models for regulating the health workforce, such as negative licensing and quality assured voluntary registers.
We identified studies in the published literature that addressed the effectiveness of other types of occupational regulation, such as voluntary certification (6,78,293,303,344–346) and negative licensing (6,28,260,261,292,293,347). In a few of these studies, researchers were critical of non-statutory certification or negative licensing schemes, instead advocating for the level of public protection afforded by statutory registration/licensing. The grey literature search found government-commissioned studies that examined the costs and benefits of different approaches to HPR in achieving the government public protection objectives (31,289,290,348–351).
Third, regulatory strengthening initiatives in LMICs aim to build stronger regulatory institutions, infrastructure, networks and governance, with some evidence of success.
The review identified studies that evaluated the impacts of HPR system strengthening initiatives, mostly in LMICs (sub-Saharan African countries of Uganda, Nigeria, Kenya, Eswatini, Malawi and South-East Asian countries of Cambodia and Vietnam). These studies suggest that the Regulatory Function Framework developed through the African Health Profession Regulatory Collaborative program is a valuable tool to assist with designing and implementing HPR strengthening projects and evaluating the effectiveness of system strengthening initiatives in LMICs.
Fourth, studies that compare regulatory regimes across multiple jurisdictions were mostly descriptive, underscoring the need for more robust outcome measures and measurement tools.
Academic and grey literature sources that compared the operation of HPR schemes across multiple jurisdictions or globally were mostly descriptive, comparing key features such as the scope and governance of schemes or specific regulatory functions, sometimes including a historical perspective (5,20,74,91,340). Some studies evaluated specific regulatory interventions, such as NLEs (73), mandated CPD (131), maintenance of certification schemes (171), processes for dealing with misconduct (264), mandatory reporting obligations (285), and the application of administrative sanctions (76). Academic and grey literature provide frameworks for comparative studies of HPR regimes that can be used to strengthen methodologies and standardize outcome measurement (19, 85, 86).
[3] Examples of mutual recognition agreements include ASEAN in South-East Asia, CARICOM, Europe, Tran-Tasman Mutual Recognition Arrangement, Licensure Compacts in the US and the previous North American Free Trade Agreement.
[4] Since 2010, statutory registration schemes have been established or extended in jurisdictions as diverse as Australia, Brazil, Burkina Faso, Cambodia, Canada, Cook Islands, Czech Republic, Fiji, India, Malaysia, Mali, New Zealand, Pakistan, Senegal, Singapore, the Philippines, Samoa, Uganda, the UK and the USA. Note this is not an exhaustive list.
[5] We use NLE here to describe a large-scale examination either provided or commissioned by a health practitioner regulator and used to determine whether an applicant is qualified to practice. We use this term to encompass examinations at the national level and at the sub-national level in federated systems of government.
[6] These practitioners are classified as health associate professionals under the ILO classification. However, the terms assistant and support workforces were often used in the literature.