World Health Organization Guidance on Health Practitioner Regulation: An Overview

The role of regulation in the context of the health workforce is often underrepresented in health policy and the planning dialogue compared to other health workforce functions such as education and management. There are various types of regulation, including statutory and non-statutory models, national and subnational jurisdictions, diverse forms of governance, and variations in administering entities. However, health practitioner regulatory functions typically include defining and enforcing education standards and entry to practice; stipulating minimum levels for the competence and conduct of health practitioners; investigating complaints and enforcing discipline; and informing the public about regulated practitioners. Practitioner regulation is essentially designed to promote the quality of the workforce and safeguard users and the wider public in clinical and non-clinical settings. Although less recognized, a second and equally critical role of health practitioner regulatory systems lies in strengthening human resource production and labor market dynamics, including improving supply, controlling costs of their production, optimizing their geographical distribution and mobility both within and outside of national borders, and managing the interface between the public and private sector. In sum, practitioner regulation can improve availability, distribution, performance, and quality of the health workforce to ensure better health system performance. Yet to date, despite recognition by the World Health Organization (WHO)¹  of the importance of effective health practitioner regulation, there has been no consolidated guidance for countries to adopt as they endeavor to design regulatory systems that align to the broader call for universal health coverage.

It is for these reasons that the WHO²  has produced a Guidance document to support the design, implementation, and reform of health practitioner regulatory systems, aided by its Technical Expert Group (TEG). The Guidance is WHO's first such normative document, consolidating global evidence on the subject and providing recommendations to strengthen regulatory systems and practice. The Guidance defines ‘health practitioners’ to include conventional professionals like doctors, dentists, midwives, and nurses and other allopathic and complementary and alternative practitioners, health assistants involved in patient and community care, and the public health workforce. The goal of the Guidance is optimizing practitioner utilization to meet growing population needs and their role in the broader efforts to achieve universal healthcare and increase public trust in health systems. The aim is to support countries in reinforcing regulatory systems to provide clear minimum standards for patient and population safety and inform health workforce planning to better align with health system priorities. This should also include assuring the quality and safety of health practitioners themselves. The Guidance provides guiding questions to help countries identify gaps in their coverage and policy options relating to the design, implementation, and reform of regulation systems in advancing universal healthcare and defining a future research agenda. Practically therefore it should help to enhance regulatory systems for health practitioners to protect the public in line with wider health system objectives. The target audience includes regulators, policymakers and the wider global health community, such as the health service industry, practitioners, and academia.

The methodology for developing the Guidance included a scoping of literature to define the nature and scale of the evidence, followed by a systematic review of 410 peer-reviewed articles, and 426 grey literature. The review was conducted by a team of experienced global researchers selected through a competitive process.³  The team assessed the documents concerned to understand the structure, processes, and outcomes of health practitioner regulation across countries globally, allowing a detailed appreciation of the influencing role of different contexts and perspectives. The literature shed light on the diversity of regulatory systems, reforms, challenges, and practice gaps, highlighting their impact on healthcare access, cost, quality, migration and mobility, as well as workforce production and health service delivery more broadly. This evidential process took place in tandem with the expertise of the TEG, comprised of carefully selected members from various WHO regions, whose experience was extensively drawn upon. Members of the TEG team listed who advised on the assessment process and policy considerations have directly co-authored this Commentary. The team also contributed to the identification, prioritization, and categorization of topics to be addressed, the interpretation of the resulting evidence, and the validation of research methods and findings. It also was instrumental in providing input on topics where there was little or no evidence to formulate policy considerations.

While the commissioned review³  provided rich insights, the reviewers noted that evidence and information on health practitioner regulation globally was limited in several respects. First, available evidence was largely descriptive and asymmetrical, coming mainly from high income countries (HICs)— predominantly Australia, Canada, New Zealand, the United Kingdom, and the United States. To highlight the asymmetry, just over half of the total number of articles included in the systematic review came from these five forementioned countries. There were also only two published comparative studies that evaluated how legislative, governance, and administrative arrangements, and functions and operations of regulatory systems affected patient safety. Further, the literature was disproportionately focused on regulatory systems for medicine, nursing, and midwifery, with minimal focus on other cadres across HICs and low-to-middle income countries (LMICs). While these inadequacies were partially counterbalanced by the experience of the TEG members, further research is required to better understand the operation and effectiveness of health practitioner regulation models globally.

Despite the limitations, the review and the TEG input provided useful insights into the global situation and the challenges involved, including disparities in regulatory systems and functions across jurisdictions. Regulatory systems were often challenged by the tensions between serving patient safety while ensuring access to health practitioners and preserving professional interests; the need to balance potentially dangerous under-regulation and counterproductive and costly over-regulation of practitioners; the gap between regulatory policies, practices, and outcomes; and asymmetry in the hierarchy of health professions. Some regulatory systems were also used to advance health system priorities. In establishing dynamic, effective and agile regulation, the Guidance²  posits that a process of assessing regulatory gaps and identifying the most appropriate interventions is required for optimal outcomes. This will involve understanding the local context and existing systems; identifying key challenges; determining the desired outcomes; assessing the risk of harm from practitioners; deliberating on risk reduction options and their impact; developing and testing regulatory interventions; managing capacity requirements; and monitoring and evaluating regulatory interventions and outcomes.

The regulatory landscape will need to be reviewed regularly to ensure a fit-for-purpose workforce that meets health system goals whilst promoting progressive reforms and innovation within and across countries. The Guidance observes that, for all its devastating consequences, the COVID-19 pandemic provided a highly significant recent example of necessary regulatory reform. This resulted in the positive introduction of flexibilities for enhancing the availability of, and access to, the health workforce. The flexibilities introduced included changes in teaching methods and graduation requirements; use of personnel under training in the workforce; streamlining practice entry and re-entry processes; ensuring the validity of practitioner licences across subnational and national borders for easier mobility; enabling more flexible scopes of practice; expanding advanced practice roles and providing greater variability in roles and task performance; minimizing regulatory barriers to telehealth; fast-tracking the recognition of foreign qualifications; and minimizing regulatory requirements for international health practitioners. These flexibilities provided the basis for desired longer-term changes such as educational innovations, expanding scopes of practice, and the extension of telehealth practices.

The review found that LMICs face steeper regulatory challenges, including inadequacies in the design and/or implementation of regulation; uneven enforcement capacity and inadequate frameworks for regulation; corruption and lack of transparency and accountability; discrepancies between official functions of regulatory bodies and the roles they actually perform; low political will to support regulation; the ‘capture’ of regulatory organizations by self-interested parties; and information asymmetries and unequal power relationships between health practitioners and community members. The Guidance identifies three areas of concern in LMICs to include variation in standards; the use of informal practitioners without proper qualifications; and the dangers posed by short-term international health volunteer practitioners. These concerns are amplified by the regulatory practice gap. The Guidance concludes by outlining the main policy considerations and principles that countries should consider when designing, reforming and implementing health practitioner regulatory interventions. These cover the design of the regulatory system, institutional structure and governance; core functions of regulatory bodies; and the role of regulation in supporting broader health system priorities.

The Guidance²  notes that it is not possible to generate a universally applicable document, emphasizing the importance of designing systems that are responsive to individual health system priorities. That said, countries can benefit from the core principles and policy options mentioned, including the need to align regulatory systems with the broader health workforce and health system agendas like equity and the attainment of other United Nations Sustainable Development Goals; addressing the dichotomy between regulation and other health workforce functions; adopting systems thinking to ensure symmetrical coverage of the workforce by effective regulatory measures; and ensuring that there is adequate capacity for implementation. As such, the Guidance stimulates thinking on topics like the influence of regulation on healthcare outcomes; gender issues arising from the regulation of the workforce; and the regulatory practice gap which may be related to factors like inappropriate design, weak governance, and the limited capacity of regulators. The Guidance represents a call to action and should spur policy-makers and other stakeholders to consider context-specific issues and their underlying drivers, and the most suitable ways of addressing them using research, including analysis of the available evidence in regulatory processes.

Overall, the Guidance provides a useful lens for identifying and addressing critical dimensions of health workforce development and improving alignment to broader universal healthcare and health system goals. In today's policy space, this involves enhancing efficiency; making regulatory intervention proportional to both the risks presented by the practitioner and the benefits to the public from regulation; ensuring cost effectiveness; responding to the public's expectations; increasing the choice of practitioners within the health service; and addressing the complex and emerging needs of health systems. We strongly encourage policy-makers, regulators, health professionals and their employers, and members of civil society to use the Guidance to assess and, where necessary, improve their practitioner regulatory systems using a risk-based approach.

The Guidance also has potential to help researchers and policy analysts to better understand the link between health practitioner regulation, health system outcomes, and population impact across different settings. Future research should give greater emphasis to standardizing terminology on health sector regulation; understanding health practitioner regulation and the practice gaps in different contexts, especially in LMICs; identifying outputs, outcomes and impacts of health practitioner regulation; adopting a gender and intersectional lens; clarifying the most cost-effective regulatory measures to secure the public welfare; and evaluating evidence on regulatory flexibilities and adaptions. As we move forward, this will help to further inform the development of still more granular and context-specific recommendations on global health practitioner regulation to the benefit of society.

Sincere thanks are due to Dr. Andre Verani who was part of the Technical Expert Group on Health Practitioner Regulation.