Health practitioner regulation: Design, reform and implementation guidance

The World Health Organization (WHO) published the first global guidance on health practitioner regulation. Health practitioner regulation: Design, reform and implementation guidance reviews the available evidence and offers policy considerations for designing regulatory systems that protect the public and support national health system goals. It provides practical steps to assess and minimize the gap between regulatory policy and practice that may arise in different contexts. It also offers insights into future strategic directions for research to better link regulation to evidence on health outcomes.

Beyond its established role in ensuring patient safety and ethical practice, the evidence also highlights how health practitioner regulation can generate added value within health systems, including health professions education, equitable distribution, workforce planning and the financial costs associated with health services.

“WHO’s latest guidance comes at a time when the landscape of health and care services is expanding alongside rising public expectations from health workers and regulators. I’m particularly struck by the compelling evidence of the added value regulation and regulators can bring to health systems and health workforce development. Implementing this evidence at scale will generate immediate benefits and I wish to acknowledge the excellent work of the health experts, scientists, regulators and WHO staff who have contributed to this global public good,” said Jim Campbell, Director, Health Workforce.

A robust health workforce is fundamental to deliver the full range of essential health services and the essential public health functions. Achieving the health-related Sustainable Development Goals requires not only the quantitative global growth in health worker employment that has been achieved in recent years, but also addressing persistent challenges like matching demand with supply, creating the right skill mix and strengthening quality and equitable distribution.

The guidance builds on the WHO Global Strategy on Human Resources for Health 2016.

Objective, scope and target audience

This guidance aims to inform the design, reform and implementation of health practitioner regulation and to strengthen regulatory systems and institutions. The term “health practitioner” is used to encompass all health professionals, associate health professionals, including community health workers, personal care workers in health services (allopathy as well as traditional, complementary and integrative medicine), health assistants, the public health workforce, and other health practitioners who are yet to be officially classified, but who are directly involved in patient diagnostics or care.

The target audience includes regulators, policymakers and the wider global health community, including the health service industry, practitioners and academic institutions. The contents of the document were informed by an integrative review of the literature and by advice from a WHO Technical Expert Group on health practitioner regulation.

Key findings

Health practitioner regulatory systems are very diverse, reflecting differences in national health and education systems, legal traditions, political history, economy, governance structure and other sociocultural aspects. There is also substantial variation in the health professions being regulated and in the type of regulation; moreover, few countries have a defined and objective criterion for regulation. Some regulators use risk-based tools to decide on the most appropriate regulatory mechanism.

Advancing the public interest in terms of patient safety is a commonly stated purpose of health practitioner regulation. Historically, such regulation was considered synonymous with elevating the professions being regulated by defining and protecting them. However, excessive inflexibility and unnecessary barriers to entry to the health labour market raise concerns that the interests of the professions are being prioritized over public welfare through regulatory capture.

Furthermore, fragmented and rigid regulatory systems operating in occupational silos can be disconnected from the broader health objectives and from associated reforms in health service delivery. The understanding of public interest has evolved over time from elevating the professions to prioritizing patient safety, enhancing cost-effectiveness and aligning with health system needs. Other common principles underlying regulation are its uniformity, transparency and proportionality to risks and benefits.

Regulatory reforms have taken place across countries to address different priorities, such as the quality and cost of educating health practitioners, their mobility and sustainability, and the transparency and accountability of regulators. For instance, temporary flexibilities in health practitioner regulation were introduced in many countries during the coronavirus disease (COVID-19) pandemic to increase practitioner availability. This provided a strategic opportunity to review the alignment of regulatory systems with broader priorities, such as universal health coverage and health security.

Regulatory practice gap

Increasing numbers of health occupations are being regulated by law, but large gaps exist between regulatory policies, practices and outcomes. A “regulatory practice gap” may occur when the existing regulatory policy is not implemented in practice, or when it does not meet the intended purpose despite being implemented. While these gaps are also common in countries with mature regulatory systems, they are more prominent in low- and middle-income countries. The factors that contribute to the regulatory practice gap include: inappropriate regulatory models; logical assumptions being given precedence over evidence; regulators having limited capacity to carry out their functions, in part because of the size of the workforce to be regulated; and weak governance.

Key considerations

Health practitioner regulation should strike the right balance between addressing the risk of harm to patients and ensuring public access to health services. Under-regulation can place patients at risk of harm from health practitioners, while over-regulation can place the public at risk of harm by reducing or removing access to health services.

It is therefore essential that regulators define patient harm in the specific context, review existing mechanisms for patient safety in terms of the intended goals and identify the reasons behind any divergence. They should also understand the extent to which health practitioner regulation can address the identified gap, their capacity to implement the regulatory measures, and the (direct and indirect) costs and negative consequences that regulation may impose on the health labour market and the health system. The regulatory practice gap can then be reduced by introducing appropriate measures.

Additional and/or more stringent regulatory measures are resource-intensive and may prove challenging to implement. Therefore, depending on the context, alternative interventions could be more effective. A universally applicable, ideal model of a health practitioner regulatory system does not exist. This is because regulation needs to be responsive to individual health system priorities and specificities, which vary between countries. Each country differs in its health system architecture and health service delivery profile, including its system of occupational regulation and the composition and division of labour in its health workforce. A country’s understanding of patient harm may also be influenced by cultural norms. Therefore, health practitioner regulatory systems and their appropriateness should be evaluated periodically to identify any need for reform. Such reforms may range from incremental changes to an overhaul of the entire regulatory system.

Dynamic, effective and agile health practitioner regulation is required to respond to complex health system needs and to keep pace with public expectations. To encourage countries to contextualize health practitioner regulation by focusing on the outcomes, this guidance suggests a progressive process of assessing regulatory gaps and identifying
the most appropriate interventions:

• understanding the local context and existing systems
• identifying the main challenges
• determining the desired outcomes
• assessing the risk of harm from practitioners
• deliberating on risk reduction options and the associated impact
• developing and testing regulatory interventions
• managing capacity requirements
• monitoring and evaluation of the regulatory interventions and outcomes.

This guidance presents common principles, key policy considerations and core elements for the design, reform and implementation of health practitioner regulation. The policy considerations on regulation design, reform and implementation are grouped into four categories:

• Design principles
• Governance
• Core functions
• Health system support

Core functions

• Setting requirements for entry to practice
• Accrediting education programmes and licensing practitioners
• Qualification recognition
• Enabling competence-based scope of practice
• Maintaining competence
• Dealing with noncompliance

Health system support

• Data to inform planning
• International mobility and cross-border service delivery
• Practitioner distribution in rural and underserved areas
• Dual practice management

Design principles

• Serves the public interest
• Proportionality
• Flexibility in emergencies

Governance

• Umbrella law and institutional structure
• Adequate state oversight

The generalizability and applicability of these policy considerations may vary substantially across settings. This should be considered before being adapted as deemed relevant to the local context.

• TDR’s Implementation Science Leadership Fellowship Programme for Public Health Impact (University of Ghana)
• TDR’s Implementation Science Leadership Fellowship Programme for Public Health Impact (Universitas Gadjah Mada)
• National Guidance for Coordination Among Humanitarian Health Partners
• Jeddah Commitments on Antimicrobial Resistance (AMR)
• ShanghaiRanking 2024: Global Ranking of Academic Subjects (Public Health)