International Health Regulations and Health Impact Assessment of Laws

Quick Answer: The International Health Regulations 2005 (IHR 2005) are a legally binding agreement among 196 state parties requiring notification of events that may constitute a public health emergency of international concern and maintenance of core surveillance and response capacities. Health Impact Assessment (HIA) is a systematic process for evaluating the potential health effects of proposed laws, policies, and regulations—often non-health sector decisions—before implementation, using screening, scoping, assessment, recommendations, reporting, and monitoring steps.

International Health Regulations (IHR 2005)

The IHR (2005), adopted by the World Health Assembly and effective June 15, 2007, replaced the earlier 1969 regulations. They are legally binding on 196 state parties, comprising all WHO member states. Their purpose is to prevent, protect against, control, and provide a public health response to the international spread of disease in ways commensurate with and restricted to public health risks, while avoiding unnecessary interference with international traffic and trade. Key structural elements include:

• National IHR Focal Points: Each state party must designate a focal point accessible at all times for WHO communication.
• WHO IHR Contact Point: WHO maintains a continuous communication channel for receiving notifications and coordinating responses.
• Event Information Site: Secure platform for notification, verification, and information exchange.
• State Party Annual Reporting: Self-assessment of core capacities and annual reporting to WHO.

The declaration of a Public Health Emergency of International Concern (PHEIC) by the WHO Director-General follows a process defined in Articles 12 and 48. The Director-General convenes an Emergency Committee of international experts to review information from the affected state party, assess whether the event constitutes a public health emergency of international concern, and issue temporary recommendations. These recommendations are non-binding but carry significant political and practical weight, guiding state parties on health measures such as travel advisories, border screening, and trade restrictions. The Director-General may extend, modify, or terminate the PHEIC as circumstances evolve. PHEICs have been declared for H1N1 influenza (2009), poliovirus (2014, extended), Ebola West Africa (2014), Zika (2016), Ebola DRC (2019, withdrawn), COVID-19 (2020, terminated May 2023), and mpox (2022, 2024).

Core Capacity Requirements and Notification Obligations

Annex 1 of IHR 2005 obliges state parties to develop, strengthen, and maintain core capacities for surveillance and response at national, intermediate, and local levels:

Notification obligations under Article 6 require states to notify WHO within 24 hours of assessing any event that may constitute a PHEIC, using the decision instrument in Annex 2. Annex 2 evaluates events across four criteria: (1) Is the public health impact serious? (2) Is the event unusual or unexpected? (3) Is there significant risk of international spread? (4) Is there significant risk of international travel or trade restrictions? Events meeting at least two of the four criteria must be notified. Even if the criteria are not met, events involving four specific diseases must always be notified: smallpox, poliomyelitis due to wild-type poliovirus, human influenza caused by a new subtype, and severe acute respiratory syndrome (SARS).

Health Impact Assessment of Laws and Policies

Health Impact Assessment (HIA) is a systematic, structured process that evaluates the potential positive and negative health effects of proposed policies, programs, or projects—particularly those outside the health sector—before implementation. It is grounded in the understanding that the majority of health determinants lie outside the clinical care system, in housing, transportation, education, employment, and the built environment.

The six standard steps of HIA are:

• Screening: Determine whether HIA is feasible and adds value for a given decision, considering available time, resources, and stakeholder interest.
• Scoping: Define research questions, populations affected, health outcomes to be analyzed, and the methods that will be used in the assessment phase.
• Assessment: Analyze baseline health conditions and predict impacts, often using quantitative modeling, qualitative evidence, and community input to estimate magnitude and direction of effects.
• Recommendations: Translate findings into specific, actionable, and prioritized recommendations for modifying the proposal to maximize health benefits and minimize harms.
• Reporting: Communicate findings to decision-makers, stakeholders, and the public in accessible formats.
• Monitoring and Evaluation: Track implementation, assess whether predicted impacts materialize, and evaluate the HIA process itself for continuous improvement.

HIA is one tool within the broader field of legal epidemiology—the scientific study of law as a factor in the distribution of health outcomes in populations. Legal epidemiology methods include policy surveillance (systematic coding and tracking of laws across jurisdictions over time), legal mapping, and evaluation of causal effects of laws on health outcomes through longitudinal studies, cross-jurisdictional comparisons, and dose-response analyses. Examples include studies of graduated driver licensing laws and crash mortality, indoor clean air laws and cardiovascular hospitalization, motorcycle helmet laws and traumatic brain injury, and prescription drug monitoring programs and opioid overdose mortality.

Practical Application of IHR and HIA

A public health practitioner may engage with IHR through reporting unusual clusters detected through surveillance to the national focal point, which coordinates with WHO. HIA engagement arises when evaluating the health implications of a proposed highway expansion, housing development, or zoning change. Both frameworks require cross-sector collaboration: IHR coordination involves animal health (One Health), food safety, and border authorities, while HIA engages transportation, housing, and economic development agencies. Both depend on timely information sharing, transparent communication of uncertainty, and a commitment to using evidence to protect population health while respecting equity.