Action Point 12 – Strategy to support regulatory intelligence during public health emergency

During the meeting of Working Group 4 (WG4) Information Sharing in January 2022, the Member States highlighted the challenges they faced during the COVID-19 pandemics, including identifying relevant information among all available information.

In time of public health emergency, the National Regulatory Authorities (NRA) play a key role in ensuring timely access to quality, safe and effective countermeasures (including medicines, vaccines, medical devices and diagnostics). In such context, they are an important part of a complex international and national ecosystem of organisations, with various scopes and responsibilities, and which all need to closely cooperate to ensure an optimal response. At the international level, the environment is mostly framed by the International Health Regulations (IHR) which is coordinated by the WHO. At the national level, the Ministry of Health usually coordinate the activities of other actors, and usually have their own intelligence for response protocols and activities. Often, an Incident management/command system is set up, in which the NRA is included. Further, most countries also have a Health Research Council which often leads on the generation of evidence (at the international level or for country-specific data). National health authorities/council, professional associations, learned societies, are usually provided with the mandate to develop and approve clinical guidelines. Finally, throughout their work, the NRAs need to actively liaise, request and review information from the manufacturers, marketing authorisation holders and Clinical Research Organisations, among other actors, as per their legal mandate and provisions.

To address this need, the Assembly adopted on 8 June 2022 the SEARN Work Plan 2022-2023 which includes the action point 8, led by Working Group 4 (WG4) Information Sharing: ‘Draft a strategy to support regulatory intelligence in times of public health emergency, including adequate considerations for resources.

The WHO has defined an infodemic as ‘too much information including false or misleading information in digital and physical environments during a disease outbreak’, which may be expanded in the scope of this work to any public health emergency (1).

While countries may have their own definitions of a public health emergency, WHO has defined an emergency as ‘a situation impacting the lives and well-being of a large number of people or a significant percentage of a population and requiring substantial multi-sectoral assistance’(2). Further, the 2005 International Health Regulations (IHR) defines public health emergency of international concern as “an extraordinary event which is determined to constitute a public health risk to other States through the international spread of disease and to potentially require a coordinated international response”, which implies that “a situation that is serious, sudden, unusual or unexpected; carries implications for public health beyond the affected State’s national border; and may require immediate international action” (3).

During public health emergencies, National Regulatory Authorities (NRAs) participate in the detection and response to false and misleading information, for which the WHO developed a strategy and a set of tools which can be accessed on its website: https://www.who.int/health-topics/infodemic#tab=tab_1

However, the NRAs also faced challenges during COVID-19 in identifying the most relevant information among the huge amount of information available, including when only considering true /correct information. This difficulty was further aggravated in a context where NRAs human resources were heavily burdened by multiple and urgent tasks which were required to ensure timely access to quality, safe and effective medical products.

Limited resources are available to support NRAs in identifying relevant information in such time, which is the focus of this strategy.

Types of information	Examples
Regulatory information	Which regulatory authorities (within and beyond the Region) have approved which products for the use in the particular emergency WHO EUL
Regulatory guidelines	FDA Guidelines EMA Guidelines Standards for key medical products (e.g. PPE)
Clinical guidelines	WHO recommendations US CDC
Scientific information	Data, evidence and related information about efficacy/effectiveness of different products
Communication	Public perception about risks and products (including misinformation/rumors) about products
Needs, access, supply, distribution	Information about cost, availability, time & special arrangements required (temperature, etc) for transportation, etc Templates, formats, draft agreements, terms & conditions, etc for import/export of such products
Safety information	E.g. AEFIs, mortality data, substandard and falsified products

Types of information	Sources of information	Challenges
Regulatory information	Reference NRAs (Decisions, public assessment reports, etc.) Other NRAs WHO (EUL, PQ, etc.) EIOS	How to identify reference authorities for each type of products and regulatory function Preparedness, including e.g. how to implement and communicate reliance and EUA processes Being informed in a timely manner Identifying the precise location of the information Interpretation of the information (e.g. recommendation of an advisory group vs. decision)
Regulatory guidelines	Reference NRAs Other NRAs WHO Medical Devices	Timely identification of standards for certain products medical products (e.g. PPE) Identifying sources of standards for medical devices Practical understanding and implementation of identified guidelines
Clinical guidelines	National guidelines WHO (SAGE recommendations, treatment guidelines) Third country guidelines Ministry of Health Professional associations EIOS	Timely identification of the guidelines Key points/summary of international guidelines
Scientific information	Scientific revues Scientific literature EIOS	Keeping up to date Keeping up with the pace/amount of publications
Communication	Media Social Media EIOS	Keeping up to date Keeping up with the pace/amount of information Consider the diversity of situations and languages in the different Member States Accessing field information to pick up issues early Reliable communication platform for the NRA (i.e. permanently accessible by the public despite increased number of connections)
Needs, access, supply, distribution	Ministry of Health WHO Reference NRA Manufacturer Industry association Hospitals	Maintaining a good coordination between the actors Accessing field information to pick up issues early
Safety information	Ministry of Health Hospitals EIOS	Maintaining a good coordination between the actors Sources of field information to pick up issues early Timely reporting into the vigilance system Reliable communication platform for the NRA (i.e. permanently accessible by the public despite increased number of connections)

Public Health Intelligence (PHI) is defined by WHO as “…a core public health function responsible for identifying, collecting, connecting, synthesizing, analyzing, assessing, interpreting and generating a wide range of information for actionable insights and disseminating these for informed and effective decision-making to protect and improve the health of the population. ” The specific objectives of Public Health Surveillance will depend on what information is needed, who needs it and how it will be used (e.g: Monitoring & Evaluation vs. Emergency preparedness and response).

Event-Based Surveillance (EBS) is defined as the organized collection, monitoring, assessment and interpretation of mainly unstructured ad hoc information regarding health events or risks, which may represent an acute risk to human health. The information collected for EBS is diverse in nature and originates from multiple, often not-predetermined sources both official and unofficial, including rumours reported by the media or ad hoc reports from informal networks. The information collection process is mainly active and carried out through a systematic framework specifically established for EBS purposes. ,

It offers key insights during various phases of outbreaks and emergencies, particularly in identifying such events and providing additional information during the response phase. As such, it's imperative to bolster EBS as an essential, integral part of national surveillance infrastructure. Especially in the context of regulatory intelligence following sources will play an important roles :

1) Internet-based EBS: Internet-based sources, both formal and informal, supply vital data for EBS. It is important that every country prioritizes strengthening this source of information. The World Health Organization's initiative, known as Epidemic Intelligence from Open Sources (EIOS), provides a useful platform for EBS, while promoting cooperative efforts through professional communities (see the Box).

2) Healthcare Worker EBS: Observations and reports by vigilant clinicians, lab staff, and other healthcare workers can often provide early warning signs. These could include an unusual cluster of symptoms, unique clinical presentations, or even diseases of unidentified origin. Therefore, it's necessary to establish and bolster a legal framework and procedures, and create an encouraging environment for such reporting.

Box. Epidemic Intelligence from Open Sources (EIOS)

The Epidemic Intelligence from Open Sources (EIOS[1]) initiative is a unique collaboration between various public health stakeholders around the globe. It brings together new and existing initiatives, networks and systems to create a unified all-hazards, One Health approach to early detection, verification, assessment and communication of public health threats using publicly available information. Since January 2022, the lead of the EIOS initiative is hosted within the new WHO Hub for Pandemic and Epidemic Intelligence. The EIOS Initiative has now over 60 Communities all over the world including 40 Member States. In the South-east Asia Region, the EIOS system has been implemented in four member states – Bangladesh, Indonesia, Nepal, and Thailand between 2022 and 2023. The regional office (SEARO) Health Emergency information management and Risk assessment (HIM) also uses the system on a daily bias to detect signals of potential public health importance in the region.

The EIOS system is a fit- for-purpose but constantly evolving web-based system designed to augment and accelerate global public health intelligence (PHI) activities, built on a long-standing collaboration between WHO and the Joint Research Centre (JRC) of the European Commission. It benefits from the experience gained in the Early Alerting and Reporting (EAR) project of the Global Health Security Initiative (GHSI) and the Hazard Detection and Risk Assessment System (HDRAS), as well as collaborations with other global initiatives and projects such as ProMED, the Global Public Health Intelligence Network (GPHIN), HealthMap and the Europe Media Monitor (EMM).

Each day, the system collates hundreds of thousands of articles from a broad range of sources, including traditional online media and specific social media sources, government and official web sites, news aggregators, blogs and expert groups, and collaborating initiatives. It runs these sources through a series of text mining and analytical modules to sort and categorize articles by topics, country, language, source and contextual indices. The system regularly checks for new information, which is downloaded and automatically processed and published through the secure EIOS user interface within a few minutes, accessible only to authorised individuals within the EIOS community. This leads to a continuous flow of new articles in the EIOS system, which registered users can interact with in various ways – both individually, as well as collaboratively with others. Within the system, each collaborating organisation has its own space and can securely share information within and across organisations.

EIOS technology does not replace the experts, but rather supports them, enabling them to rapidly sift through huge volumes of data from a wide variety of sources coming in at high velocity. This helps the identification of events in a fraction of the time it would otherwise take.

[1] https://www.who.int/initiatives/eios

The Epidemic Intelligence from Open Sources (EIOS) initiative is a unique collaboration between various public health stakeholders around the globe. It brings together new and existing initiatives, networks and systems to create a unified all-hazards, One Health approach to early detection, verification, assessment and communication of public health threats using publicly available information. Since January 2022, the lead of the EIOS initiative is hosted within the new WHO Hub for Pandemic and Epidemic Intelligence. The EIOS Initiative has now over 60 Communities all over the world including 40 Member States. In the South-east Asia Region, the EIOS system has been implemented in four member states – Bangladesh, Indonesia, Nepal, and Thailand between 2022 and 2023. The regional office (SEARO) Health Emergency information management and Risk assessment (HIM) also uses the system on a daily bias to detect signals of potential public health importance in the region.

Any SEARN Member or the secretariat can request the Network to consider initiating a SEARN coordinated response to a public health emergency when an event of concern arises. Such requests may also provide an opportunity to share and verify with the Network any information from the Member of SEARN related to an event of concern which may become a public health emergency.

The decision should be taken by the Steering group, in a formation extended to any other interested Member States, or by the Assembly of the Members of SEARN, or automatically when a Public health emergency of international concern is declared by WHO.

If SEARN agrees that an event of concern requires a coordinated response from the Network, a dedicated and temporary working group is created. The dedicated working group discusses the initial regulatory intelligence strategy and changes in this strategy when required, as well as any other matter related to the SEARN response to this public health emergency. The regulatory intelligence strategy should define the scope (e.g. which products to focus on, from which sources of information, including medical devices, and standards). The strategy should also define which documents should be recorded/reference on the internal platform for ease of access.

When SEARN decides that regulatory intelligence for public health emergency is required, the Secretariat will:

Encourage Member States to strengthen their Event-Based Surveillance system and facilitate information sharing between Member States
Disseminate relevant information from WHO headquarters
Work in collaboration with the WHO Health Emergencies Programme (WHE) to identify resources to use the EIOS platform as per the regulatory intelligence strategy defined by the dedicated working group
Support easy access to procedures to facilitate supply/donations/support from national and international stakeholders

Infodemic [Internet]. [cited 2022 Nov 21]. Available from: https://www.who.int/health-topics/infodemic
World Health Organization. Emergency response framework (ERF) [Internet]. 2nd ed. Geneva: World Health Organization; 2017 [cited 2023 Feb 7]. 68 p. Available from: https://apps.who.int/iris/handle/10665/258604
Emergencies: International health regulations and emergency committees [Internet]. [cited 2023 Feb 7]. Available from: https://www.who.int/news-room/questions-and-answers/item/emergencies-international-health-regulations-and-emergency-committees

Action Point 12 - Strategy to support regulatory intelligence during public health emergency

Background

Scope and definitions

Objectives

Information requirement in time of public health emergency

Types of information required during public health emergencies

Relevant sources of information and challenges from the perspective of the NRA

Public Health Intelligence: Event based surveillance

Public Health Intelligence

Early Warning and Response (EWAR)

Box. Epidemic Intelligence from Open Sources (EIOS)

Epidemic Intelligence from Open Sources (EIOS)

Strategy

Preparedness and initiation of a SEARN coordinated response to a public health emergency

Regulatory intelligence efforts during public health emergency

Communication of information

End of the SEARN coordinated response to a public health emergency and lessons learned

Next steps

References