Guidance

UK Focal Point communications protocol on serious cross-border threats to health

Updated 3 October 2024

Scope

1. This protocol concerns communications between the UK public health agencies^{[footnote 1]} and the UK’s Focal Point for the UK-European Union (EU) Trade and Cooperation Agreement (the TCA) on serious cross-border threats to health. It brings the UK’s public health agencies into permanent communication with one another in order to facilitate the prevention and control of serious cross-border threats to health.

2. It also supports communication for the purposes of informing the EU and sharing information about such threats affecting the UK and at least one EU member state, as required under the TCA. Where the UK has been granted ad-hoc access to the EU’s Early Warning and Response System (EWRS) in respect of a serious cross-border threat to health, this protocol also sets out the communications needed between the 4 UK public health agencies and the UK’s designated focal point (the UK Focal Point).

3. This protocol does not deal with communications with the media, or the public more generally, or with case or event management.

4. It also does not deal with communications with the British Overseas Territories or the Crown Dependencies.

Introduction

5. The Health Security (EU Exit) Regulations 2021 (‘the Health Security Regulations’) establish a legislative regime that ensures the 4 UK nations continue to coordinate in their approach to the surveillance, prevention and control of serious cross-border threats to health, and that the UK can meet its health security obligations under the TCA.

6. For the purposes of the Health Security Regulations, a serious cross-border threat to health is defined as:

• a life-threatening or otherwise serious hazard to health of biological, chemical, environmental or unknown origin which:

  • (a) spreads or entails a significant risk of spreading across the borders of at least one member state and the UK; or
  • (b) may necessitate a coordinated response by the UK authorities in order to ensure a high level of human health protection

7. This definition applies to all serious cross-border threats to health that may need a coordinated approach between UK authorities, regardless of whether the threat spreads, or entails a significant risk of spreading outside the UK or to an EU member state.

8. Under the Health Security Regulations, in order to support the early notification of and response to serious cross-border threats to health occurring within the UK, the UK’s public health agencies are required to notify the UK Focal Point (a function carried out by the UK Health Security Agency (UKHSA)), without delay and in any event no later than 24 hours from the time when they first became aware of the threat.

The UK-EU Trade and Cooperation Agreement

9. The TCA is an international treaty between the UK and the EU that took effect after the end of the transition period on 31 December 2020. Title 1 of Part 4 of the TCA concerns cooperation on health security.

10. In the EU, a serious cross-border threat to health refers to a threat that spreads or entails a significant risk of spreading across the national borders of member states and that may necessitate coordination at EU level in order to ensure a high level of human health protection. While a member state of the EU and until the end of the transition period, the UK applied this EU definition, sharing information on threats occurring within the UK with the EU via the focal point function (carried out by UKHSA).

11. For the purposes of the TCA, a serious cross-border threat to health is defined by reference specifically to the position between the UK and the EU as:

“A life-threatening or otherwise serious hazard to health of biological, chemical, environmental or unknown origin which spreads or entails a significant risk of spreading across the borders of at least one member state and the United Kingdom.”

12. Under the terms of the TCA, there is a mutual obligation on the UK and the EU to inform each other of such threats and to endeavour to do so in a timely manner.

13. In addition, where there is a serious cross-border threat to health that spreads or entails a significant risk of spreading across the borders of at least one member state and the UK, and following a written request from the UK, the EU may grant the UK ad hoc access to the EWRS in respect of the particular threat. The EU may also invite the UK to participate in a committee of the member states for the purposes of supporting the exchange of information and of coordination in relation to the threat.

14. A full version of the TCA.

Inter-relationship with the International Health Regulations (2005)

15. The requirements of the TCA are additional to those arising under the International Health Regulations (2005) (IHR). There is already an established UK National Focal Point communications protocol which deals with communications in relation to the IHR with the World Health Organization (WHO) and WHO member states.

16. The IHR define a list of diseases that must always be reported to WHO.

These are:

• smallpox
• poliomyelitis due to wild-type poliovirus
• human influenza caused by a new subtype
• severe acute respiratory syndrome (SARS)

17. In addition to the list of diseases that are always notifiable under the IHR, the state party has an obligation to assess other events occurring within the state territory and to notify WHO if they are potential Public Health Emergencies of International Concern (PHEIC)^{[footnote 2]}.

18. The TCA sets out the reporting, information and coordination requirements now in place between the UK and the EU relating to “serious cross-border threats to health” as defined in the TCA. This includes threats that meet the IHR reporting requirements detailed above, as well as those where there could be spread across the borders of the UK and one or more EU member state but WHO notification is not required.

19. This protocol builds upon the existing IHR protocol and sets out how information on serious cross-border threats to health needs to be shared between the UK’s public health agencies with the UK Focal Point, and where necessary with the EU under the TCA.

20. Where there is an event that needs to be notified under the IHR and the TCA, this protocol applies in relation to communications with the EU, and the IHR protocol applies in relation to communications with WHO, the British Overseas Territories and the Crown Dependencies.

National Focal Point functions

21. Under the existing arrangements for the IHR, UKHSA is designated to act as the National IHR Focal Point for the UK. While the UK was a member state, UKHSA, formerly Public Health England (PHE), was also the focal point for the UK’s communications with the EU. Paragraph 4 of Article HS.1 of the TCA requires the UK to designate a national focal point for the purposes of information exchange on serious cross-border threats to health and any subsequent UK request for access to the EWRS.

22. UKHSA is designated to act as the UK’s focal point for the purposes of the TCA (England, Scotland, Wales, Northern Ireland)^{[footnote 3]}.

23. The UK Focal Point is the sole route for communications with the EU in relation to a serious cross-border threat to health.

24. The activities of the UK Focal Point will be undertaken by a number of medical and scientific staff within the National Infections Service (NIS) at UKHSA, coordinated by the Travel Health section.

25. Paragraph 4(a) Article HS.1 puts an obligation on the TCA focal points to endeavour to facilitate understanding between the UK and the EU as to whether a threat is a serious cross-border threat to health. The UK Focal Point will carry out this function for the UK working, as required, in conjunction with the other UK public health agencies.

26. Where the UK is invited to participate in a committee of the member states for the purposes of supporting information exchange and of coordination in relation to a particular threat, the Department of Health and Social Care (DHSC) will send a designated representative on behalf of the UK, working in collaboration with the devolved governments.

Communicating with the National Focal Point

27. The UK NFP is accessible 24/7 via the following;

Email: ihrnfp@ukhsa.gov.uk Telephone: + 44 (0)208 327 6260

28. Any serious cross-border threat to health that occurs in England, Scotland, Wales or Northern Ireland, needs to be notified to the UK Focal Point without delay and in any event no later than 24 hours from the time when the public health agency concerned first became aware of the threat.

29. When notifying a serious cross-border threat to health to the UK Focal Point, and for the duration of that threat, public health agencies will need to provide all information available regarding a potential serious cross-border threat to health. There is a reporting template in Annexe A ^{[footnote 4]}.

30. Where a public health agency becomes aware of an incident that may also constitute a PHEIC under IHR, the International Health Regulations 2005: UK National Focal Point communications protocol applies. The section of the Annexe A reporting template on notifications under article 6 IHR must be completed.

31. All urgent matters will need to be directed to the UK Focal Point through the telephone contact. Where communication is by telephone, organisations will also be asked to provide the above information by email.

Sending information to the EU for the purposes of the TCA

32. There are 3 broad categories of situation when the UK Focal Point may need to provide information to the EU:

Initiated by the UK

Where a UK public health agency has identified what it considers to be a serious cross-border threat to health and notified it to the UK Focal Point, the threat will be discussed with that agency. A risk assessment on the potential severity of the threat and possible public health measures may be completed by the UK Focal Point, in collaboration with the public health agency concerned, based on the information available at the time. Any risk assessment must, for the purpose of coordinating a response from across the UK, be made promptly available to the other UK public health agencies.

Following consultation with the UK DHSC, where the UK Focal Point is satisfied that there is a serious cross-border threat to health which spreads or entails a significant risk of spreading across the borders of the UK and at least one member state, it must inform the EU of that threat in a timely manner.

The UK Focal Point will simultaneously inform the other UK public health agencies that the EU is being notified.

Where a decision is made to inform the EU of a serious cross-border threat to health affecting the UK, it may also be necessary for the UK Focal Point to share relevant information to facilitate a shared understanding between the UK and EU of whether there is a serious cross-border threat to health.

Initiated by the EU

Where a serious cross-border threat to health is affecting one or more EU member states, and spreads or entails a significant risk of spreading to the UK, the EU is required to inform the UK. In such cases, the UK Focal Point will follow their internal protocol for assessing and disseminating event information that comes from international sources.

The event information is classified according to relevance, the importance of the event and whether any action is required to be taken. Items are then disseminated to the public health agencies, to the UK government and the devolved governments as necessary.

Where the UK Focal Point requests any relevant information regarding a threat, this will need to be shared with the UK Focal Point in a timely manner. The UK Focal Point will then exchange information with the EU’s Focal Point to facilitate a shared understanding of whether or not there is a serious cross-border threat to health. The UK Focal Point will simultaneously share this information with the other public health agencies, where relevant and required.

Sharing information on EWRS

Where there is a serious cross-border threat to health which spreads or entails a significant risk of spreading across the borders of at least one member state and the UK, and following a written request from the UK, the EU may grant the UK ad hoc access to EWRS for the particular threat.

The final decision on whether or not to make a written request for access to EWRS for a particular threat will be taken by the Secretary of State, following advice from the Chief Medical Adviser to the UK Government or a nominated deputy, working, as required, in association with the Chief Medical Officer to the devolved government concerned.

Where the UK is granted ad-hoc access, the UK would be required to communicate through EWRS any available information in the UK’s possession that may be useful for coordinating the response. All UK public health agencies will need to continue to share any relevant information with the UK Focal Point for the duration of the UK’s EWRS access for the relevant threat. The UK Focal Point will simultaneously share EWRS information with the other public health agencies, where relevant and required.

Public statements about notification to the EU

33. The UK Focal Point will maintain electronic records of all incidents that are reported to it by the EU, and of all reports it makes to the EU.

34. Media handling of incidents occurring within the UK is a matter for the public health agencies concerned, subject to any coordination of responses. However, it is expected that public statements about notification of incidents to the EU would only be made by the UK government’s Chief Medical Adviser.

Annexe A

Template for alert notification

Event title:

Alert notification criteria (select applicable criteria):

• It is unusual or unexpected for the given place and time; or
• It causes or may cause significant morbidity or mortality in humans; or
• It grows rapidly or may grow rapidly in scale; or
• It exceeds or may exceed national response capacity

And

• There is a significant risk of it spreading across the border of the UK and at least one member state; or
• It may necessitate a coordinated response by the UK and EU authorities in order to ensure a high level of human health protection

Event details:

Category	for example biological origin: communicable diseases
Agent	for example tick-borne encephalitis virus
Agent details	(if required)
Disease	for example tick-borne viral encephalitis
Means of transmission (if known)
Date of onset of the event/threat
Date of detection of the event/threat
Location of event/threat
Countries of occurrence
Affected countries

Further relevant information

If available, please also include:

• toxicology data
• detection and confirmation methods
• risk assessment
• information on public health measures planned or undertaken
• any measures other than public health measures planned or undertaken
• risk communication measures
• additional relevant information

Non-communicable disease threats

In the case of a threat that is not a communicable disease, please include in particular details of:

• any change in geographical distribution
• spread and severity of the threat
• and of the means of detection, if available

Article 6 IHR. Notification according to the decision instrument presented in Annexe 2: An event of potential international public health concern

(complete if IHR notification required)

• Is the public health impact of the event serious?
• Is the event unusual or unexpected?
• Is there any significant risk of international spread?
• Is there any significant risk of international travel or trade restrictions?

Organisation access

Select who should have access to the notification:

• WHO
• EU Focal Point (ECDC / European Commission)
• specific countries – if so please list below

1. The lead UK public health agencies are, in relation to England, the UK Health Security Agency; in relation to Scotland, Public Health Scotland; in relation to Wales, Public Health Wales National Health Service Trust; and in relation to Northern Ireland, the Public Health Agency, Northern Ireland. In the event of organisational change, the relevant ministerial authority for that part of the UK may designate the person or body that has this role. ↩

2. The definition of PHEIC in article 1 of the IHR focuses on the extraordinary nature of the event, the risk of international spread of the disease and the potential need for a coordinated international response. There is no intermediate level of alert below a PHEIC under the IHR. ↩

3. This function will be undertaken as part of the IHR focal point operational infrastructure and transferred to the new UKHSA in 2021 ↩

4. Where it is necessary to share personal data for the purposes of contact tracing, this should follow the existing guidance on international communications for contact tracing as distributed by UKHSA ↩