Government response to the Health Protection (Notification) Regulations 2010: proposed amendments
Updated 12 December 2024
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This publication is available at https://www.gov.uk/government/consultations/health-protection-notification-regulations-2010-proposed-amendments/outcome/government-response-to-the-health-protection-notification-regulations-2010-proposed-amendments
Background
The Department of Health and Social Care (DHSC) ran a 4-month consultation between 12 July and 15 November 2023. That consultation sought views on updating the Health Protection (Notification) Regulations 2010 (HPNR).
Ensuring that schedule 1 and schedule 2 of the HPNR reflect current public health needs is critical to maintaining strong surveillance systems enabling prompt investigation, risk assessment and response to cases of infectious disease that pose a significant risk to human health.
A review by DHSC and the UK Health Security Agency (UKHSA) proposed that 7 infectious diseases could be added to schedule 1, and 12 causative agents could be added to schedule 2 of the HPNR.
The consultation sought stakeholder views on the below proposals:
Proposal 1
This proposal was the addition of these 7 infectious diseases to schedule 1 - notifiable diseases:
- Middle East respiratory syndrome (MERS)
- influenza of zoonotic origin
- chickenpox (varicella)
- congenital syphilis
- neonatal herpes
- acute flaccid paralysis or acute flaccid myelitis (AFP or AFM)
- disseminated gonococcal infection (DGI)
Proposal 2
This proposal was the addition of these 12 causative agents to schedule 2 - causative agents:
- Middle East respiratory syndrome coronavirus (MERS-CoV)
- non-human influenza A subtypes
- norovirus
- Echinococcus spp
- tick-borne encephalitis virus (TBEV)
- toxoplasma (congenital toxoplasmosis)
- Trichinella spp
- Yersinia spp
- respiratory syncytial virus (RSV)
- Neisseria gonorrhoeae (from a sterile site)
- Treponema pallidum (syphilis)
- Neisseria gonorrhoeae (non-sterile site)
Proposal 3
The consultation proposed the amending of laboratory reporting requirements so that all diagnostic laboratories in England testing human samples would have to report negative and void test results for all causative agents under schedule 2, as well as positive results which they are currently required to do.
Responses to the consultation
This consultation received 151 responses from a range of stakeholders with expertise and experience from across the health sector. Overall, the majority of respondents (87%) agreed that the HPNR should be updated at this time. Responses largely cited improved surveillance and public health protection as reasons for this.
Proposal 1
Responses included:
- the majority of respondents (66%) agreed that at least one of the proposed diseases should be added to schedule 1:
- MERS (66%)
- influenza of zoonotic origin (63%)
- congenital syphilis (62%)
- neonatal herpes (62%)
- AFP or AFM (59%)
- disseminated gonococcal infection (55%)
Proposal 2
Responses included:
- the majority (68%) of respondents agreed with the proposal to add at least one of the 12 causative agents listed to schedule 2:
- TBEV (67%)
- MERS (64%)
- congenital toxoplasmosis (57%)
- non-human influenza A subtypes (56%)
- Neisseria gonorrhoeae (from a sterile site) (55%)
- Yersinia spp (54%)
- RSV (53%)
- Echinococcosis spp (52%)
- respondents raised concerns over the proposed addition of syphilis and gonorrhoea to schedule 2
Proposal 3
Responses included:
- 39% of respondents strongly agreed or agreed with the third proposal of amending schedule 2 to require diagnostic laboratories to report void and negative test results
- 33% of respondents neither agreed nor disagreed with the proposal
- 28% of respondents disagreed or strongly disagreed with the proposal
A detailed summary of the responses to the consultation questions was published on 7 February 2024 (under ‘Feedback received’).
Government response
DHSC and UKHSA are grateful for stakeholders’ engagement on this topic.
Amendments to schedule 1 and 2 of the HPNR
Following close analysis of the consultation responses and further engagement, the government will proceed with the following amendments to the HPNR. These amendments were largely supported in the consultation and will improve the surveillance of, and public health response to, these infectious diseases.
Adding 8 infectious diseases to schedule 1 of the HPNR, making them notifiable:
- Middle East respiratory syndrome (MERS)
- influenza of zoonotic origin
- chickenpox (varicella)
- congenital syphilis
- neonatal herpes
- acute flaccid paralysis or acute flaccid myelitis (AFP or AFM)
- disseminated gonococcal infection (DGI)
- Creutzfeldt-Jakob disease (CJD)
Adding 10 causative agents to schedule 2 of the HPNR:
- Middle East respiratory syndrome coronavirus (MERS-CoV)
- non-human influenza A subtypes
- norovirus
- echinococcus spp
- tick-borne encephalitis virus (TBEV)
- toxoplasma (congenital toxoplasmosis)
- Trichinella spp
- Yersinia spp
- respiratory syncytial virus (RSV)
- Candida auris
Schedule 1
The responses to proposals are shown in the table below.
| Response | Number of responses (out of 151) |
Percentage |
|---|---|---|
| Middle East respiratory syndromes (MERS) | 100 | 66% |
| Influenza of zoonotic origin | 95 | 63% |
| Congenital syphilis | 94 | 62% |
| Neonatal herpes | 93 | 62% |
| Acute flaccid paralysis or acute flaccid myelitis (AFP or AFM) | 89 | 59% |
| Disseminated gonococcal infection (DGI) | 83 | 55% |
| Chickenpox | 71 | 47% |
| None of the above | 26 | 17% |
The majority of respondents agreed that the following diseases should be added to schedule 1, making them notifiable:
- MERS (66%)
- influenza of zoonotic origin (63%)
- congenital syphilis (62%)
- neonatal herpes (62%)
- AFP or AFM (59%)
- disseminated gonococcal infection (55%)
In explaining their answers, respondents broadly agreed adding diseases to schedule 1 would improve current reporting. The addition of these diseases will improve surveillance to inform public health action.
Some concern was raised around the impact that adding congenital syphilis and disseminated gonococcal infection to schedule 1 could have on perceptions around the confidentiality of services. Some respondents also raised concerns that adding these 2 diseases to the HPNR could impact on perceived stigma related to these diseases.
These concerns have been closely considered by UKHSA. However, the public health benefits which will be brought about through adding these diseases to schedule 1 and establishing a surveillance system, outweigh these risks. UKHSA and DHSC will take steps to mitigate possible concerns from patients.
Varicella (chickenpox)
Under half (47%) of respondents thought varicella (chickenpox) should be added to schedule 1. Respondents raised concerns around the additional workload this could place on individuals and teams responsible for reporting notifiable diseases.
In response to concerns, UKHSA conducted further impact assessment on the impact of adding varicella to the HPNR on primary care workload. UKHSA estimate the overall burden for individual GP practices of this change would be low.
This is partly because, in November 2023, the Joint Committee on Vaccination and Immunisation (JCVI) recommended a universal varicella (chickenpox) vaccination programme should be introduced as part of the routine childhood schedule. It is anticipated that cases of varicella will substantially decline with the introduction of a childhood immunisation programme. However, this will be dependent on vaccine uptake.
Additionally, UKHSA has now rolled out a web-based platform for diseases notification. Pilots of the new digital process have shown the time taken to report a notifiable disease to be much lower, which should also work to reduce the potential burden of additional disease notification requirement.
Schedule 2
The responses to proposals are shown in the table below.
| Response | Number of responses (out of 151) |
Percentage |
|---|---|---|
| Middle East respiratory syndromes coronavirus (MERS-CoV) | 97 | 64% |
| Norovirus | 71 | 47% |
| Echinococcosis spp | 78 | 52% |
| Tick-borne encephalitis virus (TBEV) | 101 | 67% |
| Congenital toxoplasmosis | 86 | 57% |
| Non-human influenza A subtypes | 85 | 56% |
| Trichinellosis spp | 76 | 50% |
| Yersinia spp | 81 | 54% |
| Respiratory syncytial virus (RSV) | 80 | 53% |
| Neisseria gonorrhoeae (from a sterile site) | 83 | 55% |
| Treponema pallidum | 73 | 48% |
| Neisseria gonorrhoeae (non-sterile site) | 75 | 50% |
| None of the above | 28 | 19% |
The majority of respondents agreed that the following should be added to schedule 2:
- TBEV (67%)
- MERS (64%)
- congenital toxoplasmosis (57%)
- non-human influenza A subtypes (56%)
- Neisseria gonorrhoeae (from a sterile site) (55%)
- Yersinia spp (54%)
- RSV (53%)
- Echinococcosis spp (52%)
The addition of these causative agents to schedule 2 would support current surveillance systems.
Norovirus
Some respondents raised concerns that adding norovirus to schedule 1 would vastly increase the workload of registered medical practitioners, who are legally required to report suspected notifiable diseases. However, the proposals in the consultation did not include adding norovirus to schedule 1 of the HPNR.
Laboratory testing requirements
The consultation proposed the amending of laboratory reporting requirements so that all diagnostic laboratories in England testing human samples would have to report negative and void test results for all causative agents under schedule 2, as well as positive results which they are currently required to do.
Respondents were mixed in their views over the impact additions to schedule 2 would have on the workload of diagnostic laboratories.
Some respondents raised concerns about the cost and operability of expanding laboratory reporting requirements to include negative and void results, and questioned the public health benefit of this requirement for all causative agents under schedule 2.
Upon further consultation with UKHSA experts and laboratories, the government does not recommend taking forward this proposal at this time. Instead, UKHSA will be pursuing negative and void reporting as part of a wider piece of work to strengthen laboratory pathogen data.
However, negative and void reporting requirements for RSV samples is recommended. This is because complete surveillance of RSV is needed to enable monitoring of the RSV vaccination programme. Requiring negative and void data for RSV would bring surveillance in line with other respiratory viruses, such as COVID-19 and influenza.
To mitigate concerns raised within consultation responses, UKHSA officials have committed to working with diagnostic laboratories and companies who provide laboratory information management systems (LIMS) to support the implementation of the electronic notification of negative results.
Additional amendments to the HPNR
While not consulted on, UKHSA recommends adding variant Creutzfeldt-Jakob disease (CJD) to schedule 1, as part of planning for future CJD surveillance.
UKHSA additionally recommend that Candida auris is added to schedule 2 to establish mandatory surveillance for the emerging multi-drug resistant fungal pathogen.
Consultation proposals not being taken forward
Sexually transmitted infections (STIs)
The consultation sought stakeholder views on the proposal to add Neisseria gonorrhoeae (non-sterile site), Neisseria gonorrhoeae (sterile-site) and Treponema pallidum (syphilis) to schedule 2 of the HPNR.
Many respondents shared concerns that as the public holds an expectation of privacy around sexual health services, the addition of these diseases to the HPNR may dissuade some users from accessing services. Some respondents raised that it could result in stigma around these diseases.
Considering these concerns, and that surveillance of these diseases is already established through the Genitourinary Medicine Clinic Activity Dataset (GUMCAD) STI surveillance system, these diseases will not be added to schedule 2 of the HPNR at this time.
The consultation sought stakeholder views on any other diseases that could be added to the HPNR. Some respondents proposed adding cytomegalovirus (CMV) and group B strep. As part of the consultation analysis process, the option to add these diseases to the HPNR was closely considered. Following an assessment of the current public health context and existing surveillance, DHSC will not be taking forward the addition of CMV and group B strep at this time.
Next steps
We will proceed to amend the relevant legislation: Health Protection (Notification) Regulations 2010 (HPNR).
The amended legislation will be laid before Parliament in due course and the proposed amendments will be subject to Parliamentary scrutiny and approval.
If approved, the changes will come into force on 6 April 2025. DHSC and UKHSA will update key stakeholders on the outcome of the consultation and update guidance for registered medical practitioners and laboratories around the reporting of notifiable diseases and causative agents to UKHSA.