Summary of responses to the Health Protection (Notification) Regulations 2010: proposed amendments consultation
Updated 7 February 2024
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This publication is available at https://www.gov.uk/government/consultations/health-protection-notification-regulations-2010-proposed-amendments/public-feedback/summary-of-responses-to-the-health-protection-notification-regulations-2010-proposed-amendments-consultation
Foreword
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 recent review (2022) 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 views on these proposals to amend the HPNR.
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
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.
This consultation received 151 responses which included a range of stakeholders with expertise and experience from across the health sector.
This report is a summary of the consultation responses and the main themes identified from written feedback.
Next steps
DHSC and UKHSA are considering the responses and are grateful for stakeholders’ engagement on this complex topic. Confirmation of any changes to the regulations will be published in due course.
Summary of responses
Who we heard from:
- 151 responses were received to the online consultation survey
- 33 respondents responded on behalf of an organisation
- 74 respondents said they were responding as an individual sharing their professional views
- 44 respondents said they were responding as an individual sharing their personal views and experiences (such as a patient or carer or member of the public)
- when answering the survey questions, respondents used survey free text boxes to make comments 609 times
- during the consultation process, a webinar on the proposals was held with over 200 stakeholders
- overall, the consultation page received 1,107 page visits
What we heard:
- 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 1 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 1 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 breakdown of responses to each question is shared below.
Detailed responses and analysis of survey questions
Question
To what extent do you agree or disagree that schedule 1 and schedule 2 of the Health Protection (Notification) Regulations (HPNR) should be updated at this time?
Responses
The breakdown of responses to this question are listed in the table below.
| Response | Number of responses | Percentage |
|---|---|---|
| Strongly agree | 68 | 45 |
| Agree | 63 | 42 |
| Neither agree nor disagree | 11 | 7 |
| Disagree | 6 | 4 |
| Strongly disagree | 3 | 2 |
| Total | 151 | 100 |
Note: percentage figures have been rounded and therefore may not total 100%.
Analysis
Most respondents (87%) either strongly agreed or agreed that the HPNR should be updated at this time.
In explaining their answer, respondents most frequently cited outdated regulations, improving surveillance, and improving public health protection as the reasons for this.
Several respondents noted that vector-borne diseases should also be considered for inclusion in schedule 1, as well as schedule 2, to mitigate current underreporting.
Several responses noted the existing burden on clinical services and laboratory reporting systems, which making additions to schedule 1 and schedule 2 could add to.
Question
To what extent do you agree or disagree with the proposal to add at least 1 of the 7 diseases listed to schedule 1?
Responses
The breakdown of responses to this question are listed in the table below.
| Response | Number of responses | Percentage |
|---|---|---|
| Strongly agree | 42 | 28 |
| Agree | 57 | 38 |
| Neither agree nor disagree | 40 | 26 |
| Disagree | 8 | 5 |
| Strongly disagree | 4 | 3 |
| Total | 151 | 100 |
Note: percentage figures have been rounded and therefore may not total 100%.
Analysis
The majority of respondents (66%) agreed that at least 1 of the proposed diseases should be added to schedule 1 and be made notifiable.
However, some concern was raised around the impact 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.
Some respondents noted the potential benefits of adding tick-borne diseases to schedule 1, which are not included in the current proposals.
In response to this question, some respondents raised concern 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.
Question
Please select the diseases that you think should be added to schedule 1, from the list of 7 diseases.
Responses
The breakdown of responses to this question are listed in the table below.
| Response | Number of responses | 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 | 83 | 55 |
| Chickenpox | 71 | 47 |
| None of the above | 26 | 17 |
| Total | 651 | not applicable |
Note: percentage figures have been rounded and therefore may not total 100%.
Analysis
The majority of respondents agreed that the following 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%)
In explaining their answers, respondents broadly agreed adding diseases to schedule 1 would improve current reporting.
However, under half (47%) of respondents thought 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. Further work has been conducted to explore this through the consultation impact assessment.
Question
To what extent do you agree or disagree that the proposed additions to schedule 1 will not significantly increase workload of registered medical practitioners?
Responses
The breakdown of responses to this question are listed in the table below.
| Response | Number of responses | Percentage |
|---|---|---|
| Strongly agree | 10 | 7 |
| Agree | 27 | 18 |
| Neither agree nor disagree | 67 | 44 |
| Disagree | 29 | 19 |
| Strongly disagree | 17 | 11 |
| Total | 150 | 99 |
Note: percentage figures have been rounded and therefore may not total 100%.
Analysis
25% of respondents strongly agreed or agreed that the proposed additions to schedule 1 will not significantly increase workload of registered medical practitioners.
44% of respondents said they neither agreed nor disagreed that the proposed additions to schedule 1 will not significantly increase workload of registered medical practitioners. Some respondents noted they chose this option as they weren’t sure of the answer.
30% of respondents disagreed or strongly disagreed that the proposed additions to schedule 1 will not significantly increase workload of registered medical practitioners.
Question
To what extent do you agree or disagree with the proposal to add at least 1 of the 12 causative agents listed to schedule 2.
Responses
The breakdown of responses to this question are listed in the table below.
| Response | Number of responses | Percentage |
|---|---|---|
| Strongly agree | 35 | 23 |
| Agree | 68 | 45 |
| Neither agree nor disagree | 37 | 25 |
| Disagree | 8 | 5 |
| Strongly disagree | 3 | 2 |
| Total | 151 | 100 |
Note: percentage figures have been rounded and therefore may not total 100%.
Analysis of responses
The majority (68%) of respondents agreed with the proposal to add at least 1 of the 12 causative agents listed to schedule 2.
Question
Please select the causative agents that you think should be added to schedule 2 (from the list of 12 causative agents).
Responses
The breakdown of responses to this question are listed in the table below.
| Response | Number of responses | 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 |
| Total | 1014 | not applicable |
Note: percentage figures have been rounded and therefore may not total 100%.
Analysis
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%)
50% of respondents agreed trichinellosis spp and Neisseria gonorrhoea (from a non-sterile site) should be added to schedule 2.
Under half of respondents agreed Treponema pallidum (48%) and norovirus (47%) should be added to schedule 2.
In explaining responses, some respondents raised concern over the impact adding sexually transmitted infections to the HPNR would have on individuals accessing sexual health services. It was raised that this may deter patients from coming forward for testing and treatment.
Question
To what extent do you agree or disagree that including syphilis and gonorrhoea in schedule 2 would be beneficial for patients and effective public health interventions?
Responses
The breakdown of responses to this question are listed in the table below.
| Response | Number of responses | Percentage |
|---|---|---|
| Strongly agree | 22 | 15 |
| Agree | 48 | 32 |
| Neither agree nor disagree | 53 | 35 |
| Disagree | 9 | 6 |
| Strongly disagree | 19 | 13 |
| Total | 151 | 100 |
Note: percentage figures have been rounded and therefore may not total 100%.
Analysis
Under half (47%) of respondents strongly agreed or agreed that adding these diseases to schedule 2 would be beneficial for patients and effective public health interventions.
35% of respondents neither agreed nor disagreed that adding these diseases to schedule 2 would be beneficial for patients and effective public health interventions.
19% of respondents disagreed or strongly disagreed that that adding these diseases to schedule 2 would be beneficial for patients and effective public health interventions.
While some respondents agreed this proposal could improve reporting of these diseases, there was concern that the risks could outweigh the benefits.
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.
Question
To what extent do you agree or disagree that the proposed additions to schedule 2 will not significantly increase workload of diagnostic laboratories?
Responses
The breakdown of responses to this question are listed in the table below.
| Response | Number of responses | Percentage |
|---|---|---|
| Strongly agree | 10 | 7 |
| Agree | 29 | 19 |
| Neither agree nor disagree | 66 | 44 |
| Disagree | 29 | 19 |
| Strongly disagree | 17 | 11 |
| Total | 151 | 100 |
Note: percentage figures have been rounded and therefore may not total 100%.
Analysis
Respondents were mixed in their views over the impact additions to schedule 2 would have on the workload of diagnostic laboratories.
Respondents agreed that engagement with Laboratory Information Management System (LIMS) stakeholders would be required to implement the proposal successfully, including consideration of service level agreements.
Some responses warned that the additional costs of this proposal may fall to laboratories, and this needed to be considered. Respondents shared that the more common diseases, notably norovirus, would have a more significant impact on increasing workload.
However, some responses agreed that increases in workload may be necessary to protect public health.
Question
To what extent do you agree or disagree with the proposal to amend schedule 2 to require diagnostic laboratories to report void and negative test results?
Responses
The breakdown of responses to this question are listed in the table below.
| Response | Number of responses | Percentage |
|---|---|---|
| Strongly agree | 27 | 18 |
| Agree | 32 | 21 |
| Neither agree nor disagree | 50 | 33 |
| Disagree | 23 | 15 |
| Strongly disagree | 19 | 13 |
| Total | 151 | 100 |
Note: percentage figures have been rounded and therefore may not total 100%.
Analysis
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.
Some respondents agreed this proposal would result in improved granularity in surveillance data. However, this is balanced against the risk of increased workload for laboratories.
Others noted that while the reporting of negative and void tests for SARS-CoV-2 worked well during the pandemic, this requirement may not be practical for all diseases listed on schedule 2.
Respondents varied in their views as to how current LIMS systems would be able to cope with this change. It is not possible to draw a single conclusion from responses.
Question
What difference do you think the requirement for diagnostic laboratories to report void and negative test results in addition to positive results (as is already required) will have on workload?
Responses
The breakdown of responses to this question are listed in the table below.
| Response | Number of responses | Percentage |
|---|---|---|
| Small increase in workload | 30 | 20 |
| No increase in workload | 6 | 4 |
| Not sure | 59 | 59 |
| Significant increase in workload | 56 | 37 |
| Total | 151 | 100 |
Note: percentage figures have been rounded and therefore may not total 100%.
Analysis
37% of respondents thought the requirement for diagnostic laboratories to report void and negative test results in addition to positive results would result in a significant increase in workload.
20% of respondents thought this requirement would result in a small increase in workload.
4% of respondents thought this would result in no increase in workload.
39% respondents were not sure.
Question
Are there any other diseases or causative agents that should be considered for addition to schedule 1 or 2?
Some respondents suggested congenital cytomegalovirus could be added to the HPNR.
Lyme disease was also suggested as a potential addition, alongside group B streptococcal infection.