The Health Protection (Notification) (Amendment) Regulations 2025
The Health Protection (Notification) (Amendment) Regulations 2025, effective April 6th, 2025, amend the 2010 regulations to enhance disease surveillance in England and Wales.
Key changes include adding respiratory syncytial virus (RSV) to the notification requirements for diagnostic laboratories and expanding the lists of notifiable diseases and causative agents in Schedules 1 and 2, respectively, to include conditions such as acute flaccid paralysis, chickenpox, and various pathogens.
Arguments For
Improved Public Health Surveillance: Expanding the list of notifiable diseases and causative agents enhances the UK's capacity to monitor and respond to emerging health threats. This allows for quicker identification and containment of outbreaks.
Enhanced Disease Control: Early detection of diseases like RSV, through mandatory notification, enables prompt public health interventions, such as targeted vaccination campaigns or improved infection control measures, potentially reducing morbidity and mortality.
Evidence-Based Policy: The amendments are likely based on scientific evidence regarding the public health significance of the newly added diseases and causative agents, informing proactive disease management.
Legal Compliance: The regulations adhere to existing legislation under the Public Health (Control of Disease) Act 1984, providing a legal framework for mandatory notification and improved public health response.
International Collaboration: Aligning UK surveillance with international standards on disease notification can facilitate better data sharing and collaborative efforts in global health security.
Arguments Against
Increased Reporting Burden: Requiring notification of additional diseases and causative agents may impose a greater administrative burden on diagnostic laboratories and healthcare professionals, potentially requiring additional resources and training.
Potential for Overwhelm: An increase in reported cases might overwhelm the existing public health infrastructure, potentially impacting the efficiency of response to more serious threats.
Data Management Challenges: Managing and analyzing a larger volume of data related to notifiable diseases requires robust data management systems and skilled personnel.
Resource Allocation Tradeoffs: Prioritizing resources for surveillance and monitoring of newly added diseases may require resource reallocation from other public health programs.
Unintended Consequences: The impact of these regulations on individual liberties (although minimized per section 45Q(3)) might require ongoing monitoring to detect and address any unintended consequences.
The Secretary of State makes these Regulations in exercise of the powers conferred by sections 45C(1), (2) and (3)(a), 45F(2)(a) and (b), and 45P(2) of the Public Health (Control of Disease) Act 1984[1].
In accordance with section 45Q(3) of that Act, the Secretary of State is of the opinion that these Regulations do not contain any provision made by virtue of section 45C(3)(c) of the Act which imposes or enables the imposition of a special restriction or requirement or any other restriction or requirement which has or would have a significant effect on a person’s rights.
These regulations are enacted under the authority of the Public Health (Control of Disease) Act 1984.
The Secretary of State believes the regulations do not significantly impact individual rights.
- Citation, commencement, extent and application (1) These Regulations may be cited as the Health Protection (Notification) (Amendment) Regulations 2025. (2) These Regulations come into force on 6th April 2025. (3) These Regulations extend to England and Wales and apply in relation to England only.
The regulations are officially titled 'Health Protection (Notification) (Amendment) Regulations 2025,' taking effect April 6th, 2025, and applicable to England.
They also extend to Wales but only apply in relation to England.
- Amendment to the Health Protection (Notification) Regulations 2010 The Health Protection (Notification) Regulations 2010[2] are amended in accordance with regulations 3 to 5.
This section indicates that Regulations 3, 4, and 5 will amend the Health Protection (Notification) Regulations 2010.
- Amendment of regulation 4 In regulation 4 (duty on the operators of diagnostic laboratories to notify the United Kingdom Health Security Agency of causative agents found in human samples and of SARS-CoV-2 or influenza virus tests processed)— (a) in the heading, after “SARS-CoV-2” insert “", respiratory syncytial virus”; (b) in paragraph (1A)(b), after “of” insert ““respiratory syncytial virus or”; (c) in paragraph (2)(ba), after “SARS-CoV-2” insert “", respiratory syncytial virus”.
Regulation 4 is amended to include respiratory syncytial virus (RSV) in the list of viruses that diagnostic laboratories must report to the UK Health Security Agency.
The amendments appear in the heading and paragraphs (1A)(b) and (2)(ba) of regulation 4.
- Amendment of Schedule 1 In Schedule 1 (Notifiable Diseases), at the appropriate alphabetical place insert— • Acute flaccid paralysis or acute flaccid myelitis (AFP or AFM) • Chickenpox (varicella) • Congenital syphilis • Creutzfeldt-Jakob disease (CJD) • Disseminated gonococcal infection (DGI) • Influenza of zoonotic origin • Middle East respiratory syndrome coronavirus (MERS) • Neonatal herpes
Schedule 1, listing notifiable diseases, is updated to include acute flaccid paralysis, chickenpox, congenital syphilis, Creutzfeldt-Jakob disease, disseminated gonococcal infection, zoonotic influenza, MERS coronavirus, and neonatal herpes.
- Amendment of Schedule 2 In Schedule 2 (Causative Agents), at the appropriate alphabetical place insert— • Candidozyma auris • Echinococcus spp • Middle East respiratory syndrome coronavirus (MERS-CoV) • Non-human influenza A subtypes • Norovirus • Respiratory syncytial virus (RSV) • Tick-borne encephalitis virus (TBEV) • Toxoplasma (congenital toxoplasmosis) • Trichinella spp • Yersinia spp
Schedule 2, which lists causative agents of notifiable diseases, is expanded to include Candidozyma auris, Echinococcus spp, MERS-CoV, non-human influenza A subtypes, norovirus, RSV, tick-borne encephalitis virus, toxoplasma (congenital toxoplasmosis), Trichinella spp, and Yersinia spp.
Signed by the authority of the Secretary of State for Health and Social Care Ashley Dalton Parliamentary Under-Secretary of State Department of Health and Social Care 5th March 2025
The regulations are signed by Ashley Dalton, Parliamentary Under-Secretary of State at the Department of Health and Social Care, on March 5th, 2025.
Explanatory Note (This note is not part of the Regulations) These Regulations amend the Health Protection (Notification) Regulations 2010 (“the Principal Regulations”). Regulation 3 amends regulation 4 of the Principal Regulations to require diagnostic laboratories to notify the United Kingdom Health Security Agency of the results of the respiratory syncytial virus (RSV) tests which they process, including where the test result is indeterminate, negative or void. Regulation 4 adds acute flaccid paralysis or acute flaccid myelitis (AFP or AFM), chickenpox (varicella), congenital syphilis, Creutzfeldt-Jakob disease (CJD), disseminated gonococcal infection (DGI), influenza of zoonotic origin, Middle East respiratory syndrome coronavirus (MERS) and neonatal herpes to the list of notifiable diseases in Schedule 1 to the Principal Regulations. Regulation 5 adds candidozyma auris, echinococcus spp, Middle East respiratory syndrome coronavirus (MERS-CoV), non-human influenza A subtypes, norovirus, respiratory syncytial virus (RSV), tick-borne encephalitis virus (TBEV), toxoplasma (congenital toxoplasmosis), trichinella spp and yersinia spp to the list of causative agents in Schedule 2 to the Principal Regulations. A full impact assessment of the effect that this instrument will have on the costs of business, the voluntary sector and the public sector is available from the Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU, which is available alongside this instrument on the legislation.gov.uk website.
This explanatory note summarizes the changes made by the regulations.
It clarifies that Regulation 3 adds RSV to the notification requirements for laboratories, Regulation 4 adds several diseases to Schedule 1, and Regulation 5 adds several causative agents to Schedule 2.
A full impact assessment is available from the Department of Health and Social Care.