The Health Security (EU Exit) Regulations 2021
| Jurisdiction | UK Non-devolved |
| Citation | SI 2021/877 |
| Year | 2021 |
2021 No. 877
Exiting The European Union
Public Health
The Health Security (EU Exit) Regulations 2021
Made 20th July 2021
Coming into force 1st September 2021
The Secretary of State makes the following Regulations in exercise of the powers conferred by section 8(1) of, and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 20181(“the 2018 Act”) and section 31 of the European Union (Future Relationship) Act 20202(“the 2020 Act”).
In accordance with paragraph 1(1) of Schedule 7 to the 2018 Act and paragraph 6(3) of Schedule 5 to the 2020 Act, a draft of this instrument has been laid before Parliament and approved by a resolution of each House of Parliament.
PART 1
PRELIMINARY
Citation, commencement, extent and application
1.—(1) These Regulations may be cited as the Health Security (EU Exit) Regulations 2021 and come into force on 1st September 2021.
(2) These Regulations extend to the whole of the United Kingdom.
(3) These Regulations apply to the whole of the United Kingdom.
Interpretation
2. In these Regulations—
“the Committee” means the UK Health Protection Committee established under regulation 4(1);
“communicable disease” means any infectious disease caused by a contagious agent which is transmitted from person to person by direct contact with an infected individual or by indirect means such as exposure to a vector, animal, fomite, product or environment, or exchange of fluid which is contaminated with the contagious agent;
“health threat” means a condition, agent or incident which may cause, directly or indirectly, ill health;
“IHR” means the International Health Regulations (2005) of the World Health Organisation adopted by the fifty-eighth World Health Assembly on 23rd May 20053;
“monitoring” means the continuous observation, detection or review of changes in a condition, in a situation, or in activities, including a continuous function that uses systematic collection of data and analysis on specified indicators relating to serious cross-border health threats;
“part of the United Kingdom” means England, Scotland, Wales or Northern Ireland;
“related special health matters” means antimicrobial resistance and healthcare associated infections related to communicable diseases;
“relevant Minister” means—
(a) in England, the Secretary of State;
(b) in Scotland, the Scottish Ministers;
(c) in Wales, the Welsh Ministers;
(d) in Northern Ireland, a Minister within the meaning of the Northern Ireland Act 19984or a Northern Ireland department;
“serious cross-border health threat” has the meaning given in regulation 5;
“TCA” means the Trade and Cooperation Agreement within the meaning in section 37(1) of the European Union (Future Relationship) Act 2020;
“UK authority” means in respect of a part of the United Kingdom—
(a) the UK public health agency for that part; and
(b) the relevant Minister for that part;
“UK focal point” means the national focal point for the United Kingdom designated by the Secretary of State for the purposes of Title 1 of Part 4 of the TCA and notified to the European Union5.
UK public health agency
3.—(1) For the purposes of these Regulations, “UK public health agency” means–—
(a)
(a) in relation to England, Public Health England6;
(b)
(b) in relation to Scotland, Public Health Scotland7;
(c)
(c) in relation to Wales, the Public Health Wales National Health Service Trust8;
(d)
(d) in relation to Northern Ireland, the Regional Agency for Public Health and Social Well-being9,
or such other person or body in relation to a part of the United Kingdom as the relevant Minister for that part designates.
(2) Where a UK public health agency is also the UK focal point, the obligations in regulations 10 and 12 on a UK public health agency to notify and provide information to the UK focal point are satisfied if the notification is made or the information is provided by the persons responsible for the exercise of its functions as a UK public health agency to the persons responsible for the exercise of its functions as the UK focal point.
UK Health Protection Committee
4.—(1) The Secretary of State must establish a committee to be known as the UK Health Protection Committee.
(2) The membership of the Committee is to be as follows—
(a)
(a) one person representing each relevant Minister;
(b)
(b) one person representing each UK public health agency.
(3) The chair of the Committee must be one of the persons representing a relevant Minister, to be elected, from time to time, by the members of the Committee.
Serious cross-border health threats
5.—(1) For the purposes of these Regulations, “serious cross-border health threat” means a life-threatening or otherwise serious health threat specified in paragraph (2) which—
(a)
(a) spreads or entails a significant risk of spreading across the borders of the United Kingdom and at least one member State; or
(b)
(b) may necessitate a coordinated response by the UK authorities in order to ensure a high level of human health protection.
(2) The following are specified for the purposes of paragraph (1)—
(a)
(a) threats of biological origin consisting of—
(i) communicable diseases;
(ii) related special health matters;
(b)
(b) biotoxins or other harmful biological agents not related to communicable diseases;
(c)
(c) threats of chemical origin;
(d)
(d) threats of environmental origin;
(e)
(e) threats of unknown origin;
(f)
(f) events which may constitute public health emergencies of international concern under the IHR provided that they fall under one of the categories of threats set out in sub-paragraphs (a) to (d).
PART 2
EPIDEMIOLOGICAL SURVEILLANCE IN THE UNITED KINGDOM
Epidemiological surveillance and sharing of information
6.—(1) For the purposes of this Part, “epidemiological surveillance” means the systematic collection, recording, analysis, interpretation and dissemination of data and analysis on the communicable diseases and related special health matters listed in the Schedule.
(2) Each UK public health agency must undertake epidemiological surveillance in relation to the part of the United Kingdom for which it is responsible.
(3) Each UK public health agency must collect the following information arising from the epidemiological surveillance—
(a)
(a) comparable and compatible data and information in relation to the epidemiological surveillance of those communicable diseases and related special health matters;
(b)
(b) information concerning the progression of any epidemic situations;
(c)
(c) information concerning unusual epidemic phenomena or new communicable diseases of unknown origin.
(4) The information in paragraph (3)(c) includes any information which comes to the attention of the UK public health agency relating to unusual epidemic phenomena or new communicable diseases of unknown origin originating or occurring outside the United Kingdom.
(5) The information specified in paragraph (3) must be shared with the other UK public health agencies in accordance with the procedures established by the Committee under regulation 7(1)(a).
(6) When sharing information under paragraph (5), the UK public health agency must, where available, use the relevant case definition for each communicable disease and related special health matter specified on a list kept by the Committee for that purpose (“the case definitions list”).
(7) The Secretary of State may, on the advice of the Committee, by regulations—
(a)
(a) add a communicable disease to the list in Part 1 of the Schedule;
(b)
(b) amend the name of a disease on that list; or
(c)
(c) remove a disease from that list.
(8) The Secretary of State may, on the advice of the Committee, by regulations—
(a)
(a) add a related special health matter to the list in Part 2 of the Schedule;
(b)
(b) amend the name of a related special health matter on that list; or
(c)
(c) remove a related special health matter from that list.
(9) In giving advice for the purposes of paragraph (7) or (8), the Committee must have regard to—
(a)
(a) the potential of the communicable disease or related special health matter to cause significant morbidity or mortality, or both, across the United Kingdom, especially where the prevention of that disease or related special health matter requires a United Kingdom-wide approach to coordination;
(b)
(b) the desirability of exchange of information between the UK authorities about the communicable disease or related special health matter in order to provide early warning of the threats to public health;
(c)
(c) whether in the case of a rare and serious communicable disease or related special health matter the pooling of data would allow hypothesis generation from a wider knowledge base;
(d)
(d) whether effective preventive measures relating to the communicable disease or related special health matter are available with a protective health gain; and
(e)
(e) whether United Kingdom-wide comparison would aid evaluation of programmes aimed at preventing the communicable disease or related special health matter in question.
(10) The case definitions list means the list of case definitions for each communicable disease and related special health matter as specified in Annex 2 of the Implementing Decision—
(a)
(a) subject to any variation to any of the case definitions as the Committee may, from time to time, consider appropriate; and
(b)
(b) including any additional case definitions added by the Committee under paragraph (11).
(11) The Committee, in order to ensure the comparability and compatibility of the data collected from across the United Kingdom from epidemiological surveillance, must add to the case definitions list any case definitions adopted by the Committee to apply—
(a)
(a) to Covid-19;
(b)
(b) to...
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