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The Health and Care Act 2022 (Commencement No. 8 and Transitional and Saving Provision) Regulations 2023

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Statutory Instruments

2023 No. 1431 (C. 102)

NATIONAL HEALTH SERVICE, ENGLAND

PUBLIC PROCUREMENT, ENGLAND

HEALTH SERVICES, ENGLAND

The Health and Care Act 2022 (Commencement No. 8 and Transitional and Saving Provision) Regulations 2023

Made

19th December 2023

The Secretary of State makes these Regulations in exercise of the powers conferred by section 186(6), (7), (9) and (11) of the Health and Care Act 2022(1).

Citation and extent

1.—(1) These Regulations may be cited as the Health and Care Act 2022 (Commencement No. 8 and Transitional and Saving Provision) Regulations 2023.

(2) These Regulations extend to England and Wales.

Interpretation

2.  In these Regulations—

the 2006 Act” means the National Health Service Act 2006(2);

the 2022 Act” means the Health and Care Act 2022;

the 2013 Regulations” means the National Health Service (Procurement, Patient Choice and Competition) (No. 2) Regulations 2013(3).

Provisions coming into force on 1st January 2024

3.  The following provisions of the 2022 Act come into force on 1st January 2024—

(a)section 78 (regulations as to patient choice);

(b)section 79 (procurement regulations);

(c)section 80 (procurement and patient choice: consequential amendments etc);

(d)Schedule 11 (patient choice: undertakings by integrated care boards).

Provisions coming into force on 31st January 2024

4.  The following provisions of the 2022 Act come into force on 31st January 2024—

(a)section 46(1) (reconfiguration of services: intervention powers);

(b)section 46(2) in so far as it relates to the provisions brought into force by paragraph (c);

(c)Schedule 6 (intervention powers over the reconfiguration of NHS services) in so far as it inserts the following paragraphs of Schedule 10A (intervention powers in relation to the reconfiguration of NHS services) into the 2006 Act—

(i)paragraphs 1 to 4;

(ii)paragraphs 6 and 7 save for the extent to which they relate to the functions in paragraph 5 of Schedule 10A.

Transitional and saving provision: procurement, patient choice and competition

5.—(1) Notwithstanding the repeal of section 6E(2)(c) of the 2006 Act (regulations as to the exercise of functions by NHS England or integrated care boards)(4) and section 75 of the 2012 Act (requirements as to procurement, patient choice and competition), any provision of the 2012 Regulations made under either of those provisions, and in force immediately before 1st January 2024—

(a)continues in force and has effect as if made under section 6E(1A) or (1B) of the 2006 Act(5), and

(b)may be varied or revoked accordingly.

(2) Subject to paragraphs (3) to (5), the following continue to have effect as they had effect immediately before 1st January 2024 (including as modified by regulation 21 of the 2022 Regulations) for the purposes of any contract award procedure or process for the procurement of a framework agreement which was commenced but had not ended before 1st January 2024—

(a)sections 75, 76 and 77 of, and Schedule 9 to, the 2012 Act (requirements as to procurement, patient choice and competition), so far as they apply in relation to the 2013 Regulations;

(b)the 2013 Regulations.

(3) For the purposes of paragraph (2), the 2013 Regulations have effect as if—

(a)regulations 11 and 12 were omitted;

(b)in regulation 13(1), for “12, or by regulations 39, 42 or 43 of the 2012 Regulations (choice of health service provider)”, there were substituted “10”;

(c)in regulation 15(1)(a), for “12, or by regulations 39, 42 or 43 of the 2012 Regulations”, there were substituted “10”;

(d)in regulation 15A(1)(6), in both places it occurs, for “12, or by regulations 39, 42 or 43 of the 2012 Regulations”, there were substituted “10”.

(4) For the purposes of paragraph (2), where, on or after 1st January 2024, NHS England commences or continues an investigation of an integrated care board under regulation 13(1) of the 2013 Regulations which—

(a)relates to a determination of a kind referred to in regulation 7(2)(a) or (b) of the 2013 Regulations, and

(b)does not fall within regulation 43B of the 2012 Regulations(7),

that investigation may be commenced or continued as though it were an investigation under section 6F(1) of the 2006 Act (enforcement of section 6E regulations relating to patient choice)(8) (and accordingly section 6F of, and Schedule 1ZA to, the 2006 Act apply to that investigation as appropriate).

(5) For the purposes of paragraph (2)—

(a)a contract award procedure has been commenced before 1st January 2024 if, before that date—

(i)a relevant body has published a contract notice in accordance with regulation 4(2) of the 2013 Regulations;

(ii)a relevant body has contacted a provider in order to—

(aa)seek an expression of interest or offer in respect of a proposed contract; or

(bb)respond to an unsolicited expression of interest or offer received from that provider in respect of a proposed contract; or

(iii)in the case of a contract to be based on a framework agreement or other technique or instrument for electronic or aggregated procurement concluded before 1st January 2024, a relevant body has taken any step with a view to making an award of such a contract;

(b)a process for the procurement of a framework agreement has been commenced before 1st January 2024 if, before that date—

(i)a relevant body has published any form of advertisement seeking offers or expressions of interest in a proposed framework agreement; or

(ii)a relevant body has contacted a provider in order to—

(aa)seek an expression of interest or offer in respect of a proposed framework agreement; or

(bb)respond to an unsolicited expression of interest or offer received from that provider in respect of a proposed framework agreement;

(c)a contract award procedure has ended before 1st January 2024 if, before that date—

(i)the contract has been awarded; or

(ii)the relevant body has taken a decision not to award the contract to any provider;

(d)a process for the procurement of a framework agreement has ended before 1st January 2024 if, before that date—

(i)the framework agreement has been concluded; or

(ii)the relevant body has taken a decision not to conclude the framework agreement with any provider.

(6) For the purposes of section 13SC of the 2006 Act (provision of regulatory information or assistance to the CMA)(9), any information held by NHS England in connection with its functions under—

(a)sections 76 and 77 of, and Schedule 9 to, the 2012 Act; or

(b)measures made under those provisions in the 2013 Regulations,

in so far as those provisions are saved by paragraph (2), continues to be treated as “regulatory information”.

(7) In this regulation—

the 2012 Act” means the Health and Social Care Act 2012(10);

the 2012 Regulations” means the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012(11);

the 2022 Regulations” means the Health and Care Act 2022 (Commencement No. 2 and Transitional and Saving Provision) Regulations 2022(12);

framework agreement” has the meaning given in regulation 7(7) of the 2013 Regulations as they had effect immediately before 1st January 2024;

integrated care board” means an integrated care board established under Chapter A3 of Part 2 of the 2006 Act;

NHS England” means the body corporate established under section 1H of the 2006 Act;

provider” has the meaning given in regulation 1(2) of the 2013 Regulations as they had effect immediately before 1st January 2024;

relevant body” means an integrated care board or NHS England.

Signed by authority of the Secretary of State for Health and Social Care

Andrew Stephenson

Minister of State

Department of Health and Social Care

19th December 2023

Explanatory Note

(This note is not part of the Regulations)

These Regulations bring into force specified provisions of the Health and Care Act 2022 (c. 31) (“the 2022 Act”) on 1st January 2024 (regulation 3) and 31st January 2024 (regulation 4). They are the eighth set of commencement regulations to be made under the 2022 Act. These Regulations also make transitional and saving provision in connection with the coming into force of provisions brought into force by these Regulations.

Regulation 3 brings into force sections 78 (regulations as to patient choice), 79 (procurement regulations) and 80 (procurement and patient choice: consequential amendments etc) of, and Schedule 11 (patient choice: undertakings by integrated care boards) to, the 2022 Act. Section 78 of, and Schedule 11 to, the 2022 Act make amendments to the National Health Service Act 2006 (c. 41) (“the 2006 Act”) in relation to patient choice, and section 79 makes amendments to the 2006 Act in relation to the procurement of health care services for the purposes of the health service. Section 80 of the 2022 Act makes amendments which are consequential on sections 78 and 79.

Regulation 4 brings into force section 46(1) (reconfiguration of NHS services: intervention powers) of the 2022 Act, and partially brings into force section 46(2) of, and Schedule 6 (intervention powers over the reconfiguration of NHS services) to, the 2022 Act. These provisions are commenced except in so far as they relate to a power of the Secretary of State to direct NHS commissioning bodies to consider a reconfiguration of NHS services.

Regulation 5 makes transitional and saving provision in connection with the provisions commenced by regulation 3. Regulation 5(1) saves any provision of the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 (S.I. 2012/2996) which was made under section 6E(2)(c) of the 2006 Act or section 75 of the Health and Social Care Act 2012 (c. 7) (repealed by sections 78(2)(c) and 80(2) of the 2022 Act respectively). Such provisions are treated from 1st January 2024 as made under section 6E(1A) or (1B) of the 2006 Act (inserted by section 78(2)(b) of the 2022 Act).

Transitional and saving provision is also made in relation to the procurement of health care services for the purposes of the NHS where a procurement process has started, but has not ended, before 1st January 2024, under the National Health Service (Procurement, Patient Choice and Competition) (No. 2) Regulations 2013 (S.I. 2013/500) (“the 2013 Regulations”) (revoked by section 80(4) of the 2022 Act). The 2013 Regulations are saved with modifications with the result that the requirements in regulations 2 to 10 of the 2013 Regulations continue to apply to such processes, and investigations and enforcement action can continue to be carried out in relation to them under regulations 13 to 17 of the 2013 Regulations.

Regulation 5(4) enables NHS England to carry out investigations in relation to determinations of a kind referred to in regulation 7(2)(a) or (2)(b) of the 2013 Regulations (which relate to patient choice) under the new patient choice enforcement powers in section 6F of the 2006 Act, as inserted by section 78 of the 2022 Act, instead of the investigation powers in the 2013 Regulations.

Regulation 5(6) ensures that information held by NHS England in connection with its investigation and enforcement functions relating to procurement saved by these Regulations continues to be “regulatory information” for the purposes of section 13SC of the 2006 Act (such information was previously “regulatory information” by virtue of regulation 20 of the Health and Care Act 2022 (Commencement No. 2 and Transitional and Saving Provision) Regulations 2022 (S.I. 2022/734)).

A full impact assessment has been prepared in relation to the 2022 Act, and a copy is available at https://www.gov.uk/government/publications/health-and-care-bill-combined-impact-assessments. A hard copy can be obtained by writing to the Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU.

NOTE AS TO EARLIER COMMENCEMENT Regulations

(This note is not part of the Regulations)

The following provisions of the Health and Care Act2022 (c. 31) have been brought into force by commencement Regulations made before the date of these Regulations.

ProvisionDate of CommencementS.I. No.
Section 1(1) (partially)9th May 2022S.I. 2022/515 (C. 20)
Section 1 (so far as not already in force)1st July 2022S.I. 2022/734 (C. 45)
Section 21st July 2022S.I. 2022/734 (C. 45)
Section 31st July 2022S.I. 2022/734 (C. 45)
Section 41st July 2022S.I. 2022/734 (C. 45)
Section 514th June 2023S.I. 2023/648 (C. 35)
Section 61st July 2022S.I. 2022/734 (C. 45)
Section 71st July 2022S.I. 2022/734 (C. 45)
Section 81st July 2022S.I. 2022/734 (C. 45)
Section 91st July 2022S.I. 2022/734 (C. 45)
Section 101st July 2022S.I. 2022/734 (C. 45)
Section 111st July 2022S.I. 2022/734 (C. 45)
Section 121st July 2022S.I. 2022/734 (C. 45)
Section 131st April 2023S.I. 2023/371 (C. 17)
Section 141st July 2022S.I. 2022/734 (C. 45)
Section 151st July 2022S.I. 2022/734 (C. 45)
Section 161st July 2022S.I. 2022/734 (C. 45)
Section 171st July 2022S.I. 2022/734 (C. 45)
Section 181st July 2022S.I. 2022/734 (C. 45)
Section 19(1)9th May 2022S.I. 2022/515 (C. 20)
Section 19(2) (partially)9th May 2022S.I. 2022/515 (C. 20)
Section 19(3)9th May 2022S.I. 2022/515 (C. 20)
Section 19(4) (partially)9th May 2022S.I. 2022/515 (C. 20)
Section 19 (so far as not already in force)1st July 2022S.I. 2022/734 (C. 45)
Section 201st July 2022S.I. 2022/734 (C. 45)
Section 211st July 2022S.I. 2022/734 (C. 45)
Section 22 (partially)1st July 2022S.I. 2022/734 (C. 45)
Section 241st July 2022S.I. 2022/734 (C. 45)
Section 251st July 2022S.I. 2022/734 (C. 45)
Section 261st July 2022S.I. 2022/734 (C. 45)
Section 271st July 2022S.I. 2022/734 (C. 45)
Section 291st July 2022S.I. 2022/734 (C. 45)
Section 311st April 2023S.I. 2023/371 (C. 17)
Section 321st July 2022S.I. 2022/734 (C. 45)
Section 331st July 2022S.I. 2022/734 (C. 45)
Section 341st July 2022S.I. 2022/734 (C. 45)
Section 351st July 2022S.I. 2022/734 (C. 45)
Section 361st July 2022S.I. 2022/734 (C. 45)
Section 371st July 2022S.I. 2022/734 (C. 45)
Section 389th May 2022S.I. 2022/515 (C. 20)
Section 38 (so far as not already in force)1st July 2022S.I. 2022/734 (C. 45)
Section 391st July 2022S.I. 2022/734 (C. 45)
Section 401st July 2022S.I. 2022/734 (C. 45)
Section 411st July 2022S.I. 2022/734 (C. 45)
Section 421st July 2022S.I. 2022/734 (C. 45)
Section 431st July 2022S.I. 2022/734 (C. 45)
Section 441st July 2022S.I. 2022/734 (C. 45)
Section 451st July 2022S.I. 2022/734 (C. 45)
Section 471st July 2022S.I. 2022/734 (C. 45)
Section 481st July 2022S.I. 2022/734 (C. 45)
Section 491st July 2022S.I. 2022/734 (C. 45)
Section 501st July 2022S.I. 2022/734 (C. 45)
Section 511st April 2023S.I. 2023/371 (C. 17)
Section 521st July 2022S.I. 2022/734 (C. 45)
Section 531st July 2022S.I. 2022/734 (C. 45)
Section 541st July 2022S.I. 2022/734 (C. 45)
Section 551st July 2022S.I. 2022/734 (C. 45)
Section 561st July 2022S.I. 2022/734 (C. 45)
Section 571st July 2022S.I. 2022/734 (C. 45)
Section 581st July 2022S.I. 2022/734 (C. 45)
Section 591st July 2022S.I. 2022/734 (C. 45)
Section 601st July 2022S.I. 2022/734 (C. 45)
Section 611st July 2022S.I. 2022/734 (C. 45)
Section 621st July 2022S.I. 2022/734 (C. 45)
Section 631st July 2022S.I. 2022/734 (C. 45)
Section 641st July 2022S.I. 2022/734 (C. 45)
Section 651st July 2022S.I. 2022/734 (C. 45)
Section 661st July 2022S.I. 2022/734 (C. 45)
Section 671st July 2022S.I. 2022/734 (C. 45)
Section 681st July 2022S.I. 2022/734 (C. 45)
Section 691st July 2022S.I. 2022/734 (C. 45)
Section 701st July 2022S.I. 2022/734 (C. 45)
Section 711st July 2022S.I. 2022/734 (C. 45)
Section 721st July 2022S.I. 2022/734 (C. 45)
Section 731st July 2022S.I. 2022/734 (C. 45)
Section 741st July 2022S.I. 2022/734 (C. 45)
Section 751st July 2022S.I. 2022/734 (C. 45)
Section 761st July 2022S.I. 2022/734 (C. 45)
Section 77 (partially)1st July 2022S.I. 2022/734 (C. 45)
Section 77 (so far as not already in force)1st April 2023S.I. 2023/371 (C. 17)
Section 811st July 2022S.I. 2022/734 (C. 45)
Section 821st July 2022S.I. 2022/734 (C. 45)
Section 831st July 2022S.I. 2022/734 (C. 45)
Section 841st July 2022S.I. 2022/734 (C. 45)
Section 851st July 2022S.I. 2022/734 (C. 45)
Section 86 1st July 2022S.I. 2022/734 (C. 45)
Section 87 1st July 2022S.I. 2022/734 (C. 45)
Section 881st July 2022S.I. 2022/734 (C. 45)
Section 891st July 2022S.I. 2022/734 (C. 45)
Section 901st July 2022S.I. 2022/734 (C. 45)
Section 911st July 2022S.I. 2022/734 (C. 45)
Section 921st July 2022S.I. 2022/734 (C. 45)
Section 931st July 2022S.I. 2022/734 (C. 45)
Section 941st July 2022S.I. 2022/734 (C. 45)
Section 971st October 2022S.I. 2022/1003 (C. 77)
Section 99 (partially)31st July 2022S.I. 2022/734 (C. 45)
Section 99 (partially)1st October 2022S.I. 2022/1003 (C. 77)
Section 1001st October 2022S.I. 2022/1003 (C. 77)
Section 1011st July 2022S.I. 2022/734 (C. 45)
Section 1021st July 2022S.I. 2022/734 (C. 45)
Section 1031st July 2022S.I. 2022/734 (C. 45)
Section 1041st July 2022S.I. 2022/734 (C. 45)
Section 1051st July 2022S.I. 2022/734 (C. 45)
Section 1061st July 2022S.I. 2022/734 (C. 45)
Section 1071st July 2022S.I. 2022/734 (C. 45)
Section 1081st July 2022S.I. 2022/734 (C. 45)
Sections 109 to 1351st October 2023S.I. 2023/1035 (C. 63)
Section 1361st July 2022S.I. 2022/734 (C. 45)
Section 1371st July 2022S.I. 2022/734 (C. 45)
Section 1381st July 2022S.I. 2022/734 (C. 45)
Section 1391st July 2022S.I. 2022/734 (C. 45)
Section 1401st July 2022S.I. 2022/734 (C. 45)
Section 1411st July 2022S.I. 2022/734 (C. 45)
Section 1421st July 2022S.I. 2022/734 (C. 45)
Section 1431st July 2022S.I. 2022/734 (C. 45)
Section 1441st July 2022S.I. 2022/734 (C. 45)
Section 1451st July 2022S.I. 2022/734 (C. 45)
Section 1461st July 2022S.I. 2022/734 (C. 45)
Section 1471st July 2022S.I. 2022/734 (C. 45)
Section 1481st July 2022S.I. 2022/734 (C. 45)
Section 1491st July 2022S.I. 2022/734 (C. 45)
Section 1501st July 2022S.I. 2022/734 (C. 45)
Section 1511st July 2022S.I. 2022/734 (C. 45)
Section 1521st July 2022S.I. 2022/734 (C. 45)
Section 1531st July 2022S.I. 2022/734 (C. 45)
Section 1541st July 2022S.I. 2022/734 (C. 45)
Section 1551st July 2022S.I. 2022/734 (C. 45)
Section 1561st July 2022S.I. 2022/734 (C. 45)
Section 1571st July 2022S.I. 2022/734 (C. 45)
Section 1581st July 2022S.I. 2022/734 (C. 45)
Section 1591st July 2022S.I. 2022/734 (C. 45)
Section 1601st July 2022S.I. 2022/734 (C. 45)
Section 161(1)1st July 2022S.I. 2022/734 (C. 45)
Section 16218th August 2023S.I. 2023/821 (C. 45)
Section 1631st April 2023S.I. 2023/371 (C. 17)
Section 1641st April 2023S.I. 2023/371 (C. 17)
Section 1651st April 2023S.I. 2023/371 (C. 17)
Section 1671st July 2022S.I. 2022/734 (C. 45)
Section 1681st July 2022S.I. 2022/734 (C. 45)
Section 169 (partially)1st October 2023S.I. 2023/1035 (C. 63)
Section 1701st July 2022S.I. 2022/734 (C. 45)
Section 1731st July 2022S.I. 2022/734 (C. 45)
Section 1741st July 2022S.I. 2022/734 (C. 45)
Section 1751st November 2022S.I. 2022/1003 (C. 77)
Section 176 (partially)1st November 2022S.I. 2022/1003 (C. 77)
Section 1771st October 2022S.I. 2022/1003 (C. 77)
Section 17830th August 2022S.I. 2022/734 (C. 45)
Section 1801st July 2022S.I. 2022/734 (C. 45)
Section 1811st July 2022 S.I. 2022/734 (C. 45)
Schedule 11st July 2022S.I. 2022/734 (C. 45)
Schedule 2 (partially)9th May 2022S.I. 2022/515 (C. 20)
Schedule 2 (so far as not already in force)1st July 2022S.I. 2022/734 (C. 45)
Schedule 3 (partially)1st July 2022S.I. 2022/734 (C. 45)
Schedule 41st July 2022S.I. 2022/734 (C. 45)
Schedule 51st July 2022S.I. 2022/734 (C. 45)
Schedule 71st July 2022S.I. 2022/734 (C. 45)
Schedule 81st July 2022S.I. 2022/734 (C. 45)
Schedule 91st July 2022S.I. 2022/734 (C. 45)
Schedule 10 (partially)1st July 2022S.I. 2022/734 (C. 45)
Schedule 10 (so far as not already in force)1st April 2023S.I. 2023/371 (C. 17)
Schedule 121st July 2022S.I. 2022/734 (C. 45)
Schedules 13 to 151st October 2023S.I. 2023/1035 (C. 63)
Schedule 16 1st July 2022 S.I. 2022/734 (C. 45)
Schedule 191st July 2022S.I. 2022/734 (C. 45)
(4)

Section 6E was inserted by section 20(1) of the Health and Social Care Act 2012 (c. 7). Section 6E(2)(c) was amended by paragraph 1(1) of Schedule 1 and paragraph 89(3) of Schedule 4 to the Health and Care Act 2022 (“the 2022 Act”), and is repealed by section 78(2)(c) of the 2022 Act, as commenced by these Regulations.

(5)

Subsections (1A) and (1B) of section 6E are inserted by section 78(2)(b) of the Health and Care Act 2022, as commenced by these Regulations.

(6)

Regulation 15A is treated as inserted after regulation 15 by regulation 21(4)(e) ofS.I. 2022/734.

(7)

Regulation 43B is inserted by regulation 2(6) ofS.I. 2023/1105.

(8)

Section 6F is inserted by section 78(3) of the Health and Care Act 2022, as commenced by these Regulations.

(9)

Section 13SC was inserted by section 82(1) of the Health and Care Act 2022. It was modified by regulation 20 ofS.I. 2022/734 for the period beginning with 1st July 2022 and ending when section 78 of the Health and Care Act 2022 came into force.

(10)

2012 c. 7.

(11)

S.I. 2012/2996, amended byS.I. 2013/2891,2014/1611,2019/248,2022/634 and635,2023/1071 and1105. There are other amending instruments but none is relevant.

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