The National Health Service (Cross-Border Healthcare and Miscellaneous Amendments etc.) (EU Exit) Regulations 2019

Year2019

2019 No. 777

Exiting The European Union

National Health Service, England And Wales

Constitutional Law

Devolution, Wales

Local Government, England

Social Security

The National Health Service (Cross-Border Healthcare and Miscellaneous Amendments etc.) (EU Exit) Regulations 2019

Made 2nd April 2019

Coming into force in accordance with regulation 1

The Secretary of State makes these 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.

In accordance with paragraph 1(1) of Schedule 7 to that Act, a draft of this instrument has been laid before Parliament and approved by a resolution of each House of Parliament.

1 Preliminary

PART 1

Preliminary

S-1 Citation, commencement, interpretation and extent

Citation, commencement, interpretation and extent

1.—(1) These Regulations may be cited as the National Health Service (Cross-Border Healthcare and Miscellaneous Amendments etc.) (EU Exit) Regulations 2019 and come into force on exit day2.

(2) In these Regulations—

“the NHS Act 2006” means the National Health Service Act 20063;

“the NHS (Wales) Act” means the National Health Service (Wales) Act 20064;

“the 2013 Regulations” means the National Health Service (Cross-Border Healthcare) Regulations 20135;

“the NHS Functions Regulations” means the National Health Service and Public Health (Functions and Miscellaneous Provisions) Regulations 20136.

(3) An amendment, repeal or revocation made by these Regulations has the same extent and application as the provision being amended, repealed or revoked.

(4) The amendments, repeals and revocations made by Parts 2 and 3 take effect subject to the provisions made by Part 5 of these Regulations.

2 Amendments to primary legislation

PART 2

Amendments to primary legislation

S-2 The Health and Social Security Act 1984

The Health and Social Security Act 1984

2.—(1) The Health and Social Security Act 19847is amended as follows.

(2) Omit section 10 (reimbursement of cost of medical and maternity treatment in member States of European Economic Community).

(3) In section 26(4) (extent) omit “section 10”.

S-3 The National Health Service Act 2006

The National Health Service Act 2006

3. In the NHS Act 2006 omit the following provisions—

(a) section 6A (reimbursement of cost of services provided in another EEA state)8;

(b) section 6B (prior authorisation for the purposes of section 6A)9;

(c) section 6BA (reimbursement of cost of services provided in another EEA state where expenditure incurred on or after 25 October 2013)10;

(d) section 6BB (prior authorisation for the purposes of section 6BA)11;

(e) section 6D (regulations relating to EU obligations)12;

(f) section 6E(7)(b) (regulations as to the exercise of functions by the Board or clinical commissioning groups)13;

(g) section 183(a)(ii) (payment of travelling expenses)14;

(h) the definition of “Regulation (EC) No. 883/2004” in section 275(1) (interpretation)15except in so far as it relates to section 183(a)(iii).

S-4 The National Health Service (Wales) Act 2006

The National Health Service (Wales) Act 2006

4.—(1) The NHS (Wales) Act is amended as follows.

(2) In section 46 (GMS contracts: prescription of drugs, etc)—

(a)

(a) in subsection (3), for “Community marketing authorization or United Kingdom” substitute “UK”;

(b)

(b) for subsection (4) substitute—

S-4

“4 “UK marketing authorisation” has the meaning given by regulation 8(1) of the Human Medicines Regulations 2012 ( S.I. 2012/1916).”.

(3) Omit the following provisions—

(a)

(a) section 6A (reimbursement of cost of services provided in another EEA state)16;

(b)

(b) section 6B (prior authorisation for the purposes of section 6A)17;

(c)

(c) section 6BA (reimbursement of cost of services provided in another EEA state where expenditure incurred on or after 25 October 2013)18;

(d)

(d) section 6BB (prior authorisation for the purposes of section 6BA)19;

(e)

(e) section 131(a)(ii) (payment of travelling expenses)20;

(f)

(f) the definition of “Regulation (EC) No. 883/2004” in section 206(1) (interpretation)21except in so far as it relates to section 131(a)(iii).

S-5 The Health and Social Care Act 2012

The Health and Social Care Act 2012

5. In the Health and Social Care Act 201222omit the following provisions—

(a) section 124(9) (local modifications of prices: agreements);

(b) section 125(9) (local modifications of prices: applications).

S-6 The Cities and Local Government Devolution Act 2016

The Cities and Local Government Devolution Act 2016

6. In the Cities and Local Government Devolution Act 201623omit section 18(2)(b) (devolving health service functions).

3 Amendments to secondary legislation

PART 3

Amendments to secondary legislation

S-7 The Welsh Ambulance Services National Health Service Trust (Establishment) Order 1998

The Welsh Ambulance Services National Health Service Trust (Establishment) Order 1998

7. The Welsh Ambulance Services National Health Service Trust (Establishment) Order 199824is amended as follows—

(a) in article 1(2) (interpretation), omit the definitions of “ Directive 2011/24/EU” and “National Contact Point”;

(b) omit article 3(2)(d) (nature and functions of the trust) but not the “and” after it.

S-8 The National Assembly for Wales (Transfer of Functions) Order 1999

The National Assembly for Wales (Transfer of Functions) Order 1999

8. In Schedule 1 (enactments conferring functions transferred by article 2) to the National Assembly for Wales (Transfer of Functions) Order 199925omit the entry relating to the Health and Social Security Act 1984.

S-9 The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004

The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004

9.—(1) The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 200426are amended as follows.

(2) In Schedule 2 (drugs, medicines and other substances that may be ordered only in certain circumstances)—

(a)

(a) in the entry in column 2 of the table that corresponds to the entry in column 1 relating to drugs for the treatment of erectile dysfunction—

(i) in paragraph (b), before “by virtue of any other enforceable EU right” insert “who immediately before exit day was entitled to treatment”;

(ii) in paragraph (c), for “who has an enforceable EU right” substitute “who immediately before exit day had an enforceable EU right”.

S-10 The National Health Service (General Medical Services Contracts) (Prescription of Drugs Etc.) (Wales) Regulations 2004

The National Health Service (General Medical Services Contracts) (Prescription of Drugs Etc.) (Wales) Regulations 2004

10.—(1) The National Health Service (General Medical Services Contracts) (Prescription of Drugs Etc.) (Wales) Regulations 200427are amended as follows.

(2) In Schedule 2 (drugs, medicines and other substances that may be ordered only in certain circumstances)—

(a)

(a) in the entry in column 2 of the table that corresponds to the entry in column 1 relating to drugs for the treatment of erectile dysfunction—

(i) in paragraph (b), before “by virtue of any other enforceable EU right” insert “who immediately before exit day was entitled to treatment”;

(ii) in paragraph (c), for “who has an enforceable EU right” substitute “who immediately before exit day had an enforceable EU right”.

S-11 The National Health Service (Cross-Border Healthcare) Regulations 2013

The National Health Service (Cross-Border Healthcare) Regulations 2013

11. The 2013 Regulations are revoked.

S-12 The National Health Service and Public Health (Functions and Miscellaneous Provisions) Regulations 2013

The National Health Service and Public Health (Functions and Miscellaneous Provisions) Regulations 2013

12.—(1) The NHS Functions Regulations28are amended as follows.

(2) Omit the following provisions—

(a)

(a) regulation 3(a) (exercise of functions);

(b)

(b) regulation 4(1)(a) and (b) (procedure for applications);

(c)

(c) regulation 6(2)(a) and (b) (form and content of determination);

(d)

(d) regulation 7(3) and (4) (CCGs);

(e)

(e) regulation 8 (applications made before 1st April 2013).

(3) For regulation 4(3)(a) substitute—

“(a)

“(a) information about the procedures the Board has in place for prior authorisation pursuant to Article 20 or Article 27(3);”

4 Revocation of retained direct EU legislation

PART 4

Revocation of retained direct EU legislation

S-13 2011/890/EU: Commission Implementing Decision

2011/890/EU: Commission Implementing Decision

13. 2011/890/EU: Commission Implementing Decision of 22 December 2011 providing the rules for the establishment, the management and the functioning of the network of national responsible authorities on eHealth is revoked.

S-14 2013/329/EU: Commission Implementing Decision

2013/329/EU: Commission Implementing Decision

14. 2013/329/EU: Commission Implementing Decision of 26 June 2013 providing the rules for the establishment, management and transparent functioning of the Network of national authorities or bodies responsible for health technology assessment is revoked.

5 Savings and Transitional Provision

PART 5

Savings and Transitional Provision

S-15 Cross-border cases arising before exit day

Cross-border cases arising before exit day

15.—(1) The legislation referred to in Parts 2 and 3, except for regulations 2, 4(2), 8, 9 and 10 is to continue to apply on and after exit day without the amendments, repeals and revocations made by those Parts, and with the modifications made by Schedule 1 in a case where any of paragraphs (2) to (5) apply.

(2) This paragraph applies where a service that satisfied the condition in section 6A(3) or (4) or 6BA(4) or (7) of the NHS Act 2006 or the NHS (Wales) Act was provided, or began to be provided, before exit day.

(3) This paragraph applies where an application for authorisation under section 6B or 6BB of the NHS Act 2006 or the NHS (Wales) Act has been made, but not determined,...

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