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

Type Statutory-Instrument

Publication 2019-04-02

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

Reform history JSON API PDF

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 2018 .

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.

PART 1 — Preliminary

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 day .

(2) In these Regulations—

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

“the NHS (Wales) Act” means the National Health Service (Wales) Act 2006 ;

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

“the NHS Functions Regulations” means the National Health Service and Public Health (Functions and Miscellaneous Provisions) Regulations 2013 .

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repeal or revocation made by these Regulations has the same extent and application as the provision being amended, repealed or revoked.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

PART 2 — Amendments to primary legislation

The Health and Social Security Act 1984

2

(1) The Health and Social Security Act 1984 is 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”.

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) ;

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

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

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

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

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

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

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

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

(b) for subsection (4) substitute—

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

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

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

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

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

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

The Health and Social Care Act 2012

5

In the Health and Social Care Act 2012 omit the following provisions—

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

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

The Cities and Local Government Devolution Act 2016

6

In the Cities and Local Government Devolution Act 2016 omit section 18(2)(b) (devolving health service functions).

PART 3 — Amendments to secondary legislation

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

7

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

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 1999 omit the entry relating to the Health and Social Security Act 1984.

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 2004 are amended as follows.

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

(a) for sub-paragraph (b) (including the “or” at the end) substitute—

(b) a man who is a national of an EEA State who— (i) immediately before IP completion day was entitled to treatment by virtue of Article 7(2) of Council Regulation 1612/68 as extended by the EEA Agreement or was entitled to treatment by virtue of any other enforceable EU right; (ii) has erectile dysfunction and was on 14th September 1998 receiving a course of treatment under a national health insurance system of an EEA State for that condition with any of the drugs listed in sub-paragraph (a); and (iii) immediately before IP completion day was receiving a course of treatment as part of the health service for the condition mentioned in paragraph (ii) of this sub-paragraph with any of the drugs listed in sub-paragraph (a); or

(b) for sub-paragraph (c) (including the “or” at the end) substitute—

(c) a man who is not a national of an EEA State but who is the member of the family of such a national and who— (i) immediately before IP completion day had an enforceable EU right to be treated no less favourably than the national in the provision of medical treatment; (ii) has erectile dysfunction and was on 14th September 1998 receiving a course of treatment for that condition with any of the drugs listed in sub-paragraph (a); and (iii) immediately before IP completion day was receiving a course of treatment as part of the health service for the condition mentioned in paragraph (ii) of this sub-paragraph with any of the drugs listed in sub-paragraph (a); or

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

10

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

11

The 2013 Regulations are revoked.

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

12

(1) The NHS Functions Regulations are amended as follows.

(2) Omit the following provisions—

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

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

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

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

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

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

PART 4 — Revocation of assimilated direct legislation

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.

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.

PART 5 — Savings and Transitional Provision

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 IP completion 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 IP completion 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, before IP completion day.

(4) This paragraph applies where authorisation has been given under section 6B or 6BB of the NHS Act 2006 or the NHS (Wales) Act before IP completion day.

(5) This paragraph applies where a cross-border healthcare service was provided or began to be provided to a visiting patient before IP completion day.

(6) Nothing in this regulation—

(a) requires reimbursement in respect of a service which was provided after the later of—

(i) the end of the period of one year beginning with the day after the day on which IP completion day falls, or

(ii) in a case where the authorisation for the service authorises the service to be provided within a specified period, the end of the specified period;

(b) imposes an obligation in relation to a charge to a visiting patient for a service which was provided after the end of the period of one year beginning with the day after the day on which IP completion day falls.

(7) In this regulation—

“cross-border healthcare service” and “visiting patient” have the same meaning as in the 2013 Regulations;

“service” is to be construed in accordance with section 6A or section 6BA of the NHS Act 2006 or, as the case may be, of the NHS (Wales) Act.

Cases arising during cross-border arrangements

16

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Savings provision for cases arising during cross-border arrangements

17

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PART 6 — Rights etc deriving from the Treaties

EU-derived rights

18

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SCHEDULE 1 — Cross-border cases arising before IP completion day

PART 1 — Modifications to primary legislation

Modifications to the NHS Act 2006

1

The NHS Act 2006 is to be read as if—

(a) in the headings to sections 6A and 6BA (reimbursement of cost of services provided in an EEA state), for references to “another EEA state” there were substituted “ an EEA state ”;

(b) in those sections, for references to “an EEA state other than the United Kingdom” there were substituted “ an EEA state ”;

(ba) in section 6A(6), after the second reference to “apply” there were inserted “by virtue of Title III of Part 2 of the withdrawal agreement (co-ordination of social security systems), Title III of Part 2 of the EEA EFTA separation agreement or social security co-ordination provisions of the Swiss citizens’ rights agreement (co-ordination of social security systems)”;

(bb) after section 6A(11), there were inserted—

(12) In subsection (6), expressions which are defined in the European Union (Withdrawal Agreement) Act 2020 have the same meaning as they have in that Act.

(bc) in section 6BA(9), after “applies” there were inserted “by virtue of Title III of Part 2 of the withdrawal agreement (co-ordination of social security systems), Title III of Part 2 of the EEA EFTA separation agreement or social security co-ordination provisions of the Swiss citizens’ rights agreement (co-ordination of social security systems)”;

(bd) after section 6BA(15), there were inserted—

(16) In subsection (9), expressions which are defined in the European Union (Withdrawal Agreement) Act 2020 have the same meaning as they have in that Act.

(c) in section 6D (regulations relating to EU obligations) and the heading to that section, for references to “EU obligations” there were substituted “assimilated obligations”;

(d) in section 6E(7)(b) (regulations as to exercise of functions by the Board or clinical commissioning groups), for the reference to “EU obligations” there were substituted “assimilated obligations”;

(e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Modifications to the NHS (Wales) Act

2

The NHS (Wales) Act is to be read as if—

(a) in the headings to sections 6A and 6BA (reimbursement of cost of services provided in an EEA state), for references to “another EEA state” there were substituted “ an EEA state ”;

(b) in those sections, for references to “an EEA state other than the United Kingdom” there were substituted “ an EEA state ”;

(ba) in section 6A(6), after the second reference to “apply” there were inserted “by virtue of Title III of Part 2 of the withdrawal agreement (co-ordination of social security systems), Title III of Part 2 of the EEA EFTA separation agreement or social security co-ordination provisions of the Swiss citizens’ rights agreement (co-ordination of social security systems)”;

(bb) after section 6A(11), there were inserted—

(12) In subsection (6), expressions which are defined in the European Union (Withdrawal Agreement) Act 2020 have the same meaning as they have in that Act.

(bc) in section 6BA(9), after “applies” there were inserted “by virtue of Title III of Part 2 of the withdrawal agreement (co-ordination of social security systems), Title III of Part 2 of the EEA EFTA separation agreement or social security co-ordination provisions of the Swiss citizens’ rights agreement (co-ordination of social security systems)”;

(bd) after section 6BA(15), there were inserted—

(16) In subsection (9), expressions which are defined in the European Union (Withdrawal Agreement) Act 2020 have the same meaning as they have in that Act.

Modifications to the Health and Social Care Act 2012

3

The Health and Social Care Act 2012 is to be read as if—

(a) in section 124(9) (local modifications of prices: agreements), for “an EU obligation” there were substituted “an assimilated obligation”;

(b) in section 125(9) (local modifications of prices: applications), for “an EU obligation” there were substituted “an assimilated obligation”.

Modification to the Cities and Local Government Devolution Act 2016

4

The Cities and Local Government Devolution Act 2016 is to be read as if for section 18(2)(b) (devolving health service functions) there were substituted—

(b) sections 6BA and 6BB of that Act (duties regarding the reimbursement of costs of services provided in an EEA state),

PART 2 — Modifications to secondary legislation

Modifications to the 2013 Regulations

5

The 2013 Regulations are to be read as if—

(a) in regulation 1(3) (interpretation)—

(i) in the definition of “resident patient”, for the reference to “the United Kingdom is” there were substituted “ immediately before IP completion day the United Kingdom was ”;

(ii) in the definition of “visiting patient”, for the reference to “a member State other than the United Kingdom is” there were substituted “ immediately before IP completion day a member State other than the United Kingdom was ”;

(b) in regulation 2 (national contact point: designation), for references to “must” there were substituted “ may ”;

(i) in paragraph (1), before “ensure” there were inserted “make reasonable efforts to”;

(ii) in paragraph (2), before “ensure” there were inserted “make reasonable efforts to”;

(d) in the heading to regulation 4 (NCP: information about treatment in a member State), for the reference to “another member State” there were substituted “ a member State ”;

(e) in regulation 4(1)—

(i) before “ensure” there were inserted “make reasonable efforts to”;

(ii) for references to “other member States” there were substituted “ member States ”;

(iii) for the reference to “another member State” there were substituted “ a member State ”;

(f) regulation 4A (NCP: information about prescriptions) were omitted;

(g) in regulation 5 (NCP: cross-border co-operation)—

(i) for paragraph (1) there were substituted—

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