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

PART 1U.K.Preliminary

Citation, commencement, interpretation and extentU.K.

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 M1.

(2) In these Regulations—

“the NHS Act 2006” means the National Health Service Act 2006 M2;

“the NHS (Wales) Act” means the National Health Service (Wales) Act 2006 M3;

“the 2013 Regulations” means the National Health Service (Cross-Border Healthcare) Regulations 2013 M4;

“the NHS Functions Regulations” means the National Health Service and Public Health (Functions and Miscellaneous Provisions) Regulations 2013 M5.

(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repeal or revocation made by these Regulations has the same extent and application as the provision being amended, repealed or revoked.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 2U.K.Amendments to primary legislation

The Health and Social Security Act 1984U.K.

2.—(1) The Health and Social Security Act 1984 M6 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 2006U.K.

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

(a)section 6A (reimbursement of cost of services provided in another EEA state) M7;

(b)section 6B (prior authorisation for the purposes of section 6A) M8;

(c)section 6BA (reimbursement of cost of services provided in another EEA state where expenditure incurred on or after 25 October 2013) M9;

(d)section 6BB (prior authorisation for the purposes of section 6BA) M10;

(e)section 6D (regulations relating to EU obligations) M11;

(f)section 6E(7)(b) (regulations as to the exercise of functions by the Board or clinical commissioning groups) M12;

(g)section 183(a)(ii) (payment of travelling expenses) M13;

(h)the definition of “Regulation (EC) No. 883/2004” in section 275(1) (interpretation) M14 except in so far as it relates to section 183(a)(iii).

The National Health Service (Wales) Act 2006U.K.

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) M15;

(b)section 6B (prior authorisation for the purposes of section 6A) M16;

(c)section 6BA (reimbursement of cost of services provided in another EEA state where expenditure incurred on or after 25 October 2013) M17;

(d)section 6BB (prior authorisation for the purposes of section 6BA) M18;

(e)section 131(a)(ii) (payment of travelling expenses) M19;

(f)the definition of “Regulation (EC) No. 883/2004” in section 206(1) (interpretation) M20 except in so far as it relates to section 131(a)(iii).

The Health and Social Care Act 2012U.K.

5.  In the Health and Social Care Act 2012 M21 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 2016U.K.

6.  In the Cities and Local Government Devolution Act 2016 M22 omit section 18(2)(b) (devolving health service functions).

PART 3U.K.Amendments to secondary legislation

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

7.  The Welsh Ambulance Services National Health Service Trust (Establishment) Order 1998 M23 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 1999U.K.

8.  In Schedule 1 (enactments conferring functions transferred by article 2) to the National Assembly for Wales (Transfer of Functions) Order 1999 M24 omit the entry relating to the Health and Social Security Act 1984.

[F1The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004U.K.

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 (Cross-Border Healthcare) Regulations 2013U.K.

11.  The 2013 Regulations are revoked.

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

12.—(1) The NHS Functions Regulations M25 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);

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

(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 4U.K.Revocation of [F3assimilated direct legislation]

2011/890/EU: Commission Implementing DecisionU.K.

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 DecisionU.K.

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 5E+WSavings and Transitional Provision

Cross-border cases arising before [F4IP completion day] E+W

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 [F4IP 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 [F4IP 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 [F4IP 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 [F4IP completion day].

(5) This paragraph applies where a cross-border healthcare service was provided or began to be provided to a visiting patient before [F4IP 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 [F4IP 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 [F4IP 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.

F7PART 6U.K.Rights etc deriving from the Treaties

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