National Health Service, England Citation, commencement, application and interpretation 1 1 These Regulations may be cited as the National Health Service (Clinical Negligence Scheme) Amendment Regulations 2013 and come into force on 1st April 2013. 2 These Regulations apply to England only. 3 In these Regulations “the principal Regulations ” means the National Health Service (Clinical Negligence Scheme) Regulations 1996 . Amendment of regulation 1 of the principal Regulations 2 1 Regulation 1 of the principal Regulations (citation, commencement and interpretation) is amended as follows. 2 In paragraph (2)— a prior to the definition of “the Act”, insert— “the 2006 Act ” means the National Health Service Act 2006; ; b after the definition of “the Act”, insert— “ CCG ” means a clinical commissioning group; ; c after the definition of “an eligible body”, insert— “first contracting party” means an NHS trust, an NHS foundation trust, a local authority or another body which provides relevant health services, the provision of which is the subject of an arrangement made between it and the Board, a CCG or a Special Health Authority; “insolvency” has the same meaning as in section 247(1) of the Insolvency Act 1986(“insolvency” and “go into liquidation”) ; ; d after the definition of “preceding year”, insert— “primary care services” means health services provided under a contract, arrangement or agreement made under or by virtue of the following sections of the 2006 Act— section 83(2) (arrangements by the Board for the provision of primary medical services); section 84(1) (general medical services contracts); section 92 (other arrangements for primary medical services); section 100(1) (general dental services contracts); section 107(1) (other arrangements for the provision of primary dental services); section 115(4) (power of the Board to make arrangements for the provision of primary ophthalmic services); section 117(1) (general ophthalmic services contracts); section 126(1) (pharmaceutical services); section 127(1) (additional pharmaceutical services); section 134 (pilot schemes); or Schedule 12 (local pharmaceutical services schemes); “primary provider body” means a body described in sub-paragraph (i) of regulation 3(1); ; e for the definition of “relevant function”, substitute— “relevant function” means the function of arranging for the provision of, or providing, services for the purposes of the health service; ; f after the definition of “relevant function”, insert— “relevant health services” means health services provided in England for the purposes of the health service, except primary care services; ; and g after the definition of “the Scheme”, insert— “sub-provider body” means a body described in sub-paragraph (j) of regulation 3(1); . Amendment of regulation 3 of the principal Regulations 3 1 Regulation 3 of the principal Regulations (eligible bodies) is amended as follows. 2 In paragraph (1)— a omit sub-paragraphs (b) and (d); and b after sub-paragraph (e), insert the following sub-paragraphs— f NICE ; g the Health and Social Care Information Centre ; h a local authority which provides, or arranges the provision of, relevant health services, the provision of which is the subject of an arrangement made with the Secretary of State, the Board, a CCG, a Special Health Authority, an NHS trust or an NHS foundation trust; i a body (A) (other than a body mentioned in sub-paragraphs (a) to (h)) which provides relevant health services, the provision of which is the subject of a direct arrangement made between it and the Board, a CCG or a Special Health Authority; j where paragraph (3) applies, a body (B) (other than a body mentioned in sub-paragraphs (a) to (h)) which provides relevant health services, the provision of which is the subject of an arrangement as mentioned in sub-paragraph (i) and a further arrangement between A and B; k where paragraph (4) applies, a body (C) (other than a body mentioned in sub-paragraphs (a) to (h)) which provides relevant health services, the provision of which is the subject of an arrangement as mentioned in sub-paragraph (i), a further arrangement between A and B as mentioned in sub-paragraph (j), and then a further arrangement between B and C; or l a person who— i immediately before 1st April 2013, is a person specified in paragraph (6) of regulation 4; and ii continues to provide the services referred to in paragraph (6)(a) of regulation 4, as that regulation appeared prior to these Regulations coming into force. . 3 After paragraph (2), insert the following paragraphs— 3 This paragraph applies where the primary provider body with which the sub-provider body has made a further arrangement as set out in paragraph (1)(j) is not itself a member of the Scheme (that is, B is only eligible to be a member of the Scheme if A, in respect of the arrangements in question, is not a member). 4 This paragraph applies where neither the primary provider body nor the sub-provider body with which arrangements are made as mentioned in paragraph (1)(k) are themselves members of the Scheme (that is, C is only eligible to be a member of the Scheme if A and B, in respect of the arrangements in question, are not members). . Amendment of regulation 4 of the principal Regulations 4 In regulation 4 of the principal Regulations (liabilities to which the Scheme applies)— a after paragraph (1), insert— 1A But where the member is a body mentioned in regulation 3(1)(i), (j) or (k), the Scheme only applies if the liability is in consequence of the arrangements by means of which the body is eligible to be a member. ; b in paragraph (3), for “person” substitute “body”; and c for paragraphs (5) to (9), substitute the following— 5 The act or omission referred to in paragraph (4) is an act or omission to act in connection with the provision of services for the purposes of the health service on the part of X or a person employed or engaged by X where the services are provided pursuant to an arrangement by means of which a body can be eligible to be a member. 6 X is a body which is— a an NHS trust, an NHS foundation trust, a local authority or another body which provides relevant health services, the provision of which by it (X1) is the subject indirectly of an arrangement made by the Board, a CCG or a Special Health Authority with another provider (that other provider being a first contracting party); or b a primary provider body (X2) whose membership of the Scheme has terminated in accordance with regulation 7(4)(a). 7 For the purposes of the Scheme and these Regulations, the liabilities of a first contracting party which is a member are to be taken to include the liabilities referred to in paragraph (3) of an X1 with which that first contracting party has made arrangements (either directly or indirectly) for the provision of relevant health services and references in these Regulations to the liabilities of a member or eligible body are to be construed accordingly. 8 For the purposes of the Scheme and these Regulations, the liabilities of the Board, a CCG or a Special Health Authority are to be taken to include the liabilities referred to in paragraph (3) of an X2 with which the Board, the CCG or the Special Health Authority had made arrangements for the provision of relevant health services, during the provision of which the liabilities referred to in paragraph (3) arose, where— a such liabilities are incurred prior to the date on which that body’s membership of the Scheme terminated; and b such liabilities fall to be met after the date on which that body’s membership of the Scheme terminated, and references in these Regulations to the liabilities of a member or eligible body are to be construed accordingly. . Amendment of regulation 7 of the principal Regulations 5 1 Regulation 7 of the principal Regulations (termination of membership) is amended as follows. 2 In paragraph (1) for “12” substitute “7”. 3 After paragraph (3), insert the following paragraph— 4 Where a member which is a primary provider body or a sub-provider body— a enters into insolvency; or b is no longer an eligible body, the Secretary of State may terminate that member’s participation in the Scheme with immediate effect. . Amendment of regulation 8 of the principal Regulations 6 1 Regulation 8 of the principal Regulations (members’ contributions to the Scheme) is amended as follows. 2 In paragraph (2)— a for “the Secretary of State shall have regard to”, substitute “the Secretary of State may have regard to”; and b after sub-paragraph (c), insert the following sub-paragraph— ca any agreement between the Secretary of State and the member under regulation 9(1A); . 3 In paragraph (3)(d), for “31st October” substitute “31st December”. 4 For paragraph (6)(d), substitute— d in relation to any subsequent membership year, at such time, or in such instalments at such times, and in such manner— i as the Secretary of State and the member may, by no later than 1st March immediately preceding the membership year in question, agree, or ii in default of such agreement by that date, as the Secretary of State may determine. . Amendment of regulation 9 of the principal Regulations 7 1 Regulation 9 of the principal Regulations (payments under the Scheme) is amended as follows. 2 In paragraph (1), for “paragraph (2)” substitute “paragraphs (2) and (2A)”. 3 After paragraph (1), insert the following paragraph— 1A Where a payment falls to be made by any body which has at any time been a member of the Scheme in connection with a claim in respect of a qualifying liability which relates to a breach of the duty of care by that body whilst it was a member and, prior to the date of the termination of that member’s participation in the Scheme— a the Secretary of State has agreed with the member that the member is to pay an amount under regulation 8(1) in respect of the membership year immediately preceding the date of the termination of the member’s participation in the Scheme determined by the Secretary of State to be sufficient to cover any qualifying liabilities which relate to a breach of the duty of care by the member during any membership year, but which fall to be met after the date of the termination of the member’s participation in the Scheme; and b the member has, prior to the date of the termination of the member’s participation in the Scheme, either— i paid the amount referred to in paragraph (a); or ii entered into an agreement with the Secretary of State to pay that amount in instalments after that date, the Secretary of State may, subject to paragraph (2A), pay to or on behalf of that body an amount to be determined by the Secretary of State in accordance with paragraph (3). . 4 Re-number paragraph (2)(d) as paragraph (2A), and at the start of that paragraph prior to “except to such extent” insert “No payment is to be made under paragraphs (1) or (1A)”. 5 After paragraph (5) insert— 6 In paragraphs (2A) and (3), “member” includes a body whose participation in the Scheme has terminated and which falls within paragraph (1A). . Signed by authority of the Secretary of State for Health. Daniel Poulter Parliamentary Under-Secretary of State, Department of Health 5th March 2013 We consent Robert Goodwill Anne Milton Two of the Lords Commissioners of Her Majesty’s Treasury 6th March 2013