PRINCIPAL REGULATIONS

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1 PRINCIPAL REGULATIONS Citation, commencement and interpretation 1. (1) These Regulations may be cited as the National Health Service (Clinical Negligence Scheme) Regulations 1996, and shall come into force on 1st March (2) In these Regulations, unless the context otherwise requires the Act means the National Health Service and Community Care Act 1990; an eligible body means a body of a kind described in regulation 3; member means an eligible body which is a member of the Scheme; membership year means, in relation to an eligible body, any period of 12 months beginning on 1st April during any part of which that body is a member of the Scheme; preceding year means, in relation to a membership year, the period of 12 months immediately preceding that membership year; qualifying liability means a liability of a kind described in regulation 4; relevant function means a function of the kind described in regulation 3(1); AMENDMENT REGS 1997 In regulation 1(2) of the principal Regulations (interpretation), for the definition of relevant function there shall be substituted the following: relevant function means the function of providing services in England for the purposes of the National Health Service Act 1977 or by virtue of section 7 of the Health and Medicines Act 1988(1) or under paragraph 14 or 15 of Schedule 2 to the Act;. Amendment Regs 2002 Amendment of regulation 1 of the principal Regulations 2. In regulation 1(2) of the principal Regulations (interpretation), in the definition of relevant function after the words services in England insert the words or securing the provision of services and for paragraph 14 or 15 substitute paragraphs 13, 14 or 15(1).. (emph added) (1) From the 2002 Regs: NHS Reform & Healthcare Professions Act 2002 Supplemental Regs

2 National Health Service (Clinical Negligence Scheme) Regulations (1) The National Health Service (Clinical Negligence Scheme) Regulations 1996(95) are amended as follows. (2) In regulation 1 (citation, commencement and interpretation), in paragraph (2), in the definition of an eligible body there is added at the end or a body which before 1 October 2002 was a Health Authority whose area was situated in England. (3) In regulation 3 (eligible bodies), in paragraph (1), for sub-paragraph there is substituted a Strategic Health Authority,. From the NHS Liabilities Schemes Amendment Regs 05 Amendment of regulation 1 of the CNS Regulations 2. In regulation 1(2) of the CNS Regulations (interpretation) in the definition of relevant function for or 15 substitute 15 or 15A(1). the Scheme means the Clinical Negligence Scheme for Trusts established by regulation 2. From the NHS (CNS) Amendment Regs 2013 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) prior to the definition of the Act, insert the 2006 Act means the National Health Service Act 2006; ; after the definition of the Act, insert CCG means a clinical commissioning group; ; 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 )(1); ; (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);

3 section 84(1) (general medical services contracts); section 92 (other arrangements for primary medical services); (d) section 100(1) (general dental services contracts); (e) section 107(1) (other arrangements for the provision of primary dental services); (f) section 115(4) (power of the Board to make arrangements for the provision of primary ophthalmic services); (g) section 117(1) (general ophthalmic services contracts); (h) section 126(1) (pharmaceutical services); section 127(1) (additional pharmaceutical services); (j) section 134 (pilot schemes); or (k) Schedule 12 (local pharmaceutical services schemes); primary provider body means a body described in sub-paragraph 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);. (1) (3) In these Regulations, a reference to a numbered regulation is a reference to the regulation which bears that number in these Regulations, and a reference in a regulation to a numbered paragraph is a reference to the paragraph which bears that number in that regulation.

4 Establishment of scheme 2. There is hereby established a scheme, to be known as the Clinical Negligence Scheme for Trusts, whereby an eligible body may, in accordance with the following provisions of these Regulations, make provision to meet qualifying liabilities. Eligible bodies 3. (1) A body is eligible to participate in the Scheme if it is a National Health Service trust, a Health Authority whose area is situated in England, or a Special Health Authority, whose functions include the function of managing for the purposes of the health service any hospital or other establishment or facility situated in England at or from which services are provided under the National Health Service Act Amendment of regulation 3 of the principal Regulations 3. In regulation 3(1) of the principal Regulations (eligible bodies) the words from whose functions to the end of the paragraph shall be omitted. From 2000 Amending Regulations Amendment of regulation 3 of the principal Regulations 2. (1) Regulation 3 of the principal Regulations(1) (eligible bodies) is amended as follows. (2) At end of sub-paragraph omit the word or. (3) At the end of sub-paragraph insert or (d) a Primary Care Trust(2).. Amendment of regulation 3 of the principal Regulations 3. Regulation 3(1) of the principal Regulations(1) (eligible bodies) is amended as follows: at the end of sub-paragraph omit the word or, and

5 at the end of sub-paragraph (d) add, or the Public Health Laboratory Service Board(2).. (e) From the Health & Social Care (Community Care and Standards Act 2004) Regs: Amend National Health Service (Clinical Negligence Scheme) Regulations In regulation 3(1) of the National Health Service (Clinical Negligence Scheme) Regulations 1996(20) (eligible bodies), after paragraph there is inserted (aa) an NHS foundation trust,. Amendment of regulation 3 of the CNS Regulations 3. In regulation 3 of the CNS Regulations (eligible bodies) for paragraph (1)(e) substitute the Health Protection Agency(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) omit sub-paragraphs and (d); and after sub-paragraph (e), insert the following sub-paragraphs (f) NICE(1); (g) the Health and Social Care Information Centre(2); (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; a body (A) (other than a body mentioned in sub-paragraphs 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 subparagraphs to (h)) which provides relevant health services, the provision of which is the subject of an arrangement as mentioned in sub-paragraph and a further arrangement between A and B;

6 (k) where paragraph (4) applies, a body (C) (other than a body mentioned in subparagraphs to (h)) which provides relevant health services, the provision of which is the subject of an arrangement as mentioned in sub-paragraph, 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 immediately before 1st April 2013, is a person specified in paragraph (6) of regulation 4; and continues to provide the services referred to in paragraph (6) 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).. (1) Established by section 232(1) of the Health and Social Care Act 2012 (c.7). (2) Established by section 252(1) of the Health and Social Care Act (2) Until 1st April 1996, paragraph (1) shall have effect as if the reference to a Health Authority whose area is situated in England were a reference to a Regional Health Authority and to any District Health Authority whose district is situated in England. Liabilities to which the Scheme applies 4. The Scheme applies to any liability in tort owed by a member to a third party in respect of or consequent upon personal injury or loss arising out of or in connection with any breach of a duty of care owed by that body to any person in connection with the diagnosis of any illness, or the care or treatment of any patient, in consequence of any act or omission to act on the part of a

7 person employed or engaged by a member in connection with any relevant function of that member. Amendment of regulation 4 of the principal Regulations 4. In regulation 4 of the principal Regulations (liabilities to which the Scheme applies) insert (1) at the beginning and at the end add the following paragraph (2) The reference in paragraph (1) to any act or omission to act on the part of a person engaged by a member includes any act or omission to act on the part of an employee or agent of the person so engaged.. From the CNS Amendment 2 Regs 2006 Amendment of regulation 4 of the CNST Regulations 2. In regulation 4 (liabilities to which the Scheme applies) of the CNST Regulations, for paragraphs (3) to (9) substitute (3) The Scheme also applies to any liability in tort under the law of England and Wales owed to a third party by a person specified in paragraph (6) ( X ) in respect of or consequent upon personal injury or loss as specified in paragraph (4). (4) The personal injury or loss referred to in paragraph (3) is personal injury or loss arising out of or in connection with any breach of a duty of care owed by X to any person, in consequence of any act or omission to act specified in paragraph (5), in connection with the diagnosis of any illness; or the care or treatment of any patient. (5) The act or omission referred to in paragraph (4) is an act or omission to act in connection with the provision of services under the 1977 Act on the part of X; or a person employed or engaged by X. (6) Subject to paragraph (7), the person referred to in paragraph (3) is a person

8 engaged by a Primary Care Trust to provide services under the 1977 Act which, immediately before that engagement, the Primary Care Trust was providing itself; and which has satisfied the Secretary of State that, were it a body falling within regulation 3 (eligible bodies), it would meet the requirements to be admitted as a member of the Scheme. (7) Paragraph (6) does not apply in the case of primary medical or dental services which, immediately before the engagement referred to in that paragraph, the Primary Care Trust was providing under section 16CA(2) (primary dental services), 16CC(2) (primary medical services) or 28C (personal medical or dental services) of the 1977 Act. (8) For the purposes of the Scheme and these Regulations, the liabilities of a Primary Care Trust shall be taken to include the liabilities referred to in paragraph (3) of a person referred to in paragraph (6) whom that Primary Care Trust has engaged to provide services and references in these Regulations to the liabilities of a member or eligible body shall be construed accordingly. (9) In this regulation, the 1977 Act means the National Health Service Act Amendment of regulation 4 of the principal Regulations 4. In regulation 4 of the principal Regulations (liabilities to which the Scheme applies) after paragraph (1), insert (1A) But where the member is a body mentioned in regulation 3(1), (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. ; in paragraph (3), for person substitute body ; and 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.

9 (6) X is a body which is 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 a primary provider body (X2) whose membership of the Scheme has terminated in accordance with regulation 7(4). (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 such liabilities are incurred prior to the date on which that body s membership of the Scheme terminated; and 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.. Administration of the Scheme 5. The Scheme shall be administered by the Secretary of State. Membership of the Scheme 6. (1) An eligible body which, before 1st December 1995, gave notice in writing to the Secretary of State of its wish to participate in a scheme under section 21 of the Act during any period beginning before 1st April 1996 shall be a member of the Scheme with effect from 1st March (2) An eligible body which, before 1st February 1996, gave notice in writing of its wish to participate in such a scheme with effect from 1st April 1996 shall be a member of the Scheme with effect from that date. (3) An eligible body to which neither paragraph (1) nor paragraph (2) applies which wishes to participate in the Scheme during any period beginning after 31st March 1997 shall apply to the Secretary of State to be admitted as a

10 member. (4) An application under paragraph (3) shall be made in writing in such form as the Secretary of State may require; and be made no later than 1st October in the calendar year preceding that in which the eligible body wishes its first membership year to begin. (5) An applicant shall provide such information as the Secretary of State may in writing request it to provide, as respects the nature of its relevant functions; the number of employees of the applicant who are engaged in its performance of any relevant function, or such part of any relevant function as the Secretary of State may specify, and the qualifications and experience of those employees; the nature and extent of any claims made against the applicant in respect of personal injuries sustained by third parties as a result of the carrying out by the applicant of any relevant function; and (d) such other information as he may request in connection with the application. (6) The Secretary of State shall, having regard to the information provided by the applicant under this regulation, and to such other factors as he considers to be material to the application, determine whether or not the applicant should be admitted as a member, and shall notify the applicant of his decision in writing. (7) Where the application of an eligible body has been successful, that body shall be admitted as a member with effect from the beginning of the membership year next following the Secretary of State s decision. (8) In this regulation applicant means an eligible body which has applied under paragraph (3) to be admitted as a member, and application shall be construed accordingly. Amendment of regulation 6 of the principal Regulations 3. (1) Regulation 6 of the principal Regulations (membership of the Scheme) is amended as follows. (2) For sub-paragraph of paragraph 4 substitute specify the date that the eligible body wishes its membership to begin.. (3) In paragraph (7) delete the words after the words effect from to the end and substitute the words such date as may be determined by the Secretary of State.. Termination of membership 7. (1) Subject to paragraph (2), a member may terminate its participation in

11 the Scheme on 31st March in any year by giving not less than 12 months' notice in writing to that effect to the Secretary of State. (2) A member s participation in the Scheme may not be terminated, by notice under paragraph (1) where its membership takes effect on 1st March 1996, before 31st March 1998; where its membership takes effect on 1st April 1996, before 31st March 1999; and in any other case, before the expiry of three consecutive membership years beginning on the date on which, by virtue of regulation 6(7), its membership takes effect. (3) Where any payment which a member is, by virtue of regulation 8 (contributions under the Scheme), liable to make to the Secretary of State has remained unpaid for a period of not less than 28 days beginning on the date on which the payment should have been made; a member has failed to provide, within 28 days, or such further period as the Secretary of State may in writing allow, of being requested to do so, any information which it is required by virtue of regulation 10 (provision of information) to provide; or the continued membership of any member would, in the opinion of the Secretary of State, be detrimental to the efficient administration of the Scheme or to the interests of other members, the Secretary of State may give notice in writing to that member that its participation in the Scheme is to cease on a date falling not less than 28 days after that on which the notice is given, and that member s participation in the Scheme shall, unless the Secretary of State in writing withdraws the notice before that date, be terminated on that date. 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 enters into insolvency; or is no longer an eligible body,

12 the Secretary of State may terminate that member s participation in the Scheme with immediate effect.. Members' contributions to the Scheme 8. (1) A member shall pay to the Secretary of State in respect of each membership year such amount as shall be determined in relation to that member, and notified to it, in accordance with this regulation. (2) When determining in relation to any member the amount of the payment to be made under paragraph (1), the Secretary of State shall have regard to his estimate of the total amount which will, by virtue of regulation 9 (payments under the Scheme), fall to be paid during that membership year in respect of all qualifying liabilities under the Scheme; the nature of the member s relevant functions; the number of employees of the member who are engaged in its performance of a relevant function, or any part of such a function, and the qualifications and experience of those employees; (d) any agreement between the Secretary of State and the member that regulation 9(2) or is not to apply in relation to certain liabilities incurred by the member; and (e) his assessment of the likely effectiveness of any steps being taken, or to be taken, by the member, as respects the manner in which it exercises any relevant function, with a view to reducing the incidence of qualifying liabilities in connection with that function, and the effectiveness of any such steps which may previously have been taken; and may have regard to any other factor concerning that or any other member or the Scheme which he considers to be material to his determination. (3) The Secretary of State shall give notice in writing to each member as respects any period before 1st April 1996, by no later than 14th March 1996; as respects the membership year beginning on 1st April 1996, by no later than 31st March 1996; and as respects any other membership year, by no later than 31st October in the preceding year; of the amount of the payment which it is to make under paragraph (1). (4) Where, after notice has been given to a member in accordance with paragraph (3) in relation to any membership year which begins after 31st

13 March 1996, it appears to the Secretary of State that the amount specified in the notice was incorrectly calculated, or determined by reference to information which was incorrect; or in the light of further information which has become available to him, the determination of that amount ought to be reconsidered, he shall reconsider the determination and may, at any time before the end of the membership year to which it relates, revise the amount of the payment to be made under paragraph (1). (5) Where an amount is revised under paragraph (4), the Secretary of State shall give to the member notice in writing of the revised amount, and that paragraph shall have effect in relation to that amount as if the notice had been given under paragraph (3). (6) Any amount which falls to be paid by a member under paragraph (1) shall be paid by the member to the Secretary of State in relation to any period before 1st April 1996, by no later than 31st March 1996; in relation to the membership year beginning on 1st April 1996, by 30th April 1996 or by such later date as the Secretary of State may allow; and in relation to any other membership year, at such time, or in such instalments at such times, and in such manner as the Secretary of State and the member may, by no later than 1st January immediately preceding the membership year in question, agree; or in default of such agreement by that date, as the Secretary of State shall determine. Amendment of regulation 8 of the principal Regulations 4. (1) Regulation 8 of the principal Regulations (members' contributions to the Scheme) is amended as follows. (2) In paragraph (3) for sub-paragraph substitute the following subparagraphs where the member was admitted to the Scheme on or after 1st April 2000 as respects its first membership year, by no later than 6 months from the date of receipt by the Secretary of State of its application in accordance with regulation 6(3), as respects its second membership year, by no later than 1st July in that year; and

14 (d) as respects any subsequent membership year, by no later than 31st October in the preceding year;. (3) In paragraph 6 for sub-paragraph substitute the following subparagraphs where the member was admitted to the Scheme on or after 1st April 2000 in relation to its first membership year, by no later than 8 months from the date of receipt by the Secretary of State of its application in accordance with regulation 6(3), in relation to its second membership year, by not later than 1st August in that year; and (d) in relation to any subsequent membership year, by no later than 30th November in the preceding year.. 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) for the Secretary of State shall have regard to, substitute the Secretary of State may have regard to ; and after sub-paragraph, 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 as the Secretary of State and the member may, by no later than 1st March immediately preceding the membership year in question, agree, or in default of such agreement by that date, as the Secretary of State may determine.. Payments under the Scheme 9. (1) Where, in any membership year, a qualifying liability falls to be met by any member, the Secretary of State may, subject to paragraph (2), pay to that member an amount to be determined by him in accordance with paragraph (3).

15 (2) No payment shall be made under paragraph (1) in respect of any liability which falls to be met after a member has given notice under regulation 7(1) to terminate its participation in the Scheme, unless the Secretary of State is satisfied that the liability would have fallen to be met at that time irrespective of the member s decision to give such notice; in respect of any liability incurred by an eligible body before the beginning of its first membership year, unless the claim by a third party against the member in respect of that liability was made after the beginning of the first membership year, the Secretary of State is satisfied that the member informed him, by no later than the qualifying date, that the claim had been made, (iii) the Secretary of State agreed, no later than the beginning of the first membership year, that this sub-paragraph shall not apply so as to preclude a payment under paragraph (1) in respect of any claim in relation to which heads and above are satisfied, and (iv) that agreement remains in force at the date on which the claim falls to be met by the member; in respect of any liability which falls to be met after the date of the termination of the member s participation in the Scheme, unless the claim by a third party against the member in respect of that liability was made prior to that date, the Secretary of State is satisfied that the member informed him, by no later than the qualifying date, that the claim had been made, (iii) prior to the date of termination of the member s participation in the Scheme, the Secretary of State agreed that this sub-paragraph shall not apply so as to preclude a payment under paragraph (1) in respect of any claim in relation to which heads and above are satisfied, and (iv) that agreement remained in force at the date of termination; (d) except to such extent as the Secretary of State may determine, in respect of any liability admitted by a member without the prior consent in writing of the Secretary of State, any liability determined by a Court in proceedings conducted by the member otherwise than in consultation with the Secretary of State, (iii) any payment which the member has agreed to make otherwise than in the

16 course of legal proceedings, or in consequence of its having compromised legal proceedings, without the prior consent in writing of the Secretary of State, or (iv) any liability of an amount which is less than that for the time being agreed between the Secretary of State and the member as the minimum amount of any liability in respect of which a payment is to be made under the Scheme. (3) The amount of any payment to a member under paragraph (1) shall be determined by reference to where an award of damages has been made against the member by a Court, the amount of that award, together with the amounts of the legal and associated costs awarded to the plaintiff and of any such costs incurred by the member; where legal proceedings have been compromised by the member, the amount of any sum paid by the member in relation to the plaintiff s claim for damages, (iii) the member s contribution towards any legal and associated costs incurred by the plaintiff, and (iii) any such costs incurred by the member; where, in any legal proceedings, a Court has declined to award damages against the member, the amount of any legal and associated costs incurred by the member, to the extent that such costs are not recoverable from the plaintiff or from the Legal Aid Board under section 18 of the Legal Aid Act 1988(1); (d) where the member has agreed to make a payment, otherwise than in the course of legal proceedings, in settlement of the plaintiff s claim, the amount of that payment. (4) In this regulation first membership year means any membership year immediately following any period during which the elegible body was not a member; member includes an eligible body whose participation in the Scheme has been terminated and in respect of whom the conditions specified in paragraph (2)(iii) and (iv) are satisfied; and qualifying date means the date falling 14 days after that on which the member became aware that a claim had been made, or after that on which, in the opinion of the Secretary of State, the member ought to have become aware of that fact, whichever is the later.

17 Amendment of regulation 9 of the principal Regulations 4. In regulation 9 of the principal Regulations (payments under the Scheme) in paragraph (1), for the words a qualifying liability falls to be met by any member there shall be substituted the words a payment falls to be made by any member in connection with a claim in respect of a qualifying liability, ; in paragraph (2)(d) after head there shall be inserted the following new head: (iia) any payment which falls to be made by a member in consequence of that member having agreed, without the prior consent in writing of the Secretary of State, to be bound by the determination of any person or body as to the making of a payment by that member in respect of a qualifying liability,, in head (iii), after the word payment there shall be inserted the words, other than one to which head (iia) above applies, ; in paragraph (3) for sub-paragraph (d) there shall be substituted the following sub-paragraphs: (d) where, otherwise than in the course of legal proceedings a member has agreed to make a payment in settlement of a claim, the amount of that payment, a member has agreed to make any contribution towards legal or associated costs incurred by a person in connection with that person s claim against the member in respect of a qualifying liability, the amount of that contribution, and the amount of any legal or associated costs incurred by the member in connection with the claim; or (e) where a member has agreed to be bound by the determination of any person or body as to the making of a payment by that member in respect of a qualifying liability, the amount of the payment and the amount of any legal or associated costs incurred by either party in connection with the claim.. Amendment Regs 1999 Amendment of regulation 9 of the National Health Service (Clinical Negligence Scheme) Regulations In regulation 9 of the National Health Service (Clinical Negligence Scheme) Regulations 1996(1) (payments under the scheme) in paragraph (1), for the words pay to that member an amount substitute the

18 words pay to or on behalf of that member an amount ; in paragraph (2)(d), after head (iia)(2), insert the following heads: (iib) any payment which falls to be made by a member where the member has not complied with any condition imposed by the Secretary of State relating to the claim, (iic) any payment into court which the member has made without the prior consent in writing of the Secretary of State, ; in paragraph (3) omit the words to a member ; in sub-paragraphs, (iii), and, after the words costs incurred by, and in sub-paragraph (d)(3), after those words appear for the second time, insert the words or on behalf of ; (iii) in sub-paragraph, after the word paid, insert the words or payable ; (iv) in sub-paragraph (e)(4), for the words incurred by either party substitute the words incurred by the person making the claim and any such costs incurred by or on behalf of the member; (v) after sub-paragraph (e) add the following sub-paragraph (f) where the member has decided to make a payment into court, the amount of that payment;. Amendment of regulation 9 of the principal Regulations 5. (1) Regulation 9 of the principal Regulations (payments under the Scheme) is amended as follows. (2) In paragraph (2) for the words the beginning of its first membership year, substitute the words it became a member,. (3) In paragraph (2) for the words the beginning of the first membership year, substitute the words it became a member,. (4) In paragraph (2)(iii) for the words beginning of the first membership year, substitute the words date on which the member became a member,. Insertion of regulation 9A into the National Health Service (Clinical Negligence Scheme) Regulations After regulation 9 of the National Health Service (Clinical Negligence Scheme) Regulations 1996 insert the following regulation Payments on account 9A. (1) Where, in any membership year, a payment (including a payment into court) falls to be made by a member in connection with a claim in respect

19 of which a payment may become payable by the Secretary of State under regulation 9, the Secretary of State may make a payment on account of any amount which may become payable by him under that regulation. (2) Such payment on account may be made to or on behalf of the member. (3) Where the amount of any such payment on account exceeds the amount of any payment the Secretary of State subsequently determines to make under regulation 9 the excess shall be recoverable from the member. Amendment of regulation 9 of the CNST Regulations 3. In regulation 9 (payments under the Scheme) of the CNST Regulations, for paragraph (5) substitute (5) In this regulation, any references to payments made or falling to be made or sums payable by, to or on behalf of a member; claims made against or falling to be met by a member; proceedings conducted by a member; (d) admissions, agreements or compromises made by a member; (e) compliance by a member with conditions imposed by the Secretary of State; (f) the award of damages against a member; (g) legal and associated costs incurred by or on behalf of a member; (h) the contribution of a member towards legal costs; or a decision by a member to make a payment into court, shall, in appropriate cases, be construed as including a reference to all such matters in respect of a person referred to in regulation 4(6).. 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

20 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 the member has, prior to the date of the termination of the member s participation in the Scheme, either paid the amount referred to in paragraph ; or 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).. EXPLANATORY NOTE (This note is not part of the Regulations) These Regulations amend the National Health Service (Clinical Negligence Scheme) Regulations 1996 ( the principal Regulations ) which established a Scheme whereby NHS trusts and certain other bodies providing services under the National Health Service Act 1977 may make provision for meeting liabilities to third parties in connection with personal injury arising out of negligence in the carrying out of the bodies' functions. The definition of relevant function in regulation 1(2) of the principal Regulations (interpretation) is amended to include, among the services to which the Scheme applies, services provided in exercise of a member s powers of income generation (regulation 2), and a consequential change is made in regulation 3 (eligible bodies). Regulation 9 of the principal Regulations (payments under the Scheme) is amended to make provision in relation to payments under the Scheme in connection with legal and other

21 costs, and where a member has agreed to be bound by the decision of an arbitrator in connection with a claim against the member in relation to a qualifying liability (regulation 4). EXPLANATORY NOTE (This note is not part of the Regulations) These Regulations further amend the National Health Service (Clinical Negligence Scheme) Regulations 1996 which established a Scheme whereby NHS trusts and certain other bodies providing NHS services may make provision for meeting liabilities to third parties in connection with personal injury arising out of negligence in the carrying out of their functions. In particular they provide for the Secretary of State to make payments under the Scheme to third parties on behalf of members. They also make minor amendments relating to the matters the Secretary of State shall consider in determining payments under the Scheme and provide for additional circumstances where he may refuse to meet any liabilities. Provision is also made, by the insertion of a new regulation 9A, enabling the Secretary of State to make payments on account of any payment which may become payable by him under regulation 9. EXPLANATORY NOTE (This note is not part of the Regulations) These Regulations further amend the National Health Service (Clinical Negligence Scheme) Regulations 1996 which established a Scheme whereby NHS trusts and certain other bodies providing NHS services may make provision for meeting liabilities to third parties in connection with personal injury arising out of negligence in the carrying out of their functions in England. Regulation 2 provides for Primary Care Trusts to be eligible to participate in the Scheme. Regulation 3 amends the requirements as to the timing for applications for membership and admission to the Scheme. Regulations 4 and 5 make consequential amendments regarding the timing of notices sent to members in relation to contributions and payments under the Scheme. EXPLANATORY NOTE (This note is not part of the Regulations) These Regulations further amend the National Health Service (Clinical Negligence Scheme) Regulations 1996 which established a Scheme whereby

22 NHS trusts and certain other bodies providing NHS services may make provision for meeting liabilities to third parties in connection with personal injury arising out of negligence in the carrying out of their functions. Regulation 3 provides for the Public Health Laboratory Service Board to be eligible to participate in the Scheme. Regulation 2 amends the definition of relevant function to include arrangements made for securing the provision of certain NHS services whether in England or elsewhere and regulation 4 provides that the liabilities to which the Scheme applies includes those in consequence of any act or omission to act on the part of any employee or agent of a person engaged by a member in connection with any relevant function of that member. EXPLANATORY NOTE (This note is not part of the Regulations) These Regulations further amend the following Regulations the National Health Service (Clinical Negligence Scheme) Regulations 1996 (CNS Regulations); the National Health Service (Existing Liabilities Scheme) Regulations 1996 (ELS Regulations ); the National Health Service (Liabilities to Third Parties Scheme) Regulations 1999 (LTPS Regulations); the National Health Service (Property Expenses Scheme) Regulations 1999 (PES Regulations). Each of these Regulations establishes a Scheme whereby NHS trusts and certain other bodies providing services under the National Health Service Act 1977 may make provision respectively for meeting liabilities to third parties in connection with personal injury arising out of, negligence in the carrying our of their functions; for meeting liabilities incurred before 1 st April 1995 to third parties in connection with personal injury arising out of negligence in the carrying out of their function; for meeting liabilities to third parties in connection with loss, damage or injury arising out of the carrying out of the bodies' functions other than liabilities to which the CNS Regulations, the ELS Regulations and the PES Regulations apply; for claiming reimbursement for expenses arising from liabilities to which the CNS Regulations, the ELS Regulations or the LTPS Regulations apply. Regulations 2,5 and 8 amend the definition of relevant function to include arrangements made for securing the provision of certain NHS services whether in England or elsewhere and regulation 7 amends the definition of relevant person in respect of the liabilities to which the LTPS Regulations apply to include an employee or agent of a person engaged by a member of the Scheme.

23 Regulations 3,4,6 and 9 include the Health Protection Agency as an eligible body able to participate in the Schemes and in regulations 3 and 4, the references to the Public Health Laboratory Service Board are omitted. From the CNS Amendment 2 REGS 2006 EXPLANATORY NOTE (This note is not part of the Regulations) These Regulations have been issued free in consequence of a defect in the National Health Service (Clinical Negligence Scheme) (Amendment) Regulations 2006 (S.I. 2006/2390) which, contrary to Statutory Instrument Practice, did not include the signatures of two Lords Commissioners of the Treasury. Regulation 4 revokes S.I. 2006/2390, and regulations 2 and 3 re-make the provisions of S.I. 2006/2390 which amended the National Health Service (Clinical Negligence Scheme) Regulations 1996 ( the principal Regulations ) which established a Scheme whereby NHS trusts and certain other bodies providing NHS services may make provision for meeting liabilities to third parties in connection with personal injury arising out of negligence in the carrying out of their functions. Regulation 2 amends regulation 4 of the principal Regulations to include as liabilities to which the scheme applies certain liabilities incurred by third parties whom a PCT has engaged to provide services under the National Health Service Act 1977 which, immediately before that engagement, it was providing itself. It further provides that for the purposes of the Scheme, such liabilities shall be treated as if they were liabilities of the PCT which has engaged the person. Regulation 3 makes consequential amendments to regulation 9 of the principal Regulations relating to payments under the Scheme to allow such payments to be made in cases relating to the liabilities to which the Scheme is applied by the foregoing amendments. From the NHS (CNS) Amendment Regs 2013 EXPLANATORY NOTE (This note is not part of the Regulations) These Regulations amend the National Health Service (Clinical Negligence Scheme) Regulations 1996 ( the principal Regulations ) which established a Scheme whereby certain NHS bodies and other bodies providing NHS services may make provision for meeting liabilities to third parties in connection with personal injury arising out of negligence in the carrying out of their functions. Regulation 3 amends the principal Regulations to enable a number of additional bodies to be eligible to participate in the Scheme. These are NICE;

24 the Health and Social Care Information Centre; local authorities which provide, or arrange the provision of, NHS services (other than primary care services) pursuant to arrangements made with the NHS Commissioning Board, a clinical commissioning group or a Special Health Authority; persons who immediately before 1st April 2013 would have been persons to whom regulation 4(6) of the principal Regulations as they appeared prior to these Regulations coming into force applied (and so whose liabilities would have been treated as those of the Primary Care Trust which had engaged them to provide services that the PCT had previously provided itself) and who continue to be such persons; bodies (which are not otherwise eligible to participate in the Scheme) which provide NHS services (other than primary care services) pursuant to arrangements made with the NHS Commissioning Board, a clinical commissioning group or a Special Health Authority, whether those arrangements are made directly by that body as a primary contractor, or indirectly as a sub-contractor. However, in the case of sub-contractors, they will only be eligible to participate in the Scheme if the bodies with whom they contract are not themselves members of the Scheme. Regulation 4 amends the principal Regulations to include as liabilities to which the Scheme applies certain additional liabilities incurred by sub-contractors which provide NHS services (other than primary care services) and certain additional liabilities incurred by certain bodies whose membership of the Scheme has been terminated as a result of insolvency. In particular it is provided that, for the purposes of the Scheme: certain liabilities of an NHS trust, an NHS foundation trust, a local authority or another body which provides NHS services (other than primary care services) pursuant to arrangements made indirectly (as a sub-contractor) with the NHS Commissioning Board, a clinical commissioning group or a Special Health Authority are to be treated as the liabilities of the main contractor with whom those arrangements are made by the NHS Commissioning Board, a clinical commissioning group or Special Health Authority; and certain liabilities of certain non-nhs bodies which provide NHS services (other than primary care services) pursuant to arrangements made directly with the NHS Commissioning Board, a clinical commissioning group or a Special Health Authority, and whose membership of the Scheme is terminated as a result of insolvency, are to be treated as the liabilities of whichever of the NHS Commissioning Board, a clinical commissioning group or Special Health Authority it made those arrangements with. Regulation 5 amends the principal Regulations to enable the Secretary of State to terminate the membership of the Scheme of a member which is a non-nhs body and provides NHS services under arrangements made with the NHS Commissioning Board, a clinical commissioning group or a Special Health Authority with immediate effect if that member becomes insolvent or the member is no longer an eligible body. It also enables a member to terminate its membership of the Scheme by means of 7 months rather than 12 months written notice. Regulation 6 amends the principal Regulations to change some of the deadlines by which notifications of payments must be made, and by which payments must be made, under the Scheme. Regulations 6 and 7 amend the principal Regulations to enable the Secretary of State to agree with a member that that member can make a payment (or

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