The National Health Service (Clinical Negligence Scheme) (Wales) Regulations 2019

Made: 4 March 2019

Laid before the National Assembly for Wales: 5 March 2019

Coming into force: 1 April 2019

The Welsh Minsters make the following Regulations in exercise of the powers conferred by sections 30, 47(1) and (2), and 203(9) and (10) of the National Health Service (Wales) Act 2006[^f00001].

Title, commencement and application

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• (1) The title of these Regulations is the National Health Service (Clinical Negligence Scheme) (Wales) Regulations 2019.

• (2) These Regulations come into force on 1 April 2019.

• (3) These Regulations apply in relation to Wales.

Interpretation

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In these Regulations—

• “the Act” (“y Ddeddf”) means the National Health Service (Wales) Act 2006;

• “eligible body” (“corff cymwys”) means a body specified in regulation 4;

• “Local Health Board” (“Bwrdd Iechyd Lleol”) means a Local Health Board established in accordance with section 11(2) of the Act;

• “member” (“aelod”) means an eligible body which is a member of the Scheme;

• “membership year” (“blwyddyn aelodaeth”) means, in respect of any eligible body, any 12 month period starting on 1 April during which the body is a member of the Scheme;

• “NHS Trust” (“Ymddiriedolaeth GIG”) means a National Health Service Trust established in accordance with section 18(2) of the Act;

• “primary medical services” (“gwasanaethau meddygol sylfaenol”) means health services provided under a contract, arrangement or agreement made under or by virtue of the following sections of the Act— section 41(2) (primary medical services); section 42(1) (general medical services contracts); section 50 (arrangements by Local Health Boards for the provision of primary medical services);

• “primary medical services provider” (“darparwr gwasanaethau meddygol sylfaenol”) means the person who has entered into a contract to provide primary medical services in accordance with section 41(2)(b), 42 or 50 of the Act:

• “relevant function” (“swyddogaeth berthnasol”) means— arranging for the provision of services for the purposes of the health service[^f00002]; providing services for the purposes of the health service; exercising functions in relation to the health service; providing primary medical services; exercising powers under, or by virtue of, section 7 of the Health and Medicines Act 1988[^f00003]; exercising powers under section 169 of, or paragraphs 19 and 20 of Schedule 3 to, the Act;

• “relevant health services” (“gwasanaethau iechyd perthnasol”) means primary medical services provided in Wales for the purposes of the health service;

• “the Scheme” (“y Cynllun”) means the Clinical Negligence Scheme for NHS Trusts and Local Health Boards established by regulation 3.

Clinical Negligence Scheme for NHS Trusts and Local Health Boards

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• (1) There is hereby established a scheme, to be known as the Clinical Negligence Scheme for NHS Trusts and Local Health Boards.

• (2) The purpose of the Scheme is to enable an eligible body to make provision to meet liabilities to which the Scheme applies.

• (3) An eligible body may participate in the Scheme only if it is a member of the Scheme.

• (4) The Scheme is to be administered by the Welsh Ministers.

Eligible bodies

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The bodies which are eligible to be a member of the Scheme are—

• (a) a NHS Trust, or

• (b) a Local Health Board.

Membership of the Scheme

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• (1) An eligible body may apply to the Welsh Ministers to become a member of the Scheme.

• (2) An application made in accordance with paragraph (1) must—

• (a) be made in writing,

• (b) be made in such form and be submitted in such manner as the Welsh Ministers may require,

• (c) specify a date on which the eligible body proposes that its membership should start, and

• (d) contain, or be accompanied by, such information as the Welsh Ministers may require.

• (3) At any time after receiving an application and before determining it, the Welsh Ministers may in writing require the applicant to provide such further information as the Welsh Ministers consider necessary for the purposes of determining the application.

• (4) Information that may be required in accordance with paragraphs (2) and (3) includes—

• (a) the nature of the applicant’s functions;

• (b) the number of employees and contractors;

• (c) qualifications and experience of such employees and contractors;

• (d) details of any previous claims in which the applicant has been the defendant in respect of personal injury claims made as a result of the exercise of any relevant function;

• (e) such other information as the Welsh Ministers may request for the purposes of determining the application.

• (5) The Welsh Ministers must—

• (a) within 6 weeks of receiving an application made in accordance with the requirements in paragraphs (2) and (3), determine whether or not to grant it, and

• (b) as soon as reasonably practicable, inform the applicant of the determination by a notice in writing which, if the application is granted, must specify the date on which the applicant’s membership is to start.

• (6) In determining whether to grant an application, the Welsh Ministers must have regard to—

• (a) the information provided by the applicant, and

• (b) such other factors as the Welsh Ministers consider relevant.

• (7) Where an eligible body’s application is granted, that body’s membership of the Scheme starts on the date specified in the notice given in accordance with paragraph (5)(b).

• (8) For the purposes of paragraph (4)(b) and (c), reference to “contractors” is to be construed in accordance with regulation 9(2).

Cancellation of membership by a member

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• (1) This regulation applies only in relation to any member which has been a member of the Scheme for at least 3 consecutive membership years.

• (2) A member of the Scheme may cancel its membership of the Scheme by giving notice of the cancellation in writing to the Welsh Ministers.

• (3) Where a notice under paragraph (2)—

• (a) is given before 1 September in a membership year, the notice takes effect at the end of that membership year;

• (b) is given on or after 1 September in a membership year, the notice takes effect at the end of the following membership year.

Cancellation of membership by the Welsh Ministers

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• (1) The Welsh Ministers may cancel a member’s membership of the Scheme in any of the circumstances specified in paragraphs (2) to (4).

• (2) The circumstances specified in this paragraph are where the member is liable to make a payment to the Welsh Ministers under regulation 11 (duty of members to make contributions to the Scheme) and that payment remains unpaid for a period of 28 days or more which starts with the date on which the payment became due.

• (3) The circumstances specified in this paragraph are where the member has failed to provide any information required under regulation 19 (duty of members to provide information)—

• (a) before the end of the period of 28 days which starts with the date on which the Welsh Ministers request the information, or

• (b) if the Welsh Ministers in writing allow a further period for providing such information, before the end of that further period.

• (4) The circumstances specified in this paragraph are where the Welsh Ministers consider that it would be detrimental to the efficient administration of the Scheme or the interests of other members for the member to remain a member of the Scheme.

• (5) The Welsh Ministers must inform the member by notice in writing that its membership of the Scheme is to cease with effect from a date specified in the notice and—

• (a) where the cancellation is in circumstances specified in paragraph (2), (3), or (4)—

• (i) the date to be specified must not be less than 28 days after the date on which the notice is given, but

• (ii) the Welsh Ministers may determine not to cancel the membership by giving the member a further notice in writing to that effect.

Liabilities of members

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• (1) The Scheme applies to—

• (a) any liability in tort under the law of England and Wales which a member of the Scheme owes to a third party in respect of or consequent upon personal injury or loss specified in paragraph (2), and

• (b) any contractual liability of a member of the Scheme—

• (i) arising as a consequence of an arrangement to provide relevant health services referred to in regulation 9(2), and

• (ii) specified as a qualifying liability of a contractor in regulation 9(4).

• (2) The personal injury or loss referred to in paragraph (1) is personal injury or loss arising out of or in connection with any breach of a duty of care, which—

• (a) the member owes to any person in connection with the diagnosis of any illness or the care or treatment of any patient, and

• (b) is in consequence of any act or omission specified in paragraph (3).

• (3) The act or omission referred to in paragraph (2) is an act or omission to act on the part of—

• (a) a person employed or engaged by the member in connection with any relevant function provided by the member, or

• (b) an employee or agent of a person engaged by the member in connection with the provision of any relevant function.

Other liabilities for which members are treated as liable

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• (1) In this regulation, “health services provider” means an NHS Trust, Local Health Board or a primary medical services provider.

• (2) The Scheme applies to the qualifying liabilities of a health services provider which is not a member of the Scheme (“the contractor”) where its provision of relevant health services is the subject of an arrangement between it and another health services provider which is a member of the Scheme.

• (3) Qualifying liabilities to which the Scheme applies under paragraph (2) are to be treated for the purposes of the Scheme and these Regulations as if they were liabilities of the health services provider who is a member of the Scheme and which entered into the arrangement.

• (4) Qualifying liabilities of a contractor are any liability in tort under the law of England and Wales which—

• (a) the contractor owes to a third party in respect of or consequent upon personal injury or loss as specified in paragraph (5), and

• (b) is in consequence of the arrangement referred to in paragraph (2).

• (5) The personal injury or loss referred to in paragraph (4)(a) is personal injury or loss arising out of or in connection with any breach of a duty of care which—

• (a) the contractor owes to any person in connection with the diagnosis of any illness or the care or treatment of any patient, and

• (b) is in consequence of any act or omission specified in paragraph (6).

• (6) The act or omission referred to in paragraph (5)(b) is an act or omission to act in connection with the provision of relevant health services on the part of—

• (a) the contractor,

• (b) a person employed or engaged by the contractor, or

• (c) an employee or agent of a person engaged by the contractor.

Determination of amounts payable by members

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• (1) The Welsh Ministers must determine the amount which each member of the Scheme must pay to the Welsh Ministers in respect of each membership year.

• (2) In determining the amount in paragraph (1) in respect of any member (“M”), the Welsh Ministers may have regard to—

• (a) the Welsh Ministers’ estimate of the total amount which, by virtue of regulation 13 (payments out of the Scheme), is likely to be payable during that membership year in respect of all liabilities to which the Scheme applies;

• (b) the nature of M’s relevant functions;

• (c) the number of M’s employees and contractors who are engaged in M’s performance of a relevant function or any part of a relevant function;

• (d) the qualifications and experience of those employees and contractors;

• (e) any agreement in respect of M which falls within regulation 13(3)(c) (agreement that the Scheme is to cover a future claim in respect of liability incurred before membership starts);

• (f) any agreement in respect of M which falls within regulation 13(5)(c) (agreement that the Scheme is to cover existing claim not met before membership ceases);

• (g) any agreement in respect of M which falls within regulation 14(2)(a) (agreement on payment of additional contribution that the Scheme is to cover a claim in respect of liability incurred before membership ceases);

• (h) the Welsh Ministers’ assessment of—

• (i) the likely effectiveness of any steps being taken, or to be taken, by M as to the manner in which M exercises any relevant function for the purpose of reducing the incidence of liabilities in connection with those functions to which the Scheme applies, and

• (ii) the effectiveness of any steps which have already been taken for that purpose;

• (i) any other factor relating to M or any other member of the Scheme which the Welsh Ministers consider relevant to the determination under paragraph (1).

• (3) In respect of each membership year, the Welsh Ministers must give each member notice in writing specifying the amount determined in respect of that member in accordance with paragraph (1).

• (4) Except as stated in paragraph (5), a notice given in accordance with paragraph (3) must be given no later than 31 December in the membership year before that to which the notice relates.

• (5) In the case of any member admitted to the Scheme—

• (a) the notice in respect of the first membership year must be given no later than 6 months after the date on which the Welsh Ministers receive the member’s application in accordance with regulation 5 (membership of the Scheme), and

• (b) the notice in respect of the second membership year must be given no later than 1 July in that membership year.

• (6) For the purposes of paragraph (2)(c) and (d), reference to “contractors” is to be construed in accordance with regulation 9(2).

• (7) For the purposes of paragraph (5), reference to the “the first membership year” of a body which is a member of the Scheme is to the whole or part of any membership year immediately following any period during which the body was not a member.

Duty of members to make contributions to the Scheme

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• (1) Each member of the Scheme must, in respect of each membership year, pay to the Welsh Ministers the amount determined in respect of the member under regulation 10(1) (determination of amounts payable by members).

• (2) Except as stated in paragraph (3), a member which receives a notice under regulation 10(3) of the amount payable in respect of a membership year must pay the amount due—

• (a) in accordance with such arrangement as may be agreed by the Welsh Ministers and the member (which may include payment in instalments to be made at agreed times);

• (b) if no agreement is reached by 1 March immediately before the start of the membership year, by such time and in such manner as the Welsh Ministers may decide.

• (3) Where a member admitted to the Scheme receives a notice under regulation 10(3) in respect of a membership year, the member must pay—

• (a) the amount due in respect of the first membership year no later than 8 months after the date on which the Welsh Ministers receive the member’s application under regulation 5 (membership of the Scheme), and

• (b) the amount due in respect of the second membership year no later than 1 August in that membership year.

• (4) For the purposes of paragraph (3), reference to “the first membership year” of a body which is a member of the Scheme is to be construed in accordance with regulation 10(7).

Revision of determination of payable amount

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• (1) Paragraph (2) applies where the Welsh Ministers identify before the end of a membership year that the amount determined by them in accordance with regulation 10(1) as being payable by the member in respect of that year—

• (a) is incorrectly calculated,

• (b) is determined by reference to information which was incorrect, or

• (c) should be reconsidered in light of further information that has become available to the Welsh Ministers.

• (2) The Welsh Ministers—

• (a) must reconsider the amount determined, and

• (b) at any time before the end of the membership year in question, may revise the amount payable by the member in respect of that year.

• (3) The Welsh Ministers must give the member notice in writing of any revised amount determined in accordance with paragraph (2)(b) and the member must pay any amount that remains due in respect of the membership year—

• (a) in accordance with such arrangements as may be agreed between the Welsh Ministers and the member (which may include payment in instalments to be made at agreed times), and

• (b) if no agreement is reached by the end of the membership year, by such time and in such manner as the Welsh Ministers may decide.

• (4) The reference in paragraph (1) to an amount determined by the Welsh Ministers in accordance with regulation 10(1) includes any revised amount determined in accordance with paragraph (2)(b).

Payments out of the Scheme: liabilities of members

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• (1) Where a payment falls to be made by a member of the Scheme in connection with a claim in respect of a liability to which the Scheme applies, the Welsh Ministers may pay to the member, or on the member’s behalf, an amount determined in accordance with regulation 17.

• (2) No payment may be made under paragraph (1)—

• (a) in respect of any liability of the member which is excluded from the Scheme by any of paragraphs (3) to (5), or

• (b) in respect of any liability of, or payment by, the member which is excluded from the Scheme by regulation 15 (exclusions).