National Health Service, England Citation, commencement and application 1 1 These Regulations may be cited as the National Health Service (Clinical Negligence Scheme for General Practice) Regulations 2019 and come into force on 1st April 2019. 2 These Regulations apply only in relation to services provided as part of the health service in England. Interpretation 2 1 In these Regulations— “2006 Act” means the National Health Service Act 2006; “ancillary health services”, subject to paragraph (2)(a), means services, other than primary medical services, provided as part of the health service by— a Part 4 contractor whose principal activity consists of the provision of primary medical services; a primary medical services sub-contractor whose principal activity consists of the provision of primary medical services; or a person (“P”) with whom a person specified in paragraph (a) or (b) has made arrangements for P to provide the ancillary health services; “eligible person” means a person specified in regulation 4; “health service” means the health service continued under section 1(1) of the 2006 Act; “Part 4 contractor” means a person providing, or arranging for the provision of, primary medical services in accordance with a contractual arrangement made with that person under one of the specified sections in Part 4 of the 2006 Act; “primary medical services” means the primary medical services that, pursuant to section 83 of the 2006 Act, NHS England is under a duty to secure and which are provided in accordance with a contractual arrangement or agreement (including any such contractual arrangement or agreement that is part of a set of arrangements for the provision of services, in addition to the primary medical services) that is— made or entered into under one of the specified sections in Part 4 of the 2006 Act; or made between a Part 4 contractor and a primary medical services sub-contractor; “primary medical services sub-contractor” means a person providing primary medical services under a contractual arrangement made with a Part 4 contractor; “relevant function” means— making arrangements for the provision of primary medical services; providing primary medical services; making arrangements for the provision of ancillary health services; providing ancillary health services; carrying out an activity in connection with any of the activities in paragraphs (a) to (d); “relevant liability” means a liability falling within regulation 5; “Scheme” means the scheme established under regulation 3(1). 2 In paragraph (1),— a in the definition of “ancillary health services”, unless determined otherwise by the Secretary of State, a person specified in paragraphs (a) to (c) of that definition excludes a subsidiary company; and b “specified sections in Part 4 of the 2006 Act” means the following sections of the 2006 Act— i section 83(2) (primary medical services); ii section 84(1) (general medical services contracts); and iii section 92(1) (arrangements by NHS England for the provision of primary medical services). 3 For the purposes of paragraph (2)(a)— a “subsidiary” has the same meaning as in section 1159(1) of the Companies Act 2006 ; and b “company” has the same meaning as in subsection (4) of that section. Establishment, purpose and administration of scheme 3 1 A scheme, to be known as the Clinical Negligence Scheme for General Practice, is established. 2 The purpose of the Scheme is to enable the Secretary of State to make provision to meet relevant liabilities of eligible persons. 3 The Scheme is to be administered by the Secretary of State. Eligible persons 4 1 An eligible person is a person who is, or who, on the relevant date, was— a a Part 4 contractor; b a primary medical services sub-contractor; or c a person with whom a Part 4 contractor or a primary medical services sub-contractor has made arrangements for that person to provide ancillary health services. 2 For the purposes of paragraph (1),— a “relevant date” means the date on which a breach of a duty of care, as mentioned in regulation 5(1), occurred; and b “arrangements” in sub-paragraph (c) excludes arrangements made under a contract of employment. Liabilities to which the Scheme applies and exclusions 5 1 The Scheme applies to any liability in tort under the law of England and Wales that arises as a consequence of a breach of a duty of care owed by an eligible person to a third party in connection with a relevant function where— a an act, or an omission to act, on the part of the eligible person, or any other person specified in paragraph (2), results in personal injury or loss to the third party; b the act, or omission to act, is in connection with the diagnosis of an illness or the provision of care or treatment to the third party; and c the act, or omission to act, occurs on or after 1st April 2019. 2 The persons specified for the purposes of paragraph 5(1)(a) are— a an employee of the eligible person; or b any other individual who is otherwise engaged, or permitted, by the eligible person to carry out an activity connected to a relevant function. 3 Where a liability of an eligible person is a liability to which both paragraph (1) and regulation 8(1) (liabilities to members) of the National Health Service (Clinical Negligence Scheme) Regulations 2015 (“CNST Regulations”) apply, the Secretary of State must determine whether the liability is to be met under this Scheme or the scheme under the CNST Regulations. Payments in respect of relevant liabilities 6 1 The Secretary of State may determine whether a payment is to be made in respect of a relevant liability. 2 Without limit to the power in paragraph (1), a payment may be made— a to, or on behalf of, an eligible person in respect of a relevant liability of the eligible person; or b where paragraph (3) applies. 3 This paragraph applies where— a an eligible person— i has died; ii has been dissolved or wound up (within the meaning of the Companies Act 2006 ); or iii is bankrupt or insolvent; and b the Secretary of State is satisfied that a relevant liability of a person falling within paragraph (a) is not also a relevant liability of any other eligible person. 4 For the purposes of this regulation, the amount of any payment to be made is to be determined by the Secretary of State in accordance with regulation 7. 5 In this regulation— a “bankrupt” has the same meaning as that given in section 381(1) of the Insolvency Act 1986 (“Bankrupt” and associated terminology); and b “insolvent” has the same meaning as that given in section 247(1) of that Act (meaning of “insolvency” and “go into liquidation”). Determination of amount of payment to be made in respect of a relevant liability 7 1 In determining the amount of any payment to be made under regulation 6 in the circumstances specified in each of paragraphs (2) to (7), the Secretary of State must have regard to the relevant matters specified in each of those paragraphs, as appropriate. 2 Where an award of damages has been made by a court against an eligible person, the relevant matters are the amount of— a the award; b the legal and associated costs awarded to the claimant; and c any legal and associated costs incurred by or on behalf of the eligible person. 3 Where, in any legal proceedings, a settlement has been agreed to by, or on behalf of an eligible person, the relevant matters are the amount of— a any sum paid or payable by the eligible person in relation to the claimant’s claim for damages; b the eligible person’s contribution towards any legal and associated costs incurred by the claimant; and c any legal and associated costs incurred by or on behalf of the eligible person. 4 Where, in any legal proceedings, a Court has declined to award damages against an eligible person, the relevant matters are— a the amount of any legal and associated costs incurred by or on behalf of the eligible person; and b the extent to which those costs are not recoverable either from the claimant or from the Legal Aid Agency under regulations made by virtue of section 26(5) of the Legal Aid, Sentencing and Punishment of Offenders Act 2012 (costs in civil proceedings). 5 Where, otherwise than in the course of legal proceedings, an eligible person has agreed to make a payment in settlement of any claim that has or may be brought against the eligible person, or otherwise, in relation to a relevant liability, the relevant matters are the amount of— a the payment agreed; and b any legal or associated costs incurred by or on behalf of the eligible person in connection with the claim. 6 Where, otherwise than in the course of legal proceedings, an eligible person has agreed to make any contribution towards legal or associated costs incurred by a person in connection with that person’s claim against the eligible person, or otherwise in respect of a relevant liability of the eligible person, the relevant matters are the amount of— a that contribution; and b any legal or associated costs incurred by or on behalf of the eligible person in connection with the claim. 7 Where an eligible person has agreed to be bound by the determination of any person or body as to the making of a payment by the eligible person in respect of a relevant liability, the relevant matters are the amount of— a the payment; b any legal or associated costs incurred by the claimant in connection with the claim; and c any legal or associated costs incurred by or on behalf of the eligible person in connection with the claim. Circumstances in which payments are not to be made 8 Without limit to the Secretary of State’s powers under regulation 6, no payments may be made in respect of a relevant liability of an eligible person or a person falling within paragraph (3)(a) of that regulation where— a the eligible person has made an admission of liability, without first obtaining the Secretary of State’s written consent; b liability has been determined by a court in proceedings conducted by, or on behalf of, the eligible person, otherwise than in consultation with the Secretary of State; c the eligible person has not complied with a condition imposed by the Secretary of State relating to a claim; d a payment falls to be made by the eligible person and, without first obtaining the Secretary of State’s written consent, the eligible person agrees to— i be bound by the determination of any person or body as to the making of a payment by the eligible person in respect of a relevant liability; or ii make any other payment in respect of the relevant liability, otherwise than in the course of legal proceedings or in consequence of a settlement of legal proceedings agreed to by the eligible person; e the payment would be of an amount less than the amount which is, for the time being, specified by the Secretary of State as being the minimum amount to be paid in respect of a relevant liability of an eligible person; or f the eligible person has failed, whether fully or in part, to comply with a notice under regulation 10. Payments on account 9 1 Without limit to the powers of the Secretary of State under regulation 6, where a payment falls to be made by an eligible person in connection with a relevant liability and the Secretary of State has not yet determined whether a payment is to be made in respect of the relevant liability, the Secretary of State may make a payment on account to, or on behalf of, the eligible person in respect of the relevant liability. 2 Where the amount of any payment on account under paragraph (1) exceeds any amount subsequently determined under regulation 7 as being the amount of payment to be made in connection with a relevant liability of an eligible person, the excess is recoverable from the eligible person. 3 Where, in accordance with the powers in regulation 6, the Secretary of State determines that no payment is to be made, the whole of the amount of any payment on account made is recoverable from the eligible person. Information and assistance to be provided by eligible persons 10 1 For the purposes of the Scheme, the Secretary of State may, by notice in writing, require an eligible person to provide the Secretary of State with any assistance or information specified by the Secretary of State in the notice. 2 A notice under paragraph (1) may specify— a the date by which the specified assistance or information must be provided; and b the manner in which the assistance or information is to be provided. 3 An eligible person must comply with a notice under paragraph (1). Directions and guidance 11 The Secretary of State must make the following information available to eligible persons in such form and at such times as the Secretary of State considers appropriate— a any directions given by the Secretary of State under section 71(6) of the 2006 Act; and b any guidance given by the Secretary of State to any of the bodies specified in that section. We consent: Craig Whittaker Paul Maynard Two of the Lords Commissioners of Her Majesty’s Treasury, Her Majesty’s Treasury 20th February 2019 Matt Hancock Secretary of State, Department of Health and Social Care 20th February 2019