The National Health Service (Clinical Negligence Scheme for General Practice) Regulations 2019

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations establish the National Health Service Clinical Negligence Scheme for General Practice (the “Scheme”) and come into force on 1^st April 2019. The Regulations apply only in relation to services provided as part of the NHS in England.

Regulation 2 defines terms used in the Regulations and regulation 3 establishes the Scheme, sets outs its purpose and provides for the Secretary of State to administer the Scheme.

The indemnity provided under the Scheme covers the clinical negligence liabilities of GPs (and others working in a general practice setting) incurred on or after 1^st April 2019 in connection with the provision of NHS services provided by general practice. The Scheme applies from 1^st April 2019 in respect of all liabilities within its scope. This means that, from that date, GPs and others providing NHS services in a general practice setting will be indemnified under the Scheme in relation to such liabilities. There are no membership requirements or any other formal processes that need to be completed for the indemnity under the Scheme to apply.

The Scheme is an ‘occurrence-based’ scheme which means that, even if a person is no longer practising or working in general practice, liabilities incurred whilst they were practising continue to be covered.

The main NHS services within the scope of the Scheme are primary medical services that are provided under contractual arrangements and agreements made under Part 4 of the National Health Service Act 2006. The Scheme also provides indemnity for clinical negligence liabilities incurred in respect of other NHS services provided by general practice but only if a provider’s principal activity is to provide primary medical services. The intention is to provide a state indemnity scheme that covers all clinical negligence liabilities of any person carrying out an activity connected with the provision of NHS services as part of the delivery of such services by general practice.

The NHS services provided by general practice that are within scope of the Scheme but which are not primary medical services are referred to in the Regulations as “ancillary health services”. They include public health services provided as part of the NHS and other NHS services, for example, those commissioned directly from general practice by clinical commissioning groups or local authorities.

Where a GP practice’s principal activity is to provide primary medical services, GPs and others in the GP practice who are carrying out activities in connection with the provision of NHS services, will be covered under the Scheme in respect of clinical negligence liabilities arising from such activities. Conversely, where a large organisation is providing a package of NHS health and other services that include primary medical services, the organisation will be covered under the Scheme in relation to the primary medical services it provides but, if the organisation’s principal activity is not the provision of primary medical services, it will not be covered in respect of any other NHS services it provides.

Regulation 4 specifies the persons who are eligible persons for the purposes of the Scheme. This includes any person with whom a contractual arrangement or agreement has been made or entered into under Part 4 of the National Health Service Act 2006 Act (i.e. contracts and agreements under which primary medical services are to be provided). Where the provision of such services are sub-contracted out to another person, the sub-contractor is also an eligible person under the Scheme.

Clinically negligent acts or omissions of an eligible person’s employees or others engaged or permitted by an eligible person to carry out activities connected to the provision of primary medical services or other NHS services for the eligible person, are also covered under the Scheme. This would include locums or trainees working in a general practice setting.

Regulation 5 specifies the liabilities covered under the Scheme. These relate primarily to clinical negligence liabilities arising from a breach of a duty of care owed to a third party by an eligible person in connection with NHS activities that are within the scope of the Scheme.

Regulations 6 to 9 deal with payments under the Scheme, including regulation 8 which specifies the circumstances in which no payments are to be made under the Scheme unless the Secretary of State decides otherwise.

Regulation 10 enables the Secretary of State to require an eligible person to provide information and assistance to the Secretary of State for the purposes of the Scheme.

Under regulation 11, the Secretary of State is under a duty to make information available to eligible persons about directions or guidance given by the Secretary of State for the purposes of the Scheme.

An impact assessment relating to this instrument has been prepared but is not publically available as it contains legally privileged, confidential and commercially sensitive information. A summary impact assessment of the impact of these Regulations is published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk. Copies may also be obtained from the Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU.