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The National Health Service (General Medical Services Contracts) (Wales) Regulations 2023

Type Welsh-Statutory-Instrument

Publication 2023-09-01

Last updated 2026-03-28

State In force

Jurisdiction Wales

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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(2) A certificate must not be issued where, for the condition to which the certificate relates, the patient is—

(a) being attended to by a medical practitioner who is not—

(i) employed or engaged by the contractor,

(ii) in the case of a contract with two or more persons practising in a partnership, one of those persons, or

(iii) in the case of a contract with a company limited by shares, one of the persons legally or beneficially owning shares in that company, or

(b) not being treated by or under the supervision of a health care professional.

(3) The exception in paragraph (2)(a) does not apply where the certificate is issued in accordance with—

(a) regulation 2(1) of the Social Security (Medical Evidence) Regulations 1976⁴⁹ (evidence of incapacity for work, limited capability for work and confinement), or

(b) regulation 2(1) of the Statutory Sick Pay (Medical Evidence) Regulations 1985⁵⁰ (medical information).

Finance

20

(1) The contract must contain a term which has the effect of requiring payments to be made under the contract promptly and in accordance with—

(a) the terms of the contract, and

(b) any other conditions relating to payment contained in directions given by the Welsh Ministers under section 12 (exercise of functions) or section 45 of the Act (GMS contracts: payments).

(2) The contract must contain a term to the effect that where, in accordance with directions given by the Welsh Ministers under section 12 (exercise of functions) or section 45 (GMS contracts: payments) of the Act, the Local Health Board is required to make a payment to a contractor under a contract but subject to conditions, those conditions must be a term of the contract.

(3) The obligation referred to in paragraph (1) is subject to any right the Local Health Board may have to set off against any amount payable to the contractor under the contract any amount—

(a) that is owed by the contractor to the Local Health Board under the contract; or

(b) that the Local Health Board may withhold from the contractor in accordance with the terms of the contract or any applicable provisions contained in directions given by the Welsh Ministers under section 45 of the Act.

Fees, charges and financial interests

21

(1) The contract must contain terms relating to fees, charges and financial interests which have the same effect as those set out in paragraphs (2) to (9).

(2) The contractor must not, either for itself or through any other person, demand or accept from any of its patients a fee or other remuneration for its own benefit or for the benefit of another person in respect of—

(a) the provision of any treatment whether under the contract or otherwise, or

(b) any prescription or repeatable prescription for any drug, medicine or appliance,

except in the circumstances set out in regulation 22.

(3) The contractor must not, either for itself or through any other person, demand or accept from any of its patients a fee or other remuneration for its own benefit or for the benefit of another person, for the completion, in relation to the patient’s mental health, of—

(a) the debt and mental health evidence form, or

(b) any examination of the patient or of the patient’s medical record in order to complete the form, the purpose of which is to assist creditors in deciding what action to take where the debtor has a mental health problem.

(4) The contractor must not, either for itself or through any other person, demand or accept from any of its patients a fee or other remuneration for its own benefit or for the benefit of another person, for the preparation or provision of—

(a) evidence that the individual is, or is at risk of being, a victim of domestic abuse which is intended to support an application by the individual for civil legal services, or

(b) any other evidence that the individual is, or is at risk of being, a victim of domestic abuse which is of a description specified in regulations made by the Welsh Ministers or Secretary of State.

(5) Subject to paragraph (6), where—

(a) a person—

(i) applies to a contractor for the provision of unified services, and

(ii) claims to be on that contractor’s list of patients, and

(b) the contractor has reasonable doubts about that person’s claim,

the contractor must give any necessary treatment to that person and may demand and accept from that person a reasonable fee in accordance with regulation 22(e).

(6) Where—

(a) a person from whom the contractor has received a fee under regulation 22(e) applies to the Local Health Board for a refund within 14 days beginning with the date of the payment of the fee (or within such longer period not exceeding 4 weeks as the Local Health Board may allow if it is satisfied that the failure to apply within 14 days was reasonable); and

(b) the Local Health Board is satisfied that that person was on the contractor’s list of patients when the treatment was given,

the Local Health Board may recover the amount of the fee from the contractor, by deduction from the contractor’s remuneration or otherwise, and must pay the amount recovered to the person who paid the fee.

(7) The contractor must in the provision of services to patients under the contract—

(a) provide information regarding services it provides otherwise than under the contract only where appropriate and in accordance with the restriction on advertising private services in paragraph 134 of Schedule 3,

(b) where it does provide such information, ensure that the information provided is fair and accurate, and

(c) where the other services are available to the patient as part of the health service established under section 1(1) of the Act (Welsh Ministers’ duty to promote health service), to inform the patient—

(i) that the services are so available,

(ii) of any charge that applies to that health service and, if no such charge applies, that the service is free, and

(iii) how to access that health service.

(8) The contractor must in making a decision—

(a) to refer a patient for other services under the Act, or

(b) to prescribe any drug, medicine or appliance to a patient,

make that decision without regard to its own financial interests.

(9) The contractor must not inform patients that any prescription for any drug, medicine or appliance must be dispensed only by the contractor or by a person with whom the contractor is associated.

Circumstances in which fees and charges may be made

22

The contractor may demand or accept (directly or indirectly) a fee or other remuneration—

(a) from any statutory body for services rendered for the purposes of that body’s statutory functions;

(b) from any body, employer or school for—

(i) a routine medical examination of persons for whose welfare the body, employer or school is responsible, or

(ii) examination of such persons for the purpose of advising the body, employer or school of any administrative action they might take;

(i) at accommodation made available in accordance with the provisions of paragraph 11 of Schedule 5 to the Act (accommodation and services for private patients), or

(ii) in a registered nursing home which is not providing services under the Act,

if, in either case, the person administering the treatment is serving on the staff of a hospital providing services under the Act as a specialist providing treatment of the kind the patient requires and if, within 7 days of giving the treatment, the contractor or the person providing the treatment supplies the Local Health Board, on a form provided by the Local Health Board for that purpose, with such information as the Local Health Board may require;

(d) under section 158 of the Road Traffic Act 1988 (payment for emergency treatment of traffic casualties);

(e) when the contractor treats a patient under regulation 21(5), in which case the contractor is entitled to demand and accept a reasonable fee (recoverable in certain circumstances under regulation 21(6)) for any treatment given, if the contractor gives the patient a receipt;

(f) for attending and examining (but not otherwise treating) a patient—

(i) at a police station, at the patient’s request, in connection with possible criminal proceedings against the patient;

(ii) for the purpose of creating a medical report or certificate, at the request of a commercial, educational or not-for-profit organisation;

(iii) for the purpose of creating a medical report required in connection with an actual or potential claim for compensation by the patient;

(g) for treatment consisting of an immunisation for which no remuneration is payable by the Local Health Board and which is requested in connection with travel abroad;

(h) for a medical examination—

(i) to enable a decision to be made whether or not it is inadvisable on medical grounds for a person to wear a seat belt, or

(ii) for the purpose of creating a report—

(aa) relating to a road traffic accident or criminal assault, or

(bb) that offers an opinion as to whether a patient is fit to travel;

(i) for testing the sight of a person to whom none of paragraphs (a), (b) or (c) of section 71(2) of the Act (arrangements for general ophthalmic services) applies (including by reason of regulations under section 71(8) and (9) of the Act).

(j) for prescribing or providing drugs or medicines for malaria chemoprophylaxis.

Activity and Appointment Data

23

(1) A contract must contain a term requiring contractors to—

(a) maintain their mapped appointments in the relevant section of the Primary Care Information Portal;

(b) review their submission data at least once a month;

(d) ensure their server is at all times switched on, maintained and available to enable the relevant software to extract the data.

(2) The activity and appointment data across the GP Collaborative must be discussed at GP Collaborative meetings by the authorised representatives from the member practices comprising the GP Collaborative, with the aim of developing measures across those member practices to manage demand and standardise good practice and, where applicable, data quality.

Dataset and business rules

24

A contract must contain a term requiring contractors to provide data, where applicable, in accordance with the business rules utilised within the Assurance Framework.

Contract assurance

25

(1) A contract must contain, in addition to the requirements in Schedule 3, a term requiring contractors to engage with the Local Health Board in the processes outlined in the latest published Assurance Framework by—

(a) providing returns and data, or facilitating the supply of data, as required for management of the contract and to satisfy contract assurance requirements,

(b) as required by the Assurance Framework, engaging with the Local Health Board in formal contract and governance practice review processes,

(c) following each formal contract and governance practice review, producing a Practice Contract and Governance Framework Response Plan to address within an agreed period any concerns raised by the Local Health Board, and

(d) if concerns need to be addressed through the escalation ladder levels of the Assurance Framework, working positively with the Local Health Board to resolve concerns.

(2) A contract must contain a term requiring the Local Health Board to follow the processes and take account of the principles outlined in the latest published Assurance Framework by—

(a) using the Assurance Framework’s nationally agreed indicators together with the self-reported assessment from the contractor, to identify the priorities in the contract assurance and governance process,

(b) determining the nature and depth of the formal contract and governance practice review taking account of the priorities identified in the contract assurance and governance process,

(d) giving verbal feedback to the contractor during the visit, including any requirements for the contractor to address any immediate concerns,

(e) sending written feedback in a Contract and Governance Visit Report to the contractor within 20 working days of the visit,

(f) evaluating a Practice Contract and Governance Framework Response Plan within 20 working days of receipt,

(g) agreeing any date for follow up with the contractor, including to review whether any immediate concerns had been addressed satisfactorily, and

(h) notifying the contractor if concerns need to be addressed through use of the escalation ladder levels of the Assurance Framework.

Sub-contracting

26

A contract must contain terms which prevent a contractor from sub-contracting any of its obligations under the contract in relation to clinical matters, or non-clinical matters directly affecting patients, except in the circumstances provided for by paragraph 76 of Schedule 3.

Variation of contracts

27

(1) Subject to paragraph (2), a variation of, or amendment to, the contract may only be made in the circumstances provided for in Part 11 of Schedule 3.

(2) Paragraph (1) does not prevent a variation of, or amendment to, a contract in the circumstances provided for in paragraphs 76(8), 109, 110, 111 and 124 of Schedule 3.

Termination of a contract

28

(1) A contract may only be terminated as provided for by Part 11 of Schedule 3.

(2) A contract must make suitable provision for the arrangements which are to have effect on termination of the contract, including the consequences (whether financial or otherwise) of the contract ending.

(3) The provisions dealing with the financial consequences of termination must include at least provisions having the effect specified in paragraphs (4) to (8) and must provide for those provisions to survive the termination of the contract.

(4) Subject to paragraphs (5) to (8), the Local Health Board’s obligation to make payments to the contractor in accordance with the contract ceases on the date of termination of the contract.

(5) On termination of the contract or termination for any reason, the Local Health Board must perform a reconciliation of the payments made by the Local Health Board to the contractor and the extent to which the contractor has performed the obligations under the contract to which those payments relate. The Local Health Board must also, in the event that the contractor has terminated the contract pursuant to paragraph 114 of Part 11 of Schedule 3 but has not performed its obligations under the contract for the duration of the notice period (or such shorter period as the Local Health Board and contractor have agreed in writing), be entitled to reflect in the reconciliation any additional costs that the Local Health Board has incurred in securing alternative services for the duration of that notice period ....

(6) The Local Health Board must serve the contractor with written details of the reconciliation as soon as reasonably practicable, and in any event no later than 28 days after the termination of the contract.

(7) If the contractor disputes the accuracy of the reconciliation, the contractor may refer the dispute to the NHS dispute resolution procedure within 28 days beginning on the date on which the Local Health Board served the contractor with written details of the reconciliation. That determination of the dispute is binding on the parties.

(8) Each party must pay the other any monies due within 3 months of the date on which the Local Health Board served the contractor with written details of the reconciliation, or the conclusion of the NHS dispute resolution procedure, as the case may be.

(9) The provisions dealing with the non-financial consequences of termination must include at least the provisions in paragraphs (10) and (11) and must provide for those provisions to survive the termination of the contract.

(10) The contract must provide that the termination of the contract, for whatever reason, is without prejudice to the accrued rights of either party under the contract.

(11) The contract must provide that on termination of the contract for any reason, the contractor must—

(a) subject to the requirements of this paragraph(11), cease performing any work or carrying out any obligations under the contract,

(b) co-operate with the Local Health Board to enable any outstanding matters under the contract to be dealt with or concluded in a satisfactory manner,

(c) co-operate with the Local Health Board to enable the contractor’s patients to be transferred to one or more other contractors or providers of unified services (or their equivalent), which must include—

(i) providing reasonable information about individual patients, and

(ii) delivering patient records

to such other appropriate person or persons as the Local Health Board specifies, and

(d) deliver up to the Local Health Board all property belonging to the Local Health Board including all documents, forms, computer hardware and software, drugs, appliances or medical equipment which may be in the contractor’s possession or control.

Other contractual terms

29

(1) A contract must, unless it is of a type or nature to which a particular provision does not apply, contain, other terms which have, the same effect as those specified in Schedule 3 except paragraphs 45(5) to (9), 46(5) to (17), 106(5) to (14), and 107.

(2) The paragraphs specified in paragraph (1) have effect in relation to the matters set out in those paragraphs.

PART 6 — Functions of Local Medical Committees

30

(1) The functions of a Local Medical Committee which are prescribed for the purposes of section 54(7) of the Act (Local Medical Committees) are—

(a) the consideration of any complaint made to it by any medical practitioner against a medical practitioner specified in paragraph (2) providing services under a contract in the relevant area involving any question of the efficiency of those services,

(b) the reporting of the outcome of the consideration of any such complaint to the Local Health Board with whom the contract is held in cases where that consideration gives rise to any concerns relating to the efficiency of services provided under a contract,

(c) the making of arrangements for the medical examination of a medical practitioner specified in paragraph (2), where the contractor or the Local Health Board is concerned that the medical practitioner is incapable of adequately providing services under the contract and it so requests with the agreement of the medical practitioner concerned, and

(d) the consideration of the report of any medical examination arranged in accordance with sub-paragraph (c) and the making of a written report as to the capability of the medical practitioner of adequately providing services under the contract to the medical practitioner concerned, the contractor and the Local Health Board with whom the contractor holds a contract.

(2) The medical practitioner referred to in paragraph (1)(a) and (c) is a medical practitioner who is—

(a) a contractor,

(b) one of two or more persons practising in partnership which holds a contract, or

(3) In this regulation, “the relevant area” means the area for which the Local Medical Committee is formed.

PART 7 — General transitional provision and saving, consequential amendments and revocations

General transitional provision and saving

31

(1) This regulation applies to—

(a) the exercise by the Local Health Board of any of its functions under the 2004 Regulations before the commencement date, and

(b) any rights or liabilities of the Local Health Board in respect of the exercise of any of its functions under the 2004 Regulations.

(2) Subject to paragraph (4), any act or omission concerning a contract to which the 2004 Regulations applied immediately before the commencement date in respect of any of the matters specified in paragraph (1), is to be treated as an act or omission concerning a contract to which these Regulations apply.

(3) Subject to paragraph (4), anything which, before the commencement date, is done or is in the process of being done under the 2004 Regulations concerning a contract to which the 2004 Regulations applied immediately before that date in respect of any of the matters specified in paragraph (1), is to be treated as if done or in the process of being done under these Regulations.

(4) Notwithstanding paragraphs (2) and (3) and the revocations provided for in Schedule 6, where the 2004 Regulations contain a provision for which there is no equivalent provision in these Regulations (“the relevant provision”), the 2004 Regulations, as they were in force immediately before the commencement date, are to continue to apply to the extent necessary for the purposes of—

(a) preserving any rights conferred or liabilities accrued by or under the relevant provision, or

(b) the assessment or determination of any rights or liabilities arising under or in accordance with the relevant provision.

(5) In this regulation—

“the commencement date” (“y dyddiad cychwyn”) means the date on which these Regulations come into force; ...

“contract” (“contract”) includes any contract to which the 2004 Regulations applied immediately before the commencement date under which medical services were provided before the commencement date (whether or not such services continued to be provided after that date).

Consequential amendments

32

Schedule 5 makes provision in respect of the amendments to secondary legislation which are consequential upon the coming into force of these Regulations.

Revocations

33

Schedule 6 makes provision in respect of the revocation of the enactments specified.

SCHEDULE 1 — List of Prescribed Medical Certificates

Description of medical certificate	Enactment under or for the purpose of which certificate required
1. To support a claim or to obtain payment either personally or by proxy; to prove incapacity to work or for self-support for the purposes of an award by the Secretary of State; or to enable proxy to draw pensions etc.	Naval and Marine Pay and Pensions Act 1865 (c. 73) Air Force (Constitution) Act 1917 (c. 51) Pensions (Navy, Army, Air Force and Mercantile Marine) Act 1939 (c. 83) Personal Injuries (Emergency Provisions) Act 1939 (c. 82) Social Security Administration Act 1992 (c. 5) Social Security Contributions and Benefits Act 1992 (c. 4) Social Security Act 1998 (c. 14)
2. To establish pregnancy for the purpose of obtaining welfare foods	Section 13 of the Social Security Act 1988 (benefits under schemes for improving nutrition: pregnant women, mothers and children)
3. To secure registration of still-birth	Section 11 of the Births and Deaths Registration Act 1953 (c. 20) (special provision as to registration of still-birth)
4. To enable payment to be made to an institution or other person in case of mental disorder of persons entitled to payment from public funds	Section 142 of the Mental Health Act 1983 (c. 20) (pay, pensions etc., of mentally disordered persons)
5. To establish unfitness for jury service	Juries Act 1974 (c. 23)
6. To support late application for reinstatement in civil employment or notification of non-availability to take up employment owing to sickness	Reserve Forces (Safeguard of Employment) Act 1985 (c. 17)
7. To enable a person to be registered as an absent voter on grounds of physical incapacity	Representation of the People Act 1983 (c. 2)
8. To support applications for certificates conferring exemption from charges in respect of drugs	National Health Service Act 2006 (c. 41)
9. To support a claim by or on behalf of a person with a significant cognitive impairment for exemption from liability to pay the Council Tax or eligibility for a discount in respect of the amount of Council Tax payable	Local Government Finance Act 1992 (c. 14)

SCHEDULE 2 — Further details about specific Unified Services

Cervical screening

1

(1) A contractor must—

(a) provide all the services described in sub-paragraph (2), and

(b) make the records specified in sub-paragraph (4) within the patient’s record kept in accordance with paragraph 78 of Schedule 3.

(2) The services referred to in sub-paragraph (1)(a) are—

(a) the provision of any necessary information and advice to assist relevant patients in making an informed decision as to participation in the Cervical Screening Wales Programme undertaken by Public Health Wales (the “Programme”),

(b) performing cervical screening tests on people who have agreed to participate in that Programme,

(d) ensuring that test results are followed up as clinically appropriate.

(3) For the purposes of sub-paragraph (2)(a) “relevant patients” means patients on the contractor’s patient list who have been identified by Public Health Wales as suitable candidates for a cervical screening test.

(4) The records referred to in sub-paragraph (1)(b) are—

(a) an accurate record of the cervical screening test undertaken, and

(b) the result of any test undertaken, and

Child health surveillance

2

(1) A contractor must in respect of any child under the age of 5 for whom it has responsibility under the contract—

(a) provide all the services described in sub-paragraph (2), other than any examination so described which a parent refuses to allow their child to undergo, until the date on which the child attains 5 years of age, and

(b) maintain the records specified in sub-paragraph (3).

(2) The services referred to in sub-paragraph (1)(a) are—

(a) the monitoring of the health, well-being and physical, mental and social development (which together are referred to in this paragraph as “development”) of a child under 5 years of age with a view to detecting any deviations from normal development—

(i) by the consideration of any information concerning the child received by or on behalf of the contractor, and

(ii) on any occasion when the child is examined or observed by or on behalf of the contractor (whether pursuant to paragraph (b) or otherwise);

(b) the examination of a child at a frequency that has been agreed with the Local Health Board in accordance with the nationally agreed evidence based programme set out in the latest clinical guidance in relation to the Newborn and Infant Physical Examination Cymru, and the Local Health Board or the contractor may seek the views of the relevant Local Medical Committee prior to reaching agreement on the appropriate frequency of such examinations.

(3) The records specified for the purposes of sub-paragraph (1)(b) must be an accurate record of—

(a) the development of the child while under 5 years of age, compiled as soon as is reasonably practicable following the first examination of that child and, where appropriate, amended following each subsequent examination, and

(b) the responses (if any) to offers made to the child’s parent for the child to undergo any examination referred to in sub-paragraph (2)(b).

Childhood vaccinations and immunisations services

3

(1) A contractor must comply with the requirements in sub-paragraphs (2) and (3).

(2) The contractor must—

(a) offer to provide to children for whom the contractor has responsibility under the contract all vaccinations and immunisations of a type and in the circumstances specified in the relevant Annex of the GMS Statement of Financial Entitlements;

(b) provide appropriate information and advice to patients and, where appropriate, their parents, about such vaccinations and immunisations;

(c) record in the patient’s record kept in accordance with paragraph 78 of Schedule 3 any refusal of the offer referred to in paragraph (a);

(d) where the offer is accepted, administer the vaccinations and immunisations and include in the patient’s record kept in accordance with paragraph 78 of Schedule 3—

(i) the name of the person who gave consent to the vaccination or immunisation and that person’s relationship to the patient,

(ii) the batch numbers, expiry date and title of the vaccine,

(iii) the date of administration,

(iv) in a case where two vaccines are administered in close succession, the route of administration and the injection site of each vaccine,

(v) any contra-indications to the vaccination or immunisation, and

(vi) any adverse reactions to the vaccination or immunisation.

(3) The contractor must ensure that all staff involved in administering vaccines are trained and their knowledge kept up to date in the recognition and initial treatment of anaphylaxis.

Contraceptive services

4

A contractor must make available to all its patients who so request them, those services described in sub-paragraphs (a) to (g)—

(a) the giving of advice about the full range of contraceptive methods,

(b) where appropriate, the medical examination of patients seeking such advice,

(c) the treatment of such patients for contraceptive purposes and the prescribing of contraceptive substances and appliances (excluding the fitting and implanting of intrauterine devices and implants),

(d) the giving of advice about emergency contraception and where appropriate, the supplying or prescribing of emergency hormonal contraception or, where the contractor has a conscientious objection to emergency contraception, prompt referral to another provider of primary medical services who does not have such conscientious objections,

(e) the provision of advice and referral in cases of unplanned or unwanted pregnancy, including advice about the availability of free pregnancy testing in the practice area and, where appropriate, where the contractor has a conscientious objection to the termination of pregnancy, prompt referral to another provider of primary medical services who does not have such conscientious objections,

(f) the giving of initial advice about sexual health promotion and sexually transmitted infections, and

(g) the referral as necessary for specialist sexual health services, including home testing or self-testing kits for sexually transmitted infections.

Maternity medical services

5

(1) A contractor must provide all the necessary maternity medical services to—

(a) patients who have been diagnosed as pregnant throughout the antenatal period;

(b) patients and their babies throughout the postnatal period, other than neonatal checks;

(c) patients whose pregnancy has terminated as a result of miscarriage or abortion or, where the contractor has a conscientious objection to the termination of pregnancy, the contractor must promptly refer the patient to another provider of primary medical services who does not have such conscientious objections.

(2) In this paragraph—

“antenatal period” (“cyfnod cynenedigol”) means the period from the start of the pregnancy to the onset of labour;

“maternity medical services” (“gwasanaethau meddygol mamolaeth”) means—in relation to patients (other than babies) all primary medical services relating to pregnancy, excluding intra partum care; andin relation to babies, any primary medical services necessary to their first 14 days of life;

“neonatal check” (“gwiriad newydd-anedig”) means the examination of the baby in the first month after birth;

“postnatal period” (“cyfnod ôl-enedigol”) means the period beginning with the conclusion of delivery of the baby or the patient’s discharge from secondary care services, whichever is the later, and ending with the 14th day after the birth.

Minor surgery

6

A contractor must—

(a) make available to patients, cryocautery, curettage and cautery of warts, verrucae and other skin lesions where clinically appropriate, and

(b) ensure that its record of any treatment provided under this paragraph includes—

(i) details of the minor surgery provided to the patient, and

(ii) the consent of the patient to that treatment.

Vaccinations and immunisations

7

(1) A contractor must—

(a) offer to administer or provide to patients all vaccinations and immunisations of a type and in the circumstances specified in the relevant Annex to the GMS Statement of Financial Entitlements and that are funded under the global sum;

(b) provide appropriate information and advice to patients and, where appropriate, to the parents of patients, about such vaccinations and immunisations;

(c) in relation to patients other than children and taking into account the individual circumstances of the patient, consider whether—

(i) immunisation ought to be administered by the contractor or by a health care professional employed or engaged by the contractor, or

(ii) a prescription form ought to be provided for the purpose of self-administration by the patient of the immunisation;

(d) record in the patient’s record any refusal of the offer mentioned in paragraph (a);

(e) where—

(i) the offer mentioned in paragraph (a) is accepted, and

(ii) in case of a patient who is not a child, the immunisation is to be administered by the contractor or another health care professional,

administer the immunisations and record the immunisation information in the patient’s record, using codes agreed by the Local Health Board for this purpose;

(f) where—

(i) the offer mentioned in paragraph (a) is accepted, and

(ii) in the case of a patient who is not a child, the immunisation is not to be administered by the contractor or another health care professional,

issue a prescription form for the purposes of self-administration by the patient.

(2) For the purposes of this paragraph—

“immunisation information” ... means—either—the patient’s consent to immunisation, orwhere another person consents to immunisation on behalf of the patient, the name of the person who gave that consent and their relationship to the patient;the batch number, expiry date and title of the vaccine,the date of administration of the vaccine,where two vaccines are administered by injections, in close succession, the route of administration and the injection site of each vaccine,any contraindications to the vaccine, andany adverse reactions to the vaccine.

(3) The contractor must ensure that all staff involved in administering vaccines are trained and their knowledge kept up to date in the recognition and initial treatment of anaphylaxis.

8

For the purposes of paragraphs 1 to 7 “a patient’s record” means the record which is kept in relation to a patient in accordance with paragraph 78 of Schedule 3.

SCHEDULE 3 — Other contractual terms

PART 1 — Provision of services

Premises, facilities and equipment

1

(1) The contractor must ensure that the premises used for the provision of services under the contract—

(a) are suitable for the delivery of those services,

(b) are sufficient to meet the reasonable needs of the contractor’s patients, and

(2) The requirement in sub-paragraph (1) is subject to any plan included in the contract in accordance with regulation 18(5) which sets out steps to be taken by the contractor to bring the premises up to the required standard.

(3) In relation to each service it provides, the contractor must provide such facilities and equipment as are necessary to enable it properly to perform that service.

Telephone services

2

(1) The contractor must not be a party to any contract or other arrangements under which the number for telephone services to be used—

(a) by patients to contact the practice for any purpose related to the contract, or

(b) by any other person to contact the practice in relation to services provided as part of the health service,

starts with the digits 084, 087, 090 or 091 or consists of a personal number, unless the service is provided free to the caller.

(2) The contractor must ensure their telephone lines are ...—

(a) staffed for the duration of core hours, unless any agreement has been reached between the Local Health Board and the contractor pursuant to regulation 18(7) which allows the use of an answer phone message for temporary periods, and

(b) answered by appropriately qualified members of the contractor’s staff that are located within the United Kingdom.

(3) In this paragraph, “personal number” means a telephone number which starts with the number 070 followed by a further 8 digits.

Cost of relevant calls

3

(1) The contractor must not enter into, renew or extend a contract or other arrangement for telephone services unless it is satisfied that, having regard to the arrangement as a whole, persons are not going to have to pay more to make relevant calls to the contractor’s practice than they would to make equivalent calls to a geographical number.

(2) In this paragraph—

“geographical number” (“rhif daearyddol”) means a number which has a geographical area code as its prefix;

“relevant calls” (“galwadau perthnasol”) means—calls made by patients to the contractor’s practice for any reason related to services provided under the contract, andcalls made by persons, other than patients, to the practice in relation to services provided as part of the health service.

Access

4

(1) The contractor must—

(a) have a telephone system with a recording function for incoming and outgoing lines, that stacks calls and allows for the analysis of call data,

(b) have a telephone introduction message recorded bilingually in Welsh and English that in total lasts no longer than 2 minutes,

(d) for the duration of core hours, ensure that patients can digitally request a non-urgent appointment or a call back, and that the necessary governance arrangements are in place for this process,

(e) publicise information via the practice’s online resource on—

(i) the access requirements specified in this paragraph 4, and

(ii) how patients can—

(aa) access the contractor’s services, and

(bb) request an urgent, routine and advanced consultation,

(f) offer a same day consultation for—

(i) children under 16 with acute presentations, and

(ii) patients clinically triaged as requiring an urgent assessment,

(g) offer pre-bookable appointments to take place during core hours; and

(h) actively signpost patients to appropriate services—

(i) available from the members of the contractor’s cluster,

(ii) provided or commissioned by the Local Health Board, or

(iii) available locally or nationally.

(2) The contractor must self-declare quarterly that the requirements in sub-paragraph (1) have been met and if requested be prepared to provide the evidence to the Local Health Board as required.

Attendance at practice premises

5

(1) The contractor must take steps to ensure that any patient who—

(a) has not previously made an appointment, and

(b) attends at the practice premises for unified services between 8.30am and 6.00pm on a working day,

is provided with such services by an appropriate health care professional on that day.

(2) Sub-paragraph (1) does not apply where—

(a) it is more appropriate for the patient to be referred elsewhere for services under the Act, or

(b) the patient is then offered an appointment to attend again within a time which is appropriate and reasonable having regard to all the circumstances and the patient’s health would not thereby be jeopardised.

Attendance outside practice premises

6

(1) Where the medical condition of a patient is such that, in the reasonable opinion of the contractor—

(a) attendance on the patient is required, and

(b) it would be inappropriate for the patient to attend at the practice premises,

the contractor must provide services to that patient at whichever of the places described in sub-paragraph (2) is in the contractor’s judgement the most appropriate.

(2) The places described in this sub-paragraph are—

(a) the place recorded in the patient’s medical records as being the patient’s last home address,

(b) such other place as the contractor has informed the patient and the Local Health Board is the place where the contractor has agreed to visit and treat the patient, or

(3) Nothing in this paragraph prevents the contractor from—

(a) arranging for the referral of the patient without first seeing the patient, in any case where the patient’s medical condition makes that course of action appropriate, or

(b) visiting the patient in circumstances where this paragraph does not place the contractor under an obligation to do so.

Newly registered patients

7

(1) Where a patient has been—

(a) accepted on a contractor’s list of patients, or

(b) assigned to that list by the Local Health Board,

the contractor must invite the patient to participate in a consultation either at the contractor’s practice premises or, if the patient’s medical condition so warrants, at one of the places referred to in paragraph 6(2).

(2) An invitation under sub-paragraph (1) must be issued by the contractor before the end of the period of 6 months beginning with the date of the acceptance of the patient on, or assignment of the patient to, the contractor’s list of patients.

(3) Where a patient (or, where appropriate, in the case of a patient who is a child, the child’s parent) agrees to participate in a consultation mentioned in sub-paragraph (1) the contractor must during the course of that consultation—

(a) make such inquiries and undertake such examinations as appear to the contractor to be appropriate in all the circumstances, and

(b) for all newly registered patients who have attained the age of 16 years, with the co-operation of the patient, complete the latest version of the national minimum dataset questionnaire issued by the Welsh Ministers in order to secure health screening information.

(4) Nothing in this paragraph affects the contractor’s other obligations under the contract in respect of the patient.

Patients not seen within 3 years

8

(1) This paragraph applies where a registered patient who has attained the age of 16 years but has not attained the age of 75 years—

(a) requests a consultation with the contractor, and

(b) has not attended either a consultation with, or a clinic provided by, the contractor within the period of 3 years prior to the date of the request.

(2) The contractor must—

(a) provide the patient with a consultation, and

(b) during that consultation, make such inquiries and undertake such examinations of the patient as the contractor considers appropriate in all the circumstances.

(3) Nothing in this paragraph affects the contractor’s other obligations under the contract in respect of the patient.

Patients aged 75 years and over

9

(1) Where a registered patient who requests a consultation—

(a) has attained the age of 75 years, and

(b) has not participated in a consultation within the year prior to the date of the request,

the contractor must provide such a consultation during which it must make such inquiries and undertake such examinations as it considers appropriate in all the circumstances.

(2) A consultation under sub-paragraph (1) must take place in the home of the patient where, in the reasonable opinion of the contractor, it would be inappropriate, as a result of the patient’s medical condition, for the patient to attend at the practice premises.

(3) Nothing in this paragraph affects the contractor’s other obligations under the contract in respect of the patient.

Clinical reports

10

(1) Where the contractor provides any clinical services, other than under a private arrangement, to a patient who is not on its list of patients, the contractor must, as soon as reasonably practicable, provide a clinical report relating to the consultation, and any treatment provided to the patient, to the Local Health Board.

(2) The Local Health Board must send any report received under sub-paragraph (1)—

(a) to the person with whom the patient is registered for the provision of unified services or their equivalent, or

(b) if the person referred to in paragraph (a) is not known to it, the Local Health Board in whose area the patient is resident.

Storage of vaccines

11

The contractor must ensure that—

(a) all vaccines are stored in accordance with the manufacturer’s instructions, and

(b) all refrigerators in which vaccines are stored have a maximum/minimum thermometer and that temperature readings are taken on all working days.

Infection control

12

The contractor must ensure that it has appropriate arrangements for infection control and decontamination.

Duty of co-operation in relation to supplementary services

13

(1) Where a contractor does not provide to its registered patients or to persons whom it has accepted as temporary residents a particular supplementary service it must comply with the requirements specified in sub-paragraph (2).

(2) The requirements specified in this sub-paragraph are that the contractor must in core hours—

(a) co-operate, insofar as is reasonable, with any person responsible for the provision of that service or those services, and

(b) comply with any reasonable request for information from such a person or from the Local Health Board relating to the provision of that service or those services.

Duty of co-operation in relation to out of hours services

14

The contractor must—

(a) ensure that any patient who contacts the contractor’s practice premises during the out of hours period is provided with information about how to obtain services during that period,

(b) ensure that the clinical details of all out of hours consultations received from the out of hours provider are reviewed by a clinician within the contractor’s practice on the same working day as those details are received by the practice or, exceptionally, on the next working day,

(c) ensure that any information requests received from the out of hours provider in respect of any out of hours consultations are responded to by a clinician within the contractor’s practice on the same day as those requests are received by the contractor’s practice, or on the next working day,

(d) take all reasonable steps to comply with any systems which the out of hours provider has in place to ensure the rapid, secure and effective transmission of patient data in respect of out of hours consultations, and

(e) agree with the out of hours provider a system for the rapid, secure and effective transmission of information about registered patients who, due to chronic disease or terminal illness, are predicted as more likely to present themselves for treatment during the out of hours period.

Membership of a cluster

15

A contract must contain a term which requires the contractor to be a member of a cluster.

Duty of co-operation: cluster working

16

(1) A contractor must comply with the requirements in sub-paragraph (2) where registered patients or temporary residents are provided with services by the contractor’s cluster.

(2) The requirements specified in this sub-paragraph are that the contractor must—

(a) co-operate, in so far as is reasonable, with any person responsible for the provision of the services,

(b) comply in core hours with any reasonable request for information from such a person or from the Local Health Board relating to the provision of the services,

(c) agree the mandate for the GP Collaborative representative at cluster meetings and take account of feedback from those cluster meetings,

(d) take reasonable steps to provide information to its registered patients about the services, including information on how to access the services and any changes to them, and

(e) ensure engagement in the planning and delivery of local services, as agreed within the cluster action plan, which includes suitable arrangements to enable the sharing of data, where appropriate safeguards are met, to support the delivery of the services and discussion of cluster funding and budgets.

(3) In this paragraph, and in paragraphs 18 and 19, “services” means primary medical services.

Membership of a GP Collaborative

17

(1) A contract must contain a term which has the effect of requiring the contractor to be a member of a GP Collaborative.

(2) A contractor must—

(a) appoint at least 1 health care professional with authority to act on the contractor’s behalf in the dealings between the contractor and the GP Collaborative to which the contractor belongs, and

(b) attend at least 4 meetings of the GP Collaborative to which the contractor belongs in each financial year (unless agreed otherwise in writing by the Local Health Board), or appoint a senior practice clinician, or where appropriate a senior administrator, employed by the practice to attend those meetings and to act on the contractor’s behalf in those meetings.

Contribution to clusters and GP Collaboratives

18

A contractor must—

(a) contribute relevant information, including demand and capacity planning, to the cluster ... Plan via the GP Collaborative, and the contribution must include information on demand and capacity planning,

(b) demonstrate how they have engaged in planning and delivery of local services agreed within the GP Collaborative’s contribution to the cluster plan, including evidence of wide partnership, multi-professional/multi-agency working, and development of integrated services, and

(c) contribute to delivering specific cluster-determined outcomes, including engagement in planning of local initiatives through engagement with the cluster via the GP Collaborative lead.

Demand and capacity

19

A contractor is required to engage with a GP Collaborative to assist the collaborative in—

(a) undertaking a population needs assessment of its patients,

(b) analysing the current services available to the GP Collaborative population, identifying any gaps in provision,

(d) undertaking a measurement of local health needs as determined by the GP Collaborative, and

(e) providing evidence of the demand and capacity assessment undertaken which is to be evidenced in the Cluster Plan.

Cessation of service provision: information requests

20

Where a contractor ceases to provide a supplementary service to its patients the contractor must comply with any reasonable request for information relating to the provision of that service, or those services, made by the Local Health Board or by any person with whom the Local Health Board intends to enter into a contract for the provision of such services.

Welsh Language

21

(1) Where the contractor provides medical services under the contract through the medium of Welsh, it must notify the Local Health Board in writing.

(2) The contractor must make available a Welsh language version of any document or form for use by patients and/or members of the public, provided by the Local Health Board.

(3) Where the contractor displays a new sign or notice in connection with medical services provided under the contract, the text on the sign or notice must be in English and Welsh, and the contractor may utilise the translation service offered by the Local Health Board for this purpose.

(4) The contractor must encourage the wearing of a badge, provided by the Local Health Board, by those delivering medical services under the contract who are Welsh speaking, to convey that they are able to speak Welsh.

(5) The contractor must encourage those delivering medical services under the contract to utilise information and/or attend training courses and events provided by the Local Health Board, so that they can develop—

(a) an awareness of the Welsh language (including awareness of its history and its role in Welsh culture), and

(b) an understanding of how the Welsh language can be used when delivering medical services under the contract.

(6) The contractor must encourage those delivering medical services under the contract to establish and record the Welsh or English language preference expressed by or on behalf of a patient.

PART 2 — Patients

List of patients

22

(1) The Local Health Board must prepare and keep up to date a list of the patients who have been—

(a) accepted by the contractor for inclusion in the contractor’s list of patients under paragraphs 22 to 25 and who have not been subsequently removed from that list under paragraphs 28 to 36, and

(b) assigned by the Local Health Board to the contractor’s list of patients under—

(i) paragraph 43(1)(a), or

(ii) paragraph 43(1)(b) (by virtue of a determination of the assessment panel under paragraph 45(7) which has not subsequently been overturned by a determination by the Welsh Ministers under paragraph 46 or by a court).

(2) The contractor must, upon receipt of a reasonable written request from the Local Health Board—

(a) take appropriate steps (including contacting patients where reasonably necessary to confirm that their patient data is correct) as soon as is reasonably practicable, to correct and update patient data held on the practice’s computerised clinical systems, and where necessary register or deregister patients to ensure that the patient list is accurate, and

(b) provide information relating to its list of patients to the Local Health Board as soon as is reasonably practicable and, in any event, no later than 30 days from the date on which the request was received by the contractor, in order to assist the Local Health Board in the exercise of its duties under sub-paragraph (1).

Application for inclusion in a list of patients

23

(1) Unless paragraph 26(1) applies, the contractor must, if the contractor’s list of patients is open, accept an application for inclusion in that list of patients made by or on behalf of any person whether or not resident in its practice area or included, at the time of that application, in the list of patients of another contractor or provider of primary medical services.

(2) If the contractor’s list of patients is closed, the contractor may only accept an application for inclusion in that list made by or on behalf of a person who is an immediate family member of a registered patient whether or not that person is resident in the contractor’s practice area or is included, at the time of that application, in the list of patients of another contractor or provider of primary medical services.

(3) Subject to sub-paragraph (4), an application for inclusion in a contractor’s list of patients must be made by the applicant, or a person authorised by the applicant, submitting to the contractor an application form (including an electronic application form). The contractor must not make proof of identification or address a prerequisite for an applicant to be included in the contractor’s list of patients (or make an application conditional upon the production of such proof of identification or address).

(4) An application may be made—

(a) where the patient is a child, on behalf of the patient by—

(i) either parent, or in the absence of both parents, the guardian or other adult who has care of the child,

(ii) a person duly authorised by a local authority to whose care the child has been committed under the Children Act 1989⁵¹, or

(iii) a person duly authorised by a voluntary organisation by which the child is being accommodated under the provisions of the Children Act 1989, or

(b) where the patient is an adult who lacks capacity to make the application, or to authorise the application to be made on their behalf, by—

(i) a relative of that person,

(ii) the primary carer of that person,

(iii) a donee of a lasting power of attorney granted by that person, or

(iv) a deputy appointed for that person by the court under the provisions of the Mental Capacity Act 2005⁵².

(5) Where a contractor accepts an application for inclusion in the contractor’s list of patients, the contractor must give notice in writing to the Local Health Board of that acceptance as soon as practicable.

(6) The Local Health Board must, on receipt of a notice given under sub-paragraph (5)—

(a) include the applicant in the contractor’s list of patients from the date on which the notice is received, and

(b) if it is the first time the applicant has been accepted as a registered patient by (or assigned by a Local Health Board to) a contractor or APMS contractor, give notice in writing of that acceptance to the applicant (or, in the case of a child or an adult who lacks capacity, the person making the application on their behalf).

Inclusion in list of patients: armed forces personnel

24

(1) Unless paragraph 26(1) applies, the contractor must, if its list of patients is open, include a person to whom sub-paragraph (2) applies in that list for a period of up to 2 years and paragraph 34(1)(b) does not apply in respect of any person who is included in the contractor’s list of patients by virtue of this paragraph.

(2) This sub-paragraph applies to a person who is—

(a) a serving member of the armed forces of the Crown who has received written authorisation from Defence Medical Services to receive primary medical services from the contractor’s practice, and

(b) living or working within the contractor’s practice area during the period in respect of which that written authorisation is given.

(3) Where the contractor has accepted a person to whom sub-paragraph (2) applies onto its list of patients, the contractor must—

(a) obtain a copy of the patient’s medical record, or a summary of that record, from Defence Medical Services, and

(b) provide regular updates to Defence Medical Services, at such intervals as are agreed with Defence Medical Services, about any care and treatment which the contractor has provided to the patient.

(4) At the end of the period of 2 years, or on such earlier date as the contractor’s responsibility for the patient has come to an end, the contractor must—

(a) notify Defence Medical Services in writing that the contractor’s responsibility for the patient has come to an end, and

(b) update the patient’s medical record, or summary of that record, and return it to Defence Medical Services.

Temporary residents

25

(1) Unless paragraph 26(1) applies, the contractor must, if its list of patients is open, accept a person as a temporary resident if that the person is—

(a) temporarily resident away from their normal place of residence and is not being provided with unified services (or their equivalent) under any other arrangement in the locality where that person is temporarily residing, or

(b) moving from place to place and not for the time being resident in any place.

(2) For the purposes of sub-paragraph (1), a person is to be regarded as temporarily resident in a place if, when that person arrives in that place, they intend to stay there for more than 24 hours but not more than 12 weeks.

(3) Where a contractor wants to terminate its responsibility for a person accepted by it as a temporary resident before the end of—

(a) 12 weeks, or

(b) such shorter period for which the contractor agreed to accept that person as a temporary resident,

the contractor must give notice of that fact to the person either orally or in writing and the contractor’s responsibility for that person ceases 7 days after the date on which notice is given.

(4) Where the contractor’s responsibility for a person as a temporary resident comes to an end, the contractor must give notice in writing to the Local Health Board of its acceptance of that person as a temporary resident—

(a) at the end of the period of 12 weeks beginning with the date on which the contractor accepted that person as a temporary resident, or

(b) if the contractor’s responsibility for that person as a temporary resident came to an end earlier than at the end of the 12 week period referred to in paragraph (a), at the end of that period.

Refusal of applications for inclusion in the list of patients or early termination of responsibility for temporary residents

26

(1) The contractor may only refuse an application made under paragraphs 23, 24 or 25 or terminate its responsibility for a person accepted by it as a temporary resident under paragraph 25(3) if it has reasonable grounds for doing so which do not relate to the applicant’s race, social class, age, religion or belief, sexual orientation, appearance, gender or gender reassignment, marriage or civil partnership, pregnancy or maternity, disability or medical condition.

(2) The reasonable grounds referred to in sub- paragraph (1) may, in the case of applications made under paragraph 23, include the ground that the applicant does not live in the contractor’s practice area.

(3) Where a contractor refuses an application made under paragraphs 23, 24 or 25 or terminates its responsibility for a person accepted by it as a temporary resident under paragraph 25(3), the contractor must give notice in writing of that refusal or termination and the reasons for it to the applicant (or, in the case of a child or an adult who lacks capacity, to the person who made the application on their behalf) before the end of the period of 14 days beginning with the date of its decision.

(4) The contractor must—

(a) keep a written record of—

(i) the refusal of any application made under paragraphs 23, 24 or 25 or termination its responsibility for a person accepted by it as a temporary resident under paragraph 25(3), and

(ii) the reasons for that refusal or termination, and

(b) make such records available to the Local Health Board on request.

Patient preference of practitioner

27

(1) Where the contractor has accepted an application made under paragraphs 23, 24 or 25 for inclusion in its list of patients, the contractor must record in writing any preference expressed by that person or a person making an application on behalf of that person to receive services from a particular performer, either generally or in relation to a specific condition.

(2) The contractor must endeavour to comply with any reasonable preference expressed under sub-paragraph (1) but need not do so if the preferred performer—

(a) has reasonable grounds for refusing to provide services to the person who expressed the preference, or

(b) does not routinely perform the service in question within the contractor’s practice.

Removal from the list at the request of the patient

28

(1) The contractor must notify the Local Health Board in writing of any request made by any person who is a registered patient to be removed from the contractor’s list of patients.

(2) Where the Local Health Board—

(a) receives notification from the contractor under sub-paragraph (1), or

(b) receives directly a request from the person to be removed from the contractor’s list of patients,

the Local Health Board must remove that person from the contractor’s list of patients.

(3) The removal of a person from a contractor’s list of patients in accordance with sub-paragraph (2) is to take effect on whichever is the earlier of—

(a) the date on which the Local Health Board is given notice of the registration of that person with another provider of unified services (or their equivalent), or

(b) 14 days after the date on which the notice given under sub-paragraph (1) or the request made under sub-paragraph (2) is received by the Local Health Board.

(4) The Local Health Board must, as soon as practicable, give notice in writing to—

(a) the person who requested the removal, and

(b) the contractor,

that the person’s name is to be, or has been, removed from the contractor’s list of patients on the date referred to in sub-paragraph (3).

(5) In this paragraph and in paragraphs 29(1)(b) and (10), 30(5) and (6), 32 and 35, a reference to a request received from or advice, information or notice required to be given to, a person must include a request received from or advice, information or notice required to be given to—

(a) in the case of a child—

(i) either parent, or in the absence of both parents, the guardian or other adult who has care of the child,

(ii) a person duly authorised by a local authority to whose care the child has been committed under the Children Act 1989, or

(iii) a person duly authorised by a voluntary organisation by which the child is being accommodated under the Children Act 1989, or

(b) in the case of an adult patient who lacks capacity to make the relevant request or receive the relevant advice, information or notice—

(i) a relative of that person,

(ii) the primary carer of that person,

(iii) a donee of a lasting power of attorney granted by that person, or

(iv) a deputy appointed for that person by the court under the Mental Capacity Act 2005.

Removal from the list at the request of the contractor

29

(1) Subject to paragraph 30, a contractor who has reasonable grounds for wanting a person to be removed from its list of patients which do not relate to the person’s race, social class, age, religion or belief, sexual orientation, gender or gender reassignment, marriage or civil partnership, pregnancy or maternity, appearance, disability or medical condition must—

(a) give notice in writing to the Local Health Board that it wants to have the person removed and provide within the notice an explanation of the grounds for the requested removal and why the removal would be reasonable, and

(b) subject to sub-paragraph (2), give notice in writing to the person of its specific reasons for requesting the removal of that person.

(2) Where in the reasonable opinion of the contractor—

(a) the circumstances of the person’s removal are such that it is not appropriate for a more specific reason to be given, and

(b) there has been an irrevocable breakdown in the relationship between the relevant person and the contractor,

the reason given to the patient under sub-paragraph (1) may consist of a statement that there has been such a breakdown.

(3) Except in the circumstances specified in sub-paragraph (4) a contractor may only request the removal of a person from its list of patients under sub-paragraph (1), if, during the period of 1 year ending with the date of the contractor’s request to the Local Health Board, the contractor has—

(a) warned that person of the risk of being removed from that list; and

(b) explained to that person the reasons for this.

(4) The circumstances referred to in sub-paragraph (3) are that—

(a) the reason for removal relates to a change of address,

(b) the contractor has reasonable grounds for believing that the giving of a warning under sub-paragraph (3)(a) would—

(i) be harmful to the person’s physical or mental health, or

(ii) put at risk the safety of one or more of the persons specified in sub-paragraph (5), or

(5) The persons referred to in sub-paragraph (4) are—

(a) the contractor, where the contractor is an individual medical practitioner,

(b) in the case of a contract with two or more persons practising in partnership, a partner in that partnership,

(c) in the case of a contract with a company limited by shares, a person who is both a legal and beneficial owner of shares in that company,

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