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The National Health Service (Personal Dental Services Agreements) Regulations 2005

Type Statutory-Instrument

Publication 2005-12-07

Last updated 2024-04-01

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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General

18

The contractor shall ensure that any prescription form for listed drugs, medicines or appliances issued by a prescriber complies as appropriate with the requirements in this Part.

Supply of drugs

19

(1) A presciber may supply to a patient such listed drugs, medicines or appliances as are required for immediate use before the issue of a prescription for such drugs, medicines or appliances in accordance with paragraph 20.

(2) A prescriber may personally administer to a patient any drug or medicine required for the treatment of that patient.

Issue of prescription forms

20

(1) A prescriber shall order listed drugs, medicines or appliances (other than those supplied under paragraph 19) as are needed for the treatment of any patient to whom it is providing services under the agreement by issuing to the patient a prescription form.

(2) The prescription form shall—

(a) be signed by the prescriber; and

(b) be issued separately to each patient to whom the contractor is providing services under the agreement,

and a separate prescription form shall be issued for each patient.

(3) For the purposes of this paragraph, “prescription form” means a form that is supplied for the purposes of paragraph (1) by NHS England.

Excessive prescribing

21

The contractor shall not prescribe drugs, medicines or appliances whose cost or quantity, in relation to any patient, is, by reason of the character of the drug, medicine or appliance in question, in excess of that which was reasonably necessary for the proper treatment of that patient.

PART 4 — PERSONS WHO PERFORM SERVICES

Dental Practitioners

22

A dental practitioner may perform dental services under the contract provided—

(a) that dental practitioner is included in the dental performers list held by NHS England; and

(b) that dental practitioner’s inclusion in that list is not subject to a suspension.

Dental care professionals

23

(1) Prior to the coming into force of the first regulations under section 36A(2) of the Dentists Act (professions complementary to dentistry)—

(a) a dental hygienist; or

(b) a dental therapist,

may perform dental services under the agreement provided he is enrolled in the appropriate register established in accordance with the Dental Auxiliaries Regulations 1986 .

(2) Upon the coming into force of the first regulations under section 36A(2) of the Dentists Act—

(a) a dental hygienist;

(b) a dental therapist; or

may perform dental services under the agreement provided he is—

(i) a dental care professional; and

(ii) his registration in the dental care professional register established under section 36B of the Dentists Act is not subject to a suspension.

Performers: further requirements

24

(1) No health care professional or other person other than one to whom paragraph 23 applies shall perform clinical services under the agreement unless he is appropriately registered with his relevant professional body and his registration is not subject to a suspension.

(2) Where—

(a) the registration of a dental practitioner, dental care professional or other health care professional; or

(b) a dental practitioner's inclusion in the dental performers list held by NHS England,

is subject to conditions, the contractor shall ensure compliance with those conditions in so far as they are relevant to the agreement.

(3) No health care professional or other person shall perform any clinical services under the agreement unless he has such clinical experience and training as are necessary to enable him properly to perform such services.

Conditions for employment and engagement: dental practitioners performing dental services

25

(1) A contractor must not employ or engage a dental practitioner to perform dental services under the contract unless the contractor has checked that the practitioner meets the requirements in paragraph 22.

(2) Where the employment or engagement of a dental practitioner is urgently needed and it is not possible to check the matters referred to in paragraph 22 in accordance with sub-paragraph (1)(b) before employing or engaging him, he may be employed or engaged on a temporary basis for a single period of up to seven days whilst such checks are undertaken.

Conditions for employment and engagement: persons performing dental services other than dental practitioners

26

(1) The contractor shall not employ or engage a dental care professional to perform dental services unless it has taken reasonable steps to satisfy itself that he has the clinical experience and training necessary to enable him to properly perform dental services and—

(a) prior to the coming into force of the first regulations under section 36A(2) of the Dentists Act, the contractor has checked that his name is on the roll of the appropriate register established in accordance with the Dental Auxiliaries Regulations 1986; and

(b) from the coming into force of the first regulations under section 36A(2) of the Dentists Act, the contractor has checked that—

(i) his name is included in the register of dental care professionals; and

(ii) his registration in the dental care professional register is not subject to a suspension.

(2) Where the employment or engagement of a person specified in sub-paragraph (1) is urgently needed and it is not possible to check the references referred to in sub-paragraph (1) (where it applies) before employing or engaging him, he may be employed or engaged on a temporary basis for a single period of up to seven days whilst such checks are undertaken.

(3) When considering a person's experience and training for the purposes of sub-paragraph (1), the contractor shall have regard in particular to—

(a) any post-graduate or post-registration qualification held by that person; and

(b) any relevant training undertaken by him and any relevant clinical experience gained by him.

Conditions for employment and engagement: all persons performing dental services

27

(1) The contractor shall not employ or engage a person to perform dental services under the agreement unless—

(a) that person has provided two clinical references that relate to two recent posts (which may include any current post) exercising the profession in which he seeks employment or engagement with the contractor which lasted for three months or more without a significant break, or where this is not possible, that person has provided a full explanation and alternative referees; and

(b) the contractor has checked and is satisfied with the references.

(2) Where the employment or engagement of a person falling within sub-paragraph (1) is urgently needed and it is not possible for the contractor to check the references in accordance with sub-paragraph (1)(b) before employing or engaging him, he may be employed or engaged on a temporary basis for a single period of up to 14 days whilst his references are checked and considered, and for an additional period of a further seven days if the contractor believes the person supplying those references is ill, on holiday or otherwise temporarily unavailable.

(3) Where the contractor employs or engages the same person on more than one occasion within a period of three months, it may rely on the references provided on the first occasion, provided that those references are not more than 12 months old.

Conditions for employment or engagement: persons assisting in the provision of services under the agreement

28

(1) Before employing or engaging any person to assist it in the provision of services under the agreement, the contractor shall take reasonable care to satisfy itself that the person in question is both suitably qualified and competent to discharge the duties for which he is to be employed or engaged.

(2) The duty imposed by sub-paragraph (1) is in addition to the duties imposed by paragraphs 25 to 27.

(3) When considering the competence and suitability of any person for the purpose of sub-paragraph (1), the contractor shall have regard, in particular, to—

(a) that person's academic and vocational qualifications;

(b) his education and training; and

Training

29

(1) The contractor shall ensure that for any dental practitioner or dental care professional who is—

(a) performing dental services under the contract; or

(b) employed or engaged to assist in the performance of such services,

arrangements are in place for the purpose of maintaining and updating his skills and knowledge in relation to the services which he is performing or assisting in performing.

(2) The contractor shall afford to each employee reasonable opportunities to undertake appropriate training with a view to maintaining that employee's competence.

Level of skill

30

The contractor shall carry out its obligations under the contract with reasonable care and skill.

Appraisal and assessment

31

The contractor shall ensure that any dental practitioner performing services under the agreement—

(a) participates in the appraisal system (if any) provided by NHS England; and

(b) co-operates with NHS England in relation to patient safety.

Sub-contracting of clinical matters

32

(1) The contractor shall not sub-contract any of its rights or duties under the agreement to any person in relation to clinical matters unless—

(a) it has taken reasonable steps to satisfy itself that—

(i) it is reasonable in all the circumstances; and

(ii) that the person is qualified and competent to provide the service; and

(b) it is satisfied in accordance with paragraphs 79 and 80 that the sub-contractor holds adequate insurance.

(2) Where the contractor sub-contracts any of its rights or duties under the agreement in relation to clinical matters, it shall—

(a) inform NHS England of the sub-contract as soon as is reasonable practicable; and

(b) provide NHS England with such information in relation to the sub-contract as it reasonably requests.

(3) Where the contractor sub-contracts clinical services in accordance with sub-paragraph (1), the parties to the agreement shall be deemed to have agreed a variation to the agreement which has the effect of adding to the list of the contractor's premises any premises which are to be used by the sub-contractor for the purpose of the sub-contract and paragraph 60 shall not apply.

(4) A contract with a sub-contractor must prohibit the sub-contractor from sub-contracting the clinical services it has agreed with the contractor to provide.

PART 5 — RECORDS, INFORMATION, NOTIFICATIONS AND RIGHTS OF ENTRY

Patient records

33

(1) The contractor shall ensure that a full, accurate and contemporaneous record is kept in the patient record in respect of the care and treatment given to each patient under the agreement, including treatment given to a patient who is referred to the contractor.

(2) The patient record may be kept in electronic form.

(3) The patient record shall include details of any private services (to the extent that it is provided with services under the agreement) and shall be kept with—

(a) a copy of any treatment plan or referral treatment plan given to the patient pursuant to paragraph 2 of Schedule 1 (referral services) or paragraph 8 of this Schedule;

(b) all radiographs, photographs and study casts taken or obtained by it as part of the services provided to that patient;

(d) where information is to be submitted to NHS England ... in accordance with paragraph 39 and that information is submitted or collated electronically—

(i) the written declaration form in respect of exemption under paragraph 1(1) of Schedule 12ZA to the Act duly made and completed in accordance with regulations made under section 79 of, and paragraph 7(a) to Schedule 12ZA to, that Act; and

(ii) a note of the evidence in support of that declaration; and

(e) the statement concerning any custom-made devices provided by any person as a consequence of regulation 15 of the Medical Devices Regulations 2002 (procedures for custom-made devices) in respect of services being provided to that patient.

(4) The patient record and the items referred to in sub-paragraph (3) shall be retained for a period of two years beginning with—

(a) the date on which—

(i) a course of treatment or orthodontic course of treatment is terminated; or

(ii) a course of treatment or an orthodontic course of treatment is completed; or

(b) in respect of courses of treatment or orthodontic courses of treatment not falling within paragraph (a)(i) or (a)(ii) the date by which no more services can be provided as part of that course of treatment or orthodontic course of treatment by virtue of paragraph 5(4)(b) of Schedule 1 or paragraph 7(4)(b) of this Schedule.

(5) Nothing in this paragraph shall affect any property right which the contractor may have in relation to the records, radiographs, photographs and study models referred to in this paragraph.

Confidentiality of personal data

34

The contractor shall nominate a person with responsibility for practices and procedures relating to the confidentiality of personal data held by it.

Patient information

35

(1) The contractor shall ensure that there is displayed in a prominent position in its practice premises, in a part to which patients have access—

(a) in respect of its practice based quality assurance system referred to in paragraph 78, a written statement relating to its commitment to the matters referred to in paragraph 78(4);

(b) such information relating to NHS Charges as is supplied by NHS England for the purposes of providing information to patients; and

(c) information about the complaints procedure which it operates in accordance with Part 6, giving the name and title of the person nominated by the contractor in accordance with paragraph 50(2)(a).

(2) The contractor shall—

(a) compile a document (in this paragraph called a “patient information leaflet”) which shall include the information specified in Schedule 4;

(b) review its patient information leaflet at least once in every period of 12 months and make any amendments necessary to maintain its accuracy; and

(3) The requirements in sub-paragraph (2) do not apply to any contractor to the extent that it provides services to persons detained in prison.

Provision of and access to information: the Board

36

(1) The contractor shall, at the request of NHS England—

(a) produce to NHS England or to a person authorised in writing by NHS England in such format, and at such intervals or within such time, as NHS England specifies; or

(b) allow NHS England, or a person authorised in writing by it to access,

the information specified in sub-paragraph (2).

(2) The information specified for the purposes of sub-paragraph (1) is—

(a) any information which is reasonably required by NHS England for the purposes of or in connection with the agreement; and

(b) any other information which is reasonably required in connection with NHS England’s functions,

and includes the contractor's patient records.

Requests for information from Patients' Forums

37

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Inquiries about prescriptions and referrals

38

(1) A contractor shall, subject to sub-paragraphs (2) and (3), sufficiently answer any inquiries whether oral or in writing from NHS England concerning—

(a) any prescription form issued by a prescriber;

(b) the considerations by reference to which prescribers issue such forms;

(d) the considerations by which the contractor makes such referrals or provides for them to be made on its behalf.

(2) An inquiry referred to in sub-paragraph (1) may only be made for the purpose either of obtaining information to assist NHS England to discharge its functions or of assisting the contractor in the discharge of its obligations under the agreement.

(3) The contractor shall not be obliged to answer any inquiry referred to in sub-paragraph (1) unless it is made—

(a) in the case of sub-paragraph (1)(a) or (1)(b), by an appropriately qualified health care professional; or

(b) in the case of sub-paragraph (1)(c) or (1)(d), by an appropriately qualified dental practitioner,

appointed in either case by NHS England to assist it in the exercise of its functions under this paragraph and the person produces, on request, written evidence that he is authorised by NHS England to make such inquiry on its behalf.

Notification of a course of treatment, orthodontic course of treatment etc.

39

(1) Subject to paragraph (2), the contractor shall, within two months of the date upon which—

(a) it completes a course of treatment in respect of mandatory or additional services;

(b) it completes a case assessment in respect of an orthodontic course of treatment that does not lead to a course of treatment;

(d) it completes a course of treatment in respect of orthodontic treatment;

(e) it completes a course of treatment in respect of mandatory services or additional services or orthodontic course of treatment is terminated; or

(f) in respect of courses not falling with sub-paragraph (d) or (e), no more services can be provided by virtue of paragraph 5(4)(b) of Schedule 1 (orthodontic course of treatment) or paragraph 7(4)(b) of this Schedule,

subject to sub-paragraph (5), send to NHS England by means of electronic submission, the information specified in paragraph (3).

(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) The information referred to in sub-paragraphs (1) and (2) comprise of —

(a) details of the patient to whom it provides services;

(b) details of the services provided (including any appliances provided) to that patient;

(d) in the case of a patient who is exempt from NHS Charges, the information required under sub-paragraph (4).

(4) In the case of a patient who is exempt from NHS Charges, the contractor must provide NHS England (or a person authorised on NHS England's behalf) with—

(a) such details of that exemption as NHS England may reasonably request; and

(b) the written declaration.

(5) NHS England may accept submission of the information mentioned in sub-paragraph (2) in paper form in such exceptional circumstances as NHS England may reasonably determine.

(6) In this regulation, ‘electronic submission’ means the submission of information electronically via a computer system approved by NHS England.

Annual report and review

40

(1) NHS England shall provide to the contractor an annual report relating to the agreement which shall contain the same categories of information for all persons who hold agreements with NHS England.

(2) Once NHS England has provided the report referred to in sub-paragraph (1), NHS England shall arrange with the contractor an annual review of its performance in relation to the agreement.

(3) NHS England shall prepare a draft record of the review referred to in sub-paragraph (2) for comment by the contractor and, having regard to such comments, shall produce a final written record of the review.

(4) A copy of the final record referred to in sub-paragraph (3) shall be sent to the contractor.

Notifications to the Relevant Body

41

(1) In addition to any requirements of notification elsewhere in these Regulations, the contractor shall notify NHS England in writing, as soon as reasonably practicable, of—

(a) any serious incident that, in the reasonable opinion of the contractor, affects or is likely to affect the contractor's performance of its obligations under the agreement; or

(b) any circumstances which give rise to NHS England’s right to terminate the agreement under paragraph 68 or 69(1).

(2) The contractor shall, unless it is impracticable for it to do so, notify NHS England in writing within 28 days of any occurrence requiring a change in the information about it published by NHS England in accordance with regulations made under section 16CA(3) of the Act (primary dental services).

(3) The contractor shall give notice in writing to NHS England when a dental practitioner who is performing or will perform services under the agreement—

(a) leaves the contractor, and the date upon which he left; or

(b) is employed or engaged by the contractor,

which shall include the name of the dental practitioner who has left, or who has been employed or engaged, together with his professional registration number.

Notice provisions specific to an agreement with a dental corporation

42

Where a dental corporation is a party to the agreement, it shall give notice in writing to NHS England forthwith when—

(a) it passes a resolution or a court of competent jurisdiction makes an order that the contractor be wound up;

(b) circumstances arise which might entitle a creditor or a court to appoint a receiver, administrator or administrative receiver for the contractor;

(d) the contractor is unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986 (definition of inability to pay debts).

Notifications to patients following a variation of the agreement

43

Where the agreement is varied in accordance with Part 9 of this Schedule and, as a result of that variation there is to be a change in the range of services provided by the contractor, the contractor shall ensure that there is displayed in a prominent position in its practice premises, in a part to which patients have access, written details of that change.

Entry and inspection by the Relevant Body

44

(1) Subject to—

(a) the conditions in sub-paragraph (2); and

(b) sub-paragraph (3),

the contractor shall allow persons authorised in writing by NHS England to enter and inspect the practice premises at any reasonable time.

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

(a) reasonable notice of the intended entry has been given;

(b) written evidence of the authority of the person seeking entry is produced to the contractor on request; and

(c) entry is not made to any premises or part of the premises used as residential accommodation without the consent of the resident.

(3) Where the contractor is providing services under the agreement in a prison, the contractor shall not be obliged to comply with sub-paragraph (1), or paragraph ... 46, if—

(a) the contractor has used its best endeavours to allow NHS England ... or the Care Quality Commission to enter and inspect the practice premises; but

(b) entry and inspection has been prevented by the prison authorities despite the contractor's best endeavours.

(4) In this paragraph “practice premises” includes a mobile surgery.

Entry and inspection by members of Patients' Forums

45

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Entry and inspection by the Commission for Healthcare Audit and Inspection

46

Subject to paragraph 44(3), the contractor shall allow persons authorised by the Care Quality Commission to enter and inspect the premises in accordance with section 62 of the Health and Social Care Act 2008 (entry and inspection).

PART 6 — COMPLAINTS

Complaints procedure

47

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Making of complaints

48

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Period for making complaints

49

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Further requirements for complaints procedures

50

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Co-operation with investigations

51

(1) The contractor ... shall co-operate with—

(a) any investigation of a complaint in relation to any matter reasonably connected with the provision of services under the agreement undertaken by—

(i) NHS England; and

(ii) the Health Service Commissioner; and

(b) any investigation of a complaint by an NHS body or local authority which relates to a patient or former patient of the contractor.

(2) In sub-paragraph (1)—

“NHS body” means NHS England, an NHS trust, an NHS foundation trust, ... a Local Health Board, a Health Board, a Health and Social Services Board, a Health and Social Services Trust or, a Health Board or Special Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978 ;

“local authority” means—any of the bodies listed in section 1 of the Local Authority Social Services Act 1970 (local authorities);the Council of the Isles of Scilly; ...a council constituted under section 2 of the Local Government etc. (Scotland) Act 1994 (constitution of councils); or a council of a county or county borough in Wales;

“Health Service Commissioner” means the person appointed Health Service Commissioner for England in accordance with section 1 of, and Schedule 1 to, the Health Service Commissioners Act 1993.

(3) The co-operation required by sub-paragraph (1) includes—

(a) answering questions reasonably put to the contractor by NHS England;

(b) providing any information relating to the complaint reasonably required by NHS England; and

(c) attending any meeting to consider the complaint (if held at a reasonably accessible place and at a reasonable hour, and due notice has been given) if the contractor's presence at the meeting is reasonably required by NHS England.

Provision of information

52

The contractor ... shall inform NHS England, at such intervals as NHS England requires, of the number of complaints it has received under the procedure established in accordance with this Part.

PART 7 — DISPUTE RESOLUTION

Local resolution of agreement disputes

53

In the case of any dispute arising out of, or in connection with, the agreement, the contractor and NHS England must make every reasonable effort to communicate and co-operate with each other with a view to resolving the dispute, before referring the dispute for determination in accordance with the NHS dispute resolution procedure (or, where applicable, before commencing court proceedings).

Dispute resolution: non-NHS contracts

54

(1) In the case of an agreement that is not an NHS contract, any dispute arising out of or in connection with the agreement, except matters dealt with under the complaints procedure pursuant to Part 6, may be referred for consideration and determination to the Secretary of State—

(a) if it relates to a period when the contractor was a health service body, by the contractor or by NHS England; or

(b) in any other case, by the contractor or, if the contractor agrees in writing, by NHS England.

(2) In the case of a dispute referred to the Secretary of State under sub-paragraph (1)—

(a) the procedure to be followed is the NHS dispute resolution procedure; and

(b) the parties agree to be bound by any determination made by the adjudicator.

NHS dispute resolution procedure

55

(1) The procedure specified in the following sub-paragraphs and paragraph 56 applies in the case of any dispute arising out of or in connection with the agreement which is referred to the Secretary of State—

(a) in accordance with section 4(3) of the 1990 Act (where the agreement is an NHS contract); or

(b) in accordance with paragraph 54(1) (where the agreement is not an NHS contract).

(2) Any party wishing to refer a dispute as mentioned in sub-paragraph (1) shall send to the Secretary of State a written request for dispute resolution which shall include or be accompanied by—

(a) the names and addresses of the parties to the dispute;

(b) a copy of the agreement; and

(3) Any party wishing to refer a dispute as mentioned in sub-paragraph (1) must send the request under sub-paragraph (2) within a period of three years beginning with the date on which the matter giving rise to the dispute happened or should reasonably have come to the attention of the party wishing to refer the dispute.

(4) Where the dispute relates to an agreement which is not an NHS contract, the Secretary of State may determine the matter herself or, if she considers it appropriate, appoint a person or persons to consider and determine it .

(5) Before reaching a decision as to who should determine the dispute, either under sub-paragraph (4) or under section 4(5) of the 1990 Act, the Secretary of State shall, within the period of seven days beginning with the date on which a matter was referred to her, send a written request to the parties to make in writing, within a specified period, any representations which they may wish to make about the matter.

(6) The Secretary of State shall give, with the notice given under sub-paragraph (5), to the party other than the one which referred the matter to dispute resolution a copy of any document by which the matter was referred to dispute resolution.

(7) The Secretary of State shall give a copy of any representations received from a party to the other party and shall in each case request (in writing) a party to whom a copy of the representations is given to make within a specified period any written observations which it wishes to make on those representations.

(8) Following receipt of any representations from the parties or, if earlier, at the end of the period for making such representations specified in the request sent under sub-paragraph (5) or (7), the Secretary of State shall, if she decides to appoint a person or persons to hear the dispute—

(a) inform the parties in writing of the name of the person or persons whom she has appointed; and

(b) pass to the person or persons so appointed any documents received from the parties under or pursuant to paragraph (2), (5) or (7).

(9) For the purpose of assisting him in his consideration of the matter, the adjudicator may—

(a) invite representatives of the parties to appear before him to make oral representations either together or, with the agreement of the parties, separately, and may in advance provide the parties with a list of matters or questions to which he wishes them to give special consideration; or

(b) consult other persons whose expertise he considers will assist him in his consideration of the matter.

(10) Where the adjudicator consults another person under sub-paragraph (9)(b), he shall notify the parties accordingly in writing and, where he considers that the interests of any party might be substantially affected by the result of the consultation, he shall give to the parties such opportunity as he considers reasonable in the circumstances to make observations on those results.

(11) In considering the matter, the adjudicator shall consider—

(a) any written representations made in response to a request under sub-paragraph (5), but only if they are made within the specified period;

(b) any written observations made in response to a request under sub-paragraph (7), but only if they are made within the specified period;

(d) the results of any consultation under sub-paragraph (9)(b); and

(e) any observations made in accordance with an opportunity given under sub-paragraph (10).

(12) In this paragraph, “specified period” means such period as the Secretary of State shall specify in the request, being not less than two, nor more than four weeks, beginning with the date on which the notice referred to is given, but the Secretary of State may, if she considers that there is good reason for doing so, extend any such period (even after it has expired) and, where she does so, a reference in this paragraph to the specified period is to the period as so extended.

(13) Subject to the other provisions of this paragraph and paragraph 56, the adjudicator shall have wide discretion in determining the procedure of the dispute resolution to ensure the just, expeditious, economical and final determination of the dispute.

Determination of dispute

56

(1) The adjudicator shall record his determination and the reasons for it in writing and shall give notice of the determination (including a record of the reasons) to the parties.

(2) In the case of any dispute referred for determination in accordance with paragraph 54(1), subsection (8) of section 4 of the 1990 Act shall apply as that subsection applies in the case of any dispute referred for determination in accordance with subsection (3) of section 4 of that Act.

Interpretation of Part 7

57

(1) In this Part, “any dispute arising out of, or in connection with, the agreement” includes any dispute arising out of, or in connection with, the termination of the agreement.

(2) Any term of the agreement that makes provision in respect of the requirements in this Part shall survive even where the agreement has terminated.

PART 8 — MID-YEAR REVIEW OF ACTIVITY UNDER AGREEMENTS

Mid-year reviews

58

(1) This paragraph and paragraph 59 apply where services are to be provided under the agreement from 1st April in any financial year.

(2) In this paragraph and paragraph 59, references to requirements to provide units of dental activity or units of orthodontic activity are to such requirements under the terms of the agreement giving effect to regulation 13 (units of dental activity) or 14 (units of orthodontic activity).

(3) NHS England shall, by 31st October in each financial year, determine the number of—

(a) units of dental activity; or

(b) units of orthodontic activity,

that the contractor has provided between 1st April and 30th September of that financial year based on the data provided to it by virtue of paragraph 39.

(4) Where NHS England determines under sub-paragraph (3) that the contractor has, between 1st April and 30th September, provided less than 30 per cent of the total number of—

(a) units of dental activity; or

(b) units of orthodontic activity,

that it is required to provide in that financial year, sub-paragraph (5) shall apply.

(5) Where this sub-paragraph applies, NHS England may—

(a) notify the contractor that it is concerned about the level of activity provided under the agreement in the first half of the financial year, setting out—

(i) the number of units of dental activity or units of orthodontic activity (as the case may be) that it has determined that the contractor has provided; and

(ii) the percentage of the total number of units of dental activity or units of orthodontic activity (as the case may be) required to be provided during the financial year that the number in sub-paragraph (i) represents; and

(b) require in that notification that the contractor participate in a mid-year review of its performance in relation to the agreement with NHS England.

(6) Where a mid-year review is required by NHS England under sub-paragraph (5), NHS England and the contractor shall discuss at that review—

(a) any written evidence the contractor puts forward to demonstrate that it has performed a greater number of units of dental activity or units of orthodontic activity during the first half of the financial year than those notified to it pursuant to sub-paragraph (5)(a)(i); and

(b) any reasons that the contractor puts forward for the level of activity in the first half of the financial year.

(7) NHS England shall prepare a draft record of the mid-year review for comment by the contractor and, having regard to such comments, shall produce a final written record of the review.

(8) A copy of the final record of the mid-year review shall be sent to the contractor.

Action the Relevant Body can take following a mid-year review

59

(1) Where, following the mid-year review and the provision of the final record of that review to the contractor, NHS England, having taken account of any evidence or reasons put forward by the contractor at that review, nevertheless has serious concerns that the contractor is unlikely to provide the number of—

(a) units of dental activity; or

(b) units of orthodontic activity,

that it is required to provide by the end of the financial year, NHS England shall be entitled to take either or both of the steps specified in paragraph (2).

(2) NHS England may—

(a) require the contractor to comply with a written plan drawn up by NHS England to ensure that the level of activity during the remainder of the financial year is such that the contractor will provide the number of units of dental activity or units of orthodontic activity it is required to provide; or

(b) withhold monies payable under the agreement.

(3) The maximum amount that may be withheld under sub-paragraph (2)(b) is—

(a) the amount that is payable under the agreement in respect of the number of units of dental activity or units of orthodontic activity required to be provided in a financial year, less

(b) the amount that would be payable under the agreement as a relevant proportion of that amount if the contractor provided in the whole of the financial year only twice the number of units of dental activity or orthodontic activity that it provided between 1st April and 30th September.

(4) Nothing in this paragraph shall prevent NHS England and the contractor agreeing to vary the contract in accordance with paragraph 61 to adjust—

(a) the level of activity to be provided under the agreement; or

(b) the monies to be paid by NHS England to the contractor under the agreement.

(5) Where NHS England withholds monies pursuant to paragraph (2), it shall ensure that it pays the withheld monies to the contractor as soon as possible following the end of the financial year where the contractor has—

(a) provided the number of units of dental activity or units of orthodontic activity required to be provided; or

(b) failed to provide that number of units of dental activity or units of orthodontic activity, but that failure amounts to 4 per cent or less of the total number of units of dental activity or units of orthodontic activity that ought to have been provided during that financial year (and therefore regulation 15 applies).

PART 9 — VARIATION AND TERMINATION OF AGREEMENTS

60

(1) Subject to paragraph 32(3), no amendment or variation shall have effect unless it is in writing and signed by or on behalf of NHS England and the contractor.

(2) In addition to the specific provision made in paragraphs 61A and 73, NHS England may vary the agreement without the contractor's consent where it—

(a) is reasonably satisfied that it is necessary to vary the agreement so as to comply with the Act, any regulations made pursuant to that Act, or any direction given by the Secretary of State pursuant to that Act; and

(b) notifies the contractor in writing of the wording of the proposed variation and the date upon which that variation is to take effect,

and, where it is reasonably practicable to do so, the date that the proposed variation is to take effect shall be not less than 14 days after the date on which the notice under paragraph (b) is served on the contractor.

Variation of an agreement: activity under the agreement

61

(1) Where the contractor or NHS England is of the opinion that there needs to be a variation to the number of—

(a) units of dental activity; or

(b) units of orthodontic activity,

to be provided under the agreement, sub-paragraphs (2) and (3) shall apply.

(2) The contractor or NHS England shall notify the other party to the agreement in writing of its opinion of the need for a variation, specifying in that notice the variation that it considers necessary, together with its reasons.

(3) Following service of the notice referred to in sub-paragraph (2), both parties shall use their best endeavours to communicate and co-operate with each other with a view to determining what (if any) variation should be made to the number of—

(a) units of dental activity; or

(b) units of orthodontic activity,

and any related variations to the agreement, including to the monies to be paid to the contractor under the agreement, and shall where appropriate effect the variation in accordance with paragraph 60.

Termination by agreement

62

NHS England and the contractor may agree in writing to terminate the agreement, and if the parties so agree, they shall agree the date upon which that termination should take effect and any further terms upon which the agreement should be terminated.

Termination on the death of an individual

63

(1) Where the agreement is with a single individual and that individual dies, the agreement shall terminate at the end of the period of 28 days after the date of his death unless, before the end of that period—

(a) subject to sub-paragraph (2), NHS England has agreed in writing with that individual's personal representatives that the agreement should continue for a further period, not exceeding 6 months after the end of the period of 28 days; and

(b) that individual's personal representatives have confirmed in writing to NHS England that they are employing or engaging one or more dental practitioners to assist in the provision of dental services under the agreement throughout the period for which it continues.

(2) Where NHS England is of the opinion that another individual may wish to enter into an agreement in respect the mandatory services which were provided by the deceased, the 6 month period referred to in sub-paragraph (1)(a) may be extended by a period not exceeding six months as may be agreed.

(3) Sub-paragraph (1) does not affect any other rights to terminate the agreement which NHS England may have under paragraphs 67 to 71.

Termination by the contractor

64

(1) A contractor may terminate the agreement by serving notice in writing on NHS England at any time.

(2) Where a contractor serves notice pursuant to sub-paragraph (1), the agreement shall terminate three months after the date on which the notice is served (“the termination date”), save that if the termination date is not the last calendar day of a month, the agreement shall instead terminate on the last calendar day of the month in which the termination date falls.

(3) This paragraph and paragraph 65 are without prejudice to any other rights to terminate the agreement that the contractor may have.

Late payment notices

65

(1) The contractor may give notice in writing (a “late payment notice”) to NHS England if NHS England has failed to make any payments due to the contractor in accordance with a term of the agreement that has the effect specified in regulation 17, and the contractor shall specify in the late payment notice the payments that NHS England has failed to make in accordance with that regulation.

(2) Subject to sub-paragraph (3), the contractor may, at least 28 days after having served a late payment notice, terminate the agreement by a further written notice if NHS England has still failed to make the payments that were due to the contractor and that were specified in the late payment notice served on NHS England pursuant to sub-paragraph (1).

(3) If, following receipt of a late payment notice, NHS England refers the matter to the NHS dispute resolution procedure within 28 days of the date upon which it is served with the late payment notice, and it notifies the contractor in writing that it has done so within that period of time, the contractor may not terminate the agreement pursuant to sub-paragraph (2) until—

(a) there has been a determination of the dispute pursuant to paragraph 56 and that determination permits the contractor to terminate the agreement; or

(b) NHS England ceases to pursue the NHS dispute resolution procedure,

Termination by the Relevant Body: general provisions

66

NHS England may only terminate the agreement in accordance with the provisions in this Part.

Termination by the Relevant Body: notice

67

(1) NHS England may terminate the agreement by serving notice in writing on the contractor at any time.

(2) Where a notice is served pursuant to sub-paragraph (1), the agreement shall terminate on the date provided for in the agreement.

Termination by the Relevant Body for the provision of untrue etc. information

68

NHS England may serve notice in writing on the contractor terminating the agreement forthwith, or from such date as may be specified in the notice if, after the agreement has been entered into, it comes to the attention of NHS England that written information provided to it by the contractor before the agreement was entered into in relation to the conditions set out in regulation 4 or 5 (and compliance with those conditions) was, when given, untrue or inaccurate in a material respect.

Termination by the Relevant Body on grounds of suitability etc.

69

(1) NHS England may serve notice in writing on the contractor terminating the agreement forthwith, or from such date as may be specified in the notice if—

(a) in the case of an agreement with an individual as a party, that individual;

(b) in the case of an agreement with a dental corporation, any director, chief executive or secretary of that corporation;

(d) in the case of a limited liability partnership, any member of that partnership.

(2) A person falls within this sub-paragraph if—

(a) he or it is the subject of a national disqualification;

(b) subject to sub-paragraph (3), he or it is disqualified or suspended (other than by an interim suspension order or direction pending an investigation or a suspension on the grounds of ill-health) from practising by any licensing body anywhere in the world;

(c) subject to sub-paragraph (4), he has been dismissed (otherwise than by reason of redundancy) from any employment by a health service body unless before NHS England has served a notice terminating the agreement pursuant to this paragraph, he is employed by the health service body that dismissed him or by another health service body;

(d) he or it is removed from, or refused admission to, a primary care list by reason of inefficiency, fraud or unsuitability (within the meaning of section 49F(2), (3) and (4) of the Act respectively) unless his name has subsequently been included in such a list;

(e) he has been convicted in the United Kingdom of—

(i) murder; or

(ii) a criminal offence other than murder, committed on or after 14th December 2001, and has been sentenced to a term of imprisonment of over six months;

(f) subject to sub-paragraph (5), he has been convicted outside the United Kingdom of an offence—

(i) which would, if committed in England and Wales, constitute murder; or

(ii) committed on or after 14th December 2001, which would if committed in England and Wales, constitute a criminal offence other than murder, and been sentenced to a term of imprisonment of over six months;

(g) he has been convicted of an offence referred to in Schedule 1 to the Children and Young Persons Act 1933 (offences against children and young persons with respect to which special provisions of this Act apply) or Schedule 1 to the Criminal Procedure (Scotland) Act 1995 (offences against children under the age of 17 years to which special provisions apply);

(h) he or it has—

(i) been made bankrupt or had sequestration of his estate awarded or is a person in relation to whom a moratorium period under a debt relief order (under Part 7A of the Insolvency Act 1986) applies unless ... he has been discharged from the bankruptcy or the sequestration or the bankruptcy order has been annulled;

(ii) been made the subject of a bankruptcy restrictions order or an interim bankruptcy restrictions order under Schedule 4A, or a debt relief restrictions order or interim debt relief restrictions order under Schedule 4ZB, to the Insolvency Act 1986 , unless that order has ceased to have effect or has been annulled;

(iii) made a composition or arrangement with, or granted a trust deed for, his or its creditors unless he or it has been discharged in respect of it; or

(iv) been wound up under Part 4 of the Insolvency Act 1986;

(i) there is—

(i) an administrator, administrative receiver or receiver appointed in respect of it; or

(ii) an administration order made in respect of it under Schedule B1 to the Insolvency Act 1986 ;

(j) he has been—

(i) removed from the office of charity trustee or trustee for a charity by an order made by the Charity Commissioners or the High Court on the grounds of any misconduct or mismanagement in the administration of the charity for which he was responsible or to which he was privy, or which he by his conduct contributed to or facilitated; or

(ii) removed under section 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990 (powers of the Court of Session to deal with management of charities) or under section 34 of the Charities and Trustee Investment (Scotland) Act 2005 (powers of Court of Session), from being concerned in the management or control of any body;

(k) he is subject to a disqualification order under the Company Directors Disqualification Act 1986 , the Companies (Northern Ireland) Order 1986 or to an order made under section 429(2)(b) of the Insolvency Act 1986 (failure to pay under county court administration order); or

(l) he has refused to comply with a request by NHS England for him to be medically examined on the ground that it is concerned that he is incapable of adequately providing services under the agreement.

(3) NHS England shall not terminate the agreement pursuant to sub-paragraph (2)(b) where it is satisfied that the disqualification or suspension imposed by a licensing body outside the United Kingdom does not make the person unsuitable to be—

(a) a contractor; ...

(b) in the case of an agreement with a dental corporation, any director, chief executive or secretary of that corporation;

(d) in the case of a limited liability partnership, any member of that partnership.

(4) NHS England shall not terminate the agreement pursuant to sub-paragraph (2)(c)—

(a) until a period of at least three months has elapsed since the date of the dismissal of the person concerned; or

(b) if, during the period of time specified in paragraph (a), the person concerned brings proceedings in any competent tribunal or court in respect of his dismissal, until proceedings before that tribunal or court are concluded,

and NHS England may only terminate the agreement at the end of the period specified in paragraph (b) if there is no finding of unfair dismissal.

(5) NHS England shall not terminate the agreement pursuant to sub-paragraph (2)(f) where it is satisfied that the conviction does not make the person unsuitable to be—

(a) a contractor; ...

(b) in the case of an agreement with a dental corporation, any director, chief executive or secretary of that corporation;

(d) in the case of a limited liability partnership, any member of that partnership.

Termination by the Relevant Body: patient safety and material financial loss

70

NHS England may serve notice in writing on the contractor terminating the agreement forthwith or with effect from such date as may be specified in the notice if—

(a) the contractor has breached the agreement and as a result of that breach, the safety of the contractor's patients is at serious risk if the agreement is not terminated; or

(b) the contractor's financial situation is such that NHS England considers that NHS England is at risk of material financial loss.

Termination by the Relevant Body: remedial notices and breach notices

71

(1) Where a contractor has breached the agreement other than as specified in paragraphs 68 to 70 and the breach is capable of remedy, NHS England shall, before taking any action it is otherwise entitled to take by virtue of the agreement, serve a notice on the contractor requiring it to remedy the breach (“remedial notice”).

(2) A remedial notice shall specify—

(a) details of the breach;

(b) the steps the contractor must take to the satisfaction of NHS England in order to remedy the breach; and

(3) The notice period shall, unless NHS England is satisfied that a shorter period is necessary to—

(a) protect the safety of the contractor's patients; or

(b) protect itself from material financial loss,

be no less than 28 days from the date that notice is given.

(4) Where NHS England is satisfied that the contractor has not taken the required steps to remedy the breach by the end of the notice period, NHS England may terminate the agreement with effect from such date as NHS England may specify in a further notice to the contractor.

(5) Where a contractor has breached the agreement otherwise than as specified in paragraphs 68 to 70 and the breach is not capable of remedy, NHS England may serve notice on the contractor requiring the contractor not to repeat the breach (“breach notice”).

(6) If, following a breach notice or a remedial notice, the contractor—

(a) repeats the breach that was the subject of the breach notice or the remedial notice; or

(b) otherwise breaches the agreement resulting in either a remedial notice or a further breach notice,

NHS England may serve notice on the contractor terminating the agreement with effect from such date as may be specified in that notice.

(7) NHS England shall not exercise its right to terminate the agreement under sub-paragraph (6) unless it is satisfied that the cumulative effect of the breaches is such that NHS England considers that to allow the agreement to continue would be prejudicial to the efficiency of the services to be provided under the agreement.

(8) If the contractor is in breach of any obligation and a breach notice or a remedial notice in respect of that default has been given to the contractor, NHS England may withhold or deduct monies which would otherwise be payable under the agreement in respect of that obligation which is the subject of the default.

Termination by the Relevant Body: additional provisions specific to contracts with qualifying bodies

72

(1) Where a party to the agreement is a dental corporation, company limited by shares, or limited liability partnership, if NHS England becomes aware that the dental corporation, company limited by shares, or limited liability partnership is carrying on any business which NHS England considers to be detrimental to the contractor's performance of its obligations under the agreement—

(a) NHS England shall be entitled to give notice to the contractor requiring that the dental corporation, company limited by shares, or limited liability partnership ceases carrying on that business before the end of a period of not less than 28 days beginning on the day on which the notice is given (“the notice period”); and

(b) if the contractor has not satisfied NHS England that the dental corporation, company limited by shares, or limited liability partnership has ceased carrying on that business by the end of the notice period, NHS England may, by a further written notice, terminate the agreement forthwith or from such date as may be specified in the notice.

(2) Where the contractor is a dental corporation or company limited by shares and on or after the coming into force for all purposes of article 39 of the Dentists Act Order during the existence of the agreement—

(a) the majority of the directors of the dental corporation or company limited by shares cease to be either dental practitioners or dental care professionals;

(b) the dental corporation or company limited by shares has been convicted of an offence under section 43(1) of the Dentists Act (directors of bodies corporate); or

(c) the dental corporation or company limited by shares, or a director or former director of that dental corporation or company limited by shares, has had a financial penalty imposed on it or him by the General Dental Council pursuant to section 43B (financial penalties in relation to bodies corporate) or 44 (further financial penalties on bodies corporate) of the Dentists Act,

NHS England may, by written notice, terminate the agreement if it considers that as a consequence the dental corporation or company limited by shares is no longer suitable to be a contractor.

(3) Where the contractor is a company limited by shares and the company ceases—

(a) to be a company limited by shares; or

(b) to satisfy the conditions in section 108(1A) of the 2006 Act,

NHS England shall serve notice in writing on the contractor terminating the contract forthwith.

(4) Where the contractor is a limited liability partnership and—

(a) the partnership ceases to be a limited liability partnership; or

(b) section 108(1B) or (1C) of the 2006 Act ceases to apply in respect of that partnership,

NHS England shall serve notice in writing on the contractor terminating the contract forthwith.

Agreement sanctions

73

(1) In this paragraph and paragraph 74, “agreement sanction” means—

(a) termination of specified reciprocal obligations under the agreement;

(b) suspension of specified reciprocal obligations under the agreement for a period of up to six months; or

(2) Where NHS England is entitled to terminate the agreement pursuant to paragraph 68, 69, 70, 71(4), 71(6) or 72, it may instead impose any of the agreement sanctions if NHS England is reasonably satisfied that the agreement sanction to be imposed is appropriate and proportionate to the circumstances which provide grounds for NHS England to terminate the agreement.

(3) If NHS England decides to impose an agreement sanction, it must notify the contractor of the agreement sanction that it proposes to impose, the date upon which that sanction will be imposed and provide in that notice an explanation of the effect of the imposition of that sanction.

(4) Subject to paragraph 74, NHS England shall not impose the agreement sanction until at least 28 days after it has served notice on the contractor pursuant to sub-paragraph (3) unless it is satisfied that it is necessary to do so in order to—

(a) protect the safety of the contractor's patients; or

(b) protect itself from material financial loss.

(5) Where NHS England imposes an agreement sanction, it shall be entitled to charge the contractor the reasonable costs of additional administration that NHS England has incurred in order to impose, or as a result of imposing, the agreement sanction.

Agreement sanctions and the NHS dispute resolution procedure

74

(1) If there is a dispute between NHS England and the contractor in relation to an agreement sanction that NHS England is proposing to impose, NHS England shall not, subject to sub-paragraph (4), impose the proposed agreement sanction except in the circumstances specified in sub-paragraph (2).

(2) If the contractor refers the dispute relating to the agreement sanction to the NHS dispute resolution procedure within 28 days beginning on the date on which NHS England served notice on the contractor in accordance with paragraph 73(3) (or such longer period as may be agreed in writing with NHS England), and notifies NHS England in writing that it has done so, NHS England shall not impose the agreement sanction unless—

(a) there has been a determination of the dispute pursuant to paragraph 56 and that determination permits NHS England to impose the agreement sanction; or

(b) the contractor ceases to pursue the NHS dispute resolution procedure,

whichever is the sooner.

(3) If the contractor does not invoke the NHS dispute resolution procedure within the time specified in sub-paragraph (2), NHS England shall be entitled to impose the agreement sanction forthwith.

(4) If NHS England is satisfied that it is necessary to impose the agreement sanction before the NHS dispute resolution procedure is concluded in order to—

(a) protect the safety of the contractor's patients; or

(b) protect itself from material financial loss,

NHS England shall be entitled to impose the agreement sanction forthwith, pending the outcome of that procedure.

Termination and the NHS dispute resolution procedure

75

(1) Where NHS England is entitled to serve written notice on the contractor terminating the agreement pursuant to paragraph 68, 69, 70, 71(4), 71(6) or 72, it shall, in the notice served on the contractor pursuant to those provisions, specify a date on which the agreement terminates that is not less than 28 days after the date on which NHS England has served that notice on the contractor unless sub-paragraph (2) applies.

(2) This sub-paragraph applies if NHS England is satisfied that a period less than 28 days is necessary in order to—

(a) protect the safety of the contractor's patients; or

(b) protect itself from material financial loss.

(3) In a case falling with sub-paragraph (1), where—

(a) the exceptions in sub-paragraph (2) do not apply;

(b) the contractor invokes the NHS dispute resolution procedure before the end of the period of notice referred to in sub-paragraph (1); and

the agreement shall not terminate at the end of the notice period but instead shall only terminate in the circumstances specified in sub-paragraph (4).

(4) The agreement shall only terminate if and when—

(a) there has been a determination of the dispute pursuant to paragraph 56 and that determination permits NHS England to terminate the agreement; or

(b) the contractor ceases to pursue the NHS dispute resolution procedure,

whichever is the sooner.

(5) If NHS England is satisfied that it is necessary to terminate the agreement before the NHS dispute resolution procedure is concluded in order to—

(a) protect the safety of the contractor's patients; or

(b) protect itself from material financial loss,

sub-paragraphs (3) and (4) shall not apply and NHS England shall be entitled to confirm, by written notice to be served on the contractor, that the agreement will nevertheless terminate at the end of the period of the notice it served pursuant to paragraph 68, 69, 70, 71(4), 71(6) or 72.

PART 10 — MISCELLANEOUS

Evidence of exemption under the Act

76

(1) Subject to sub-paragraph (2), the contractor shall ensure that it requests, in respect of a person who makes a declaration relating to exemption under paragraph 1(1) of Schedule 12ZA to the Act, evidence in support of that declaration.

(2) The contractor shall ensure that—

(a) a note of the type of evidence submitted is made; or

(b) in the case where no evidence is submitted, a note of that fact is made.

(3) Sub-paragraphs (1) and (2) do not apply where the contractor is satisfied that the person in respect of whom the declaration is made is under the age of 18 years.

Clinical governance arrangements

77

(1) Subject to paragraph (2), the contractor shall comply with such clinical governance arrangements as NHS England may establish in respect of contractors providing services under an agreement.

(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) The contractor shall nominate a person who manages services under the agreement to have responsibility for ensuring compliance with clinical governance arrangements.

(4) In this paragraph, “clinical governance arrangements” means arrangements through which the contractor endeavours to continuously improve the quality of its services and safeguard high standards of care by creating an environment in which clinical excellence can flourish.

Quality assurance system

78

(1) The contractor shall establish and operate a practice based quality assurance system which is applicable to all persons specified in sub-paragraph (2).

(2) The specified persons are—

(a) any dental practitioner who performs services under the agreement; and

(b) any other person employed or engaged by the contractor to perform or assist in the performance of services under the agreement.

(3) A contractor shall ensure that in respect of its practice based quality assurance system, it has nominated a person (who need not be connected with the contractor's practice) to be responsible for operating that system.

(4) In this paragraph, “a practice based quality assurance system” means one which comprises a system to ensure that—

(a) effective measures of infection control are used;

(b) all legal requirements relating to health and safety in the workplace are satisfied;

(d) any requirements of the General Dental Council in respect of the continuing professional development of dental practitioners are satisfied.

Insurance: negligent performance

79

(1) The contractor shall at all times have in force in relation to it an indemnity arrangement which provides appropriate cover.

(2) The contractor shall not sub-contract its obligations to provide clinical services under the agreement unless it has satisfied itself that the sub-contractor has in force in relation to it an indemnity arrangement which provides appropriate cover.

(3) In this paragraph—

(a) “indemnity arrangement” means a contract of insurance or other arrangement made for the purpose of indemnifying the contractor;

(aa) “appropriate cover” means cover against liabilities that may be incurred by the contractor in the performance of clinical services under the agreement, which is appropriate, having regard to the nature and extent of the risks in the performance of such services; and

(b) a contractor or sub-contractor shall be regarded as having in force in relation to it an indemnity arrangement if there is an indemnity arrangement in force in relation to an employee of its in connection with clinical services which that employee provides under the agreement or, as the case may be, sub-contract.

Public liability insurance

80

(1) The contractor shall at all times hold adequate public liability insurance in relation to liabilities to third parties arising under or in connection with the agreement which are not covered by an indemnity arrangement referred to in paragraph 79(1).

(2) In this paragraph, “indemnity arrangement” has the same meaning as in paragraph 79.

Gifts

81

(1) The contractor shall keep a register of gifts which are given to any of the persons specified in sub-paragraph (2) by or on behalf of—

(a) a patient;

(b) a relative of a patient; or

(c) any person who provides or wishes to provide services to the contractor or its patients in connection with the agreement,

and have, in its reasonable opinion, an individual value of more than £100.00.

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

(a) the contractor;

(b) where the agreement is with a dental corporation, a director, chief executive or secretary of the corporation;

(ba) where the agreement is with a company limited by shares, a director, chief executive or secretary of the company;

(bb) where the agreement is with a limited liability partnership, a member of the partnership;

(d) any dental practitioner engaged by the contractor for the purposes of the agreement;

(e) any spouse or civil partner of a contractor (where the contractor is an individual) or of a person specified in paragraphs (b) to (d); or

(f) any person whose relationship with the contractor (where the contractor is an individual) or with a person specified in paragraphs (b) to (d) has the characteristics of the relationship between husband and wife or civil partners.

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

(a) there are reasonable grounds for believing that the gift is unconnected with services provided or to be provided by the contractor;

(b) the contractor is not aware of the gift; or

(c) in a case falling within sub-paragraph (1)(c), the contractor is not aware that the donor wishes to provide services to the contractor.

(4) The contractor shall take reasonable steps to ensure that it is informed of gifts which fall within sub-paragraph (1) and which are given to any of the persons specified in sub-paragraph (2)(b) to (2)(f).

(5) The register referred to in sub-paragraph (1) shall include the following information—

(a) the name of the donor;

(b) in a case where the donor is a patient, the patient's National Health Service number or, if the number is not known, his address;

(d) the nature of the gift;

(e) the estimated value of the gift; and

(f) the name of the person or persons who received the gift.

(6) The contractor shall make the register available to NHS England on request.

Compliance with legislation and guidance

82

The contractor shall—

(a) comply with all relevant legislation; and

(b) have regard to all relevant guidance issued by NHS England and the Secretary of State.

Third party rights

83

The agreement shall not create any right enforceable by any person not a party to it.

Signing of documents

84

(1) In addition to any other requirements relating to such documents whether in these Regulations or otherwise, the contractor shall ensure that the documents specified in paragraph (2) include—

(a) the name and clinical profession of the professional who signed the document; and

(b) the name of the contractor on whose behalf it is signed.

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

(a) forms that are required to be completed pursuant to these Regulations, where such forms require a signature;

(b) prescription forms; and

SCHEDULE 4 — PATIENT INFORMATION LEAFLET

A patient leaflet shall include—

1

The name of the party or parties comprising the contractor.

2

In the case of an agreement with a dental corporation—

(a) the names of the directors, chief executive and secretary of that corporation, in so far as those positions exist in relation to the dental corporation; and

(b) the address of the corporation's registered office.

3

The full name of each person performing services under the agreement.

4

In the case of each person performing dental services under the agreement, his professional qualifications.

5

Whether the contractor undertakes the teaching or training of persons who provide dental services or who intend to do so.

6

The address of each of the practice premises.

7

The contractor's telephone and fax numbers and the address of its website (if any).

8

Whether the practice premises have suitable access for disabled patients and, if not, the alternative arrangements for providing services to such patients.

9

How to request services as a patient.

10

The rights of a patient to express a preference of practitioner in accordance with paragraph 2 of Schedule 3 and the means of expressing such a preference.

11

The services available under the agreement.

12

The normal surgery days and hours of the practice.

13

The arrangements for dental services for the hours and days that fall outside normal surgery hours (whether or not provided by the contractor) and how the patient may contact such services.

14

If the services in paragraph 13 are not provided by the contractor, the fact that NHS England referred to in paragraph 20 is responsible for commissioning the services.

15

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16

How patients may make a complaint or comment on the provision of services.

17

The rights and responsibilities of the patient, including keeping appointments.

18

The action that may be taken where a patient is violent or abusive to the contractor, its staff, persons present on the practice premises or in the place where treatment is provided under the agreement or other persons specified in paragraph 3(2) of Schedule 3.

19

Details of who has access to patient information (including information from which the identity of the individual can be ascertained) and the patient's rights in relation to disclosure of such information.

20

The name, postal and website address and telephone number of NHS England with which the contractor is a party to the agreement.

21

The full name, postal, email and website address, and telephone number of NHS England.

SCHEDULE 5 — MODIFICATION OF PATIENT PROVISIONS WHERE THE CONTRACTOR IS A PRIMARY CARE TRUST

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Signed

Signed by authority of the Secretary of State for Health

Rosie Winterton — Minister of State, — Department of Health — 2005-12-07

Explanatory note

(This note is not part of the Regulations)

Footnotes

[^f00001]: 1977 c. 49; section 28D was inserted by section 21(1) of the National Health Service (Primary Care) Act 1997 (c. 46) (“the 1997 Act”); and is amended by the Health Act 1999 (c. 8) (“the 1999 Act”), section 65(1) and Schedule 4, paragraphs 4 and 16(a); the National Health Service Reform and Health Care Professions Act 2002 (c. 17) (“the 2002 Act”), section 4(3), Schedule 3, paragraph 7(3); and the Health and Social Care (Community Health and Standards) Act 2003 (c. 43) (“the 2003 Act”), section 177(1) to (6) and section 184 and Schedule 11, paragraph 15. Section 28E is inserted by section 22(1) of the 1997 Act; and amended by the 1999 Act, section 65(2) and Schedule 5; the Health and Social Care Act 2001 (c. 15) (“the 2001 Act”), section 27(5)(a); the 2002 Act, section 4(3) and Schedule 3, paragraph 8; and the 2003 Act, section 177(7) to (11). Section 126(4) is amended by the National Health Service and Community Care Act 1990 (c. 19) (“the 1990 Act”), section 65(2); the 1999 Act, Schedule 4, paragraph 37(6); and the 2001 Act, Schedule 5, paragraph 5(13)(b). See section 128(1) of the Act as amended by the 1990 Act, section 26(2)(g) and (i), for the definitions of “prescribed” and “regulations”.

[^f00002]: 1990 c. 19.

[^f00003]: As regards Wales, the functions of the Secretary of State under sections 28D, 28E and 126(4) of the Act and section 4 of the 1990 Act were transferred to Wales under S.I. 1999/672, article 2 and Schedule 1, as amended by the 1999 Act, section 66(5) and as read with section 40(1) of the 2002 Act and section 197(1) of the 2003 Act.

[^f00004]: 1971 c. 80.

[^f00005]: S.I. 1986/887; relevant amending instrument is S.I. 2002/1671.

[^f00006]: Section 28X was inserted into the Act by section 179(1) of the 2003 Act.

[^f00007]: Section 16CB was inserted into the Act by section 171(1) of the 2003 Act.

[^f00008]: 1984 (c. 24) amended by section 41(1) of, and Schedule 2 paragraph 62 to, the 1997 Act, sections 31 and 37 of, and Schedule 9 to, the 2002 Act, section 187 of, and Schedule 12 to, the 2003 Act and S.I. 1987/2047, 1991/1705, 1996/1496, 1998/811 and 2840, 2001/3926, 2002/3135, 2003/833, 2004/1947 and 2005/2011.

[^f00009]: S.I. 2005/2011.

[^f00010]: Section 14 of the Dentists Act 1984 is prospectively substituted by the Dentists Act Order, article 6.

[^f00011]: Schedule 12ZA was inserted into the Act by section 183(2) of the 2003 Act.

[^f00012]: 1989 c. 41.

[^f00013]: Section 49S was inserted into the Act by section 27(1) of the 2001 Act.

[^f00014]: S.I 2005/ .

[^f00015]: Section 28M was inserted into the Act by section 172(1) of the 2003 Act.

[^f00016]: Section 4(2) was amended by the Health Authorities Act 1995 (c. 17), Schedule 1, paragraph 68, the Health Act 1999 (c. 8), Schedule 4, paragraph 76(a) and Schedule 5, the 2002 Act, Schedule 1, paragraph 40 and Schedule 5, paragraph 31.

[^f00017]: Section 41 of the Act was substituted by the 2001 Act, section 42(1) and amended by the 2002 Act, section 2(5) and Schedule 3, paragraphs 1 and 13, by the 2003 Act, section 184 and Schedule 11, paragraphs 7 and 18(1), (2) and (3) and by S.I. 2003/1590, article 3 and the Schedule, paragraph 3.

[^f00018]: Section 49N was inserted into the Act by section 25 of the 2001 Act. Section 28X was inserted by section 179 of the 2003 Act.

[^f00019]: S.I. 2001/3744 amended by S.I. 2002/2469.

[^f00020]: S.I. 2002/1920.

[^f00021]: S.I. 2005/.

[^f00022]: Section 46 was revoked by the 2001 Act, section 67, Schedule 5, paragraph 5 and Schedule 6, Part 1.

[^f00023]: See S.I. 2001/3738, article 2(5) and (6)(b), which sets out the prescribed cases for England and S.I. 2002/1919, article 2(2) and (3)(b), which sets out the prescribed cases for Wales.

[^f00025]: Section 28X was inserted into the Act by section 179(1) of the 2003 Act.

[^f00026]: Section 39 is amended by sections 1 and 2 of, paragraph 52 of Schedule 1 to, the Health Services Act 1980 (c. 53); sections 1 and 24 of, Schedule 9 to, the Health and Social Security Act 1984 (c. 48); section 9 of the 1999 Act; section 20 of the 2001 Act; and section 2 of, paragraphs 1 and 12 of Schedule 2 to, the 2002 Act. Section 42 is amended by section 3 of the National Health Service (Amendment) Act 1986 (c. 66); section 2 of, paragraph 30 of Schedule 1 to, the Health Authorities Act 1995 (c. 17); sections 20, 23, 43 and 67 of, Schedule 6 to, the 2001 Act; and section 2 of, paragraphs 1 and 16 of Schedule 2 to, the 2002 Act. Section 43 is amended by section 21 to the Health Services Act 1980; section 66 of, paragraph 18 of Schedule 9 to, the 1990 Act; section 2 of, paragraph 31 of Schedule 1 to, the Health Authorities Act 1995; sections 29 and 41 of, paragraph 14 of Schedule 2 to, the 1997 Act; section 1 of, paragraph 6 of Schedule 1 to, the Pharmacists (Fitness to Practice) Act 1997 (c. 19); section 20 of the 2001 Act; sections 2 and 42 of, paragraphs 1 and 17 of Schedule 2 to, the 2002 Act; and section 184 of, paragraphs 7 and 19 of Schedule 11 to, the 2003 Act.

[^f00027]: Section 43D was inserted into the Act by section 24 of the 2001 Act.

[^f00028]: Sections 29 and 36 were repealed by sections 175(2) and 196 of, and Schedule 14 Part 4 to, the 2003 Act.

[^f00029]: 1997 c. 46. Section 8ZA was inserted into this Act by section 26(2) of the Health and Social Care Act 2001 and repealed by section 196 and Schedule 14 Part 4 to the 2003 Act.

[^f00030]: 2001 c. 15.

[^f00031]: 2000 c. 6.

[^f00032]: Section 36B is prospectively inserted into the Dentists Act 1984 by article 29 of the Dentists Act Order.

[^f00033]: A “qualifying body” is defined in section 28D(2) of the Act.

[^f00034]: Section 49F was inserted into the Act by section 25 of the 2001 Act and amended by the 2002 Act, Schedule 2, paragraph 21 and the 2003 Act, Schedule 14, Part 2.

[^f00035]: 1933 c. 12; as amended by the Domestic Violence, Crime and Victims Act 2004 (c. 28), section 58(1), Schedule 10, paragraph 2; the Sexual Offences Act 2003 (c. 42), section 139 and Schedule 6, paragraph 7; the Criminal Justice Act 1988 (c. 33), section 170 and Schedule 15, paragraph 8 and Schedule 16, paragraph 16; and the Sexual Offences Act 1956 (c. 69), sections 48 and 51 and Schedules 3 and 4; and modified by the Criminal Justice Act 1988, section 170(1), Schedule 15, paragraph 9.

[^f00036]: 1995 c. 46.

[^f00037]: 1986 c. 45. Schedule 4A was inserted by section 257 of, and Schedule 20 to, the Enterprise Act 2002 (c. 40).

[^f00038]: 1990 c. 40.

[^f00039]: 1986 c. 46 as amended by the Insolvency Act 2000 (c. 39).

[^f00040]: S.I. 1986/1032 (N.I.6).

[^f00041]: 1986 c. 45.

[^f00042]: Section 17 of the Act was substituted by the Health Act 1999 (c. 8), section 12(1), and amended by the 2001 Act, section 67(1) and Schedule 5, paragraph 5(1) and (3) and the 2002 Act, section 1(3) and Schedule 1, paragraph 7. Section 28E(3A) was inserted by section 177(8) of the 2003 Act.

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