OpenLegislation

The Medical Profession (Responsible Officers) Regulations 2010

S.I. 2010/2841 · Made 24 November 2010 · Extends to England, Wales and Scotland

Up to date with all changes known to legislation.gov.uk, revised to 28 March 2026.

Health Care And Associated Professions

Doctors

Made 24th November 2010

Coming into force 1st January 2011

The Secretary of State makes the following Regulations in exercise of the powers conferred by section 45A of the Medical Act 1983f1 and section 120 of the Health and Social Care Act 2008f2.

The Secretary of State has consulted the Scottish Ministers and the Welsh Ministers in accordance with section 45E(2) of the Medical Act 1983.

A draft of this instrument has been laid before and approved by a resolution of each House of Parliament in accordance with section 45E(4) of that Act and section 162(3)(e) of the Health and Social Care Act 2008.

Annotations to the whole text

Footnotes

f1

1983 c. 54; sections 45A to 45F were inserted by section 119 of the Health and Social Care Act 2008 (c. 14). Under section 45F, “appropriate authority” means the Secretary of State in relation to England and Wales or Scotland; section 45F also includes a definition of “prescribed”.

f2

2008 c. 14.

Contents

  1. Part 1: General
  2. 1Citation, commencement and interpretation
  3. 1AIntegrated care provider contracts
  4. 2Application of these Regulations to armed forces bodies
  5. 3Application and extent
  6. Part 2: Responsible Officers
  7. 4Designated bodies
  8. 5Duty to nominate or appoint responsible officers
  9. 6Duty to nominate or appoint additional responsible officers in cases of conflict of interest or appearance of bias
  10. 7Conditions for nomination or appointment of responsible officers and for remaining as responsible officers
  11. 8Nomination or appointment of one person as responsible officer for two or more designated bodies
  12. 9Nomination of responsible officer by the Secretary of State
  13. 10Connection between designated bodies and medical practitioners
  14. 11Responsibilities of responsible officers: prescribed connection under regulation 10
  15. 12Connection between designated bodies and medical practitioners who are responsible officers
  16. 13Responsibilities of responsible officers: prescribed connection under regulation 12
  17. 14Provision of resources to responsible officers
  18. 15Duty to have regard to guidance
  19. Part 3: Additional Responsibilities of Responsible Officers: England
  20. 16Additional responsibilities of responsible officers: prescribed connection under regulation 10
  21. 17Additional responsibilities of responsible officers: prescribed connection under regulation 12
  22. 18Duty to have regard to guidance
  23. 19Provision of resources to responsible officers
  24. Signature
  25. Schedule: Designated Bodies
  26. Part 1: Designated bodies
  27. 1Paragraph 1
  28. 2Paragraph 2
  29. 2AParagraph 2A
  30. 3Paragraph 3
  31. 4Paragraph 4
  32. 5Paragraph 5 Repealed
  33. 6Paragraph 6
  34. 7Paragraph 7
  35. 8Paragraph 8
  36. 9Paragraph 9
  37. 10Paragraph 10
  38. 11Paragraph 11
  39. 12Paragraph 12
  40. 13Paragraph 13
  41. 14Paragraph 14
  42. 14AParagraph 14A Repealed
  43. 14BParagraph 14B
  44. 14CParagraph 14C
  45. Part 2: Designated bodies which employ or contract with medical practitioners
  46. 15Paragraph 15
  47. 16Paragraph 16
  48. 17Paragraph 17
  49. 18Paragraph 18
  50. 19Paragraph 19
  51. 20Paragraph 20
  52. 21Paragraph 21
  53. 22Paragraph 22
  54. 23Paragraph 23 Repealed
  55. 24Paragraph 24
  56. 25Paragraph 25
  57. 25AParagraph 25A
  58. 25BParagraph 25B
  59. 25CParagraph 25C
  60. 25DParagraph 25D
  61. 25EParagraph 25E
  62. 26Paragraph 26
  63. 27Paragraph 27
  64. 28Paragraph 28
  65. 29Paragraph 29
  66. 30Paragraph 30
  67. 31Paragraph 31
  68. 32Paragraph 32
  69. 33Paragraph 33
  70. 34Paragraph 34
  71. 35Paragraph 35
  72. 36Paragraph 36
  73. 37Paragraph 37
  74. 38Paragraph 38
  75. Explanatory note

1Citation, commencement and interpretationI1

(1)

These Regulations may be cited as the Medical Profession (Responsible Officers) Regulations 2010 and shall come into force on 1st January 2011.

(2)

In these Regulations—

  • “the Act” means the Medical Act 1983;

  • F1“the 2006 Act” means the National Health Service Act 2006;

  • “armed forces bodies” means the bodies referred to in paragraphs 12 to 14 of the Schedule to these Regulations;

  • F2...

  • “hospital” has the same meaning as in section 275 of the National Health Service Act 2006f1;

  • “integrated care provider” means a person, other than a person specified in regulation 1A(3), who is party to an integrated care provider contract;

  • “integrated care provider contract” has the meaning given in regulation 1A;

  • “medical practitioner”, except in regulation 7(1)(b), means a registered medical practitionerf2;

  • F3“NHS body” means any of the bodies listed in paragraphs 1 to 6, 15 to 17 and 25C of the Schedule to these Regulations;

  • F4“NHS England” means the body corporate established under section 1H of the 2006 Act;

  • “non-departmental public body” means a body established by an Act of Parliament, an Act of the Scottish Parliament or by a statutory instrument made under any such Act to perform functions conferred on it under or by virtue of that Act or instrument or any other Act or instrument;

  • “practising privileges” means the grant, by a person managing a hospital, to a medical practitioner of permission to practise as a medical practitioner in that hospital;

  • “primary medical services” has the meaning given in regulation 1A(7);

  • “Scottish training governance body” means a body which exercises, on behalf of Scottish Ministers, functions conferred on Scottish Ministers that relate to education and training relating to the health service, including without prejudice to that generality, functions specified in section 47 of the National Health Service (Scotland) Act 1978f3;

  • F5“sufficient number of responsible officers” means the number of responsible officers required to ensure that each responsible officer appointed under regulation 5(2) has the capacity to carryout their responsibilities in regulations 11 and 13.

1AIntegrated care provider contractsF1 E

(1)

For the purposes of these Regulations, an integrated care provider contract is a contract entered into on or after 1st April 2019 which satisfies the following paragraphs.

(2)

An integrated care provider contract must be between—

(a)

one or more of the persons specified in paragraph (3); and

(b)

a person who is a provider of services specified in paragraph (5).

(3)

The persons specified in this paragraph are—

(a)

F2NHS England ;

(b)

one or more CCGs; or

(c)

one or more local authorities in England.

(4)

An integrated care provider contract must—

(a)

relate to the provision of two or more services specified in paragraph (5); and

(b)

not be a contract to which paragraph (6) applies.

(5)

The services specified in this paragraph are—

(a)

primary medical services;

(b)

secondary care services;

(c)

public health services; and

(d)

adult social care services,

and include such services where they are provided under arrangements entered into by an NHS body or a local authority in England by virtue of section 75 of the 2006 Act.

(6)

This paragraph applies to a contract for the provision of primary medical services to which directions given by the Secretary of State under section 98A of the 2006 Act (exercise of functions) relating to the provision of alternative provider medical services under section 83(2) of the 2006 Act apply.

(7)

In this regulation—

  • “adult social care services” means services provided pursuant to the exercise of the adult social services functions of a local authority in England;

  • “adult social services functions” means social services functions within the meaning of section 1A of the Local Authority and Social Services Act 1970 so far as relating to persons aged 18 or over, excluding any function to which Chapter 4 of Part 8 of the Education and Inspections Act 2006 applies;

  • F3...

  • F4“integrated care board” means an integrated care board established under Chapter A3 of Part 2 of the 2006 Act;

  • “primary medical services” means services which NHS England considers appropriate to secure the provision of under section 83(2) of the 2006 Act (primary medical services);

  • “public health functions” means—

    1. (a)

      the public health functions of the Secretary of State under the following provisions of the 2006 Act—

      1. (i)

        section 2A (Secretary of State’s duty as to protection of public health);

      2. (ii)

        section 2B (functions of local authorities and Secretary of State as to improvement of public health);

      3. (iii)

        paragraph 8 and 12 of Schedule 1 (further provision about the Secretary of State and services under this Act);

    2. (b)

      the public health functions of a local authority in England under the following provisions of the 2006 Act, and any regulations made under these provisions—

      1. (i)

        section 2B (functions of local authorities and Secretary of State as to improvement of public health);

      2. (ii)

        section 111 (dental public health);

      3. (iii)

        paragraphs 1 to 7B or 13 of Schedule 1 (further provision about the Secretary of State and services under this Act);

    3. (c)

      the public health functions of the Secretary of State that a local authority in England is required to exercise by virtue of regulations made under section 6C(1) (regulations as to the exercise by local authorities of certain public health functions) of the 2006 Act; or

    4. (d)

      the public health functions of the Secretary of State where they are exercised by NHS England, a CCG or a local authority in England, where those bodies are acting pursuant to arrangements made under section 7A (exercise of the Secretary of Health’s public health functions) of the 2006 Act;

  • “public health services” means services which are provided pursuant to the exercise of public health functions;

  • “secondary care services” means—

    1. (a)

      such services, accommodation or facilities as F5an integrated care board considers it appropriate to make arrangements for the provision of under or by virtue of section 3 (duties of integrated care boards as to commissioning of health services) or 3A (power of integrated care boards to commission certain health services) of the 2006 Act; or

    2. (b)

      such services or facilities as NHS England is required by the Secretary of State to arrange by virtue of regulations made under section 3B (power to require Board to commission certain health services) of the 2006 Act.

(8)

For the purposes of this regulation, any of the following is a local authority in England—

(a)

a county council;

(b)

a county borough council;

(c)

a district council;

(d)

a London borough council;

(e)

the Common Council of the City of London;

(f)

the Council of the Isles of Scilly.

2Application of these Regulations to armed forces bodiesI1

(1)

These Regulations apply to serving members of the armed forces bodies as if they were employed by those bodies.

(2)

For the purposes of paragraph (1) a member of a reserve force is to be treated as a serving member of the armed forces body which that reserve force supports, and for this purpose “reserve force” is to be construed in accordance with section 374 of the Armed Forces Act 2006f1.

(3)

Where the sole or main role of a medical practitioner employed by the Ministry of Defence is to work in support of any of the armed forces bodies, for the purposes of these Regulations that medical practitioner shall be treated as employed by that body.

3Application and extentI1

(1)

These Regulations, except Part 3, extend to England and Wales, and Scotland.

(2)

Part 3 (additional responsibilities of responsible officers) extends to England and Wales, and applies in relation to England only.

F1(3)

In so far as these Regulations are amended by Part 4 of the Amendments Relating to the Provision of Integrated Care Regulations 2019—

(a)

they extend to England and Wales; and

(b)

they apply in relation to England only.

4Designated bodiesI1

(1)

The designation of bodies for the purposes of section 45A of the Act is prescribed as follows.

(2)

The bodies listed in Part 1 of the Schedule to these Regulations are designated bodies.

(3)

The bodies listed in Part 2 of the Schedule to these Regulations, to the extent that they do not fall within Part 1 of the Schedule, are designated bodies only if and for so long as they employ or contract with one or more medical practitioners.

5Duty to nominate or appoint responsible officersF1I1

(1)

Subject to the following provisions of this regulation, every designated body must nominate or appoint a responsible officer.

(2)

F2NHS England F3, the Department of Health and Social Care and the General Council must nominate or appoint a sufficient number of responsible officers.

F4(2A)

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

(3)

When a responsible officer nominated or appointed in accordance with F5paragraphs (1) or (2) ceases to hold that position, subject to paragraph (4), the designated body must nominate or appoint a replacement as soon as reasonably practicable.

(4)

When a responsible officer nominated or appointed in accordance with paragraph (2) ceases to hold that position, F6the designated body is not required to nominate or appoint a replacement if, in its opinion, there remains a sufficient number of responsible officers appointed or nominated under that paragraph.

F7(4A)

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

(5)

Subject to paragraph (6), a body listed in Part 2 of the Schedule to these Regulations which is a designated body by virtue of regulation 4(3) is not required to nominate or appoint a responsible officer if, and for so long as, there is no prescribed connection under regulation 10 between that body and any medical practitioner.

(6)

Paragraph (5) does not apply where a medical practitioner would have, but for the application of regulation 12, a prescribed connection with a designated body under regulation 10.

6Duty to nominate or appoint additional responsible officers in cases of conflict of interest or appearance of biasI1

(1)

A designated body must nominate or appoint a second responsible officer where—

(a)

the designated body has nominated or appointed a responsible officer in accordance with regulation 5; and

(b)

there is a conflict of interest or an appearance of bias between that responsible officer and a medical practitioner in respect of whom that responsible officer has responsibilities under regulation 11 or 13 (“the relevant practitioner”).

(2)

In considering whom to nominate or appoint as a second responsible officer in accordance with paragraph (1), the designated body must ensure that there is no conflict of interest or appearance of bias between the person to be nominated or appointed and the relevant practitioner.

(3)

Where a second responsible officer has been nominated or appointed in accordance with paragraph (1), that responsible officer, and not the first responsible officer, has the responsibilities specified in regulation 11 or 13 in relation to the relevant practitioner.

7Conditions for nomination or appointment of responsible officers and for remaining as responsible officersI1

(1)

The following conditions must be satisfied in order for a person to be nominated or appointed as a responsible officer of a designated body under regulation 5 or 6—

(a)

the person must be a medical practitioner; and

(b)

the person must, at the time of appointment, have been a medical practitioner throughout the previous 5 years, and for this purpose “medical practitioner” means a person who was fully registered under the Act.

(2)

A responsible officer must continue to be a medical practitioner in order to remain as a responsible officer.

8Nomination or appointment of one person as responsible officer for two or more designated bodiesI1

The same person may be nominated or appointed as the responsible officer for two or more designated bodies where each designated body concerned is satisfied that—

(a)

the person satisfies the conditions in regulation 7;

(b)

the person has the capacity to carry out their responsibilities under regulation 11 or 13 for each body; and

(c)

no conflict of interest is likely to arise.

9Nomination of responsible officer by the Secretary of StateI1

(1)

Subject to the following provisions of this regulation, the Secretary of State may nominate a responsible officer for a designated body where—

(a)

the designated body has failed to nominate or appoint a responsible officer F1or a sufficient number of responsible officers in accordance with regulation 5 or 6; or

(b)

the designated body has nominated or appointed as a responsible officer a person who does not meet the conditions in regulation 7.

(2)

Before making a nomination under paragraph (1) for an NHS body in Scotland, the Secretary of State must consult the Scottish Ministers.

(3)

Before making a nomination under paragraph (1) for an NHS body in Wales, the Secretary of State must consult the Welsh Ministers.

(4)

Before making a nomination under paragraph (1) for an NHS Foundation Trust, the Secretary of State must consult F2NHS England.

10Connection between designated bodies and medical practitionersI1

(1)

For the purposes of section 45B of the Act, and subject to the following provisions of this regulation and to regulation 12, a designated body has a prescribed connection with a medical practitioner in the following circumstances—

F1(za)

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

(a)

the designated body is—

(i)

a postgraduate medical deanery and the medical practitioner is a doctor in training who is a member of a foundation or specialty training programme managed by that deanery; or

F2(ia)

F3NHS England and the medical practitioner is a doctor in training who is a member of a foundation or speciality training programme managed by NHS England; or

(ii)

a Scottish training governance body, and the medical practitioner is a doctor in training on a postgraduate medical programme which is managed by that Scottish training governance body and has been approved by the General Council;

F4(aa)

where none of the preceding sub-paragraphs apply, the designated body is an integrated care provider where the medical practitioner—

(i)

is employed by an integrated care provider to provide primary medical services; or

(ii)

provides health services under the 2006 Act (which are not primary medical services) for or on behalf of an integrated care provider or is engaged by such a provider to provide such services;

(b)

F5where none of the preceding sub-paragraphs apply, the medical practitioner is on the designated body’s medical performers list F6or ophthalmic performers list prepared in accordance with—

F7(i)

regulations 3(1)(a) or 3(1)(c) (as the case may be) of the National Health Service (Performers Lists) (England) Regulations 2013;

(ii)

regulation 3(1)(a) of the F8National Health Service (Performers Lists) (Wales) Regulations 2026; or

(iii)

regulation 4(1) of the National Health Service (Primary Medical Services Performers Lists) (Scotland) Regulations 2004f1;

F9(ba)

where none of the preceding sub-paragraphs apply, the designated body is F10the Department of Health and Social Care and the medical practitioner is employed by a local authority in England;

(bb)

where none of the preceding sub-paragraphs apply, the designated body is the Pathology Delivery Board and the medical practitioner is on the Home Office Register of Forensic Pathologists;

F11(c)

where none of the preceding sub-paragraphs apply, the medical practitioner is employed by the designated body;

(d)

the designated body is a locum agency referred to in paragraph 20 of the Schedule to these Regulations, and the medical practitioner contracts with that agency;

(e)

sub-paragraph (d) does not apply and—

(i)

the designated body is a primary care organisation, and for this purpose “primary care organisation” means a body referred to in paragraph 1, 2 or 6 of the Schedule to these Regulations;

(ii)

the medical practitioner contracts with a locum agency which is not a designated body referred to in paragraph 20 of the Schedule to these Regulations; and

(iii)

the medical practitioner’s address as registered with the General Council is located within the primary care organisation’s area;

F12(f)

the designated body owns or manages a hospital and the medical practitioner has responsibility for treating patients in that hospital in accordance with practising privileges for that hospital;

F13(g)

where none of the preceding sub-paragraphs apply, the designated body is—

(i)

the Faculty of Occupational Medicine,

(ii)

the Faculty of Public Health,

(iii)

the Faculty of Pharmaceutical Medicine,

(iv)

the Faculty of Homeopathy,

(v)

the Faculty of Medical Leadership and Management, or

(vi)

the British College of Aesthetic Medicine,

and the medical practitioner is a member of that body, or where the medical practitioner is a member of more than one of those bodies, that body with which the medical practitioner has been a member for the longest period;

(h)

where none of the preceding sub-paragraphs applies, the designated body is the Independent Doctors’ Federation and the practitioner is a member of that body.

(2)

Where a medical practitioner would otherwise have a prescribed connection with more than one designated body under paragraph (1), the prescribed connection is as follows—

(a)

in any case where sub-paragraph (a) of paragraph (1) (doctor in training) applies, the prescribed connection is in accordance with that sub-paragraph;

(b)

subject to sub-paragraph (c) and paragraph (4), in any case where sub-paragraph (b) of paragraph (1) (medical practitioner on a performers list) applies, the prescribed connection is in accordance with that sub-paragraph (b);

(c)

where a prescribed connection with more than one designated body arises under paragraph (1)(b)—

(i)

the medical practitioner has a prescribed connection with the designated body for whom the practitioner carries out most of their clinical practice; and

(ii)

if there is no significant difference in the amount of clinical practice which the practitioner carries out for each designated body, the medical practitioner has a prescribed connection with the designated body which is located the shortest distance from the practitioner’s address as registered with the General Council;

(d)

subject to sub-paragraph (e), in any case where sub-paragraph (c) of paragraph (1) (medical practitioner employed by a designated body) applies, the prescribed connection is in accordance with that sub-paragraph (c);

(e)

where a prescribed connection with more than one designated body arises under paragraph (1)(c)—

(i)

the medical practitioner has a prescribed connection with the designated body for whom the practitioner carries out most of their clinical practice; and

(ii)

if there is no significant difference in the amount of clinical practice which the practitioner carries out for each designated body—

(aa)

if one and only one of the designated bodies concerned is an NHS body, the medical practitioner has a prescribed connection with that body; and

(bb)

in any other case, the medical practitioner has a prescribed connection with the designated body which is located the shortest distance from the practitioner’s address as registered with the General Council;

(f)

where a prescribed connection with more than one designated body arises under paragraph (1)(d) (medical practitioner contracting with a locum agency), the medical practitioner has a prescribed connection with the designated body in respect of which the practitioner carried out most of their clinical practice in the previous calendar year;

(g)

in any other case—

(i)

the medical practitioner has a prescribed connection with the designated body for whom the practitioner carries out most of their clinical practice; and

(ii)

if there is no significant difference in the amount of clinical practice which the practitioner carries out for each designated body—

(aa)

if one and only one of the designated bodies concerned is an NHS body, the medical practitioner has a prescribed connection with that body; and

(bb)

in any other case, the medical practitioner has a prescribed connection with the designated body which is located the shortest distance from the practitioner’s address as registered with the General Council.

(3)

Where—

(a)

a medical practitioner (“M”) would otherwise have a prescribed connection with a designated body;

(b)

M has a prescribed connection with a designated body under regulations made under section 45A of the Act in relation to Northern Ireland; and

(c)

M carries out most of M’s clinical practice in Northern Ireland,

M does not have a prescribed connection with a designated body under this regulation.

(4)

Where a medical practitioner is on a designated body’s medical performers list in accordance with paragraph (1)(b) and is also employed by an armed forces body—

(a)

the medical practitioner has a prescribed connection with the designated body for whom the practitioner carries out most of their clinical practice; and

(b)

if there is no significant difference in the amount of clinical practice which the practitioner carries out for each designated body, the prescribed connection is with the armed forces body.

(5)

For the purposes of paragraphs (2)(c)(ii), (2)(e)(ii)(bb) and (2)(g)(ii)(bb), the location of a designated body is the address of its principal office.

11Responsibilities of responsible officers: prescribed connection under regulation 10I1

(1)

Subject to paragraph (6), the responsible officer for a designated body has the following responsibilities relating to the evaluation of the fitness to practise of every medical practitioner who has a prescribed connection with that body by virtue of regulation 10.

(2)

The responsibilities referred to in paragraph (1) are—

(a)

to ensure that the designated body carries out regular appraisals on medical practitioners in accordance with paragraph (3);

(b)

to establish and implement procedures to investigate concerns about a medical practitioner’s fitness to practise raised by patients or staff of the designated body or arising from any other source;

(c)

where appropriate, to refer concerns about the medical practitioner to the General Council;

(d)

where a medical practitioner is subject to conditions imposed by, or undertakings agreed with, the General Council, to monitor compliance with those conditions or undertakings;

(e)

to make recommendations to the General Council about medical practitioners’ fitness to practise;

(f)

to maintain records of practitioners’ fitness to practise evaluations, including appraisals and any other investigations or assessments.

(3)

The responsible officer must ensure that appraisals carried out under paragraph (2)(a) involve obtaining and taking account of all available information relating to the medical practitioner’s fitness to practise in the work carried out by the practitioner for the designated body, and for any other body, during the appraisal period.

(4)

Procedures under paragraph (2)(b) must include provision for the medical practitioner’s comments to be sought and taken into account where appropriate.

(5)

Responsible officers must co-operate with the General Council and any of its committees, or any persons authorised by the General Council, in connection with the exercise by them of any of their functions under Part 3A or 5 of the Act.

F1(6)

Where a responsible officer is nominated or appointed in accordance with regulation 5(2) (F2... sufficient number of responsible officers) the division of responsibilities under paragraph (1) for each responsible officer is to be determined by F3the designated body that nominated or appointed the responsible officer.

12Connection between designated bodies and medical practitioners who are responsible officersF1I1

(1)

A registered medical practitioner who is a responsible officer for a body referred to in column 1 of the table has, for the purposes of section 45B of the Act, a prescribed connection with the body, department or persons referred to in the corresponding entry in column 2 of that table.

Table

Column 1Column 2
(Body of which a registered medical practitioner is a responsible officer)(Body with which there is a prescribed connection)
1.

Any Government department or executive agency of a Government department in England, except—

(a)

the Department of Health and Social Care;

(b)

the United Kingdom Health Security Agency; and

(c)

the Medicines and Healthcare products Regulatory Agency.

1.

NHS England.

2.

Any non-departmental public body in England.

2.

NHS England.

3.

NHS England, except a registered medical practitioner who holds the post of National Medical Director of NHS England.

3.

NHS England.

4.

Any body in England not falling within the preceding entries, except the Faculty of Medical Leadership and Management.

4.

NHS England.

5.

Any body in Scotland.

5.

The Scottish Ministers.

6.

Any body in Wales.

6.

The Welsh Ministers.

(2)

A registered medical practitioner who is a responsible officer for—

(a)

the Department of Health and Social Care, except a medical practitioner who holds the post of Chief Medical Officer of that Department;

(b)

the United Kingdom Health Security Agency; or

(c)

the Medicines and Healthcare products Regulatory Agency,

has, for the purposes of section 45B of the Act, a prescribed connection with the Department of Health and Social Care.

(3)

A registered medical practitioner who is a responsible officer for—

(b)

the Department of Health and Social Care and who holds the post of Chief Medical Officer of that Department;

(c)

the Scottish Ministers;

(e)

the Welsh Ministers; or

(f)

NHS England and who holds the post of National Medical Director of NHS England,

has, for the purposes of section 45B of the Act, a prescribed connection with the General Council.

13Responsibilities of responsible officers: prescribed connection under regulation 12I1

(1)

Subject to paragraph (6), the responsible officer for a designated body has the following responsibilities relating to the evaluation of the fitness to practise of every medical practitioner who has a prescribed connection with that body by virtue of regulation 12.

(2)

The responsibilities referred to in paragraph (1) are—

(a)

to take all reasonably practicable steps to ensure that the medical practitioner undergoes regular appraisals in accordance with paragraph (3);

(b)

to take all reasonably practicable steps to investigate concerns about a medical practitioner’s fitness to practise raised by patients or staff of the body for whom the medical practitioner is the responsible officer, or arising from any other source;

(c)

where appropriate, to refer concerns about the practitioner to the General Council;

(d)

where a medical practitioner is subject to conditions imposed by, or undertakings agreed with, the General Council, to monitor compliance with those conditions or undertakings;

(e)

to make recommendations to the General Council about the medical practitioner’s fitness to practise;

(f)

to maintain records of the medical practitioner’s fitness to practise evaluations, including appraisals and any other investigations or assessments.

(3)

The responsible officer must take reasonably practicable steps to ensure that appraisals under paragraph (2)(a)—

(a)

are carried out by the body for whom the medical practitioner is the responsible officer; and

(b)

involve obtaining and taking account of all available information relating to the medical practitioner’s fitness to practise in the work carried out by the practitioner during the appraisal period.

(4)

Procedures under paragraph (2)(b) must include provision for the medical practitioner’s comments to be sought and taken into account where appropriate.

(5)

Responsible officers must co-operate with the General Council and any of its committees, or any persons authorised by the General Council, in connection with the exercise by them of any of their functions under Part 3A or 5 of the Act.

F1(6)

Where a responsible officer is nominated or appointed in accordance with regulation

5(2) (F2... sufficient number of responsible officers) the division of responsibilities under paragraph (1) for each responsible officer is to be determined by F3the designated body who nominated or appointed the responsible officer.

14Provision of resources to responsible officersI1

(1)

Subject to paragraph (2), each designated body must provide the responsible officer F1or responsible officers (as the case may be) nominated or appointed for that body with sufficient funds and other resources necessary to enable the officer to discharge their responsibilities for that body under regulations 11 and 13.

(2)

Where the designated body does not employ its responsible officer, the body must provide the resources referred to in paragraph (1) to—

(a)

where the responsible officer is employed, the employer of the officer; and

(b)

in any other case, the responsible officer.

(3)

Where a medical practitioner has a prescribed connection with a designated body by virtue of sub-paragraph (d), (e), (f), (g) or (h) of regulation 10(1), the medical practitioner must provide the designated body with sufficient funds necessary to enable the responsible officer nominated or appointed for that body to discharge their responsibilities under regulation 11 relating to that medical practitioner.

(4)

The designated body must determine the amount of the sufficient funds referred to in paragraph (3) and provide to the medical practitioner a written demand for the sum required to be paid.

15Duty to have regard to guidanceI1

In discharging their responsibilities under regulations 11 and 13, responsible officers shall have regard to the following—

(a)

guidance given by the Secretary of State in accordance with section 45C(2) of the Act; and

(b)

guidance given by the General Council, including Good Medical Practice and guidance on fitness to practise procedures, to the extent that it relates to the nomination or appointment of responsible officers or their prescribed responsibilities.

16Additional responsibilities of responsible officers: prescribed connection under regulation 10I1 E+W

(1)

Where a responsible officer has responsibilities under regulation 11 in respect of a medical practitioner who has a prescribed connection with a designated body in accordance with regulation 10, the responsible officer has the following additional responsibilities to the extent that the medical practitioner concerned is practising in England.

(2)

In relation to the entry by the designated body into contracts of employment or for the provision of services with medical practitioners, the responsible officer must—

(a)

ensure that medical practitioners have qualifications and experience appropriate to the work to be performed;

F1(aa)

ensure that medical practitioners have sufficient knowledge of the English language necessary for the work to be performed in a safe and competent manner;

(b)

ensure that appropriate references are obtained and checked;

(c)

take any steps necessary to verify the identity of medical practitioners;

(d)

where the designated body is a Primary Care Trust, manage admission to the performers list in accordance with the National Health Service (Performers Lists) Regulations 2004; and

(e)

maintain accurate records of all steps taken in accordance with sub-paragraphs (a) to (d).

(3)

In relation to monitoring medical practitioners’ conduct and performance, the responsible officer must—

(a)

review regularly the general performance information held by the designated body, including clinical indicators relating to outcomes for patients;

(b)

identify any issues arising from that information relating to medical practitioners, such as variations in individual performance; and

(c)

ensure that the designated body takes steps to address any such issues.

(4)

In relation to ensuring that appropriate action is taken in response to concerns about medical practitioners’ conduct or performance, the responsible officer must—

(a)

initiate investigations with appropriately qualified investigators;

(b)

ensure that procedures are in place to address concerns raised by patients or staff of the designated body or arising from any other source;

(c)

ensure that any investigation into the conduct or performance of a medical practitioner takes into account any other relevant matters within the designated body;

F2(d)

where the designated body is F3NHS England, manage admission to the medical performers list in accordance with the National Health Service (Performers Lists) Regulations 2013;

(e)

ensure that a medical practitioner who is subject to procedures under this paragraph is kept informed about the progress of the investigation;

(f)

ensure that procedures under this paragraph include provision for the medical practitioner’s comments to be sought and taken into account where appropriate;

(g)

where appropriate—

(i)

take any steps necessary to protect patients;

(ii)

recommend to the medical practitioner’s employer that the practitioner should be suspended or have conditions or restrictions placed on their practice; and

(h)

identify concerns and ensure that appropriate measures are taken to address these, including but not limited to—

(i)

requiring the medical practitioner to undergo training or retraining;

(ii)

offering rehabilitation services;

(iii)

providing opportunities to increase the medical practitioner’s work experience;

(iv)

addressing any systemic issues within the designated body which may have contributed to the concerns identified;

(i)

maintain accurate records of all steps taken in accordance with this paragraph.

17Additional responsibilities of responsible officers: prescribed connection under regulation 12I1 E+W

(1)

Where a responsible officer has responsibilities under regulation 13 in respect of a medical practitioner who has a prescribed connection with a designated body in accordance with regulation 12, the responsible officer has the following additional responsibilities to the extent that the medical practitioner concerned is practising in England.

(2)

The responsible officer must ensure that the medical practitioner has established systems and procedures which will enable them to carry out their responsibilities under regulation 16(2) effectively.

(3)

In relation to monitoring medical practitioners’ conduct and performance, the responsible officer must—

(a)

review regularly the general performance information held by the designated body, including clinical indicators relating to outcomes for patients;

(b)

identify any issues arising from that information relating to medical practitioners, such as variations in individual performance; and

(c)

take all reasonably practicable steps to ensure that the designated body addresses any such issues.

(4)

In relation to ensuring that appropriate action is taken in response to concerns about medical practitioners’ conduct or performance, the responsible officer must take all reasonably practicable steps to—

(a)

ensure that the body for whom the medical practitioner is the responsible officer initiates investigations with appropriately qualified investigators;

(b)

ensure that procedures are in place to address concerns raised about the medical practitioner by patients or staff of that body or arising from any other source;

(c)

ensure that any investigation into the conduct or performance of a medical practitioner takes into account any other relevant matters within that body;

(d)

consider the need for further monitoring of the practitioner’s conduct and performance and take steps to ensure that this takes place where appropriate;

(e)

ensure that a medical practitioner who is subject to procedures under this paragraph is kept informed about the progress of the investigation;

(f)

ensure that procedures under this paragraph include provision for the medical practitioner’s comments to be sought and taken into account where appropriate;

(g)

where appropriate—

(i)

take any steps necessary to protect patients;

(ii)

recommend to the medical practitioner’s employer that the practitioner should be suspended or have conditions or restrictions placed on their practice; and

(h)

identify concerns and ensure that appropriate measures are taken to address these, including but not limited to—

(i)

requiring the medical practitioner to undergo training or retraining;

(ii)

offering rehabilitation services;

(iii)

providing opportunities to increase the medical practitioner’s work experience;

(i)

maintain accurate records of all steps taken in accordance with this paragraph.

18Duty to have regard to guidanceI1 E+W

In discharging their responsibilities under regulations 16 and 17, responsible officers must have regard to the following—

(a)

guidance given by the Secretary of State in accordance with section 120(6) of the Health and Social Care Act 2008; and

F1(b)

guidance given by the National Clinical Assessment Service division of the National Health Service Litigation Authority, to the extent that it relates to the nomination or appointment of responsible officers or their prescribed responsibilities; and

(c)

guidance given by F2NHS England to the extent that it relates to the responsible officer’s duties under regulation 16(2)(aa).

19Provision of resources to responsible officersI1 E+W

(1)

Each designated body must provide its responsible officer F1or responsible officers (as the case may be) with sufficient funds and other resources necessary to enable the officer to discharge their responsibilities for that body under regulations 16 and 17.

(2)

Where the designated body does not employ its responsible officer, the body must provide the resources referred to in paragraph (1) to—

(a)

where the responsible officer is employed, the employer of the officer; and

(b)

in any other case, the responsible officer.

(3)

Where a medical practitioner has a prescribed connection with a designated body by virtue of sub-paragraph (d), (e), (f), (g) or (h) of regulation 10(1), the medical practitioner must provide the designated body with sufficient funds necessary to enable the responsible officer nominated or appointed for that body to discharge their responsibilities under regulation 16 relating to that medical practitioner.

(4)

The designated body must determine the amount of the sufficient funds referred to in paragraph (3) and provide to the medical practitioner a written demand for the sum required to be paid.

Signature

Signed by authority of the Secretary of State for Health.

Anne Milton

Parliamentary Under-Secretary of State,

Department of Health

24th November 2010

1I1

F1NHS England.

2I1

Local Health Boards.

2AF1 E

Integrated care providers.

3I1

F1National Health Service trusts other than Ambulance Trusts.

4I1

F1NHS foundation trusts other than Ambulance Trusts.

5F1

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

6I1

Health Boards.

7I1

The Department of Health F1and Social Care.

8I1

The Scottish Ministers.

9I1

The Welsh Ministers.

10I1

Postgraduate medical deaneries in England and Wales.

11I1

Any Scottish training governance body.

12I1

The Royal Navy.

13I1

The regular army within the meaning of section 374 of the Armed Forces Act 2006.

14I1

The Royal Air Force.

14AF1

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

14BF1

Pathology Delivery Board.

14CF1

The General Council.

15I1

Special Health Boards.

16I1

Special Health Authorities.

17I1

The Common Services Agency for the Scottish Health Servicef1.

18I1

Bodies which provide independent health care services within the meaning of F1section 10F(1)(a) to (d) of the National Health Service (Scotland) Act 1978.

19I1

A Government department or any executive agency of a Government department.

20I1

The following locum agencies—

(a)

limited companies with shares owned wholly by the Secretary of State for Health, which are concerned with the contracting of locum doctorsf1; and

F1(b)

locum agencies in England and Wales which supply medical locums under the Framework Agreement for the supply of locum doctors (including locum general practitioners) to NHS bodies and the wider public sector.

21I1

A non-departmental public body.

22I1

Any body whose principal office is located in the United Kingdom and whose President or Dean is a member of the Academy of Medical Royal Colleges.

23F1

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

24I1

The Independent Doctors’ Federation.

25I1

Any organisation engaged in the provision of treatment for disease, disorder or injury by or under the supervision of a medical practitioner.

25AF1

Any organisation engaged in providing the services of medical practitioners to work as resident medical officers in independent hospitals.

25BF1

Any organisation engaged in providing medical defence services to medical practitioners in respect of claims for medical negligence or professional misconduct.

25CF1

Ambulance Trusts.

25DF1

The British College of Aesthetic Medicine.

25EF1

The Faculty of Homeopathy.

26I1

(1)

Any organisation which carries out surgical procedures (including any pre-operative and post-operative care associated with such procedures) undertaken by or under the supervision of a medical practitioner who is employed by, or who contracts with, that organisation for—

(a)

the purpose of treating disease, injuries or disorders;

(b)

subject to sub-paragraph (2), cosmetic purposes, where the procedure involves the use of instruments or equipment which are inserted into the body; or

(c)

the purpose of religious observance.

(2)

The following cosmetic procedures are excepted from sub-paragraph (1)(b)—

(a)

ear and body piercing;

(b)

tattooing; and

(c)

the removal of hair roots or small blemishes on the skin by the application of heat using an electric current.

27I1

(1)

Subject to sub-paragraph (2), any organisation which carries out diagnostic and screening procedures involving—

(a)

the use of X-rays and other methods in order to examine the body through the use of radiation, ultrasound or magnetic resonance imaging;

(b)

the use of instruments and equipment which are inserted into the body to—

(i)

view its internal parts; or

(ii)

gather physiological data; and

(c)

the use of equipment in order to measure and monitor complex physiological characteristics in major organ systems of the body and to examine bodily tissues, fluids and cells for the purposes of obtaining information on—

(i)

the causes and extent of disease; or

(ii)

the response to a therapeutic intervention.

(2)

The taking and analysis of blood samples is excepted from sub-paragraph (1) where—

(a)

the procedure is carried out by means of a pin prick; or

(b)

it is not necessary to send such samples to a specialist facility for analysis.

28I1

Any organisation which is engaged in the analysis and reporting of the results of the procedures referred to in paragraph 27.

29I1

Any organisation which engages in the management of—

(a)

supply of blood, blood components and blood derived products intended for transfusion;

(b)

the supply of tissues and tissue-derived products intended for transplant, grafting or use in a surgical procedure; and

(c)

the matching and allocation of donor organs intended for transplant, and of stem cells and bone marrow intended for transfusion.

30I1

Any organisation engaged in the termination of pregnancies.

31I1

Any organisation engaged in the provision of medical services in slimming clinics, including the prescribing of medicines for the purposes of weight reduction.

32I1

A body engaged in the provision of residential accommodation together with nursing care.

33I1

A body engaged in the provision of first aid treatment and established for that purpose.

34I1

A body engaged in the provision of treatment in a sports ground or gymnasium where it is provided for the sole benefit of persons taking part in sporting activities and events.

35I1

A body engaged in the carrying out of any of the activities authorised by a licence granted by the Human Fertilisation and Embryology Authority under paragraph 1 of Schedule 2 to the Human Fertilisation and Embryology Act 1990f1.

36I1

A body engaged in the provision of residential accommodation for a person, together with treatment for drug or alcohol misuse, where acceptance by the person of such treatment is a condition of the provision of the accommodation.

37I1

A body engaged in the provision of medical advice in cases where immediate action or attention is needed, or triage provided, over the telephone or by electronic mail and established for that purpose, and for the purposes of this provision “triage” means the assignment of degrees of urgency to diseases, disorders or injuries in order to decide the order and place of treatment of patients.

38I1

An organisation engaged in the provision of medical services (otherwise than in a hospital) in which such services are provided only under arrangements made on behalf of service users by an insurance provider with whom the service users hold an insurance policy, other than an insurance policy which is solely or primarily intended to provide benefits in connection with the diagnosis or treatment of physical or mental illness, disability or infirmity.

Explanatory note

(This note is not part of the Regulations)

These Regulations establish arrangements for the introduction of “responsible officers” (“ROs”) under the Medical Act 1983 (“the Act”). ROs will be appointed by health care organisations and certain other bodies, and will have responsibilities relating to the evaluation of the fitness to practise of doctors who work in the organisation. The Regulations come into force on 1st January 2011.

Part 1 of the Regulations contains general provisions: regulation 1 contains citation, commencement date and interpretation provisions; regulation 2 contains interpretation provisions for the armed forces, and regulation 3 deals with the application of the Regulations.

Part 2 of the Regulations applies to England, Scotland and Wales. This Part deals with the appointment of ROs and their responsibilities under the Act.

Regulation 4 and the Schedule specify the bodies which are “designated bodies” under the Act. These are the bodies that will be required to nominate or appoint ROs. Regulation 4(2) and Part 1 of the Schedule list bodies that are always required to have ROs, for example NHS hospitals; regulation 4(3) and Part 2 of the Schedule list bodies that will be required to have ROs only while they employ or contract with doctors, for example, Government departments. Government-owned locum agencies (NHS Professionals Ltd currently being the sole such agency in the class described in paragraph 20(a)) are designated bodies; other locum agencies in England and Wales are designated bodies only if they are on the NHS Purchasing and Supply Agency’s framework agreement (paragraph 20(b) of the Schedule); this agreement can be viewed at the following website:

http://www.buyingsolutions.gov.uk/healthcms/Productsandservices/Agencystaffandoutsourcedservices/temporarystaff/Medicallocums/.

Regulation 5 sets out the duty on designated bodies to nominate or appoint ROs. A body is not required to have an RO if all the doctors who work for that body already have a connection under the Regulations with another designated body (see regulation 10).

Regulation 6 requires designated bodies to nominate or appoint an additional RO in cases where there is a conflict of interest or appearance of bias between a doctor and the original RO.

Regulation 7 sets out the conditions that must be met for a person to be nominated or appointed as an RO: the person must be a registered medical practitioner, which under current legislation means a licensed doctor; they must also have been a registered doctor for the preceding 5 years. A responsible officer must continue to be a registered medical practitioner.

Regulation 8 sets out the conditions that must be satisfied for a person to be nominated or appointed as an RO for more than one designated body: the person must be capable of carrying out the ROs’ responsibilities for each body concerned, and there must be no conflict of interest.

Regulation 9 provides that the Secretary of State may nominate an RO for a designated body when the body has failed to do so, or has appointed someone unsuitable. The Secretary of State must consult the Scottish or Welsh Ministers, as applicable, before making such an appointment in respect of an NHS body in Scotland or Wales, and must consult the independent regulator (Monitor) before making such an appointment in relation to an NHS Foundation Trust.

Regulation 10 sets out the “prescribed connection” between designated bodies and doctors. When a doctor is linked to a designated body under this regulation, the RO for that body has responsibilities in respect of the doctor under regulation 11. Doctors in training in England and Wales are linked to the postgraduate deanery that is responsible for their training; doctors in training in Scotland are linked to a Scottish training governance body (NHS Education for Scotland currently being the sole body falling within that class). Where a doctor is on the performers list of a primary care organisation, that organisation (a Primary Care Trust in England, a Health Board in Scotland or a Local Health Board in Wales) will be the designated body for the doctor, except for doctors in the armed forces who will be linked to the organisation where they do most of their work. Where the doctor is an employee of a designated body (and is not a trainee or on a performers list), the employing organisation will be the designated body for that doctor. Doctors working as locums will be linked to their locum agency if that agency is NHS Professionals Ltd, or is on an approved list (the NHS PASA framework) in England and Wales; other locums will be linked to their nearest Primary Care Trust, Health Board or Local Health Board. Where a doctor is providing services to patients in an independent hospital, the body managing that hospital will be the designated body for that doctor. Where none of the other provisions applies and the doctor is a member of one of certain designated professional bodies, the doctor will be linked to that body. A doctor who is a member of the Independent Doctors’ Federation (“the IDF”) will be linked to that body if none of the preceding provisions applies; the IDF is a body which represents doctors who work outside other structures, and it sought designation under the Regulations during consultations with the Department of Health. The regulation also sets out an order of priority in the event that the doctor could be connected to more than one body.

Regulation 11 sets out the responsibilities of ROs in relation to doctors who are connected with the designated body under regulation 10. ROs are required to evaluate doctors’ fitness to practise. This includes ensuring that regular appraisals are carried out, developing procedures to address any concerns about doctors’ fitness to practise, and reporting concerns to the General Medical Council where appropriate.

Regulation 12 sets out the prescribed connection between designated bodies and doctors who are themselves ROs. It is necessary to have special provisions in these cases because ROs cannot be responsible for evaluating themselves.

Regulation 13 makes provision similar to regulation 11 in respect of ROs’ responsibilities in relation to doctors who are connected with the designated body under regulation 12.

Regulation 14 contains a requirement for designated bodies and medical practitioners to provide resources to ROs, and regulation 15 contains a duty for ROs to have regard to guidance.

Part 3 of the Regulations applies to England only. This Part contains additional responsibilities for ROs under section 120 of the Health and Social Care Act 2008.

Regulation 16 sets out the additional responsibilities for ROs in England in respect of the doctors for whom they are responsible under regulation 10; these include carrying out pre-employment checks on doctors, monitoring doctors’ conduct and performance, and investigating and taking appropriate action to deal with concerns about doctors. Regulation 17 makes similar provision for ROs’ responsibilities in relation to doctors for whom they are responsible under regulation 12.

Regulation 18 contains a duty for ROs to have regard to guidance, and regulation 19 concerns the requirement for designated bodies and medical practitioners to provide resources to ROs.

An impact assessment has been prepared in relation to these Regulations and is available from the Department of Health, Quarry House, Quarry Hill, Leeds LS2 7UE; see also http://www.dh.gov.uk/en/Publicationsandstatistics/Legislation/Regulatoryimpactassessment.