The Medical Profession (Responsible Officers) (Amendment) Regulations 2025

Made: 26th February 2025

Laid before Parliament: 27th February 2025

Coming into force: 27th March 2025

The Secretary of State makes these Regulations in exercise of powers conferred by section 45A of the Medical Act 1983[^f00001].

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

Citation, commencement and extent

1

• (1) These Regulations may be cited as the Medical Profession (Responsible Officers) (Amendment) Regulations 2025 and come into force on 27th March 2025.

• (2) These Regulations extend to England and Wales and Scotland.

Amendments to the Medical Profession (Responsible Officers) Regulations 2010

2

• (1) The Medical Profession (Responsible Officers) Regulations 2010[^f00002] are amended as follows.

• (2) In regulation 5 (duty to nominate or appoint responsible officers)[^f00003]—

• (a) in paragraph (2), after “NHS England” insert “, the Department of Health and Social Care and the General Council[^f00004]”;

• (b) in paragraph (4), for “NHS England” substitute “the designated body”.

• (3) In regulation 10 (connection between designated bodies and medical practitioners)—

• (a) omit paragraph (1)(za)[^f00005];

• (b) in paragraph (1)(ba)[^f00006], for “the United Kingdom Health Security Agency” substitute “the Department of Health and Social Care”.

• (4) In regulation 11 (responsibilities of responsible officers: prescribed connection under regulation 10), in paragraph (6)[^f00007]—

• (a) in the brackets after “regulation 5(2)”, omit “NHS England:”;

• (b) after “to be determined by”, for “NHS England” substitute “the designated body that nominated or appointed the responsible officer”.

• (5) For regulation 12 (connection between designated bodies and medical practitioners who are responsible officers)[^f00008] substitute—

(12) (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.

(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.

• (6) In regulation 13 (responsibilities of responsible officers: prescribed connection under regulation 12), in paragraph (6)[^f00009]—

• (a) in the brackets after “regulation 5(2)”, omit “NHS England:”;

• (b) after “to be determined by”, for “NHS England” substitute “the designated body who nominated or appointed the responsible officer”.

• (7) In the Schedule (designated bodies)[^f00010]—

• (a) after paragraph 14B, insert—

(14C) The General Council.

• (b) omit paragraph 23 (bodies which have functions under the Act in relation to the regulation of medical practitioners).

Signed

Signed by authority of the Secretary of State for Health and Social Care

Karin Smyth — Minister of State — Department of Health and Social Care — 26th February 2025

Explanatory note

(This note is not part of the Regulations)

Explanatory Note

These Regulations amend the Medical Profession (Responsible Officers) Regulations 2010 (S.I. 2010/2841) (“the 2010 Regulations”). The 2010 Regulations establish arrangements for the introduction of “responsible officers” (“ROs”) under the Medical Act 1983. ROs are appointed by designated bodies and have responsibilities relating to the evaluation of the fitness to practise of medical practitioners who work in the organisation. Designated bodies are health care organisations and certain other bodies that are required to nominate or appoint ROs.

Regulation 2(2) makes amendments to the 2010 Regulations in relation to the duty on designated bodies to nominate or appoint ROs. The effect of the amendments is that NHS England, the Department of Health and Social Care and the General Council will all have a duty to nominate or appoint a sufficient number of ROs, and to nominate replacements, where a sufficient number are not already appointed. A “sufficient number” of ROs means the number required to ensure that each RO has the capacity to carry out their responsibilities in accordance with regulation 11 or 13 of the 2010 Regulations.

Regulations 2(4) and 2(6) make related amendments in relation to the responsibilities of ROs, so that where multiple ROs are nominated or appointed, the body may determine the division of responsibilities.

Regulation 2(3) makes amendments in relation to the prescribed connection between medical practitioners and designated bodies. Where a medical practitioner has a “prescribed connection” to a designated body, the RO for that body has responsibilities relating to evaluation of the medical practitioner. The amendments include removing a prescribed connection to the Faculty of Medical Leadership and Management and replacing a prescribed connection to the United Kingdom Health Security Agency with a prescribed connection to the Department of Health and Social Care.

Regulation 2(5) substitutes regulation 12 of the 2010 Regulations which prescribes the connections between designated bodies and medical practitioners who are ROs. ROs of any non-departmental public body in England, or any Government department or executive agency of a Government department in England (subject to the exceptions identified) have a prescribed connection with NHS England, rather than with the Department for Health and Social Care. An RO of the designated bodies identified continues to have a prescribed connection with the Department of Health and Social Care. The ROs of the Department of Health and Social Care, the Scottish Ministers and the Welsh Ministers and the National Medical Director of NHS England, have a prescribed connection with the General Council.

The effect of regulation 2(7) is such that the General Council (by virtue of being in Part 1 of the Schedule to the 2010 Regulations) is always required to have an RO.

A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen.

Footnotes

[^f00001]: 1983 c. 54; Part VA (sections 45A to 45F) was inserted by section 119 of the Health and Social Care Act 2008 (c. 14). ‘Prescribed’ means prescribed by regulations under section 45A; and the ‘appropriate authority’ means the Secretary of State in relation to England and Wales and Scotland (section 45F).

[^f00002]: S.I. 2010/2841; relevant amending instruments are S.I. 2011/2581, S.I. 2012/1641, S.I. 2013/391, S.I. 2018/378, S.I. 2019/248, S.I. 2021/974, S.I. 2022/634, S.I. 2023/368 and S.I. 2023/1071.

[^f00003]: Regulation 5 was substituted by regulation 3(2) of S.I. 2013/391; relevant amending instruments are S.I. 2023/1071 and S.I. 2023/368.

[^f00004]: “General Council” has the meaning given in section 1(1) of the Medical Act 1983.

[^f00005]: Paragraph (1)(za) was inserted by regulation 3(4)(a) of S.I. 2013/391; amended by S.I. 2023/1071.

[^f00006]: Paragraph (1)(ba) was inserted by regulation 3(4)(e) of S.I. 2013/391; amended by S.I. 2021/974.

[^f00007]: Regulation 11(6) was substituted by regulation 3(5) of S.I. 2013/391; amended by S.I. 2023/1071.

[^f00008]: Regulation 12 was substituted by regulation 3(6) of S.I. 2013/391; relevant amending instruments are S.I. 2018/378, S.I. 2023/368 and S.I. 2023/1071.

[^f00009]: Regulation 13(6) was substituted by regulation 3(7) of S.I. 2013/391; amended by S.I. 2023/1071.

[^f00010]: The Schedule to the 2010 Regulations has been amended by S.I. 2011/2581, S.I. 2013/391, S.I. 2018/378, S.I. 2019/248, S.I. 2022/634, S.I. 2023/368 and S.I. 2023/1071.