The National Institute for Clinical Excellence (Amendment) Regulations 2005

Made7th March 2005

Laid before Parliament10th March 2005

Coming into force1st April 2005

The Secretary of State for Health, in exercise of the powers conferred by sections 16(4) and 126(4) of, and paragraphs 10, 12 and 16 of Schedule 5 to, the National Health Service Act 19771, and of all other powers enabling him in that behalf, hereby makes the following Regulations:

Citation, commencement, interpretation and application1

1

These Regulations may be cited as the National Institute for Clinical Excellence (Amendment) Regulations 2005 and shall come into force on 1st April 2005.

2

In these Regulations “the principal Regulations” means the National Institute for Clinical Excellence Regulations 19992.

3

These Regulations apply in England.

Amendment of regulations 1 of the principal Regulations2

Regulation 1 of the principal Regulations (citation, commencement and interpretation) is amended as follows—

a

the following definitions are inserted in the appropriate alphabetical order—

“the FHSAA” means the Family Health Service Appeal Authority constituted under section 49S of the Act3;
“national NHS disqualification” means—
a
a decision made by the FHSAA under section 49N of the Act4,or
b
a decision by the NHS Tribunal which is treated as a national disqualification by the FHSAA by virtue of regulation 6(4)(b) of the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 20015 or regulation 6(4)(b) of the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 20026;
“the NHS Tribunal” means the Tribunal constituted under section 46 of the Act7 for England and Wales;
“primary care list” means—
a
a list referred to in section 49N(1)(a) to (c) of the Act,
b
a list of persons undertaking to provide general medical services prepared in accordance with regulations under section 29 of the Act8 as the list existed on or before 31st March 2004,
c
a list of persons approved by a Primary Care Trust for the purpose of assisting in the provision of general medical services prepared in accordance with regulations under section 43D(1)of the Act9 as the list existed on or before 31st March 2004, or
d
a services list referred to in section 8ZA(1)(a) of the National Health Service (Primary Care) Act 199710 as the list existed on or before 31st March 2004;

b

for the definition of “the Institute” substitute the following definition—

“the Institute” means the National Institute for Health and Clinical Excellence established by the Order11;

c

for the definition of “health service body” substitute the following definition—

“health service body” means—
a
a Strategic Health Authority12, Special Health Authority13, Primary Care Trust14, NHS trust15, Local Health Board16 or NHS foundation trust17,
b
a Health Board or Special Health Board constituted under section 2 of the National Health Service (Scotland) Act 197818 or the Scottish Dental Practice Board, the Common Service Agency for the Scottish Health Service or an NHS trust constituted under, respectively, sections 4, 10 or 12A of that Act19,
c
the Dental Practice Board constituted under section 37(1) of the Act20,
d
the Commission for Health Improvement21,
e
the Commission for Healthcare Audit and Inspection22,
f
the Public Health Laboratory Service Board23,
g
the Health Protection Agency24;
h
the Secretary of State,
i
the Independent Regulator of NHS Foundation Trusts,
j
the Northern Ireland Central Services Agency for the Health and Social Services established under the Health and Personal Social Services (Northern Ireland) Order 197225,
k
a special health and social services agency established under the Health and Personal Social Services (Special Agencies) (Northern Ireland) Order 199026,
l
a Health and Social Services Board constituted under the Health and Personal Social Services (Northern Ireland) Order 1972,
m
a Health and Social Services trust established under the Health and Personal Social Services (Northern Ireland) Order 199127, and
n
the Department of Health, Social Services and Public Safety for Northern Ireland;

Amendment of regulation 4 of the principal Regulations3

In regulation 4 of the principal Regulations (appointment of chief officers) delete the words “and a clinical director” and insert the words “,a director of clinical and public health and a director of health improvement.”.

Amendment of regulation 5 of the principal Regulations4

For regulation 5(1) of the principal Regulations (disqualification for appointment) substitute the following paragraph—

5
1
Subject to regulation 4 (cessation of disqualification), a person shall be disqualified for appointment as the chairman or as a non-officer member if—
a
he has, within the preceding five years, been convicted in the United Kingdom of any offence or convicted elsewhere of an offence which, if committed in any part of the United Kingdom would constitute a criminal offence in that part, and in either case has been sentenced to a period of imprisonment (whether suspended or not) for a period of not less than three months without the option of a fine, and which has not been quashed on appeal;
b
he is the subject of a bankruptcy restrictions order or an interim bankruptcy restrictions order;
c
he has been dismissed within the previous five years, otherwise than by reason of redundancy, from any paid employment with a health service body;
d
he is a person whose tenure of office as the chairman, a member, a director or a governor of a health service body has been terminated on the grounds that—
i
it was not in the interests of, or conducive to the good management of, the health service body or of the health service that he should continue to hold that office,
ii
he failed, without reasonable cause, to attend any meeting of that health service body for three successive meetings, or
iii
he failed to declare a pecuniary interest or withdraw from consideration of any matter in respect of which he had a pecuniary interest;
e
he—
i
is the subject of a national NHS disqualification,
ii
was refused nomination or approval to fill a vacancy for a medical practitioner pursuant to regulations made under section 29B(2A) of the Act and was not subsequently nominated or approved or included in a primary care list28,
iii
has been refused admission to a primary care list on grounds corresponding to the conditions referred to in section 49F(2), (3) or (4) of the Act29 and has not subsequently been included in a primary care list,
iv
is conditionally included in a primary care list30,
v
has been removed from a primary care list on any of the grounds set out in section 49F(2), (3) or (4) of the Act or by a direction of the NHS Tribunal and has not subsequently been included in such a list,
vi
is contingently removed from a primary care list31, or
vii
is suspended from a primary care list32 or treated as so suspended by virtue of regulation 6(2) of the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 2001 or regulation 6(2) of the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 2002,
and in this sub-paragraph any reference to a provision in the Act includes a reference to the provision corresponding to that provision in legislation relating to Scotland and Northern Ireland;
f
he is subject to a disqualification order under the Company Directors Disqualification Act 198633, the Companies (Northern Ireland) Order 198634 or to an order made under section 429(2)(b) of the Insolvency Act 198635 (disabilities on revocation of administration order against an individual);
g
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 199036 (powers of Court of Session to deal with management of charities) from being concerned in the management or control of any body.

Amendment of Regulation 6 of the principal Regulations5

For regulation 6 of the principal Regulations (cessation of disqualification) substitute the following—

6
1
Subject to paragraph (2), where a person is disqualified under regulation 5(1)(c) or (g)(i) he may, after the expiry of two years beginning on the date on which he was dismissed or removed, apply in writing to the Secretary of State to remove the disqualification, and the Secretary of State may direct that the disqualification shall cease.
2
Where the Secretary of State refuses an application to remove a disqualification no further application may be made by that person until the expiry of the period of two years beginning with the date of the application and this paragraph shall apply to any subsequent application.
3
Where a person is disqualified under regulation 5(1)(d), the disqualification shall cease on the expiry of the period of two years beginning on the date of the termination of his tenure of office or such longer period as the Secretary of State specifies when terminating his period of office but the Secretary of State may, on application being made to him by that person, reduce the period of disqualification.

Amendment of regulation 8 of the principal Regulations6

Regulation 8 of the principal Regulations (termination of tenure of office of chairman and non-officer members) is amended as follows—

a

in regulation 8(5) (b)after the word “appointment” insert the words “or later”;

b

in regulation 8(6) after the word “pecuniary” delete the words “or other personal”.

Amendment of regulation 9 of the principal Regulations7

In regulation 9 of the principal Regulations (appointment of committees and sub-committees) at the end of regulation 9(5) insert the following paragraph—

6
Subject to such directions as may be given by the Secretary of State, regulations 5 and 6 apply to the appointment of members of committees and sub-committees of the Institute appointed under this regulation as they apply to the appointment of members of the Institute.

Amendment of regulation 12 of the principal Regulations8

In regulation 12 of the principal Regulations (disability of chairman and members in proceedings on account of pecuniary or other personal interest) for the heading and paragraphs (1) – (7) substitute the following—

Disability of chairman and members in proceedings on account of pecuniary interest12
1
Subject to the following provisions of this regulation, if the chairman or a member has any pecuniary interest, direct or indirect, in any contract, proposed contract or other matter and is present at any meeting of the Institute to which the contract, proposed contract or other matter is the subject of consideration, he shall at the meeting and as soon as practicable after its commencement, disclose his interest and shall not take part in the consideration or discussion of the contract, proposed contract or other matter or vote on any question with respect to it.
2
The Secretary of State may, subject to such conditions as he may think fit to impose, remove any disability imposed by this regulation in any case in which it appears to him to be in the interests of the health service that the disability should be removed.
3
The Institute may, by Standing Orders made under regulation 11(2), provide for the exclusion of the chairman or a member from a meeting of the Institute while any contract, proposed contract or other matter in which he has a pecuniary interest, direct or indirect, is under consideration.
4
Any remuneration, compensation or allowances payable to the chairman or a member by virtue of paragraph 9 of Schedule 5 to the Act (pay and allowances) shall not be treated as a pecuniary interest for the purpose of this regulation.
5
Subject to paragraphs (2) and (6), the chairman or member shall be treated for the purpose of this regulation as having an indirect pecuniary interest in a contract, proposed contract or other matter if—
a
he, or a nominee of his, is a director of a company or other body, not being a public body, with which the contract was made or is proposed to be made or which has a direct pecuniary interest in the other matter under consideration; or
b
he is a partner of, or is in the employment of, a person with whom the contract was made or is proposed to be made or who has a direct pecuniary interest in the other matter under consideration,
and in the case of two persons living together as a couple (whether married or not) the interest of one shall, if known to the other, be deemed for the purpose of this regulation to be also an interest of the other.
6
Neither the chairman nor a member shall be treated as having a pecuniary interest in any contract, proposed contract or other matter by reason only—
a
of his membership of a company or other body if he has no beneficial interest in any securities of that company or other body; or
b
of an interest in any company, body or person with which he is connected as mentioned in paragraph (5) which is so remote or insignificant that it cannot reasonably be regarded as likely to influence him in the consideration or discussion of, or voting on, any question with respect to that contract, proposed contract or other matter.
7
Where the chairman or a member—
a
has an indirect pecuniary interest in a contract, proposed contract or other matter by reason only of beneficial interest in securities of a company or other body; and
b
the total nominal value of those securities does not exceed £5,000 or one-hundredth of the total nominal value of the issued share capital of the company or body, whichever is the lesser; and
c
if the share capital is of more than one class, the total nominal value of shares of any one class in which he has a beneficial interest does not exceed one-hundredth of the total issued share capital of that class,
this regulation shall not prohibit him from taking part in the consideration or discussion of the contract, proposed contract or other matter, or from voting on any question with respect to it without prejudice however to his duty to disclose his interest.

Signed by authority of the Secretary of State

WarnerParliamentary Under Secretary of State,Department of Health7th March 2005

(This note is not part of the Regulations)

These Regulations amend the National Institute for Clinical Excellence Regulations 1999 (the principal Regulations) which make provision concerning membership and procedure of the National Institute for Clinical Excellence (the Institute) which is a Special Health Authority established under the National Health Service Act 1977.

Regulation 2 makes certain consequential amendments to definitions including an amendment to the definition of “the Institute” consequent on the change of the name of the Institute from the National Institute for Clinical Excellence to the National Institute for Health and Clinical Excellence. Regulation 3 requires the Institute to appoint a director of health improvement and renames the office of clinical director to that of director of clinical and public health.

Regulations 4 and 5 make amendments to the provisions relating to the disqualification for appointment and cessation of disqualification as chairman or a non officer member of the Institute and regulation 7 extends those provisions to the appointment of members of committees and sub committees.

Regulations 6 and 8 amend the provisions relating to the disability of chairman and members in proceedings on account of pecuniary or other personal interest.