Health Act 2006 (c. 28)

(The document as of February, 2008)

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(b) consult such persons as he considers appropriate about the change.

(3) Where, following consultation under subsection (1) or (2), the Secretary of State issues the code or revised code (whether in the form of the draft or with such modifications as he thinks fit), it comes into force at the time when it is issued by the Secretary of State.

(4) Where--

(a) any document by reference to whose provisions the code operates as mentioned in section 47A(5)(a) and (b) is a document published by the Secretary of State in connection with his functions relating to health,

(b) the Secretary of State proposes to revise the document, and

the Secretary of State must, before revising the document, consult such persons as he considers appropriate about the change.

(5) Where--

(a) any document by reference to whose provisions the code operates as mentioned in section 47A(5)(a) and (b) is not one to which subsection (4)(a) above applies,

(b) the document is revised, and

the Secretary of State must consult such persons as he considers appropriate about whether the code should be revised in connection with the change.

(6) Consultation undertaken by the Secretary of State before the commencement of this section is as effective for the purposes of this section as consultation undertaken after that time.

47C Effect of code under section 47A

(1) Where any provisions of a code of practice issued under section 47A apply to an NHS body, the body must observe those provisions in discharging its duty under section 45.

(2) A failure to observe any provision of a code of practice issued under section 47A does not of itself make a person liable to any criminal or civil proceedings.

(3) A code of practice issued under section 47A is admissible in evidence in any criminal or civil proceedings. "

15 Code of practice: effects on existing functions of Commission for Healthcare Audit and Inspection

(1) Sections 50 to 52 and 54 of the 2003 Act are amended as follows.

(2) In section 50 (annual reviews), for subsection (4) substitute--

" (4) In exercising its functions under this section in relation to any health care, the CHAI must take into account--

(a) the standards set out in statements published under section 46, and

(b) any code of practice issued under section 47A.

(4A) In conducting a review under subsection (1) in relation to a particular body to which provisions of such a code apply, the CHAI must accordingly consider (among other things) the extent, if any, to which those provisions are being observed by the body. "

(3) In section 51 (reviews: England and Wales), in subsection (4)(a) after "section 46" insert "and any code of practice issued under section 47A".

(4) In section 52 (reviews and investigations: England), for subsection (3) substitute--

" (3) The CHAI has the function of conducting reviews of--

(a) the arrangements made by English NHS bodies and cross-border SHAs for the purpose of discharging their duty under section 45;

(b) the arrangements made by particular bodies within paragraph (a) for the purpose of discharging that duty. "

(5) For section 52(5) substitute--

" (5) In exercising its functions under this section in relation to any health care, the CHAI must take into account--

(a) the standards set out in statements published under section 46, and

(b) any code of practice issued under section 47A.

(5A) In conducting a review under subsection (3) in relation to a particular body to which provisions of such a code apply, the CHAI must accordingly consider (among other things) the extent, if any, to which those provisions are being observed by the body. "

(6) In section 54 (functions relating to Secretary of State and Assembly), in subsection (2) after "section 46 or 47" insert ", or any code of practice issued under section 47A,".

16 Code of practice: improvement notices

After section 53 of the 2003 Act insert--

" 53A Failings in connection with code under section 47A: improvement notices

(1) This section applies where, following such a review or investigation as is mentioned in section 53(1), the CHAI--

(a) is of the view that any provisions of a code of practice issued under section 47A and applying to an English NHS body or a cross-border SHA are not being observed in any material respect in relation to the provision of health care by or for the body, but

(b) having regard to all the circumstances, is not of the view that it is required to make a report under section 53(2) (or, if relevant, section 53(6)).

(2) The CHAI may serve a notice under this section (an "improvement notice") on the body in respect of the failure to observe the code, if it considers that serving the notice is the most appropriate course of action for it to take with a view to securing that the failure is remedied.

(3) An improvement notice must--

(a) state that the CHAI has formed the view mentioned in subsection (1)(a) in relation to the provision of health care by or for the body, giving particulars of the material respect in which the CHAI considers that the provisions of the code are not being observed as mentioned in that subsection,

(b) state the CHAI's reasons for its view, and

(c) require the body to remedy the failure to observe the code, and to do so within such period as is specified in the notice.

(4) An improvement notice may (but need not) include a recommendation by the CHAI as to the way in which the failure should be remedied.

(5) An improvement notice may relate to more than one failure within subsection (1)(a), and in such a case--

(a) subsections (2) to (4) and section 53B apply separately in relation to each such failure, but

(b) any report required by that section may relate to more than one such failure.

(6) Where the CHAI serves an improvement notice on a body under this section, the CHAI must notify the Secretary of State and--

(a) the regulator, if the body is an NHS foundation trust, and

(b) any relevant Strategic Health Authority, if the body is a Primary Care Trust or an NHS trust.

(7) In this section and section 53B "relevant Strategic Health Authority" means--

(a) in relation to a Primary Care Trust, any Strategic Health Authority whose area includes any part of the Trust's area;

(b) in relation to an NHS Trust (other than one responsible for providing ambulance services), the Strategic Health Authority in whose area all or most of the Trust's hospitals, establishments or facilities are situated;

(c) in relation to an NHS Trust responsible for providing ambulance services, the Strategic Health Authority in whose area the headquarters establishment responsible for the control of those services is situated.

(8) Subsection (9) applies where--

(a) an improvement notice is served on a body in respect of a particular failure to observe a code of practice issued under section 47A, and

(b) a review under section 52(3)(b) is conducted by the CHAI in pursuance of section 53B(4)(a) with a view to assessing the body's compliance with the notice.

(9) In such a case subsection (1)--

(a) does not apply in relation to that review so as to enable the CHAI to serve a further improvement notice on that body in respect of that failure; but

(b) does apply in relation to that review so as to enable the CHAI (if the conditions in subsections (1) and (2) are satisfied) to serve an improvement notice on that body in respect of a different failure to observe the code.

53B Code of practice: action by CHAI following service of improvement notice

(1) This section applies where the CHAI has served an improvement notice on a body under section 53A.

(2) If, before the end of the specified period--

(a) the body requests the CHAI to extend that period, and

(b) the CHAI considers that there are exceptional circumstances which justify its extending that period by a further period of time,

the CHAI may, by a notice served on the body, extend the specified period by that further period.

(3) In this section "the specified period" means--

(a) the period specified under section 53A(3)(c), or

(b) if that period has been extended under subsection (2) above, that period as so extended.

(4) Where the specified period has ended or the body notifies the CHAI before the end of that period that it has complied with the improvement notice, the CHAI must--

(a) conduct a review under section 52(3)(b) with a view to assessing the body's compliance with the notice, and

(b) then comply with subsection (5) or (6);

and the making of any report in accordance with subsection (5) or (6) is to be taken as satisfying the requirement to publish a report under section 52(7) in respect of the review.

(5) If the CHAI--

(a) remains of the view that the relevant provisions of the code are not being observed in any material respect in relation to the provision of health care by or for the body, and

(b) having regard to all the circumstances, is of the view that it is required to make a report under section 53(2) (and, if relevant, section 53(6)),

the CHAI must accordingly make a report under that provision (or, as the case may be, under each of those provisions).

(6) If the CHAI does not make any such report or reports, it must instead make a report--

(a) to the Secretary of State, and

(b) (if the body is an NHS foundation trust) to the regulator,

setting out the matters mentioned in subsection (7) or (8).

(7) If the CHAI is of the view that the relevant provisions of the code are being observed in relation to the provision of health care by or for the body, the matters are--

(a) that the CHAI is of that view, and

(b) its reasons for that view.

(8) If the CHAI is of the view that the relevant provisions of the code are not being so observed in any respect (material or otherwise), the matters are--

(a) that the CHAI is of that view,

(b) its reasons for that view,

(c) if its view is that those provisions are not being observed in any material respect, its reasons for not forming the view mentioned in subsection (5)(b), and

(d) (whether or not paragraph (c) applies) any action which it proposes to take in relation to the body in connection with the failure to observe the code.

(9) The CHAI must send a copy of any report made by it in accordance with subsection (5) or (6) in relation to a Primary Care Trust or an NHS trust to the relevant Strategic Health Authority.

(10) In this section "the relevant provisions of the code" means the provisions of the code in relation to which the CHAI formed the view mentioned in section 53A(1)(a). "

Part 3 Drugs, Medicines and Pharmacies

Chapter 1 Supervision of management and use of controlled drugs

17 Accountable officers and their responsibilities as to controlled drugs

(1) The relevant authority may by regulations make provision for or in connection with requiring designated bodies to nominate or appoint persons who are to have prescribed responsibilities in relation to the safe, appropriate and effective management and use of controlled drugs in connection with--

(a) activities carried on by or on behalf of the designated bodies, and

(b) activities carried on by or on behalf of bodies or persons providing services under arrangements made with the designated bodies.

(2) The person who is to be so nominated or appointed by a designated body is to be known as its accountable officer.

This is subject to any regulations made by virtue of subsection (5)(e).

(3) In this Chapter "designated body" means--

(a) a body falling within any description of bodies prescribed as designated bodies for the purposes of this section, or

(b) a body prescribed as a designated body for those purposes.

(4) The descriptions of bodies, or bodies, that may be so prescribed are descriptions of bodies, or bodies, appearing to the relevant authority--

(a) to be directly or indirectly concerned with the provision of health care (whether or not for the purposes of the health service), or

(b) to be otherwise carrying on activities that involve, or may involve, the supply or administration of controlled drugs.

(5) Regulations under this section may make provision--

(a) for conditions that must be satisfied in relation to a person if he is to be nominated or appointed by a designated body as the body's accountable officer;

(b) for a single person to be nominated or appointed as the accountable officer for each of two or more designated bodies where those bodies are satisfied as to the prescribed matters;

(c) requiring a designated body that has an accountable officer to provide the officer with funds and other resources necessary for enabling the officer to discharge his responsibilities as accountable officer for the body;

(d) for ensuring that an accountable officer, in discharging his responsibilities, has regard to best practice in relation to the use of controlled drugs;

(e) for the persons required to be nominated or appointed as mentioned in subsection (1) to be known by such name as is prescribed;

(f) for making such amendments of any enactment as appear to the relevant authority to be required in connection with any provision made in pursuance of paragraph (e);

(g) for creating offences punishable on summary conviction by a fine not exceeding level 5 on the standard scale or for creating other procedures for enforcing any provisions of the regulations.

(6) The responsibilities that may be imposed on a designated body's accountable officer by regulations under this section include responsibilities as to the establishment and operation of arrangements for--

(a) securing the safe management and use of controlled drugs;

(b) monitoring and auditing the management and use of such drugs;

(c) ensuring that relevant individuals receive appropriate training and that their training needs are regularly reviewed;

(d) monitoring and assessing the performance of such individuals in connection with the management or use of such drugs;

(e) making periodic inspections of premises used in connection with the management or use of such drugs;

(f) recording, assessing and investigating concerns expressed about incidents that may have involved improper management or use of such drugs;

(g) ensuring that appropriate action is taken for the purpose of protecting patients or members of the public in cases where such concerns appear to be well-founded;

(h) where required by regulations under section 18, the sharing of information.

(7) The arrangements mentioned in subsection (6) may be arrangements established (according to the circumstances)--

(a) by the accountable officer,

(b) by the designated body (or any of the designated bodies) for which he is the accountable officer, or

(c) by a body or person acting on behalf of, or providing services under arrangements made with, the designated body (or any of the designated bodies).

(8) In subsection (6)--

(a) references to the management or use of controlled drugs are to the management or use of drugs in connection with activities carried on by a body or person within subsection (7)(b) or (c), and

(b) "relevant individual" means an individual who, whether as--

(i) a health care professional, or

(ii) an employee who is not a health care professional, or

(iii) otherwise,

is engaged in any activity carried on by a body or person within subsection (7)(b) or (c) that involves, or may involve, the management or use of controlled drugs.

(9) A designated body may confer on its accountable officer such powers as it thinks appropriate to enable him to discharge any of the responsibilities imposed on him as accountable officer for the body by regulations under this section.

(10) Nothing in subsections (5) to (7) is to be read as prejudicing the generality of subsection (1).

(11) In this section "prescribed" means prescribed by regulations under this section.

18 Co-operation between health bodies and other organisations

(1) The relevant authority may by regulations make provision for or in connection with requiring responsible bodies to co-operate with each other in connection with--

(a) the identification of cases in which action may need to be taken in respect of matters arising in relation to the management or use of controlled drugs by relevant persons (see section 19);

(b) the consideration of issues relating to the taking of action in respect of such matters;

(2) In this Chapter "responsible body" means--

(a) a body falling within any description of bodies prescribed as responsible bodies for the purposes of this section, or

(b) a body prescribed as a responsible body for those purposes.

(3) The descriptions of bodies, or bodies, that may be so prescribed are--

(a) descriptions of bodies, or bodies, which fall within subsection (4); and

(b) police forces.

(4) Descriptions of bodies, or bodies, fall within this subsection if they appear to the relevant authority--

(a) to be directly or indirectly concerned with the provision of health care (whether or not for the purposes of the health service),

(b) to be otherwise carrying on activities that involve, or may involve, the supply or administration of controlled drugs,

(d) to be public or local authorities with responsibilities in relation to social care, or

(e) to be public or local authorities (not within paragraphs (a) to (d)) whose responsibilities include responsibilities with respect to matters such as are mentioned in subsection (1).

(5) Regulations under this section may make provision--

(a) for requiring a responsible body to disclose information to any other such body or bodies in prescribed circumstances, or in circumstances where it appears to the responsible body that the prescribed conditions are satisfied, whether or not the disclosure of information has been requested;

(b) in relation to a responsible body which has an accountable officer, for requiring disclosures to be made by or to that officer instead of by or to the body;

(d) for requiring a responsible body, in prescribed circumstances, to consult the prescribed accountable officer in connection with any requirement imposed on the body under the regulations;

(e) for imposing duties on accountable officers in relation to the taking of action for the purpose of protecting the safety of patients or the general public.

(6) The duties that may be imposed on an accountable officer in pursuance of subsection (5)(e) include a duty to make recommendations to a responsible body as to any action which the officer considers that the body should take for the purpose mentioned in that provision.

(7) The action that may be so recommended includes action in relation to the institution of disciplinary proceedings.

(8) Nothing in subsections (5) to (7) is to be read as prejudicing the generality of subsection (1).

(9) In this section--

(a) "chief officer" means--

(i) in relation to a police force in England and Wales, the chief officer of police;

(ii) in relation to a police force in Scotland, the chief constable;

(iii) in relation to the Police Service of Northern Ireland or the Police Service of Northern Ireland Reserve, the Chief Constable of the Police Service of Northern Ireland;

(b) "police force" means--

(i) a police force in England, Wales or Scotland, or

(ii) the Police Service of Northern Ireland or the Police Service of Northern Ireland Reserve;

19 Meaning of "relevant person" in section 18

(1) In section 18 "relevant person" means--

(a) a person falling within any description of persons prescribed as relevant persons for the purposes of that section, or

(b) an individual to whom subsection (3) applies.

(2) The descriptions of persons that may be prescribed for the purposes of section 18 are descriptions of persons appearing to the relevant authority to be carrying on, or engaged in, activities that involve, or may involve, the supply or administration of controlled drugs.

(3) This subsection applies to an individual who, whether as--

(a) a health care professional, or

(b) an employee who is not a health care professional, or

is engaged in any activity carried on by a designated body, or by a body or person acting on behalf of, or providing services under arrangements made with, a designated body that involves, or may involve, the management or use of controlled drugs.

(4) In this section "prescribed" means prescribed by regulations under section 18.

20 Controlled drugs: power to enter and inspect

(1) A constable or an authorised person may, for the purpose of securing the safe, appropriate and effective management and use of controlled drugs--

(a) enter any relevant premises;

(b) inspect any precautions taken on the premises for the safe custody of controlled drugs;

(d) require any relevant records kept on the premises to be produced for his inspection.

(2) The powers conferred by subsection (1) may be exercised only--

(a) at a reasonable hour, and

(b) on production (if required) of the written authority of the person exercising them.

(3) The power conferred by subsection (1)(a) may be exercised by an authorised person to enter relevant premises which are or form part of a private dwelling only if he is accompanied by a constable.

But this subsection does not apply in such circumstances as may be prescribed by regulations made by the relevant authority.

(4) The power conferred by subsection (1)(d) includes power--

(a) to take copies of or extracts from relevant records, and

(b) to take possession of any relevant records kept on the premises and retain them for so long as the person exercising the power considers necessary.

(5) In this section "authorised person" means (subject to subsection (6))--

(a) a person authorised by the relevant authority,

(b) an accountable officer, or

(c) where a designated body is required by regulations under section 17 to nominate or appoint an accountable officer, a member of the staff of the designated body authorised by it.

Authorisations given under this subsection may be general or specific.

(6) The accountable officer of a designated body specified, or of a description specified, in directions given by the relevant authority is not an authorised person for the purposes of this section; and such a designated body may not authorise members of its staff under subsection (5)(c).

(7) The relevant authority may by regulations prescribe descriptions of premises which are to be "relevant premises" for the purposes of this section in relation to constables and authorised persons of descriptions prescribed in the regulations.

(8) The descriptions of premises that may be so prescribed are descriptions of premises (or parts thereof) appearing to the relevant authority to be used in connection with--

(a) the provision of health care (whether or not for the purposes of the health service), or

(b) the supply or administration of controlled drugs.

(9) In this Chapter "relevant records" means records kept with respect to controlled drugs in pursuance of regulations under section 10 of the Misuse of Drugs Act 1971 (c. 38).

(10) Directions under subsection (6) are to be given by regulations or in writing; but any such directions which relate to more than one designated body are to be given by regulations.

(11) Directions under subsection (6) given in writing may be varied or revoked by subsequent directions under that subsection.

21 Offences in connection with power to enter and inspect

(1) A person commits an offence if he--

(a) intentionally obstructs a person in the exercise of his powers under section 20(1),

(b) conceals from a person acting under section 20(1) anything which that person is entitled to inspect, or

(c) without reasonable excuse fails to produce any relevant records which a person acting under section 20(1) requires to be produced.

(2) A person guilty of an offence under subsection (1) is liable--

(a) on conviction on indictment, to imprisonment for a term not exceeding two years or to a fine, or to both;

(b) on summary conviction, to imprisonment for a term not exceeding 12 months or to a fine not exceeding the statutory maximum, or to both.

(3) In the application of this section to Scotland and Northern Ireland, the reference to 12 months in subsection (2)(b) is to be read as a reference to 6 months.

22 Guidance

(1) The relevant authority may issue guidance to designated bodies in connection with--

(a) determining whether conditions specified in regulations under section 17 have been satisfied in relation to the nomination or appointment of a person as a designated body's accountable officer;

(b) the discharge by a designated body's accountable officer of any responsibilities imposed on him by regulations under section 17;

(d) the exercise by designated bodies of their powers under section 20(5)(c).

(2) The relevant authority may issue guidance to responsible bodies in connection with their discharge of any duties imposed on them by regulations under section 18.

(3) Guidance under this section may make different provision for different cases or circumstances.

(4) Designated bodies and responsible bodies must have regard to any guidance under this section in exercising any functions to which the guidance relates.

23 Crown application

(1) This Chapter binds the Crown.

(2) No contravention by the Crown of any provision of this Chapter shall make the Crown criminally liable; but the High Court (or, in Scotland, the Court of Session) may declare unlawful any act or omission of the Crown which constitutes such a contravention.

(3) The provisions of this Chapter apply to persons in the public service of the Crown as they apply to other persons.

24 Relevant authorities

(1) This section applies to functions conferred on the relevant authority by this Chapter.

(2) Subject to subsection (4), any functions to which this section applies are exercisable in relation to England by the Secretary of State.

(3) Subject to subsection (4), any functions to which this section applies are exercisable in relation to Wales by the National Assembly for Wales.

(4) Any power of the relevant authority to make regulations under this Chapter is exercisable in relation to cross-border bodies by the Secretary of State after consultation with the Assembly.

(5) A "cross-border body" is a body which--

(a) performs (and only performs) functions in respect of England and Wales, and

(b) does not perform functions mainly in respect of England or mainly in respect of Wales.

(6) Any functions to which this section applies are exercisable in relation to Scotland by the Secretary of State after consultation with the Scottish Ministers.

(7) Any functions to which this section applies are exercisable in relation to Northern Ireland by the Department of Health, Social Services and Public Safety.

25 Interpretation

(1) In this Chapter--

"accountable officer" is to be read in accordance with section 17(2);
"body" includes an unincorporated association;
"controlled drug" has the meaning given by section 2 of the Misuse of Drugs Act 1971 (c. 38);
"designated body" has the meaning given by section 17(3);
"health care" means--
(a)
services provided to individuals for or in connection with the prevention, diagnosis or treatment of illness, and
(b)
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