|
| |
|
(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 |
| 5 |
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; |
| 10 |
(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 |
| 15 |
incidents that may have involved improper management or use of such |
| |
| |
(g) | ensuring that appropriate action is taken for the purpose of protecting |
| |
patients or members of the public in cases where such concerns appear |
| |
| 20 |
(h) | where required by regulations under section 17, the sharing of |
| |
| |
(7) | The arrangements mentioned in subsection (6) may be arrangements |
| |
established (according to the circumstances)— |
| |
(a) | by the accountable officer, |
| 25 |
(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 |
| |
| 30 |
| |
(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 a person who, whether as— |
| 35 |
(i) | a health care professional, or |
| |
(ii) | an employee who is not a health care professional, or |
| |
| |
| 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 |
| 40 |
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 |
| |
| 45 |
(10) | Nothing in subsections (5) to (7) is to be read as prejudicing the generality of |
| |
| |
(11) | In this section “prescribed” means prescribed by regulations under this section. |
| |
|
| |
|
| |
|
17 | 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 |
| |
| |
(a) | the identification of cases in which action may need to be taken in |
| 5 |
respect of matters arising in relation to the management or use of |
| |
controlled drugs by relevant individuals; |
| |
(b) | the consideration of issues relating to the taking of action in respect of |
| |
| |
(c) | the taking of action in respect of such matters. |
| 10 |
(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 bodies that may be prescribed as responsible bodies for the purposes of |
| 15 |
| |
(a) | bodies which fall within subsection (4); and |
| |
| |
(4) | 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 |
| 20 |
(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, |
| |
(c) | to have powers of inspection in relation to the management or use of |
| |
| 25 |
(d) | to be public or local authorities with responsibilities in relation to social |
| |
| |
(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). |
| 30 |
(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 |
| 35 |
| |
(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 |
| |
| |
(c) | in relation to a responsible body which is a police force, for imposing |
| 40 |
duties on the chief officer; |
| |
(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 |
| 45 |
action for the purpose of protecting the safety of patients or the general |
| |
| |
|
| |
|
| |
|
(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 |
| 5 |
institution of disciplinary proceedings. |
| |
(8) | Nothing in subsections (5) to (7) is to be read as prejudicing the generality of |
| |
| |
| |
(a) | “chief officer” means— |
| 10 |
(i) | in relation to a police force in England and Wales, the chief |
| |
| |
(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 |
| 15 |
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; |
| 20 |
(c) | “prescribed” means prescribed by regulations under this section; |
| |
(d) | “relevant individual” means a person who, whether as— |
| |
(i) | a health care professional, or |
| |
(ii) | an employee who is not a health care professional, or |
| |
| 25 |
| 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. |
| |
18 | Controlled drugs: power to enter and inspect |
| 30 |
(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 |
| |
| 35 |
(c) | inspect any stocks of controlled drugs kept on the premises; |
| |
(d) | require any relevant records kept on the premises to be produced for |
| |
| |
(2) | The powers conferred by subsection (1) may be exercised only— |
| |
(a) | at a reasonable hour, and |
| 40 |
(b) | on production (if required) of the written authority of the person |
| |
| |
(3) | 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 |
| |
| |
(4) | In this section “authorised person” means (subject to subsection (5))— |
| |
(a) | a person authorised by the relevant authority, |
| 5 |
(b) | an accountable officer, and |
| |
(c) | where a designated body is required by regulations under section 16 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. |
| 10 |
(5) | The accountable officer of a designated body 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 (4)(c). |
| |
(6) | The relevant authority may by regulations prescribe descriptions of premises |
| 15 |
which are to be “relevant premises” for the purposes of subsection (1) in |
| |
relation to constables and authorised persons of descriptions prescribed in the |
| |
| |
(7) | The premises that may be so prescribed are premises (or parts thereof) |
| |
appearing to the relevant authority to be used in connection with— |
| 20 |
(a) | the provision of health care (whether or not for the purposes of the |
| |
| |
(b) | the supply or administration of controlled drugs. |
| |
(8) | In this Chapter “relevant records” means records kept with respect to |
| |
controlled drugs in pursuance of regulations under section 10 of the Misuse of |
| 25 |
| |
(9) | Directions under subsection (5) are to be given by regulations or in writing; but |
| |
any such directions which relate to more than one designated body are to be |
| |
| |
(10) | Directions under subsection (5) given in writing may be varied or revoked by |
| 30 |
subsequent directions under that subsection. |
| |
19 | 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 |
| |
| 35 |
(b) | conceals from a person acting under section 18(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 18(1) requires to be produced. |
| |
(2) | A person guilty of an offence under subsection (1) is liable— |
| 40 |
(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 |
| |
| |
| |
(1) | The relevant authority may issue guidance to designated bodies in connection |
| 5 |
| |
(a) | determining whether conditions specified in regulations under section |
| |
16 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 |
| 10 |
responsibilities imposed on him by regulations under section 16; |
| |
(c) | the exercise by designated bodies of their powers under section 16(9); |
| |
(d) | the exercise by designated bodies of their powers under section |
| |
| |
(2) | The relevant authority may issue guidance to responsible bodies in connection |
| 15 |
with their discharge of any duties imposed on them by regulations under |
| |
| |
(3) | Guidance under this section may make different provision for different cases |
| |
| |
(4) | Designated bodies and responsible bodies must have regard to any guidance |
| 20 |
under this section in exercising any functions to which the guidance relates. |
| |
| |
(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 |
| 25 |
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. |
| |
| 30 |
(1) | This section applies to functions conferred on the relevant authority by this |
| |
| |
(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 |
| 35 |
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— |
| 40 |
(a) | performs (and only performs) functions in respect of England and |
| |
| |
|
| |
|
| |
|
(b) | does not perform functions mainly in respect of England or mainly in |
| |
| |
(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 |
| 5 |
Northern Ireland by the Department of Health, Social Services and Public |
| |
| |
| |
| |
“accountable officer” is to be read in accordance with section 16(2); |
| 10 |
“body” includes an unincorporated association; |
| |
“controlled drug” has the meaning given by section 2 of the Misuse of |
| |
| |
“designated body” has the meaning given by section 16(3); |
| |
| 15 |
(a) | services provided to individuals for or in connection with the |
| |
prevention, diagnosis or treatment of illness, and |
| |
(b) | the promotion and protection of public health; |
| |
“health care professional”— |
| |
(a) | in relation to England and Wales, has the meaning given by |
| 20 |
section 28X(3)(a) of the National Health Service Act 1977 (c. 49) |
| |
(referred to in this Act as “the 1977 Act”), |
| |
(b) | in relation to Scotland, has the meaning given by section 17D(2) |
| |
of the National Health Service (Scotland) Act 1978 (c. 29), and |
| |
(c) | in relation to Northern Ireland, has the meaning given by |
| 25 |
Article 15C of the Health and Personal Social Services |
| |
(Northern Ireland) Order 1972 (S.I. 1972/1265 (N.I. 14)); |
| |
| |
(a) | in relation to England and Wales, has the meaning given by |
| |
section 128(1) of the 1977 Act, |
| 30 |
(b) | in relation to Scotland, has the meaning given by section 108(1) |
| |
of the National Health Service (Scotland) Act 1978, and |
| |
(c) | in relation to Northern Ireland, has the meaning given by |
| |
Article 2(2) of the Health and Personal Social Services (Northern |
| |
| 35 |
“relevant authority” is to be read in accordance with section 22; |
| |
“relevant records” has the meaning given by section 18(8); |
| |
“responsible body” has the meaning given by section 17(2). |
| |
(2) | In this Chapter any reference to the management or use of controlled drugs |
| |
| 40 |
(a) | the storage, carriage and safe custody of such drugs, |
| |
(b) | the prescribing and supply of such drugs, |
| |
(c) | the administration of such drugs, |
| |
(d) | the recovery of such drugs when no longer needed, and |
| |
(e) | the disposal of such drugs. |
| 45 |
|
| |
|
| |
|
| |
| |
24 | Requirements about supervision |
| |
(1) | In section 10 of the Medicines Act 1968 (c. 67) (which provides for exemptions |
| |
for pharmacists in relation to certain dealings with medicinal products), after |
| 5 |
| |
“(7A) | The Health Ministers may make regulations prescribing conditions |
| |
which must be complied with if a thing is to be considered for the |
| |
purposes of this section as done under the supervision of a pharmacist. |
| |
(7B) | Compliance with the applicable conditions is sufficient for the thing to |
| 10 |
| |
(7C) | Conditions prescribed under subsection (7A) may relate to supervision |
| |
in the case where the pharmacist is not at the place where the thing is |
| |
| |
(2) | In section 52 of that Act (sale or supply of medicines not on general sale list)— |
| 15 |
(a) | the existing text is to be subsection (1), |
| |
(b) | after that subsection insert— |
| |
“(2) | The Health Ministers may make regulations prescribing |
| |
conditions which must be complied with if a transaction |
| |
mentioned in subsection (1)(c) is to be considered for the |
| 20 |
purposes of this section as done under the supervision of a |
| |
| |
(3) | Compliance with the applicable conditions is sufficient for the |
| |
transaction to be so considered. |
| |
(4) | Conditions prescribed under subsection (2) may relate to |
| 25 |
supervision in the case where the pharmacist is not on the |
| |
| |
25 | Control of pharmacy premises: individuals and partnerships |
| |
(1) | For section 70 of the Medicines Act 1968 (pharmacy business carried on by |
| |
individual pharmacist or by partners) substitute— |
| 30 |
“70 | Business carried on by individual pharmacist or by partners |
| |
(1) | The conditions referred to in section 69(1)(a) of this Act are that |
| |
subsections (2) and (3) of this section are both satisfied as respects each |
| |
of the premises where the retail pharmacy business is carried on and |
| |
medicinal products, other than medicinal products on a general sale |
| 35 |
list, are sold by retail. |
| |
(2) | This subsection is satisfied if a responsible pharmacist who satisfies the |
| |
requirements of subsections (4) and (5) of this section is in charge of the |
| |
business at those premises, so far as concerns— |
| |
(a) | the retail sale at those premises of medicinal products (whether |
| 40 |
they are on a general sale list or not), and |
| |
|
| |
|