The National Health Service (Pharmaceutical Services) Regulations 2005

Criteria for decisions on removal

46.—(1) Where a Primary Care Trust is considering removal of a chemist’s name from its pharmaceutical list under section 49F(4)(1) of the Act (an unsuitability case), it shall—

(a) consider the information from the chemist supplied under paragraphs 29 and 30 of Schedule 1 or paragraphs 16 and 17 of Schedule 3,

(b) consider any information held by the Secretary of State as to any record about past or current investigations or proceedings involving him or related to him; and

(c) in reaching its decision take into consideration the matters set out in paragraph (2).

(2) The matters referred to in paragraph (1) are—

(a) the nature of any offence, investigation or incident;

(b) the length of time since any such offence, incident, conviction or investigation;

(c) whether there are other offences, incidents or investigations to be considered;

(d) the penalty imposed by any licensing or regulatory body, the police or the courts as a result of any such offence, incident or investigation;

(e) the relevance of any offence, investigation or incident to the provision by the chemist of pharmaceutical services and any likely risk to users of pharmaceutical services or to public finances;

(f) whether any offence was a sexual offence to which Part 1 of the Sexual Offences Act 2003 applies, or if it had been committed in England and Wales, would have applied;

(g) whether the chemist (and where the chemist is a body corporate, any director or superintendent of the chemist) has been refused admittance to, conditionally included in, removed, contingently removed or is currently suspended from, any list or any equivalent list, on fitness to practise grounds, and if so, the facts relating to the matter which led to such action and the reasons given by the Primary Care Trust or equivalent body for such action;

(h) whether the chemist (and where the chemist is a body corporate, any director or superintendent of the chemist) was a director or superintendent, at the time of the originating events, of a body corporate which has been refused admittance to, conditionally included in, removed or contingently removed from, any of a Primary Care Trust’s lists or from equivalent lists, on fitness to practise grounds and if so, the facts relating to the matter which led to such action and the reasons given by the Primary Care Trust or equivalent body for such action; and

(i) whether the chemist (and where the chemist is a body corporate, any director or superintendent of the chemist) was a director or superintendent, at the time of the originating events, of a body corporate which is currently suspended from any of a Primary Care Trust’s lists or from equivalent lists, and if so, the facts relating to the matter which led to the suspension and the reasons given by the Primary Care Trust or equivalent body for the suspension.

(3) Where a Primary Care Trust is considering removal of a chemist’s name from its pharmaceutical list under section 49F(3) of the Act (a fraud case), it shall consider—

(a) any information from the chemist supplied under paragraphs 29 and 30 of Schedule 1 or 16 and 17 of Schedule 3;

(b) any information held by the Secretary of State as to any record about past or current investigations or proceedings involving or related to the chemist; and

(c) the matters set out in paragraph (4).

(4) The matters referred to in paragraph (3)(c) are—

(a) the nature of the incidents of fraud;

(b) the length of time since the last incident of fraud occurred, and since any investigation into that incident of fraud was concluded;

(c) whether there are other incidents of fraud or other criminal offences to be considered;

(d) any action taken by any licensing or regulatory or other body, the police or the courts as a result of any such incident or offence;

(e) the relevance of any investigation into the incident of fraud to the provision by the chemist of pharmaceutical services, and any likely risk to users of pharmaceutical services or to public finances;

(f) whether the chemist (and, where the chemist is a body corporate, any director or superintendent of the chemist) has been refused admittance to, conditionally included in, removed, contingently removed or is currently suspended from, any list or equivalent list, on fitness to practise grounds, and if so, the facts relating to the matter which led to such action and the reasons given by the Primary Care Trust or equivalent body for such action;

(g) whether the chemist (and where the chemist is a body corporate, any director or superintendent of the chemist) was a director or superintendent, at the time of the originating events, of a body corporate which has been refused admittance to, conditionally included in, removed or contingently removed from, any list or equivalent list, on fitness to practise grounds, and if so, the facts relating to the matter which led to such action and the reasons given by the Primary Care Trust or equivalent body for such action; and

(h) whether the chemist (and, where the chemist is a body corporate, any director or superintendent of the chemist) was a director or superintendent, at the time of the originating events, of a body corporate which is currently suspended from any list or equivalent list, and if so, the facts relating to the matter which led to the suspension and the reasons given by the Primary Care Trust or equivalent body for the suspension.

(5) Where a Primary Care Trust is considering removal of a chemist’s name from its pharmaceutical list under section 49F(2) of the Act (an efficiency case), it shall—

(a) consider the information from the chemist supplied under paragraphs 29 and 30 of Schedule 1 or 16 and 17 of Schedule 3;

(b) consider any information held by the Secretary of State as to any record about past or current investigations or proceedings involving or related to the chemist; and

(c) in reaching its decision, take into consideration the matters set out in paragraph (6).

(6) The matters referred to in paragraph (5)(c) are—

(a) the nature of any incident which was prejudicial to the efficiency of the pharmaceutical services provided by the chemist;

(b) the length of time since the last such incident occurred, and since any investigation into that incident was concluded;

(c) any action taken by any licensing, regulatory or other body, the police or the courts as a result of any such incident;

(d) the nature of any incident and whether there is a likely risk to users of pharmaceutical services;

(e) whether the chemist has previously failed to supply information, make a declaration or comply with an undertaking required by these Regulations;

(f) whether the chemist (and, where the chemist is a body corporate, any director or superintendent of the chemist) has been refused admittance to, conditionally included in, removed, contingently removed or is currently suspended from, any list or equivalent list, on fitness to practise grounds, and if so, the facts relating to the matter which led to such action and the reasons given by the Primary Care Trust or equivalent body for such action;

(g) whether the chemist (and, where the chemist is a body corporate, any director or superintendent of the chemist) was a director or superintendent, at the time of the originating events, of a body corporate which has been refused admittance to, conditionally included in, removed or contingently removed from, any list or equivalent list, on fitness to practise grounds, and if so, the facts relating to the matter which led to such action and the reasons given by the Primary Care Trust or equivalent body for such action; and

(h) whether the chemist (and, where the chemist is a body corporate, any director or superintendent of the chemist) was a director or superintendent, at the time of the originating events, of a body corporate which is currently suspended from any list or equivalent list, and if so, the facts relating to the matter which led to the suspension and the reasons given by the Primary Care Trust or equivalent body for the suspension.

(7) In making any decision under section 49F of the Act, the Primary Care Trust shall take into account the effect of all relevant incidents and offences relating to the chemist of which it is aware, whichever condition it relies on.

(8) When making a decision on any condition in section 49F of the Act, the Primary Care Trust shall state in its decision on which condition (or conditions) in section 49F of the Act it relies.

(1)

Section 49F was inserted by the 2001 Act, section 25 and amended by the 2002 Act, section 2(5) and Schedule 2, Part I , paragraphs 1 and 21 and by the 2003 Act, section 196 and Schedule 14, Part 4.