The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020

Refusal of applications on fitness grounds E+W

37.—(1) This regulation applies to applications made under—

(a) regulation 15(1)(a) (applications to be included in or make amendment to a pharmaceutical list), except where the application is made by a person who has a valid preliminary consent in accordance with regulation 18(5), and

(b) regulation 18 (applications for preliminary consent and effect of preliminary consent) where the applicant is not already included in that Local Health Board’s pharmaceutical list.

(2) A Local Health Board may refuse to grant an application where—

(a) having considered the information and undertakings required by Part 2 of Schedule 2 and any other information in its possession in relation to the application, the Local Health Board considers that the applicant is unsuitable to be included in its pharmaceutical list,

(b) having contacted the referees nominated by the applicant in accordance with Part 2 of Schedule 2, it is not satisfied with the references given,

(c) having checked with the NHS Business Services Authority for any facts that it considers relevant relating to past or current fraud investigations involving or related to the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant), and having considered these and any other facts in its possession relating to fraud involving or relating to the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant), it considers these justify such refusal,

(d) having checked with the Welsh Ministers for any facts that they consider relevant relating to past or current investigations or proceedings involving or relating to the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) and having considered these and any other facts in its possession involving or relating to the applicant (and where the applicant is a body corporate any director or superintendent of the applicant), it considers that these justify such a refusal, or

(e) it considers that admitting the applicant to the list would be prejudicial to the efficiency of the pharmaceutical service which they would undertake to provide.

(3) A Local Health Board must refuse to grant an application where—

(a) the applicant (or where the applicant is a body corporate, any director or superintendent of the applicant) has been convicted in the United Kingdom of murder,

(b) the applicant (or where the applicant is a body corporate, any director or superintendent of the applicant) has been convicted in the United Kingdom of a criminal offence, other than murder, which was committed after the date on which these Regulations come into force and has been sentenced to a term of imprisonment of over 6 months,

(c) the applicant is the subject of a national disqualification, or

(d) on appeal the Tribunal determines that the applicant may be included in the pharmaceutical list subject to conditions but the applicant has not, within 30 days of that decision notified the Local Health Board that they agree to the imposition of conditions.

(4) Where the Local Health Board is considering a refusal of an application under paragraph (2), it must consider all facts which appear to it to be relevant and must, in particular, take into consideration in relation to paragraph (2)(a), (c) and (d)—

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

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

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

(d) any action taken or 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 applicant of pharmaceutical services and any likely risk to users of pharmaceutical services or public finances,

(f) whether any offence was a sexual offence to which Part 2 of the Sexual Offences Act 2003(1) applies, or if it had been committed in England and Wales would have applied,

(g) whether the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) 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 Local Health Board or equivalent body for such action, or

(h) whether the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) was, at the time of the originating events, or has in the preceding 6 months been, a director or superintendent of a body corporate which has been refused admittance to, conditionally included in, removed or contingently removed from any list or equivalent list, or is currently suspended from any such list on fitness to practise grounds, and if so, what the facts were in each such case and the reasons given by the Local Health Board or equivalent body in each case.

(5) When the Local Health Board takes into account the matters set out in paragraph (4), it must consider the overall effect of the matters being considered.

(6) If a Local Health Board refuses an application to which this regulation applies under grounds in paragraph (2) or (3), the Local Health Board must notify the applicant of that decision and it must include with the notification an explanation of—

(a) the reasons for the decision;

(b) the applicant’s right of appeal against the decision to the Tribunal, and

(c) the time limit within which, in accordance with the Tribunal Procedure (First-tier Tribunal) (Health, Education and Social Care Chamber) Rules 2008(2), the application notice must be sent to the Tribunal if an appeal is to be brought.

Commencement Information

I1 Reg. 37 in force at 1.10.2021, see reg. 1(3)

(1)

2003 c. 42.

(2)

S.I. 2008/2699 (L. 16), see rule 19 of those Rules.