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PART 11Enforcement, reviews and appeals relating to fitness matters

Extended meaning of “health scheme” in fraud cases

78.  The schemes prescribed under section 151(7)(b) of the 2006 Act (disqualification of practitioners) are schemes in the course of which health or medical services are paid for out of public funds and provided—

(a)other than as part of the health services referred to in section 151(7)(a)—

(i)by port health authorities,

(ii)by the armed forces of the Crown, or

(iii)to persons in accommodation in which they are required in accordance with law to be detained (but not naval, military and air force prisons, which are covered by sub-paragraph (ii)); or

(b)by or on behalf of the government of a country or territory outside the United Kingdom.

Review of decisions to impose fitness conditions originally imposed on grants of applications

79.—(1) Where a Primary Care Trust (PCT1) has imposed a condition on an NHS chemist (C) under regulation 35 (or thereafter under this regulation), it may review the decision to impose the condition—

(a)at its own volition; or

(b)where requested to do so by C, but C may not make such a request—

(i)in the case of the first such request, until at least 3 months have elapsed since C was included in the Primary Care Trust’s pharmaceutical list, or

(ii)thereafter, until at least 6 months have elapsed since the Primary Care Trust determined the outcome of the previous review.

(2) If PCT1 is undertaking the review of its own volition, it must inform C that it is doing so.

(3) As part of any review under paragraph (1), PCT1 must afford C an opportunity to make representations to it in writing.

(4) As a result of the review, PCT1 may remove the condition, leave the condition unchanged, vary the condition or impose a different condition, but any varied or different condition must be a condition with a view to—

(a)preventing any prejudice to the efficiency of the services, or any of the services, which C has undertaken to provide; or

(b)preventing any act or omission within section 151(3)(a) of the 2006 Act (disqualification of practitioners).

(5) PCT1 must notify C of a decision under paragraph (4), and it must include with the notification an explanation of—

(a)the reasons for the decision;

(b)C’s right of appeal against its decision on the review to the First-tier Tribunal (which C has by virtue of this sub-paragraph);

(c)the time limit within which, in accordance with the Tribunal Procedure (First-tier Tribunal) (Health, Education and Social Care Chamber) Rules 2008(1), the application notice must be sent to the Tribunal if an appeal is to be brought; and

(d)the continuing application of the condition that applied prior to the review, if there is an appeal, pending the outcome of the appeal.

(6) If the outcome of the review is that the condition is to be varied or a different decision is to be imposed, that decision is to take effect—

(a)if no appeal is brought against the decision, once the period for bringing an appeal has elapsed; or

(b)if an appeal is brought against the decision, and the decision of PCT1 is not changed by the First-tier Tribunal, once the First-tier Tribunal has determined the appeal (if the First-tier Tribunal takes a different decision to the decision taken by PCT1, that decision takes effect upon the taking of that decision, unless the First-tier Tribunal directs otherwise).

Removal for breach of fitness conditions imposed under regulation 35 or 79

80.  If, in the course of a review under regulation 79 or otherwise, a Primary Care Trust determines that an NHS chemist has failed to comply with a condition imposed under regulation 35 or 79, or as varied under regulation 79, it may remove that NHS chemist from its pharmaceutical list.

Mandatory removal in suitability cases

81.  In unsuitability cases, a Primary Care Trust must remove an NHS chemist (C) from its pharmaceutical list if—

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

(b)C (or where C is a body corporate, any director or superintendent of C) has been convicted in the United Kingdom of a criminal offence, other than murder—

(i)which was committed after 1st April 2005, and

(ii)has been sentenced to a term of imprisonment of over 6 months; or

(c)C is the subject of a national disqualification.

Fitness cases: procedures for removal or contingent removal from pharmaceutical lists

82.—(1) This paragraph applies where a Primary Care Trust (PCT1) is considering—

(a)removing an NHS chemist (C) from its pharmaceutical list under section 151 or 152(3)(b) of the 2006 Act (which relate to disqualification of practitioners and contingent removal);

(b)removing C from its pharmaceutical list under regulation 80; or

(c)contingently removing C from its pharmaceutical list under section 152(1) of the 2006 Act.

(2) Where paragraph (1) applies, before reaching its decision, PCT1 must—

(a)notify C of the action PCT1 is considering taking and its grounds for considering taking that action; and

(b)as part of that notification—

(i)inform C of any allegation against C, and

(ii)advise C that C may make—

(aa)written representations to PCT1 with regard to that action, provided C notifies PCT1 with those representations within 30 days beginning with the date of the notification by PCT1, and

(bb)oral representations to PCT1 with regard to that action, provided C notifies PCT1 of C’s wish to do so within 30 days beginning with the date of the notification by PCT1 and C (or a representative of C) attends the hearing that PCT1 arranges for the purpose of hearing those representations, which PCT1 must give C reasonable notice of; and

(c)in an unsuitability case to which regulation 81(a) or (b) applies, if C is a body corporate, advise C that PCT1 will not remove C from its pharmaceutical list as a consequence of that regulation (without prejudice to any other action it may take), provided that—

(i)the director or superintendent ceases to be a director or superintendent of C within the period of 30 days that begins on the date of the notification by PCT1, and

(ii)within that period, C notifies PCT1 of the date on which the director or superintendent has ceased or is to cease to be a director or superintendent of C.

(3) Once PCT1 has taken its decision, it must notify C of its decision, and it must include with the notification (which may be combined, in appropriate cases, with a notification under regulation 79(5)) an explanation of—

(a)the reasons for the decision;

(b)if PCT1 has decided to remove or contingently remove C from its pharmaceutical list—

(i)C’s rights of appeal in relation to that decision under section 158 of the 2006 Act(2) (appeals), and

(ii)the time limit within which, in accordance with the Tribunal Procedure (First-tier Tribunal) (Health, Education and Social Care Chamber) Rules 2008(3), the application notice must be sent to the Tribunal if an appeal is to be brought; and

(c)if PCT1 has decided to contingently remove C, the arrangements for review of the conditions under section 157(1) of the 2006 Act(4) (review of decisions).

(4) If PCT1 has decided to remove or contingently remove C from its pharmaceutical list in accordance with this regulation, that decision is not to take effect—

(a)if C does not appeal against the decision, until the period for bringing an appeal against the decision has elapsed; or

(b)if C does appeal against the decision, unless the First-tier Tribunal has determined the appeal and confirmed the decision of PCT1 (if the First-tier Tribunal takes a different decision to the decision taken by PCT1, that decision takes effect upon the taking of that decision, unless the First-tier Tribunal directs otherwise).

Procedure for suspensions in fitness cases

83.—(1) Where a Primary Care Trust (PCT1) is considering suspending an NHS chemist (C) from its pharmaceutical list under section 154(1) or section 155(2) of the 2006 Act(5) (which relate to suspension and suspension pending appeal), before reaching its decision, it must—

(a)notify C of the action PCT1 is considering taking and its grounds for considering taking that action; and

(b)as part of that notification—

(i)where PCT1 is considering taking action under section 154(1), inform C of any allegation against C, and

(ii)advise C that C may make oral representations to PCT1 with regard to the possible suspension on a specified day, provided C notifies PCT1 of C’s wish to do so within a specified period (of not less than 24 hours).

(2) If, within the specified period—

(a)C does not advise PCT1 that C wishes to make oral representations to PCT1 on the specified day, thereafter PCT1 may suspend C with immediate effect; or

(b)C does advise PCT1 that C wishes to make oral representations to PCT1 on the specified day, PCT1 must not suspend C until after the oral hearing, but may then do so with immediate effect.

(3) Once PCT1 has taken its decision, it must notify C of its decision as soon as is practicable, and it must include with the notification of its decision an explanation of—

(a)the reasons for the decision;

(b)if PCT1 has decided to suspend C under section 154(1), the arrangements for review of the suspension under section 157(1) of the 2006 Act (review of decisions).

Procedure for reviewing some suspensions and contingent removal conditions

84.—(1) This paragraph applies where a Primary Care Trust (PCT1)—

(a)is required to review a contingent removal or a suspension under section 157(1) of the 2006 Act(6) (review of decisions); or

(b)decides to review a contingent removal or a suspension that it could be required to review under that section (if section 157(2) were satisfied).

(2) Where paragraph (1) applies, as part of the review, PCT1 must afford the NHS chemist who has been contingently removed or is suspended (C) the opportunity to make—

(a)written representations to PCT1, provided C notifies PCT1 with those representations within 30 days beginning with the date of the notification by PCT1; and

(b)oral representations to PCT1 with regard to that action, provided—

(i)C notifies PCT1 of C’s wish to do so within 30 days beginning with the date of the notification by PCT1, and

(ii)C (or a representative of C) attends the hearing that PCT1 arranges for the purpose of hearing those representations, which PCT1 must give C reasonable notice of.

(3) Once PCT1 has taken its decision under section 157(3), it must notify C of its decision, and it must include with the notification of its decision an explanation of—

(a)the reasons for the decision;

(b)if C has a right of appeal in relation to the decision—

(i)the right of appeal that C has in relation to that decision under section 158 of the 2006 Act(7) (appeals), and

(ii)the time limit within which, in accordance with the Tribunal Procedure (First-tier Tribunal) (Health, Education and Social Care Chamber) Rules 2008(8), the application notice must be sent to the Tribunal if an appeal is to be brought; and

(c)if C has been or remains suspended or contingently removed, the arrangements for review of the suspension or the conditions under section 157(1) of the 2006 Act.

General power to revoke suspensions in appropriate circumstances

85.—(1) If an NHS chemist is suspended from the pharmaceutical list of a Primary Care Trust (PCT1), in addition to PCT1’s powers to terminate suspensions under section 157(3)(b) of the 2006 Act (review of decisions) on a review, PCT1 may terminate a suspension at any time, in appropriate circumstances.

(2) If PCT1 terminates a suspension under paragraph (1), it must notify the NHS chemist that it has done so.

Evidence of unsuitability, fraud or inefficiency in service provision: specific matters

86.—(1) When considering whether or not—

(a)to vary or impose a condition on an NHS chemist (C) under regulation 79 or section 152(2) or (3)(a) of the 2006 Act (contingent removal);

(b)to remove C from its pharmaceutical list under section 151 (disqualification of practitioners) or 152 of the 2006 Act or regulation 80, or to contingently remove C from its pharmaceutical list under section 152 of the 2006 Act;

(c)to suspend C from its pharmaceutical list under section 154 or 155 of the 2006 Act(9) (which relate to suspension and suspension pending appeal),

a Primary Care Trust (PCT1) is to have regard, as appropriate, to the matters set out in paragraph (2) (in addition to other relevant matters).

(2) Those matters are—

(a)in a case that is or may be a fraud case or an efficiency case, relevant breaches of any condition imposed by virtue of regulation 35 or 79 or section 152(2) or (3)(a) of the 2006 Act, or as varied by virtue of regulation 79 or section 152(3)(a) of the 2006 Act;

(b)any evidence received from C, or which C is required to provide, under paragraph 31 of Schedule 4 or paragraph 21 of Schedule 5;

(c)any evidence received by PCT1 from the Secretary of State, the NHS BSA, the police or any regulatory or licensing body relating to past or current investigations or proceedings involving or relating to C (and where C is a body corporate, any director or superintendent of C), and where PCT1 does receive such evidence, it must take into account in particular—

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

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

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

(iv)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;

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

(vi)in a case that is or may be an unsuitability case, whether any offence was a sexual offence to which Part 1 of the Sexual Offences Act 2003(10) (sexual offences) applies, or if it had been committed in England and Wales, would have applied;

(vii)where C (and where C is a body corporate, any director or superintendent of C) has been refused inclusion in, conditionally included in, removed, contingently removed or is currently suspended from a relevant list for a reason relating to unsuitability, fraud or efficiency of service provision, the facts which led to such action and the reasons given by the Primary Care Trust or other primary care organisation for such action; or

(viii)where C (and where C is a body corporate, any director or superintendent of C) is—

(aa)a director or superintendent of a body corporate which has been refused inclusion in, conditionally included in, removed or contingently removed from a relevant list, or

(bb)suspended from a relevant list,

for a reason relating to unsuitability, fraud or efficiency of service provision, the facts which led to such action and the reasons given by the Primary Care Trust or other primary care organisation in each case.

(3) When PCT1 has regard to matters set out in paragraph (2), it must consider the overall effect of all the matters being considered.

Review periods for national disqualifications

87.—(1) Section 159(8)(a) of the 2006 Act(11) (national disqualification) is to have effect as if the reference to “two years” were a reference to “five years”, if the First-tier Tribunal determines, when it imposes the national disqualification, that the conduct of the person on whom the national disqualification has been imposed has been such that there is no realistic prospect of a review being successful if held within five years.

(2) Section 159(8)(b) of the 2006 Act is to have effect as if the reference to “one year” were a reference to “three years”, if the First-tier Tribunal determines, on a review, that the conduct of the person on whom the national disqualification has been imposed has been such that there is no realistic prospect of a further review being successful if held within three years.

(3) Section 159(8) of the 2006 Act is to have effect as if the references to “two years” and “one year”—

(a)in a case where—

(i)a national disqualification has been imposed as a consequence of a criminal conviction, and

(ii)on appeal, the conviction has been quashed or the penalty imposed by the court has been reduced; or

(b)in a case where—

(i)a national disqualification has been imposed as a consequence of an adverse decision of a licensing body, and

(ii)on appeal, the decision of the licensing body has been quashed or the penalty imposed by it has been reduced,

were a reference to a period equal to the period between the date on which that appeal was determined and the date on which the national disqualification was imposed or last reviewed.

Wider notifications of fitness decisions

88.—(1) Where a Primary Care Trust (PCT1)—

(a)refuses an application from a person (P) by virtue of regulation 33;

(b)grants an application subject to conditions imposed on P by virtue of regulation 35;

(c)imposes or varies a condition imposed on P by virtue of regulation 79;

(d)removes P from its pharmaceutical list by virtue of section 151 or 152(3)(b) of the 2006 Act (which relate to disqualification of practitioners and contingent removal);

(e)contingently removes P from its pharmaceutical list by virtue of section 152 of the 2006 Act, or varies or imposes a different condition on P by virtue of that section; or

(f)suspends P under section 154 or 155 of the 2006 Act(12) (which relate to suspension and suspension pending appeal),

PCT1 must notify the persons listed in paragraph (2) that it has done so.

(2) Those persons are—

(a)the Secretary of State;

(b)where known to PCT1, any other Primary Care Trust or other primary care organisation that—

(i)has included P, or a body corporate of which P is a director or superintendent, in a relevant list, or

(ii)is considering including P, or a body corporate of which P is a director or superintendent, in a relevant list;

(c)the Scottish Ministers;

(d)the Welsh Ministers;

(e)the Northern Ireland Executive;

(f)the General Pharmaceutical Council;

(g)any Local Pharmaceutical Committee for PCT1’s area (including a Local Pharmaceutical Committee for its area and that of one or more other Primary Care Trusts);

(h)the National Health Service Commissioning Board;

(i)in a case that is or may be a fraud case, the NHS BSA; and

(j)any person who may and does request to be notified of an adverse fitness decision as regards P.

(3) A person (Q) comes within paragraph (2)(j) if Q establishes to the satisfaction of PCT1 that Q—

(a)has employed or engaged, is employing or engaging or is considering employing or engaging P, or a director or superintendent of P, in a professional capacity; or

(b)is a member of a partnership of which P has been or is a member, or which is considering inviting P to be a member.

(4) A notification under paragraph (1) must include—

(a)where P is an individual or a partnership—

(i)P’s, or each member of the partnership’s, name, address and date of birth, and

(ii)P’s, or each member of the partnership’s, registration number in the Register of Pharmacists; and

(b)where P is a body corporate—

(i)P’s name, company registration number and the address of P’s registered office, and

(ii)the registration number in the Register of Pharmacists of P’s superintendent and of any director of P who is a registered pharmacist;

(c)a copy of the notification of the decision that was sent to P; and

(d)the name of and contact details for a person at PCT1 who is in a position to respond to further enquiries.

(5) PCT1 must notify P of whom it has notified under paragraph (1) and include, when it does so, the content of that notification.

(6) If, in response to an enquiry from a person notified under paragraph (1), PCT1 notifies that person with further documentation (including documentation in an electronic form) that relates to P, PCT1 must also notify P with—

(a)that documentation; and

(b)details of the person to whom it has been sent.

(7) If PCT1 is notified by the First-tier Tribunal of a national disqualification, or the outcome of the review of a national disqualification, it must notify that information to the persons it notified about its own decision in relation to P under paragraph (2)(b) and (g) to (j).

(8) If, having notified a person (Q) under paragraph (1) of a suspension or a condition (including a condition imposed on contingent removal), PCT1 terminates the suspension or removes the condition, PCT1 must notify Q with the notification given to P of the decision to terminate the suspension or remove the condition.

(1)

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

(2)

Section 158 has been amended by S.I. 2010/22.

(3)

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

(4)

Section 157 has been amended by S.I. 2010/22.

(5)

Sections 154 and 155 have been amended by S.I. 2010/22.

(6)

Section 157 has been amended by S.I. 2010/22.

(7)

Section 158 has been amended by S.I. 2010/22.

(8)

See rule 19 of those Rules.

(9)

Sections 154 and 155 have been amended by S.I. 2010/22.

(11)

Section 159 has been amended by S.I. 2010/22.

(12)

Sections 154 and 155 have been amended by S.I. 2010/22.