Citation and commencement

1. These Regulations may be cited as the Council of the Pharmaceutical Society of Northern Ireland (Statutory Committee, Scrutiny Committee and Advisers) Regulations (Northern Ireland) 2012 and come into operation on 1st October 2012.

Interpretation

2. In these Regulations-

"disqualification allegation" means a complaint to, or concern of, the Society which gives rise to, or may give rise to, an inquiry under Part 4 of the Medicines Act;

"interim suspension order" means an order referred to in paragraph 8(1)(a) of Schedule 3 to the Order;

"legally qualified" means a person who is a barrister or solicitor;

"licensing body" means any body anywhere in the world which licenses or regulates any profession;

"order for interim conditional entry" means an order referred to in paragraph 8(1)(b) of Schedule 3 to the Order;

"the Order" means the Pharmacy (Northern Ireland) Order 1976; and

"the register" means the register mentioned in Article 6 (1)(a) of the Order.

Composition of the Scrutiny Committee

3.-(1) The Scrutiny Committee is to consist of-

(a)a lay member who is the chair;

(b)a lay member who is the deputy chair;

(c)2 other lay members; and

(d)4 members who are registered persons

all of whom shall be appointed by the Council.

(2) The quorum of the Scrutiny Committee shall be 3 which must include-

(a)the chair or a deputy chair;

(b)a lay member; and

(c)a member who is a registered person.

(3) The chair and deputy chair referred to in paragraph (1)(a) and (b) may be legally qualified.

(4) In the absence of the chair of the Scrutiny Committee at a meeting the deputy chair may perform the functions of the chair.

(5) The Council may remove any member of the Scrutiny Committee from office for inability to perform their duties or for misbehaviour.

Eligibility for appointment to the Statutory Committee or Scrutiny Committee

4.-(1) Former members of the Council may be appointed to the Statutory Committee or Scrutiny Committee provided that they have not held office as a member of the Council for a period of 4 years prior to the date of application for membership of the Statutory Committee or Scrutiny Committee.

(2) An employee of the Society, a member of the Council, or a member of the Scrutiny Committee may not be appointed to the Statutory Committee.

(3) An employee of the Society, a member of Council or a member of the Statutory Committee may not be appointed to the Scrutiny Committee.

Disqualification from appointment to the Statutory Committee or Scrutiny Committee

5. A person is disqualified from appointment as a member of the Statutory Committee or Scrutiny Committee if that person-

(a)has at any time been subject to any investigation or proceedings concerning that person's professional conduct (including fitness to practise) conducted by any licensing body, other than the Society, the final outcome of which was-

(i)the person's suspension from a register held by that licensing body, and that suspension has not expired or been terminated,

(ii)the person's erasure from a register held by that licensing body or a decision that had the effect of preventing the person from practising the profession licensed or regulated by that licensing body, or

(iii)a decision that had the effect of only allowing the person to practise that person's profession subject to conditions, and those conditions have not expired or been terminated;

(b)has at any time been subject to any investigation or proceedings concerning that person's professional conduct (including fitness to practise) by the Society, the final outcome of which was-

(i)the person's entry in the register was suspended (including by an interim suspension order), and that suspension has not expired or been terminated,

(ii)the person's name being struck off the register, or

(iii)the person's entry in the register was made subject to an order imposing conditions with which the person must comply (including an order for interim conditional entry), and those conditions have not expired or been terminated;

(c)has at any time been subject to any investigation or proceedings relating to an allegation that the person's entry in the register was fraudulently procured-

(i)in the course of which the person's entry in the register was suspended, and that suspension has not expired or been terminated, or

(ii)the final outcome of which was the person's name being struck off the register;

(d)has at any time been subject to any investigation or proceedings concerning the person's professional conduct (including fitness to practise) by-

(i)the Society, or

(ii)any other licensing body,

and the Council is satisfied that the person's membership of the Statutory Committee or Scrutiny Committee would be liable to undermine public confidence in the regulation of pharmaceutical chemists;

(e)has at any time been convicted of an offence-

(i)in the United Kingdom where the final outcome of the proceedings was a sentence of imprisonment or detention, and the conviction is not spent,

(ii)in the United Kingdom where the final outcome of the proceedings was not a sentence of imprisonment or detention, the conviction is not spent, and the Council is satisfied that the person's membership of the Statutory Committee or Scrutiny Committee would be liable to undermine public confidence in the regulation of pharmaceutical chemists, or

(iii)outside the United Kingdom and the Council is satisfied that the person's membership of the Statutory Committee or Scrutiny Committee would be liable to undermine public confidence in the regulation of pharmaceutical chemists;

(f)has received a caution for a criminal offence in the United Kingdom and the Council is satisfied that the person's membership of the Scrutiny Committee would be liable to undermine public confidence in the regulation of pharmaceutical chemists;

(g)has at any time been included in-

(i)any barred list within the meaning of the Safeguarding Vulnerable Groups Act 2006 (4), or

(ii)any barred list within the meaning of the Safeguarding Vulnerable Groups (Northern Ireland) Order 2007(5)

unless that person was removed from the list either on the grounds that it was not appropriate for that person to have been included in it or as a result of a successful appeal;

(h)is included in the children's list or the adult's list maintained under the Protection of Vulnerable Groups (Scotland) Act 2007(6)

(i)has at any time been adjudged bankrupt, or sequestration of the person's estate has been awarded, and-

(i)the person has not been discharged, or

(ii)the person is the subject of a bankruptcy restrictions order or an interim bankruptcy restrictions order under Schedule 4A to the Insolvency Act 1986(7) or Schedule 2A to the Insolvency (Northern Ireland) Order 1989(8) or sections 56A to 56K of the Bankruptcy (Scotland) Act 1985(9)

and the Council is satisfied that the person's membership of the Statutory Committee or Scrutiny Committee would be liable to undermine public confidence in the regulation of pharmaceutical chemists;

(j)is a person to whom a moratorium period under a debt relief order Part VIIA of the Insolvency Act 1986 (debt relief orders) applies, or is the subject of a debt relief restrictions order or an interim debt relief restrictions order under Schedule 4ZB to that Act(10) (debt relief restrictions order and undertaking), and the Council is satisfied that the person's membership of the Statutory Committee or Scrutiny Committee would be liable to undermine public confidence in the regulation of pharmaceutical chemists;

(k)is subject to-

(i)a disqualification order or disqualification undertaking under the Company Directors Disqualification Act 1986(11)

(ii)a disqualification order under Part II of the Companies (Northern Ireland) Order 1989(12)

(iii)a disqualification order or disqualification undertaking under the Company Directors Disqualification (Northern Ireland) Order 2002(13), or

(iv)an order made under section 429(2) of the Insolvency Act 1986(14) (disabilities on revocation of a county court administration order);

(l)has at any time been removed from the office of charity trustee or trustees for a charity by an order made by the Charity Commissioners, the Charity Commission, the Charity Commission for Northern Ireland or the High Court on the grounds of any misconduct or mismanagement in the administration of the charity-

(i)for which that person was responsible or to which that person was privy, or

(ii)which was contributed to, or facilitated by, that person's conduct;

(m)has at any time been removed from being concerned with the management or control of any body in any case where removal was by virtue of-

(i)section 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990(15) (powers of Court of Session to deal with management of charities), or

(ii)section 34(5)(e) of the Charities and Trustees Investment (Scotland) Act 2005(16) (powers of Court of Session);

(n)has at any time been removed from office as the chair, or a member, convenor or director, of any public body on the grounds that it was not in the interests of, or conducive to the good management of, that body that the person should to continue to hold that office; or

(o)has at any time made a composition or arrangement with, or granted a trust deed for, the person's creditors and the person has not been discharged in respect of it.

Suspension and removal of Statutory Committee or Scrutiny Committee members

6.-(1) The Council must remove from the Statutory Committee or Scrutiny Committee any member-

(a)who resigns from membership of the Statutory Committee or Scrutiny Committee in accordance with these regulations;

(b)whose term of office has expired;

(c)who, in the case of a registered person, has ceased to be registered;

(d)who, in the opinion of the Council,-

(i)has ceased to be an appropriate person to be a member of the Statutory Committee or Scrutiny Committee (for example, by reason of misconduct or a criminal conviction),

(ii)has seriously or persistently failed to meet the standards of performance, conduct, attendance or participation in training required of a member of the Statutory Committee or Scrutiny Committee in the ordinary course of a member's duties,

(iii)is unable to perform the duties of a member because of ill health,

(iv)has improperly disclosed confidential information obtained by the member in the course of membership of the Statutory Committee or Scrutiny Committee,

(v)has brought the Society into disrepute,

(vi)has failed to comply with the code of conduct for Statutory Committee and Scrutiny Committee members,

(vii)should no longer continue to be a member of the Statutory Committee or Scrutiny Committee in the public interest.

(2) The Council may suspend a member of the Statutory Committee or Scrutiny Committee while investigations are being undertaken into the member's suitability to remain as a member of that committee.

(3) The Council must afford any member of the Statutory Committee or Scrutiny Committee who is under investigation the opportunity to make written and oral representations before reaching a decision as to whether to remove that member from the relevant committee.

(4) The procedure for the suspension or removal of a member of the Statutory Committee or Scrutiny Committee is to be prepared by the Council and a copy must be given to every member of the Statutory Committee and Scrutiny Committee.

Additional functions of the Scrutiny Committee

7.-(1) The Scrutiny Committee has the following additional functions-

(a)providing an annual report to the Council in respect of each calendar year, by a date specified by the Council, which is to include-

(i)trends, patterns and learning points observed from cases considered by the Scrutiny Committee,

(ii)details of the numbers of fitness to practise and disqualification allegations which were disposed of by the Scrutiny Committee by means of warnings and undertakings during that year, and

(iii)the reasons why the allegations referred to in sub-paragraph (ii) were not referred to the Statutory Committee;

(b)preparing, publishing and amending from time to time its referral criteria.

(c)determining whether or not disqualification allegations that have been referred to it should be referred to the Statutory Committee.

Terms of office of Scrutiny Committee members

8.-(1) A member of the Scrutiny Committee shall hold office for a period of 4 years from the date of appointment, but shall be eligible for re-appointment at the expiration of that period.

(2) No member of the Scrutiny Committee (including the chair and deputy chair) is to hold office as a member of that committee for more than an aggregate of 8 years in any 20 year period.

Resignation of Statutory Committee or Scrutiny Committee members

9. A member of the Statutory Committee or Scrutiny Committee may resign from that committee at any time by notifying the Council in writing.

Validation of proceedings

10. The proceedings of the Statutory Committee or Scrutiny Committee are not invalidated-

(a)by any vacancy in the membership of the Statutory Committee or Scrutiny Committee

(b)by any defect on the appointment of any members of the Statutory Committee or Scrutiny Committee

Reserve list

11.-(1) The Council must maintain a reserve list of appropriate persons who are eligible to serve as-

(a)the chair of the Statutory Committee or the Scrutiny Committee;

(b)deputy chair of the Statutory Committee or the Scrutiny Committee; and

(c)other members of the Statutory Committee or the Scrutiny Committee (which is to include both prospective lay members and prospective members who are registered persons).

(2) Persons may only be retained on the reserve list for a period of 3 consecutive years, after which time their suitability for continued inclusion in that list is to be reconsidered by the Council.

(3) Persons on the reserve list who are eligible to serve as the chair of the Statutory Committee or Scrutiny Committee may be appointed as the chair, deputy chair or member of that committee without further interview, in the event that a vacancy arises on that committee.

(4) Persons on the reserve list who are eligible to serve as a deputy chair of the Statutory Committee or the Scrutiny Committee may be appointed as deputy chair or member of that committee without further interview, in the event that a vacancy arises on that committee.

(5) Persons on the reserve list who are eligible to serve as a member of the Statutory Committee or Scrutiny Committee may be appointed as a member of that committee without further interview, in the event that a vacancy arises on that committee.

(6) Persons on the reserve list may be invited to attend training provided or arranged by the Society (which may be training provided by another body) to maintain their suitability for continued inclusion on the reserve list.

(7) In the event that a member of the Statutory Committee or Scrutiny Committee (including a deputy chair but excluding a chair) is unable to sit to consider a case for any reason, persons on the reserve list who are eligible to serve as a chair, deputy chair or other member of the Statutory Committee or Scrutiny Committee may be co-opted to that committee, if its chair decides that it is appropriate to do so, to serve as a member of that committee (including as a deputy chair) for that particular case.

Casual vacancies

12. Where a vacancy occurs on the Statutory Committee or Scrutiny Committee as a result of the resignation, removal or death of a chair, deputy chair or other member of that committee, the Council must-

(a)appoint a replacement chair, deputy chair or other member from the reserve list: or

(b)where no suitable replacement member is available from the reserve list, appoint a replacement in accordance with these regulations.

Power to co-opt members of the Statutory Committee or Scrutiny Committee

13.-(1) Subject to paragraphs (3) and (4) the chair of the Statutory Committee or Scrutiny Committee may co-opt appropriate persons to act as members of that committee where it is necessary or desirable to do so in order for that committee to be able to dispose of a particular case.

(2) The power in paragraph (1) is in addition to the power in regulation 11 (7).

(3) The following persons may not be co-opted as a member of the Statutory Committee-

(a)a member of the Council;

(b)a member of the Scrutiny Committee; and

(c)an employee of the Society.

(4) The following persons may not be co-opted as a member of the Scrutiny Committee-

(a)a member of the Council;

(b)a member of the Statutory Committee; and

(c)an employee of the Society.

Secretaries of the Statutory and Scrutiny Committees

14.-(1) The Statutory Committee and the Scrutiny Committee are to be assisted by a secretary.

(2) No person may act as secretary to either committee if that person is a member of the Council.

(3) Any person acting as secretary to the Scrutiny Committee in relation to a fitness to practise allegation, must not act as secretary to the Statutory Committee in any proceedings in connection with that allegation.

(4) The secretary to either committee is to be responsible for the administrative arrangements relating to the proceedings of that committee.

(5) The secretary to either committee must, in consultation with the chair of the relevant committee, select the legal, clinical and specialist advisers to advise the committee, as required in any particular case.

(6) The secretary to either committee must keep a record, or ensure a record is kept, of all decisions made by the committee and the reasons for them.

(7) The secretary to either committee must not participate in the decision making of the committee (and is not entitled to vote).

The composition of the Statutory Committee and Scrutiny Committee at particular meetings or hearings

15.-(1) Subject to paragraphs (3) to (5), the chair of the Statutory Committee must, having consulted the secretary of the committee, and with regard to-

(a)matters to be considered by the committee; and

(b)availability, experience and expertise of committee members,

determine the particular size and composition of the committee required for each hearing and any related meetings.

(2) Case management meetings of the Statutory Committee are to be conducted by the chair.

(3) The chair of the Statutory Committee must ensure that a member of the Committee who has sat in a formation of the Committee that has made an interim suspension order or an order for interim conditional entry in a particular case must not sit in subsequent proceedings in that case.

(4) Paragraph (3) does not apply where the subsequent proceedings relate solely to measures under paragraph 8 of Schedule 3 to the Order.

(5) For the purposes of paragraph (3), where an interim suspension order or an order for interim conditional entry is made in the course of the proceedings to determine a case substantively, the rest of the proceedings to determine the case substantively are not "subsequent proceedings" even if the case is adjourned (for whatever reason).

(6) At any meeting or hearing of the Statutory Committee or Scrutiny Committee, the number of registrant members considering a case must not exceed the number of lay members by more than 1.

Provisions against bias

16. No member of either the Statutory Committee or Scrutiny Committee may sit as a member considering a particular case, at any stage of the proceedings relating to that case, if that member has an actual, or potential, conflict of interest in relation to that case.

Voting

17.-(1) Decisions of either the Statutory Committee or Scrutiny Committee must be taken by a simple majority of the members, with the chair not having a casting vote.

(2) If a member of either the Statutory Committee or Scrutiny Committee abstains from a vote at a meeting or hearing of either committee, the member's abstention must be treated as a vote against the motion that has been put to the vote.

(3) Where the Statutory Committee is considering pursuant to paragraph 7 of Schedule 3 to the Order whether or not a person's fitness to practise is impaired, a tied vote is to be treated as a determination that the person's fitness to practise is not impaired.

Functions of legal advisers

18.-(1) A legal adviser (except where the chair is legally qualified)-

(a)must be present at all meetings of the Scrutiny Committee at which a decision is to be taken as to whether or not to-

(i)refer a case to the Statutory Committee, or

(ii)notify the Department to consider exercising any of its powers to bring criminal proceedings; and

(b)may be present at any other hearing before, or meeting of, the Statutory Committee or Scrutiny Committee, at the request of the chair or secretary of the relevant committee.

(2) The function of the legal adviser who is present at a meeting or hearing referred to in paragraph (1) is to ensure that proceedings before the Statutory Committee or Scrutiny Committee are conducted fairly.

(3) The legal adviser who is present at a meeting or hearing referred to in paragraph (1) must-

(a)advise the Statutory Committee or Scrutiny Committee on questions of law that are referred to the legal adviser by members of the relevant Committee;

(b)intervene to advise the Statutory Committee or Scrutiny Committee on an issue of law where it appears to the legal adviser that, without the legal adviser's intervention, there is a possibility of an error of law being made;

(c)inform the Statutory Committee or Scrutiny Committee immediately of any irregularity in the conduct of proceedings before it; and

(d)at the request of the chair, advise the Statutory Committee or Scrutiny Committee on the structure, format and presentation of the reasons for a decision of that committee.

(4) If the chair of the Statutory Committee is not legally qualified, a legal adviser must be present at any case management meeting conducted by the chair of the Statutory Committee.

(5) At the request of the chair, the legal adviser who is present at a meeting of the Statutory Committee or Scrutiny Committee referred to in paragraph (1) may be present during the private deliberations of either committee, but must not participate in the decision making of either Committee (and is not entitled to vote).

Functions of clinical advisers

19.-(1) A clinical adviser-

(a)must be present at any meeting of the Scrutiny Committee at which a decision is to be taken as to whether or not to refer a case to the Statutory Committee where the health of the person who is the subject of the case is to be, or is likely to be, considered;

(b)may be present at any other meeting of the Scrutiny Committee where health related issues are to be, or are likely to be, considered; and

(c)must be present at any meeting of, or hearing before, the Statutory Committee where health related issues are to be, or are likely to be, considered.

(2) The function of the clinical adviser who is present at a meeting or hearing referred to in paragraph (1) is to-

(a)advise the Statutory Committee or Scrutiny Committee on any issues within the clinical adviser's areas of medical expertise that may be referred to the clinical adviser by a member of the relevant committee; and

(b)intervene to advise the Statutory Committee or Scrutiny Committee on an issue where it appears to the clinical adviser that, without the clinical adviser's intervention, there is a possibility of an error being made.

(3) A clinical adviser who is present at a meeting or hearing referred to in paragraph (1)(c) must not be present during the private deliberations of the Statutory Committee.

(4) A clinical adviser must not participate in the decision making of any committee (and is not entitled to vote).

Functions of specialist advisers

20.-(1) A specialist adviser-

(a)may be present at any meeting of the Scrutiny Committee at which issues falling within the specialist adviser's specialty, or related to it, are under consideration by the Scrutiny Committee; and

(b)may be present at any meeting of, or hearing before, the Statutory Committee at which issues falling within the specialist adviser's specialty, or related to it, are under consideration by the Statutory Committee.

(2) The function of a specialist adviser at a meeting or hearing referred to in paragraph (1) is to advise the Statutory Committee or Scrutiny Committee on issues within the specialist adviser's areas of expertise that may be referred to the specialist adviser by a member of the relevant committee.

(3) A specialist adviser who is present at a meeting or hearing referred to in paragraph (1)(b) must not be present during the private deliberations of the Statutory Committee.

(4) A specialist adviser must not participate in the decision making of any committee (and is not entitled to vote).

Requirements to give or repeat advice in public

21.-(1) Subject to paragraph (2) any advice tendered by a legal, clinical or specialist adviser at a meeting or hearing of the Statutory Committee must be tendered in the presence of every party, or person representing a party, in attendance at the meeting or hearing.

(2) Where the Statutory Committee has begun to deliberate on its decision and needs to obtain advice in the course of its deliberations, a legal adviser may tender advice to that Committee notwithstanding the absence of the parties or any person representing a party.

(3) Where advice is tendered in the absence of the parties or their representative in accordance with paragraph (2)

(a)the legal adviser must repeat the advice tendered to the Statutory Committee before the parties, or any person representing a party, in attendance at the hearing; and

(b)the parties or their representatives in attendance at the hearing must be provided with a reasonable opportunity to comment on the advice given by the legal adviser, before the Statutory Committee makes its decision on the issue under consideration.

Requirements to keep records of advice and intervention

22.-(1) The secretary to the Statutory Committee or Scrutiny Committee must keep a record of any advice tendered to either Committee by the legal, clinical or specialist adviser to either committee.

(2) The secretary to the Statutory Committee or Scrutiny Committee must keep a record of any interventions made by the legal adviser during the private deliberations of either committee.

(3) A record of any advice tendered by the legal, clinical or specialist adviser must be sent to the parties to the proceedings (that is, the Society and the appellant or person concerned, as the case may be) or their representatives, as appropriate, as soon as practicable after it has been tendered.

Refusal by the Statutory Committee or Scrutiny Committee to accept advice

23. Where any advice tendered by the legal, clinical or specialist adviser to the Statutory Committee or Scrutiny Committee is not accepted by that committee-

(a)the chair of the relevant committee must announce the reasons for not accepting the advice tendered; and

(b)the secretary of the relevant committee must-

(i)keep a record of the advice tendered, and the reasons why the relevant committee refused to accept that advice, and

(ii)send a copy of the record of the advice and the reasons why the relevant committee refused to accept that advice, to the parties to the proceedings (that is, the Society and the appellant or person concerned, as the case may be) or their representatives, as appropriate.

Questioning of witnesses

24. A legal, clinical or specialist adviser advising the Statutory Committee in accordance with these Regulations may, with the permission of the chair of that committee, question any witnesses appearing before that committee.

Sealed with the Common Seal of the Pharmaceutical Society of Northern Ireland on 8th August 2012.

Roberta Tasker

President

Trevor Patterson

Chief Executive

The Department of Health, Social Services and Public Safety hereby approves the foregoing Regulations.

Sealed with the Official Seal of the Department of Health, Social Services and Public Safety on 8th August 2012

Diane Taylor

A senior officer of the

Department of Health, Social Services and Public Safety

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations set out various matters relating to the Statutory Committee and Scrutiny Committee of the Council and to the functions of advisers to the Statutory Committee and Scrutiny Committee.

Regulations 1 and 2 deal with preliminary matters, including commencement and interpretation and regulation 3 sets out the composition of the Scrutiny Committee.

Regulations 4 and 5 set out the eligibility of former members of Council for appointment to the Statutory Committee or Scrutiny Committee and the disqualifications which apply for appointment to the Statutory Committee or Scrutiny Committee.

Regulation 6 sets out the circumstances in which the Council may suspend or remove a member of the Statutory Committee or Scrutiny Committee from office.

Regulation 7 confers additional functions on the Scrutiny Committee including the provision of an annual report to the Council.

Regulations 8 and 9 deal with the term of office of Scrutiny Committee members and the procedure for resignation from office of members of the Statutory Committee or Scrutiny Committee.

Regulation 10 sets out the circumstances where the proceedings of the Statutory Committee or Scrutiny Committee are not invalidated.

Regulations 11 to 13 deal with how vacancies on the Statutory Committee or Scrutiny Committee are to be filled (including provision requiring the Council to maintain a reserve list of Statutory Committee and Scrutiny Committee members) and providing a power for the chair of the Statutory Committee or Scrutiny Committee to co-opt members.

Regulations 14 to 17 contain provisions relating to meetings and hearings of the Statutory Committee and the Scrutiny Committee, including the requirement for each committee to have a secretary and that the number of members who are registered persons considering a case must not be in a majority of more than one. Additionally there are provisions against bias and which set out that voting will be by simple majority.

Regulations 18 to 24 deal with the functions of legal, clinical and other specialist advisers to both the Statutory Committee and the Scrutiny Committee. There are requirements relating to the manner in which advice is to be tendered and recorded, and to the announcing and recording of decisions not to accept advice from professional advisers. Professional advisers are also given the power, with the permission of the chair of the Statutory Committee, to question witnesses.