The Pharmacy (1976 Order) (Amendment) Order (Northern Ireland) 2012

Made: 3rd August 2012

Coming into operation in accordance with Article 1

In accordance with paragraph 9(2) of Schedule 4 to that Act the Department of Health, Social Services and Public Safety has published a draft of this Order and invited representations to be made to it about the draft by— persons appearing to the Department appropriate to represent the profession, persons appearing to the Department appropriate to represent those provided with services by the profession, and any other person appearing to the Department appropriate to consult about the draft.

persons appearing to the Department appropriate to represent the profession,

persons appearing to the Department appropriate to represent those provided with services by the profession, and

any other person appearing to the Department appropriate to consult about the draft.

Citation, commencement and interpretation

1

• (1) This Order may be cited as the Pharmacy (1976 Order) (Amendment) Order (Northern Ireland) 2012 and, subject to paragraph 2, shall come into operation on 1st October 2012.

• (2) Article 4, in so far as it relates to Article 4A of the principal Order, shall come into operation on 1st June 2013.

• (3) In this Order—

• “the Department” means the Department of Health, Social Services and Public Safety;

• “the principal Order” means the Pharmacy (Northern Ireland) Order 1976[^f00003].

Amendment to Article 2 of the principal Order

2

In Article 2(2) of the principal Order (Interpretation)—

• (a) after the definition of “the Directive”[^f00004] insert—

• “electronic communication” has the meaning given in section 15(1) of the Electronic Communications Act (Northern Ireland) 2001[^f00005] (general interpretation);

• (b) after the definition of “General Systems Regulations” [^f00006] insert—

• “lay member” means a person who– is not and has never been a registered person: and does not hold qualifications which would entitle him to apply for registration under this Order.

• (c) after the definition of “the reference date”[^f00007] insert—

• “regulatory body” means a regulatory body which has the function of authorising persons to practise as a member of a health or social care profession;

• (d) after the definition of “retail pharmacy business” insert—

• “Scrutiny Committee” means the committee established under paragraph 2(4) of Schedule 2;

Amendment to Article 4 of the principal Order

3

In Article 4 of the principal Order (The Council) for paragraph (2) substitute the following paragraph—

(2) The provisions of Schedule 2 shall have effect with respect to the Council.

4

After Article 4 of the principal Order (The Council) insert the following Articles—

(4A) (1) The Council shall— (a) set the standards of proficiency for the safe and effective practise of pharmacy which it is necessary for a registered person to maintain in order for their name to be retained in the register; and (b) set the standards of continuing professional development which it is necessary for a registered person to maintain in order to continue to meet the standards of proficiency referred to in sub-paragraph (a); (2) The Council shall keep the standards set under this Article under review and may vary or withdraw those standards whenever it considers it appropriate to do so. (3) The Council must publish the standards set under this Article, as they exist from time to time, in such manner as it considers appropriate. (4) Before varying or withdrawing the standards referred to in paragraph (1), the Council shall consult such persons as it considers appropriate. (5) The Council shall— (a) consult such persons as it considers appropriate about the development of criteria by reference to which compliance with the standards set under paragraph (1)(b) is to be monitored, and (b) publish those criteria as they exist from time to time in such manner as it considers appropriate. (6) The Council shall— (a) adopt and maintain a framework relating to the requirements and conditions to be met by registered persons in respect of their continuing professional development; and (b) require registered persons— (i) to complete an annual declaration regarding their compliance with such requirements and conditions in respect of their continuing professional development as they are obliged to meet by that framework, and (ii) to submit records about any continuing professional development undertaken by them to the registrar for review. (7) The framework adopted by the Council under paragraph (6)(a)— (a) must include provision relating to— (i) the amount and type of continuing professional development that a registered person is required to undertake, (ii) the information to be provided by a registered person about the continuing professional development that the registered person has undertaken and the form and manner in which that information is to be provided, (iii) the times at which information about the continuing professional development that a registered person has undertaken is to be provided (including any continuing professional development that relates to an annotation in respect of a particular specialist area of practice that is to be recorded against the registered person’s name in the register), (iv) the keeping of records about the continuing professional development undertaken by registered persons; and (b) must require that any continuing professional development that is undertaken by a registered person in accordance with it is relevant to— (i) the safe and effective practice of pharmacy, and (ii) a learning need for the individual registered person that is relevant to the current scope of the practice of pharmacy including any specialist area of practice of that individual registered person and the environment in which they practise; (c) in so far as it relates to a person (“P”) who is a registered person only as a result of being registered in the register mentioned in Article 6(1)(d)— (i) may not impose requirements on P if P is required to undertake, in P’s home State, continuing professional development in relation to the profession of pharmacy; and (ii) where they impose requirements on P— (aa) must take account of the fact that P is fully qualified to pursue the profession in P’s home State, and (bb) must specify that continuing professional development which P is required to undertake by the requirements may be undertaken outside Northern Ireland. (8) The Council must publish the framework adopted by it under paragraph (6)(a), as it exists from time to time, in such manner as it considers appropriate. (9) The Council must make such provision in regulations as it considers appropriate with respect to registered persons who fail to comply with any requirements of the framework adopted by the Council under paragraph (6)(a). (10) Regulations under paragraph (9) must— (a) make provision about the circumstances in which the registrar may remove the name of the registered person from the register, or impose such other remedial measures as may be specified in the regulations, where the registered person— (i) has failed to comply with the requirements or conditions of the framework adopted by the Council under paragraph (6)(a) relating to the continual professional development of registered persons; or (ii) has made a false declaration about compliance with those requirements or conditions; (b) where the framework adopted by the Council under paragraph (6)(a) makes provision in respect of a person (“P”) who is a registered person only as a result of being registered in the register mentioned in Article 6(1)(d), secure that any sanction imposed in relation to P by reference to that provision is appropriate and proportionate in view of P’s continued lawful establishment in P’s home State as a pharmacist; (c) make provision for the registrar to send a statement in writing to the registered person concerned giving the registered person notice of the removal and the reasons for it and of right of appeal to the Statutory Committee under paragraph (13); (d) make provision for the suspension of a registered person’s entry in the register pending the outcome of any appeal against a decision to remove the name of the registered person from the register; (e) make provision about the circumstances in which the registrar, upon an application being made by a person whose name has been removed from the register, may restore the name to the register and whether, and if so what, continuing professional development is required after restoration, and the regulations may make provision— (i) for these issues to be determined in individual cases by the registrar, (ii) enabling the registrar to determine that the application for restoration is to be granted subject to the applicant agreeing to comply with such undertakings with regard to continuing professional development as the registrar considers appropriate, and (iii) refusal of applications. (11) Where a person who has agreed to comply with an undertaking pursuant to regulations made under paragraph (10)(e) breaches that undertaking, that breach may be treated as misconduct for the purposes of paragraph (4)(1)(a) of Schedule 3 and the registrar must consider, in accordance with paragraph (5)(1) of Schedule 3, whether or not to refer the matter to the Scrutiny Committee or (where regulations under paragraph (5)(1) of Schedule 3 so provide) to the Statutory Committee. (12) Where the registrar refuses an application for restoration of a person’s name to the register, the registrar must send to the applicant a statement in writing giving the applicant notice of decision and the reasons for it and the right of appeal to the Statutory Committee under paragraph (13). (13) In accordance with regulations made under paragraph (10), a person in respect of whom a decision has been made by the registrar to— (a) remove their name from the register; (b) impose such remedial measure as may be specified; or (c) refuse an application for restoration of their name to the register, may appeal from that decision to the Statutory Committee which may decide the appeal. (14) In this Article “home State” in relation to a pharmaceutical chemist registered in the register mentioned in Article 6(1)(d), means the relevant European State in which the registered person is lawfully established as a pharmacist. (4B) (1) The Council shall from time to time publish or provide in such manner as it sees fit information about the regulation of pharmaceutical chemists and registered pharmacies. (2) The Council may from time to time publish or provide in such manner as it sees fit guidance to registered persons, employers and such other persons it considers appropriate in respect of the standards for the education, training, supervision and performance of persons who are not registered persons but who provide services in connection with those provided by registered persons. (4C) (1) The Council shall be responsible for ensuring that the Society— (a) keeps accounts, which shall be in such form as the Department may determine; and (b) prepares annual accounts in respect of each year, which shall be in such form and shall be prepared by such date as the Department may determine. (2) Those annual accounts shall be audited by auditors appointed by the Council, but no person may be appointed as an auditor under this paragraph unless that person is eligible for appointment as a statutory auditor under Part 42 of the Companies Act 2006[^f00008] (statutory auditors). (3) As soon as is reasonably practicable after those accounts have been prepared, the Council shall— (a) cause them to be published together with any report on them made by the auditors appointed under paragraph (2); and (b) send a copy of those annual accounts and of any such report to the Department, and the Department shall lay before the Assembly a copy of those annual accounts and any report on the accounts made by the auditors appointed under paragraph (2). (4D) The Council shall publish in such manner as it sees fit, at least once in each year, by such date as the Department shall determine— (a) a statistical report in respect of, and which includes a description of, the procedures which the Society has in place to protect members of the public from registered persons whose fitness to practise is impaired, together with the Council’s observations on the report; and (b) a report, submitted to the Department, on the Society’s exercise of its functions, and the Department shall lay before the Assembly a copy of the report submitted by the Council under this sub-paragraph.

Amendment to Article 5 of the principal Order

5

• (1) For the heading to Article 5 of the principal Order (Regulations) substitute the following heading—

• (2) In Article 5 of the principal Order (Regulations)—

• (a) in paragraph (1) after sub-paragraph (ff) insert the following sub-paragraph—

(fff) the recording in the register of fitness to practise matters, including any warnings or advice given by, or undertakings agreed with, the Statutory Committee or the Scrutiny Committee; (ffg) the recording in the register of continuing professional development matters.

• (b) omit paragraphs (2) and (4).

Amendment to Article 11 of the principal Order

6

In Article 11(2) of the principal Order (Evidence of qualification to be registered) after “the registrar” insert “under this Article”.

Amendment of Article 19 of the principal Order

7

For paragraphs (2) to (11) of Article 19 of the principal Order (The Statutory Committee) substitute—

(2) The Statutory Committee shall consist of— (a) a lay member who is the chair; (b) 2 lay members who are deputy chairs; (c) 3 other lay members; and (d) 6 members who are registered persons all of whom shall be appointed by the Council. (3) A member of the Statutory 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. (4) No member of the Statutory Committee may hold office for more than an aggregate of 8 years in any 20 year period. (5) There shall be paid to the members of the Statutory Committee such remuneration and such travelling, subsistence or other expenses as the Council may determine. (6) The expenses of the Statutory Committee (including any such fees payable to any of the members thereof as may be fixed by the Council) shall be defrayed by the Society. (7) The quorum of the Statutory 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. (8) The Council may by regulations make provision as to— (a) the procedure of the Statutory Committee (including the validation of proceedings in the event of vacancies or defects in appointment); (b) the grounds on which persons are to be disqualified from appointment as members of the Statutory Committee; and (c) the circumstances in which members cease to hold office or may be removed or suspended from office.

Substitution of Article 20 to the principal Order

8

For Article 20 of the principal Order (Removal of registered persons from, and restoration to, register) substitute the following Article—

(20) The provisions of Schedule 3 shall have effect with respect to fitness to practise functions and proceedings of the Statutory Committee and the Scrutiny Committee.

Insertion of Article 25A to the principal Order

9

After Article 25 of the principal Order (Fees) insert the following Article—

(25A) (1) Regulations made under this Order shall be subject to negative resolution. (2) Regulations made by the Council under this Order shall not come into operation unless and until they are approved by the Department.

Substitution of Schedule 2 to the principal Order

10

For Schedule 2 to the principal Order (The Council of the Society) substitute Schedule 2 as set out in Schedule 1 to this Order.

Substitution of Schedule 3 of the principal Order

11

For Schedule 3 to the principal Order (Proceedings of the Statutory Committee) substitute Schedule 3 as set out in Schedule 2 to this Order.

Transitional Provisions

12

The transitional provisions set out in Schedule 3 shall have effect.

Repeal

13

Article 18 of the principal Order (Disqualification of persons suffering from disability) shall cease to have effect.

14

Article 21 of the principal Order (Conditions as to the giving of directions by Statutory Committee in case of conviction, etc., of employee) shall cease to have effect.

15

Article 22 of the principal Order (Provisions as to directions given by Statutory Committee and as to appeals) shall cease to have effect.

SCHEDULE 1 — Schedule 2 to the principal Order as substituted by this Order

SCHEDULE 2 — Schedule 3 to the principal Order as substituted by this Order

SCHEDULE 3 — Transitional provisions

Outstanding referrals to, and cases before, the Statutory Committee where no direction has been given

1

In this Schedule—

• “appointed day” means the day specified under Article 1(1);

• “the former provisions” means Articles 20 to 22 of the principal Order as they had effect immediately before the appointed day;

• “the new provisions” means Schedule 3 to the principal Order as substituted by Schedule 2 to this Order;

• “the register” means the appropriate register kept under Article 6 of the principal Order;

• “the Statutory Committee”, “the registrar” and “the Society” have the same meaning as in Article 2(2) of the principal Order.

2

• (1) Where—

• (a) before the appointed day, an application for registration in or restoration to the register has been referred to the Statutory Committee;

• (b) immediately before the appointed day there was no direction of the Statutory Committee in force in relation to the applicant; and

• (c) an inquiry has not already opened in respect of the application,

the Statutory Committee shall dispose of it in accordance with the new provisions.

• (2) Where—

• (a) before the appointed day, an application for registration in or restoration to the register has been referred to the Statutory Committee;

• (b) immediately before the appointed day there was no direction of the Statutory Committee in force in relation to the applicant; and

• (c) an inquiry has already opened in respect of the application (including where a decision on the application has been postponed),

the Statutory Committee shall dispose of it in accordance with, and any appeal shall be disposed of in accordance with, the former provisions.

Outstanding disciplinary proceedings

3

• (1) Subject to the following provisions of this Schedule, where, as regards the registration of a person in the register, before the appointed day—

• (a) a case of alleged misconduct has been referred by the registrar to the Statutory Committee whether or not a day has been appointed for holding an inquiry into the matter (including cases where an inquiry has been postponed or adjourned), the Statutory Committee shall dispose of the case in accordance with the former provisions but other allegations of misconduct that have been brought to the attention of the Society shall be dealt with in accordance with the new provisions.

• (b) information about a conviction for a criminal offence has been submitted to the Statutory Committee by the registrar whether or not a day has been appointed for holding an inquiry into the matter (including cases where an inquiry has been postponed or adjourned), the Statutory Committee shall dispose of the matter in accordance with the former provisions but other information about a conviction for a criminal offence that has been brought to the attention of the Society shall be dealt with in accordance with the new provisions.

• (2) Where the Department had been considering a case of a person suffering from a physical or mental disability under Article 18 of the principal Order as it had effect immediately before the appointed day the Department shall refer the case to the Statutory Committee which shall dispose of the case in accordance with the new provisions.

Applicants for registration or restoration who are subject to directions given under the principal Order

4

• (1) Where the Statutory Committee has given a direction in relation to a case falling within Article 20(5) of the principal Order, prior to the coming into operation of this Order, if the person in respect of whom the direction was given, (“the person concerned”) makes or before the appointed day has made, a further application for registration—

• (a) the application shall be determined by the registrar, even if it has already been referred to the Statutory Committee; and

• (b) the registrar shall determine the application in accordance with the provisions of Part III of the principal Order, except that the application may not be granted unless—

• (i) if the Statutory Committee has given a direction that an application for registration from the person concerned shall not be entertained until the expiration of a specified period, that period has expired,

• (ii) if the Statutory Committee has given a direction that an application for registration from the person concerned shall not be entertained until specified conditions have been fulfilled, those conditions have been fulfilled, and

• (iii) the Statutory Committee has been consulted and it has advised the registrar that the person concerned’s fitness to practise is not or is no longer impaired.

• (2) Where the Statutory Committee has given a direction in relation to a case falling within Article 20(4) or (6) of the principal Order, prior to the coming into operation of this Order, if the person in respect of whom the direction was given (“the person concerned”) makes or before the appointed day has made an application (or in relation to a case falling within Article 20(6) a further application) for restoration to the registrar—

• (a) the application shall be referred by the registrar to the Statutory Committee; and

• (b) the Statutory Committee shall dispose of the case in accordance with the new provisions except that—

• (i) if it is the first application that the person concerned has made which is to be disposed of in accordance with the new provisions, paragraph 9(2) of Schedule 3 to the principal Order, as it has effect after the appointed day, shall not apply, but if the Statutory Committee has given a direction that an application for restoration from the person concerned shall not be entertained until the expiration of a specified period, that period must have expired, and

• (ii) if the Statutory Committee has given a direction that an application for restoration from the person concerned shall not be entertained until specified conditions have been fulfilled, those conditions must have been fulfilled.

Signed

Sealed with the Official Seal of the Department of Health, Social Services and Public Safety on 3rd 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 Order)

EXPLANATORY NOTE

This Order, which amends the Pharmacy (Northern Ireland) Order 1976 (“the 1976 Order”), makes provision for the following matters:-

• (a) the reconstitution of the Council of the Pharmaceutical Society of Northern Ireland (“the Council”) and the extension of its regulation making powers in relation to various matters;

• (b) the reconstitution of the Statutory Committee and the extension of its powers in relation to discipline and fitness to practise matters; and

• (c) the establishment of a Scrutiny Committee of the Council to deal with fitness to practise matters.

Articles 3, 10 and Schedule 1 amend the 1976 Order by substituting new provisions in respect of the composition, membership and functions of the Council. The Department has power to make regulations with regard to various matters which include the procedure of the Council and the appointment of a President and Vice President of the Council. A Scrutiny Committee is established and the Council has power to provide in regulations for its constitution, appointment and procedure etc.

The Council is also given various duties in respect of publications, including publication of annual accounts and an annual report. The Council is under a duty to establish and promote the standards of continuing professional development necessary for a registered person to achieve and maintain those standards of proficiency, to adopt a framework setting out the requirements and conditions in respect of a registered person’s continuing professional development and to make regulations in respect of persons who fail to comply with the requirements or conditions of the framework (Article 4).

Article 5 inserts new powers into the 1976 Order which enable the Council to make regulations with regard to the recording in the register of fitness to practise and continuing professional development matters.

Article 7 amends the 1976 Order to reconstitute the Statutory Committee. Articles 8, 11 and Schedule 2 amend the 1976 Order to insert a new Schedule 3 which provides for the procedure for the Scrutiny Committee and the Statutory Committee in relating to the fitness to practise of registered persons.

The Council is to establish the professional standards expected of registered persons and is given powers to obtain information from third parties about a particular registered person. The Council may also publish any information about the fitness to practise of a registered person where it is in the public interest to do so. (Paragraphs 1 to 3 of Schedule 3 to the 1976 Order).

Provision is included about what it means for fitness to practise to be impaired and a framework is set out within which allegations of impairment are to be considered. Usually, cases will firstly be considered by the registrar, who will then refer them to the Scrutiny Committee of the Council. The Scrutiny Committee has power to deal with the case by way of issuing warnings or advice. In addition, the Statutory Committee may suspend registered persons or attach conditions to their entry in the register and may also direct that the registered person be struck off the register. Provision also exists for the review of earlier decisions to suspend a registered person or to impose conditions on their entry in the register.

Provision is also made for interim orders suspending a registered person’s entry in the register or attaching temporary conditions to an entry in the register while an investigation is ongoing. (Paragraphs 4 to 8 of Schedule 3 to the 1976 Order)

If a person has been struck off the register for fitness to practise reasons, there are arrangements for restoration to the register in defined circumstances (Paragraph 9 of Schedule 3 to the 1976 Order)

Provision is also made for appeals to the High Court against appealable fitness to practise decisions and in respect of when fitness to practise decisions are to take effect – including provision for temporary measures pending the outcome of an appeal, if a decision is being appealed. (Paragraphs 10 to 12 of Schedule 3 to the 1976 Order)

Provision is also made for the registrar to make alterations to the register in accordance with any direction of the Statutory Committee and provision is made for the Council to make regulations as to voluntary removal from the register and to enable the registrar to refuse application for voluntary removal where there are outstanding fitness to practise proceedings. There are also provisions relating to proceedings before the Scrutiny Committee and the Statutory Committee. Essentially, these matters are to be provided for in regulations however, there are particular provisions relating to the use of legal, clinical and other specialist advisers. There are also provisions for dealing with witness summonses and orders for the production of documents, which may be enforced through the courts. (Paragraphs 13 to 18 of Schedule 3 to the 1976 Order)

Articles 12 to 14 of the Order contain repeals of provisions required as a result of the establishment of new provisions to deal with fitness to practise and discipline matters.

Schedule 3 to the Order deals with transitional provisions in relation to outstanding registration cases, disciplinary proceedings, and applicants for registration or restoration who are subject to directions given under the principal Order prior to the coming into operation of this Order.

Footnotes

[^f00001]: S.I. 1999/283 (N.I. 1) Article 3(6)

[^f00002]: 2001 c.3 (N.I.)

[^f00003]: S.I. 1976/1213 (N.I.22) as amended by 1981 c.45 & c.55; 1983 c. 54; S.I.1984/703 (N.I.3); S.R. 1987 No.457; S.I. 1994/429 (N.I. 2); S.R.1996 No.393; 2004 c.33; S.R. 2004 No.78 and S.R. 2008 No.192

[^f00004]: Definition inserted by regulation 3(b) S.R. 2008 No. 192

[^f00005]: 2001 c.9 (N.I.)

[^f00006]: Definition inserted by regulation 3(c) S.R. 2008 No.192

[^f00007]: Definition inserted by regulation 3(g) S.R. 2008 No.192

[^f00008]: 2006 c.46

[^f00009]: 1998 c.29

[^f00010]: 1992 c.8; section 109A was inserted by the Social Security Administration (Fraud) Order (Northern Ireland) 1997 SI 1997/1182 (N.I.11), Article 14

[^f00011]: 2006 c.47

[^f00012]: S.I. 2007 /1351 (N.I.11)

[^f00013]: 2007 asp 14

[^f00014]: S.I. 2010 No.231

[^f00015]: 1983 c.54