The Pharmacy Order 2010

PART 5Education, training and acquisition of experience and continuing professional development

Education, training and acquisition of experience

42.—(1) In connection with its general function under article 4(3)(e), in so far as that function relates to the education, training and acquisition of experience of registrants and prospective registrants, the Council must—

(a)except in the case of persons who are appropriately qualified by virtue of article 21(1)(b) or (c) or article 22(1)(b), set the standards of proficiency for the safe and effective practice of pharmacy which it is necessary for a person to achieve in order to be entered in Part 1 or 2 of the Register as a pharmacist or, as the case may be, a pharmacy technician; and

(b)set—

(i)the standards of education, training and experience that providers of education and training must meet in order to enable a person undertaking such education or training, or acquiring such experience, to achieve the standards referred to in sub-paragraph (a) having regard, in particular, to the outcomes to be achieved, and

(ii)any requirements to be satisfied for admission to, and continued participation in, education and training for prospective pharmacists or prospective pharmacy technicians, which may include requirements as to fitness to practise unimpaired by health.

(2) The Council must publish the standards and requirements set under this article, as they exist from time to time, in such manner as it considers appropriate.

(3) The Council must—

(a)ensure that all providers in Great Britain concerned with the education and training of prospective pharmacists and prospective pharmacy technicians are notified of the standards and requirements set under paragraph (1)(b)(i) and (ii); and

(b)take appropriate steps to satisfy itself that those standards and requirements are met.

(4) The Council may—

(a)approve, or arrange with others to approve, courses of education or training which the Council is satisfied confer, or would confer, on persons completing them successfully the standards of proficiency referred to in paragraph (1)(a);

(b)approve, or arrange with others to approve, such other courses of education or training as the Council considers appropriate;

(c)approve, or arrange with others to approve, qualifications which are granted following success in an examination, or some other assessment, taken as part of an approved course;

(d)approve, or arrange with others to approve, such tests of competence, or tests of proficiency in the knowledge and use of English, as the Council may require; or

(e)approve, or arrange with others to approve—

(i)institutions,

(ii)other providers, including tutors,

of postgraduate education and training which leads to an approved qualification, if the Council considers that they are properly organised and equipped for conducting the whole or part of an approved course;

(f)approve, or arrange with others to approve, premises as being suitable for postgraduate education and training which leads to an approved qualification.

(5) In connection with paragraph (4), the Council may approve, or arrange with others to approve—

(a)a course of education or training run outside Great Britain which is intended to lead to an approved qualification;

(b)an institution or other provider of a course of education or training to which sub-paragraph (a) refers.

(6) The Council must publish a statement of—

(a)the criteria by reference to which the standards of education, training and experience referred to in paragraph (1)(b)(i) are set; and

(b)the criteria that will be taken into account in deciding whether to grant approval under paragraph (4),

as they exist from time to time.

(7) The Council must publish and maintain a list of the courses of education and training, qualifications and institutions or other providers (including tutors)—

(a)which are for the time being approved under this Order; or

(b)which have been approved under this Order but which are no longer so approved,

together with a record of the periods in respect of which approval was given.

(8) References in this Part to an approved course of education and training, an approved qualification, an approved test or an approved institution or other provider are references to such a course, qualification, test, institution or other provider approved under paragraph (4).

Continuing professional development

43.—(1) In connection with its general function under article 4(3)(e), in so far as that function relates to the continuing professional development of registrants, the Council must—

(a)set the standards of proficiency for the safe and effective practice of pharmacy which it is necessary for a registrant to maintain in order to have an entry in Part 1 or 2 of the Register renewed; and

(b)set the standards of continuing professional development which it is necessary for a registrant to maintain in order to continue to meet the standards of proficiency referred to in sub-paragraph (a).

(2) The Council must publish the standards set under this article, as they exist from time to time, in such manner as it considers appropriate.

(3) The Council must—

(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.

(4) The Council must—

(a)adopt and maintain a framework relating to the requirements and conditions to be met by registrants in respect of their continuing professional development; and

(b)require registrants—

(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.

(5) The framework adopted by the Council under paragraph (4)(a)—

(a)must include provision relating to—

(i)the amount and type of continuing professional development that a registrant is required to undertake,

(ii)the information to be provided by a registrant about the continuing professional development that the registrant 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 registrant has undertaken is to be provided (including any continuing professional development that relates to an annotation in respect of a particular specialisation that is to be recorded in the Register),

(iv)the keeping of records about the continuing professional development undertaken by registrants; and

(b)must require that any continuing professional development that is undertaken by a registrant in accordance with it is relevant to—

(i)the safe and effective practice of pharmacy, and

(ii)a learning need for the individual registrant that is relevant to the current scope of the practice of pharmacy including any specialisation of that individual registrant and the environment in which they practise;

(c)in so far as it relates to a person (“P”) who is a registrant only as a result of being entered in Part 4 or 5 of the Register—

(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 pharmacist or, as the case may be, pharmacy technician; 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 Great Britain.

(6) The Council must publish the framework adopted by it under paragraph (4)(a), as it exists from time to time, in such manner as it considers appropriate.

(7) The Council must make such provision in rules as it considers appropriate with respect to registrants who fail to comply with any requirements of the framework adopted by the Council under paragraph (4)(a).

(8) Rules under paragraph (7) must—

(a)make provision about the circumstances in which the Registrar may remove the entry of a registrant from the Register, or impose such other remedial measures as may be prescribed in the rules, where the registrant—

(i)has failed to comply with the requirements or conditions of the framework adopted by the Council under paragraph (4)(a) relating to the continuing professional development of registrants; or

(ii)has made a false declaration about compliance with those requirements or conditions;

(b)where the framework adopted by the Council under paragraph (4)(a) makes provision in respect of a person (“P”) who is a registrant only as a result of being entered in Part 4 or 5 of the Register, 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 or, as the case may be, a pharmacy technician;

(c)make provision for the Registrar to send a statement in writing to the registrant concerned at the registrant’s last known home address giving that registrant notice of the removal and the reasons for it and of right of appeal to the Appeals Committee under article 40; and

(d)make provision for the suspension of a registrant’s entry in the Register pending the outcome of any appeal against a decision to remove the registrant from the Register.

(9) In this article “home State”, in relation to a registrant entered in Part 4 or 5 of the Register, means the relevant European State in which the registrant is lawfully established as a pharmacist or, as the case may be, a pharmacy technician.

Specific obligations and powers of the Council in respect of education and training

44.—(1) In the exercise of its function under article 4(3)(e), the Council must—

(a)determine—

(i)programmes or courses in respect of, or any combination of, education, training or experience required in order to obtain an annotation in respect of a specialisation,

(ii)the amount and type of education, training and experience required in order to obtain an annotation in respect of a specialisation,

(iii)the education, training and experience that is necessary to address fitness to practise matters;

(b)hold or cause to be held assessments in respect of—

(i)approved qualifications, or any education, training or experience leading to an approved qualification,

(ii)additional education, training or experience required for the purposes of article 20(1)(a)(iii), and

(iii)becoming and acting as tutors of, or in relation to, any education, training or experience leading to an approved qualification or any additional education, training or experience required for the purposes of article 20(1)(a)(iii),

and determine the arrangements under which those assessments are to be held (including arrangements for dealing with disciplinary matters with regard to candidates and prospective candidates);

(c)appoint or arrange for the appointment of persons (“examiners”) to carry out or oversee assessments of the type mentioned in paragraph (b), and pay them such remuneration, pensions, allowances, expenses or gratuities, or make such contributions or payments towards provision for such pensions, allowances or gratuities, as it may reasonably determine; and

(d)establish, publish and maintain lists of premises that are to be used as training establishments.

(2) The duty imposed by paragraph (1)(c) does not prevent the Council from determining arrangements under which assessments of the type mentioned in paragraph (1)(b) are to be held which do not involve examiners.

Visitors

45.—(1) The Council may appoint persons (“visitors”) to visit any place at which, or any institution or other provider by which, or under whose direction—

(a)any relevant course of education or training is, or is proposed to be, given;

(b)any examination or other assessment is, or is proposed to be, held in connection with any such course; or

(c)any test of competence is, or is proposed to be, conducted in connection with any such course or for any other purposes connected with this Order.

(2) For the purposes of this article, “test of competence” includes such tests of proficiency in the knowledge and use of English as the Council may require.

(3) In this article, “relevant course of education or training” means—

(a)any course of education or training which forms, or is intended to form, part of an approved course of education or training; or

(b)any course which a registrant may be required to undergo for the purpose of applying for an annotation in respect of a specialisation to be made to an entry in a part of the Register in accordance with rules made by the Council under article 27.

(4) No visitor may exercise the functions of a visitor under this Order in relation to—

(a)any place at which that visitor regularly gives instruction in any subject; or

(b)any institution or other provider with which that visitor has, in the opinion of the Council, a significant connection.

(5) A person is not prevented from being a visitor merely because that person is a member of the Council or any of its committees; but no person may be a visitor if that person is employed by the Council.

(6) Visitors must be selected with due regard to the profession with which the education and training they are to report on is concerned and at least one of the visitors must be entered in a part of the Register which relates to that profession.

(7) Where a visitor visits any place or institution or other provider in the exercise of the functions of a visitor under this article, the visitor—

(a)must report to the Council—

(i)on the nature, content and quality of the instruction given, or to be given, and the facilities provided, or to be provided, at that place or by that institution or provider, and

(ii)on such other matters (if any) as the Council may require; and

(b)may, having regard to the contents of the report in so far as it relates to the matters referred to in sub-paragraph (a)(i), send a copy of the report to the inspectorate established under article 8(1).

(8) Requirements of the kind mentioned in paragraph (7)(a)(ii) may be imposed by the Council—

(a)generally in relation to all visits made to a specified kind of place or institution or other provider or in respect of a specified type of course; or

(b)specifically in relation to a particular visit.

(9) Where a visitor reports to the Council in accordance with paragraph (7)(a), the Council must on receipt of the report—

(a)send a copy of it to the institution or other provider concerned; and

(b)notify that institution or other provider of the period within which it may make observations on the report.

(10) The period specified by the Council in a notice given under paragraph (9)(b) must not be less than one month beginning with the date on which a copy of the report is sent to the institution or other provider concerned under paragraph (9)(a).

(11) The Council must not take any steps in the light of any report made under paragraph (7) before the end of the specified period mentioned in paragraph (10).

(12) The Council must publish such reports together with, at the request of the institution or other provider concerned, the response of that institution or provider to the report.

(13) The Council may make such provision in respect of visitors as it may reasonably determine—

(a)for the payment of allowances, including the payment of allowances to employers of visitors, for the purposes of enabling visitors to perform functions under this article; and

(b)for the reimbursement of such expenses as visitors may reasonably have incurred in the course of carrying out their functions under this article.

Information to be given by institutions or other providers

46.—(1) This article applies to any institution or other provider in Great Britain by which, or under whose direction, whether inside or outside Great Britain—

(a)any relevant course of education or training is, or is proposed to be, given; or

(b)any test of competence is, or is proposed to be, conducted in connection with any such course or for any other purpose connected with this Order.

(2) In paragraph (1), “test of competence” and “relevant course of education or training” have the same meaning as in article 45.

(3) Whenever required to do so by the Council, any institution or other provider to which this article applies must give to the Council such information and assistance as the Council may reasonably require in connection with the exercise of its functions under this Order.

(4) Where an institution or other provider refuses any reasonable request for information made by the Council under this article, the Council may, in accordance with article 47, refuse to approve or withdraw approval from, any course of education or training, qualification, test or institution or other provider to which the information relates.

Refusal or withdrawal of approval of courses, qualifications and institutions

47.—(1) Paragraph (2) applies to a case where, as a result of any visitor’s report or other information acquired by the Council, the Council is of the opinion that—

(a)the standards set under article 42(1)(b)(i) are not, or will not, be met by an institution or other provider; or

(b)an institution or other provider is not observing the requirements referred to in article 42(1)(b)(ii).

(2) In a case to which this paragraph applies, the Council may—

(a)impose such probationary or remedial arrangements (including action plans for providers of new courses) or such conditions as may be prescribed; or

(b)refuse to approve, or withdraw approval from, any course of education or training, qualification, test, or institution or other provider to which that opinion relates.

(3) If the Council is considering taking any action under paragraph (2)(a) or (b), the Council must act in accordance with paragraphs (4) to (6).

(4) The Council must—

(a)notify the institution or other provider concerned of its opinion, setting out its reasons; and

(b)inform the institution or other provider of the period within which it may make observations on the matters raised, which must not be less than one month beginning with the date on which the reasons are sent to the institution or other provider under sub-paragraph (a).

(5) The Council may take no further steps before the expiry of the period about which the institution or other provider has been informed under paragraph (4)(b).

(6) If, taking account of any visitor’s report or other information acquired by the Council together with any observations submitted by the institution or other provider under paragraph (4), the Council decides that it is appropriate to—

(a)impose probationary or remedial arrangements or conditions on the institution or other provider; or

(b)refuse or withdraw approval,

it must send to the institution or other provider concerned at the last known address of the institution or provider a statement in writing giving the institution or other provider notice of the decision and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

(7) A decision under paragraph (6) has effect from the date of the decision or from such later date as may be specified in the decision.

(8) Where, under this article, approval of a course of education or training or an institution or other provider is withdrawn, the Council must use its best endeavours to secure that any person who, at that time, is undertaking that course or is studying at that institution or with that other provider is given the opportunity to attend an approved course conducted by an approved institution or other provider.

(9) Where, under this article, approval of a qualification, a course of education or training or an institution or other provider is withdrawn, that withdrawal does not affect the entitlement of any person to be entered in a part of the Register on the basis of the award of a qualification to that person before the date on which the decision withdrawing approval from that qualification, the course of education or training which led to the award of that qualification or, as the case may be, the institution or other provider that conducted the course that led to the award of that qualification, had effect.