Pharmacy Act 2025: Health Law & Ethics (SAPC) | PDF

Health Law & Ethics Dr Deanne Johnston  Let’s start with the terminology An Act is a document that brings change to the law BROAD or constitution of a country Bill before the parliament → r...

Health Law & Ethics Dr Deanne Johnston  Let’s start with the terminology An Act is a document that brings change to the law BROAD or constitution of a country Bill before the parliament → read & deliberated by ACT the parliament → vote is taken Signed by the president Regulations provide support to the new laws and are enforceable by law REGULATIONS Signed by the minister Provides more detail on how to RULES implement the law and SPECIFIC regulations  PHARMACY ACT NO. 53 OF 1974 To provide for the establishment of the South African Pharmacy Council and for its objects and general powers; to extend the control of the council to the public sector; and to provide for pharmacy education and training, requirements for registration, the practice of pharmacy, the ownership of pharmacies and the investigative and disciplinary powers of the council; and to provide for matters connected therewith.  CHAPTER I ESTABLISHMENT OF THE SOUTH AFRICAN PHARMACY COUNCIL, ITS OBJECTS, GENERAL POWERS AND FUNCTIONS ▪ Establishment of South African Pharmacy Council. ▪ Objects of council ▪ General powers of council ▪ Constitution of council ▪ Vacation of office and the filling of vacancies ▪ Fees of council ? What does “salutier populo” mean?  Establishment of South African Pharmacy Council ▪ There is hereby established a juristic person to be Juristic person: known as the South African Pharmacy Council, which Non-human legal entity recognized by the shall be deemed to be the successor-in-title of the law and entitled to rights and duties in the same way as a human being Interim Pharmacy Council of South Africa, and the first meeting of the council shall be convened by the registrar. SAPC is an independent statutory council ▪ The head office of the council shall be situated in Pretoria. Registrar of the council: Appointed in terms of section 4 (u) of this Act or a person lawfully acting in that capacity  South African Pharmacy Council (SAPC) ? What’s the difference between a Council and Association?  Objects of council To assist in the promotion of the health of the population of the Republic; To advise the Minister or any other person on any matter relating to pharmacy; To promote the provision of pharmaceutical care which complies with universal norms and values, in both the public and the private sector, with the goal of achieving definite therapeutic outcomes for the health and quality of life of a patient; Refer to patients rights & responsibility (see posters) To uphold and safeguard the rights of the general public to universally acceptable standards of pharmacy practice in both the public and the private sector; Universally acceptable To establish, develop, maintain and control universally acceptable standards; standards – Refer to next side To be transparent to the profession and the general public in achieving its objects Dignity – quality of being and in performing its functions and executing its powers; and worthy of honour or respect To maintain and enhance the dignity of the pharmacy profession and the integrity of Integrity – trustworthiness persons practising that profession. ? How does SAPC ensure it is transparent to the profession and public?  Objects of council‐ What standards are they referring to? ▪ In pharmaceutical education and training; Pharmacy Education SAPC departments ▪ For the registration of a person who provides one or more or all of the services which form part of the scope of practice of the category in which such person is registered; Pharmacy Practice ▪ Of the practice of the various categories of persons required to be registered in terms of this Act; CPD & Registrations ▪ Of professional conduct required of persons to be registered in terms of this Act; and Pre-registrations ▪ Of control over persons registered in terms of this Act by investigating in accordance with this Act, complaints or accusations relating to the conduct of Legal Services & registered persons Professional Conduct  General powers of council ▪ To cause copies of the registers or of supplementary lists showing amendments of the registers, to be printed and published ▪ To issue extracts from the registers and to charge such fees in respect thereof as may be prescribed ▪ To require any registered person to pay to the council the prescribed annual fee NB: ▪ In such circumstances as may be prescribed, or where otherwise authorized by this act, to remove any name from the registers or, upon payment of the prescribed fee, to restore it Refer to the Act thereto for the ▪ To appoint examiners and moderators, conduct examinations and grant certificates, and to charge such fees in respect of such examinations or certificates as may be prescribed comprehensive list of general powers ▪ To approve, on such conditions as it may deem fit, the training of pharmacists of Council ▪ Subject to the provisions of this act, to register a person as a pharmacist, to inspect the records and accounts of or investigate the activities at a pharmacy carried on by a person so registered, or to require any person so registered to submit to the council such information as the council may deem necessary ▪ In such circumstances as may be prescribed, to suspend or cancel any registration entitling a person to carry on the profession of a pharmacist  General powers of council ▪ On the application of any person, to recognize any qualifications held by him (whether such qualifications have been obtained in the republic or elsewhere) as being equal, either wholly or in part, to any prescribed qualifications, whereupon such person shall, to the extent to which the qualifications have so been recognized, be deemed to hold such prescribed qualifications ▪ To appoint any committee it may deem necessary and to delegate any of its powers to any such committee and to prescribe the conditions of such delegation, including the power to subdelegate any delegated power to any member of its staff or officer duly appointed in terms of this act ▪ To appoint or dismiss a registrar or such other staff members as it may deem necessary and to determine their conditions of service: provided that the appointment or dismissal of the registrar shall be subject to the approval of the minister ▪ To determine the fees payable to the council for services performed by the council in terms of this act or for any other reason the council may decide on ▪ To require any person or institution registered in terms of this act, or involved in pharmacy practice or offering pharmaceutical education or training, to furnish the council with the information the council requires ▪ To establish professional boards for pharmacy support personnel registered in terms of this act, when the council, in consultation with the minister, deems it necessary ▪ To prescribe the scope of practice of the various categories of persons registered in terms of this act  Constitution of council ▪ 25 members ▪ 9 elected pharmacists (registered SAPC; Reside in SA) ▪ 9 pharmacists nominated by the Members of the Executive Council responsible for health matters in the provinces of the Republic and appointed by the Minister; ▪ 1 officer of the Department appointed by the Minister; ▪ 2 pharmacists who are members of the staff of a university at which provision is made for the education and training of pharmacists, nominated by such a university and appointed by the Minister: Provided that such pharmacists shall not be from the same university; ▪ 4 other persons appointed by the Minister, one of whom shall be a person appointed on account of his or her legal knowledge; ▪ The council shall have a president and vice-president, and all members of the council shall be entitled to vote during the election of the president and the vice-president and other office-bearers of the council. ▪ The members of the council shall hold office for a period of five years, but shall be eligible for reappointment or re-election, as the case may be, for one term only.  Vacation of office and the filling of vacancies A member of the council shall vacate his office if— (a) his estate is sequestrated; (b) he is or becomes disqualified under this Act from practising his profession; (c) he becomes a patient as defined in section l of the Mental Health Act, 1973 (Act No. 18 of 1973); (d) he is convicted of an offence in respect whereof he is sentenced to imprisonment without the option of a fine; (e) he ceases to be a South African citizen; (f) he has been absent from more than two consecutive ordinary meetings of the council without the council’s leave; (g) he or she ceases to hold any qualification necessary for his or her appointment or tenders his or her resignation in writing to the Minister and the Minister accepts his or her resignation; (h) the Minister, in the public interest, terminates his membership. CHAPTER II REGISTRATION OF PHARMACISTS AND BODIES CORPORATE CARRYING ON BUSINESS AS A PHARMACIST AND MAINTENANCE OF REGISTERS ▪ Registration ▪ Registration of persons, recording of licensed premises and maintenance of registers ▪ Licensing of pharmacies Understand these terms: ▪ Ownership of pharmacies Registration ▪ Removal of name from, and restoration to register Ownership Recording ▪ Appeal against refusal to register or against removal of name from register License ▪ Publication of registers Removal ▪ Register as proof Penalty ▪ Issue of duplicate registration certificate, extract from register or certificate by registrar Appeal ▪ Registration of additional qualifications and of specialities Restoration ▪ Penalties for professing to be or practising as pharmacist while unregistered ▪ Penalty for false representation inducing registration, for false entry in register and for impersonation ▪ Limitations in respect of unregistered persons and proof required for the issue of licences  Persons and Premises PERSONS PREMISES Pharmacy student Pharmacy categories Pharmacist intern Community Pharmacist REGISTRATION Consultant Responsible pharmacist Institutional in a private Assessor / Moderator Preceded by and application; health facility OR public PSP Learners submit the relevant health facility Pharmacist assistant’s documentation and pay the Manufacturing applicable fee (basic and post basic) Wholesale Pharmacy Technician Pharmacy Owner  Registration INTERN COMMUNITY STUDENT Complete internship SERVICE Completing an PHARMACIST at a premises Designated accredited BPharm approved for training placement NDoH ▪ No person shall be entitled to provide the services which form part of the services specially pertaining to the scope of practice of a pharmacist or assist therewith, unless he or she is duly registered in one of the categories prescribed in terms of this Act. ▪ No person shall practise as a specialist pharmacist or shall conduct himself or herself as such a specialist, or shall in any other manner profess to be a person in respect of whom any such speciality has been registered, unless the speciality in question has been registered in terms of this Act in respect of such person. ▪ Every person who has been suspended from practising in terms of this Act or whose name has been removed from a register, shall be disqualified from providing any of the services or performing any act specially pertaining to the scope of practice of pharmacy as determined in the practice rules made by the council, and his or her registration certificate shall be deemed to be withdrawn until the period of suspension has expired or until his or her name has been restored to the register by the council. ▪ Any person who has been suspended from practising in terms of this Act or whose name has been removed from a register in terms of subsection 45 (1) (c) and whose name has not been restored to such register shall not be entitled to remain, or be registered as the owner of a pharmacy, or hold any beneficial interest in a pharmacy.  Registration of persons, recording of licensed premises and maintenance of registers ▪ The requirements and conditions for registration, removal, restoration or reinstatement of the various categories of persons shall be prescribed REGISTRATION ▪ The council shall require any person who is entitled and intends to provide one or more or all of the services which are deemed to be services specially pertaining to the scope of practice of a pharmacist, PRACTICE and pharmacy support personnel, or any person who assists in the provision thereof, to register with the council ▪ The council shall keep, amend, correct and maintain such registers in RESTORATION / the format as the council deems necessary and cause copies of such REINSTAEMENT registers to be printed at the discretion of the council ▪ The council may remove, in the prescribed manner, the name of any person from the relevant register REMOVAL ▪ The council may restore, in the prescribed manner, the name of any person to the relevant register on such conditions as the council may NO LONGER deem fit PRACTICE  Licensing of pharmacies REGISTRATION RECORDING APPLICATION APPLICATION SUBMITTED TO DIRECTOR GENERAL SUBMITTED TO SAPC (submit NDoH license) NDoH SAPC APPROVED RECORD: APPROVED PHARMACY PHARMACY OWNERS ISSUED WITH A LICENSE BY NDoH RESPONSIBLE PHARMACIST  Licensing of pharmacies ▪ A person authorised in terms of section 22A to own a pharmacy shall in the prescribed manner, specifying the prescribed particulars, apply to the Director-General for a licence for the premises wherein or from which such business shall be carried on and the Director-General may be entitled to issue or refuse such licence on such conditions as he or she may deem fit. ▪ A person issued with a licence in terms of subsection (1) shall notify the council thereof in writing and on production of the said licence the council shall record the name, address, date of licence, licence number and any other particulars as prescribed. (3) A licence issued in terms of subsection (1) may be subject to conditions as determined by the Director-General. ▪ A pharmacy shall, subject to such conditions as may be prescribed, be conducted under the continuous personal supervision of a pharmacist, in accordance with good pharmacy practice as determined in the rules made by the council. ▪ The council shall have the right to inspect premises in which the business of a pharmacy is carried on in terms of this Act, and the registrar shall provide the Director-General and the person who made the application in terms of subsection (1) with a written report of the findings of its inspection if it has been found that the inspected premises are not suitable for the business of a pharmacy. ▪ The Director-General may cancel or suspend any licence contemplated in subsection (1) which does not comply with the licensing conditions as determined in terms of subsection (3), after giving notice in writing to the owner of the pharmacy or the responsible pharmacist, and affording the owner or the responsible pharmacist an opportunity to furnish reasons why the licence should not be cancelled or suspended. ▪ The Director-General in consultation with the council may close a pharmacy which is being conducted in contravention of this Act and the Medicines and Related Substances Act, 1965, or which does not comply with the licensing conditions, after giving notice to the owner or the responsible pharmacist, and affording the owner or the responsible pharmacist an opportunity to furnish reasons to the Director-General why the pharmacy should not be closed. ▪ Any person aggrieved by a decision of the Director-General or the council, as the case may be, may within the prescribed period, in the prescribed manner appeal against such decision to an appeal committee appointed by the Minister: Provided that the chairperson of such appeal committee shall be a person appointed on account of his or her knowledge of the law.  Ownership of pharmacies ▪ A person authorised in terms of section 22A to own a pharmacy shall in the prescribed manner, specifying the prescribed particulars, apply to The Minister may prescribe who may own a pharmacy, the conditions under which such person may own such pharmacy, and the conditions upon which such authority may be withdrawn SOLE CLOSED COMPANY STATE PARTNERSHIP PROPRIATOR CORPORATION PUBLIC PRIVATE  Removal of name from, and restoration to register ▪ who has been absent from the Republic during the three years preceding such removal; ▪ who has failed to notify the registrar, within a period of three months as from the date of an enquiry sent by the registrar by registered letter to the address appearing in the register in respect of such person, of his present address; APPEAL ▪ who has requested that his name be removed from the register, in which case such person may be required to lodge with the registrar an affidavit to the effect that no disciplinary or criminal proceedings are being or are likely to be taken against him; REMOVAL ▪ who has failed to pay to the council, within three months as from the date on which it became due for payment, any prescribed annual fee; ▪ who has failed to furnish the registrar, within a period to be determined by the RESTORATION council, with such information as the registrar may require in terms of regulations made under this Act; or ▪ whose name has been removed from the register, record or roll of any university, college, society or other body from which that person received the qualification by virtue of the holding whereof he was registered.  Registration of additional qualifications and of specialities ▪ The council may from time to time by notice in the Gazette make rules providing for the recognition by the council of the degrees, diplomas or certificates which may be registered as additional qualifications, and only qualifications so recognized shall be registrable under this section. ▪ The Minister may from time to time, on the recommendation of the council, prescribe the specialities which may be registered as specialities, and only specialities so prescribed shall be registrable under this section ▪ Any person who desires to have a degree, diploma or certificate other than the degree, diploma or certificate by virtue of which he has in the first instance been registered, or who desires to have a prescribed speciality contemplated in subsection (1), registered, shall apply to the registrar, – submitting such documentary proof that he holds the additional qualification in question as the board may require, or, in the case of an application for registration of a speciality, – submitting proof that he complies with the prescribed requirements, and if the registrar is satisfied that such additional qualification is a degree, diploma or certificate recognized in terms of subsection (1), or, in respect of a speciality, that such speciality has been prescribed and – that the prescribed requirements have been complied with, he shall, upon payment of the prescribed fee, cause such degree, diploma or certificate, or speciality, as the case may be, to be entered in the register  Penalties for professing to be or practising as pharmacist while unregistered Subject to the provisions of subsection (3), any person who, not being registered as a pharmacist— for gain practises as a pharmacist, or carries on business as a pharmacist or for gain performs any act specially pertaining to the profession of a pharmacist: or pretends, or by any means whatsoever holds himself out, to be a pharmacist (whether or not he purports to be registered), or uses the name of pharmacist or any name, title, description or symbol indicating or calculated to lead persons to infer that he possesses a degree or diploma or other pharmaceutical qualification or that he is registered under this Act, or in describing his business activities or premises uses the term “pharmacy” or “chemist’s shop” or “drug store” or any other term of like meaning, shall be guilty of an offence and on conviction liable to a fine not exceeding the amount determined by the Minister in consultation with the Minister of Justice from time to time by notice in the Gazette. PERMISSION FROM THE MINISTER EXEMPTIONS ▪ in consultation with the council grant any person not registered in term of this Authorized persons (e.g. dr, dentist) keeping medicines / supply medicines to his own Act authority to perform a service specially pertaining to the scope of practice of patients a pharmacist, or in writing exempt any person from the provision of this Act, on Employment of the following under direct supervision of pharmacist e.g. Intern, PSP such conditions as he or she may determine Manufacture or packing of any medicine or medicinal or chemical substance by a person by virtue of a permit ▪ If he or she is of the opinion that it is in the public interest to do so, the Director Handling of medicines or the supply of medicines to members of the armed forces, under General may, pending the Ministers’ decision in respect of an application for the supervision of a medical practitioner or pharmacist, by members of the medical service authorisation referred to in subsection (4), grant a provisional authorisation to of the armed forces (undergone training) the applicant concerned, authorising him or her to manufacture, pack or sell any Keeping of medicines and its supply to patients in hospitals or other institutions for the medicine or medicinal or chemical substance specified in such provisional authorisation, subject to such conditions to be determined by the said Director- treatment of sick persons, under the direction of a medical practitioner and in accordance General and set out in the provisional authorisation Act 101 by any person registered or enrolled under the Nursing Act, 1957 Keeping of medicine and its supply by any person or organization performing a health service and authorized in writing by the Director-General acting after consultation with the council, to acquire medicines for the performance of such service  Penalty for false representation inducing registration, for false entry in register and for impersonation ▪ procures or attempts to procure for himself or any other person registration under this Act or any certificate, licence, permit, order or prescription referred to in this Act by means of a false representation, whether verbally or in writing, or aids or abets any person in so doing; or ▪ makes or causes to be made any unauthorized entry or alteration in or removal from a register or a certified copy thereof or extract therefrom or on any certificate issued under this Act; or ▪ wilfully destroys or damages or renders illegible or causes to be destroyed, damaged or rendered illegible any entry in a register or, without the permission of the holder thereof, any certificate issued under this Act; or ▪ forges or, knowing it to be forged, utters any document purporting to be a certificate issued under this Act; or ▪ impersonates any person registered under this Act  CHAPTER III CONTROL OF PHARMACEUTICAL EDUCATION ▪ Pharmacy education and training ▪ Pharmacy education and training institutions LEARNERS Pharmacist’s assistant STUDENTS (basic) PERSONS BPharm I – IV Pharmacist’s INVOLVED PHARMACIST INTERNS assistants (post-basic) Pharmacy technician Look out for Pharmacy technician trainee Pharmacist specialists  Pharmacy education and training The Minister may in consultation with the council make regulations to— Institution / Provider ▪ develop, establish, maintain and control standards of pharmacy education and training; E.g. ELO for BPharm ▪ require any institution or person intending to provide education and training to apply for the approval of such institution or person; ▪ evaluate and authorise any institution or person to offer education and training to qualify a Accreditation person for registration in terms of this Act, lay down the conditions upon which such education and training may be provided and amend such conditions from time to time, or cancel or withdraw such authority; ▪ make rules regarding the evaluation of a person applying for registration in terms of this Act Monitoring to ensure competence; ▪ prescribe the unit standards for pharmaceutical education and training required from a person entitled to be registered in terms of this Act; ▪ conduct a pre-registration examination or evaluation to ensure competence of a person applying for registration in terms of this Act; INTERNSHIP, EISA, PROFESSIONAL EXAMS ▪ conduct, recognise and control supplementary training of a person registered in terms of this Act; E.g. IMMUNISATION & INJECTION TECHNIQUE  Pharmacy education and training ▪ recognise qualifications, competencies and skills for purposes of registration in terms of this Act; ▪ determine the number of pharmacy support personnel or pharmacist interns who may be trained under the supervision of a pharmacist; ▪ investigate or cause to be investigated any institution or premises recognised by the council for purposes of education and training in terms of this Act, or request such information as may be deemed necessary from such institution to enable the council to establish compliance with the requirements prescribed by the council relating to such education and training; ▪ conduct examinations or evaluations for purposes of registration or continued registration in terms of this Act; ▪ appoint or accredit examiners or moderators needed for purposes of conducting any examination or evaluation prescribed by the council; INTERNSHIP, EISA, PROFESSIONAL EXAMS ▪ award, cancel or withdraw certificates or documents issued in respect of any examination or training provided or recognised by the council; ▪ upon notice to the institution and pharmacy students who may be affected thereby, and after furnishing reasons, withdraw further recognition of any qualification for purposes of registration in terms of this Act on such conditions as the council may deem fit; Continual Professional Development ▪ require any person registered in terms of this Act to remain competent in the manner prescribed; ▪ make rules as to the additional qualifications, specialities or titles that may be registered in terms of this Act.  CHAPTER IV CONDUCT OF PHARMACEUTICAL PRACTICE ▪ Authorisation for provision and levies for services ▪ Pharmacy practice ▪ Restriction in respect of business names ▪ Continuation of pharmacy business of person registered in terms of this Act by executor, trustee, liquidator, curator, or judgment creditor ▪ Restriction in, or suspension from, practice of registered person  Pharmacy practice ▪ the following shall be prescribed: Scope of practice: – the scope of practice of persons registered in terms of this Act, or the services or acts refers to those which shall for purposes of this Act be deemed to be services or acts specially activities that a pertaining to pharmacists or pharmacy support personnel, and the conditions under which those services may be provided or the acts which may be performed; person licensed to – the services which may be provided in the various categories of pharmacies, and the practice as a health conditions under which these services shall be provided; professional is permitted to ▪ the council shall be entitled to make rules as to: perform – a code of conduct for pharmacists and other persons registered in terms of this Act; determined by – what constitutes good pharmacy practice; statutes enacted by – the services for which a pharmacist may levy a fee and guidelines for levying such a state legislatures fee or fees; there are rules ▪ the council may approve the title or name under which a pharmacy may be adopted by the conducted; appropriate licensing entity. ▪ the council shall be entitled to investigate and inspect the practice and the conduct of the business of a pharmacy.  Restriction in respect of business names ▪ Subject to the provisions of subsections (2) and (3), no person shall carry on business as a pharmacist, either alone or in partnership with another person, under any name, title or description which is or includes in any form the surname of a natural person, living or dead, if the use of such name, title or description is calculated or likely to lead persons to infer that a person of that surname is or has been associated with the pharmacy business in question. ▪ The provisions of subsection (1) shall not prohibit— – the inclusion in the name, title or description of any pharmacy business of the surname of an owner thereof; – the use in respect of any pharmacy business of any name, title or description under which that business has lawfully been carried on immediately prior to the commencement of this Act. ▪ The provisions of subsection (1) shall not apply in respect of any pharmacist whose business activities consists solely of the manufacture of medicines and the sale thereof to pharmacists or dealers and who does not carry on business as a retail pharmacist. ▪ Any person who contravenes any of the provisions of this section shall be guilty of an offence and liable on conviction to a fine not exceeding the amount determined by the Minister from time to time by notice in the Gazette.  Restriction in, or suspension from, practice of registered person ACTIONS TAKEN ▪ If the council, after holding an inquiry in terms of subsection (1), finds that any of the circumstances contemplated in paragraph (a), (b), (c) or (d ) of that subsection exists in respect of the person CONDITIONS: concerned, it may, by order— – in the case of a person in respect of whom the circumstances contemplated in ▪ has become mentally or physically disabled to such an paragraph (a) of subsection (1) exist— extent that it would be detrimental to the public interest ▪ suspend such person for a specified period from practising his profession or to allow him to continue to practise; performing any act specially pertaining to his profession; or ▪ impose such conditions as it may deem fit subject to which such person shall be ▪ has become unfit to purchase, acquire, keep, use, order, entitled to continue practising his profession supply or possess any scheduled substance; ▪ in the case of a person in respect of whom any of the circumstances ▪ has been using a scheduled substance regularly for other contemplated in paragraph (b), (c) or (d) of subsection (1) exists— than medicinal purposes as defined in section 1 of the – impose upon such person any of the penalties referred to in section 45 (1); Medicines and Related Substances Control Act, 1965; or – prohibit such person for a specified period from purchasing, acquiring, keeping, using, dispensing, ordering, supplying or possessing any scheduled ▪ has become addicted to the use of any scheduled substance; or substance, – impose for a specified period such conditions as it may deem fit subject to which such person shall be entitled to purchase, acquire, keep, use, dispense, The council shall cause the matter to be investigated and the order, supply or possess any scheduled substance. council may, if it deems it necessary, hold an inquiry mutatis mutandis in accordance with the provisions of section 40 and the regulations made under section 49 (1) (o), in respect of such person Have you heard of the Health Committee? CHAPTER V DISCIPLINARY POWERS OF THE COUNCIL ▪ Powers of officers and other persons ▪ Inquiry by the council into charges of misconduct ▪ Procedure for the conduct of an inquiry. ▪ Council to make rules relating to offences under this Chapter ▪ Charges by pharmacists. ▪ Commission on prescription ▪ Cognizance by council of conduct of registered persons under certain circumstances ▪ Penalties the council may impose ▪ Postponement of imposition, and suspension of operation, of penalty ▪ Recovery of fines and cost orders ▪ Penalty for false evidence ▪ Effect of suspension or removal from register ▪ Limitation of liability  Powers of officers and other persons ▪ Any officer appointed in terms of this Act who is required or authorized to perform any duty on behalf of the council and any person appointed by virtue of the provisions of section 49 (1) (l ) (v) to make any inspection, may enter any pharmacy at any time reasonable for the proper performance of such duty or the making of such inspection. INSPECTION ▪ Any person who fails to give or refuses access to any officer or person referred to in OFFICERS subsection (1), if he requests entrance to any pharmacy, or obstructs or hinders him in the execution of his duties under this Act, or who fails or refuses to give information that he may lawfully be required to give to such officer or person, or who gives to such officer or person false or misleading information knowing it to be false or misleading, shall be guilty of an offence. ▪ Every officer or person referred to in subsection (1) shall be issued with a document signed by the registrar and containing the name of the officer or person concerned as well as a statement to the effect that such officer or person is empowered to perform any duty or make any inspection in terms of this section. ▪ Whenever any officer or person performs any duty or makes any inspection as contemplated in this section, he shall exhibit to any person affected thereby the document issued to him in terms of subsection (3). Inquiry by the council into charges of misconduct ▪ The council shall have the power to enquire into any matter which is brought to the attention of the council or any complaint, charge or allegation of improper or disgraceful conduct against any person registered in terms of this Act and, on finding such person guilty of such conduct, to impose any of the penalties prescribed in section 45 (1). ▪ If the council is in doubt as to whether any inquiry should be held, it may, in connection with the complaint, charge or allegation in question, consult with or seek information from any person, including the person against whom the complaint, charge or allegation has been lodged. ▪ In the case of a complaint, charge or allegation which forms or is likely to form the subject of a criminal case in a court of law the council may postpone the holding of an inquiry until such case has been concluded. ▪ The council may appoint a person with adequate experience in the administration of justice to be present as an assessor at any inquiry held by the council under this Chapter and to advise it on matters of law, procedure or evidence.  Procedure for the conduct of an inquiry ▪ For the purpose of any inquiry held in terms of section 39, the council may take evidence and may, under the hand of the president or the registrar, summon witnesses and require the production of any book, record, document or thing and may, through the president, administer an oath to any witness or accept an affirmation from him, and may examine any book, record, document or thing which any witness had been required to produce. ▪ Every person summoned in terms of this subsection shall be bound to obey the summons and any person who, having been duly summoned— – refuses, or without sufficient cause fails, to attend and give evidence relevant to the inquiry at the time and place specified in the summons; – refuses to take the oath or to make an affirmation when required by the president to do so; – refuses to produce any book, record, document or thing which he has in terms of the summons been required to produce; or – attends before the council and refuses to answer, or to answer fully and satisfactorily to the best of his knowledge and belief, any question lawfully put to him, shall be guilty of an offence and liable on conviction to a fine not exceeding the amount to be determined by the Minister from time to time by notice in the Gazette: Provided that every person so summoned shall be entitled to all the privileges to which a witness subpoenaed to give evidence before a provincial division of the Supreme Court is entitled. ▪ Every person whose conduct is the subject of an inquiry under section 39, shall be afforded an opportunity, by himself or through his legal representative, of answering the charge and of being heard in his defence.  Penalties the council may impose ▪ Any person registered under this Act who, after an inquiry held by the council in accordance with the provisions of this Chapter, has been found guilty of improper or disgraceful conduct, or conduct which when regard is had to such person’s profession is improper or disgraceful, shall be liable to one or other of the following penalties: – a reprimand or a caution or a reprimand and a caution; or – suspension for a specified period from practising or performing any acts forming part of his or her scope of practice as prescribed in terms of this Act; – removal of his name from the register; – a fine not exceeding the amount determined by the Minister from time to time by notice in the Gazette. ▪ When the council has imposed one or other of the penalties referred to in subsection (1) the registrar shall cause to be published in the Gazette the name of the person concerned, the nature of the conviction and the penalty imposed. ▪ Any person aggrieved by a finding of or penalty imposed by the council in terms of this section, may, after notice to the council and within a period of two months after the date of such finding or the imposition of the penalty, appeal to the provincial or local division of the Supreme Court of South Africa having jurisdiction in the area wherein the appellant normally practises in the capacity in which he is registered, against such finding or penalty, and the provisions of section 24 shall apply mutatis mutandis to such an appeal: Provided that no finding of or penalty imposed by the council shall be set aside by reason only of an irregularity which did not embarrass or prejudice the appellant in answering the charge or in the conduct of his defence.  Postponement of imposition, and suspension of operation, of penalty ▪ Where the council finds a If at the end of the period for which the imposition of a penalty has been person referred to in postponed in terms of subsection (1) (a), the council is satisfied that the person section 45 (1) guilty of concerned has observed all the relevant conditions, the council shall inform conduct referred to him that no penalty will be imposed upon him. therein, it may— – postpone, for such period and on such conditions as it may determine, the If the execution of a penalty has been suspended in terms of subsection (1) (b), imposition of a penalty; or and the council is satisfied that the person concerned has observed all relevant – impose any penalty conditions throughout the period of suspension, the council shall inform him mentioned in section 45 (1) that such penalty will not be executed. (b) or (c), but order the If the execution of a penalty has been suspended in terms of subsection (1) (b) execution of such penalty to and the person concerned fails to observe any of the conditions of suspension, be suspended for such the council shall put such penalty into operation unless such person satisfies the period and on such council that the non-observance of the condition in question was due to conditions as it may determine. circumstances beyond his control. Effect of suspension or removal from register Every person who has been suspended or whose name has been removed from the register under this Chapter shall, if his profession is one which, under this Act, cannot be lawfully carried on by an unregistered person, be disqualified from carrying on his profession and his registration certificate shall be deemed to be cancelled until the period of suspension has expired or until his name has been restored to the register by the council. CHAPTER VI GENERAL AND SUPPLEMENTARY PROVISIONS ▪ Regulations ▪ Abolition of Interim Pharmacy Council of South Africa, and transitional provisions ▪ Savings ▪ Act binding on State ▪ Short title and commencement  Regulations How does council communicate this to the profession and stake holders? ▪ The Minister may, in consultation with The council shall, not less than two months before any rule is the council, make regulations (refer to made in terms of this Act, cause the text of such rule to be list in the Act) published in the Gazette together with a notice declaring the ▪ The Minister may, after consultation council’s intention to make such a rule and inviting interested with the executive committee of the persons to furnish the council with comments thereon or any council, if he deems it to be in the representations they may wish to make in regard thereto. public interest- The Minister shall, not less than three months before any regulation is made in terms of this Act, cause the text of such draft – without the recommendation of the council make regulations relating to any regulation to be published in the Gazette together with a notice of the matters referred to in subsection declaring the Minister’s intention to make such a regulation and (1) or amend or repeal any regulation inviting interested persons to furnish the Minister with comments made in terms of that subsection; thereon or any representations they may wish to make in regard – amend or repeal any rule made in terms thereto: Provided that if the Minister thereafter decides to alter of the provisions of this Act. the draft regulations as a result of any objections or representations so submitted, it shall not be necessary to publish such alterations before making the regulations.