The South African Pharmacy Council An introduction to our Legal Team FMU Investigator Indaba 1 & 2 November 2010 D. Hoffmann & T Boase 1
INTRODUCTION TO THE SOUTH AFRICAN PHARMACY COUNCIL The South African Pharmacy Council is a statutory health council, recognised in terms of the National Health Act, 61 of 2003 and established as a juristic person in terms of Section 2 of the Pharmacy Act, 53 of 1974. 2
INTRODUCTION TO THE SAPC Council consists of 25 members (elected and appointed in terms of Section 5 of the Act) Committees formed by a make up of those 25 people (inter alia) Executive Committee Education Committee Continuing Profession Development Committee Practice Committee Committee of Preliminary Investigation Committee of Informal Inquiry Committee of Formal Inquiry Health Committee
INTRODUCTION TO THE SAPC The Office of the Registrar provides the administration function to Council and all the committees. All correspondence is addressed through the Registrar. The Registrar is assisted by the following technical departments: Customer Services and Public Relations Education and Training Pharmacy Practice Finance CPD and Registrations Legal Services and Professional Conduct 4
SCOPE OF JURISDICTION The objects of the Council shall be to establish, develop, maintain and control universally acceptable standards In pharmaceutical education and training; 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; Of the practice of the various categories of persons required to be registered in terms of this Act; Of professional conduct required of persons to be registered in terms of this Act; and 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 registered persons. 5
SCOPE OF JURISDICTION Pharmacies Community pharmacies Institutional (hospital) pharmacies Wholesale pharmacies Manufacturing pharmacies Consultant pharmacies no medicines 6
SCOPE OF JURISDICTION Pharmacists Registered pharmacists Responsible pharmacists (one per pharmacy irrespective of which sector) Specialist Pharmacists Clinical Pharmacokineticist Radio-Pharmacist PCDT (Primary Care Drug Therapists) hold Section 22A(15) permit (Medicines Act) can diagnose, prescribe and dispense within a particular indication and medicine framework. 7
SCOPE OF JURISDICTION Pharmacy Support Personnel Pharmacist s Assistants Must work under direct supervision of a pharmacist (limited exceptions within the public sector) Basic Pharmacist s Assistant Post Basic Pharmacist s Assistant 8
Registration Process - Pharmacies Pharmacy owner must apply for a license from the Department of Health GPP compliance Responsible Pharmacist Obtain License Owner, Pharmacy and Responsible Pharmacist recorded with SAPC and issued with certificates 9
Registration Process Pharmacists & Pharmacy Support Personnel Pharmacists Registered as students from 2 nd year of BPharm Internship (12 months) Community Service (12 months in the public sector) Foreign qualifications reviewed by Education Committee & write professional examinations. Complete internship and community service Pharmacy Support Personnel Register as learners Change registration after qualification In-service training Practice under supervision 10
LEGAL PROCESS FOR COMPLAINTS AGAINST PHARMACIES, PHARMACISTS AND PHARMACY SUPPORT PERSONNEL Disciplinary Powers of the Council is detailed in Chapter V of the Pharmacy Act, 53 of 1974 together with the Regulations relating to the conduct of inquiries held in terms of Chapter V of the Act, GNR 496 published on 8 June 2001. Rules relating to acts or omissions in respect of which Council may take disciplinary steps (GNR 599 published on 31 March 1989) more commonly known as the Ethical Rules Rules relating to the Code of Conduct, (BN 108 published on 24 October 2008) Good Pharmacy Practice Medicines and Related Substances Control Act, 101 of 1965 together with the General Regulations (GNR 510 published on 10 April 2003). 11
LEGAL PROCESS FOR COMPLAINTS AGAINST PHARMACIES, PHARMACISTS AND PHARMACY SUPPORT PERSONNEL Legal Services and Professional Conduct Department Senior Manager Secretarial Support Officer Deputy Manager Professional Conduct Practitioners (2) Disciplinary Inspectors Receive complaint Investigate Request explanation Explanation given Panel/Committee 12
LEGAL PROCESS FOR COMPLAINTS AGAINST PHARMACIES, PHARMACISTS AND PHARMACY SUPPORT PERSONNEL Committees in the disciplinary process Registrar s Complaints Review Panel No further action required Refer to the Committee of Preliminary Investigations (CPI) Committee of Preliminary Investigations No further action required Recommend an admission of guilt fine/committee of Informal Inquiry Recommend Committee of Formal Inquiry 13
LEGAL PROCESS FOR COMPLAINTS AGAINST PHARMACIES, PHARMACISTS AND PHARMACY SUPPORT PERSONNEL Committee of Informal Inquiry Respondent appears personally Council appoints pro forma complainant (no legal qualifications) Inquiry of consensus no public records Uphold the recommended admission of guilt fine Reduce the admission of guilt fine Remove/dismiss the charges Refer the matter to the Committee of Formal Inquiry 14
LEGAL PROCESS FOR COMPLAINTS AGAINST PHARMACIES, PHARMACISTS AND PHARMACY SUPPORT PERSONNEL Committee of Formal Inquiry Formal Hearing Public access Public record Council appoints a pro forma complainant/prosecutor Legal representation permitted 15
LEGAL PROCESS FOR COMPLAINTS AGAINST PHARMACIES, PHARMACISTS AND PHARMACY SUPPORT PERSONNEL Consequences Reprimand and warning, or Suspended from practice, or Removal from the register, and/or Fine Cost order Suspended Sentence If criminal charges are opened, the SAPC stays proceedings in terms of Chapter V until the conclusion of such criminal charges 16
FORMAL INQUIRIES Fraud cases are referred to the Committee of Formal Inquiries and the respondent is charged with conducting his/her practice or him/herself in such a manner that the dignity and the honour of the profession is harmed (Ethical Rule 10) 17
FORMAL INQUIRIES Hand over of evidence Volume Quality versus hearsay Technical in nature Witnesses Affidavits Must be available for pre-hearing consultation Availability to provide evidence Expert assistance/co-operation Affidavits Availability for pre-hearing consultation Availability to provide evidence 18
QUESTIONS & ANSWERS