PIASA Presenter Profile of the Association Pharmaceutical Trade organisation - voluntary membership Members comprise research based multinational, local/ generic and empowerment pharmaceutical companies operating in SA 18 members Approximately 25 % Private Sector Market Share Represents South Africa internationally as a member of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Represent members’ interests in Africa as a member of NEPAD Business Foundation www.piasa.co.za Pharmaceutical Associations Self Medication SMASA 17% Local Manufacturing IMSA Innovative Medicines 32% PHARMISA 15% PIASA 25% Innovative / Local + Generic NAPM 11% Generics Our Mission To sustain a favourable environment for the continued development of the pharmaceutical industry in South Africa as it strives to increase access to quality medicines, with the ultimate aim of saving lives and improving the quality of life for all South Africans PIASA’s Role • Represent members and industry in dealing with government, business and professional organisations • Promote and safeguard members interests in South Africa by striving to influence policy developments affecting the health sector • Analyse and interpret trends (national & international) and the impact of changes to legislation on the industry • Keep abreast of African and international policy through our representation as a member of the NEPAD Business Foundation and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) • Keep members abreast of legal, labour, scientific, technical, economic and trade issues • Provide relevant information and advice as appropriate What are the Goals of PIASA? • To promote the environment for the provision of quality medicines to all South Africans • To sustain a favourable environment for the pharmaceutical industry locally • To partner with government and the private sector • To be a unifying force in helping find South African solutions to South Africa’s challenges in healthcare PIASA’s Role • Respect for intellectual property rights • Commitment to good corporate governance • Commitment to the Code of Marketing Practice • Adherence to best practice in manufacturing, clinical research, distribution and regulatory issues The PIASA Structure • Executive Council (elected 8 Multinational and 4 Local/Generic/ Black Empowered) – Strategic Direction & Leadership Management Council – Financial & Administration • Identified Strategic Priority Areas • Management Council Pierre Bosch Jonathan Louw Steve Speller Laura Engelbrecht Joubert Science & Technology Committee (SciTech) Kobus Venter Executive Council President Pierre Bosch Marketing Committee Steve Speller Government Affairs, Policy and IP Steve Speller Transformation Health Outcomes Communication Amanda Wilde Laura Engelbrecht Joubert Richard de Chastelain Skills Group Vicki St Quintin Supported by the Secretariat Strategic Priority Areas Science & Technology Committee (SciTech) scientific, clinical and technical Executive Council PIASA’s decision making body, sets strategy & determines policy matters Marketing Committee Government Affairs, Policy and IP • Ensure good relationship with Government; • Continued liaison with DoH and DTI; • Constructive input legislative issues; and • Discussions on trading conditions • Strives to maintain a sound IP environment to encourage investment Transformation Focus on Black Economic Empowerment • • • Communication Image of industry and PIASA Communication with members & their staff Communication to professional bodies, trade associations and others Health Outcomes Address issues affecting funding of medicines in the private sector with a focus on the interest of patients Standing Committees Executive Council SciTech (Science & Technology Committee) Acts in members’ interest on scientific, clinical and technical matters Analyses and interprets the effect of national & international changes in regulatory, scientific and technical matters impacting on the local pharmaceutical industry Deals with Good Manufacturing Practice & Good Clinical Practice Marketing Committee Compliance with ethical marketing practices Self-regulation on Code complaints SciTech Sub Groups: Clinical – Market SA’s clinical research capability Regulatory - Leadership in ITG • Drive awareness & influence key stakeholders to improve operational efficiency of MCC • Active participation in harmonisation initiatives • Influencing technical guideline updates Pharmacovigilance & Medical Info • Share best practice • Support companies audit readiness • Improve quality of Medical Information services • Influencing technical guideline updates Quality Management – Share best practice • Risk management audit & readiness • Chair industry Cold Chain Forum Members of PIASA Abbott Laboratories South Africa (Pty) Ltd GlaxoSmithKline South Africa Acro (Pty) Ltd GlaxoSmithKline Southern Africa Adcock Ingram Healthcare (Pty) Ltd iNova Pharmaceuticals (Pty) Ltd Alcon Laboratories (Pty) Ltd Janssen Allergan Pharmaceuticals (Pty) Ltd Key Oncologics (Pty) Ltd AstraZeneca Pharmaceuticals (Pty) Ltd Nkunzi Pharmaceuticals (Pty) Ltd Bayer HealthCare Novo Nordisk (Pty) Ltd Covidien (Pty) Ltd Servier Laboratories SA Pty) Ltd Galderma Laboratories (Pty) Ltd Umsinsi Health Care Pty Ltd Secretariat Structure Chief Operating Officer Vicki St Quintin Reports to Management Council Financial Function Contracted out Head: Scientific and Regulatory Affairs Kirti Narsai Personal Assistant & Office Administrator Betsie Von Wielligh Office Assistant Agreta Njeje Scientific and Regulatory Affairs Coordinator Christine Schoeman Pharmaceutical Industry The pharmaceutical industry in SA is represented by a number of trade Associations i.e.: • Pharmaceutical Industry Association of SA (PIASA) – represents 18 research based multinational, local generic and local empowerment pharmaceutical companies • represents South Africa internationally as a member of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) • represent members’ interests in Africa as a member of NEPAD Business Foundation • Innovative Medicines SA (IMSA) - represents research based pharmaceutical companies • National Association of Pharmaceutical Manufacturers (NAPM) - represents the majority of generic medicine companies operating in South Africa • Self Medication Association of SA (SMASA) – represents the interests of companies involved in the marketing of self-medication products • Pharmaceuticals Manufactured in South Africa (PHARMISA) – represents generic medicine in South Africa Bringing Hope & Health to All South Africans • Global MNC’s • Local / Generic Cos