WHO Good Governance for Medicines programme Technical Briefing Seminar 19 November 2009, Geneva Dr Guitelle Baghdadi-Sabeti Department of Essential Medicines and Pharmaceutical Policies

Department of Essential Medicines and Pharmaceutical Policies November 2009 – Good Governance for Medicines 2 Pharmaceutical sectors is a great target to corruption and unethical practices Conflict of interest Pressure Bribery Falsification safety/ efficacy data State Capture Patent R&D and clinical trials Manufacturing Pricing Distribution Registration Selection Procurement & import Promotion Inspection Prescription Dispensing Pharmacovigilance R&D priorities Cartels Unethical promotion Thefts Over- invoicing Unlawful appropriation royalties Tax evasion Counterfeit/ substandard Collusion Unethical donations

Department of Essential Medicines and Pharmaceutical Policies November 2009 – Good Governance for Medicines 3 What is the impact?  Health impact ì Lack EM in health facilities ì Unsafe medicines on the market ì Irrational use of medicines  Economical impact ì Waste limited public funding ì Not stable business environment ì Poor most affected  Image and trust impact ì Erodes public trust ì Reduces credibility of health profession

Department of Essential Medicines and Pharmaceutical Policies November 2009 – Good Governance for Medicines 4 Numerous technical guidelines already exist… the challenge is to balance them with ethical practices Technical guidelines  Rule of law  Accountability  Transparency  Participation  Merit system  Evidence-based decision- making  Honesty  Efficiency and effectiveness  Etc…  GMP  GCP  Counterfeits  Manual on Marketing Authorization  WHO model list of EM  Good procurement practices  Ethical criteria  Etc… Ethical practices

Department of Essential Medicines and Pharmaceutical Policies November 2009 – Good Governance for Medicines 5 WHO Good Governance for Medicines Programme: an innovative initiative  Goal ì To strengthen pharmaceutical systems by promoting transparency and integrity.  Specific objectives ì To increase awareness of all stakeholders on the potential for unethical practices in the pharmaceutical sector and its impact. ì To increase transparency and accountability in medicines regulatory and supply management systems. ì To build national capacity for good governance in medicines regulation and supply management systems.

Department of Essential Medicines and Pharmaceutical Policies November 2009 – Good Governance for Medicines 6 GGM started as a pilot project in 2004 and is now a global programme Number of countries

Department of Essential Medicines and Pharmaceutical Policies November 2009 – Good Governance for Medicines 7 Good Governance for Medicines programme: a model process PHASE II Development national GGM framework PHASE III Implementation national GGM programme PHASE I National transparency assessment Assessment report GGM framework officially adopted GGM Strategic Plan of Action Clearance MOH

Department of Essential Medicines and Pharmaceutical Policies November 2009 – Good Governance for Medicines 8 Bottom-up approach in policy development lead to the 'GGM technical package' PHASE II PHASE III PHASE I

Department of Essential Medicines and Pharmaceutical Policies November 2009 – Good Governance for Medicines 9 Common strengths and weaknesses in supply chain PHASE II PHASE I PHASE III Common strengthsAreas of improvement Selection - Use of n al essential medicines lists - Clear criteria for selection process - Committees (multi-discipl. Experts) - Update and dissemination - Consultation with stakeholders - Conflict of interest policy - Selection criteria for members & TOR Procurement - Formal systems in place - Written procedures - Well-established tender committees - Conflict of interest policy - Audit results publicly available - Bribery in tender process - TOR for committee and members Distribution - Shelving - Inventory - Independent audits - Coding government medicines - Gift-giving needed for port-clearing - Security management (all levels) - Computerization - Performance monitoring & evaluation - Leakages

Department of Essential Medicines and Pharmaceutical Policies November 2009 – Good Governance for Medicines 10 Efforts to address corruption need coordinated application of two basic strategies  "Discipline-based approach" (top-down) ì Laws, policies and procedures against corruption and for pharmacy practice with adequate punitive consequence for violation ì Attempts to prevent corrupt practices through fear of punishment  "Values-based approach" (bottom-up) ì Promotes institutional integrity through promotion moral values and ethical principles ì Attempts to motivate ethical conduct of public servant PHASE II PHASE I PHASE III

Department of Essential Medicines and Pharmaceutical Policies November 2009 – Good Governance for Medicines 11 PHASE II PHASE I PHASE III GGM frameworks effective only if translated into action: some preliminary results  Strengthening systems by increasing transparency and accountability ì Increased number of hospitals with best practices in drugs procurement (Thailand) ì Amendment of laws, regulations and procedures (COI in Mongolia) ì Web-based procedures and information (Malaysia, Mongolia, Thailand)  Promoting awareness (public & health professionals) ì Dissemination of information & social marketing ì Critical thinking and discussions  Building capacity (managers and public policy makers) ì Technical training programme ì Leadership training programme ì GGM in University Curriculum

Department of Essential Medicines and Pharmaceutical Policies November 2009 – Good Governance for Medicines 12 Countries efforts focus on moving from phase I to phase III Phase I (7 countries) Phase II (13 countries) Phase III (6 countries)

Department of Essential Medicines and Pharmaceutical Policies November 2009 – Good Governance for Medicines 13 Key observations and lessons learnt 1.Great interest in subject area 2.Preventive and constructive approach appealing 3.Assessment can be educational 4.Involvement of high-level and technical officials essential for sustainability 5.Collaboration with key stakeholders extremely valuable 6.Some countries need more time than others 7.Cross-fertilization between countries best learning platform

Department of Essential Medicines and Pharmaceutical Policies November 2009 – Good Governance for Medicines 14 Department of Medicines Policy and Standards September 2007 – Good Governance for Medicines 14 "Corruption is a powerful force, but it is not inevitable or unavoidable. Diminishing its impact restores diverted resources to their intended purpose, bringing better health, nutrition and education to victims of corruption around the world, and with them, opportunity and hope." Transparency International

Department of Essential Medicines and Pharmaceutical Policies November 2009 – Good Governance for Medicines 15 Thank you!