WHO Good Governance for Medicines programme Technical Briefing Seminar 3 November 2010, Geneva Dr Guitelle Baghdadi-Sabeti Department of Essential Medicines and Pharmaceutical Policies

Good Governance for Medicines 2 Corruption requires two parties: the corrupter and the corruptee "Whose is the greater blame? She who sins for pay or he who pays for sin?" Sor Juana Inés de la Cruz

Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 3 "The abuse of entrusted power for personal gain" Transparency International What is the definition of corruption?

Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 4 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 Unethical practices can be found throughout medicines chain

Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 5  Health and pharmaceutical sectors attractive targets ì US$ 5.3 trillion spent on health services annually ì Global pharmaceutical market: > US$ 750b  No global estimate on financial losses, but: ì 10 to 25% procurement spending lost into corruption ì Some countries report losses:  2/3 medicines supplies lost in hospitals  10% national expenditures on health care Corruption identified as the single greatest obstacle to economic and social development "Corruption is a worldwide problem, existing in both high- and low- income countries… no country should feel offended and restrained to talk about it". Dr H. Hogerzeil, Director, WHO

Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 6  Health impact ì Unsafe medicines on the market ì Lack EM in health facilities ì Irrational use of medicines  Economical impact ì Waste limited public/donor funding ì Not stable environment ì Not easy to conduct business  Image and trust impact ì Erodes public trust ì Reduces credibility of health profession Unethical practices can have significant impact on health systems

Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 7 WHO Good Governance for Medicines Programme: an innovative initiative  Goal ì To contribute to health systems strengthening and prevent corruption by promoting good governance in the pharmaceutical sector  Specific objectives ì To raise awareness on the impact of corruption in the pharmaceutical sector and bring this to the national health policy agenda ì To increase transparency and accountability in medicine regulatory and supply management systems ì To promote individual and institutional integrity in the pharmaceutical sector ì To institutionalize good governance in pharmaceutical systems by building national capacity and leadership

Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 8 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 Good Governance for Medicines 9 GGM started as a pilot project in 2004 and is now a global programme

Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 10 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 integrated in MOH plan Clearance MOH

Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 11 Bottom-up approach in policy development lead to the 'GGM technical package' PHASE II PHASE III PHASE I In process Country case studies and compilation of best practices Working draft

Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 12 Common strengthsAreas of improvement Registration - Written procedures for applications - Operational committees - Conflict of interest policy - Committee composition & TOR Promotion - Provisions exist (major variations) - No DTCA for prescription-only med. - Complete provisions to cover all - Establish responsible unit Inspection - Inspection report required - Reports subject to internal review - Conflict of interest policy - Appeals mechanisms Selection - Clear criteria for selection process - Committees (multi-discipl. Experts) - Conflict of interest policy - Selection criteria for members Procurement - Written procedures - Well-established tender committees - Conflict of interest policy - Audit results publicly available Summary qualitative findings PHASE II PHASE I PHASE III

Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 13 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 Good Governance for Medicines 14 PHASE II PHASE I PHASE III GGM frameworks effective only if translated into action: some preliminary achievements  Lower costs for quality medicines procurement  National pharmaceutical laws, regulations and procedures revised  Web-based pharmaceutical activities (registration, licensing) and information  Conflict of interest policies developed and implemented  Integrity and Leadership training programmes for health officials  Good governance introduced in University curriculum  Communications and advocacy campaigns  Culture of transparency is emerging in institutions

Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 15 Countries efforts focus on moving from phase I to phase III Phase I (7 countries) Phase II (12 countries) Phase III (7 countries)

Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 16 Key observations and lessons learnt 1.Great interest in subject area (preventive approach appealing) 2.A dedicated and motivated national team to champion the issue 3.Involvement of high-level and technical officials essential 4.Collaboration with key stakeholders 5.Promotion of integrity together with legislative reforms 6.Timeframe different between countries 7.Institutionalization needed for sustainability

Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 17 Priorities for  Identify best practices in phase III countries  Integrate corruption on the health agenda (global & countries)  Institutionalization of the GGM  Communications strategy  Monitoring and evaluation  Training phase III and GGM resources  Fundraising

Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 18 "I never worry about action, but only inaction." Winston CHURCHILL

Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 19 A few questions for reflection…  Do you believe that corruption exists in your country? Isolated cases or permissive culture?  What are the most common forms?  What are the possible causes?  What makes the pharmaceutical sector so vulnerable to corruption?  What do you think needs to be done to tackle corruption in the pharmaceutical sector on the long run?