WHO Good Governance for Medicines programme Technical Briefing Seminar 3 November 2010, Geneva

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

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

3. What is the definition of corruption? "The abuse of entrusted power for personal gain" Transparency International

4. Conflict of interest Counterfeit/ substandard Tax evasion Pressure Unethical donations Collusion Thefts Over- invoicing Bribery Falsificationsafety/ efficacy data State Capture R&D and clinical trials Unethical practices can be found throughout medicines chain Patent R&D priorities Manufacturing Unlawful appropriation royalties Registration Pricing Selection Procurement & import Cartels Distribution Inspection Prescription Dispensing Pharmacovigilance Promotion Unethical promotion

5. 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 • Health and pharmaceutical sectors attractive targets • US$ 5.3 trillion spent on health services annually • Global pharmaceutical market: > US$ 750b • No global estimate on financial losses, but: • 10 to 25% procurement spending lost into corruption • Some countries report losses: • 2/3 medicines supplies lost in hospitals • 10% national expenditures on health care

6. Health impact Unsafe medicines on the market Lack EM in health facilities Irrational use of medicines Economical impact Waste limited public/donor funding Not stable environment Not easy to conduct business Image and trust impact Erodes public trust Reduces credibility of health profession Unethical practices can have significant impact on health systems

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

8. Numerous technical guidelines already exist… the challenge is to balance them with ethical practices 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…

9. GGM started as a pilot project in 2004 and is now a global programme

10. Clearance MOH Good Governance for Medicines programme: a model process PHASE II Development national GGM framework PHASE I National transparency assessment PHASE III Implementation national GGM programme Assessmentreport GGM integrated in MOH plan GGM framework officially adopted

11. In process Country case studies and compilation of best practices Working draft PHASE II PHASE III PHASE I Bottom-up approach in policy development lead to the 'GGM technical package'

12. PHASE I PHASE II PHASE III Summary qualitative findings

13. PHASE I PHASE II PHASE III Efforts to address corruption need coordinated application of two basic strategies • "Discipline-based approach" (top-down) • Laws, policies and procedures against corruption and for pharmacy practice with adequate punitive consequence for violation • Attempts to prevent corrupt practices through fear of punishment • "Values-based approach" (bottom-up) • Promotes institutional integrity through promotion moral values and ethical principles • Attempts to motivate ethical conduct of public servant

14. PHASE I PHASE II 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

15. Countries efforts focus on moving from phase I to phase III Phase I (7 countries) Phase II (12 countries) Phase III (7 countries)

16. Key observations and lessons learnt • Great interest in subject area (preventive approach appealing) • A dedicated and motivated national team to champion the issue • Involvement of high-level and technical officials essential • Collaboration with key stakeholders • Promotion of integrity together with legislative reforms • Timeframe different between countries • Institutionalization needed for sustainability

17. Priorities for 2010 - 2012 • 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

18. "I never worry about action, but only inaction." Winston CHURCHILL

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?