WHO Good Governance for Medicines programme Making the Invisible Visible Conference

1. WHO Good Governance for Medicines programme Making the Invisible Visible Conference University of Brighton (Falmer Campus) 17 December 2010 Dr Guitelle Baghdadi-Sabeti Department of Essential Medicines and Pharmaceutical Policies

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

3. 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

4. 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 • Countries with higher indices for corruption have higher infant mortality rates

5. 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

6. 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

7. 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…

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

9. 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

10. Working draft PHASE II PHASE III PHASE I Bottom-up approach in policy development lead to the 'GGM technical package'

11. PHASE I PHASE II PHASE III Summary quantitative findings

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 (12 countries) Phase II (12 countries) Phase III (7 countries)

16. Current monitoring mechanisms: measuring outputs and milestones

17. Common challenges faced in implementation • Cultural and behavioural: resistance to change, passive attitude or tolerance • Political: instability, delays • Managerial: lack staff, rotation • Technical: integration in day to day affairs, new subject • Time: workload, other priorities • Lack of resources: human and financial

18. Lessons learnt to date: great interest in subject area • National "champions" that are persistent and dedicated • Political will and technical support • Strong collaboration with all stakeholders • GGM is integrated into existing structures and committees. • Time-frame for implementation adapted to each country's context • Effective communication within the MOH and by the government • Government's willingness to institutionalize the GGM • Integrity is promoted together with legislative reforms

19. Priorities for 2010 - 2012 • Identify best practices in phase III countries • Monitoring and evaluation • Integrate corruption on the health agenda (global & countries) • Institutionalization of the GGM • Communications strategy • Training phase III and GGM resources • Fundraising

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