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. Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 2 "The abuse of entrusted power for personal gain" Transparency International What is corruption?

3. Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 3 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

4. Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 4  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  Countries with higher indices for corruption have higher infant mortality rates 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

5. Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 5  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

6. Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 6 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

7. Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 7 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

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

9. Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 9 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

10. Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 10 Bottom-up approach in policy development lead to the 'GGM technical package' PHASE II PHASE III PHASE I Working draft

11. Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 11 Summary quantitative findings PHASE II PHASE I PHASE III

12. 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

13. 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

14. 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

15. 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 (12 countries) Phase II (12 countries) Phase III (7 countries)

16. Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 16 Current monitoring mechanisms: measuring outputs and milestones

17. Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 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. Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 18 Lessons learnt to date: great interest in subject area 1.National "champions" that are persistent and dedicated 2.Political will and technical support 3.Strong collaboration with all stakeholders 4.GGM is integrated into existing structures and committees. 5.Time-frame for implementation adapted to each country's context 6.Effective communication within the MOH and by the government 7.Government's willingness to institutionalize the GGM 8.Integrity is promoted together with legislative reforms

19. Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 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. Department of Essential Medicines and Pharmaceutical Policies Good Governance for Medicines 20 "I never worry about action, but only inaction." Winston CHURCHILL