WHO Good Governance for Medicines programme MeTA Launch Dr Guitelle Baghdadi-Sabeti

1. WHO Good Governance for Medicines programme MeTA Launch Dr Guitelle Baghdadi-Sabeti Geneva, 21 May 2008 61st World Health Assembly Department of Medicines Policy and Standards

2. Corruption identified as the single greatest obstacle to economic and social development • US$ 3 trillion spent on health services annually • Global pharmaceutical market: > US$ 600b • 10 to 25% procurement spending lost into corruption (including health sector) • Some countries report that 2/3 medicines supplies lost through corruption and fraud in hospitals • Low quality trials exaggerate the benefits of treatment by an average of 34% • Bribery of high officials in regulatory authorities has led to unsafe medicines circulating on the market resulting in deaths

3. R&D and clinical trials Unethical practices can be found throughout medicines chain & are very diverse Patent Manufacturing Evergreening R&D priorities Registration Collusion Bribery Pricing Fraud Selection Overinvoicing Cartels Procurement & import Falsification of safety/Efficacy data Counterfeit/ substandards Distribution Conflict of interest Promotion Unethical donations Inspection Unethicalpromotion State/regulatory capture Pressure Tax evasion Thefts

4. Health impact Unsafe medicines on the market Lack EM in health facilities Irrational use of medicines Economical impact Pharma. expenditure low-income countries: 10-40% of public health budget 20-50% of total health care expenditures Poor most affected  inequalities Image and trust impact Reduces government capacity Reduces credibility of health profession Erodes public trust Unethical practices can have significant impact on health systems

5. 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…

6. WHO Good Governance for Medicines Programme • Goal • To curb corruption in pharmaceutical sector systems through the application of transparent and accountable administrative procedures and the promotion of ethical practices among health professionals. • Specific objectives • To increase the awareness of all stakeholders on the potential for corruption in the pharmaceutical sector and its impact on health systems functioning. • To increase transparency and accountability in medicines regulatory systems and supply management systems. • To build national capacity for good governance in medicines regulation and supply management systems.

7. 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 Communication plan GGM framework officially adopted

8. 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

9. Discipline based approach Values based approach What could be the components of a national GGM Framework? • Established anti-corruption legislation • Whistle-blowing mechanism • Sanctions on reprehensible acts • Transparent and accountable regulations and administrative procedures • Collaboration with other GG & AC initiatives • Management, coordination and evaluation of GGM programme (Steering Committee & task force) • Ethical framework of moral values & ethical principles • Justice/fairness • Truth • Service to common good • trusteeship • Code of conduct • Socialization programme • Promotion of Moral Leadership

10. Phase I (13 countries) Phase II (10 countries) Phase III (4 countries) Bottom-up approach in implementation of project and policy development

11. PHASE I PHASE II PHASE III Progress in countries • Nb countries: • 18 completed • 9 currently on-going • Publications: • 4-country study: Laos, Malaysia, Philippines, Thailand • 5-country study: Bolivia, Cambodia, PNG, Mongolia, Indonesia (upcoming) • Future: individual country reports

12. PHASE I PHASE II PHASE III Progress in countries • National workshops: • Share results assessment • Consult on national GGM framework • National GGM Steering Group and/or Task Force • Consultation phase to finalize national GGM framework • Official adoption of national GGM framework

13. PHASE I PHASE II PHASE III Progress in countries • Mongolia • Official establishment of national GGM committee • Regional technical groups (including training) • Campaigns to promote awareness (educational material) • Philippines • GGM pharmaceutical benchbook • Awards system for local units • Thailand • Workshops on GGM framework • Newsletters, public communications (media, brochures, websites) • Introduction in university curricula • Bolivia (waiting clearance PoA by MOH) • Develop national GGM programme (national and regional consultations) • Orientation meeting for MOH staff • Campaign for promoting awareness

14. Key next steps for 2008 Analyse experience from 4 phase III countries and further refine WHO global guidance Establish system to collect learning in countries and facilitate communications b/w countries Scale up to more countries Publish more country assessment reports Next Global Stakeholders Group in Alexandria Explore collaboration with private sector Raise funding for wider implementation of the programme

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