Good g overnance in the pharmaceutical sector Gilles Forte Deirdre Dimancesco Cécile Macé Department of Essential

1. Good governance in the pharmaceutical sector Gilles Forte Deirdre Dimancesco Cécile Macé Department of Essential Medicines and Health Products Side event at the 66th WHA

2. Ten leading causes of inefficiencyWorld Health Report 2010, Chapter 4

3. R&D and clinical trials Tax evasion Conflict of interest Counterfeit/ substandard Pressure Unethical donations Collusion Thefts Over- invoicing Falsificationsafety/ efficacy data Bribery State Capture Patent Inefficiencies and unethical practices can occur throughout the medicines supply chain Manufacturing R&D priorities Registration Inspection Selection Procurement & import Cartels High prices Distribution Pricing Prescription Waste Dispensing Pharmacovigilance Promotion Losses Inappropriate use Unethical promotion

4. Why improve good governance in the pharmaceutical sector • To improve health, health service delivery and access to quality and affordable medicines • To contribute to Universal Health Coverage, through reduced inefficiencies, unethical behavior and corruption • To establish relevant structures and processes for efficient implementation of medicines policies and the enforcement of laws and regulations in countries • To increase transparency, accountability and ethical management of pharmaceutical systems • To improve public trust and confidence on the health system and prevent misuse of public, patients and donors funds

5. Common elements of governance relevant to the pharmaceutical sector Information Rule of law Regulation Leadership Equity Efficacy Policy formulation & planning • Transparency • Accountability • Participation • Consensus • Ethics • Efficiency

6. WHO contribution to good governancein the pharmaceutical sector GGM MeTA Leadership Ethics Anti-corruption Rule of law Regulation Transparency Participation Accountability Efficiency Policy Information Better access to medicines

7. WHO Good Governance for Medicines programme (GGM) • Goal To contribute to health systems strengthening and to 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. Good Governance for Medicines programme: a model process Clearance MOH PHASE II Development national GGM framework PHASE I National transparency assessment PHASE III Implementation national GGM programme GGM integrated in MoH plan GGM framework officially adopted Assessmentreport

10. National TransparencyAssessment PHASE I PHASE II PHASE III • Assesses transparency and vulnerability to corruption of pharmaceutical systems • Looks at key functions such as: • Regulation: registration, licensing, inspection, promotion, clinical trials • Supply: selection, procurement, distribution • Elements evaluated: • Regulations and official documents • Written procedures and decision-making processes • Committees, criteria for membership and conflict of interest policy • Appeals mechanisms and other monitoring systems Assessmentreport

11. PHASE I PHASE II PHASE III Development of a GGM Framework • "Discipline-based approach" • Aims to put into place laws, policies and procedures for the pharmaceutical sector and against corruption • Attempts to prevent unethical and corrupt practices through fear of sanctions on reprehensible acts • "Values-based approach" • Attempts to motivate ethical conduct of public servants • Promotes institutional and individual integrity through promotion of ethical principles GGM framework officially adopted

12. Implementation of National GGM Programme PHASE I PHASE II PHASE III • Increase of information publicly available (regulations, laws, procedures, inspection reports, procurement contracts and tenders, web-based platforms with procurement prices…) • Revision of policies and procedures; Operational guidelines developed; Appeal mechanisms put in place • Adoption of codes of conduct for people working in the pharmaceutical sector; Development and adoption of policies on conflicts of interest • Clarification of TORs and selection criteria for various committees • GGM fully institutionalized, funded by government budget and part of the anti-corruption national plan • Regular training sessions on ethical leadership and Good Governance at national and regional level • GGM included in the curricula of pharmacy students GGM integrated in MoH plan

13. Next steps/Final words • Develop methodologies for assessing good governance interventions and their impact on reducing inefficiencies and on improving access to quality and affordable medicines. • Strengthen WHO support to countries for good governance in pharmaceutical and health systems as a contribution to the achievement of universal health coverage. • Facilitate sharing of experiences among countries and explore synergies with other partners and sectors.