Good Governance for Medicines Technical Briefing Seminar WHO, Geneva, 10 October 2007 Dr Guitelle Baghdadi-Sabeti Department of Medicines Policy and Standards

Department of Medicines Policy and Standards September 2007 – Good Governance for Medicines 2 Patent R&D and clinical trials Manufacturing Pricing Distribution Registration Selection Procurement & import Promotion Inspection Conflict of interest Evergreening Counterfeit/ substandards Tax evasion Falsification of safety/Efficacy data Bribery State/regulatory capture Overinvoicing Pressure Unethical promotion Thefts Fraud Cartels Collusion Unethical donations Unethical practices can be found throughout medicines chain & are very diverse R&D priorities

Department of Medicines Policy and Standards September 2007 – Good Governance for Medicines 3 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

Department of Medicines Policy and Standards September 2007 – Good Governance for Medicines 4 Unethical practices can have significant impact on the health system Health impact ìLack EM increases morbidity & mortality ìUnsafe medicines on the market ìIrrational use of medicines Economical impact ìPharma. expenditure low-income countries: 10-40% of public health budget 20-50% of total health care expenditures ìPoor most affected inequalities Image and trust impact ìReduces government capacity ìReduces credibility of health profession ìErodes public trust

Department of Medicines Policy and Standards September 2007 – Good Governance for Medicines 5 Why is the pharmaceutical system vulnerable to corruption? Market volume and economic interests Information imbalance to make independent assessments on quality, safety & efficacy of medicines High degree of government involvement in its regulation Poorly defined and documented processes Limited or too many institutional checks Inappropriate incentive structures Difficulty to differentiate corruption to inefficiency

Department of Medicines Policy and Standards September 2007 – Good Governance for Medicines 6 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

Department of Medicines Policy and Standards September 2007 – Good Governance for Medicines 7 WHO Good Governance for Medicines Programme Goal ìTo 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 ìTo increase the awareness of all stakeholders on the potential for corruption in the pharmaceutical sector and its impact on health systems functioning. ìTo increase transparency and accountability in medicines regulatory systems and supply management systems. ìTo build national capacity for good governance in medicines regulation and supply management systems.

Department of Medicines Policy and Standards September 2007 – Good Governance for Medicines 8 Efforts to address corruption need coordinated application of two basic strategies "Discipline-based approach" (top-down) ìLaws, policies and procedures against corruption and for pharmacy practice with adequate punitive consequence for violation ìAttempts to prevent corrupt practices through fear of punishment "Values-based approach" (bottom-up) ìPromotes institutional integrity through promotion moral values and ethical principles ìAttempts to motivate ethical conduct of public servant

Department of Medicines Policy and Standards September 2007 – Good Governance for Medicines 9 Good Governance for Medicines programme: a model process PHASE II Development national GGM programme PHASE III Implementation national GGM programme PHASE I National assessment Assessment report GGM officially adopted Communication plan Clearance MOH

Department of Medicines Policy and Standards September 2007 – Good Governance for Medicines 10 Assessment of transparency and accountability Assesses vulnerability to corruption of systems in place Looks at key functions of the pharmaceutical sector systems ìRegulation: registration, licensing, inspection, promotion ìSupply: selection, procurement, distribution Elements evaluated: ìCountry's regulations and official documents ìWritten procedures and decision-making processes ìCommittees, criteria for membership and conflict of interest policy ìAppeals mechanisms and other monitoring systems National assessment Assessment report PHASE II PHASE I PHASE III

Department of Medicines Policy and Standards September 2007 – Good Governance for Medicines 11 Development of National GGM Programme Developed through a national consultation process with all stakeholders Components of GGM programme: ìEthical framework of moral values & ethical principles Justice/fairness Truth Service to common good trusteeship ìCode of conduct ìTransparent and accountable regulations and administrative procedures ìCollaboration mechanism with other GG & AC initiatives ìWhistle-blowing mechanism ìSanctions on reprehensible acts ìGGM implementing task force Discipline based approach Values based approach National GGM programme GGM officially adopted PHASE II PHASE I PHASE III

Department of Medicines Policy and Standards September 2007 – Good Governance for Medicines 12 Implementation of National GGM Programme Strengthening systems by increasing transparency and accountability Promoting awareness (general public & health professionals) ìDissemination of information (newsletter, website, etc.) ìSocial marketing (radio, TV jingles, posters, etc.) ìCritical thinking and discussions (seminars, conferences) Building capacity (managers and public policy makers) ìTechnical training programme ìLeadership training programme Implementation national GGM programme Communication plan PHASE II PHASE I PHASE III

Department of Medicines Policy and Standards September 2007 – Good Governance for Medicines 13 Bottom-up approach in implementation of project and policy development Phase I (9 countries) Phase II(6 countries) Phase III(4 countries)

"Corruption is a powerful force, but it is not inevitable or unavoidable. Diminishing its impact restores diverted resources to their intended purpose, bringing better health, nutrition and education to victims of corruption around the world, and with them, opportunity and hope." Transparency International Department of Medicines Policy and Standards September 2007 – Good Governance for Medicines 14

Department of Medicines Policy and Standards September 2007 – Good Governance for Medicines 15 Group work 1.Do you believe that corruption exists in your country? Isolated cases or permissive culture? 2.What are the most common forms? 3.What are the possible causes? 4.What makes the pharmaceutical sector so vulnerable to corruption? 5.What do you think needs to be done to tackle corruption in the pharmaceutical sector on the long run?