1. WHO-Technical Briefing Seminar | October-November 2012 Dr Cécile Macé 1 |1 | Good Governance for Medicines Programme Dr Cécile Macé EMP/MPC

2. WHO-Technical Briefing Seminar | October-November 2012 Dr Cécile Macé 2 |2 | 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 Unethical practices can be found throughout medicines chain Prescription Dispensing Pharmacovigilance R&D priorities Cartels Unethical promotion Thefts Over- invoicing Tax evasion Counterfeit/ substandard Collusion Unethical donations

3. WHO-Technical Briefing Seminar | October-November 2012 Dr Cécile Macé 3 |3 | Why a Good Governance for Medicines Programme? To improve transparency, accountability, effective, efficient and ethical management of pharmaceutical systems To improve the health service delivery to the population in countries through improved access to quality-assured medicines and rational use To avoid wastage or misuse of public or donor funding in the pharmaceutical sector To improve public trust and confidence on health system To support countries to identify, prioritize and mitigate risks To develop guidance to support countries in improving good governance in the pharmaceutical system

4. WHO-Technical Briefing Seminar | October-November 2012 Dr Cécile Macé 4 |4 | WHO Good Governance for Medicines Programme: 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

5. WHO-Technical Briefing Seminar | October-November 2012 Dr Cécile Macé 5 |5 |

6. WHO-Technical Briefing Seminar | October-November 2012 Dr Cécile Macé 6 |6 | 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

7. WHO-Technical Briefing Seminar | October-November 2012 Dr Cécile Macé 7 |7 | Achievements in countries Increased awareness of impact of corruption in the Pharmaceutical Sector and Importance of having Good Governance and Transparency 1.National Assessments done and published 2.GGM incorporated in National Health Agenda by nominating a task force and steering committee to work on framework 3.Increase in political will to implement GGM 4.Collaboration between various stakeholders (MoH, other ministries, anti- corruption commission, NGOs, private sector…)

8. WHO-Technical Briefing Seminar | October-November 2012 Dr Cécile Macé 8 |8 | Achievements in countries Increased Transparency and Accountability in Medicine Regulatory and Supply Systems 1.Various laws, regulations, SOPs created or reviewed/updated 2.Management of conflicts of interest put in place for various committees 3.Information publicly available to increase transparency 4.Whistle-blower protection bill passed, increase in number of corruption cases investigated 5.Increased accessibility of medicines at lower costs 6.Appeal mechanism put in place

9. WHO-Technical Briefing Seminar | October-November 2012 Dr Cécile Macé 9 |9 | Achievements in countries Increased promotion of individual and institutional integrity in the pharmaceutical sector 1.National GGM Framework developed, adopted and published 2.Creation of Code of conduct for people working in the public pharmaceutical sector 3.Continuous training workshops on ethical leadership and GGM at national and regional level 4.Continuous collaboration with other stakeholders 5.GGM included in the curricula of phamacy students

10. WHO-Technical Briefing Seminar | October-November 2012 Dr Cécile Macé 10 | Achievements in countries Institutionalization of GGM 1.In Mongolia, the MoH has designated by law in 2010 the Drug Regulatory Agency to implement GGM 2.In Philippines, the GGM team in the MoH is having a specific budget to conduct activities 3.Still in progress in other countries…

11. WHO-Technical Briefing Seminar | October-November 2012 Dr Cécile Macé 11 | Common challenges faced in implementation Cultural and behavioural: resistance to change, passive attitude or tolerance Political: instability, change in government Managerial: lack staff, rotation, lack of financial resources Structural: more difficult if basic systems not in place Technical: integration in day to day affairs, new subject, access to legislation documents Time: workload, other priorities; GGM not a priority

12. WHO-Technical Briefing Seminar | October-November 2012 Dr Cécile Macé 12 | Key observations and lessons learnt 1.Great interest in subject area 2.A dedicated and motivated national team to tackle the issue 3.Involvement of high-level and technical officials essential 4.Collaboration with key stakeholders 5.Promotion of integrity together with legislative reforms 6.Timeframe different between countries 7.Institutionalization needed for sustainability

13. WHO-Technical Briefing Seminar | October-November 2012 Dr Cécile Macé 13 | Thank you! macec@who.int http://www.who.int/medicines/ggm/en/index.html