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WHO Good Governance for Medicines programme
Technical Briefing Seminar 19 November 2009, Geneva
Dr Guitelle Baghdadi-Sabeti
Department of Essential Medicines and Pharmaceutical Policies
Department of Essential Medicines and Pharmaceutical Policies November 2009 – Good Governance for Medicines 2
Pharmaceutical sectors is a great target to corruption and unethical practices
Conflict of interest
Pressure
BriberyFalsificationsafety/
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
Unethicalpromotion
TheftsOver-
invoicing
Unlawful appropriation
royalties
Tax evasionCounterfeit/substandard
CollusionUnethical donations
Department of Essential Medicines and Pharmaceutical Policies November 2009 – Good Governance for Medicines 3
What is the impact?
Health impact Lack EM in health facilities Unsafe medicines on the market Irrational use of medicines
Economical impact Waste limited public funding Not stable business environment Poor most affected
Image and trust impact Erodes public trust Reduces credibility of health
profession
Department of Essential Medicines and Pharmaceutical Policies November 2009 – Good Governance for Medicines 4
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
Department of Essential Medicines and Pharmaceutical PoliciesNovember 2009 – Good Governance for Medicines 5
WHO Good Governance for Medicines Programme: an innovative initiative
Goal
To strengthen pharmaceutical systems by promoting transparency and integrity.
Specific objectives
To increase awareness of all stakeholders on the potential for unethical practices in the pharmaceutical sector and its impact.
To increase transparency and accountability in medicines regulatory and supply management systems.
To build national capacity for good governance in medicines regulation and supply management systems.
Department of Essential Medicines and Pharmaceutical PoliciesNovember 2009 – Good Governance for Medicines 6
GGM started as a pilot project in 2004 and is now a global programme
0
10
20
30
2004 2005 2006 2007 2008
Number of countries
4
8
11
22
26
Department of Essential Medicines and Pharmaceutical PoliciesNovember 2009 – Good Governance for Medicines 7
Good Governance for Medicines programme: a model process
PHASE II
Developmentnational GGM
framework
PHASE III
Implementation national GGM
programme
PHASE I
Nationaltransparencyassessment
Assessmentreport
GGM frameworkofficiallyadopted
GGM Strategic Plan of Action
ClearanceMOH
Department of Essential Medicines and Pharmaceutical PoliciesNovember 2009 – Good Governance for Medicines 8
Bottom-up approach in policy development lead to the 'GGM technical package'
PHASE II PHASE IIIPHASE I
Department of Essential Medicines and Pharmaceutical PoliciesNovember 2009 – Good Governance for Medicines 9
Common strengths and weaknesses in supply chain
PHASE IIPHASE I PHASE III
Common strengths Areas of improvement
Selection - Use of nal essential medicines lists
- Clear criteria for selection process
- Committees (multi-discipl. Experts)
- Update and dissemination
- Consultation with stakeholders
- Conflict of interest policy
- Selection criteria for members & TOR
Procurement - Formal systems in place
- Written procedures
- Well-established tender committees
- Conflict of interest policy
- Audit results publicly available
- Bribery in tender process
- TOR for committee and members
Distribution - Shelving
- Inventory
- Independent audits
- Coding government medicines
- Gift-giving needed for port-clearing
- Security management (all levels)
- Computerization
- Performance monitoring & evaluation
- Leakages
Department of Essential Medicines and Pharmaceutical PoliciesNovember 2009 – Good Governance for Medicines 10
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
PHASE IIPHASE I PHASE III
Department of Essential Medicines and Pharmaceutical PoliciesNovember 2009 – Good Governance for Medicines 11
PHASE IIPHASE I PHASE III
GGM frameworks effective only if translated into action: some preliminary results
Strengthening systems by increasing transparency and accountability
Increased number of hospitals with best practices in drugs procurement (Thailand)
Amendment of laws, regulations and procedures (COI in Mongolia) Web-based procedures and information (Malaysia, Mongolia,
Thailand)
Promoting awareness (public & health professionals) Dissemination of information & social marketing Critical thinking and discussions
Building capacity (managers and public policy makers) Technical training programme Leadership training programme GGM in University Curriculum
Department of Essential Medicines and Pharmaceutical PoliciesNovember 2009 – Good Governance for Medicines 12
Countries efforts focus on moving from phase I to phase III
Phase I (7 countries)
Phase II (13 countries)
Phase III (6 countries)
Department of Essential Medicines and Pharmaceutical PoliciesNovember 2009 – Good Governance for Medicines 13
Key observations and lessons learnt
1. Great interest in subject area
2. Preventive and constructive approach appealing
3. Assessment can be educational
4. Involvement of high-level and technical officials essential for sustainability
5. Collaboration with key stakeholders extremely valuable
6. Some countries need more time than others
7. Cross-fertilization between countries best learning platform
Department of Essential Medicines and Pharmaceutical PoliciesNovember 2009 – Good Governance for Medicines 14Department of Medicines Policy and StandardsSeptember 2007 – Good Governance for Medicines 14
"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 Essential Medicines and Pharmaceutical PoliciesNovember 2009 – Good Governance for Medicines 15
Thank you!