WHO Good Governance for Medicines programme MeTA Launch Dr Guitelle Baghdadi-Sabeti
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WHO Good Governance for Medicines programme
MeTA Launch
Dr Guitelle Baghdadi-SabetiGeneva, 21 May 2008
61st World Health Assembly
Department of Medicines Policy and Standards
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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
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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
Unethicalpromotion
Thefts
Fraud
Cartels
Collusion
Unethicaldonations
Unethical practices can be found throughout medicines chain & are very diverse
R&D priorities
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Unethical practices can have significant impact on health systems
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
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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
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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.
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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
Communicationplan
ClearanceMOH
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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
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What could be the components of a national GGM Framework?
1. Ethical framework of moral values & ethical principles
Justice/fairness Truth Service to common good trusteeship
2. Code of conduct
3. Socialization programme
4. Promotion of Moral Leadership
Discipline based approachValues based approach
5. Established anti-corruption legislation
6. Whistle-blowing mechanism
7. Sanctions on reprehensible acts
8. Transparent and accountable regulations and administrative procedures
9. Collaboration with other GG & AC initiatives
10.Management, coordination and evaluation of GGM programme (Steering Committee & task force)
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Bottom-up approach in implementation of project and policy development
Phase I (13 countries)Phase II (10 countries)Phase III (4 countries)
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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
Progress in countriesPHASE IIPHASE I PHASE III
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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
Progress in countriesPHASE IIPHASE I PHASE III
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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
Progress in countriesPHASE IIPHASE I PHASE III
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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
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"I never worry about action, but only inaction."
Winston CHURCHILL