Transcript WHO Good Governance for Medicines programme
WHO Good Governance for Medicines programme
MeTA Launch Dr Guitelle Baghdadi-Sabeti Geneva, 21 May 2008 61 st World Health Assembly Department of Medicines Policy and Standards
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
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Unethical practices can be found throughout medicines chain & are very diverse R&D and clinical trials Patent Manufacturing Registration Falsification of safety/Efficacy data Pricing Conflict of interest Fraud Selection Bribery Cartels Procurement & import State/regulatory capture R&D priorities Unethical promotion Evergreening Distribution Collusion Overinvoicing Counterfeit/ substandards Promotion Unethical donations Thefts Pressure Tax evasion Inspection Department of Medicines Policy and Standards
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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 Department of Medicines Policy and Standards
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Numerous technical guidelines already exist… the challenge is to balance them with ethical practices
Technical guidelines
GMP GCP Counterfeits Manual on Marketing Authorization WHO model list of EM Good procurement practices Ethical criteria Etc…
Ethical practices
Rule of law Accountability Transparency Participation Merit system Evidence-based decision making Honesty Efficiency and effectiveness Etc… Department of Medicines Policy and Standards
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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.
Department of Medicines Policy and Standards
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Good Governance for Medicines programme:
a model process
Clearance MOH PHASE I National transparency assessment Assessment report PHASE II Development national GGM framework GGM framework officially adopted PHASE III Implementation national GGM programme Communication plan Department of Medicines Policy and Standards
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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 Department of Medicines Policy and Standards
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What could be the components of a national GGM Framework?
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Ethical framework of moral values & ethical principles
Justice/fairness Truth Service to common good trusteeship
Code of conduct Socialization programme Promotion of Moral Leadership Values based approach 5.
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Established anti-corruption legislation Whistle-blowing mechanism Sanctions on reprehensible acts 8.
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Transparent and accountable regulations and administrative procedures Collaboration with other GG & AC initiatives 10.
Management, coordination and evaluation of GGM programme (Steering Committee & task force) Discipline based approach Department of Medicines Policy and Standards
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Bottom-up approach in implementation of project and policy development
Department of Medicines Policy and Standards
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Phase I (13 countries) Phase II (10 countries) Phase III (4 countries)
PHASE I PHASE II PHASE III
Progress in countries
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 Department of Medicines Policy and Standards
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PHASE I PHASE II PHASE III
Progress in countries
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 Department of Medicines Policy and Standards
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PHASE I PHASE II PHASE III
Progress in countries
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 Department of Medicines Policy and Standards
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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 Department of Medicines Policy and Standards
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"I never worry about action, but only inaction."
Winston CHURCHILL
Department of Medicines Policy and Standards
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