Transcript WHO Good Governance for Medicines programme

WHO Good Governance for Medicines
programme
MeTA Launch
Dr Guitelle Baghdadi-Sabeti
Geneva, 21 May 2008
st
61 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
May 2008 – Good Governance for Medicines 2
Unethical practices can be found throughout
medicines chain & are very diverse
R&D and clinical trials
Evergreening
R&D priorities
Collusion
Patent
Fraud
Manufacturing
Overinvoicing
Registration
Falsification of
safety/Efficacy data
Thefts
Cartels
Pricing
Department of Medicines Policy and Standards
May 2008 – Good Governance for Medicines 3
Unethical
donations
Procurement & import
Unethical
promotion
Pressure
Counterfeit/
substandards
Selection
Conflict
of interest
State/regulatory
capture
Bribery
Tax evasion
Distribution
Promotion
Inspection
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
May 2008 – Good Governance for Medicines 4
Numerous technical guidelines already exist… the
challenge is to balance them with ethical practices
Ethical practices
Technical guidelines

Rule of law

Accountability

Transparency

Participation

Merit system
WHO model list of EM


Good procurement
practices
Evidence-based decisionmaking

Honesty

Ethical criteria


Etc…
Efficiency and
effectiveness

Etc…

GMP

GCP

Counterfeits

Manual on Marketing
Authorization

Department of Medicines Policy and Standards
May 2008 – Good Governance for Medicines 5
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
May 2008 – Good Governance for Medicines 6
Good Governance for Medicines programme:
a model process
Clearance
MOH
PHASE I
PHASE II
PHASE III
National
transparency
assessment
Development
national GGM
framework
Implementation
national GGM
programme
Assessment
report
Department of Medicines Policy and Standards
May 2008 – Good Governance for Medicines 7
GGM framework
officially
adopted
Communication
plan
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
May 2008 – Good Governance for Medicines 8
What could be the components of a national
GGM Framework?
1. Ethical framework of moral
values & ethical principles
5. Established anti-corruption
legislation
 Justice/fairness
6. Whistle-blowing mechanism
 Truth
7. Sanctions on reprehensible
acts
 Service to common good
 trusteeship
2. Code of conduct
3. Socialization programme
4. Promotion of Moral
Leadership
Values based approach
Department of Medicines Policy and Standards
May 2008 – Good Governance for Medicines 9
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)
Discipline based approach
Bottom-up approach in implementation of
project and policy development
Phase I (13 countries)
Phase II (10 countries)
Phase III (4 countries)
Department of Medicines Policy and Standards
May 2008 – Good Governance for Medicines 10
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
May 2008 – Good Governance for Medicines 11
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
May 2008 – Good Governance for Medicines 12
PHASE I
PHASE II
PHASE III
Progress in countries

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Mongolia

Official establishment of national GGM committee
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Regional technical groups (including training)
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Campaigns to promote awareness (educational material)
Philippines

GGM pharmaceutical benchbook
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Awards system for local units
Thailand
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Workshops on GGM framework
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Newsletters, public communications (media, brochures, websites)
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Introduction in university curricula
Bolivia (waiting clearance PoA by MOH)
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Develop national GGM programme (national and regional consultations)
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Orientation meeting for MOH staff
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Campaign for promoting awareness
Department of Medicines Policy and Standards
May 2008 – Good Governance for Medicines 13
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
May 2008 – Good Governance for Medicines 14
"I never worry about action,
but only inaction."
Winston CHURCHILL
Department of Medicines Policy and Standards
May 2008 – Good Governance for Medicines 15