Transcript WHO Good Governance for Medicines programme Technical Briefing Seminar 3 November 2010, Geneva Dr Guitelle Baghdadi-Sabeti Department of Essential Medicines and Pharmaceutical Policies.

WHO Good Governance for
Medicines programme
Technical Briefing Seminar
3 November 2010, Geneva
Dr Guitelle Baghdadi-Sabeti
Department of Essential Medicines and Pharmaceutical Policies
Corruption requires two parties: the
corrupter and the corruptee
"Whose is the greater blame?
She who sins for pay or he
who pays for sin?"
Sor Juana Inés de la Cruz
Department of Essential Medicines and Pharmaceutical Policies
Good Governance for Medicines 2
What is the definition of corruption?
"The abuse of entrusted power
for personal gain"
Transparency International
Department of Essential Medicines and Pharmaceutical Policies
Good Governance for Medicines 3
Unethical practices can be found throughout
medicines chain
R&D and clinical trials
R&D
priorities
Patent
Unlawful
appropriation
royalties
Counterfeit/
substandard Tax evasion
Conflict
of interest
Manufacturing
Registration
Pricing
Cartels
Selection
Unethical
donations
Collusion
Pressure
Procurement & import
Overinvoicing
Thefts
Distribution
Inspection
Falsification
safety/
efficacy data
Bribery
Prescription
Dispensing
State Capture
Pharmacovigilance
Unethical
promotion
Department of Essential Medicines and Pharmaceutical Policies
Good Governance for Medicines 4
Promotion
Corruption identified as the single greatest obstacle
to economic and social development
 Health and pharmaceutical sectors attractive
targets
 US$ 5.3 trillion spent on health services
annually
"Corruption is a worldwide problem,
 Global
market:
750b
existing
in pharmaceutical
both highand> US$
low No global
estimate on financial
losses, but:
income
countries…
no country
 10 to 25% procurement spending lost into
should feel
offended and restrained
corruption
to talk
about
it".
 Some
countries
report losses:
 2/3 medicines supplies lost in hospitals
Dr H. Hogerzeil, Director, WHO
 10% national expenditures on health care
Department of Essential Medicines and Pharmaceutical Policies
Good Governance for Medicines 5
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

Waste limited public/donor funding

Not stable environment

Not easy to conduct business
 Image and trust impact

Erodes public trust

Reduces credibility of health
profession
Department of Essential Medicines and Pharmaceutical Policies
Good Governance for Medicines 6
WHO Good Governance for Medicines
Programme: an innovative initiative
 Goal
 To contribute to health systems strengthening and
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
Department of Essential Medicines and Pharmaceutical Policies
Good Governance for Medicines 7
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 Essential Medicines and Pharmaceutical Policies
Good Governance for Medicines 8
GGM started as a pilot project in 2004 and
is now a global programme
30
25
20
15
Number of
countries
10
5
0
Department of Essential Medicines and Pharmaceutical Policies
Good Governance for Medicines 9
2004
2005
2006
2007
2008
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 Essential Medicines and Pharmaceutical Policies
Good Governance for Medicines 10
GGM framework
officially
adopted
GGM
integrated
in MOH plan
Bottom-up approach in policy development
lead to the 'GGM technical package'
Country case studies and
compilation of best
practices
Working draft
PHASE I
Department of Essential Medicines and Pharmaceutical Policies
Good Governance for Medicines 11
PHASE II
In process
PHASE III
PHASE I
PHASE II
PHASE III
Summary qualitative findings
Common strengths
Registration
Promotion
Inspection
Selection
Procurement
Areas of improvement
- Written procedures for applications
- Conflict of interest policy
- Operational committees
- Committee composition & TOR
- Provisions exist (major variations)
- Complete provisions to cover all
- No DTCA for prescription-only med.
- Establish responsible unit
- Inspection report required
- Conflict of interest policy
- Reports subject to internal review
- Appeals mechanisms
- Clear criteria for selection process
- Conflict of interest policy
- Committees (multi-discipl. Experts)
- Selection criteria for members
- Written procedures
- Conflict of interest policy
- Well-established tender committees
- Audit results publicly available
Department of Essential Medicines and Pharmaceutical Policies
Good Governance for Medicines 12
PHASE I
PHASE II PHASE III
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 Essential Medicines and Pharmaceutical Policies
Good Governance for Medicines 13
PHASE I
PHASE II
GGM frameworks effective only if translated into
action: some preliminary achievements
 Lower costs for quality medicines procurement
 National pharmaceutical laws, regulations and procedures
revised
 Web-based pharmaceutical activities (registration, licensing)
and information
 Conflict of interest policies developed and implemented
 Integrity and Leadership training programmes for health
officials
 Good governance introduced in University curriculum
 Communications and advocacy campaigns
 Culture of transparency is emerging in institutions
Department of Essential Medicines and Pharmaceutical Policies
Good Governance for Medicines 14
PHASE III
Countries efforts focus on moving from phase I
to phase III
Phase I
(7 countries)
Phase II
(12 countries)
Phase III
Department of Essential Medicines and Pharmaceutical Policies
Good Governance for Medicines 15
(7 countries)
Key observations and lessons learnt
1. Great interest in subject area
(preventive approach appealing)
2. A dedicated and motivated national
team to champion 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
Department of Essential Medicines and Pharmaceutical Policies
Good Governance for Medicines 16
Priorities for 2010 - 2012
 Identify best practices in phase III
countries
 Integrate corruption on the health
agenda (global & countries)
 Institutionalization of the GGM
 Communications strategy
 Monitoring and evaluation
 Training phase III and GGM resources
 Fundraising
Department of Essential Medicines and Pharmaceutical Policies
Good Governance for Medicines 17
"I never worry about action,
but only inaction."
Winston CHURCHILL
Department of Essential Medicines and Pharmaceutical Policies
Good Governance for Medicines 18
A few questions for reflection…
 Do you believe that corruption exists in your country?
Isolated cases or permissive culture?
 What are the most common forms?
 What are the possible causes?
 What makes the pharmaceutical sector so vulnerable to
corruption?
 What do you think needs to be done to tackle corruption
in the pharmaceutical sector on the long run?
Department of Essential Medicines and Pharmaceutical Policies
Good Governance for Medicines 19