WHO Good Governance for Medicines programme Technical Briefing Seminar 3 November 2010, Geneva Dr...
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Transcript of WHO Good Governance for Medicines programme Technical Briefing Seminar 3 November 2010, Geneva Dr...
WHO Good Governance for Medicines programme
Technical Briefing Seminar3 November 2010, Geneva
Dr Guitelle Baghdadi-Sabeti
Department of Essential Medicines and Pharmaceutical Policies
Department of Essential Medicines and Pharmaceutical PoliciesGood Governance for Medicines 2
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 PoliciesGood Governance for Medicines 3
"The abuse of entrusted power for personal gain"
Transparency International
What is the definition of corruption?
Department of Essential Medicines and Pharmaceutical PoliciesGood Governance for Medicines 4
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
Unethical practices can be found throughout medicines chain
Department of Essential Medicines and Pharmaceutical PoliciesGood Governance for Medicines 5
Health and pharmaceutical sectors attractive targets
US$ 5.3 trillion spent on health services annually
Global pharmaceutical market: > US$ 750b
No global estimate on financial losses, but:
10 to 25% procurement spending lost into corruption
Some countries report losses:
2/3 medicines supplies lost in hospitals 10% national expenditures on health care
Corruption identified as the single greatest obstacle to economic and social development
"Corruption is a worldwide problem, existing in both high- and low-income countries… no country
should feel offended and restrained to talk about it".
Dr H. Hogerzeil, Director, WHO
Department of Essential Medicines and Pharmaceutical PoliciesGood Governance for Medicines 6
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
Unethical practices can have significant impact on health systems
Department of Essential Medicines and Pharmaceutical PoliciesGood Governance for Medicines 7
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 PoliciesGood Governance for Medicines 8
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 PoliciesGood Governance for Medicines 9
GGM started as a pilot project in 2004 and is now a global programme
0
5
10
15
20
25
30
2004 2005 2006 2007 2008
Number ofcountries
Department of Essential Medicines and Pharmaceutical PoliciesGood Governance for Medicines 10
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 integrated
in MOH plan
ClearanceMOH
Department of Essential Medicines and Pharmaceutical PoliciesGood Governance for Medicines 11
Bottom-up approach in policy development lead to the 'GGM technical package'
PHASE II PHASE IIIPHASE I
In process
Country case studies and compilation of best
practices
Working draft
Department of Essential Medicines and Pharmaceutical PoliciesGood Governance for Medicines 12
Common strengths Areas of improvement
Registration - Written procedures for applications
- Operational committees
- Conflict of interest policy
- Committee composition & TOR
Promotion - Provisions exist (major variations)
- No DTCA for prescription-only med.
- Complete provisions to cover all
- Establish responsible unit
Inspection - Inspection report required
- Reports subject to internal review
- Conflict of interest policy
- Appeals mechanisms
Selection - Clear criteria for selection process
- Committees (multi-discipl. Experts)
- Conflict of interest policy
- Selection criteria for members
Procurement - Written procedures
- Well-established tender committees
- Conflict of interest policy
- Audit results publicly available
Summary qualitative findings
PHASE IIPHASE I PHASE III
Department of Essential Medicines and Pharmaceutical PoliciesGood Governance for Medicines 13
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 PoliciesGood Governance for Medicines 14
PHASE IIPHASE I PHASE III
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 PoliciesGood Governance for Medicines 15
Countries efforts focus on moving from phase I to phase III
Phase I (7 countries)
Phase II (12 countries)
Phase III (7 countries)
Department of Essential Medicines and Pharmaceutical PoliciesGood Governance for Medicines 16
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 PoliciesGood Governance for Medicines 17
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 PoliciesGood Governance for Medicines 18
"I never worry about action, but only inaction."
Winston CHURCHILL
Department of Essential Medicines and Pharmaceutical PoliciesGood Governance for Medicines 19
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?