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Good g overnance in the pharmaceutical sector Gilles Forte Deirdre Dimancesco Cécile Macé Department of Essential Medicines and Health Products Side event at the 66 th WHA. Ten leading causes of inefficiency World Health Report 2010, Chapter 4. R&D and clinical trials. Tax evasion. - PowerPoint PPT Presentation
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1 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013
Good governance in the pharmaceutical sector
Gilles Forte
Deirdre DimancescoCécile Macé
Department of Essential Medicines and Health Products
Side event at the 66th WHA
2 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013
Ten leading causes of inefficiencyWorld Health Report 2010, Chapter 4
1. Medicines: underuse of generics and higher than necessary prices formedicines
6. Health-care services: inappropriate hospital admissions and length of stay
2. Medicines: use of substandard andcounterfeit medicines
7. Health-care services: inappropriate hospital size (low use of infrastructure)
3. Medicines: inappropriateand ineffective use
8. Health-care services: medical errors andsuboptimal quality of care
4. Health-care products and services: overuse or supply of equipment,investigations and procedures
9. Health system leakages: waste, corruption and fraud
5. Health workers: inappropriate or costlystaff mix, unmotivated workers
10. Health interventions: inefficient mix/inappropriate level of strategies
3 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013
Inefficiencies and unethical practices can occur throughout the medicines supply chain
Promotion
Conflict of interest
Pressure
Falsificationsafety/
efficacy data
State Capture
Bribery
PatentR&D and clinical trials
Manufacturing
Inspection
Distribution
Registration
SelectionProcurement & import
PricingPrescription
DispensingPharmacovigilance
R&D priorities
Cartels
Thefts Over-invoicing
Tax evasionCounterfeit/substandard
CollusionUnethical donations
Unethicalpromotion
High prices
Waste
Inappropriate use
Losses
4 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013
Why improve good governance in the pharmaceutical sector
To improve health, health service delivery and access to quality and affordable medicines
To contribute to Universal Health Coverage, through reduced inefficiencies, unethical behavior and corruption
To establish relevant structures and processes for efficient implementation of medicines policies and the enforcement of laws and regulations in countries
To increase transparency, accountability and ethical management of pharmaceutical systems
To improve public trust and confidence on the health system and prevent misuse of public, patients and donors funds
5 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013
Common elements of governance relevant to the pharmaceutical sector
TransparencyAccountabilityParticipationConsensusEthicsEfficiency
Information Rule of lawRegulationLeadershipEquityEfficacyPolicy formulation &
planning
6 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013
WHO contribution to good governance in the pharmaceutical sector
Transparency
Participation
Accountability
Efficiency
Policy
Leadership
Ethics
Anti-corruption
Rule of law
Regulation
MeTAGGM
Information
Better access to medicines
7 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013
WHO Good Governance for Medicines programme (GGM)
GoalTo contribute to health systems strengthening and to 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
8 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013
Good Governance for Medicines programme: a model process
PHASE II
Developmentnational GGM
framework
PHASE III
Implementation national GGM programme
PHASE I
Nationaltransparencyassessment
ClearanceMOH
GGM frameworkofficiallyadopted
Assessmentreport
GGM integrated in MoH plan
9 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013
10 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013
National TransparencyAssessment
Assesses transparency and vulnerability to corruption of pharmaceutical systems
Looks at key functions such as:– Regulation: registration, licensing, inspection,
promotion, clinical trials– Supply: selection, procurement, distribution
Elements evaluated:– Regulations and official documents– Written procedures and decision-making
processes– Committees, criteria for membership and conflict of
interest policy– Appeals mechanisms and other monitoring
systems
PHASE IIPHASE I PHASE III
Assessmentreport
11 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013
Development of a GGM Framework"Discipline-based approach"
– Aims to put into place laws, policies and procedures for the pharmaceutical sector and against corruption
– Attempts to prevent unethical and corrupt practices through fear of sanctions on reprehensible acts
"Values-based approach" – Attempts to motivate ethical conduct of public
servants– Promotes institutional and individual integrity
through promotion of ethical principles
PHASE IIPHASE I PHASE III
GGM frameworkofficiallyadopted
12 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013
Implementation of National GGM Programme
1. Increase of information publicly available (regulations, laws, procedures, inspection reports, procurement contracts and tenders, web-based platforms with procurement prices…)
2. Revision of policies and procedures; Operational guidelines developed; Appeal mechanisms put in place
3. Adoption of codes of conduct for people working in the pharmaceutical sector; Development and adoption of policies on conflicts of interest
4. Clarification of TORs and selection criteria for various committees
5. GGM fully institutionalized, funded by government budget and part of the anti-corruption national plan
6. Regular training sessions on ethical leadership and Good Governance at national and regional level
7. GGM included in the curricula of pharmacy students
PHASE IIPHASE I PHASE III
GGM integrated in MoH plan
13 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013
Next steps/Final words
Develop methodologies for assessing good governance interventions and their impact on reducing inefficiencies and on improving access to quality and affordable medicines.
Strengthen WHO support to countries for good governance in pharmaceutical and health systems as a contribution to the achievement of universal health coverage.
Facilitate sharing of experiences among countries and explore synergies with other partners and sectors.
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