Transcript Good governance in the pharmaceutical sector Cécile Macé Department of Essential Medicines and Health Products English Technical Briefing Seminar 30 October 2013 Good Governance in the.

Good governance in the
pharmaceutical sector
Cécile Macé
Department of Essential Medicines and Health Products
English Technical Briefing Seminar
30 October 2013
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Good Governance in the pharmaceutical sector
30 October 2013
Ten leading causes of inefficiency
World Health Report 2010, Chapter 4
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1. Medicines: underuse of generics and
higher than necessary prices for
medicines
6. Health-care services: inappropriate hospital
admissions and length of stay
2. Medicines: use of substandard and
counterfeit medicines
7. Health-care services: inappropriate hospital
size (low use of infrastructure)
3. Medicines: inappropriate
and ineffective use
8. Health-care services: medical errors and
suboptimal 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 costly
staff mix, unmotivated workers
10. Health interventions: inefficient mix/
inappropriate level of strategies
Good Governance in the pharmaceutical sector
30 October 2013
Inefficiencies and unethical practices can occur
throughout the medicines supply chain
R&D and clinical trials
R&D
priorities
Patent
Manufacturing
Counterfeit/ Tax evasion
Conflict
of interest substandard
Registration
Cartels
Inspection
High prices
Selection
Unethical
donations
Pressure
Procurement & import
Collusion
Distribution
Waste
Falsification
safety/
efficacy data
Overinvoicing
Thefts
Pricing
Losses
Bribery
Prescription
Dispensing
Inappropriate
use
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Good Governance in the pharmaceutical sector
30 October 2013
State Capture
Pharmacovigilance
Unethical
promotion
Promotion
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
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Good Governance in the pharmaceutical sector
30 October 2013
Common elements of governance
relevant to the pharmaceutical sector
Transparency
Accountability
Participation
Consensus
Ethics
Efficiency
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Good Governance in the pharmaceutical sector
30 October 2013
Information
Rule of law
Regulation
Leadership
Equity
Efficacy
Policy formulation &
planning
WHO contribution to good governance in
the pharmaceutical sector
GGM
MeTA
Information
Transparency
Leadership
Participation
Ethics
Accountability
Anti-corruption
Efficiency
Rule of law
Policy
Regulation
Better access to medicines
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Good Governance in the pharmaceutical sector
30 October 2013
WHO Good Governance for Medicines
programme (GGM)
 Goal
To 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
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Good Governance in the pharmaceutical sector
30 October 2013
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
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Good Governance in the pharmaceutical sector
30 October 2013
GGM framework
officially
adopted
GGM integrated
in MoH plan
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Good Governance in the pharmaceutical sector
30 October 2013
PHASE I
PHASE II
PHASE III
National Transparency
Assessment
 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:
Assessment
report
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Good Governance in the pharmaceutical sector
30 October 2013
– 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 I
PHASE II
PHASE III
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"
GGM framework
officially
adopted
– Attempts to motivate ethical conduct of public
servants
– Promotes institutional and individual integrity
through promotion of ethical principles
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Good Governance in the pharmaceutical sector
30 October 2013
PHASE I
PHASE II
PHASE III
Proposed components for National GGM
Frameworks
Values based approach
1. Key ethical principles
 Investigation of the truth
Discipline based approach
5. Enforcement of established anticorruption legislation
 Establishment of justice
6. Whistle-blowing mechanism
 Service to the common good
7. Sanctions on reprehensible acts
 Accountable trusteeship
8. Transparent and accountable
regulations and administrative
procedures
 Unity in diversity
2. Code of conduct
3. Socialization programme
4. Promotion of Ethical Leadership
9. Collaboration with other GG & AC initiatives
10.Management, coordination and evaluation of GGM
programme (Steering Committee & Task force)
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12 GGM
Phase II countries
30 October
2013 meeting , Kuwait November 7, 2015
Department of Medicines Policy and Standards
April 2008 – Good Governance for Medicines 12
PHASE I
PHASE II
Implementation of
National GGM Programme
PHASE III
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
management of conflicts of interest
4. Clarification of TORs and selection criteria for various committees
GGM integrated
in MoH plan
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
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Good Governance in the pharmaceutical sector
30 October 2013
Common challenges faced in
implementation
 Cultural and behavioural: resistance to change, passive
attitude or tolerance
 Political: instability, change in government
 Managerial: lack staff, rotation, lack of financial resources
 Structural: more difficult if basic systems not in place
 Technical: integration in day to day affairs, new subject,
access to legislation documents
 Time: workload, GGM not always seen as a priority
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Good Governance in the pharmaceutical sector
30 October 2013
Key observations and lessons learnt
1. Great interest in subject area
2. A dedicated and motivated national team to tackle 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
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Good Governance in the pharmaceutical sector
30 October 2013
Thank you!
[email protected]
http://www.who.int/medicines/areas/policy/goodgov
ernance/en/index.html
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Good Governance in the pharmaceutical sector
30 October 2013