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

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

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

Inefficiencies and unethical practices can occur throughout the medicines supply chain

Promotion

Conflict of interest

Pressure

Falsificationsafety/

efficacy data

State Capture

Bribery

Patent

R&D and clinical trials

Manufacturing

Inspection

Distribution

Registration

Selection

Procurement & import

Pricing

Prescription

Dispensing

Pharmacovigilance

R&D priorities

Cartels

TheftsOver-

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

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

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

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)

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

8 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013

Good Governance for Medicines programme: a model process

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

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 FrameworkDevelopment 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

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 wordsNext 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.