1. World Health Organization
8 April 2017
Good governance in the pharmaceutical sector
Gilles Forte
Deirdre Dimancesco
Cécile Macé
Department of Essential Medicines and Health Products
Side event at the 66th WHA

2. Ten leading causes of inefficiency World Health Report 2010, Chapter 4
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
From the 2010 WHR, out of the 10 leading causes of health system inefficiency, 4 are related to medicines: prices, quality, use and waste. Waste could be attributed to medicines supply chain inefficiencies, unethical practices and corruption. In the WHR 2010, it is estimated that «Reducing unnecessary expenditure on medicines and using them more appropriately, and improving quality assurance, could save countries up to 5% of their health expenditure.»

3. Falsification safety/ R&D and clinical trials
Inefficiencies and unethical practices can occur throughout the medicines supply chain
Conflict of interest
Pressure
Falsification safety/
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
Thefts
Over-
invoicing
Tax evasion
Counterfeit/
substandard
Collusion
Unethical
donations
High prices
Waste
Losses
Promotion
Throughout the various steps of the medicine supply chain, from Research and production and up to prescription and dispensing, inefficiencies, unethical practices and corruption can lead to weaker pharmaceutical systems and waste of financial resources that could have been reallocated to cover more services, more medicines and more people.
Inappropriate
use
Unethical
promotion

4. 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. Common elements of governance relevant to the pharmaceutical sector
World Health Organization
8 April 2017
Common elements of governance relevant to the pharmaceutical sector
Transparency
Accountability
Participation
Consensus
Ethics
Efficiency
Information
Rule of law
Regulation
Leadership
Equity
Efficacy
Policy formulation & planning
There is no ideal/universal definition of Good Governance
Selection of Good Governance elements is based on established hypothesis (e.g. MeTA); country contexts and priorities; and on principles and values

6. WHO contribution to good governance in the pharmaceutical sector
World Health Organization
8 April 2017
GGM
MeTA
Leadership
Ethics
Anti-corruption
Rule of law
Regulation
Transparency
Participation
Accountability
Efficiency
Policy
Information
Currently WHO is implementing two programmes to improve transparency and good governance in the pharmaceutical sector
The Good Governance for Medicines Programme (GGM)
The Medicine Transparency Alliance (MeTA) in collaboration with HAI. These two programmes have in common 5 core elements, meanwhile other elements are programme specific e.g. Ethics, Rule of law etc.
WHO integrates transparency and good governance into the work done on pharmaceutical policies in countries e.g. EC partnership
Better access to medicines

7. 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
Today we will focus on the Good Governance for Medicines programme, called GGM

8. Good Governance for Medicines programme: a model process
PHASE II
Development
national GGM
framework
PHASE III
Implementation
programme
PHASE I
National
transparency
assessment
Clearance
MOH
GGM integrated
in MoH plan
GGM is a 3 phase model: Phase I for carrying out a National Transparency Assessment and assess vulnerability to corruption; Phase II for the development of a national GGM Framework/programme and Phase III for implementation of the GGM programme in the country.
Assessment report
GGM framework
officially
adopted

9. World Health Organization
8 April 2017
Today 36 countries are implementing GGM: 13 countries/territory in Phase I, 11 countries in Phase II and 12 countries in Phase III. Both, Malawi and Thailand are in Phase III.

10. National Transparency Assessment
PHASE II
PHASE I
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:
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
Assessment report
National transparency assessments available (33 countries) and published (17 countries)

11. Development of a GGM Framework
PHASE II
PHASE I
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"
Attempts to motivate ethical conduct of public servants
Promotes institutional and individual integrity through promotion of ethical principles
GGM Phase 2 is about the development of a national GGM framework or policy which is carried out through a national consultative process involving key stakeholders. Task forces and steering committees including other stakeholders (MoH, other ministries, anti-corruption commission, NGOs, private sector) are put in place to develop national frameworks. National framework identifies interventions necessary to address gaps identified in the Transparency Assessment.
GGM framework
officially
adopted

12. Implementation of National GGM Programme
PHASE II
PHASE I
PHASE III
Increase of information publicly available (regulations, laws, procedures, inspection reports, procurement contracts and tenders, web-based platforms with procurement prices…)
Revision of policies and procedures; Operational guidelines developed; Appeal mechanisms put in place
Adoption of codes of conduct for people working in the pharmaceutical sector; Development and adoption of policies on conflicts of interest
Clarification of TORs and selection criteria for various committees
GGM fully institutionalized, funded by government budget and part of the anti-corruption national plan
Regular training sessions on ethical leadership and Good Governance at national and regional level
GGM included in the curricula of pharmacy students
GGM integrated
in MoH plan
Translation of the GGM national frameworks into action. Institutionalization and fully integrated within the MoH. 13 countries in Phase III, implementation of GGM, including Malawi and Thailand.
Examples of countries by activity
1- Mongolia and Thailand
2- Lebanon and Philipinnes
3- Malaysia, Jordan, Thailand
4- Mongolia, Malawi
5- Thailand, Philipinnes
6- Malaysia, Mongolia
7- Mongolia, Thailand

13. 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.