Transparency Monitoring Study:
A Rapid Assessment of
Transparency in Key Functions of
Pharmaceutical Services
in 15 countries
Rasha Hamra, PharmD, MPH
Ministry of Health, Lebanon
Antalya, November 17, 2011
Corruption: Barrier to Access
to Quality Essential Medicines

Medicines represent one of the largest components of Health Expenditure;
20-50%

In 2009, the Total Value of the Pharmaceutical Market estimated US$ 837
Billion

Pharmaceutical sector is vulnerable to corruption

Corruption identified as the single greatest obstacle to Economic and Social
Development & to world’s efforts to reach the (MDGs)

Direct Negative impact on quality of health services, wastes limited
resources & erodes public and donors trust

Unsafe medicines on the market  A matter of Life & Death

Poor most affected  Inequalities
The Good Governance
for Medicines programme
Goal:

To contribute to health systems strengthening and prevent
corruption by promoting good governance in the
pharmaceutical sector
SOME of the 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
Good Governance for Medicines
programme: a model process
3-Step Approach
Clearance
MOH
PHASE I
PHASE II
PHASE III
National
transparency
assessment
Development
national GGM
programme
Implementation
national GGM
programme
Assessment
Report
GGM
officially
adopted
Institutionalization
of GGM
Where is GGM Now
GGM started in 2004,
Global Program implemented in 26 countries
across the 6 WHO regions, at different stages
of implementation
+ 5 New Comers in 2010 from EMRO
Phase I of GGM:
National Transparency Assessment
•
Provide countries with:
Level of Transparency and Vulnerability to Corruption in the
Pharmaceutical Sector at the time of the assessment and to measure
progress over time
•
Key functions of the pharmaceutical sector systems
 Regulation: Registration of medicines, Licensing of pharmaceutical
business, Inspection of establishments , Medicine Promotion
& Control of clinical trials

•
Supply: Selection of essential medicines, Procurement &
Distribution of medicines
Elements evaluated:
 Country's 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
26 countries
conducted the
Assessment between
2005 & 2008
Summary of Baseline Data

Common Weaknesses among countries:
-
Include a lack of conflict of interest guidelines for all functions across
pharmaceutical systems
-
Lack of publicly available terms of reference and written selection criteria
for members of various committees
-
Lack of public access to information about the pharmaceutical sector
(legislation, regulations, written procedures)
-
Poor enforcement and implementation of laws and regulations if they are
in place
-
Absence of a responsible unit within medicines regulatory authorities for
monitoring medicines promotion
GGM Monitoring
Transparency Mechanism

To measure progress after six years, WHO decided to assess the
CHANGE in transparency in participating countries and to analyse the
extent of implementation of the recommendations made after the baseline
assessments

The objectives of this first monitoring study are:
1.
To develop and implement a monitoring and evaluation mechanism for
the transparency component of the GGM, and to analyse progress to date
in participating countries
2.
To analyse data on transparency for both baseline and 2010 for countries
participating in the GGM who reported back among the 26 countries
3.
To provide recommendations for improving GGM policies based on the
findings from these countries & new set of baseline data as of 2010 for
the 8 important pharmaceutical functions
Results: General Findings

15 country out of 26 reported back;
Benin, Bolivia, Cameroon, Costa Rica, Indonesia, Jordan, Lao,
Lebanon, Macedonia, Malaysia, Moldova, Mongolia,
Philippines, Thailand and Zambia

The other 11 countries choose not to participate in 2010 analysis for various
reasons: not a priority, change of government, time constraints, change of
GGM focal points, work loads, etc...

In some countries, certain functions were not assessed at baseline due to
adding functions to the instrument at later stages. As a result, comparison of
certain functions in some countries was not possible

Some countries did not complete all functions
Results: General Findings (cont)
No. of Countries involved in 2010 analysis, availability of Baseline Data and No. of countries Improved per Function
16
n° of countries
14
12
10
Baseline
8
2010
6
Improvement
4
2
0
Registration
1
2
Licensing
Inspection
3
CT5
4
Promotion
6
7
8
Procurement
Distribution
Selection

The most significant improvement in pharmaceutical functions was
observed in Selection, Procurement and Registration

Some improvement was observed in Inspection and Promotion as well

Improvements in licensing and Control of Clinical Trials cannot be
assessed as there was complete data for baseline and status for only 3
countries
Results: General Findings (cont)
Conflict of
Interest
Many countries
developed
guidelines on COI &
set Form across all
functions
No rules on
acceptance of gifts ,
reporting of COI ,
protecting informers,
& actions in cases of
failure to comply with
COI
Public
Availability
& Easy
Accessibility
of Documents
Made available laws
& Regulations
Decisions of
committees
(Registration,
Selection)
not publicly available
Terms of
References &
Standard
Operating
Procedures
Developed mainly for
Registration, Selection
& Tender committees
Still lacking for
Licensing &
Promotion committees
Rotation of
Members of
Committees
Adopted in some
countries for
Registration
Committees
Not applicable for
Selection committees
and Inspectors
Still Lacking:
-Independent Appeal Systems for Registration & Procurement
- Complain Systems for unethical practices for promotional activities
-Monitoring systems for performance of procurement office, suppliers & distribution
-Various guidelines on: classifications of GMP & GDP deficiencies, regulations to
prevent capture with inspectors, transportation of medicines from/to warehouses
Results: General Findings (cont)
High Priority
Functions that
need
“Immediate
Attention“
Promotion
Control of Clinical
Trials
Inspection
& Selection
Detailed Results

Indicators Improved per function

Status of Pharmaceutical Functions: Common Strengths & Weakness
in 2010

Country profiles: Vulnerability comparison between baseline & 2010,
Functions improved, High priority functions
Lessons Learnt

Transparency Study enabled policy makers to understand strengths & weakness in
their Pharmaceutical system, set priorities & implement appropriate interventions
in a step-wise approach at different levels and across various functions of the
Public Pharmaceutical Sector

This analysis showed which weaknesses were addressed most and which were
given least attention. The results will be a guide where efforts should be focused

The results of this analysis and future ones will help in identifying agendas for
policy change and setting realistic priorities for action in countries
Lessons Learnt (cont)

Changes were seen where WHO provided technical support: ex: COI
forms

Changes were seen at the MOH level: development of TORs & SOPs, but
no changes in existing Laws, where higher level commitment is needed

Momentum for change is increasing, but speed of progress varies
depending on the country context

The GGM programme is contributing to the movement forward of the
International anti-corruption agenda within the pharmaceutical sector
Implications on Policies to
Improve Use of Medicine

The GGM programme is currently focusing on strengthening the public
pharmaceutical sector to resist corruption from inside and outside, thus
building a system with as few loopholes as possible

Reducing corruption in the pharmaceutical sector will have a lasting impact
on countries’ investment in health care and improve access to quality
medicines for the long term

It will reduce the waste of public and donor funding, as well as out-of-pocket
expenditure, thus better use of resources and contribute to improved access
to medicines for all and especially for the poor and indigent populations

It will improve the credibility of public institutions, which in turn increases
public confidence in governments and in medicine available in the market
and distributed by ministries of health
Future Research

WHO plans to conduct this analysis every 2 to 3 years in order to allow a
consistent assessment and monitoring of transparency and vulnerability of
the pharmaceutical sector

This analysis will expand to include all twenty six countries as well as the
new-comers

Expand the assessment to cover both increase of transparency &
improvement of governance & the other phases of GGM

There is a need not only to monitor policy change but implementation as
well as performance
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