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Rasha Hamra, PharmD, MPHMinistry of Health, Lebanon
Antalya, November 17, 2011
Transparency Monitoring Study: A Rapid Assessment of
Transparency in Key Functions of Pharmaceutical Services
in 15 countries
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
PHASE II
Developmentnational GGMprogramme
PHASE III
Implementation national GGM programme
PHASE I
National transparencyassessment
AssessmentReport
GGMofficiallyadopted
Institutiona-lization of GGM
ClearanceMOH
3-Step Approach
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
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
26 countries conducted the Assessment
between 2005 & 2008
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
No. of Countries involved in 2010 analysis, availability of Baseline Data and No. of countries Improved per Function
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)
Results: General Findings (cont)
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
High Priority Functions that need
“Immediate Attention“
Promotion Control of Clinical Trials
Inspection & Selection
Results: General Findings (cont)
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
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
Lessons Learnt (cont)
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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