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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