Rasha Hamra, PharmD, MPH Ministry 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 Development national GGM programme PHASE III Implementation national GGM programme PHASE I National transparency assessment Assessment Report GGM officially adopted Institutiona- lization of GGM Clearance MOH 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)

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

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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