Transparency Monitoring Study A Rapid Assessment Of Transparency In Key Functions Of Pharmaceutical Services In 15 Countries

Rasha Hamra, Alessandra Ferrario, Maryam Bigdeli & Guitelle BaghdadiWorld Health Organization/Alliance for Health Policy and Systems Research

BackgroundBackground

Corr ption is a major obstacle to strengthening pharmace tical s stemsCorruption is a major obstacle to strengthening pharmaceutical systems.In 2004, WHO launched the Good Governance for Medicine (GGM) programme with the goal of preventing corruption in the public pharmaceutical sector by promoting good governanceTransparent and accountable pharmaceutical sector can improve equitable access to good quality and safe medicine26 countries joined the GGM since 2004 and conducted an in-depth national assessment of the level of transparency and potential vulnerability to corruption as part of the first step of the three-step WHO strategy to improve good governance in the pharmaceutical sectorA standardised transparency instrument was designed to measure transparency in eight functions of the medicine chain at the time of the assessment and to measure progress over timeThe findings of these assessments enabled Ministries of Health and National Regulatory Authorities to identify weaknesses and gaps in the systems and develop strategies to address themTo measure progress after six years since the GGM programme’s inception, WHO decided to assess the change in the level of transparency in participating countries and to analyse the extent of implementation of the recommendations made after the baseline assessments

ObjectivesObjectives

This study will highlight the relevance of sound evidence in formulating pharmaceutical policies aiming at improving Good Governance for MedicinesThe 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 countries2. To analyse data on transparency for both baseline and 2010 for countriesparticipating 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

4. To develop a new set of baseline data as of 2010 for the 8 important pharmaceutical functionspharmaceutical functions

MethodologyMethodology

O i i l t d t d b t 2005 d 2008 i th WHO A tOriginal assessments were conducted between 2005 and 2008 using the WHO AssessmentInstrument allowing the measurement of the level of transparency with respect to different pharmaceutical functions: Registration, Licensing, Inspection, Promotion, Clinical Trials, Selection, Procurement, and DistributionSelection, Procurement, and DistributionA checklist was developed based on the WHO Assessment Instrument Only objective questions requiring Y/N answers were retainedChecklists were populated with data from the baseline assessment and sent to the 26 country GGM focal points to complete the status as of 2010 through desk-reviewsGuidance was provided alongside the checklist. Countries were asked to provide evidence to pgpsupport submitted data

Results IResults I

Fifteen countries participated in this study: Benin, Bolivia, Cameroon, Costa Rica, Indonesia, Jordan, Lao PDR, Lebanon, Former Yugoslav Republic of Macedonia, Malaysia, Republic of Moldova, Mongolia,p , y , p , g ,Philippines, Thailand and Zambia

Th h 11 i h i i i 2010 l i fThe other 11 countries choose not to participate in 2010 analysis forvarious 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 ddi f ti t th i t t t l t t A lt iadding 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 IIResults II

No. of Countries involved in 2010 analysis, availability of Baseline Data and No. of countries Improved per Function

14

16

6

8

10

12

n°of

cou

ntrie

s

Baseline

2010

Registration Inspection CT P t0

2

4

1 2 3 4 5 6 7 8

Improvement

RegistrationLicensing

InspectionPromotion

C

SelectionProcurement

Distribution1 2 3 4 5 6 7 8

The most significant improvement in pharmaceutical functions was observed in Selection, Procurement and Registration, gSome improvement was observed in Inspection and Promotion as wellImprovements in licensing and Control of Clinical Trials cannot be assessed as there was complete data for baseline and status for only 3 countries

Public Pharmaceutical SectorResults III

Public Pharmaceutical Sector

Registration Selection ProcurementPromotionInspection OthersPolicy Change at the Different Pharmaceutical Functions (No. of Countries )

-*COI:Guidelines (7) & F

-Written criteria for selection of

itt

-Provision on Promotion & Ad ti t(3)

-Written Criteria for tender

itt &

-COI:Guidelines &

Distribution:- Setting M t lForms

(9), Enforcement of rules (4)- Written Documents

committeemembers(4)- TORs for committee(5)- *SOPs (5): rules

Advertisement(3):- Guidelines on control of symposia&scientific

committee &rotation of membership(2)- Setting Management

Forms(4), Enforcement of rules (2)- Written*GMP G id li

Master planfor location of medicines,- Security checks &Documents

made publicly available- **TORs for committee (3):

- SOPs (5): ruleson decision makingprocess, Decisions taken

&scientificmeetings, speaker fees,& restrictions ongifts, Enforcement

ManagementInformationSystem(2)- Monitoring Suppliers

Guidelines(2), Measures for non-compliance(4)- Written**GDP

checks, &SOPs for stockmanagement

Licensing:( )Rotation for Members, Set Timeframe, - Formal Appeal S t (2)

independently, minutes produced, & resultsdisseminated

COI f (7)

gof law(4)- Establishment of monitoringcommittee(4)

St d d

ppperformance(3)- Independent Audit(3)

Written GDPGuidelines(2), Measures for non-compliance(3)

Licensing:-Formalcommittee to assessapplicationsSystems (2) - COI forms (7)- Standard

checklist for pre-approval (2)

- Rotation of Inspectors (2)

app cat o s- Guidelines forsubmission*Conflict of Interest

** Terms of Reference*Good Manufacturing Practices**Good Distribution Practices *Standard Operating Procedures

Results IVStatus of Pharmaceutical Sector 2010

Registration Licensing ProcurementPromotionInspection Others

- Updated list of all registered products (13)- Written

Selection:-Official National* EML (14)-Formal Committee

-Legislationscoveringpromotion (14)- Enforcement of

- Written procedures for procurementprocess (11)

- Legislationsdealing with inspection of pharmaceutical

-Legalrequirement to have a license to operate aWritten

procedures for applicants (13)- Written procedures for

for selection EML (15)- TORs&SOPs (11)- Written criteria for selection of

Enforcement oflaws (13)-Laws include: advertising to professionals, pu

process (11)- Written guidelines on specifications of procurement

pharmaceuticalestablishments(15)- SOPs to conduct

to operate apharmaceuticalestablishment(14)-Formal

assessors (13)-Formalcommittees for registration (14)

Written criteria

committee members (10)**CT:- Legal provision to control CT (9)

blic, free samples & labeling - Formal Committee for monitoring

method (13)- Objective quantificationmethod (13)

Tender

inspections (11)-ComprehensiveGMP guidelines (9)

Committee (9)- Written procedures for applicants (10)

Pre & post- Written criteriafor selecting committeemembers (10)-TORs (12)

( )-Formal Committee(9)- Application include: objective, trial design, inclusion &

monitoringpromotion (10)- Pre-approval of promotionalmaterial (10)

- Tendercommittees(12)- Formal appeals for

- Internal Review of inspection reports (11)-Inspection done in teams (9)

- Pre-& post-licensinginspection (13)- Updated list of all licensedTORs (12) g ,

Exclusion criteria, etc (10)

material (10) appeals forrejected bids (9)

in teams (9)- COI guidelines (9)

of all licensedestablishment(11)

*Essential Medicine List **Clinical Trials

Results VStatus of Pharmaceutical Sector 2010

Registration Selection ProcurementPromotionInspection Others

-Decisions of registrationcommittee are

Licensing:-No written criteria for selection of committee members and No

- No written complaintsprocedures to

- No obligation for COI declaration for

-Noclassifications of GDP

- Decisions of the selection committee are

Not made available (10)- No rules on acceptance of

ift ti

members and NoTORs (8)

CT:-No Inspection system for CT (9)

N COI li (10)

report unethical practices (8)- No TORs for committee

b (8)

procurementoffice staff & Tender committee (8)

N t

GDPdeficiencies(7)- No written procedures to prevent

Not made publiclyavailable (9) neither widely di i t dgifts , reporting

of COI (8), protecting informers, & actions in cases

- No COI policy (10)- No publicly available list of approved/rejected CT (10)

members (8)- No SOPs for pre-approval or monitoringpromotion (10)

- No reports on operating costs of procurement office (8)

regulatorycapture with inspectors (9)- No Rotation of inspectors (8)

disseminatedamong health professionals(8)- No Rotationactions in cases

of failure to comply with COI (11)

Distribution:-No written guidelines on transportation & delivery of medicines from/to warehouse (8)

promotion (10)- No COI guidelines (9)

inspectors (8)- No specific Training for inspectors (8)

No Rotationof committee members (8)- No COI guidelines (10)

- No monitoring of performance of distribution system in the country (9)

Results VIResults VI

High Priority Functions thatFunctions that

need“I di t“Immediate

Attention“

Promotion in 7 countries

Control of Clinical Trials

Inspection & Selection in 2 countriesTrials

in 4 countriesin 2 countries

ImplicationsImplications

The changes introduced and documented as a result of the transparencyThe changes introduced and documented as a result of the transparencyassessment will lead countries to increase their acknowledgement of theimportance of good governance.

Positive changes in specific countries can be used as concrete examplesfollowed by others. These examples should encourage to further implementthe recommendations of both the baseline assessment and this analysis so asto improve performance within the pharmaceutical sectorto improve performance within the pharmaceutical sector.

As a result of the initial assessments, countries made efforts to translate someof the key principles of good governance into actions. Increasing

b ki i fi bli l il bl i itransparency by making information publicly available, increasingaccountability through declarations of conflict ofi nterests and by theparticipation of different stakeholders in the various committees were someof the key areas strengthenedof the key areas strengthened.

The results of this analysis and future ones can help countries to identifyagendas for policy change and setting realistic priorities for action. This canb hi d b l i l d i i i d d ibe achieved by applying clear administrative procedures and promotingethical conduct, not only in the pharmaceutical sector but also to expandthese practices and concepts across the entire health system.

Policy Recommendations

A regulatory framework is needed to allow the development of guidelinesand procedures for implementation

A transparent policy dialogue process and communication strategy should bein place among all stakeholders to facilitate policy development andp g p y pimplementation

Guidelines and procedures should be developed to ensure effectivetranslation of policies across all 8 functions

Emphasis should be put on monitoring the application and implementationof guidelines and procedures

ConclusionConclusion

Achievements in GGM countries:

New culture of transparencyNew culture of transparency

More comprehensive and rubust laws and regulationsMore comprehensive and rubust laws and regulations

Introduction of the concept of conflict of interestp

AbstractAbstract

Problem statement: WHO launched Good Governance for Medicine program with goal to contrib-ute to health system strengthening and prevent corruption by promoting good governance: 26 coun-tries joined since 2004. First step was to conduct a national assessment of level of transparency and potential vulnerability to corruption in pharmaceutical sector. A standardized instrument was designed to measure transparency in 8 functions of medicine chain: registration, licensing, inspec-tion, promotion, clinical trials, selection, procurement and distribution. The assessment provides a baseline for countries to revise, adjust their laws, policies, administrative structures and processes. It measures vulnerability in systems at time of assessment and vulnerability scoring can be used to monitor progress over time.

Objectives: Analyze data on transparency for baseline and 2010 status; provide recommendations for improving GGM policies

Design: Comparative analysis between baseline transparency indicators with 2010 status. Indica-tors checklist was developed to collect data for 2010 based on the original Transparency Assess-ment Instrument indicators.

Setting: Public pharmaceutical sector.

Study population: All 26 countries that conducted Transparency assessment initially, were asked to participate on voluntary basis and were sent checklist to fill, but some choose not to participate in 2010 analysis for various reasons; not a priority, short time given to fill the checklist, change of focal points. Data were received from 15 countries: Benin, Bolivia, Cameroun, Costa Rica, Indone-sia, Jordan, Lao, Lebanon Macedonia, Malaysia, Moldova, Mongolia, Philipine, Thailand, and Zambia.

Policies: Initial findings of assessments enabled ministries of health and national regulatory authori-ties to identify weaknesses and gaps in systems and develop strategies to address them. Current study will show which policies were addressed most and which were given least attention.

Outcome measures: Improvement in indicators across the 8 pharmaceutical functions and overall improvement in transparency and vulnerability to corruption of a given function.

Results: Improvement in pharmaceutical functions was most seen in selection, procurement and registration. Some improvement was seen in inspection and promotion as well. Improvement in licensing and control of clinical trials cannot be seen since we had complete data for baseline and status only for 3 countries to compare. Countries’ efforts to improve good governance consisted in making information publicly available, accountability of committee members, and participation of different stakeholders in various committees. Many pre-existing written documents, procedures and guidelines were made publicly available to increase transparency. Some countries worked on devel-oping detailed terms of reference and guidelines for different committees.

Conclusions: Transparency assessment had power to initiate change at different levels and across various functions of the public pharmaceutical sector. Findings of this analysis gave a clear visuali-zation of policy changes in different functions of pharmaceutical systems. The change introduced and documented will lead countries to further acknowledge importance of good governance. Re-sults of this analysis and future ones will help in identifying agendas for policy change and setting realistic priorities for action in the pharmaceutical sector.

Funding source: AHPSR-WHO