AIDS Medicines and Diagnostics Services (AMDS) …4. Drug delivery times are equally important as drug prices. AMDS partners agreed that they will provide information on drug delivery

AIDS Medicines and Diagnostics Services (AMDS)

Partners and Stakeholders Meeting

Geneva, 12-13 December 2007

Final Report

February 2008

AIDS Medicines and Diagnostics Services (AMDS)

Systems Strengthening and HIV

HIV Department

World Health Organization

2

CONTENT

Acronyms ………………….…………………….…………………………………………………3

Executive Summary……………..…………………………………………………………………4

I. Introduction……………..…………………………………………………………………..8

II. Objectives of the Meeting ………………………………………………………………….8

III. Proceedings of the meeting and action points …………………………………………….8

III.1. Global Price Reporting Mechanism (GPRM) …………………………………….8

III.2. PMTCT ………………...…………………………………………………………..10

III.3. PSM Toolbox………………...……………………………………………………..10

III.4. PSM training………………...……………………………………………………..11

III.5. Handbook of supply management at 1st level health facilities………………......12

III.6. Harmonization of M&E Requirements of ART PSM systems……………….....13

III.7. Forecasting………….……...………………………………………………………13

III.8. Discussion of other new PSM topics……………...………………………………14

ANNEX 1. FINAL AGENDA………………...…………………………...……………………16

ANNEX 2. FINAL LIST OF PARTICIPANTS………………...………………………………20

3

ACRONYMS

AMDS: AIDS Medicines and Diagnostic Service

ART: Antiretroviral Therapy

CDC: Centers for Disease Control and Prevention

CHAI: Clinton HIV/AIDS Initiative

CPS: Contracting and Procurement Service

EDM: Essential Drugs and traditional Medicines

EHT: Essential Health Technologies

ESTHER: Ensemble pour une Solidarité Thérapeutique Hospitalière En Réseau

EXW: ExWorks

FOB: Free on Board

GDF: Global Drug Facility

GMP: Global Malaria Programme

GPRM: Global Price Reporting Mechanism

HBAg: Hepatitis B Antigens

HCV: Hepatitis C Virus

HIV: Human Immunodeficiency Virus

IDA: International Dispensary Association

INSP: Instituto Nacional de Salud Publica

IT: Information Technology

JSI: John Snow Inc.

LMIS: Logistic Management Information System

M&E: Monitoring and Evaluation

MeTA: Medicines Transparency Alliance

MSH: Management Sciences for Health

NPO: National Programme Officer

PMTCT: Prevention of Mother to Child Transmission

PSM: Procurement and Supply Management

SCMS: Partnerships for Supply Chain Management System

SSH: Systems Strengthening and HIV

TA: Technical Assistance

TCM: Technical Cooperation for essential drugs and traditional Medicines

UNAIDS: Joint United Nations Programme on HIV/AIDS

UNDP: United Nations Development Programme

UNICEF: United Nations Children Fund

USG: United States Government

WHO: World Health Organization

WR: WHO Representative

4

EXECUTIVE SUMMARY

AMD partners met on 12-13 December 2007 to take stock of the progress made in procurement and

supply management, exchange PSM experiences and to identify PSM priority areas on which

effective collaboration can be engaged. There were 30 participants representing the following

institutions: Crown Agents, ESTHER, GDF, Global Fund, IDA Foundation, IDA Solutions, JSI,

Missionpharma, MSH, SCMS, UNAIDS, UNDP, UNICEF, UNITAID, WHO/GMP, WHO/PSM,

WHO/TCM, WHO/EHT, WHO/CPS, and WHO/HIV. The following decisions and action points

were taken:

Global Price Reporting Mechanism (GPRM)

1. AMD partners, recognizing the importance of the GPRM, will continue to work together through the provision of procurement data and through the dissemination of the GPRM tool.

2. Partners will, to the extent possible, report EXW or FOB prices to standardize figures reported in GPRM. EXW and FOB will be used interchangeably as the difference between

them is negligible. As the EXW price is the future reporting standard for the price reporting

mechanism of the Global Fund, AMD partners agreed to request manufacturers to quote ex-

works prices, in addition to any other prices and INCOTERMS quoted. The Global Fund

will look at how to facilitate the reporting of ex-works price by countries. Additional

discussion on data harmonization was deferred to follow-up discussions between the

procurement partners and the AMD secretariat. AMD will include in the database and the

GPRM summary report, clear caveats (different INCO terms, pre-qualified versus non-

prequalified products) for using and interpreting data from the GPRM.

3. All partners agreed that GPRM should expand to Malaria and TB products. Relevant partners agreed in principle to provide procurement information related to these products.

However, it was felt that it is important to be selective about which products to add. The

potential benefits generated should be greater than that of the effort associated with the

burden of reporting. The AMD Secretariat will conduct further discussions with GDF, GMP

and the procurement partners to decide on the products to be included.

4. Drug delivery times are equally important as drug prices. AMDS partners agreed that they will provide information on drug delivery times which will be included in the GPRM

database.

5. Production and dissemination of the quarterly GPRM report will be continued with an expanded and updated mailing list, in particular to include all partners and additional

contacts that they would provide. AMD Secretariat will use WRs and EDM NPOs to

disseminate the GPRM reports to nationals.

6. AMD Secretariat was advised to include ACAME (Association des Centrales d'Achats des Médicaments Essentiels) in the partnership.

7. It was decided to verify whether GPRM and other AMD partners websites providing price information refer to one another. If not, cross-referral will be included on our respective

websites and in future print reports. There should be no duplication with other price

reporting databases, in particular the International Essential Drugs Price Indicator (produced

by MSH).

PMTCT kit

1. UNICEF will continue discussion with interested parties: ex. WHO Prevention Unit, SCMS and Stop TB Partnership. SMCS has a PMTCT working group that would like to be

involved. Stop TB through the DOTS strategy has extensive experience with treatment

packages for use at home which will be explored.

5

2. The need to be able to trace the products and their quality in the pack was recommended by partners.

3. UNICEF will take into account the possibility of in-country packaging activities as an option for a decentralized procurement.

4. UNICEF will take into account the fact that PMTCT guidelines are under discussion right now.

PSM Toolbox

1. The AMD Secretariat and its partner organizations will continue to collaborate on this project and will pursue the feasibility to expand its coverage to other diseases.

2. The toolbox will be regularly updated to ensure that new versions of various tools are in the system. The first working group meeting will be held early 2008 to discuss the inclusion of

new PSM tools and the development of the PSM toolbox.

3. IDA Solutions in collaboration with the AMD Secretariat will plan the first working group meeting.

4. The partners will collaborate with the AMD secretariat by providing new and updated products, contributing their experiences in using PSM tools, and participating in the working

group meeting.

5. AMD Secretariat will follow up on the feedback and comments of users to ensure that the toolbox is improved.

6. AMDS will develop a marketing strategy of the toolbox through WHO regional and country offices, and other staff working on PSM at country level.

Technical assistance and PSM training

1. AMD partners will work with academic institutions in the revision of curricula to ensure pre-service PSM training.

2. Partners will share information on past, ongoing and future training and TA activities, as well as summaries on training content and outcome (number of participants and countries)

through the AMD secretariat which will maintain a training calendar on the AMDS Website.

3. Partners are encouraged to share information and collaborate on curricula development and on training workshops.

4. Implementation of the task shifting concept in the in-service training activities will help ensure that all professionals involved in PSM receive an adequate training.

5. Priority areas for training in specific topics were identified and include: quantification, IT/LMIS, M&E and warehousing.

6. Training should as much as possible be combined with in-country technical assistance and should be coupled with supervision.

7. The impact of training activities in term of performance of trainees in their work should be monitored/evaluated

8. AMDS will seek lessons learned from Malaria and GDF experiences on TA/training information sharing. These lessons learned will be sought during the harmonization meeting

with these two departments.

6

Handbook of supply management at 1st level health facilities

1. AMDS and partner organizations will continue to collaborate on this project and to improve its usability at country level. A draft revised version which includes the changes

incorporated in the WHO-OGAC operations manual will be shared with all partners for

comments.

2. Country staff from various levels of the PSM system should be involved in the national adaptation process to ensure that the tool adequately reflects the PSM country needs and

practices.

Harmonization of M&E Requirements of ART PSM Systems

1. SCMS, JSI, MSH, UNDP and IDA Solutions agreed to field test the indicators where possible in their existing programs. EPN will be approached to explore its interest in the

field-testing activity. The field test purpose is to check if the 12 core indicators alone or, if

needed, with a few supplementary indicators (which will be identified during the analysis of

the field test results) capture the performance of the ART-PSM system (effectiveness of the

national PSM system), PSM bottlenecks, the causes underlying these bottlenecks, the effort

required in information gathering, availability of the information required to measure the

indicators, and the views of partners involved in ART PSM systems at country level.

2. Once they are finalized, they will be published, disseminated to partners, to WHO regional and country Offices.

Forecasting

1. An electronic information platform with data used for formulating assumptions and making projections as well as a WHO/UNAIDS baseline on global demand forecasts will be

established.

2. JSI and SCMS will contribute any country ARV forecast in PEPFAR countries, subject to agreement by USG and the country or the implementing partner concerned.

3. It was recommended to perform a reality check by measuring the difference between forecasting data and real consumption data for a defined period. This will require additional

human and financial resources as the triangulation between global forecast and the country

data was found useful but labour intensive.

4. It was recommended to increase the country capacity to do reliable quantification and effective supply plan to avoid ARVs stock out.

5. AMDS will organize a brainstorming meeting with UNAIDS, Futures Institute, JSI and SCMS to discuss methodological approaches and develop a plan of action.

Regulatory data base

This subject was discussed and partners agreed to provide information on ARV regulatory

status. AMD Secretariat will continue effort to validate these data for quality assurance.

Laboratory services

1. Lab items are numerous and create a PSM challenge: EHT has a list of HIV, HCV, HBsAg, malaria, syphilis test kits that have been evaluated and found to meet performance criteria

that would make them suitable for procurement in resource-limited settings by UN

agencies. Various countries usually perform in-country evaluation of assays to assess their

performance at the local situation and derive national testing algorithms.

2. Standardization of lab equipments is tricky as it creates the risk of one supplier dominating the market. A sole supplier would result in lessened competition and incentive to provide a

7

good service and price to the country. Countries should ensure that lab equipments are

sought from pre-qualified suppliers.

3. There is a need for a guidance manual on what sort of tests should be available at different levels of health facilities. The Consensus Meeting on Clinical Laboratory Testing

Harmonization and Standardization (Maputo, 22-24 January 2008) will provide more

information on this issue.

4. JSI agreed to document the experience of national standardization of lab equipments in three countries.

5. EHT is currently preparing a document that will outline generic technical specifications for test kits. This document is a tool to assist people involved in national tender process and

other persons involved in procurement of test kits for HIV, malaria, etc.

6. When the final report and the final clinical laboratory testing harmonization/standardization manual from the above mentioned Consensus Meeting on Clinical Laboratory Testing

Harmonization and Standardization will be ready, AMDS will organize a meeting with the

following objectives: (1) to take stock of the recommendations, the content of the meeting

report, the final clinical laboratory testing harmonization/standardization manual; (2) to be

informed about the results of the JSI case studies in three countries; (3) to be briefed on the

above mentioned document on generic technical specifications from EHT and (4) to use the

recommendations from Maputo and other lessons learned to address the PSM issues related

to lab items. The following institutions agreed to participate: UNDP, Crown Agents, SCMS,

JSI, MSH, UNICEF, Global Fund, EHT: other potential interested institutions which will be

invited include: the World Bank, CHAI, UNITAID and CDC.

Frequency of the AMDS Partners and Stakeholders Meeting

Partners agreed that the meeting will continue to be annual. Whenever possible,

opportunities around important events will be explored to follow up some agreed

deliverables. The next AMD partners' meeting is scheduled in October 2008.

I. INTRODUCTION

Strengthening procurement and supply management (PSM) of HIV/AIDS medicines and

diagnostics in developing countries requires effective partnership at global, regional and country

levels. The AMD Network has been established for this purpose and meets on annual basis. Since

the last AMD Partners Meeting in May 2006, significant progress has been made in various PSM

projects. AMD partners met on 12-13 December 2007 to take stock of the progress made in

procurement and supply management, exchange PSM experiences and to identify PSM priority

areas on which effective collaboration can be engaged. There were 30 participants representing the

following institutions: Crown Agents, ESTHER, GDF, Global Fund, IDA Foundation, IDA

Solutions, JSI, Missionpharma, MSH, SCMS, UNAIDS, UNDP, UNICEF, UNITAID, WHO/GMP,

WHO/PSM, WHO/TCM, WHO/EHT, WHO/CPS and WHO/HIV. They discussed the following

PSM topics: the Global Price Reporting Mechanism (GPRM), procurement issues in PMTCT, PSM

toolbox, coordination of technical assistance and PSM training workshops, Handbook of supply

management at first level health facilities, Harmonization of M&E requirements for ART - PSM

systems, Forecasting of global ARVs consumption, regulatory data base and laboratory services.

The final agenda and the list of participants are respectively found in annexes 1 and 2.

After a short presentation which highlighted progress and challenges on each of the above

mentioned topics, participants exchanged experiences and made recommendations for further

improvement of PSM system. The decisions and action points listed under each topic in this report

will be part of the work plan 2008-2009.

II. OBJECTIVES OF THE MEETING

1. To take stock of current joint projects (progress and achievements) and agree on future PSM priorities

2. To agree on next steps and involved partners for the implementation of the current and future activities.

III. PROCEEDINGS OF THE MEETING AND ACTION POINTS

The meeting was chaired by Dr Jos Perriëns, Coordinator, HIV/SSH. The opening remarks and

welcome to partners were pronounced by Dr Teguest Guerma, Associate Director, HIV Department.

There were 30 participants representing the following institutions: Crown Agents, ESTHER, Global

Fund, IDA Foundation, IDA Solutions, JSI, Missionpharma, MSH, SCMS, UNAIDS, UNDP,

UNICEF, UNITAID, WHO/GMP, WHO/GDF, WHO/PSM, WHO/TCM, WHO/EHT, WHO/CPS,

and WHO/HIV. The following PSM topics were discussed in the order they are presented in:

III.1. GLOBAL PRICE REPORTING MECHANISM (GPRM)

1) Introduction

Boniface Dongmo Nguimfack made a short introductory presentation of the current status of the

project (searchable database accessible on the WHO website), the main challenges (expansion of

the project to include the malaria and TB drugs) and the suggested next steps. Following the

presentation, there was a plenary discussion and the key points discussed are described below.

9

2) Key discussion points:

1. Standardization of data entry and harmonization of INCO terms 2. Inclusion of products for TB, malaria, diagnosis and prevention 3. The need to strengthen quality assurance of the information in the database 4. The importance of developing a dissemination strategy 5. Quarterly and annual summary GPRM reports 6. The use of GPRM in supporting discussions on access to ARVs (e.g. during missions in

Morocco and Serbia).

7. There was some discussion that GPRM is too narrowly linked to prices. Other PSM important strategic information were suggested.

8. The need for cross-referral between GPRM and other medicines price reports operated by AMD partners.

9. Possible collaboration between GPRM and the DFID-sponsored medicine transparency alliance (MeTA) was mentioned.

3) Decisions and action points

1. AMD partners, recognizing the importance of the GPRM, will continue to work together through the provision of procurement data and through the dissemination of the GPRM tool.

2. Partners will, to the extent possible, report EXW or FOB prices to standardize figures reported in GPRM. EXW and FOB will be used interchangeably as the difference between

them is negligible. As the EXW price is the future reporting standard for the price reporting

mechanism of the Global Fund, AMD partners agreed to request manufacturers to quote ex-

works prices, in addition to any other prices and INCOTERMS quoted. The Global Fund

will look at how to facilitate the reporting of ex-works price by countries. Additional

discussion on data harmonization was deferred to follow-up discussions between the

procurement partners and the AMD secretariat. AMD will include in the database and the

GPRM summary report, clear caveats (different INCO terms, pre-qualified versus non-

prequalified products) for using and interpreting data from the GPRM.

3. All partners agreed that GPRM should expand to Malaria and TB products. Relevant partners agreed in principle to provide procurement information related to these products.

However, it was felt that it is important to be selective about which products to add. The

potential benefits generated should be greater than that of the effort associated with the

burden of reporting. The AMD Secretariat will conduct further discussions with GDF, GMP

and the procurement partners to decide on the products to be included.

4. Drug delivery times are equally important as drug prices. AMDS partners agreed that they will provide information on drug delivery times which will be included in the GPRM

database.

5. Production and dissemination of the quarterly GPRM report will be continued with an expanded and updated mailing list, in particular to include all partners and additional

contacts that they would provide. AMD Secretariat will use WRs and EDM NPOs to

disseminate the GPRM reports to nationals.

6. AMD Secretariat was advised to include ACAME (Association des Centrales d'Achats des Médicaments Essentiels) in the partnership.

7. It was decided to verify whether GPRM and other AMD partners websites providing price information refer to one another. If not, cross-referral will be included on our respective

websites and in future print reports. There should be no duplication with other price

reporting databases, in particular the International Essential Drugs Price Indicator (produced

by MSH).

10

III.2. PMTCT

This topic was introduced by Bianca Kamps (UNICEF). The low coverage of PMTCT in

developing countries was of great concern. In order to increase the coverage, and as part of

UNITAID PMTCT Scale-up, UNICEF is going to test a Mother & Baby (supply) pack. This

endeavour will take into account several issues such as stigma, storage space and management,

individual clinical differences, etc. The target countries include Rwanda, Malawi, India, Zambia, B.

Faso, Cameroon, Cote d'Ivoire, and Tanzania.

The project will take into consideration the following issues: (a) countries might set the requirement

to have all individual items of the pack registered; (b) the packs might take more space to store than

the individual items; (c) preventing facilities from pulling individual items from the packs for which

there is a shortage, making the remainder of the pack worthless.

At the end of the discussion, it was agreed that:

1. UNICEF will continue discussion with interested parties: ex. WHO Prevention Unit, SCMS and Stop TB Partnership. SMCS has a PMTCT working group that would like to be

involved. Stop TB through the DOTS strategy has extensive experience with treatment

packages for use at home which will be explored.

2. The need to be able to trace the products and their quality in the pack was recommended by partners.

3. UNICEF will take into account the possibility of in-country packaging activities as an option for a decentralized procurement.

4. UNICEF will take into account the fact that PMTCT guidelines are under discussion right now.

III.3. PSM TOOLBOX

1) Introduction:

The PSM toolbox project initiated early 2007 has shown a substantial progress during the year. The

first version of toolbox in excel format has been released on the AMDS website early April 2007,

and it has been downloaded more than 1200 times from the site. In December 2007, a new web

based PSM toolbox searchable database was launched on a dedicated website outside the WHO

system. This allowed AMD and the partners to have more flexibility in terms of its design, contents

and accessibility. Kenji Tamura (AMD Secretariat) introduced some of the new functions of the

new website and explained other characteristics such as statistic analysis of country access and the

forum for experience exchange. He indicated that the first working group meeting to discuss the

inclusion of new PSM tools is scheduled early February 2008. A plan to expand the coverage of

toolbox to other diseases such as Malaria and TB is under discussion with the chair of the PSM

working group of the Roll Back Malaria Partnership, and its further development was welcomed.


This tool was well accepted by most of the partners and its success was very much appreciated as an

achievement of partner collaboration. It was suggested by the participating partners to:

1. Update the Toolbox on a regular basis to ensure that new and revised versions are included. 2. Collect and share users' feedback and comments. 3. Market the toolbox through AMDS partners as well as WHO system including WHO

regional and country offices, and other staff working on PSM at country level.

11

3) Decisions and action points:

1. The AMD Secretariat and its partner organizations will continue to collaborate on this project and will pursue the feasibility to expand its coverage to other diseases.

2. The toolbox will be regularly updated to ensure that new versions of various tools are in the system. The first working group meeting will be held early 2008 to discuss the inclusion of

new PSM tools and the development of the PSM toolbox.

3. IDA Solutions in collaboration with the AMD Secretariat will plan the first working group meeting.

4. The partners will collaborate with the AMD secretariat by providing new and updated products, contributing their experiences in using PSM tools, and participating in the working

group meeting.

5. AMD Secretariat will follow up on the feedback and comments of users to ensure that the toolbox is improved.

6. AMDS will develop a marketing strategy of the toolbox through WHO regional and country offices, and other staff working on PSM at country level.

III.4. PSM TRAINING

1) Introduction

PSM training was presented by Clarisse Morris (IDA Solutions). IDA Solutions has developed two

HIV/AIDS related courses. The two curricula are focused on ART PSM and on M&E of ART PSM.

They have the merit of being available in English, French and Portuguese. Next steps are to develop

more in-depth modules on specific topics: warehousing, quantification, information technology etc.

depending on how the needs evolve such as country requests for training in specific PSM areas.

2) Key discussion points

One of the discussion points was the lack of knowledge among partners on the various PSM

training and technical assistance activities conducted by various institutions. The possible

duplication of capacity building efforts was a concern expressed by some. Partners agreed to share

information on training activities and to be more coordinated on PSM activities in particular

capacity building training workshops and technical assistance to countries. Malaria and GDF may

have positive experience to share with AMDS, in term of discussions based on specific themes,

deliverable oriented with clear partner coordination mechanism and clear definition of partners roles.

A second key discussion point was the high staff turnover rate in the health sector in low and

middle income countries. Continuous training efforts will be required to train new recruits. This will

be easier if courses from different partners complement each other. Another way of ensuring

capacity building is pre-service training. Working with academic institutions in the revision of

curricula was highlighted as an approach to ensure pre-service PSM training (ex. MSH with

Makerere University in Uganda). Training modules can be added to the undergraduate curricula of

pharmacists and other staff with PSM responsibilities.

Another issue was the measurement of the impact of capacity building after participants return to

their work. This is especially difficult to measure when people have been trained outside the

country they work in.

12


1. AMD partners will work with academic institutions in the revision of curricula to ensure pre-service PSM training.

2. Partners will share information on past, ongoing and future training and TA activities, as well as summaries on training content and outcome (number of participants and countries)

through the AMD secretariat which will maintain a training calendar on the AMDS Website.

3. Partners are encouraged to share information and collaborate on curricula development and on training workshops.

4. Implementation of the task shifting concept in the in-service training activities will help ensure that all professionals involved in PSM receive an adequate training.

5. Priority areas for training in specific topics were identified and include: quantification, IT/LMIS, M&E and warehousing.

6. Training should as much as possible be combined with in-country technical assistance and should be coupled with supervision.

7. The impact of training activities in term of performance of trainees in their work should be monitored/evaluated

8. AMDS will seek lessons learned from Malaria and GDF experiences on TA/training information sharing. These lessons learned will be sought during the harmonization meeting

with these two departments.

III.5. HANDBOOK OF SUPPLY MANAGEMENT AT 1ST LEVEL HEALTH FACILITIES

1) Introduction:

The original version of the handbook of supply management at the first level health facilities

(handbook) has been developed in collaboration with AMDS partner organizations. In 2006, the

working document version (zero draft) of handbook was released and field-tested in Uganda and

Lesotho for the English version, and Benin for the French version. Both versions were subsequently

revised based on the inputs from field test and uploaded on the AMD web site in early 2007. Since

then, both versions have been downloaded over 3000 (English) and 2400 times (French),

respectively. Since early 2007, the English version of the handbook has been used as a basis of the

WHO-OGAC operations manual (the chapter 8; supply management). The resulting revised text

will be used to revise the handbook.


Several partners expressed their reservation on the usefulness of some chapters of the document. In

particular certain terms/approaches, including the use of "re-order factor" and "re-order level" are

considered confusing. When using the training tools, the training should be tailored to the local

needs.

3) Decisions and action points:

1. AMDS and partner organizations will continue to collaborate on this project and to improve its usability at country level. A draft revised version which includes the changes

incorporated in the WHO-OGAC operations manual will be shared with all partners for

comments.

2. Country staff from various levels of the PSM system should be involved in the national adaptation process to ensure that the tool adequately reflects the PSM country needs and

practices.

13

III.6. HARMONIZATION OF M&E REQUIREMENTS OF ART PSM SYSTEMS

1) Introduction

The introductory presentation was made by Vincent Habiyambere (AMDS). Participants were

informed that this product dates from October 2005 where a consultation was organized to define a

harmonized approach to report on PSM systems. The objective is to avoid that partners ask different

indicators to nationals. From this consultation and subsequent work, 51 indicators were proposed.

When these indicators were analysed by potential users (facilitators and participants) who were in

IDA Solutions M&E PSM training courses, they came up with 12 core indicators and 31

supplementary indicators which are ready for field testing.


Partners suggested that the availability of information required for measuring these indicators be

checked and that the objectives for using these indicators (satisfying the donor reporting

requirements and measuring the performance of the national ART PSM systems) be clear in the

document.


1. SCMS, JSI, MSH, UNDP and IDA Solutions agreed to field test the indicators where possible in their existing programs. EPN will be approached to explore its interest in the

field-testing activity. The field test purpose is to check if the 12 core indicators alone or, if

needed, with a few supplementary indicators (which will be identified during the analysis of

the field test results) capture the performance of the ART-PSM system (effectiveness of the

national PSM system), PSM bottlenecks, the causes underlying these bottlenecks, the effort

required in information gathering, availability of the information required to measure the

indicators, and the views of partners involved in ART PSM systems at country level.

2. Once they are finalized, they will be published, disseminated to partners, to WHO regional and country Offices.

III.7. FORECASTING

1) Introduction

This subject was introduced by Françoise Renaud-Thery (AMDS) and Robert Greener (UNAIDS).

A forecasting working group, consisting of UNAIDS, CHAI, INSP, SCMS, JSI and UNICEF was

formed and a baseline demand forecast for ARV drugs in low and middle income countries, 2007-

2008 has been published and discussed during an annual meeting with industry (R&D, Generic, and

API producers) and technical partners. The main challenges faced include: limitation in availability

of data to formulate the assumptions, data not being in the public domain or not easily accessible

from one central location. The main next step is the creation of an electronic information platform

for the production of global forecasts.

Possible contributions to an electronic information platform include:

• HIV treatment data with number of patients receiving ART (UA report), WHO treatment guidelines, national treatment guidelines and consumption of ARVs per country.

• Procurement data with data from Global Price Reporting Mechanism, database on regulatory status, and API production capacity data.

• Clinical data with switching rate, loss to follow up, survival rate:

• Prequalification list.

• Baseline rolling ARV forecasts.

14


Partners found that ARV global demand forecasts are useful information for API producers as well

as for finished products producers even if the finished product producers know who will buy when

they have the order. In practice, country level quantifications are based on the number of people

targeted to be on treatment in 2 or 3 years. The reality on the ground in terms of infrastructure,

availability of funds, trained human resources, patients tested, etc. were essential. Based on the

capacity of the service delivery systems (number of treatment sites and number of patients by sites),

a supply plan is developed in such a way an uninterrupted supply is guaranteed. After discussion,

partners agreed on the following:


1. An electronic information platform with data used for formulating assumptions and making projections as well as a WHO/UNAIDS baseline on global demand forecasts will be

established.

2. JSI and SCMS will contribute any country ARV forecast in PEPFAR countries, subject to agreement by USG and the country or the implementing partner concerned.

3. It was recommended to perform a reality check by measuring the difference between forecasting data and real consumption data for a defined period. This will require additional

human and financial resources as the triangulation between global forecast and the country

data was found useful but labour intensive.

4. It was recommended to increase the country capacity to do reliable quantification and effective supply plan to avoid ARVs stock out.

5. AMDS will organize a brainstorming meeting with UNAIDS, Futures Institute, JSI and SCMS to discuss methodological approaches and develop a plan of action.

III.8. DISCUSSION OF OTHER NEW PSM TOPICS

III.8.1 Regulatory data base

This subject was discussed and partners agreed to provide information on ARV regulatory status.

AMD Secretariat will continue effort to validate these data for quality assurance.

III.8.2 Laboratory services

This topic was discussed with great interest by AMDS partners. The following issues were agreed

by partners:

1. Lab items are numerous and create a PSM challenge: EHT has a list of HIV, HCV, HBsAg, malaria, syphilis test kits that have been evaluated and found to meet performance criteria

that would make them suitable for procurement in resource-limited settings by UN

agencies. Various countries usually perform in-country evaluation of assays to assess their

performance at the local situation and derive national testing algorithms.

2. Standardization of lab equipments is tricky as it creates the risk of one supplier dominating the market. A sole supplier would result in lessened competition and incentive to provide a

good service and price to the country. Countries should ensure that lab equipments are

sought from pre-qualified suppliers.

3. There is a need for a guidance manual on what sort of tests should be available at different levels of health facilities. The Consensus Meeting on Clinical Laboratory Testing

15

Harmonization and Standardization (Maputo, 22-24 January 2008) will provide more

information on this issue.

4. JSI agreed to document the experience of national standardization of lab equipments in 3 countries.

5. EHT is currently preparing a document that will outline generic technical specifications for test kits. This document is a tool to assist people involved in national tender process and

other persons involved in procurement of test kits for HIV, malaria, etc.

6. When the final report and the final clinical laboratory testing harmonization/standardization manual from the above mentioned Consensus Meeting on Clinical Laboratory Testing

Harmonization and Standardization will be ready, AMDS will organize a meeting with the

following objectives: (1) to take stock of the recommendations, the content of the meeting

report, the final clinical laboratory testing harmonization/standardization manual; (2) to be

informed about the results of the JSI case studies in three countries; (3) to be briefed on the

above mentioned document on generic technical specifications from EHT and (4) to use the

recommendations from Maputo and other lessons learned to address the PSM issues related

to lab items. The following institutions agreed to participate: UNDP, Crown Agents, SCMS,

JSI, MSH, UNICEF, Global Fund, EHT: other potential interested institutions which will be

invited include: the World Bank, CHAI, UNITAID and CDC.

III.8.3 Frequency of the AMDS Partners and Stakeholders Meeting

Partners agreed that the meeting will continue to be annual. Whenever possible, opportunities

around important events will be explored to follow up some agreed deliverables. The next AMD

partners' meeting is scheduled in October 2008.

16

ANNEX 1: FINAL AGENDA

DAY 1: Wednesday, 12 December 2007

Chairperson: Dr Jos Perriëns, Coordinator HIV/SSH

10:00 – 11:30 : Opening and exchange among partners on new PSM priority areas,

current status and future development of existing collaborative projects

• Opening remarks: Dr Teguest Guerma, Associate Director, HIV Department

• Introduction: self presentation of participants

• Identification of new products for collaboration and joint development

11:30 – 11:45: Coffee break

11:45 – 13:00 : Current status and future development of existing collaborative projects

1. GPRM :

• Introduction of the topic by Boniface Dongmo Nguimfack (AMD Secretariat):

rationale/purpose (why), current progress status, challenges (current or

expected); proposed next steps

• Interventions/contributions from participating partners: CPS; Global Fund;

IDA HIV Group; Global Malaria Programme; Missionpharma; MSH;

SCMS; Stop TB partnership; UNDP; UNICEF; UNITAID

• Plenary discussions on priorities for future developments of the project

2. PMTCT+ :

• Introduction by Bianca Kamps (UNICEF): rationale; potential contributors; expected deliverables

• Plenary discussions

3. PSM toolbox:

• Introduction of the topic by Kenji Tamura (AMD Secretariat):



• Interventions/contributions from participating partners: IDA Solutions, JSI


13:00 – 14:00 : Lunch


(cont'd)

4. PSM training and capacity building:

• Introduction of the topic by Clarisse Morris (IDA Solutions):



• Interventions/contributions from participating partners:


15:30 – 16:00 : Coffee break


(cont'd)

5. Handbook of supply management at 1st -level health facilities

• Introduction of the topic by Kenji Tamura (AMD Secretariat):



• Interventions/contributions from participating partners


6. Harmonization of M&E Requirements of ART PSM systems

• Introduction of the topic by Vincent Habiyambere (AMD Secretariat):



• Interventions/contributions from participating partners


7. Forecasting:

• Introduction of the topic by Françoise Renaud-Théry (AMD Secretariat):



• Interventions/contributions from participating partners: UNICEF, JSI, SCMS,

UNAIDS


19:00 Informal Dinner

DAY 2: Thursday, 13 December 2007

09:00 – 10:30: Discussion of new topics identified on day 1 :

PSM of lab equipment & commodities; regulatory issues; Coordination of

technical assistance and training workshops.

• Introduction by the partner

• Plenary discussions

10:30 - 10:45 Coffee Break

10:45 - 13:00: Discussion of new topics identified on day 1 (cont'd.)

13:00 - 14:00 Lunch

Chairperson: Peter Graaff, Team Leader, AMD

14:00 - 15:00: Group work on of specific joint products:

• GPRM: Harmonization session for data providers (standardization of Inco terms, inclusion of new medicines in GPRM)

• Forecasting

15:00 - 16:00: Group reports and plenary discussions:

• GPRM

• Forecasting

• Other topics: ex. next steps on Harmonization of M&E requirements for PSM

16:00 END OF THE MEETING

_________________________________________________________________________

20

ANNEX 2. FINAL LIST OF PARTICIPANTS

PARTNERS AND STAKEHOLDER

Volker Welter

Procurement Adviser, Office of Legal and

Procurement Support, Bureau of

Management

Email: [email protected]

Ann Janssens

Consultant

Office of Legal and Procurement Support

Bureau of Management

UNDP

Copenhagen

Denmark


Bianca Kamps

Team Leader HIV/AIDS and Malaria

HIV/AIDS and Health Centre

UNICEF Supply Division

UNICEF

Tullinsgade 7, 4 TU

Copenhagen

Denmark


Laurent Lombart

Director, Business Development and

Strategic Marketing

Mission Pharma

Herstd∅stergade 18

Albertstlund

Denmark


Caroline Damour

Pharmacist

ESHTER

36 rue de Charenton

75012 Paris

France

Email. [email protected]

Wendy Eggen

Product Manager

HIV/AIDS, Tuberculosis and Malaria

IDA Foundation

Slochterweg 35

1027 AA Amsterdam

The Netherlands


Clarisse Morris

Technical Officer

IDA Solutions

Westdam 3b

The Nertherlands


Rino Meyers

Manager

Consultancy Department

IDA Solutions

Westdam 3b

The Nertherlands


Claudia Allers

Senior Technical Adviser

John Snow. Inc.

USAID Delivery Project

1616 N. Fort Myer Drive, 11th floor

Arlington, VA 22209

USA

E-mail: [email protected]

David Jamieson

Integrated Supply Chain Management

System

1616 N. Myer Drive, 12th floor

Arlington, VA 22209

USA


Helena Walkowiak

Senior Program Associate

Center for Pharmaceutical Management

Management Sciences for Health

460 East 79th Street, Apt. 14G

New York, NY 10075

USA


Hilary Vaughan

Senior Health Adviser

Crown Agents

St. Nicholas House, St. Road, Sutton

Surrey, SM1 1 EL

United Kingdom

E-mail:

[email protected]

Steen Stottrup

Procurement Data and Reporting Officer

The Global Fund to Fight AIDS,

Tuberculosis and Malaria

Chemin Blandonnet 6-8

1214 Vernier

Switzerland


Robert Greener

Economic Adviser

UNAIDS

20 Avenue Appia

CH-1211 Geneva 27

Switzerland


Jorge Bermudez

Executive Secretary

UNITAID

20 Avenue Appia

CH.1211 Geneva 27

Switzerland


Lorenzo Witherspoon

UNITAID

20 Avenue Appia

CH.1211 Geneva 27

Switzerland


Louise Kleberg

UNITAID

20 Avenue Appia

CH.1211 Geneva 27

Switzerland


Lisa Regis

UNITAID

20 Avenue Appia

CH.1211 Geneva 27

Switzerland


Stephanie Xueref

Global Partnerships Unit - SCMS

Rue Antoine Carteret, 3

1202 Geneva

Switzerland


WHO SECRETARIAT

Sergio Spinaci

Associate Director

Global Malaria Programme Department


20 Avenue Appia

CH-1211, Geneva 27


Silvia Schwarte

Technical Officer

Supply Chain Management

Global Malaria Programme


20 Avenue Appia

CH-1211, Geneva 27


Robert H. Matiru

Manager, GDF

Stop TB Partnership Secretariat


20 Avenue Appia

CH-1211, Geneva 27


John Loeber

Manager, Procurement

Stop TB Partnership Secretariat


20 Avenue Appia

CH-1211, Geneva 27


Hans V. Hogerzeil

Director

Medicines Policy and Standards Department


20 Avenue Appia

CH-1211, Geneva 27


Helen Tata

Technical Officer

Medicines Policy and Supply Management


20 Avenue Appia

CH-1211, Geneva 27


Magali Babaley Technical Officer



20 Avenue Appia

CH-1211, Geneva 27


Helen Moller

Technical Officer



20 Avenue Appia

CH-1211, Geneva 27


Ms Anita Sands

Technical Officer

Diagnostics and Laboratory Technology Team

Department of Essential Health Technologies


Ave Appia 20

CH-1211 Geneva 27

SWITZERLAND


Prof Willy Urassa

Scientist

Diagnostics and Laboratory Technology Team

Department of Essential Health Technologies


20 Avenue Appia

Switzerland

phone +41 22 791 1368

email [email protected]

Françoise Blanche Mas

Procurement Officer

Contract and Procurement Staff


20 Avenue Appia

CH-1211, Geneva 27


Kevin M. De Cock

Director

Department of HIV/AIDS


20 Avenue Appia

CH-1211, Geneva 27


Teguest Guerma

Associate Director



20 Avenue Appia

CH-1211, Geneva 27


Jos Perriëns

Coordinator




20 Avenue Appia

CH-1211, Geneva 27


Peter Graaff

Scientist




20 Avenue Appia

CH-1211, Geneva 27


Françoise Renaud-Thery

Technical Officer




20 Avenue Appia

CH-1211, Geneva 27


Boniface Dongmo Nguimfack

Technical Officer




20 Avenue Appia

CH-1211, Geneva 27


Kenji Tamura

Medical Officer




20 Avenue Appia

CH-1211, Geneva 27


Vincent Habiyambere

Medical Officer




20 Avenue Appia

CH-1211, Geneva 27


Documents

AIDS Medicines and Diagnostics Services (AMDS) …4. Drug delivery times are equally important as drug prices. AMDS partners agreed that they will provide information on drug delivery