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
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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
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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
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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.
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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.
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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
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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.
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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).
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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.
2) Key discussion points:
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.
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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.
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3) Decisions and action points
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.
2) Key discussion points:
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.
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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.
2) Key discussion points
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.
3) Decisions and action points
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.
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2) Key discussion points
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:
3) Decisions and action points
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):
rationale/purpose (why), current progress status, challenges (current or
expected); proposed next steps
• Interventions/contributions from participating partners: IDA Solutions, JSI
• Plenary discussions on priorities for future developments of the project
13:00 – 14:00 : Lunch
14:00 – 15:30 : Current status and future development of existing collaborative projects
(cont'd)
4. PSM training and capacity building:
• Introduction of the topic by Clarisse Morris (IDA Solutions):
rationale/purpose (why), current progress status, challenges (current or
expected); proposed next steps
• Interventions/contributions from participating partners:
• Plenary discussions on priorities for future developments of the project
15:30 – 16:00 : Coffee break
16:00 – 18:00 : Current status and future development of existing collaborative projects
(cont'd)
5. Handbook of supply management at 1st -level health facilities
• Introduction of the topic by Kenji Tamura (AMD Secretariat):
rationale/purpose (why), current progress status, challenges (current or
expected); proposed next steps
• Interventions/contributions from participating partners
• Plenary discussions on priorities for future developments of the project
6. Harmonization of M&E Requirements of ART PSM systems
• Introduction of the topic by Vincent Habiyambere (AMD Secretariat):
rationale/purpose (why), current progress status, challenges (current or
expected); proposed next steps
• Interventions/contributions from participating partners
• Plenary discussions on priorities for future developments of the project
7. Forecasting:
• Introduction of the topic by Françoise Renaud-Théry (AMD Secretariat):
rationale/purpose (why), current progress status, challenges (current or
expected); proposed next steps
• Interventions/contributions from participating partners: UNICEF, JSI, SCMS,
UNAIDS
• Plenary discussions on priorities for future developments of the project
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
Email: [email protected]
Bianca Kamps
Team Leader HIV/AIDS and Malaria
HIV/AIDS and Health Centre
UNICEF Supply Division
UNICEF
Tullinsgade 7, 4 TU
Copenhagen
Denmark
Email: [email protected]
Laurent Lombart
Director, Business Development and
Strategic Marketing
Mission Pharma
Herstd∅stergade 18
Albertstlund
Denmark
Email: [email protected]
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
Email: [email protected]
Clarisse Morris
Technical Officer
IDA Solutions
Westdam 3b
The Nertherlands
Email: [email protected]
Rino Meyers
Manager
Consultancy Department
IDA Solutions
Westdam 3b
The Nertherlands
Email: [email protected]
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
Email: [email protected]
Helena Walkowiak
Senior Program Associate
Center for Pharmaceutical Management
Management Sciences for Health
460 East 79th Street, Apt. 14G
New York, NY 10075
USA
Email: [email protected]
Hilary Vaughan
Senior Health Adviser
Crown Agents
St. Nicholas House, St. Road, Sutton
Surrey, SM1 1 EL
United Kingdom
E-mail:
Steen Stottrup
Procurement Data and Reporting Officer
The Global Fund to Fight AIDS,
Tuberculosis and Malaria
Chemin Blandonnet 6-8
1214 Vernier
Switzerland
Email: [email protected]
Robert Greener
Economic Adviser
UNAIDS
20 Avenue Appia
CH-1211 Geneva 27
Switzerland
Email: [email protected]
Jorge Bermudez
Executive Secretary
UNITAID
20 Avenue Appia
CH.1211 Geneva 27
Switzerland
Email: [email protected]
Lorenzo Witherspoon
UNITAID
20 Avenue Appia
CH.1211 Geneva 27
Switzerland
Email: [email protected]
Louise Kleberg
UNITAID
20 Avenue Appia
CH.1211 Geneva 27
Switzerland
Email: [email protected]
Lisa Regis
UNITAID
20 Avenue Appia
CH.1211 Geneva 27
Switzerland
Email: [email protected]
Stephanie Xueref
Global Partnerships Unit - SCMS
Rue Antoine Carteret, 3
1202 Geneva
Switzerland
Email: [email protected]
WHO SECRETARIAT
Sergio Spinaci
Associate Director
Global Malaria Programme Department
World Health Organization
20 Avenue Appia
CH-1211, Geneva 27
Email: [email protected]
Silvia Schwarte
Technical Officer
Supply Chain Management
Global Malaria Programme
World Health Organization
20 Avenue Appia
CH-1211, Geneva 27
Email: [email protected]
Robert H. Matiru
Manager, GDF
Stop TB Partnership Secretariat
World Health Organization
20 Avenue Appia
CH-1211, Geneva 27
Email: [email protected]
John Loeber
Manager, Procurement
Stop TB Partnership Secretariat
World Health Organization
20 Avenue Appia
CH-1211, Geneva 27
Email: [email protected]
Hans V. Hogerzeil
Director
Medicines Policy and Standards Department
World Health Organization
20 Avenue Appia
CH-1211, Geneva 27
Email: [email protected]
Helen Tata
Technical Officer
Medicines Policy and Supply Management
World Health Organization
20 Avenue Appia
CH-1211, Geneva 27
Email: [email protected]
Magali Babaley Technical Officer
Medicines Policy and Supply Management
World Health Organization
20 Avenue Appia
CH-1211, Geneva 27
Email: [email protected]
Helen Moller
Technical Officer
Medicines Policy and Supply Management
World Health Organization
20 Avenue Appia
CH-1211, Geneva 27
Email: [email protected]
Ms Anita Sands
Technical Officer
Diagnostics and Laboratory Technology Team
Department of Essential Health Technologies
World Health Organization
Ave Appia 20
CH-1211 Geneva 27
SWITZERLAND
Email: [email protected]
Prof Willy Urassa
Scientist
Diagnostics and Laboratory Technology Team
Department of Essential Health Technologies
World Health Organization
20 Avenue Appia
Switzerland
phone +41 22 791 1368
email [email protected]
Françoise Blanche Mas
Procurement Officer
Contract and Procurement Staff
World Health Organization
20 Avenue Appia
CH-1211, Geneva 27
Email: [email protected]
Kevin M. De Cock
Director
Department of HIV/AIDS
World Health Organization
20 Avenue Appia
CH-1211, Geneva 27
Email: [email protected]
Teguest Guerma
Associate Director
Department of HIV/AIDS
World Health Organization
20 Avenue Appia
CH-1211, Geneva 27
Email: [email protected]
Jos Perriëns
Coordinator
Systems Strengthening and HIV
Department of HIV/AIDS
World Health Organization
20 Avenue Appia
CH-1211, Geneva 27
Email: [email protected]
Peter Graaff
Scientist
Systems Strengthening and HIV
Department of HIV/AIDS
World Health Organization
20 Avenue Appia
CH-1211, Geneva 27
Email: [email protected]
Françoise Renaud-Thery
Technical Officer
Systems Strengthening and HIV
Department of HIV/AIDS
World Health Organization
20 Avenue Appia
CH-1211, Geneva 27
Email: [email protected]
Boniface Dongmo Nguimfack
Technical Officer
Systems Strengthening and HIV
Department of HIV/AIDS
World Health Organization
20 Avenue Appia
CH-1211, Geneva 27
Email: [email protected]
Kenji Tamura
Medical Officer
Systems Strengthening and HIV
Department of HIV/AIDS
World Health Organization
20 Avenue Appia
CH-1211, Geneva 27
Email: [email protected]
Vincent Habiyambere
Medical Officer
Systems Strengthening and HIV
Department of HIV/AIDS
World Health Organization
20 Avenue Appia
CH-1211, Geneva 27
Email: [email protected]