in English - Roll Back Malaria

MINUTES
RBM/WG/2014/MEET.1
August 2014
Final draft
General distribution
English, French
The 11th Meeting of the
Procurement & Supply chain Management Working Group
(PSM-11)
Geneva, 10-11 June 2014
Contents
1.
ACRONYMS ................................................................................................................................................................. 3
2.
BACKGROUND............................................................................................................................................................. 5
3.
AGENDA AND PARTICIPANTS...................................................................................................................................... 5
4.
OBJECTIVES AND EXPECTED OUTCOMES ................................................................................................................... 5
5.
METHODOLOGY .......................................................................................................................................................... 5
6.
HIGHLIGHTS OF PRESENTATIONS ............................................................................................................................... 5
a.
LLINs and Insecticides for Indoor Residual Spraying (IRS) .......................................................................................... 7
b.
ACTs/ other antimalarials ........................................................................................................................................... 9
c.
Global Demand Forecast ............................................................................................................................................ 9
d.
RDTs .......................................................................................................................................................................... 11
e.
LMIS .......................................................................................................................................................................... 11
f.
PSM bottleneck resolution ....................................................................................................................................... 12
g.
WHO update ............................................................................................................................................................. 13
h.
PSMWG Consensus statement and call for action ................................................................................................... 14
7.
BREAKOUT SESSION SUMMARY AND OUTCOMES + Workstream activities for 2014-2015 .................................... 15
a.
LMIS Workstream ..................................................................................................................................................... 15
b.
PSM bottleneck resolution Workstream .................................................................................................................. 15
c.
LLINs/IRS Workstream .............................................................................................................................................. 15
d.
ACT/other antimalarials Workstream + Global demand forecast Workstream ....................................................... 17
e.
RDTs Workstream ..................................................................................................................................................... 17
8.
OTHER POINTS DISCUSSED & GOVERNANCE............................................................................................................ 18
a.
Next PSMWG meeting .............................................................................................................................................. 18
b.
Election of co-chairs ................................................................................................................................................. 18
c.
Conflict of interest .................................................................................................................................................... 18
9.
NEXT STEPS ............................................................................................................................................................... 18
10.
CALENDAR OF EVENTS .......................................................................................................................................... 18
11.
ANNEX 1: LIST OF PARTICIPANTS .......................................................................................................................... 19
12.
ANNEX 2: AGENDA OF PSM-11 ............................................................................................................................. 21
13.
ANNEX 3: MEMBERSHIP OF THE PSMWG ............................................................................................................ 23
2
1. ACRONYMS
ACT
AEDES
AMP
APLMA
AQ
AS
BCG
CAMEG
CCM
CHAI
DFID
ERP
FDC
FIND
GF
GMP
HWG
IFU
IMDRF
IR
IRM
IRS
ISO
ITMA
JSI
KPI
LLIN
LMIS
MC
MIT
MMV
MSH
NFM
NGO
NMCP
OECD
PCR
PMI
PQ
PR
PSM
PSMWG
Q&A
QA
QC
Artemisinin-based combination therapy
European Agency for Development and Health
Agence de Medecine Preventive
Asia Pacific Leaders Malaria Alliance
Amodiaquine
Artesunate
Boston Consulting Group
Centrale d’Achat des Médicaments Essentiels et Génériques du
Burkina Faso
Country Coordination Mechanism
Clinton Health Access Initiative
Department for International Development UK
Expert Review Panel mechanism of the Global Fund
Fixed dose combination
Foundation for Innovative New Diagnostics
The Global Fund to Fight AIDS, Tuberculosis and Malaria
WHO Global malaria programme
Harmonization Working Group
Instruction for Use
International Medical Device Regulators Forum
Insecticide resistance
Insecticide resistance monitoring
Indoor Residual Spraying
International Standard Organization
Institute of Tropical Medicines of Antwerp
John Snow Inc.
Key Performance Indicator
Long lasting insecticidal mosquito net
Logistics Management Information System
Malaria Consortium
Massachusetts Institute of Technology
Medicines for Malaria Venture
Management Sciences for Health
New Funding Model of the GF
Non Governmental Organization
National Malaria Control Programme
Organization for Economic Co-operation and Development
Polymerase Chain Reaction
President's Malaria Initiative
Prequalification (WHO)
Principal Recipient of the Global Fund
Procurement and supply chain management
The Procurement and Supply chain Management working group of
RBM
Question and answer
Quality assurance
Quality control
3
RBM
R&D
RDT
RFI
SMC
SSFFC
SP
SRN
SSA
TA
TBD
TRP
UNDP
UNICEF
USAID
VC
VCWG
WARN
WHO
WHO/IST
WHOPES
WS
Roll Back Malaria Partnership
Research and Development
Rapid diagnostic test
Request for Interest
Seasonal Malaria Chemo-prevention
Substandard/spurious/falsely labelled/falsified and counterfeit
Sulphadoxine-Pyriméthamine
Subregional Network of RBM
Sub-Saharan Africa
Technical Assistance
To be determined
Technical Review Panel
United Nations Development Programme
United Nations Children's Fund
United States Agency for International Development
Vector Control
Vector Control Working Group
RBM sub-regional network for West Africa
World Health Organization
WHO Inter-country Support Team
World Health Organization Pesticide Evaluation Scheme
Workstream
4
2. BACKGROUND
Since 2006, the Procurement & Supply Chain Management Working Group (PSMWG) has contributed to
enhance and coordinate the efforts of Roll Back Malaria partners, including countries, particularly through addressing
challenges related to the procurement and the supply chains of malaria health products. The PSMWG, based in
Geneva, focuses on the following five PSM challenges: i) technical assistance to countries, ii) coordination of
forecasting and quantification of health products for prevention, treatment, and raw materials, iii) resolution of
quality assurance/quality control issues, in particular regarding product selection and supply chain management, iv)
production, updating and dissemination of tools, best practices, information and v) advocacy for resource
mobilization for in-country PSM operations.
To take stock of the progress made on PSMWG activities and re-orient priorities in the light of current
challenges, the PSMWG regularly convenes meetings bringing together partners from all constituencies: NGOs for the
North and the South, private sector, foundations, research and academia, multilateral development partners, OECD
donor countries and malaria endemic countries.
3. AGENDA AND PARTICIPANTS
The agenda and list of participants for this meeting are attached in Annexes 1 and 2.
50 participants from 35 partner institutions attended the meeting.
4. OBJECTIVES AND EXPECTED OUTCOMES
The objectives of PSM-11 were
 to review the progress of the 2014 PSMWG workstreams’ activities and develop next steps.
 to review the 2015 PSMWG work plan and priority activities, timelines and budget
5. METHODOLOGY
The two-day meeting, held in Geneva on June 10-11 2014, was designed with plenary and breakout sessions.
Plenary sessions were dedicated to updating participants on the progress of each PSMWG workstream and short
updates from partners. Breakout sessions on specific themes were undertaken on the second day, allowing smaller
groups to debate current topics of particular interest. Summaries of these discussions were presented and discussed
in the following plenary session. Breakout sessions were as follows:
 Group A: Logistic Management Information System (LMIS), PSM bottleneck resolution and Helpdesk.
 Group B: Quality Control issues of LLINs & Insecticides
6. HIGHLIGHTS OF PRESENTATIONS
For full details, please note that all the presentations of the PSM-11
http://www.rollbackmalaria.org/mechanisms/psmwg.html and click on the tab “meetings”.
are
available
at
By way of introducing the meeting, the PSMWG Co-chairs reminded the audience of the groups’ composition, terms
of reference and mandate. The PSMWG, as of June 2014, comprises 166 people representing 67 partner
organisations (compared to 147 and 54 in 2013). See Annex 3 for organizations members of the PSMWG.
A mapping exercise of activities of PSMWG members is being undertaken to facilitate communication and allow
partners to better understand each other’s roles and activities. A draft survey was shown and a pilot will be run
before all PSMWG partners are encouraged to respond to the survey, which will take less than 15 minutes to
complete.
5
The 2014-2015 RBM Strategic objective for PSMWG is to Improve global, country and local availability of affordable,
quality commodities for the control and elimination of malaria. To reach this objective, the PSMWG has developed a
Workplan for 2014 and 2015 with priority activities that will be undertaken based on funds available today and
tomorrow thanks to the efforts of PSMWG for resource mobilization.
For 2014, the RBM Board has allocated 70,000 USD to the PSMWG. The table below shows the PSMWG high priority
activities to be undertaken in 2014 with the 70,000 USD.
Activities
Workstream or partners responsible
Activity budget
received
1.
Joint RBM-GF Workshop on Logistic
Management Information System
(LMIS) for 47 Sub-Saharan African
countries
Information/knowledge and PSM bottleneck resolution
workstreams
in collaboration with The Global Fund, Countries through
their GF grant, WHO/HQ, AFRO, WHO/IST, UNICEF,
AEDES, I+solutions, CHAI, JSI, MSH, PSI, USAID/Deliver,
Empower school of health, SRNs, RBM secretariat
40,000$
2.
PSM-11,
meeting
PSMWG
30,000$
3.
Conference on Artemisinin market
intelligence in Asia
ACT/Antimalarials Workstream
in collaboration with UNITAID, The Global Fund, PATH
0$
Budget conference already
funded by Global Fund, PATH
and UNITAID
annual
Workplanning
70,000$
In 2013, PSMWG Workstreams were restructured as shown in the slide below. The PSMWG co-chairs made a plea for
second workstream leads for the LLIN/IRS, ACTs/other anti-malarial and PSM Bottleneck resolution workstreams.
A call was also made for external funding and contributions (in kind/time) from partners for implementation of
PSMW activities.
6
In addition to the activities mentioned above, the co-chairs represented the PSMWG in various venues; by holding
the Market place stand at the May RBM Board meeting; at the World Malaria Day 2014 event in India and in
promoting quality of insecticides and promoting quality of antimalarial commodities in the Asia Pacific region during
APLMA meeting in March 2014..
Highlights of the plenary presentations are as follows:
a. LLINs and Insecticides for Indoor Residual Spraying (IRS)
1. The Global Fund’s LLIN procurement strategy, Procurement for Impact (P4i), aims at having long term contracts
with suppliers for better visibility and more stability in the market. The Tender evaluation is done both on
commercial (Price, production capacity, volume discounts) and non-commercial factors (plant ownership,
customer history, delivery performance, quality performance and a narrative on innovation and additional
services). Local production is a factor that is considered in evaluating bids, but without compromise on price and
quality, which must be at international standards. The Global Fund, like the PSM WG, supports LLIN durability
studies.
The LLIN tender (90M LLINs forecasted) organised in 2013, has reduced the weighted average price for the most
common LLIN by 8.2%, reduced fees and pooled commitments up to 80M. The Global Fund will be more
proactive with PRs and their demand/forecasting but it is encouraging to note that so far there has been little
deviation between the forecast and actual procurement volumes.
Next steps include:
 monitoring raw material prices
 monitoring delivery/quality performance,
 coordinating the 2015 forecast and allocation.
2. IRS pooled procurement was undertaken for 6 countries with short delivery timelines (average ~20 weeks) for a
range of 5 products. Concerns around IRS insecticides include the limited number of manufacturers for certain
formulations especially outside pyrethroids, as shown in the slide below.
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3. Regarding quality challenges, 5 out of 9 orders through the Pooled Procurement Mechanism, insecticides ordered
(and WHOPES approved) did not pass QC tests which look at all quality criteria defined for these products, not
just presence of the active ingredient. Existence of these poor quality IRS products have impacts on the IRS
planning because products have to be replaced (delaying implementation, possibly missing the spraying season)
as well as financial (product replacement, emergency transport by air rather than ship) and on the reputation of
the supplier.
The Global Fund held a supplier meeting in Geneva in April 2014 where they discussed current procurement
practices and challenges as well as future plans and next steps. Challenges include: Timely procurement of
appropriate insecticide; quality failures of insecticides that have delayed LLIN deliveries and IRS in countries;
Limited number of WHOPES approved IRS formulations; Long lead times; Limited local capacity and systems to
sustain the IRS effort; Higher cost of new compounds resulting in programme size reduction; Manufacturers
desire longer term agreements.
The way forward was mapped out as the following 5 points:
 discuss and improve IRS product specifications & quality testing protocols;
 Work towards increasing the range of WHOPES approved IRS products and the number of qualified quality
control laboratories (It is not enough to be ISO certified, it is equally important to have certification for the
scope of work for IRS products);
 Improve forecasting & identify opportunities to foster collaboration to optimize the balance between quality,
lead times and price;
 Better management of the IRS equipment and
 Bring these actions together into the GF procurement strategy.
The need for QC for sprayers and for trainings for teams in charge of IRS campaigns was also flagged.
4. Implications for procurement of whether LLINs and IRS should be combined were presented by Abraham Mnzava,
WHO/GMP. There is no evidence that combining IRS with LLINs in areas of high LLIN coverage reduces malaria
8
burden. IRS and LLINs should only be combined when managing insecticide resistance and essentially with a nonpyrethroid. Thus, Malaria Control programmes should deliver either IRS or LLINs at high coverage. These
interventions should not be used jointly as a means to compensate the deficiencies of one or the other.
Programmes that are currently implementing both should evaluate the effectiveness of the two interventions –
evidence is needed in this regard. On managing old LLINs, Control Programmes are advised not to collect them
unless i) they are being replaced, ii) regulations are in place for their disposal and iii) these efforts do not divert
attention from core control measures like maintaining universal coverage.
b. ACTs/ other antimalarials
1. This workstream updated the group on various efforts relating to Seasonal Malaria Chemoprevention (SMC) and severe malaria, noting that ~1M children covered in 6 countries in 2013
Two SP-AQ presentations manufactured by Guilin have ERP approval through Dec 2014
75mg AQ (x3) + (250mg/12.5mg) SP (x1) – for 3-11 month olds
150mg AQ (x3) + (500mg/25mg) SP (x1) – for 12-59 month olds
The Request For Interest (RFI) for a second prequalified manufacturer is now on MMV website.
RBM WARN is leading the development of roadmaps and the quantification there-in of SMC drugs and funding
demand; 10 key countries have plans for 2014 and timing is critical for the ~3million children that could benefit.
UNITAID Board approved a grant up to $67M for scale up of SMC: ACCESS-SMC project led by Malaria Consortium.
MMV have developed with the support of partners, including countries, WARN and CARN, an SMC toolkit
available online at http://www.mmv.org/access/areas-work/seasonal-malaria-chemoprevention-tool-kit.
2. The update on severe malaria noted that Guilin remains the sole WHO-prequalified provider of injectable
artesunate: 60mg approved in Nov 2010; 30mg and 120mg approved in May 2013. A second facility with double
capacity will come into production in 2014.
MMV, CHAI and MC are working with six country programs to prepare for procurement and introduction of
injectable artesunate. The Global Fund is harmonizing its emergency requirements in two of those six countries.
It’s important to match training and drug delivery schedules for rational use. Securing waivers on import taxes
supports speedier delivery – cf MOU agreements between MMV’s in-country partners and government
counterparts.
3. The RBM – PSMWG Artemisinin Conference will be held on 23-24 Sept 2014 in Guangzhou with the support of
UNITAID, GF and PATH. This meeting is typically attended by artemisia growers, extractors, manufacturers,
donors and other partners. The conference aims to assess the current status of the market and discuss the way
forward – including forecasts. Among the issues expected to be hot topics for discussion are the limitations and
anticipated challenges such as artemisinin resistance, impact of the rollout of diagnostics on artemisnin needs
and the arrival of new drugs. As in previous years, the delegates will also discuss prices and market dynamics,
how to reduce and stabilize prices, as well as traditional vs semi-synthetic productions. For more details, contact
[email protected]
c. Global Demand Forecast
1. Key messages from the ninth and final report (dated 24 Feb 2014, www.unitaid.eu/actforecasting) of the BCG,
CHAI, MITz, RBM forecasting consortium were presented. Lack of data on funding for ACT procurement is the
9
main factor for the uncertainty of the forecasts of quality-assured ACTs. In 2013, 340M prequalified ACTs were
estimated to be procured – and 367M in 2014 (see slide below), particularly with DFID and PMI financial
commitments while the Global Fund managed its transition to the NFM. There is no global demand forecast for
2015.
2. Some of the countries continuing with a private sector co-payment mechanism in 2014 have adjusted their copayment amounts, for example Uganda has chosen a 50% co-payment for adult and adolescent formulations. An
estimated 161M ACTs (85.1M of which in Nigeria alone) could be procured through the Private Sector CoPayment Mechanism in 2014. There remains some uncertainty around NFM concept notes and private sector copayment. The level of funding is a critical limiting factor of the forecasting model, but support from the RBM
Partnership (HWG, PSM, GF) in relation to the NFM offers a more stabilized and predictable marketplace.
10
d. RDTs
Each component of an RDT kit can impact on use,
performance and compliance to test results.
RDTs vary in:
 Components (e.g. shape of cassette, number of wells,
specimen transfer devices, lancets)
 Procedure (e.g. specimen volume, numbers of buffer
drops, reading time).
 Labeling and terminology for the RDT box and device
 Cassette packaging
 Buffer vials
 Accessories (e.g. type of blood transfer device, lancet)
 Instructions For Use (e.g. content, order)
The differences can contribute to
 Performance issues when end users switch from one
RDT to another;
 Additional training requirements for healthcare workers when new RDTs are used or
 Non-competitive public tenders when product specifications are such that only one or few manufacturers can
participate.
In the RBM – PSMWG stakeholder consultation held at the Institute of Tropical Medicine in Antwerp (December
2013), 66 elements that could be improved and harmonized were identified, 54 of which are low-hanging fruit (easy
to implement and at little or no cost) eg labelling and instructions for use (IFU). Other elements are not feasible at the
moment, being much more difficult and potentially costly, such as buffer and sample volume, reading time and
order/colour of test lines.
Potential benefits of harmonisation could be: Improved procurement and supply management; Reduced training/retraining and supervision requirements; Improved adherence to manufacturer’s and regulators’ recommended
protocols; Increased performance through uniform, easy to follow and consistent labelling and instructions for use
(IFU). As a result, harmonization can contribute to cost savings in procurement through more competitive tenders
and fewer trainings and improved health outcomes through fewer end user errors.
Next steps include:
 preparing recommendations for the RBM Board;
 Discussing implementation & timeline with regulators and donors;
 Organizing 2nd consultation to disseminate recommendations on outstanding proposals (venue TBD- Q3-Q4
2014);
 Discussing how to tackle the outstanding 12 elements that need further evidence/research;
 Consider the applicability of these harmonization efforts for other RDTs.
 Some outcomes of this work are feeding into documents and processes like WHO prequalification.
e. LMIS
Very good outcomes from the LMIS workshop in Ouagadougou organized by the RBM-PSMWG in collaboration with
GF, UNAIDS and Stop TB/GDF partnership were presented. 164 participants attended and each of the 28 participating
countries (27 from SSA and Haiti) provided a LMIS self-assessment before the workshop. The objective of the
workshop was that each country develop a draft action plan for strengthening their LMIS for health products by the
end of the 3 days. Technical plenary sessions were followed by group work where peer review processes between
countries were used. Discussions were facilitated by partners and sparked by their self-assessments. A marketplace
was also held, showcasing country and partner LMIS and tools. A visit of the offices and warehouses (8000m2 +
11
380m2 air-conditioned rooms + 160m2 cold rooms) of the new headquarters of CAMEG, the national procurement
agency of essential medicines in Burkina Faso, was organized. The new site has been completely funded by CAMEG.
Considerations of which data need to be collected for a LMIS – and which decisions are to be made based upon them
– were discussed throughout the workshop. Which data need to be reported to higher levels and whether they
should be collected through routine systems, surveys or supervision was also discussed. Integration across disease
programs and of logistics with health information systems was discussed. It was noted how increased transparency
plays into accountability and possibly changing roles and responsibilities.
After the workshop, country teams were encouraged to assign a “whip-cracker” to keep the momentum of
discussions and organise a post-workshop meeting with national key stakeholders to finalise the LMIS strengthening
action plan. The updated LMIS assessment tool will be posted on the RBM website, and the Global Fund has shown
that the LMIS action plans developed in Ouagadougou are facilitating the development of the PSM section of the
NFM concept notes. The workshop was rated 8.1/10 by participants (evaluation questionnaires), with the group work
and some technical sessions rated highest (up to 8.9). In 2015 an LMIS workshop is planned for Asian countries.
f. PSM bottleneck resolution
It has been suggested that having a single point of contact for PSM requests/queries would be beneficial for the RBM
Partnership. This would also allow the number and frequency of such activities to be measured and estimate the
workload and resource needed. Requests/queries come from partners and country, and from other RBM working
groups. These requests/queries concern technical documents, publications, guidelines, PSM tools, PSM trainings but
also people to be contacted for further information on a specific topic or to exchange experiences/lessons learned, or
for Technical Assistance. Questions are mostly related to prequalification of malaria commodities, specifications and
QC of malaria commodities, QC sampling procedures, suppliers and prices but also on how to set up a coordination
committee for quantification of health products, what are the most appropriate assumptions to avoid excess & stock
outs when purchasing HLLIN for mobile populations? etc.
How can we leverage what is already available (toolbox, websites etc..) to best respond to these requests? There are
urgent or emergency requests and other much less urgent and perhaps even repetitive requests that could be part of
a Q&A.
12
g. WHO update
1. The WHO Guidelines for the Treatment of Malaria are currently being updated and the 3rd edition is expected to
be available towards the end of 2014. One new recommendation focusses on the single administration of lowdose primaquine as a gametocytocide in Plasmodium falciparum malaria. At present, an additional WHO policy
brief is being prepared to support country implementation of this recommendation; this briefing will be available
on the WHO/GMP web page in the 3rd quarter 2014.
2. The WHO policy recommendation on malaria diagnostics in low transmission settings was presented. Most
malaria infections (microscopic and sub-microscopic) should be considered as potentially infectious and able to
contribute to ongoing transmission. Despite PCR and other nucleic acid amplification-based assays being more
sensitive than diagnosis by microscopy or RDTs, for the clinical management of patients with suspected malaria,
routine surveillance and passive detection in low transmission areas, the use of quality-assured microscopy and
quality-assured rapid diagnostic tests is sufficient. Nucleic acid amplification based diagnostic methods are not
required
for
these
applications.
The
full
policy
recommendation
is
available
at
http://www.who.int/malaria/publications/atoz/who-recommendation-diagnostics-low-transmission-settingsmar2014.pdf.
3. The report on the results of the Round 5 WHO RDT product testing programme is expected to be published soon.
The WHO Information note on recommended selection criteria for the procurement of malaria rapid diagnostic
tests (RDTs) will be updated subsequently; both the current and the updated versions are/will be available via the
following links:
English: http://www.who.int/entity/malaria/publications/atoz/rdt_selection_criteria_en.pdf
French: http://www.who.int/entity/malaria/publications/atoz/rdt_selection_criteria_fr.pdf
4. The list of WHO pre-qualified antimalarial medicines constantly grows, showing a clear trend towards fixed-dose
combinations. Studies on two EMA-reviewed products with regard to the scope of adverse events are currently
being undertaken. A number of medicines recommended by WHO are still not available at pre-qualified standards,
i.e. AQ+SP for seasonal malaria chemoprevention, SP for the intermittent preventive treatment in pregnancy and
rectal AS for the pre-referral treatment of severe malaria in children under five.
5. An update on oral artemisinin-based monotherapies (oAMTs) noted that 9 National Medicines Regulatory
Authorities still allow oAMTs (latest update May 2014), six of them in the African region. At least 30 companies
are still involved in the production and marketing of oAMTs, more than one third of these manufacturers being
located in India, and mainly followed by Nigeria, Pakistan, China (detailed country and manufacturer data
available at the following link:
http://www.who.int/malaria/areas/treatment/withdrawal_of_oral_artemisinin_based_monotherapies/en/
6. In January 2014, the WHO Global Malaria Programme published the latest status report on artemisinin resistance:
foci of artemisinin resistance have been identified in five countries in the Greater Mekong subregion, and
resistance is suspected in two countries and one territory in South America (full report available at
http://www.who.int/malaria/publications/atoz/status_rep_artemisinin_resistance_jan2014.pdf?ua=1).
The continued use of oral artemisinin-based monotherapy is one of the main contributing factors to the
development and spread of resistance to artemisinin and its derivatives. In view of the latest evidence on
artemisinin resistance, intensified action is required to protect the therapeutic life of ACT, which is the mainstay
of treatment for malaria caused by Plasmodium falciparum.
A WHO briefing paper “Emergence and spread of artemisinin resistance calls for intensified efforts to withdraw
oAMTs from the markets” is available at http://www.who.int/malaria/publications/atoz/oral-artemisinin-basedmonotherapies-1may2014.pdf and provides an overview of WHO’s recommended regulatory actions, country
progress to date, and practical guidance to withdraw oAMTs from the market, based on experiences from
successful countries. No alternative medicine is ready to enter the market in the next few years to replace ACT.
13
The recent identification of a molecular marker for artemisinin resistance is expected to facilitate the mapping of
emergence and spread of artemisinin resitance. To particularly address drug resistant malaria In the Asian Pacific
region, the APLMA Taskforce on Access to Quality Medicines and Other Technologies was established to –
amongst other areas of work – halt the use of oAMTs and enhance access to affordable quality medicines.
h. PSMWG Consensus statement and call for action
1. The PSMWG is preparing a consensus statement on PSM planning and financing at country level – an advocacy
document for better PSM to increase investment/funding.
2. A draft call for action on fighting SSFFC medicines was circulated with PSMWG members for comments prior to
the meeting. Questions from the group included “Are we sure we want to mix SSFFC and theft/diversion”? and
why this call for action is only focused on pharmaceuticals and did not include Vector Control or other products.
The WHO has a database to collate data on SSFFC products, currently looking at medicines, vaccines and
diagnostics, in the future may also contain medical devices, pesticides and bednets.
PSMWG Members will be called upon to contribute and finalise these documents before they are sent to the RBM
Board.
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7. BREAKOUT SESSION SUMMARY AND OUTCOMES + Workstream activities for
2014-2015
a. LMIS Workstream
The discussion were focused on the follow up of the LMIS workshop in Ouagadougou, May 2014.
The LMIS self-assessment tool was shown to be useful for organizing discussions at the workshop and comparing
across countries. Feedback from the workshop participants and PSMWG members will help to revise and simplify the
tool. The group discussion also acknowledged that the terminology used in different countries and regions differ, so
the vocabulary in the tool will need to be editable/adaptable to their context.
The mapping of country supply and information systems was seen as a key element for discussion (flow of
commodities and information and then tie key questions to their system).
The LMIS is not a replacement for the national health information system, and its scope needs to be well defined,
because the tool must be a mean for an end; collecting data for decision making.
The idea of helping countries develop a business case as a tool for advocacy for resource mobilisation in support of
LMIS strengthening was tabled. The group also discussed the need to harmonize existing logistic information systems
and highlighted that some disease programmes were not aware of other information systems either for other
diseases or for national reporting.
WS next steps:
 This workstream will support implementation of country LMIS action plans, potential areas were identified as:
Harmonizing donor requirements concerning data to be collected and indicators to be calculated, develop or
update norms for LMIS, advocate and support development or expansion of in-country PSM coordinating
mechanism (potentially the CCM).
 Develop or link countries to existing communities of practice, e.g. e-drug, emed, IAPHL to facilitate crosscountry learning and support;
 Contributing to the consensus statement on planning and funding of PSM and of LMIS specifically.
 The workstream will also be preparing the Asia LMIS workshop, for which key partners will be identified to
understand commonalities and differences with Africa. A similar approach will be taken, with a cross-disease
reach and invitations through the CCM with attention to having the best possible participants attend.
 Continue collaboration with the HWG in support of relevant meetings and workshops for countries for
PSM/LMIS issues.
 PSMWG members are called to contribute to developing the self-assessment tool and the consensus
statement
b. PSM bottleneck resolution Workstream
WS next steps: This group will pilot the questionnaire for mapping PSMWG members activities, support information
sharing of current resources/tools/documents with countries and pursue discussions on RBM-PSM Helpdesk.
c. LLINs/IRS Workstream
In the breakout session participants discussed the development and adherence to minimum vector product
specifications developed by manufacturers in collaboration with WHOPES. The summary of discussions was reported
as:
15
Problem definition:
 Manufacturers collaborate with WHOPES to develop and agree upon multiple minimum specifications for
product recommendation, then fail to meet these specifications
 There are indications that donors may not consistently adhere to all of these minimum specifications for QC
 These minimum specifications are developed with consideration of variations in production and testing
processes
 Therefore there is no room for deviations from minimum specifications as this will undermine the quality
standards and product efficacy established by WHOPES
Clarification on the importance of QC for vector control products:
 WHO will develop a position statement on the scientific justification for consultative development of, and
adherence to, minimum specifications and the necessity for full pre-shipment testing of all physical
properties (ie. not just active ingredients)
 The workstream requests the PSMWG Call for Action Against SSFFC to be reviewed for potential inclusion of
vector control products (ie. to be generalized to all malaria health products) for consideration by the RBM
Board
Penalties to suppliers/defaulters:
 Failure to meet specifications is unacceptable and should be penalised to prevent further declines in product
quality or delayed delivery resulting in death toll
 UNDP experience indicates that enforcing penalties defined in the terms of contracts are effective in
improving quality
 Donors and procurement agents should seek to pursue processes of integrating such measures to ensure
compliance with quality standards
Supporting countries for improved planning:
 We welcome and support GF's new Procurement for Impact strategy including active engagement with
manufacturers to allow longer-term planning and to address quality concerns
 We request RBM Secretariat to consolidate information from donors and procurement agencies on the
quality issues and challenges that compromise the timely supply of vector control products
Strengthening capacity for quality control testing:
 Currently there are limited resources and capacity for quality control of vector control products and there is a
critical need to identify additional independent QC laboratories
 RBM Secretariat should identify current QC labs used by all major donors and procurement agencies
 A process for evaluating current QC labs and identifying potential new QC labs should be undertaken in
consultation with WHOPES to ensure adherence to established testing requirements
WS next steps:
 The workstream requests the PSMWG Call for Action Against SSFFC to be reviewed for potential inclusion of
vector control products (ie. to be generalized to all malaria health products) for consideration by the RBM
Board.
 The group also discussed penalties for suppliers/defaulters and
 the need for consolidating information from donors and procurement agencies on the quality issues and
challenges that compromise the timely supply of vector control products.
 Strengthening capacity for quality control testing is needed and identifying current QC labs used by all major
donors and procurement agencies would be a useful first step.
 Strengthening planning to include time for pre and post-shipment QC
16
d. ACT/other antimalarials Workstream + Global demand forecast Workstream
WS next steps: The Artemisinin Conference (23-24 September 2014, Guangzhou), the quarterly global demand
forecasts (pending UNITAID renewed funding) and Innovative commodities – inputs to UNITAID landscapes.
e. RDTs Workstream
WS next steps were identified as follows:
 Publication of the final report
 Develop further QA guidance for selection/procurement of product and normative/regulatory framework
 Collect available evidence about actual use of methods/policies/ tools
 Collect other evidence on use of tools (e.g. hits on website links to RDT procurement guide, RDT market
changes triggered by QA guidelines, etc.)
 Improve use/awareness of methods/tools used : and develop recommendations/best practices around use
and communication
 Share/communicate tool inventory with relevant persons/meetings (e.g. Regional RBM meetings)
 Create a working proposal for IMDRF ( or other standards or guidelines body)
Immediate next steps are:
 Finalizing discussions on Labeling
 Discuss implementation & timeline with regulators and donors
 Organize 2nd consultation to disseminate and recommendations on outstanding proposals (Q3-Q4 2014)
 Discuss next steps for outstanding proposals
 Discuss applicability of this harmonization to other RDTs
(Image above: the Blue Box example of what harmonized packaging and labelling could look like)
17
8. OTHER POINTS DISCUSSED & GOVERNANCE
a. Next PSMWG meeting


The PSM-12 will be held in Geneva in June 2015
The organization of a Market place for PSM Partners during the PSM-12 should be further discussed.
b. Election of co-chairs
The PSMWG re-elected Paul Lalvani (Empower School of Health in India) and Sophie Logez (Global Fund) as co-chairs of
the Working Group for another 2 year mandate.
c. Conflict of interest
All PSMWG members were reminded to fill and sign the Declaration of Interest Form and send back to the RBM
secretariat as soon as possible.
9. NEXT STEPS


10.
RBM secretariat will share with PSMWG members:
o the PSM-11 meeting report
o the call for co-leads and participation in Workstreams
o the PSMWG Workplan for 2015 for inputs/comments
o the call for participation in the development of the call for fighting SSFFC medical products and the
consensus statement on country level PSM planning and financing for PSM activities
o reminder on RBM Conflict of Interest policy and declaration forms
Each PSMWG workstream will continue implementation of their work plan and report quarterly to the PSMWG
Co-chairs on their progress.
CALENDAR OF EVENTS




Sept 23-24 2014, Artemisinin conference in Guangzhou, China
Q3/4 2014, Second consultation for RDT Harmonisation, venue TBD
June 2015, PSM-12 meeting, Geneva
2015 – Asia LMIS workshop
18
11.
ANNEX 1: LIST OF PARTICIPANTS
Name
Email
1 AEDES (Agence Européenne pour le
Développement Et la Santé)
Institution name
Jean Marie Kindermans
[email protected]
2 AMP (Agence de Médecine préventive)
Isabelle Delrieu
[email protected]
3
4
5
6
7
8
Aaron Woolsey
Luke Rooney
Graciela Diap
Franck Biayi
Paul Lalvani
Luc Besançon
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
Nora Champouillon
[email protected]
Sandra Incardona
Shamit Shah
Richard Ansbro
Wesley Kreft
Michiel de Goeje
Vanessa Klaassen
Florence Camus-Bablon
Gloria Osei-Bonsu
Morteza Zaim
Rahul Kapadia
Lisa Hare
Philippe Verstraete
Joaniter Nankabirwa
Aleksandra
Misiorowska
Alexis Kamdjou
George Jagoe
Pierre Hugo
Rachel Hinder
Henk den Besten
Hana Bilak
Jan Van Erps
Magali Babaley
Marilyne Vonlanthen
François Desbrandes
Renia Coghlan
Azizkhon Jafarov
Melisse Murray
Shimelis Endailalu
Belaineh
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
Sophie Logez
[email protected]
CHAI (Clinton Health Access Initiative)
CHAI (Clinton Health Access Initiative)
DNDi
RDC, CAG
Empower School of Health, India
Federation Internationale
Pharmaceutique (FIP)
9 FIND
10
11
12
13
14
15
16
17
18
19
20
21
22
23
FIND
Freight in time
GSK (Glaxo Smith kline)
I plus solutions
Ida Foundation
Ida Foundation
Independent consultant
Independent consultant
Independent consultant
IPCA
JSI (John Snow Inc.)
LSHTM - ACT Consortium
Malaria Consortium
MMV (Medicine for Malaria Venture)
24
25
26
27
28
29
30
31
32
33
34
35
36
37
MMV (Medicine for Malaria Venture)
MMV (Medicine for Malaria Venture)
MMV (Medicine for Malaria Venture)
Novartis
PFSCM
PSI
RBM secretariat
RBM secretariat
RBM secretariat
Sanofi-aventis
TESS Development Advisors
The Global Fund
The Global Fund
The Global Fund
38 The Global Fund
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
19
Institution name
Name
Email
39
40
41
42
43
44
UNDP
UNICEF Supply Chain Division
UNICEF-WCARO
Vestergaard Frandesen
WHO/EMP
WHO/EMP
Rino Meyers
Bertrand Jacquet
Caroline Damour
Caroline Desrousseaux
Helena Ardura-Garcia
Pernette BourdillonEsteve
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
45
46
47
48
49
50
WHO/EMP
WHO/GMP
WHO/GMP
WHO/GMP
WHO/NTD
Zimbabwe, Ministry of Health and Child
Welfare, Pharmacy services
Robyn Meurant
Abraham Mnzava
Silvia Schwarte
Tessa Knox
Anna Drexler
Ropafadzai Hove
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
20
12.
ANNEX 2: AGENDA OF PSM-11
AGENDA
“Improving access to quality assured malaria health products”
Day 1
08.30 – 09.00
09.00 – 09.45
09.45 – 10.10
10.10 – 10.25
10.25 – 10.45
10.45 – 11.00
11.00 – 11.30
11.30 – 12.00
12.00 – 12.30
12.30 – 14.00
14.00 – 14.45
14.45 – 15.30
15.30 – 16.00
16.00 – 16.30
16.30 – 17.00
17.00 - 17.15
17.15 – 17.30
17.30
Tuesday 10 June 2014
PLENARY SESSIONS (Salon)
Registration
 Welcome and introduction, Sophie Logez, PSM Co-Chairs
 Objectives, PSM landscape and expected outcomes, Paul Lalvani, PSM Co-Chairs
Updates from PSMWG Workstreams (WS): Short briefing presentations + discussion
 LLINs/IRS WS:
o Quality control issues with vector control products, Abraham Mnzava, WS leader
(5mn)
o Results of the Global fund LLIN procurement in terms of price, quality and delivery
lead-time, Azizkhon Jafarov, The Global Fund (10mn)
o Summary of the discussions and outcomes of the GF – IRS supplier conference, 1516 April 2014 in Geneva, Azizkhon Jafarov, The Global Fund (10mn)
Coffee break
Updates from PSMWG Workstreams (WS): Short briefing presentations + discussion
 ACT/other antimalarials WS:
o Updates on PSM challenges related to severe malaria and SMC, George Jagoe, WS
leader (10mn)
o Information on the Artemisinin conference, 23-24 September 2014 in Guangzhou ,
Jean-Marie Kindermans, AEDES (10mn)
 Global demand forecast WS, Aaron Woolsey , CHAI (10mn) on behalf WS Co-leads
Lunch
Updates from PSMWG Workstreams (WS): Short briefing presentations + discussion
 RDTs WS: Recommendations and next steps for RDT harmonization, Robyn Meurant on
behalf WS Co-leads (20mn)
 LMIS WS: Joint RBM/GF workshop on Logistic Management Information System (LMIS), 6-8
May 2014, Ouagadougou, Lisa Hare, WS Co-leads (20mn)
 PSM bottleneck resolution WS: PSM helpdesk, Henk Den Besten, WS leader (10mn)
Coffee break
 WHO updates on Primaquine + Malaria Diagnostics in Low Transmission Settings,
Silvia Schwarte, WHO/GMP (15mn)
Other activities related to PSMWG KPIs to be submitted to the RBM Board
 PSMWG Consensus statement on PSM planning and financing at country level
 PSMWG call for actions against SSFFC medicines and theft/diversion of medicines
End of Day 1
21
Day 2
Wednesday 11 June 2014
PLENARY SESSIONS (Salon)
09.00 – 09.15
9.15 – 12.30
Opening + recap of Day 1
BREAKOUT SESSIONS, including a coffee break at 10.45
Group A (Salon)
Group B (Salon)
LMIS/PSM bottleneck/Helpdesk
Insecticides/LLINs
Objectives:
 Follow up of the LMIS workshop in
Ouagadougou:
1. Feedback on the LMIS self-assessment tool,
2. Follow up of the country LMIS action plans
3. Support from the PSMWG to implement
country LMIS action plans
4. Outline the joint GF/RBM - LMIS workshop
with Asian countries in 2015
 PSM bottleneck/helpdesk
5. Set up of the RBM - PSM Helpdesk
6. Support to the development and review of
country NFM concept notes
12.30 – 14.00
14.00 – 16.00
16.00 – 16.30
16.30 – 17.00
17.00 – 17.30
17.30
Objective: Identify ways for resolving quality control
issues with vector control products


WHO specifications for quality control testing,
Anna Drexler, WHOPES (10mn)
IRS procurement: UNDP experience , Rino
Meyers, UNDP (10mn)
Group discussion, in particular on:
 What needs to be done by way of:
 Instituting penalties to
suppliers/defaulters – who does it and
how
 Supporting countries and procurers to
plan well in advance making provision for
pre and post shipment testing
 Strengthening capacity for quality control
testing facilities
 Any other issue….
Lunch
PLENARY SESSIONS (Salon)
Breakouts outcomes + review of WS activities for mid 2014/2015 (10mn each)
 LMIS Workstream, Lisa Hare
 PSM bottleneck resolution WS, Henk den Besten
 LLINs/IRS Workstream, Abraham Mnzava
 ACT/other antimalarials WS, George Jagoe
 RDTs Workstream, Robyn Meurant



Coffee break
2015 PSM Working Group priority activities, timelines and budget, Sophie Logez, PSM CoChairs (10mn)
Discussion and validation of the 2015 PSMWG workplan
Conclusions & Recommendations, PSM Co-Chairs
Next PSMWG meeting date
End of Day 2 + Closure
22
13.
ANNEX 3: MEMBERSHIP OF THE PSMWG
23