6th RBM Procurement and Supply Management

Transcription

6th RBM Procurement and Supply Management Working Group
Meeting
February 2-4, 2011: Geneva
Agenda: Thursday 3rd February 2011
Day 1
Thursday 3 February 2011
Presenter
9.00
Welcoming remarks and opening of PSMWG meeting
Prof. Awa Coll-Seck
9.30

Introductions

Review of agenda

Approval of minutes from last meeting

RBM Board decisions and resolutions

Implications for membership and Co Chair elections

Guidance on Conflict of Interest Policy

Declaration of Interest
Break
Overview of 2010-2011 PSM Workplan (PWP)

Budget available and priority activities

Tool box and RBM endorsement
Pharmacovigilance

Update from workstream
PSM WG co-Chair
10.00
10.45
11.15
12.00
12.30
13.00
Forecasting and quantification

Update from forecasting workstream

RDT quantification meeting

AS/AQ lower weight bands and implications for
RBM Secretariat
Martins Pavelsons
(RBM Secretariat)
PSM WG co-Chair
Alex Dodoo
Paul Lalvani
Prashant Yadav (MIT-Z)
Rima Shretta (MSH)
Lunch
6th PSM WG Meeting, Geneva, February 3-4 2011
1
Agenda: Thursday 3rd February 2011
14.00
14.30
ACT/Artemisinin mapping

Update from work stream (Madagascar conference)

Artemisinin synthetic

A2S2 update
PSM bottlenecks

Accra PSM work shop report

Country level bottlenecks by region
o
Communication and role of SRN´s vs PSMWG
15.30
15.45
Break
Discussion
16.15
Use of cell-phone technologies

Update SMS for Life: Tanzania going to scale

Update SMS for Life: Ghana

Outcomes SMS for Health: The Gambia pilot

Preventing stockouts proactively

No stocks Outs No Drops Out
17.00
Discussion
17.45
Information and update HWG
18:00
Reception / Cocktail
Cafeteria D Building
2
Agenda: Friday 4 February
Day 2
Friday 4 February 2011
9.00
Clarifications and questions from Day 1
Overview of Day 2
9:30
Information and update RBM mechanisms
MAWG
MIP
CMWG
EARN
SARN
Community Systems Strengthening
10.30
10.45
Break
Global Fund Market Dynamics Committee
Presenter
PSM WG co-chair
Michel Smitall
Viviana Mangiaterra
Franco Pagnoni
Athuman Chiguzo
Boniface Maket
Marlou de Rouw
Sophie Logez
(GFTAM)
11.15
AMFm Update

Phase 1, planning Evaluation, initial feedback and uptake,
ACT manufacturing
Fabienne Jouberton
11.45
RDT update

Procurement guidelines

Next Round of WHO Malaria RDT Product Testing
Programme
Andrea Bosman
(WHO GMP)
David Bell (FIND)
12.15
Vector Control

Update on AMP

Procurement guidelines

Implication of resistance for PSM

IRS - PSM issues
13.00.
(AMFm)
Jason Peat (AMP)
Jo Lines
(WHO/GMP)
Dr Rabindra
Abeyasinghe
(Sri Lanka NMCP)
Lunch
3
Agenda: Friday 4 February
13.00.
14.00
Lunch
Vector Control
 Routine distribution
 Replacement of nets
14.45
Discussion
15.15
15.30
Break
PSM issues in GF R10/R11 grants
Jo Lines
(WHO/GMP)
The Global Fund
PSM Co Chair
16.00
16.45
Conclusions and recommendations
 PSM WG key next steps
 Next PSM WG meeting
Close
PSMWG Co Chair
4
Performance and expenditures (2010)
• Total requested budget: 1,109,743
•Total allocated budget: 219,472
• Expenditure budget: 129,472
• SAF: 90,000
• Outside RBM: 106,000
• Unfunded: 784,272
•Performance:
• November 30, 2010: (expenditures and encumbrances); 98%
5
Key Challenges
•
•
•
•
•
•
•
•
Lack of staff/support at RBM secretariat for PSMWG
Budget limitations and changing rules and guidelines on accessing funding:
• Expenditure, SAF, Abu Dhabi Funds
• Unclear criteria for allocation of additional funds
Changing methodologies and templates for workplanning and budgeting
Changing targets and deliverables
Conflict of interest (real and percieved) issues. Is a declaration of COI enough?
Board guidance needed
Retaining interest from previously active members due to above
Endemic country participation in WG
Cohesiveness across RBM mechanisms
6
Workplan: 2011-2012
Activity
Expenditure Budget
SAF
Country Public and private forecasting for ACT's, SP, RDT's, LLIN's and IRS (LLIN, SP and IRS not for private) Global RDT Forecasting 0
43,700
Monthly roadmap monitoring scheme in place and functioning ‐ bottlenecks threatening milestone achievement are anticipated, detected, and addressed Develop documents outlining gaps in scale up of ACT's, SP, RDT's LLIN and IRS
Gaps in scale up of ACT’s and RDT’s
0
78,540
Document on SP supply situation 0
18,000
identify bottlenecks and solutions Provide regular updates on PSM aspects of malaria commodities Collaborate with WIN on routine 0
21,500
distribution Starting meeting with a selected 0
28,500
group of existing distributors, WIN, NMCP's, PSI, JSI/Deliver, funders(PMI) and UNICEF Support scale up of ACT's, SP, RDT's, LLINs and IRS
Meeting on IRS; supply chain 0
75,222
challenges 6th PSM WG Meeting, Geneva, February 3-4 2011
7
Workplan: 2011-2012
Anticipate, and pro actively detect and resolve PSM bottlenecks in implementation and scale up for ACTs, LLINs, RDTs, IRS Mobilize support for country level PSM bottlenecks including ACT stock‐outs and removal if near expiry or expired products OGAC‐SRN funding max 5 countries
0
91,080
Timely and appropriate response to long‐ and short‐term assistance requests
Provision of global and country level 0
0
PSM TA needs : maintain consultant roster Partnership support for all countries with resource gaps in their roadmaps to obtain full funding
participate in MOCK TRP meetings 11,080
0
in collaboration with HWG Support the acceleration of GF Proposals grant signatures and negotiations to secure timely funding Round 10 PSM plan workshop
95,080
0
High level advocacy with donors for continued control funding for countries where malaria is suppressed to low levels Support to rolling out of new technologies for RDT and other new technologies for all commodities in at least 3 countries. Where requested provide TA. Cell phone meeting 26,580
1,000
8
Workplan: 2011-2012
All Constituencies are implementing a WHO GMP agreed resistance management strategy
Activity STI, follow up of 2010 APW 48,080
9,000
outcome Tracking of manufacturers of antimalarials including oral artemisinin monotherapies
SOW in preparation with JP/MC.
18,003
20,425
Liaise with MAWG for messaging 0
34,283
Meeting with a extractors to map
sales to the small industrial partners and local African players Global public and private forecasting for ACTs, SP, RDTs, LLINs and IRS
0
37,039
Continue to input to and disseminate output from BCG activity All RBM mechanisms processes are carried out properly and assessed annually 0
Cross‐cutting issues: PSM meetings 39,619
participation between WG/SRN meetings Total 238,445
458,370
9
RDT Quantification Meeting
ACT/RDT quantification meeting held in November 2010 in Arlington. 5
action items decided:
• Need for a short term RDT global forecast based on PSM plans, targeted to
suppliers. A meeting with them is planned for February 2011. This will be an
update of previous PSMWG work on the scale up of ACTs and RDTs and
will be conducted by MMV.
• Long term RDT global forecast needed for donors: based on future needs as
well as case management
• Table on RDT policies and implementation progress in countries
• Five country case studies identifying how RDT and ACT quantification is
carried out:MMV.
• A manual to guide countries on ACT/RDT quantification needed: MSH/SPS
developed a draft, sent for review. Review meeting being planned for March
2011.
10
AS/AQ FDC
FDC AS/AQ blister packs by weight band Weight Tablet strength
4.5 – 9 kg artesunate 25mg/amodiaquine 67.5mg 9 – 18 kg artesunate 50mg/amodiaquine 135mg 18 – 36 kg artesunate 100mg/amodiaquine 270mg > 36kg artesunate 100mg/amodiaquine 270mg Pack size
3 x 3 tablets
3 x 3 tablets
3 x 3 tablets 3 x 6 tablets
11
AS/AQ FDC
Each of the different treatment bands of the FDC AS/AQ are not
interchangeable due to the different strengths:
• It is not possible to combine or break the pack sizes to treat patients
weighting less than 18 kg.
• For example, if a patient weighting 8 kgs needs treatment but the facility is
stocked out of the AS 25 mg/AQ 67.5 mg 3 x 3 tablet presentation, the
health worker cannot substitute the AS 50 mg/AQ 135 mg.
• For AS/AQ, over-dosing of children is particularly dangerous.
• USAID/PMI recommends adding an additional 10% to forecasted quantities
of the first two, lower weight bands of FDC AS/AQ to help ensure adequate
availability and provide additional ‘buffer’ stock.
• Discussion?
12
6th RBM Procurement and Supply chain
Management Working Group Meeting
3-4 February 2011
Geneva, Switzerland
1
Historical perspective: roadmap towards good governance
2003
Q1
Q2
Q3
2006
Q4
Q1
Q2
2008
Q3
Q4
Q1
Q2
Q3
2009
Q4
Q1
Q2
Q3
2010
Q4
Q1
Q2
Q3
Q4
3rd RBM Board meeting: Operating Framework adopted
11th RBM Board
meeting: Partnership
Handbook & Hosting
MOU approved
New Delhi: 15th RBM Board meeting
Proposed Framework deferred
Independent Evaluation RBM Partnership
TF I: GMAP Implementation, TFII: Accountability Framework, TF III: KM
Rio de Janeiro: 17th RBM Board meeting
Accountability Framework adopted
Geneva: 18th RBM Board meeting Accountability
operationalization plan adopted
Lusaka: 19th RBM Board meeting
Operating Framework revised
2
The logic behind the 3 accountability levels:
•
In order to achieve the global goals to reduce the overall burden of malaria (Level One:
Impact) certain levels of interventions and deployment of tools must be achieved (Level
Two: Outcomes).
•
In order to achieve the necessary levels of these outcomes or interventions, the relevant RBM
Mechanisms (Working Groups, Secretariat, etc.) will propose Action Plans to the Board, who will
hold them accountable for proper completion (Level Three: Outputs). To achieve these Action
Plans, individual partners (alone or collectively) must accept responsibility and be held
accountable for specific elements of the Action Plans.
•
In addition, individual partners will have developed action plans that they are solely
responsible for implementing but which must be co-ordinated with other RBM-developed action
plans to avoid conflict and maximize the overall chances of success (Level Three: Outputs).
3
Proposed KPIs for reporting to the RBM Board
Level 1:
Impact
Global burden of malaria (number of cases)
Global mortality due to malaria
Number of countries entering elimination phase of GMAP
Level 2:
Outcomes
%
%
%
%
%
Level 3:
Outputs
Number of doses of ACTs distributed against GMAP target
Number of LLINs distributed against GMAP target
Number of RDTs distributed against GMAP target
Number of Global Fund Grants for malaria approved (% total applications)
Number of Global Fund Agreements for malaria signed (% total approvals)
Average time from approval to signature (with range)
Number of Global Fund Signed Agreements with funds disbursed to
countries (% total signed agreements)
Average time from signature to disbursement (with range)
coverage
coverage
coverage
coverage
coverage
of LLIN distribution
of IRS
of effective diagnosis
of effective treatment (ACTs for P falciparum infections)
of IPTp in high transmission areas
4
Performance Work-Stream: 2011 KPIs
PWP Target
RBM Key Performance Indicator
KPI #1: Percentage of m alaria-endemic countries in Africa reporting progress on roadmaps
according to plan
(A) 100% of all country roadm aps are tracked
(B) 80% of country assistance requests via
SRNs receive, within two weeks, a response that
outlines a plan to meet the request and is
satisfactory to the country concerned
(C) RBM Community and Heads of State
informed on 2010 Universal Coverage
achievements and preparation for 2015 targets
KPI #2: Regional action plans developed by SRN focal points that address challenges to
achieving roadm ap goals for each country
KPI #3: Percentage of country TA requests receiving a satisfactory response from the SRN
focal points within two weeks
KPI #4: Percentage of Global Fund disbursements delayed with clear plans to address
country bottlenecks
KPI #5: Percentage of Ministers of Health of the 46 African malaria-endemic countries who
have been briefed on country progress and malaria achievements, leading to action plans
against malaria in 2011
KPI #6: Number of high-level events convened, attended, or supported by the RBM
Secretariat, the MAWG, or RBM Champions in an effort to raise awareness and mobilize
resources for international m alaria control
KPI #7: Percentage of reports published by the Secretariat and MERG according to
publication plan
KPI #8: Percentage of countries receiving RBM support to sign Global Fund grants
(D) Resources to be mobilized to fill the gap to
reach the $6B annual target to fund the GMAP
by the end of 2011
KPI #9: Percentage of Ministers of Foreign Affairs in G20 countries informed of the
financing gap to GMAP in 2011
KPI #10: Developm ent of fund raising strategy and action plan for 2011 - 2013 by RBM
Resource Mobilization Sub-Committee
KPI #11: Proportion of applications submitted by countries to the Global Fund with RBM
support that are approved
(E) 45 countries / territories to align their
strategic / operational plans with GMAP
KPI #12: Percentage of malaria-endemic countries for which Malaria Program Reviews are
conducted and completed in 2011
KPI #13: 2011 Knowledge Managem ent milestones achieved according to plan
(F) Global and regional strategies for drug and
insecticide supply and resistance managem ent
to be developed by relevant RBM Working
Groups and WHO-GMP, rolled out, and fully
im plemented by end 2011
(G) By end 2011, eight countries to start
receiving support (to their satisfaction) to align
their strategic / operational plans with GMAP in
order to begin programs by end 2015 to achieve
the elimination of malaria
KPI #14: Global and regional strategies for drug- and insecticide-resistance managem ent
developed by W HO-GMP that receive specific support from RBM mechanisms
KPI #15: Percentage of countries (among those that signed the Ministerial Commitment)
that have not yet changed national guidelines on artemisinin-based monotherapies where
RBM action plan is in place in 2011
KPI #16: SARN Secretariat achieved its milestones in E8 Action Plan for 2011
KPI #17: Percentage of respondents from mechanism rating Secretariat support as having
"met expectations" or better
(H) Effective management support for RBM
mechanisms consistent with Board decisions
KPI #18: Percentage of 2011 PWP Budget execution by RBM mechanisms
KPI #19: Percentage of 2011 PWP Budget execution by target
KPI #20: Percentage of required funding mobilized for implementation of 2011 PWP
5
KPI #18: Percentage of 2011 PWP Budget execution by RBM mechanisms Data Source
Actual expenditures as booked in GSM (WHO ERP software system) and 2011 budget allocation as also loaded in GSM
Frequency
Responsible for Data Gathering
The data should be collected each month and consolidated every six Dirk Steller / Secretariat
months for presentation at the two Board meetings Performance Levels
Criteria for on‐track performance assume spending patterns are linear:
‐The May Board meeting (4 months)
"Excellent" = > 20%
"Satisfactory" = > 15% ‐ 20%
"Unsatisfactory" = 10% ‐15%
"Poor" = < 10%
‐The November Board meeting shows (10 months)
"Excellent" = >70% ‐100%
"Satisfactory" = 60% ‐ 69%
"Unsatisfactory" = 50% ‐ 59%
"Poor" = < 50%
Accountable for KPI
‐Executive Director for the Secretariat ‐ Awe Coll‐Seck
‐Chairs of each working group
‐Focal points of the respective SRNs
Relevant Target
H
6
RBM KPI 2011 - Overview
#
1
2
3
4
5
Result
Result
Reporting
December May 2011
2011
Performance levels
May 2011
Target
KPI
A
KPI #1: % of African countries / territories that have comprehensive roadmaps
CARN
EARN
SARN
WARN
88%
64%
91%
31%
25%
91%
45%
13%
Excellent
Satisfactory
Unsatisfactory
Poor
90%
70%
50%
0%
- 100%
- 90%
- 70%
- 50%
A
KPI #2: % of malaria endemic countries in Africa reporting progress on roadmaps according to plan
CARN
EARN
SARN
WARN
88%
9%
0%
25%
100%
18%
73%
75%
Excellent
Satisfactory
Unsatisfactory
Poor
80%
60%
50%
0%
- 100%
- 80%
- 60%
- 50%
A
KPI #3: % of monthly update meetings held between country partners and SRN focal points
CARN
EARN
SARN
WARN
4%
3%
3%
2%
4%
3%
3%
2%
Excellent
Satisfactory
Unsatisfactory
Poor
90%
70%
50%
0%
- 100%
- 90%
- 70%
- 50%
A
KPI #4: % of country partnerships having at least one meeting with respective SRN focal point
CARN
EARN
SARN
WARN
4%
3%
3%
2%
4%
3%
3%
2%
Excellent
Satisfactory
Unsatisfactory
Poor
90%
70%
50%
0%
- 100%
- 90%
- 70%
- 50%
B
KPI #5: % of country TA requests receiving a response from the SRN focal points within 2 weeks of submission to SRN focal point
CARN
EARN
SARN
WARN
4%
3%
3%
2%
4%
3%
3%
2%
Excellent
Satisfactory
Unsatisfactory
Poor
85%
60%
50%
0%
- 100%
- 85%
- 60%
- 50%
Performance levels
December 2011
(if different from May)
7
Performance Work-Stream: GMAP Implementation Overview to set targets
and KPIs in 2012 and beyond
8
Task Force to define specific targets for the second phase of GMAP
implementation chaired by WHO and BMGF.
Objective Targets
Milestones
Objective 1 ‐ reduced cases by Achieve Universal Coverage preventive measures in remaining regions by 2012.
75% in 2015
Sustain universal coverage where already achieved by By 2012 and beyond, universal coverage maintained. 2015.
Accelerate development surveillance systems towards 100% monthly reporting of stats by 2015
Objective 2 ‐ reduce malaria deaths to zero in 2015
By 2012, 50% of countries to have met 2015 target. Public Sector: Universal access to case management by 2012
Private Sector: Universal access to case management By 2012, X% of high burden countries % Y% of private by 2015
health providers comply WHO case management guidelines.
Community Level target: Universal access to case By 2012, Z% of high burden countries implemented management by 2015.
community case management strategies covering all pops at risk
Objective 3 ‐ elimination in 10 10 Countries
countries + one WHO region
By 2012, malaria elimination in 3 countries. Prioritized WHO region: Europe
9
Financial Planning and Budgeting Framework
Timing
Nov-Dec Y1
Task
High level needs assessment agreed by Board
Jan Y2
Secretariat holds discussions on priorities for Y3
Discussions with working groups and SRNs
Mar
First draft Targets and Priorities for discussion with
EC
Prepare and issue pre-read document on Targets
and Priorities in consultation with the FPC and the
Chair and Co-Chair of the Board
FPC meeting two days prior to the Board meeting to
review Targets and Priorities
Board reviews Targets and Priorities
Day after Board meeting Budget kick off meeting
takes place with WGs, SRNs, relevant Board
members and Secretariat
First draft activities from WGs, SRNs and
Secretariat structured by Target
Secretariat works with WGs and SRNs to fully
cost the activities proposed
First draft budget by Target and Mechanism and
proposed KPIs by target and mechanism
Budget prioritisation meeting takes place with
WGs, SRNs, relevant Board members and
secretariat representatives.
Revised Draft Budget circulated to FPC for
endorsement
Final Draft Budget sent to EC for final clearance to
go to the Board
Pre-read of Budget sent to Board
Two days before Board FPC meets for full briefing on
the Budget
Board meets and approves the Budget
Budget is uploaded into Financial Reporting System
Apr
May
May
May
Mid July
July to Sept
Early Sept
Mid Sept
End Sept
Mid Oct
End Oct
Mid Nov
Mid Nov
Dec
Parties Involved
Secretariat, RMWG,
Board
Secretariat
Secretariat, WGs,
SRNs
Secretariat, EC
Secretariat, FPC,
Chair and Co-Chair of
the Board
Secretariat, FPC
Secretariat, Board
Secretariat, WGs,
SRNs, FPC, other
stakeholders
Secretariat, WGs,
SRNs
Secretariat, WGs,
SRNs
Secretariat, WGs,
SRNs,
Secretariat, WGs,
SRNs, FPC, other
stakeholders
Secretariat, FPC
Secretariat, EC
Secretariat, Board
Secretariat, FPC
Secretariat, Board
Secretariat
10
Operating Framework
3.7. Working Groups
The Board may decide to establish one or more Working Groups (WGs) when there is a need to generate
Partner alignment or to provide coordinated implementation support on a specific issue or a set of issues
critical for scaling up malaria control efforts.
– Roles and Responsibilities of the Working Groups
WGs submit detailed Terms of Reference to the Board, outlining among other things the specific functions of
the WG. In general, the role of the WG is to address implementation issues, including how to put standards
and guidelines into practice. The WG convenes the interested partners, facilitates communication between
these partners to address key implementation issues, and then co-ordinates between the partners at global &
regional level to ensure that the implementation of the solutions the WG has agreed is carried out efficiently.
The role of WGs is not to address technical normative or standard setting issues. These are the responsibility
of the WHO. In case of the need to co-ordinate at a country level, it is the role of the Sub-Regional Networks,
facilitated by the Focal Point.
Detailed roles and responsibilities of WGs are defined by each WG in their Terms of Reference (TORs) and
are approved by the Board. The TORs of the existing WGs are attached to this document as Annex 4.
– Accountability of Working Groups
WGs are accountable to the RBM Board through Executive Director. The WG Secretariat shall report to the
Executive Director on quarterly basis on progress in achieving the work plan objectives, including a financial
report. The semi-annual reports to the Board summarize progress of the previous six months.
11
By-Laws: issue of membership
9.2 Working Groups
3.
Working Groups have two types of members: (1) Core Members and (2) Observers.
4.
Core members represent their institutions. Any member of an institutional partner can become a core
member of the Working Group if s/he meets the following criteria: expertise and experience in relevant field for
Working Group; appropriate level of seniority and credibility; ability to fund their own participation/ attendance
at Working Group meetings, unless they qualify for financial support for participation via the RBM partnership
Secretariat or other RBM partner.
5.
Institutional partners who wish to become core members and who meet the criteria are approved for
membership by the Chair / Co-chair.
6.
Observer status is reserved for those interested individuals/ organizations that cannot commit to the same
degree as core members; they are allowed to participate in WG meetings at the discretion of the (co-) chairs
as observers and contribute as possible. Observers have no voting power
9.2.1.
Membership
The group of core members should meet the following criteria:



Balanced geographic representation
Balanced representation of constituencies
Representation of key organizations/institutions relevant for functions of Working Group
12
By-Laws: institutional responsibility
9.2.2.
Chair /Co-Chair
(Co-) chairs must provide an explicit assurance from their employer agreeing to the additional travel
and workload related to assuming the role as chair of a RBM Working Group prior to their
endorsement by the Board.
9.2.3
Election of Chair/Co-chairs
5. Prior to the (co-) chair’s endorsement by the Board, the Secretariat shall obtain an explicit
assurance from their employer agreeing to the additional travel and workload related to
assuming the role as chair of a RBM Working Group.
13
By-Laws: election of Chair (Co-Chairs)
9.2.3
Election of Chair/Co-chairs
1. Two co-chairs or alternatively one chair and one co-chair (at the discretion of the core WG
members) are elected by the Working Group members prior to the mid-year meeting of the
RBM Board. (Co-) chairs are elected for a two year term with potential renewal
2. The election procedure shall be transparent and open to all core members of the Working
Group with one vote per core member.
3. The Secretariat shall send out notifications one month prior to the election, soliciting
nominations. Each core member has the right to nominate one person or self-nominate.
4. Two weeks prior to the election the Secretariat shall obtain a confirmation from the nominees
that they are interested and willing to run for election.
5. Prior to the (co-) chair’s endorsement by the Board, the Secretariat shall obtain an explicit
assurance from their employer agreeing to the additional travel and workload related to
assuming the role as chair of a RBM Working Group.
6. The election should be carried out through a secret ballot and can either take place during one
of the Working Group meetings or through the use of electronic vote. A simple majority decides.
7. The (co-) chairs are endorsed by the RBM Board at the mid-year Board meeting
14
Other relevant Board decisions
•
TF3 on Knowledge management: development of RBM-wide KM strategy.
•
RBM Expenditure Budget 2011 approved in amount of USD 17,996,105 (with the
Supplemental Activity Framework (SAF) 2011 of USD 5,213,894).
•
Renaming the current Resource Mobilization Working Group as the Board Resource
Mobilization Subcommittee (RMSC) and task it to establish a resource mobilization strategy,
including traditional and new donors and innovative financing methods .
•
Task Force on Central Africa, chaired by Angola. Initial members include delegations from
WHO, France, World Bank, Academia, Special Envoy. This Task Force under supervision of the
Performance Work-Stream should undertake a comprehensive analysis of the factors that may
be responsible for the inadequate progress in the subregion, including, but not limited to:
Financing (Global Fund, PMI, World Bank, DFID, and other funding entities); Long-term
technical support (from PMI, UNICEF, WHO, and other organizations); Political will (high level
political commitment at country level); Technical (appropriate malaria policies and strategic
plans); Logistical; Resistance (antimalarials and insecticides); and Health Systems.
•
Major theme for the 20th Board meeting: relationships among WGs and SRNs.
15
6th RBM Procurement and Supply chain
Management Working Group Meeting
3-4 February 2011
Geneva, Switzerland
1
Submission rates for Declarations of Interest (DOI)
# of Submissions
80
79
78
79
71
60
56
54
40
27
24
65%
20
13
69%
52%
52%
32%
44%
20%
0
13%
0%
Board Exec. MAWGVCWG HWG PSM CMWGMERG MIP
Comm.
Not yet submitted
4
100%
2
7
100% 100%
100%
0%
FPC WARN CARN EARN SARN
Submitted
2
COI Policy Implementation
Roll Back Malaria Partnership
Declaration of Interests Matrix
Procurement and Supply Chain Management Working Group (PSMWG)
Version of 2 February 2011
NAME
Akhabuhaya Jonathan
Ambachew M. Yohannes
Ansbro Richard
Assih Mamessilé
Azeez Joycelyn
Basu Suprotik
Bell David
RBM Constituency
Malaria-endemic
countries
Multilateral
development
partners
Private sector
Malaria-endemic
countries
Malaria-endemic
countries
Multilateral
development
partners
NGOs
AFFILIATION
DECLARATION
SUBMITTED
Tanzania
V
UNITAID
V
GSK
V
V
With
funding
V
Nonmonetary
INTELLECTUAL
PROPERTY
Patents,
Proprietary
trademarks, or
know-how
copyrights
HOLDING
OFFICE/
POSITION
V
COMPETING
PRODUCTS
THIRD
PARTY
INTERESTS
OTHER
ASPECTS
DETAILS
V
The member himself and his
spouse are employed by GSK
and have stocks in the
company. Also employed by
MMV and an unpaid industrial
advisor to the CNAP project to
develop high yielding
artemisinin plants.
V
FIND Diagnostics
V
V
V
V
V
Cazetien René
Private sector
Sanofi
V
Chang Ellen
Daily Jen
Foundations
CHAI
CNAP, University of
York
AEDES
MMV
Clinton HIV/AIDS
Initiative (CHAI)
V
Cloez Sandrine
Coghlan Renia
Foundations
Research and
academia
NGOs
NGOs
de Bruijn Karel
Private sector
Novartis
de Leoni Imelda
Multilateral
development
partners
UNITAID
den Besten Henk
NGOs
IDA Solutions
Fernandez Alfonso
Multilateral
development
partners
UNDP
Fournier-Wendes Sanne
Private sector
Vestergaard-Frandsen
Clayton David
Consulting
INVESTMENT
INTERESTS
Commercial
Stocks/
business
bonds etc.
interests
Malaria No More
Caudron Jean Michel
Bosman Andrea
Employment
RESEARCH
SUPPORT
Togo
Ghana
Multilateral
development
partners
Multilateral
development
partners
NGOs
Blanco Francisco
EMPLOYMENT AND
CONSULTING
V
Employment with FIND. FIND
receives funding from Becton
Dickinson, which may produce
malaria diagnostics in the
future. Has coordinated
malaria evaluation activities
for WHO and FIND.
V
Employed by Sanofi Aventis,
has investment interst in
stocks. As a director of
operations of Sanofi Aventis
company has to defend the
position of the company.
UNICEF
WHO
AEDES
V
V
V
Consultancy work for CNAP
University of York.
V
Employed by MMV.
V
V
V
V
V
V
V
Income from i+Solutions,
Netherlands.
V
V
Used to work for the Global
Fund and is currently
employed by Vestergaard
Frandsen SA.
V
Employed by Novartis.
Together with his spouse has
shares in Novartis.
3
COI Policy Implementation
Entering the phase of management of COI:
•
Step 1: Based on the review of the COI Matrix, the Responsible Officer shall make an initial
assessment to determine whether the declared interest is insignificant or significant. If the COI
is significant, an evaluation of the situation has to be done together with the Coordinator and
appropriate limitation of participation determined.
•
Step 2: The Responsible Officer contacts the Partner concerned to inform about the possible
limitations, find out additional information and agree on disclosure statement at the meeting.
•
Step 3: The Responsible Officer shall discuss the above findings of insignificant and significant
COI with the Chair of the meeting. The declarations made orally at the meeting shall be noted
by the Secretariat and reflected in the minutes/summary record of the meeting.
4
Revised PWP and Budget 2011
February 3, 2011
Key ingredients of the Partnership Work Plan (PWP)
GMAP
Targets
A
B
C
GMAP
D
E
KPIs
F
G
1. Scale up for
impact
2. Sustain
achievements
3. Elimination &
eradication
RBM Board Presentation_04-Dec-2010_v2.ppt
Most important
goals for 2011 that
will enable RBM to
fulfill the GMAP
Strategy
Deliverables
Activities
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
Tangible results of
the activities in the
work plans –
quantifiable and
easily measured
Initiatives a
mechanism
undertakes to
achieve a
deliverable
1
This year's planning process was compressed into three months
PWP reviewed and
revised through
consultation
September
PWP review workshop
conducted with all
mechanisms
Targets, deliverables and
activities refined
Outcomes of refinement
process diseminated to
all mechanisms for final
review
Final comments
incorporated into PWP
document
Costing model
developed and
activities costed by
mechanisms
Budget submissions colated
and presented to the
FWS-FPC as well as expected
2011 resources
October
Costing model and guidance
on how to use the model
developed and provided to all
mechanisms
Costing model was pre-filled
with the activities identified by
mechanisms in the preceeding
review process
Mechanisms were assisted by
the Secretariat in completeing
the costing model
Budgets submissions colated
into a firsty draft budget for
presentation to FWS-FPC (first
draft budget totaled US$27
million)
Analysis of available funds for
2011 prepared and presented to
FWS-FPC (Budget ceiling of
US$18 million for EB and
US$4.5 for SAF was set)
FWS-FPC requested Secretariat
to work with mechanisms to
reduce the initial requests to
within the ceilings set
2
Second round submissions by
mechanisms
October
All mechanisms were informed of the
advice of the FWS-FPC to reduce the
Budget submissions to with in the US$18
million and US$4.5 million ceilings and
provided
To ensure full transparency, mechanisms
were provided with the consolidated
submissions, including the submissions of
all other mechanisms
Second round submissions collated
and process for final prioritization
discussed with EC
November
Second round submissions collated but still
totalled more than US$22 million
The EC was informed that further reductions
would be necessary
A proposal to establish an Ad-hoc Budget
Review Committee consisting of the EC Chair,
the FWS-FPC Chair and the Executive Director
was presented to the EC
The EC stated that budget prioritization is the
prerogative of the Board.
Given short timelines to finalize the PWP, the
interim process was adopted as an ad hoc
measure December 2010 Board meeting only.
3
Prioritization criteria established by
Ad-hoc Budget Review Committee
November
Three main prioritization criteria were
identified:
The activity should be a unique function of
the RBM Partnership and not duplicate
functions of other partners.
Urgent emergency activities should be given
priority (Currently these are in the areas of
Resistance Management and Resource
Mobilization to allow the implementation of
GMAP).
Final round of prioritization
undertaken in coujunction with
mechanisms
November
These criteria an revised costed activity plans
of all mechanisms were sent to all Co-Chairs
by the Chair of the EC along with a request to
for final submissions
Final submissions collated and it was identified
that an additional $US800,000 needed to be
reduced.
The Ad-hoc Committee reviewed the work
plans of all mechanisms and based on the
prioritization criteria identified lower priortiy
activities to move to the SAF.
This proposal was sent to all mechanisms for
Past spending patterns of mechanisms over comment. No comments were received and
the prior year will be taken into consideration. the proposal was finaliyed and submitted to the
FPC for endorsement.
4
Benefits from revision of RBM Partnership Work Plan 2011
Increased
accountability
• Standardized work plans developed per mechanism will allow
accurate and consistent reporting
More efficient
coordination
• All work plans provided to all mechanisms, enabling increased
coordination among mechanisms
• Allows Secretariat to better facilitate actions across mechanisms
Builds
prioritization
discipline
• Enhances structure and rigor to the planning process; activities
are considered based on priorities, cost, and contribution
towards achieving targets
Greater financial
transparency
• Three-dimensional structure of Budget and financial reports
provides external and internal stakeholders increased
transparency in financial management of RBM
5
Budget 2011 was prepared and will track performance in
three dimensions
Target A
Target B
Target C
"Results
based"
Target D
Target E
Target F
SAR
N
WA
RN
SEC
EAR
N
CAR
N
VCW
G
G
RM
W
G
CM
W
PSM
MA
WG
MI P
ME
RG
HW
G
Target G
t
en
m
uip lies
Eq pp ing
Su ain com s
Tr ele vice
T r 1 ting
Se FC sul
D n
Co taff el
S av x
Tr p E
O
Target
Expenditure type
"Cost structure
based"
Mechanism
"Organization
based"
1. DFC stands for "Direct Financial Cooperation"
6
Budget 2011 includes large carry over which may not be
available in future years
2011 projected revenues
in USD m
20
1.05
0.72
0.73
18.06
17.99
Others
Total
expected
income
Total
budget
request
1.14
2.00
15
5.00
10
7.43
5
Includes OGAC ($3 M)
and USAID ($.95 M)
received at end of 2010
0
Carry
forward
Abu Dhabi
(HAAD)
Gates
core
World Bank
Gates
SARN
UK DFID
7
Budget 2011 priorities focus on resource mobilization for
GMAP and resistance management
in USDM
2.4721
2.471
2.5
2.0
1.613
1.568
1.5
1.107
24%
24%
1.0
16%
15%
0.602
0.461
11%
0.5
6%
4%
0.0
Target A
Main
Role
Roadmap
Tracking
Target B
Target C
Target D
Target E
Target F
Target G
Bottleneck
Global
Resource
GMAP
Supply & Support to
Resolution Reporting Mobilization Alignment Res. Mgmt Mechanisms
1. Activity budgets reflected above - target G excludes staff budget of USD 6.0 M and 1.7 M in fees to WHO
8
RBM Budget 2011 is ~11% higher than the Budget 2010
SRNs
Working Groups
+20%
in USD M
in USD M
4.92
5
in USD M
-7%
3
Secretariat
Fees to
WHO
15
2.78
2.59
4.11
+3%
4
10.21
2
10
3
10.48
1.70
2.05
2
1
1
5
Rio
approved
0.73
0
0
Budget 2010
Proposed
Budget 2011
8.78
0
Budget 2010
Proposed
Budget 2011
Budget 2010
Proposed
Budget 2011
9
Budget spread primarily across staff, travel, consulting, and
direct country assistance
in USD m
1.76
2.17
15
2.90
3.28
10
6.00
1.67
0.12
9%
.7%
0.05
.3%.
0.04
.2%
17.99
Equipment
Total
10%
12%
16%
18%
5
33%
0
Staff
Travel Consulting DFC
General Contract Telecom Training
opex services
10
Working group allocations have changed based on
prioritization exercise and absorption capacity
in USD M
1.5
-32%
1.25
1.0
-31%
0.85
0.45
+86%
0.49
+139%
0.40
0.31
0.17
0.08 0.09
0.29
0.34
0.22 0.24
0.12
0.07
0.0
HWG
MERG
MIP
VCWG
Budget 2010
MAWG
PSM
CMWG
RMWG
Proposed Budget 2011
11
SRN budgets comprised mainly of OGAC and Gates funding
that can only be used by SRNs
in USD M
-29%
2.0
+185%
1.77
-28%
1.5
1.0
1.34
1.51
+150%
1.26
1.19
0.96
0.48
0.5
0.53
0.0
CARN
EARN
Budget 2010
SARN
WARN
Requested Budget 2011
12
Secretariat has reduced budget for activities and staff in
order to provide additional funding for the other mechanisms
Secretariat activities
in USD M
Secretariat staff
in USD M
6
8
5.121
-10%
6.80
4.591
-12%
6.00
6
4
4
2
2
0
0
2010
Budget
2011
Request
2010
Budget
2011
Request
1.Totals exclude fees to WHO 2. Year to date expenditures as of October 31, 2010
13
SAF overview as of the Rio Board Meeting
in USD M
20
15
-43%
10
5
0
Approved at Rio
Board Meeting
SAF after 2010 reallocations
SAF 2011 Proposed
14
SAF activities total $5.2M and are well distributed across the
targets
in USD M
1.5
1.04
1.0
1.02
0.96
0.87
0.62
0.5
0.36
0.34
B
C
0.0
A
Main
Role
Roadmap
Tracking
D
E
F
G
Bottleneck
Global
Resource
GMAP
Supply & Support to
Resolution Reporting Mobilization Alignment Res. Mgmt Mechanisms
15
Update from the
Pharmacovigilance Workstream
Alex Dodoo
Paul Lalvani
PV Workstream co-chairs
PSM Working Group
Geneva, Feb 3-4, 2011
PV Workstream
 Created in 2009
 Reason:

Although a well functioning pharmacovigilance system is of high
importance for drug safety, such systems are mostly absent in low
resource countries….. This lack of existing Pharmacovigilance system
…., is increasingly recognized by major donors, …. which has made
pharmacovigilance activities a basic requirement for … proposals …
 Developed Terms of Reference for PV Workstream
 TOR developed and shared with all members of the PSM
WG
 Co-chaired currently by Alex Dodoo and Paul Lalvani
2
6th RBM PSM WG Meeting 02-03 Feb 2011.
PV Workstream Update
Terms of Reference of PV Workstream






3
To coordinate and guide the various international and in-country
efforts in pharmacovigilance of antimalarials on behalf of RBM’s PSMWG
To create a central repository of all independent malaria-focused
pharmacovigilance activities
To participate in policy development on PV for antimalarials in
collaboration with WHO
To work with all partners including the WHO on resource
mobilization for PV
To assist countries in the implementation of PV programmes
To contribute to the advocacy process for PV in malaria-endemic
countries
Membership of PV Workstream
 Membership of the PSM PV WG is open to all stakeholders
involved in drug safety
 Please contact us if you are interested in participating in this
workstream
4
Expected Output of PV Workstream
 Support materials and tools for PV in countries deploying
ACTs
 Identify financial resources for PV in malaria endemiccountries
 Increase number of countries in malaria-endemic countries
participating in the WHO Programme for International Drug
Monitoring
 Establish a central repository of malaria-focused
pharmacovigilance activities – who is doing what, when,
where, how, why
5
Activities Conducted
1.
2.
Mapping of malaria focused pharmacovigilance capacities
and activities in countries served by the AMFm.
Increase awareness of need of PV with donors and decision
makers

3.
4.
5.
6
Participation in ISoP 2010
Development of a malaria focused web based
pharmacovigilance tool kit
Assessment of current state of ADR reporting for antimalarials
Assessment of types of ADRs from artemisinin-based
compounds
Output - I
 Mapping of malaria focused pharmacovigilance capacities and
activities in countries served by the AMFm
 Report published in January 2011
 Key points
Mapping undertaken by way of data collection through a
structured questionnaire sent to PV centres of the
corresponding countries, and follow-up phone interviews
 All ten AMFm phase 1 countries namely Cambodia, Ghana,
Kenya, Madagascar, Niger, Nigeria, Rwanda, Tanzania,
Zanzibar and Uganda sent questionnaires
 9 replied

7
Output – I continued

Results:
 All countries stated to have a PV system in place, which has been set-up
between 1993 and 2008, one country is still in the planning phase and the
other one has just started to implement its PV activities such as the collection
of Adverse Drug Reaction (ADR) reports
 2 became members in 2010 and 4 for more than two years
 Mentioned key challenges for the implementation of PV activities included
lack of trained, experienced and dedicated staff, lack of “core” funding for PV
systems, lack of a legal framework for PV, and slow and limited internet
connection
8
Output - II
 Encourage pro-pharmacovigilance policies with major donors
and countries
 How:
By hosting an RBM session and promoting the need for PV during
the International Society of Pharmacovigilance meeting in Accra,
Ghana 03-06 November 2010
 By disseminating information through publication of a paper on PV
of ACTs

 Paper in final stages of review with the Malaria Journal
 Title – Assessment of global reporting of adverse drug reactions for anti-malarials,
including artemisinin-based combination therapy, to the WHO Programme for
International Drug Monitoring
9
Output - III
Development of a malaria-focused web-based pharmacovigilance
toolkit
 Approach:

 Work in partnership with other technical agencies to leverage
existing pharmacovigilance tools, and make them:
,
 malaria specific (drugs, activities, stakeholders, etc), web-based
user friendly, widely accessible to Phase 1 AMFm countries

Output:
 Malaria toolkit developed (draft for consultation) based on existing
WHO/GF/Partners Pharmacovigilance Toolkit
 Available at www.pvafrica.org/malariatoolkit
10
Output - IV
Assessment of global reporting of adverse drug reactions for antimalarials
including Artemisinin-based Combination Therapies (ACTs),
to the WHO Programme for International Drug Monitoring
Paper in final stages of review with the Malaria Journal
PHARMACOVIGILANCE WORKSTREAM
PSM WORKING GROUP
RBM PARTNERSHIP SECRETARIAT
Presentation at ISoP
Nov 5, 2010, Ghana
Authors
 Andrea Kuemmerle - Andrea.Kuemmerle@unibas.ch;
 Alex N.O.Dodoo - alexooo@yahoo.com;
 Sten Olsson - Sten.Olsson@who-umc.org;
 Jan Van Erps - VanErpsJ@who.int ;
 Christian Burri - Christian.Burri@unibas.ch;
 Paul S. Lalvani* - paul.lalvani@rapidpharmacovigilance.org
 * Corresponding author
Background
 This project was undertaken to profile the country of origin of the
pharmacovigilance reporting of all antimalarials, including ACTs to the WHO
ADR database (Vigibase™)
 Data reported over the past 40 years – 1968-2008
 Database now has 5.7 million ADRs
Methods
 The WHO Programme for International Drug Monitoring, the Uppsala
Monitoring Centre (UMC) provided anonymised extracts of Vigibase™
covering the period 1968-2008.
 All countries in the programme were clustered according to their malaria
control phase and income status
Summary of Results
 From 1968 to 2008, 21’312 ICSRs (Individual Case Safety
Reports) suspecting all antimalarials were received from 64
countries.
 Low income countries, that are also ‘malaria-endemic’
(categorised as priority 1 countries) submitted only 1.2% of
the ICSRs.
 Only 60 out of 21,312 ICSRs related to ACTs, 51 of which
were from four Sub-Saharan African countries.
 Although very few ICSRs involved artemisinin-based
compounds, many of the adverse events reported were
potentially serious.
Table 1 - Classification of reporting countries into priority groups
Malaria control phase
[1] / Income [17]
Control
Pre-elimination /
elimination
Prevention of
reintroduction /
Malaria free
Low income
Middle income
High income
Table 1 - Classification of reporting countries into priority groups
Malaria control phase
[1] / Income [17]
Low income
Middle income
High income
Control
Priority 1
Priority 2
Priority 3
Pre-elimination /
elimination
Priority 2
Priority 2
Priority 3
Prevention of
reintroduction /
Malaria free
Priority 3
Priority 3
Priority 3
Table 2 - List and characteristics of the reporting countries participating to the
WHO-UMC programme in 2008 (in brackets: year of entry in the WHO-UMC
programme)
Malaria c ontrol
phase [1] / Income
[17]
Control
Low income
Middle income
High income
Priority 1:
Ghana (2001)
Mozambique (2005)
Tanzania (1993)
Vietnam (1999)
Zimbabwe (1998)
Pr iority 2:
Brazil (2001)
China (1998)
Colombia (2004)
Costa Rica (1991)
India (1998)
Indonesia (1990)
Nigeria (2004)
Peru (2002)
Philippines (1995)
South Af rica (1992)
Suriname (2007)
Thailand (1984)
Venezuela (1995)
None
5 countries did not submit any
report
report
report
Pre-elimination /
eliminat ion
Pr iority 2:
Argentina (1994)
Iran (1998)
Malaysia (1990)
Mexico (1999)
Turkey (1998)
1 country did not submit any
report
1 country did not submit any
report
None
Pr iority 3:
Pri ori ty 3:
Bulgaria (1975)
Chile (1996)
Cuba (1994)
Lithuania (2005)
Macedonia (2000)
Morocco (1992)
Poland (1972)
Romania (1976)
Tunisia (1993)
Uruguay (2001)
Australia (1968)
Austria (1991)
Belgium (1977)
Canada (1968)
Croatia 1992)
Cyprus (2001)
Czech Republic (1992)
Denmark (1971)
Finland (1974)
France (1976)
Germany (1968)
Greece (1990)
Hungary (1990)
Iceland (1990)
Ireland (1968)
Israel (1973)
Italy (1975)
Japan (1972)
Netherlands (1968)
New Zealand (1968)
Norway (1971)
Oman (1995)
Port ugal (1993)
Singapore (1993)
Slovakia (1993)
Spain (1984)
Sweden (1968)
Switzerland (1991)
United Kingdom (1968)
United States (1968)
Former Socialis t
Federal Republic of
Yugoslavia
Prevent ion of
reint roduction /
Malaria f ree
11 count ries did not submit
any report
report
Table 3 - Numbers, percentages and reporting rates of Individual Case Safety
Reports (ICSR) suspecting antimalarials submitted to WHO-UMC, clustered
according to the country priority groups
Number of
ICSR
submitted
Priority 1
countries
Priority 2
countries
Priority 3
countries
All reporting
countries
255
2’983
18’074
21’312
Priority 1
countries
Priority 2
countries
Priority 3
countries
All reporting
countries
Number of
ICSR
submitted
255
2’983
18’074
21’312
% of total
reports
1.2%
14.0%
84.8%
100%
Priority 1
countries
Priority 2
countries
Priority 3
countries
All reporting
countries
Number of
ICSR
submitted
255
2’983
18’074
21’312
% of total
reports
1.2%
14.0%
84.8%
100%
Number of
ICSR (20002008)
247
686
8149
9082
% of total
reports (20002008)
2.7%
7.6%
89.7%
100%
Conclusions
 This paper illustrates the low reporting of ADRs to antimalarials in
general and ACTs in particular.
 Most reports were submitted by non-endemic and/or high income
countries.
 Bringing together the competencies of national pharmacovigilance
programmes and various types of organisations in the NGO,
academic and private sectors with global coordination to create
short- and long-term solutions may help address the lag between
rapidly growing ACT use and poor ADR reporting to ACTs.
Output - V
Assessment of ADRs
caused by ACTs and AMTs
Paul Lalvani
Alex Dodoo
Christian Burri
Sten Olsson
Verena Renglli
Feb 2, 2011
Introduction
 WHO recommends use of ACTs in 2001
 Large scale use of ACTs in 2010 (>200 million treatments)
 Use of AMTs continues, mostly in the private sector
 Large scale safety studies have not been conducted on
artemisinin drugs
 Some CEM studies and sporadic spontaneous reporting
continues
 Spontaneous reports are aggregated by the WHO and its
collaborating partner UMC into a global database
 This study is the first such assessment of ADRs of
artemesinin-based compounds
Methodology
 104 countries are full members of WHO Programme for
International Drug Monitoring + 30 associate members
 Focus on Artemesinin compounds only (AMT, ACTs)
 22 countries reported 7602 ADRs over 15 years (from 1995
to 2010)
Findings
 Total ADRs reported



By country
By type of drug
By year
 Cross analysis





 ADR segmentation

By critical non critical
 Death
 By SOC




By age group
By gender
By SOC
By cultural background
By type of drug

critical/non critical
Age group
Gender
SOC
By Age group
 gender
 Critical /non critical
 SOC
ADRs by country
 12 African, 2 Asian, 5
N= 6955
US/Europe,
3
from ROW
Top country (Thailand)
accounted for almost 95% of
reports
AMTs
N= 647
Top 4 countries account
for almost 90% of
reports
ACTs
ADRs by Drug
Artemisinin Based Monotherapies
ADRs
Artemether
67
Artemisinin
03
Dihydroartemisinin
12
Artesunate
6782
No. of ADR Reports
6955

Artesunate ADRs were reported by Thailand, all in a single year
ACTs
ADRs
Artemether/Lumefantrine
154
Amodiaquine/Artesunate
413
Trimethoprim/Dihydroartemisnin/Piperaquine
09
No. of ADR Reports
647
Top 4/top 3 reported
ADRs by year

ADRs started being
submitted in 1995

ADRs from ACTs started in
2001

There is a trend of
increasing ADRs, with a
peak in 2010 with 400
ADRs
ADR Segmentation – Section 2
ADRs segmented by age
Age groups
<1 Year
AMTs
Total ADRs
14
%of total ADRs
1-4 Year
58
0.20%
0.83%
5-12 Year
426
13-18 Year
ACTs
Total ADRs
08
%of total ADRs
1.24%
30
4.64%
6.13%
24
3.71%
907
13.04%
53
8.19%
19-45 Year
4473
64.31%
297
45.90%
46-60 Year
760
10.93%
132
20.40%
>60 Year
176
2.53%
42
6.49%
Not indicated
141
2.04%
61
9.43%
Total ADRs
6955
100%
647
100%
Critical ADRs
Out of total of 7602 ADRs, 162 critical ADRs were reported
AMTs
ACTs
Critical ADR reported by AMTs and ACTs
Drug
Artemether
Artemisnin
Dihydroartemisnin
Artesunate
Artemether /Propane
Trimethoprim/Dihydroartemisnin/Pipe
raquine
TOTAL
Critical
ADRs
08
01
04
78
00
36
33
02
162
% of
Total
4.94%
0.62%
2.47%
48.15%
00%
22.22%
20.37%
1.23%
100%
Critical ADRs
Out of total of 7602 ADRs, 162 critical ADRs were reported
AMTs
Critical ADR reported by AMTs and ACTs
Drug
Artemether
Artemisnin
Dihydroartemisnin
Artesunate
Artemether /Propane
Trimethoprim/Dihydroartemisnin/Pipe
raquine
13
ACTs
0
0
0
1
r
e
p
10
r
e
9p
0
0
10
TOTAL
Critical
ADRs
08
01
04
78
00
36
33
02
162
% of
Total
4.94%
0.62%
2.47%
48.15%
00%
22.22%
20.37%
1.23%
100%
Critical ADRs by age group
Age Group
AMT
Critical ADRs
ACT
% of Critical AMT Critical ADRs
ADRs
% of Critical ACT ADRs
<1 Year
00
00%
01
1.41%
1‐4 Year
02
2.20%
02
2.82%
5‐12 Year
18
19.78%
04
5.63%
13‐18 Year
07
7.69%
10
14.08%
19‐45 Year
40
43.96%
31
43.66%
46‐60 Year
10
10.99%
14
19.72%
>60 Year
02
2.20%
04
5.63%
Not avail
12
13.19%
05
7.04%
Total ADRs
91
100%
71
100%
Deaths by ACTs/AMTs
Critical ADRs from AMTs affected the following SOCs
AMTs
Artemether
Liver & Biliary System
Skin & Integumentary
Musculo-Skeletal disorder
Myo endo-pericardial valve disorder
Platelet, bleeding &Clotting disorder
Red blood disorder
CNS/PNS
GIT
Reproductive
Heart
Body as whole
Foetal disorder
Neonatal & Infancy disorder
Psychiatric disorder
Urinary disorder
White cell and Res disorder
Hearing & vestibular disorder
Respiratory system disorder
Metabolic Nutritional
Total
%
Artemisnin
Dihydroartemisnin
Artesunate
3
1
0
0
0
0
1
0
0
0
0
0
0
2
0
1
0
0
0
8
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
1
0
0
0
0
1
1
0
0
0
0
0
0
1
0
0
0
0
4
8.79
1.10
4.40
Total
0
4
0
1
3
2
8
1
3
0
6
4
6
31
6
2
1
0
0
78
%
4
6
0
1
3
2
10
2
3
0
6
4
6
33
7
3
1
0
0
91
85.71 100%
4.40
6.59
0.00
1.10
3.30
2.20
10.99
2.20
3.30
0.00
6.59
4.40
6.59
36.26
7.69
3.30
1.10
0.00
0.00
100.0
Critical ADRs from ACTs affected the following SOCs
ACTs
Artemether/
Lumefantrine
Amodiaquine/
Artesunate
Trimethoprim/
Dihydroartemisnin/
Piperaquine
Total
%
Liver & Biliary System
Skin & Integumentary
Musculo-Skeletal disorder
Myo endo-pericardial valve disorder
Platelet, bleeding &Clotting disorder
3
0
0
3
4.23
8
1
0
9
12.68
1
0
0
1
1.41
0
0
0
0
0.00
1
0
0
1
1.41
Red blood disorder
CNS/PNS
GIT
Reproductive
Heart
Body as whole
Foetal disorder
Neonatal & Infancy disorder
Psychiatric disorder
Urinary disorder
White cell and Res disorder
Hearing & vestibular disorder
Respiratory system disorder
Metabolic Nutritional
3
0
0
3
4.23
4
23
0
27
38.03
1
0
0
1
1.41
0
0
0
0
0.00
2
0
0
2
2.82
5
3
1
9
12.68
1
0
0
1
1.41
0
0
0
0
0.00
1
3
1
5
7.04
4
2
0
6
8.45
0
0
0
0
0.00
0
0
0
2
0
0
0
2
0.00
2.82
0
1
0
1
1.41
36
33
2
71
100.00
50.70
46.48
2.82
100.00
SOCs
Total
%
Critical ADRs from ACTs affected the following Top 10
SOCs (segmented by drug)
Critical ADRs from ACTs affected the following Top 10 SOCs
(segmented by gender)
Outstanding Activities
39
Outstanding Activities
 Supporting AMFm (and other malaria endemic) countries in
their PV activities



Direct technical support during implementation of PV
Some countries may need assistance in starting a PV system
Advocacy
 Mobilisation of funds for PV in malaria-endemic countries
 Creating a repository of malaria-focused PV activities on the
Malaria Toolkit (and other spaces)
 Policy development in pharmacovigilance – at country level
and globally
 Explore additional focus on ‘Central Africa’
40
PRELIMINARY– Not For Distribution
Update on Forecasting Activities
Procurement and Supply Management Working Group
Feb 3-4, 2011
ACT forecasting - 31Jan2011 update - Jan31 v03.ppt
0
Update
1. ACT Forecasting
• UNITAID Consortium has started working on ACT Forecasting Activities
• Update follows
2. RDT Forecasting
• First meeting convened in Arlington, VA
• Several modeling approaches being investigated
• Rima Shretta to provide a detailed update
1
Collaborative forecasting process
DATA SOURCES
GF
Grants
R1-10
n
PSM
Plans
Pilot
Studies
Kiszewski
(2009)
ACT
Watch
Surveys
AMFm
Proc.
Records
DHS/MIS
WMR
2010
PMI
World
Bank
PQR
Malaria
Atlas
Project
Vetting
of data
MODELING
Updated
funding-based
model
Aligns outputs with
PSM-based model
Resolves
high variance
Aligns outputs with
funding-based model
Updated
PSM-based
model
CURRENT FOCUS IS ON ALIGNING AND REFINING PRELIMINARY OUTPUTS
Steering Committee
Vetting of
assumptions
CHAI AMFm Teams
In-country experts
ANALYSIS
Outside experts
Scenario and Sensitivity
Analysis (BCG)
Implications and
Recommendations
Global Forecasts
Vetting of
results EXTERNAL
RESOURCES
QUARTERLY REPORTING
Q1
2011
...
Q2
2012
2
Musings with RDT Quantification
Prashant Yadav
Procurement and Supply Management Working Group
Understanding the RDT “needs funnel”
“Malaria like fever” cases in public sector health
facilities
RDT
Microscopy
High EIR
region
Low EIR region
Push vs. Pull
Supply
Push vs. Pull
Supply
RDT uptake
curve 1
RDT uptake
curve 2
A small fraction
still use RDTs
Aggregate RDT Needs
Disclaimer: Simplified for brevity and ease of presentation
Yadav : Gordon College, April 28, 2009
2
RDT quantification feeds into the ACT quantification
Aggregate RDT Needs
High EIR
region
RDT
negative
Low EIR
region
positivity rate
A small
fraction still
use ACTs
Aggregate ACT Needs
Disclaimer: Simplified for brevity and ease of presentation
3
Understanding ACT and RDT consumption relationships
• Almost everyone who tests positive obtains an ACTs
• However, 65% of people who test negative still buy ACTs
Source: Jessica Cohen et al, Prices, Diagnostic Tests and the Demand for Malaria Treatment: Evidence
from a Randomized Trial 2010
RDT Quantification depends on scale-up plans
Fever
cases
Referral
Hospital
Regional
Hospitals
District
Hospitals
Health Clinics
Village Health
Posts
Community
Health
Workers
Microscopy
yes/no
Positive
rate
Years since
diagnosis
included in
case
management
1000%
Angola
Benin
Botswana
Burkina Faso
Burundi
C.A.R.
Cameroon
Chad
Comoros
Congo
Cote d'Ivoire
Djibouti
DRC
Eritrea
Ethiopia
Gabon
Gambia
Ghana
Guinea
Guinea Bissau
Kenya
Liberia
Madagascar
Malawi
Mali
Mauritania
Mozambique
Namibia
Niger
Nigeria
Rwanda
Senegal
Sierra Leone
Somalia
South Africa
Sudan S
Sudan N
Swaziland
Tanzania
Togo
Uganda
Zambia
Zimbabwe
Zanzibar
RDT to ACT ratio in estimated needs
1200%
1100%
2009
2010
2011
900%
800%
700%
600%
500%
400%
300%
200%
100%
0%
Source Data : Coghlan, Renshaw and Shretta, 2010
ACT and RDT estimated needs: is there something we can understand from
this trend?
90,000,000
80,000,000
70,000,000
ACT Needs as calculated
60,000,000
50,000,000
40,000,000
y = 1.5798x + 2E+06
R² = 0.1923
30,000,000
20,000,000
10,000,000
0
0
2,000,000
4,000,000
6,000,000
8,000,000
10,000,000
12,000,000
RDT Needs As Calculated
Source Data : Coghlan, Renshaw and Shretta, 2010
14,000,000
16,000,000
ARTEMISININ CONFERENCE
CONFERENCE HISTORY
•
2005 – Arusha, Tanzania (WHO)
•
2007 – Bangkok, Thailand (WHO, MMV)
•
2008 – Guilin, China (WHO, MMV)
•
2009 – Mumbai, India (WHO,MMV)
•
2010 – Antananarivo, Madagascar (WHO, RBM, MMV – DFID)
•
2011 - ?
Attended by up to 150 delegates from over 21 countries.
CONFERENCE OBJECTIVES
Inform, Disseminate, Discuss, Coordinate
•
•
•
•
•
Bring together Producers, Extractors, API/ACT manufacturers, relevant
organisations etc involved in the ‘Artemisia to ACT’ supply chain –
“Artemisinin Club”
Review Recent Technological Developments – increase efficiency & reduce
costs
Supply & Demand Projections for Artemisinin & ACTs, including Artemisinin
pricing
Financing & Support Mechanisms for Artemisinin Supply e.g. Global Fund,
AMFm, A2S2
Develop Future Actions
1
PROPOSALS FOR ACTION
ARTEMISIA PRODUCTION, ARTEMISININ PROCESSING & ANALYSIS
• Earliest Roll Out of Affordable High Yielding Seeds
• Promote Development & Dissemination of New Processing Technology
• Improve and Standardise Artemisinin Analytical Techniques
ACT FORECASTS
• Urgently Implement Coordinated ACT Forecasting System (UNITAID supported)
• Implications of Vector Control, RDTs and Semi- Synthetic Artemisinin
ARTEMISININ PRICING
• Not to Exceed $400/kg to Ensure Sustainability of Artemisinin , API & ACT Supply
ENSURING ARTEMISININ SUPPLY
• Essentiual for A2S2 to Continue & Adapt to Meet Industry Needs
• Artemisinin Conference to be Annual & Increase Regular Market Intelligence &
Technical Dissemination Throughout the ‘Artemisia to ACT’ Supply Chain
ARTEMISININ AS A STARTING MATERIAL AND MONOGRAPH UPDATE
• Finalise Technical Specifications for Artemisinin as a Starting Material
ARTEMISININ RESISTANCE
• Support Containment/Elimination Methods now being Introduced
• Ensure Reports of Resistance do not Negatively Effect Artemisinin Production
MONOTHERAPIES & NON STANDARD DRUGS
• Support Efforts to Eliminate Oral Monotherapies and Sub-Standard Treatments
2
Semi synthetic artemisinin
6th RBM Procurement and Supply chain Management
Working Group Meeting
Geneva, February 2011
Philippe Farabolini – sanofi-aventis
The context
Source: Mathieu Lamiaux, BCG Madagascar Oct.2010
Demand and supply of Artemisinin
Demand and supply of Artemisinin
Tonnes of Artemisinin
350
300
250
200
150
Other assumptions
• 0.8% yield (art. content in leaves)
• 2M ACTs / MT artemisinin
Historic production
Stock from previous year
Minimum production floor
Uncertain production
Demand
Safety Stock
Overproduction in
2007/8 resulted in ~85
MT excess stock in
supply chain, which is
used to cover demand
in 2009/10
100
50
03
04
Based on BCG model 2009
05
06
07
08
09
10
11
12
13
14
15
16
17
Minimum Production
• 2009 planting of 7,000 HA drives 2010 artemisinin production
• We assume this establishes future "floor" of committed farmers since price in
2008 was below estimated cost of cultivating artemisinin
18
19
20
Semi-Synthetic Artemisinin Project Goals
Create a complementary source of non-seasonal, highquality
artemisinin to supplement the current plant-derived supply
Contribute to stabilizing the price to benefit farmers and
extractors
Ensure semi-synthetic artemisinin is available to all highquality
derivative manufacturers
From LABS to WORKSHOPS
Semi-Synthetic ARTEMISININ Project
The Challenge
Bring a highly sophisticated technology from Academic to Industrial level, in a
very short timeframe (3 years)
Improve the fermentation performances, in cooperation with Amyris, our
biotech partner
Increase the recovery yield from 60% to more than 80% from fermentation
broth
Develop an industrial process for the Chemistry of a very unstable molecule
And finally, reach economical performances to be close to the “fair price” of
Artemisinin (350 - 400$/Kg)
Chemical
Conversions
Synthetic
Biology
Simple Sugar
Acetyl-CoA
Amorphadiene
ERG10
ADS
Acetoacetyl-CoA
Microbially
Derived
Artemisinin
H
H
ERG13
HMG-CoA
Oxidation and
Ring-Closure
AMO/CPR
tHMGR X2
H
Mevalonate
ERG12
H
HO
Mevalonate-P
AMO/CPR
ERG8
ERG19
IPP
IDI1
H
H
Mevalonate-PP
H
H
Non-Enzymatic
H
HO
HO
DMAPP
Initial route not
Dihydroartemisinic
productive enough
Acid Ester
Hydroperoxide
to reach economical
target
Peroxidation
Dihydroartemisinic
Acid Ester
O
ERG20
AMO/CPR
GPP
Esterification
H
ERG20
Artemisinic acid
H
FPP
Met
erg9::PMET3-ERG9
HO
Dihydroartemisinic
Acid
O
Squalene
H
ERG1,7,11,24,25,6,2,3,5,4
Ergosterol
Reduction
Purification
H
HO
O
Artemisinic acid
Simple Sugar
Acetyl-CoA
Strain Improvement
(Amyris)
Adding some genes
discovered by Pat Covello
ERG10
Acetoacetyl-CoA
ERG13
HMG-CoA
tHMGR X2
H
Mevalonate
H
CYP71AV1
CYP71AV1
CYP71AV1
AaCYB5
AaCYB5
AaADH1
AaCYB5
AaALDH1
AaCPR1
AaCPR1
ERG12
Mevalonate-P
ERG8
H
AaCPR1
HO
Mevalonate-PP
H
ERG19
IPP
IDI1
H
O
H
DMAPP
ERG20
HO
Art. Acid
GPP
ERG20
FPP
Met
erg9::PMET3-ERG9
Squalene
ERG1,7,11,24,25,6,2,3,5,4
Ergosterol
Fermentation improvement:
•Feeding optimization
•Cheaper Raw Material
•Energy adjustment
Chemical
Conversions
Synthetic
Biology
Simple Sugar
Acetyl-CoA
Amorphadiene
ERG10
ADS
Acetoacetyl-CoA
Microbially
Derived
Artemisinin
H
H
ERG13
HMG-CoA
Oxidation and
Ring-Closure
AMO/CPR
tHMGR X2
Purification process to
be simplified and with
a better yield
H
Mevalonate
ERG12
Dihydroartemisinic
Acid Ester
Hydroperoxide
H
HO
Mevalonate-P
AMO/CPR
ERG8
ERG19
IPP
IDI1
H
H
Non-Enzymatic
H
HO
HO
DMAPP
Peroxidation
H
H
Mevalonate-PP
Dihydroartemisinic
Acid Ester
O
ERG20
AMO/CPR
GPP
Esterification
H
ERG20
Artemisinic acid
H
FPP
Met
erg9::PMET3-ERG9
HO
O
Purification
Dihydroartemisinic
Acid
Squalene
H
Reduction
ERG1,7,11,24,25,6,2,3,5,4
H
Ergosterol
HO
O
Artemisinic acid
Synthetic
Biology
Simple Sugar
Acetyl-CoA
Amorphadiene
ERG10
Acetoacetyl-CoA
Redesign the Recovery Process
• Direct Extraction with a solvent
• Removing Impurities
• Crystallisation in water
H
ADS
H
ERG13
HMG-CoA
AMO/CPR
tHMGR X2
H
Mevalonate
ERG12
H
HO
Mevalonate-P
AMO/CPR
ERG8
H
Mevalonate-PP
ERG19
IPP
IDI1
H
HO
O
ERG20
GPP
H
Non-Enzymatic
H
HO
DMAPP
Performances
•Yield > 80%
•Recovery costs divided by 3
•Down Stream Process in
standard equipments
AMO/CPR
•Very safe powder crystallisation
Artemisinic acid • High Quality (Assay > 95%)
H
H
ERG20
H
FPP
Met
erg9::PMET3-ERG9
HO
O
Purification
Squalene
H
Reduction
ERG1,7,11,24,25,6,2,3,5,4
H
Ergosterol
HO
O
Artemisinic acid
Chemical
Conversions
Synthetic
Biology
Simple Sugar
Acetyl-CoA
Amorphadiene
ERG10
ADS
Acetoacetyl-CoA
Microbially
Derived
Artemisinin
H
H
ERG13
HMG-CoA
Oxidation and
Ring-Closure
AMO/CPR
tHMGR X2
Initial Route cannot
ERG12
reach
technical and
ERG8
economical
targets
H
Mevalonate
Dihydroartemisinic
Acid Ester
Hydroperoxide
H
HO
Mevalonate-P
AMO/CPR
H
Mevalonate-PP
ERG19
IPP
IDI1
H
H
Non-Enzymatic
H
HO
HO
DMAPP
Peroxidation
H
Dihydroartemisinic
Acid Ester
O
ERG20
AMO/CPR
GPP
Esterification
H
ERG20
Artemisinic acid
H
FPP
Met
erg9::PMET3-ERG9
HO
O
Purification
Dihydroartemisinic
Acid
Squalene
H
Reduction
ERG1,7,11,24,25,6,2,3,5,4
H
Ergosterol
HO
O
Artemisinic acid
Synthetic
Biology
Simple Sugar
Acetyl-CoA
Amorphadiene
ERG10
H
ADS
Acetoacetyl-CoA
H
ERG13
HMG-CoA
AMO/CPR
tHMGR X2
H
Mevalonate
ERG12
H
HO
Mevalonate-P
AMO/CPR
ERG8
ERG19
IPP
IDI1
H
H
Mevalonate-PP
H
H
Non-Enzymatic
H
HO
HO
DMAPP
We developed a new route
(patent pending)
• Optimized Hydrogenation to
Produce DHAA
• Activation of the DHAA
• Photo-oxydation
• Crystallization of Pure Artemisinin
O
ERG20
AMO/CPR
GPP
H
ERG20
Artemisinic acid
H
FPP
Met
erg9::PMET3-ERG9
HO
O
Purification
Squalene
H
Reduction
ERG1,7,11,24,25,6,2,3,5,4
H
Ergosterol
HO
O
Artemisinic acid
The scale up of Photo-Oxydation
And the Photo-Oxydation tomorrow….
Quality of semi-synthetic Artemisinin
Project Outcomes
We obtain a high quality product, with assay > 95%
Overall quality is close to WHO specifications for a Starting Material
Many successful tests of transformation into Artesunate (API produced within sanofi-aventis)
0.070
Artemisiten - 6.090
0.050
0.040
0.030
0.010
3.911
4.012
0.020
3.345
AU
0.060
19.884
0.080
12.204
0.090
Artemisinin - 7.203
0.100
Artemisinin diastereoisomer - 6.663
Current representative quality Artemisinin sample
(NRA-090045PFI)
0.000
0.00
1.00
2.00
3.00
4.00
5.00
6.00
7.00
8.00
9.00
10.00
Minutes
11.00
12.00
13.00
14.00
15.00
16.00
17.00
18.00
19.00
20.00
And now, what we plan to do ?
Project Outcomes
We are transferring the technology into the plants, in order
start building capacity.
We can propose samples of Industrial Quality mid-2011.
Second half of 2012, we will propose commercial quantities.
Development Phases & Timing
Semi-Synthetic Artemisinin
Development
2009
Technical
Transfer
Q2, 2008
2009-10
CoDevelopment
1000L
Pilot Scale Up
10,000L
2011
Production
Capacity
building
100,000L
Dev. Phase 1
2012
1st integration
in ACT’s
2nd source of
artemisinin for ACT
Dev. Phase 2
Industrialization
Manufacturing
Thank You
A2S2 - Assured Artemisinin Supply System
RBM PSM WG
GENEVA - 3 – 4 FEBRUARY 2011
PROGRESS AND STATUS
OF
A2S2
1. Introduction - General concepts
•
The A2S2 initiative was launched with a duration of 2 years aiming
to facilitate the support to contracts for additional Artemisia and
artemisinin production.
•
The A2S2 initiative will only support extractors or API producers
supplying to ACT manufacturers, whose ACT products are found
eligible by WHO/UNICEF and GFTAM: presently including Ajanta,
Cipla, Novartis, IPCA, Sanofi Aventis, Guilin, Strides, Mepha.
•
The A2S2 initiative is therefore aiming to support sustainable
artemisinin producers (in terms of product quality and pricing),
through secured long term contracts with manufacturers.
1. Introduction - General concepts
•
The finance facility of the A2S2 initiative operates as a contract (pre)
financing mechanism, where up to a maximum of 60% of the sales
contract between the extractor and the eligible ACT manufacturer
can be financed.
•
The A2S2 initiative is open to extractors from all growing regions i.e.
China, Vietnam, India and Africa (including Madagascar) and other
regions in the future.
•
The actual contract is managed by Triodos Bank through their
Sustainable Trade Fund, with technical support from the other A2S2
partners.
1. Introduction - Organisational structure
UNITAID
Secretariat
i+solutions
Triodos
Artepal
Project
Management
Group
FSC
Project
GMP
Advisory RBM
Group
MSF
2. Additional supply of artemisinin under A2S2
CONTRACTS
FINALISED
CONTRACT A
Country
CONTRACT B
CONTRACT C
Madagascar
Volume
Status
6MT
Signed
China
10MT
Signed
Vietnam
10MT
Signed
CONTRACTS PENDING Country
Volume
Status
CONTRACT D
Hong Kong
3
Awaiting official application, investigating Hong
Kong route
CONTRACT F
Kenya
10 MT
To be approved
CONTRACT G
China
10 MT
To be financed under A2S2 Phase 1 or Phase 2?
CONTRACTS
FACILITATED
CONTRACT I
Country
Volume
Status
Vietnam
6MT
2010 supply contract for 6MT agreed in Jan/Feb
2010
CONTRACT J
Vietnam
1-2MT
Supply agreement initially agreed for 1-2MT
through A2S2 ‘support’ in May 2010 (1st time
this extractor has supplied an approved ACT
manufacturer direct).
CONTRACT K
Uganda
0.5MT
Around 500kg
CONTRACT L
China
10MT
The additional 10MT initially planned for
disbursement, but the contract cancelled due to
signing delays, was only made possible by the
involvement of A2S2.
3. Market intelligence figures
• Collect information on artemisinin situation from
extractors and ACT producers
• Discussions with ACT manufacturers and the BCG
forecasting task force.
• Artemisinin market evaluation for 2011:
Demand:
130 – 140 T
production: 115 – 135 T
Thank you.
Comments / questions?
Workshop on Procurement and Supply Management for Malaria Products
28‐30 September 2010
Accra, Ghana
Presentation at the RBM PSMWG Meeting
3‐4 February, 2011
Background
• First joint Global Fund/RBM PSM of LLINs workshop was organized in October 2009 with a focus on LLINs only. • Follow‐up workshop aimed at consolidating all bottlenecks in PSM of malaria commodities (ACTs, RDTs, LLINs, IRS)
Main Objectives
• To share best practices, guidance, solutions from other countries • To benefit from additional technical expertise from Partners, in order to unravel bottlenecks
Methodology
 Through peer review and discussion through exchange of ideas between delegations
 The experiences of the workshop GAS Kampala in 2008 and "Mock TRPs" showed the effectiveness of this approach
Participating Countries
West African
Regional Network
Cote d’Ivoire
Guinea Bissau
Guinea Conakry
Liberia
Togo
Ghana
Niger
Senegal
Mauritania
Nigeria
Central African
Regional Network
DRC
Congo Brazzaville
Chad
East African
Regional Network
Burundi
Comoros
Sudan
South African
Regional Network
Zanzibar
Zambia
Zimbabwe
Groups
•
•
•
•
•
•
•
•
Togo & Comoros & Burundi
Senegal & Guinea Bissau & Côte d'Ivoire
Niger & Chad & Mauritania
Congo & RDC & Guinea Conakry
Zambi & Zimbabwe
Malawi & Zanzibar
Nigeria & Ghana
Sudan & Liberia
Classification of Bottlenecks
Selection
(Specifications,
guidelines, resistance…)
treatment Storage
(inappropriate
conditions...)
storage
Forecasting/Quantification (Inaccurate and Drug management (waste drugs, stock
incomplete consumption data…)
out…)
Procurement
(Tender
administrative delays…)
process, Distribution (Weakness of logistic means,
cold chain…)
Registration/Intellectual Property Right Rational Use (Inappropriate prescription
(lack of registration near NDRA…)
use…)
Quality Assurance (Sampling, Quality Information System
Control)
incomplete data…)
Receipt
and
clearances,…)
deliveries
(Customs
(Inaccurate
and
Feedback on Procurement and Supply Management Workshop
Training Workshop on PSM for Malaria Health Products
27-29 September 2010, Accra, Ghana
Marlon Banda
Senior Technical Officer
Pharmaceutical Management Unit
Presentation Outline
1. Backgound
2. PSM Workshop objectives
3. Workshop Organisation
4. Workshop Methodology
5. Key Follow‐up actions
The Global Fund “Making a “sustainable and significant” contribution
to the achievement of the Millennium Development Goals”
Extract of TGF Guiding principles :
• Operate as a financial instrument , not implementing agency
• Make available and leverage additional financial resources • Support programs that evolve from national plans and priorities
• Performance‐based funding mechanism
678
678 grants
grants in
in 140
140 countries
countries (Nov.
(Nov. 09)
09)
Rapid scaling up of results
Global Fund Top 3 result indicators (2009)
Intervention
mid 2007
mid 2008
July 2009
HIV:
People on ARV treatment
1.1 million
1.75 m
2.3 m
TB:
People treated under DOTS
2.8 million
3,9 m
5.4 m
Malaria:
Insecticide-treated nets
distributed
30 million
59 m
88 m
..
..
74 m
Malaria treatments
Attaining Grant Performance and Market Dynamics objectives
• Improved Grant
•Market dynamics impact
Core products Core products &
&
Non‐core Non‐core products
products
Core Core products
products
Participating PRs
•Grant performance impact
Management
• Addressing
procurement
challenges of PR
• Package of essential
health products for
prevention, diagnosis
and treatment
• Leveraging
purchasing power
• Improved prices,
quality, supply and
sustainability
• Impact Global level
supply issues
The Global Fund Approach for PSM
• Focus on principles and minimum standards, rather than detailed procedures
• Build upon existing (national) systems
• Principal Recipients responsible for all PSM activities ‐ even if contracted out
Operational principles for
Good Pharmaceutical Procurement, Storage and Distribution.
Policies and Principles
Guide outlines what PRs need to do
• Quality‐assured products • Lowest possible price
• National laws and international agreements
• Conduct procurement processes in a transparent and competitive manner
Workshop Objectives
• Provide an update on PSM principles and processes
• Learn from “best practices” for PSM strengthening
• Share experiences on PSM processes and support needed
• Foster inter‐country sharing of lessons‐learnt and appropriate solutions
Organisation of Workshop
•Use of Sub‐regional Networks to identify workshop themes and participants •Links to Global Fund grants and mobilization of Global Fund Portfolio Managers
•Involvement of Partners
Workshop Methodology
Preparation was critical:
• Collection and characterization of PSM bottlenecks
• Clustering of Country Participants for peer‐peer discussions and lesson learning
• Expert Partner facilitation of groups
• Post workshop activities and support to resolve PSM bottlenecks
Key Follow‐up Actions
PSM Bottleneck
No. of Countries Reporting
Storage
18
Forecasting/Quantification
Quality Assurance
Procurement
Drug management
Information System
Distribution
Product Selection
Receipt and delivery
13
13
11
9
9
8
7
4
Registration/Intellectual Property Right
Rational Use
2
1
Peer‐Peer PSM Bottleneck/Solution Sharing
Togo, Comoros, Burundi
Senegal, Guinea Bissau, Ivory Coast; Niger, Chad, Mauritania; Congo, DRC, Guinea Conakry
Zambia, Zimbabwe; Malawi, Zanzibar; Nigeria, Ghana
Sudan, Liberia;
Countries paired with
partners to provide
on-going facilitation
of PSM bottleneck
resolution
Progress Update: Jun’ 09 – Sep’ 10
•
•
•
•
•
•
•
Cumulatively 83 grants; 42 countries
$ 384 million products (91% core)
65 million LLINs
12 million courses ACT
4.1 million HIV and 5 million malaria rapid tests
Request‐to‐delivery: 6‐8 months (dependent on product type)
ARV and ACT prices fallen on average by 14% from negotiated price ceilings
• ARV prices at or below MSF and CHAI benchmarks
• LLINs 6.5% below average by other PRs (= $18 million)
• Procurement agent fees for ARVs and ACTs 26% & 29%
Progress Update, continued
•3 countries implementing comprehensive PSM interventions – Nigeria, Liberia and Gambia
•3 countries finalizing CBS/SCMA Provider support –
Uganda, Malawi, Guinea Bissau
•5 countries registered in the CBS/SCMA process –
Djibouti, Swaziland, Zanzibar, Togo, Zambia, Sudan
> 72 Grants Expected for 2011
72
68
45
25
26
25
2009
2010
‐1
2011
‐23
number grants participating
number grants joining
number grants leaving
SRN: -PSMWG DISCUSSION POINTS
3 February 2011
Major bottlenecks
Selection (specifications,
treatment guidelines,
resistance…);
 Forecasting/Quantification
(inaccurate and incomplete
consumption data…);
 Procurement (tender
process, administrative
delays…);

Quality Assurance (sampling,
Quality Control…);
 Receipt and deliveries
(customs clearance
procedures,
tarrifs…brokers…);
 Storage (inappropriate
storage conditions...);

PSM Performance Areas
 Drug management
 Rational Use
(expired drugs, stock
out…);
 Distribution (lack of
logistic means, cold
chain…);
(inappropriate prescription
use…);
 Information System
(inaccurate and incomplete
data…).
Underlying factors
Delay in grant signing and disbursement
 (a) transparency
 (b) accountability, PSM issues:
Weak health systems and HR capacity
-low absorptive capacity
-poor health infrastructure
-information systems
TA Plan
 Mobilize, organize and strengthen in-country
partnerships/constituencies to form a vibrant in-country
RBM partnerships
 Assessment missions to identify and resolve
bottlenecks/challenges threatening achievement of
milestones
 PSM training workshops at all levels of health system.
TA Plan

Provide immediate support to improve on their Global Fund
implementation/performance and rating

Building capacity for development of robust planning cycles.

Tracking GF and Road Maps

Work with PSMWG to address country-specific PSM needs.
SRN: -PSMWG DISCUSSION POINTS
3 February 2011
Major bottlenecks
• Selection (specifications,
treatment guidelines,
resistance…);
• Forecasting/Quantificatio
n (inaccurate and
incomplete consumption
data…);
• Procurement (tender
process, administrative
delays…);
• Quality Assurance
(sampling, Quality
Control…);
• Receipt and deliveries
(customs clearance
procedures,
tariffs…brokers…);
• Storage (inappropriate
storage conditions...);
PSM Performance Areas
• Drug management
(expired drugs, stock
out…);
• Distribution (lack of
logistic means, cold
chain…);
• Rational Use
(inappropriate
prescription use…);
• Information System
(inaccurate and
incomplete data…).
Underlying factors
Delay in grant signing and disbursement
• (a) transparency
• (b) accountability, PSM issues:
Weak health systems and HR capacity
-low absorptive capacity
-poor health infrastructure
-information systems
TA Plan
• Mobilize, organize and strengthen in-country
partnerships/constituencies to form a vibrant incountry RBM partnerships
• Assessment missions to identify and resolve
bottlenecks/challenges threatening achievement
of milestones
• PSM training workshops at all levels of health
system.
TA Plan
• Provide immediate support to improve on their Global
Fund implementation/performance and rating
• Building capacity for development of robust planning
cycles.
•
Tracking GF and Road Maps
• Work with PSMWG to address country-specific TA
needs.
The problem being addressed?
Maintaining adequate supplies of anti-malarial medicines
at the health facility level is a major barrier to effective
management of the disease.
Lack of visibility of anti-malarial stocks at the health facility
level is a significant contributor to this problem.
How does it work?
Every week “SMS for Life” collects health facility ACT and
Quinine stock levels via SMS. It then uses Internet and
electronic mapping technology to provide comprehensive
and accurate stock counts from all health facilities to each
district management team via internet and smart mobile
phones.
Methods.
A 21-week pilot study, ‘SMS for Life’, was undertaken
during 2009-2010 in three districts of rural Tanzania,
involving 129 health facilities, covering a population of 1.2
million.
Results.
A high response rate (≥93%) was maintained throughout the
pilot. Data accuracy, based on surveillance visits to health
facilities, was 94%.The proportion of health facilities with no
stock of one or more anti-malarial medicine fell from 78% at
week 1 to 26% at week 21. The proportion of facilities with no
dose form of any ACT fell from 26% to 0.8%. In Lindi Rural
district, stock-outs were eliminated by week 8 with virtually no
stock-outs thereafter.
Future/Next Steps ?
With funding from MMV and SDC, the country scale-up to all 131
districts and 5000 health facilities has started. This will be complete
by Q3 2011.
With funding from Swiss TPH, Ghana will implement a six district
pilot to track malaria medicines, one antibiotic and RDT’s
With funding from Novartis, Kenya will implement a five district
pilot to track ACT’s, and RDT’s in addition to weekly surveillance
data on no. of outpatients total, no. treated for malaria, no. tested
and no. positive.
The Novartis Foundation plan to extend the data collection to
Leprosy and TB medicines and pilot six districts in Tanzania.
A full medicine stock tracking module is being added which
allows full tracking of medicines from arrival in a country central
medical stores, through zonal or regional store distribution and
down to arrival at the health facility. (the additional monthly service
cost for running this addition is $155 per month for Tanzania)
Backup Slides
“SMS for Life” | Geneva, May 7th. 2010
Lindi Rural – % of the 48 facilities with a
stock-out by ACT dosage form.
(57% stock-out to 0% stock-out)
Ulanga – % of the 30 facilities with a stockout by ACT dosage form
Kigoma Rural – % of the 51 facilities with a
stock-out by ACT dosage form
(93% stock-out to 47%)
All Districts – % of the 129 Facilities with a
stock-out of Quinine Injectable
Results
•
At the start of the Pilot only 29 of the 129 facilities had all 5
medicines in stock (77% stock-out)
•
At the end of the pilot 96 of the 129 had all 5 medicines in
stock(26% stock-out). A threefold or 300% improvement.
•
At the start of the Pilot 26% of facilities had no ACT of any dosage
form in stock.
•
At the end of the Pilot 99% of facilities had at least one dose form of
ACT in stock.
mHealth Solutions for
Supply Chain Management
Need for Health Systems Integration
Don de Savigny
Swiss Tropical & Public Health Institute
SMS for Life
A “system-level and system-wide intervention”
Transparency &
accountability
Procurement & supply
chain management
Scaleable ICT support
for electronic HIS
Access to essential
medicines
Pay-for-performance;
Savings “in-kind”
Intrinsic
motivation
Face of quality in the
health system
Integration in Health Systems
 Needs broad stakeholder “buy-in” across the MoH and
Ministries concerned with Science, Technology,
Communications;
 Within MoH, needs support from Policy & Planning,
Finance, Human Resources, HMIS, PSU, not only
political levels, NMCP and Medical Stores;
 Needs to signal plans to broaden to other priority
essential medicines & commodities (e.g. ARVs, pediatric
antibiotics, TB, Vaccines, RDTs).
Beyond Increasing Stock Data Visibility
Putting analytics to work to do better pro-active planning
Jérémie Gallien
London Business School
Zachary Leung
MIT Operations Research Center
Ana Chen
Romain Davroux
Analytics Operations Engineering
Prashant Yadav
MIT Zaragoza Logistics Program
Acknowledgements:
Ecole Centrale Paris
Jed Friedman, Monique Vledder, Mirja Sjoblom World Bank
Tom Brown, David Johanssen, Chipopa Kazuma Medical Stores Limited,
Zambia
Some portions are work in progress. Please do not cite or quote without permission
Utilizing stock and consumption data for better planning
stock
on hand
consumption
SMS for Life
SMS for Health
Others
stockout period
time
local demand
rate estimate
lost demand
estimate
demand estimate = consumption + lost demand estimate
service level = consumption / demand estimate
Yadav . Global Health Supply Chains
Allows understanding demand pattern accurately
4
Substantial stockouts after peak
demand
Excessive inventory levels
5
Optimal shipment and inventory planning
Σ Σ
Min
facility i
week t
Lost_Demand(i,t)
Decision variable Shipment(i,t)
Subject to:
HC_Inventory(i,t+1) = HC_Inventory(i,t) – [Demand(i,t) – Lost_Demand(i,t)]
+ Σweek k<t Shipment(i,k) x Prob{LeadTime(i,k) + k = t}
WH_Inventory(i,t+1) = WH_Inventory(i,t) –
Σ
facility i
Σ
facility i
Shipment(i,t) + WH_Receipts(t)
Shipment(i,t) ≤ WH_Inventory(t)
HC_Inventory(i,t) ≤ Storage_Capacity(i)
Shipment(i,t) = 0 if t ∉ Shipping_Dates
Lost_Demand definition constraints
Joint work with Jeremie Gallien, Zachary Leung and Ana Chen
Shipment Optimization Model
Output
Lost Demand
Minimize
Lost Demand
By changing
Shipments
Subject to
Constraints:
Inventory
Lead-times
Shipping Schedule
Storage
Expected
Demand
(Forecast)
Expected
Demand
(Forecast)
Inventory
Level I
22
Inventory
Control
Method
Average onhand
inventory
Fraction of
demand lost
(%)
Total unmet
demand
Total
shipment
quantity
Min/Max rule,
Max = 3
months
273
37
2504
4199
Min/Max rule,
Max = 4
months
561
23
1572
5771
Min/Max rule,
Max = 5
months
946
17
1174
6639
Shipment
Optimization
531
1
75
6088
8
Mobile Phones and Access to Medicines
• Patient transport systems
• Enhancing rural reach pilot
• Samaan-guru
User
Location
Drug
Supply
services
location
Users and health
workers expectations
of product
Quantity
Demanded
Safe,
Effective
and
Quality
Product
Characteristics
of product
•Sproxil
•m-Pedigree
•Pharma-Secure
•SMS for Life
•SMS for Health
•Zambia DISI
•Several Others
Quantity
Supplied
Price of product
and services
User’s
willingness
and ability to
pay
•Mobile voucher systems
•Price verification systems?
Source: Lalvani, Yadav and Curtis (2009) and MSH-WHO-SEAM workshop on Access to Medicines
9
O
ut
s
St
oc
k
No
No
Dr
op
O
ut
s™
Leveraging sms technology in Public Health
Paul S. Lalvani
Dean: Empower School of Health, New Delhi
PSM Working Group
RBM Partnership Secretariat
1
•
•
Short term (days/weeks) and 1 and 2 year programs in – Public Health
– PV
– Clinical Research (with public health focus)
– Supply Chain
In partnership with:
– University College London, UK
– Swiss Tropical and Public Health Institute
– Uppsala Monitoring Centre (WHO CC)
– University of Ghana (WHO CC)
– MIT‐Zaragoza International Logistics Program, Spain: Supply Chain Systems, Data Management & Process expertise
2
3
Overview of the Presentation
• No Stockouts No Dropouts
• The technology
• The application
4
The Vision
No Stock Outs No Drop Outs™
NO
Stock Outs
Drug / Health commodity focused
Supply Focused
Drops Outs
Patient / User focused
Demand Focused
5
No Stock Outs No Drop Outs™
NO
Stock Outs
Drops Outs
Procurement
Affordable
Inventory Management
Effective
Distribution
Safe
Used properly
(Rational Use )
6
No Stockouts
Focus on the Product
• Procurement
– Buying good quality, TRACEABLE products
• Inventory Management
– Capturing stock and stock-out data (re-order, re-distribute)
• Distribution/sale
– Capture data along the distribution chain as product moves
– Control diversion and theft (public to private sector; East to West
Africa)
– Stop counterfeit products from entering the supply chain
7
The Global Fund Proposes Joint Action to Prevent
Theft of Medicines
FOR IMMEDIATE RELEASE; 10 December 2010
•
GENEVA – The Global Fund to Fight AIDS, Tuberculosis and Malaria will invite
major international funders of drug supplies to developing countries, technical and
law enforcement agencies and implementers of health programs to intensify joint
efforts to prevent theft of medical drugs.
• The Global Fund will invite the agencies to take concerted action to stem drug thefts,
ranging from information-sharing and joint strengthening of procurement and
distribution capacity in developing countries to applying stringent security measures
around drug storage and transport. A preliminary meeting will be held in January to
draw up a joint action plan.
• “Theft of medicines is a problem that affects all institutions investing in health
services, and we must clamp down on it,” said Michel Kazatchkine, the Global Fund’s
Executive Director. “However, no single institution can act on its own. We can only
solve this challenge if we all work together.”
• In an initiative that complements the work to secure drug storage and distribution, the
Global Fund is leading a US$216 million global innovation to finance improved
access to ACTs (AMFm) by subsidizing the costs to buyers and patients in the
private, non-governmental and public sectors.
8
No Dropouts
Focus on the Patient
•
Affordable
– Capture information on price paid by consumer
– Identify price of ACTs in the public and private sectors
•
Effective
– Capture data on counterfeits, relapse of patient
•
Safe
– Follow up on adverse reactions (PV)
•
Used properly (rational use)
– Compliance (3 day treatment or life-long)
– Patient education (use bed nets; take medicines with food / or not; avoid
exposure to sunlight; do not mix medicines)
9
Technology
10
Technology
The ideal enabling technology solution should
• Provide real-time data on the key indicators
• Easy to use by program managers and patients
• Easy to understand
• Not require any special device, equipment or
training
• Easily scalable
• Be cheap
11
PharmaSecure’s sms technology
•
•
•
•
•
•
3 years in existence
Extensive market research in Africa and India
US-based company with operations in India
Uses mobile-based technology services
Coding over 100 million drug ‘strips’ with generic
MNC companies
Exploring public health initiatives—in discussions with
–
•
DFID, IFPMA, MoH India, US FDA, USAID,
International service capability
12
PharmaSecure Anti-Counterfeiting and Tracking Services
Is this drug Authentic?
Unique identifying alpha-numeric numbers
affixed on drug packaging via printer
integration at the point of manufacturing
To Check
SMS 3k7rchu5c
TO: +91 99010 99010
TRY It !!
13
14
Customizable Dashboards
Data Captured
Advantage of Mobile sms Verification?
15
UIMV TECHNOLOGY OVERVIEW
16
How it is implemented
PharmaSecure’s Unique ID Mobile Verification codes are printed online in
the pharmaceutical production factory with inkjet printers installed with
minimal changes to the manufacturing line, and can be authenticated
anywhere in the world by consumers or professionals.
17
18
19
20
21
No Stockouts
Focusing on the Product
• Procurement
– Buying good quality, TRACEABLE products
• Inventory Management
– Capturing stock and stock out data (re-order, re-distribute)
• Distribution/sale
– Capture data along the distribution chain as product moves
(geographic mapping)
– Control diversion and theft
– Stop counterfeit products from entering the supply chain
22
No Dropouts
Focusing on the Patient
• Affordable
– Capture information on price paid by consumer
• Effective
– Capture data on drug resistance, quality, counterfeits, relapse of
patient
• Safe
– Follow up on adverse reactions (PV)
• Used properly (rational use)
– Compliance (3 day treatment or life-long)
– Patient education (use bed nets; take medicines with food / or
not; avoid exposure to sunlight; do not mix medicines)
23
Managing the complete health program:
Patients &Products
Demand & Supply
24
25
Why India
• ‘Factory to the world’
– Number of US FDA approved
facilities in India are highest in the
world, outside the USA
– High level of GMP/GLP
compliance with ‘top end’
manufacturers
• High concern of counterfeit
production—used in India and
exported
• Ubiquitous use of cellphones
and sms
26
The Spurious Drug Menace
“75% of fake drugs in
the whole world had
originated from India”
– OECD, 2005
27
The Spurious Drug Menace
28
Sources DGCI, Assocham, WHO. Upper limit of estimates accrued between 2005-2008: PSI-inc.org
Why mobile phone based technology
- Almost 600 million connections as of
December 2009
- 15 million new connections being added
every month
- Extensive capacity expanded to rural
areas
29
Source: ADB, UNDP, Bloomberg
Information and update- RBM
Mechanisms
Harmonization Working Group
-Peter Olumese (Co-chair)
HWG meeting – Dec 2010
• Review collaboration between SRNs and
Working Groups to resolve bottlenecks
and improve country performance;
• Discuss collaboration between HWG and
other WGs to ensure that other WG
products are developed and shared at the
appropriate time;
Some key conclusions
•
Harmonization and alignment of working groups/workstreams:
– it was agreed that harmonization between working groups, workstreams
and SRNs should be improved.
•
It was noted that on the short term harmonization could be best
achieved through existing structures/activities, e.g.
–
–
–
–
monthly (or regularly scheduled) SRN - WG teleconferences,
WG participation in SRN annual meetings,
WG input into SRN meeting agendas;
structuring the HWG meetings to allow better sharing of information and
joint planning between WGs, Workstreams and SRNs;
– have WG representatives sitting on the SRN steering committees;
– better information sharing among mechanisms; etc….
Examples of immediate follow-up actions
to improve coordination
• SRNs to send 5-6 bullets to the HWG where support is
needed to achieve their 2011 WP
– indicating what type of support, from who (if known), where and
when it is required.
– The HWG will then draft an action plan.
– The joint action plan can then be reviewed and updated during
the regularly scheduled SRN- HWG calls.
• The SRNs will also prepare summaries of their
activities/challenges/support needs to be sent out in
advance of the regularly scheduled SRN-WGs
teleconference.
– Improving Roadmap quality and updates should facilitate this,
and demonstrate Partnership response to bottlenecks identified
in Roadmaps
Examples of immediate follow-up actions
to improve coordination
•
It was also agreed that each WG and HWG Workstreams will
prepare, on a regular (monthly) basis, a few bullet points on recent
and upcoming activities/products that are being developed.
– This information will be compiled, updated and sent out by the HWG on
a monthly basis to facilitate information sharing.
•
It was agreed that the HWG website could be deployed to further
enhance communication and coordination.
– As an immediate action point, minutes from all workstream calls can be
placed on the site, so there is an understanding of workstream activities
across the WG. In addition, the AMP workstream weekly call minutes
will also be placed on the HWG website, along with the Roadmap
updates, and the monthly updates from the SRNs and other WGs
agreed in the above section.
– The Secretariat has been asked to incorporate this in the website, and
propose additional changes to improve functionality.
Coordination – PSMWG /HWG
• Some immediate practical steps
– Workstream membership (at least critical
workstreams)
• e.g. Rd 10 signature, Rd11/consolidation, AMP,
etc…..
– Participation in SRN-HWG regular
teleconferences
– Attendances to other WG meetings AND
information sharing thereafter.

6th RBM Procurement and Supply Management

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