Global Fund Updates on QA, PPM, wambo.org and Supply Chain activities

Transcription

1 Global Fund Updates on QA, PPM, wambo.org and Supply Chain activities IPC meeting, WHO Headquarters, Geneva June 2017 Martin Ellis, Head Supply Chain Department Sophie Logez, Manager, HPM, Supply Chain Department Mariatou Tala Jallow, Acting Chief Procurement officer

2 QUALITY ASSURANCE POLICIES 1

3 Revised Global Fund Quality Assurance Policy for Diagnostic Products 37 th Board meeting in Rwanda, May 2017 The development of the QA Policy developed in 2009 with experts support (regulators, association of manufacturers, WHO) approved by the Board in 2010 based on the Market Dynamics Committee recommendation updated in 2014, noting needs for future revisions for the phase-in of specific products The QA Policy is based on 3 sets of requirements Clinical standards : ensure consistency with WHO guidance and national guidelines Quality standards: establish minimum standards and additional standards for specific products Quality of use: refer to guidance for ensuring quality use and adequate outcome Rationale for proposed policy revisions Alignment with new or updated WHO guidelines for key products Alignment with the Global Fund Policy on co-infection and co-morbidities (COIMs) 2

4 Revisions related to changes/updates to normative guidance and policies HIV self testing Procurement eligibility mrdts WHO guidelines encourage countries to pilot/explore self-testing to scale up testing Global Fund supports operational research on HIV Self testing Proposed revisions to the policy include specific quality requirements for HIV self testing RDTs (section 8) As of 31 Dec 2017, WHO Prequalification Programme will determine procurement eligibility Proposed revisions to the policy reflect alignment with these changes (section 8) PMS on IVDs G6PD testing In 2015, WHO guidance on Post-Market Surveillance of IVDs that describe measures to ensure on-going compliance of Diagnostics Proposed revisions to the policy include this WHO guidance (section 13) WHO recommends G6PD testing in regions with high prevalence of G6PD deficiency prior to primaquine treatment. Proposed revisions include quality requirements for G6PD tests Co-infections Proposed revisions include quality requirements for In-vitro diagnostics (IVDs) for Hepatitis B and C, Syphilis co-infections (section 8) 3

5 POOLED PROCUREMENT MECHANISM (PPM) AND WAMBO.ORG 4

6 Evolution of PPM to implement Market Shaping Strategy Tender and Framework Agreement Profiles LLIN ACT/antimalarials ARV T T T T T Value creation Phase III Phase II Phase I Performance-based contracting Supplier Relationship Management Improved data management Value creation by optimizing demand Building Market Knowledge, including through supplier visits Understanding cost First Framework Agreements Simple KPIs Outcome-based contracting Cross-supplier collaboration A focus on responsible procurement Wambo.org implementation Legacy Price and Lead time based Spot tendering Minimal performance monitoring

7 The Global Fund has introduced a more balanced supply system based on 5 elements to improve performance Benefit sharing E A Cost completiveness A B Providing products at the lowest possible affordable and sustainable price to reach the maximum number of patients Reducing price volatility and eliminating predatory pricing Supplying product timely and in full (OTIF) Incentivizing suppliers to introduce better formulations D Risk management Balanced supply system B Performance C D Supporting new suppliers to ensure sufficient supply and mitigate geographic supply risks Investing in suppliers with sustainable manufacturing practices Maintaining well-diversified supplier base Meeting The Global Fund and national quality requirements Mitigating implementation risks C Sustainability E Publishing reference prices Building capacity and implementing rapid supply mechanisms 6

8 PPM underwriting wambo.org wambo.org as the face of PPM All health products in wambo.org are managed through either PPM framework agreements; Procurement Service Agent (PSA) catalogues; or Partner MoUs. Performance is managed by PPM. Added value of wambo.org some key aspects Country ownership > Flexible approval chains mirror all different in-country processes > One more tool available to in-country procurement professionals, empowering them; In synergy with, not in lieu of, capacity building Transparency and auditability > Complete audit trail automatically generated and stored > Immediate visibility to country teams, LFAs, empowering preventative controls Potential to accelerate scale-up of innovative products > Partnership with UNITAID > Levers in the platform inform the PR about certain characteristics of products at key moments in the P2P process 7

9 Extending access to framework agreement to support access to price in view of transition Access to quality commodities at sustainable prices is key if countries are to take on increasing responsibility for programs, thus guaranteeing sustainability of GF investments ~50% of GF funding spent on procurement of commodities Sustainability, Transition and co-financing policy calls for greater focus of GF funding in MICs on specific areas of intervention implies that countries need to finance a greater share of commodities domestically Challenges: small volumes, limiting countries negotiating leverage; IP restrictions that limit number of suppliers competing; higher prices charged to MICs Risks: lower health impact of each $ spent on commodities; difficulty in mobilizing domestic resources; higher effort needed to reach lesser impact Responses Several cases where Framework Agreements extended to Governments with national funding (e.g. Cameroun, Georgia, Guyana) and partner agencies Practice recognized by Market Shaping Strategy, which encouraged to consider doing this more systematically Opportunity: wambo.org as a practical tool supporting procurement sustainability agenda ( phase 1b pilot ongoing) Preparing for country transition and supporting long-term market viability, among other things, by seeking to provide continued access to long-term agreements negotiated through the PPM to transitioning countries or regional bodies engaged in pooled procurement 8

10 SUPPLY CHAIN 9

11 The Supply Chain Implementation Plan was developed in three Phases Oct 24 - Dec 23 Jan 16 Apr 7 Apr 10 - Jun 24 I Diagnose and assess current state II Develop vision and approach III Create detailed implementation plan I.1 Define global health supply chain ecosystem > Define partner roles > Define trends & learnings I.2 Develop assessment frameworks related to > Supply chain, country investment and cross- portfolio performance I.3 Identify data sources & commence compilation I.4 Establish portfolio baseline II.1 Develop vision Define supply chain vision and goals Develop approaches, KPIs, tools to support ongoing investment mgmt. II.2 Develop supply chain approach Define portfolio segmentation Recommend elements along the grant lifecycle for in-country supply chain grants Develop high-level rollout of the supply chain implementation plan II.3 Articulate benefits of strategic approach Estimate benefits of the proposed approach III.1 Develop rollout plan Define implementation plan roadmap III.2 Define organizational focus Recommend organizational focus for investment approach III.3 Define process focus Establish performance mgmt. framework Recommend investment process changes III.4 Define supportive tools Rollout tool to manage country-specific interventions & invests IV Communicate and align approach with stakeholders via change and stakeholder management 10

12 We developed a structural frame for The Global Fund Supply Chain Implementation Plan A Supply Chain Vision Universal availability of health products at the point of service through sustainable, resilient and high performing supply chains B Strategic objectives To satisfy patient needs when they come to a point of service, product availability should reach % In order to ensure efficient use of limited resources, product wastage should go down to % Supply Chain cost per patient should at least remain stable while increasing product availability To anticipate product orders, forecast accuracy must reach % at Secretariat level Responsive supply chains require fast replenishment so inventory turnover rate should be p.a. C Guiding principles End-to-end supply chain visibility Enduring sustainability and country ownership Dedication to health impact Application of cross-cutting innovation Collaborative mindset People: Dedicated and competent personnel across all levels of the health system, relevant organizational structure D Enablers Processes : Clear responsibilities, interfaces and continuous process improvements Policies: Advocacy and support towards implementation of in-country policies for effective Supply Chain system Technologies: Data enabled decision making and performance management 11

13 1. Countries diagnostic progress will be tracked through a seven stage process with three gates STAGE Engage/D esk Develop ToR Select/mobilize Supplier Conduct Supply Chain Diagnostic Develop ToR Gate 1 Issue/ Assess Gate 2 Mobilize Vendor In-country / data Analyze Solution/ Plan Supply Chain Diagnostic Supply Chain Transformation > Gate 3 Develop Transform. Proj. RFP Develop Select/mobilize Supplier Issue/ Assess Select/ Mobilize Select country ToR Ready Select Vendor Portfolio Agreed Gate D1 D2 In-Country Check-in Transformation Check-in D3 D2a D2b Hard Gate Soft Gate Go/No Go Check-in SCA Supply Chain Assessment D Diagnostic T Transformation Project 12

14 1. $12M for the first twelve diagnostics has been approved by the GAC Countries are now progressing through the gated process?? Determine Country 0 STAGE Engage/D esk Develop ToR Select/mobilize Supplier Conduct Supply Chain Diagnostic Develop ToR Gate 1 Issue/ Assess Gate 2 Mobilize Vendor In-country / data Analyze Solution/ Plan Gate 3 Develop Transform. Proj. RFP Develop Select/mobilize Supplier Issue/ Assess Select/ Mobilize? TBD Ethiopia DRC Kinshasa Burkina Faso? TBD Haiti India 2 States Cameroon? TBD Uganda Liberia?? Ivory Coast? 13

15 APPENDIX 14

16 HIV Self Testing compliant with the revised Policy 15

17 HIV Co-infections compliant with the revised policy Hepatitis C, Syphilis, Hepatitis B 16

18 Pooled Procurement Mechanism health product spend 2016 PPM spend is approximately 55% of the total Global Fund health product spend Antimalarial medicines USD [VALUE]m [PERCENTAGE] Other pharma USD [VALUE]m [PERCENTAGE] [CATEGORY NAME] USD [VALUE]m [PERCENTAGE] [CATEGORY NAME] USD [VALUE]m [PERCENTAGE] [CATEGORY NAME] [CATEGORY NAME] USD [VALUE]m USD [VALUE]m [PERCENTAGE] [PERCENTAGE] [CATEGORY NAME] USD [VALUE]m [PERCENTAGE] Core products represent +/- 85% of procurement value between 25% and 70% of procurements financed by the Global Fund are channeled through PPM (depending on the category) [CATEGORY NAME] USD [VALUE]m [PERCENTAGE] Source: Financial data from PPM 2016 approved orders Acronyms: ARVs Antiretroviral drugs ACTs Artemisinin Combination Therapy LLINs Long-Lasting Insecticide treated nets RDTs Rapid Diagnostic Tests Lab Laboratory equipment and supplies, medical consumables, etc. 17

19 The proposed new supply chain department consists of three sub-departments Ongoing operations Transformational operations Department head level Head of Supply Chain Management level Global supply chain operations Supply chain transformation projects Supply chain Performance & Assurance Execution level teams 1 Forecasting and demand planning 3 Upstream logistics management Country diagnostic and transformation Supply chain investment consultation 7 Key donor / partner coordination Supply chain risk management and assurance 6 Global supply chain performance management 18

20 $54m of Catalytic Funding is dedicated to Supply Chain activities 1. Diagnostics (~20) and Planning for the development of strategies for improving in-country Supply Chain systems ($20m) 2. Innovation incentivize testing of new approaches and their evaluation ($10m) 3. Developing local resources for countries local and regional expertise to support implementation of procurement and supply chain strategies and generation of best practices ($12m) 4. Pre-qualification of medicines, in vitro diagnostics and other relevant health products ($12m) Governed by WHO 19