The Global Fund experience on malaria RDTs. Rationale to enhance harmonization

Transcription

1 The Global Fund experience on malaria RDTs Rationale to enhance harmonization Stakeholder Consultation on enhanced Harmonization of malaria Rapid Diagnostic Tests 3rd 5th December 2013, Antwerp (Belgium) Joelle Daviaud Quality Assurance Specialist 1

2 Outline of presentation 1. The Global Fund 2. Procurement of Malaria RDTS Quality Assurance of Malaria RDTs Challenges 3. Rational for an harmonisation 4. Procurement for Impact (P4i) Initiative 2

3 The Global Fund what is it? The Global Fund is an international financing institution that provides resources to low and middle-income countries in the fight against AIDS, TB and malaria. Health programs supported by the Global Fund have saved millions of lives.

4 Key Global Fund Guiding Principles Financing mechanism, not implementer Countries implement grants, not the Global Fund Country ownership Performance-based Funding Value for Money Investing for Impact Costs High impact countries, populations, interventions

5 Key Facts & Figures Total Pledges: US$30.6 billion Total grants approved: US$22.9 billion 40 % funds go to procure Health Products Supporting more than 140 countries 6 Million People Are Currently Receiving Antiretroviral Therapy, 11.2 Million New Smear- Positive TB Cases Detected And Treated 360 million Insecticide-treated nets distributed.

6 Malaria RDT reported in PQR, orders since 1 March 2011: Top ten products Total value: USD 58,7 million Total volume: 127,4 million tests Source: PQR data as at 30 Nov 2013 Buyers: 80 grants in 62 countries

7 Malaria RDT reported in PQR, orders since 1 March 2011: Value and number of tests per year Antwerp 7 Dec 2013 Source: PQR data as at 30 Nov 2013

8 Global Fund s procurement principles Procure quality assured products Conduct procurement processes in a transparent and competitive manner In the most adequate form to support adherence (Fixed dose combinations, children forms) At the lowest possible price Adhere to National and International Laws General principles while executing procurement: Best value for money Fairness, Integrity, Transparency Effective International Competition

9 Quality Assurance for Health Products To ensure safe, effective health products and acceptable to end users. Good Procurement Practices Principal Recipients must procure all products in accordance with principles set out in the interagency guidelines A Model Quality Assurance System for Procurement Agencies. 4 Critical functions 1- Prequalification of products and manufacturers 2- Purchase 3- Storage 4- Distribution

10 Pharmaceutical Products QA Policy ( Implemented 1 st July 2009 amended in December 2010) Condoms Procurement guidelines (WHO 2010) Global Fund Quality Assurance for Health Products Diagnostic Products QA Policy ( adopted in Dec 2010 Implemented in March 2011 ) Long Lasting Insecticidal Nets, IRS WHOPES recommendations and specs

11 Global Fund QA policy for Diagnostics (March 2011) : principles Main principles Clinical criteria Quality criteria Quality monitoring at country level Ensuring quality of use Monitoring of compliance of POs with GF QA policy requirements Products subject to the policy: All durable and non-durable In Vitro Diagnostic Products and important for diagnosis Rapid diagnostic tests Equipment/consumables Reagents, Calibrators, Software Microscopes Imaging equipment, for example X-ray machines Not subject to this policy: Products for general laboratory use: gloves, syringes, needles, general reagents, test tubes 11

12 The Global Fund Quality Criteria : requirements 1. Compliant with National laws 2. Compliant with National and WHO Treatment Guidelines 3. Quality standards for manufacturing sites: ISO Quality Standards for products: For Malaria RDTs, ELISA, - Approved by WHO after technical assessment ( Product Quality Testing program or WHO PQ) or - After positive advice received from WHO when assessed according to requirements of authorities founder member of GHTF ( (USA, Japan, EU, Canada, Australia ), As classified as Low Risk for these countries LIST OF RAPID DIAGNOSTIC TEST (RDT) KITS FOR MALARIA 12

13 Ensuring quality of use Recipients must : 1. follow WHO guidance for good practice in storage and distribution of diagnostic products, 2. ensure that diagnostic products are only used by appropriately trained and qualified staff in adequate settings, 3. use best efforts to participate in External Quality Assessment (EQA) programs, 4. organize calibration and maintenance of equipment, 5. arrange for systematic reporting of defects. 13

14 Procurement principles: Selecting appropriate Malaria Diagnostic Test Kits Recipients to use the results of the WHO Malaria RDT Product Testing Programme. In country-studies to determine performance (sensitivity specificity) of the RDTs are not recommended as a primary basis for product selection. Ease of use assessments in local conditions may be highly relevant in informing procurement decisions within a short list of RDTs. Procurement of malaria RDTs In line with national malaria guidelines Guided by programmatic needs: training requirements for health workers, completeness of the kits, and ease of use, previous experience in use of RDTs, and level of deployment in the country 14

15 Procurement principles: Selecting appropriate Malaria RDT Global Fund List of Malaria Diagnostic Test Kits List developed as a tool to facilitate Recipients selection of Malaria Diagnostic Test Kits compliant with GF QA assurance criteria It includes products assessed by: 1.by the WHO Malaria RDT Product Testing Programme and found to comply with WHO procurement criteria, 2.WHO Prequalification of Diagnostic programme. Products identified by their catalogue number-product code Updated based on WHO information, Note on Recommended Selection Criteria for Procurement of Malaria Rapid Diagnostic Tests WHO prequalification lits of Diagnostics 15

16 Procurement process (2) Frequency of Competitive process: Recipients might continue to procure a selected RDT/from a short list of RDTs provided 1.a competitive selection process had been performed within, at least, the previous 3 years, and 2.evidence of: continued compliance of the product with the quality criteria defined in the Global Fund QA Policy ; evidence of adequate performance in WHO-FIND Lot testing; absence of reports of failure in the field. Cost of M RDT/ Total Cost of ownership Expected additional costs must be compared against estimated procurement cost unit price of eligible RDTs, including all the components needed to preform the test Additional costs linked to the introduction of a new RDT: re-training, or re-design of j job aids. 16

17 Lot Testing 1. Routine lot testing Pre-shipment lot testing: check a QC lot release certificate issued by the manufacturer or an independent regulatory body, Through lot-testing using the WHO-FIND Lot Testing of Malaria Rapid Diagnostic Tests and its recognized laboratories. 2. In case of suspected quality problem Quarantine suspected faulty Diagnostic Test Kits, Inform the national reference laboratory for preliminary investigation, Inform Global Fund PSM and WHO for guidance. 17

18 Providing the means for QA system 1. Each Recipient must develop and maintain a QA system for the PSM and use of Diagnostics 2. Principal Recipients should budget and consider the total cost associated with a specific product, including for example: (Re-)design of guidelines, job aids etc. and (re-)training of staff if introduction of a new product, Maintenance of equipment and costs of consumables, and reagents for durable products. It is strongly recommended that Recipients refer to WHO Good Practices for selecting and procuring rapid diagnostic tests for malaria,

19 Implementation challenges Difficulty in getting appropriate information on products status, lack of transparency on origin of rebranded products, same product code used for different manufcaturing site Selection of appropriate products and definition of requirements for tenders/request for quotations, Non-availability/lack of registrations of tests compliant with QA policy in some countries/regions Lack of interchangeability (or transparency on interchangeability): challenge when product not available or in case of failures Quality monitoring at pre shipment and post shipment level: reference materiel to use? Country capacity? Countries did not systematically report on quality failures 19

20 A compilation of relevant guidance is available on Global Fund website Global Fund s QA policy for Diagnostic Products List of Malaria RDTs Price and quality reporting Guidance for best practice Quick Facts on Procuring Malaria Rapid Diagnostic Test Kits ostics/ 20

21 Rational for an harmonisation (1) Short Term Short term approach versus long term approach Harmonization of the Malaria RDTs package content and IFU, with clear and systematic approach should Improve the use of the Malaria RDTs by the Health Workers and reduce operational errors Facilitate the interpretation of the results, if clear information on positive, negative, invalid test is systematically provided Increase quality of test results leading to appropriate treatment to the patients 21

22 Rational for an harmonisation (2) Harmonization should lead to more transparency of the product information provided ( packaging/ catalogue information.) Increase understanding of product specificity, Facilitate identification of similarities and possible interchangeability Facilitate procurement and supply management Facilitate training, retraining and supervision Facilitate the introduction in countries of new quality assured Malaria RDTs, Increase competition process, lead to cost reduction and Facilitate the use of new Malaria RDT in case of quality failure

23 Procurement for Impact (P4i) Initiative The new approach in the context of ACTs and RDTs and the implications for suppliers

24 Procurement 4 Impact: Our Objectives Are directly aligned to the Global Fund s strategy The Global Fund will become the benchmark organisation in the sector for Sourcing and Procurement Using simple, clear leading edge processes and tools designed by and for the organisation Minimising waste and eliminating non-value adding activities With measurable performance in value and lives saved Ensuring effective governance and watertight compliance Building collaborative relationships with partner agencies suppliers and donors

25 Improving our forecasting accuracy To support our new planning process we will change the way we interact with our primary recipients. This approach will also be facilitated by the new funding proposals. Today Demands are triggered by PSM plans which are presented in an inconsistent format. Overall demand is calculated reactively and manually Orders are placed on PSA for onward transmission to manufacturers The Future Overall demand will be calculated from available funding This demand can be placed on manufacturers as an underwritten volume Detailed PR requirements will be presented in a consistent format We will use a planning tool to convert our forecast in to specific orders by type

26 Defining the Procurement Strategy A Closer, more strategic relationship With appropriate governance and regular reviews. Longer term contracts supported by increased focus on planning and scheduling Collaboration to drive continuous improvement Joint teams working together to achieve specific objectives A fair return Based on market norms and with the opportunity for incentivisation. Our Commitment We are committed to this way forward and will ensure our people have the right skills and attitude to make it work.

27 Thank You Questions??