1. WHO’s guidance on procurement of IVDs
Anita SANDS, Essential Medicines and Health Products
13 December 2018

2. Why specific guidance for IVDs?
Are IVDs all that different?
A wide variety of malaria RDTs
IVDs are more labile, less stable than medicines
Product selection is more difficult
For HIV, verification of testing algorithms due cross-reactivity between assays. This precludes substitution but streamline procurement
Diversity within IVDs leads to complex management needs
Single-use disposable RDTs
Analyzers and other equipment that need to be placed, calibrated, maintained, decommissioned

3. Challenges for procurement of IVDs
Siloed procurement
Existing polices for procurement and service delivery are not adhered to
E.g. standardisation/harmonization, and tiered testing networks
Lack of coordination, competing priorities, political agendas
Managing frequent shifts in technology, insufficient human resources
Inadequate equipment maintenance and lack of data availability
Williams J, Umaru F, Edgil D, Kuritsky J. Progress in Harmonizing Tiered HIV Laboratory Systems: Challenges and Opportunities in 8 African Countries. Glob Health Sci Pract. 2016 Sep 29;4(3):467-80

4. How to plan for procurement
Procurement planning
WHO has issued guidance in English and Français - any other languages needed?
Planning and coordination are critical
Determine who is being tested and where
Are you planning to fulfil the current testing needs or projecting an expansion of testing to new sites?
Where are the testing gaps? Through-put of clients (high/low) Infrastructure (electricity yes/no) Staff skills and competency (specimen collection)

5. How to quantify for procurement
Quantification of supplies
Quantification = supply planning + forecasting Quantification determines when commodities must be delivered to ensure uninterrupted supply, e.g. expected demand, stock already on order, expired stock and other wastage, freight, logistics, insurance and other costs, lead times and buffer stocks. Forecasting is the expected consumption of commodities in a particular timeframe (1 year) Suggest to use FORLAB tool (maintained by USAID and CHAI)

6. Technical specifications
Set specifications
Product selection
Quality
WHO PQ or ISO 13485
Any other form of quality assessment
Performance
Qualitative - sensitivity, specificity, invalid rate
Quantitative – intra/inter assay variation, trueness of measurement
Operational
Specimen type
Through-put
Time to first result
Consumables required but not provided
National authorities may wish to conduct small-scale verification study to guide product selection For example, WHO recommends to establish and verify HIV testing algorithm (not competitive bidding). Don’t repeat studies to re-confirm sensitivity/specificity. Must be adequately documented to justify sole sourcing

7. Procurement methods for IVDs
If no national capacity for procurement
Provide justification for product selection
Use WHO PQ Public Report and verification study report
Use WHO/UNICEF/UNDP for procurement services who have already established long term agreements with suppliers of WHO prequalified products
Provide required quantities and desired delivery time
Provide payment on time to ensure goods are released

8. UN joint tender for IVDs
One RFQ issued that covers supply to
WHO
UNICEF
UNDP
UNFPA
RFQ send to suppliers of WHO prequalified products or otherwise eligible products
Technical and commercial evaluation conducted jointly by UN agencies
LTA signed by each organization against their terms and conditions for the same price/test (non-volume dependent)

9. Procurement methods for IVDs
If nationally conducted procurement
Request bid from suppliers for products identified during product selection
Review documentation submitted against specifications
Refer to WHO Public Report labelling for exact identification of WHO PQed IVD
Check expiry dates of quality certificates
Negotiate guaranteed shelf life upon delivery which differs from shelf life upon manufacture
Suggest staggered deliveries rather than 12 months supply delivered at once
Consider all the clauses with price impact such as INCOTERMS, warranties, agent/distributor fees
If analyzer, ensure provision for installation, training and maintenance

10. How to contract for IVDs analyzers
Contracting
Better purchasing models
An all-inclusive price per reportable test result structure that can be made available to all implementing partners within a country Ensure contracts are inclusive service and maintenance with continued need for training and technical support Confirm data solutions for patient results and post-market surveillance
Pursue reagent rental/leasing over purchase Leverage data to negotiate contract terms and best fit solutions for existing analyzers Reagent bundling for existing analyzers Amortizing instruments in reagent costs Ensuring back-up contingency plans Revisit and renegotiate agreements bi- annually
Williams J USAID. Personal communication

11. Quality control for IVDs
Ensure that quality control materials are often supplied separately but must procured when reagents are procured
Test kit controls for RDTs
Control kits for IVD analyzers
Use QC materials to validate test runs and to gather post-market data for IVD manufacturers
Monitor rate of invalid/unreturnable results

12. Evaluating supplier performance
Suggest to use On-Time In-Full (OTIF) as an indicator of performance, including:
if the goods were delivered in acceptable condition;
if orders were full and complete;
if guaranteed shelf life was delivered;
if complaints were handled appropriately; and
if responses to breakdowns were dealt with efficiently.

13. Thank you www.who.int Anita Sands WHO
.int Safety and Vigilance Team, Essential Medicines and Health Products
20, Avenue Appia Geneva
Switzerland