July 11, 2023
Problem Statement
Efforts to spur local production of diagnostics in low and middle-income countries risk failure without sustained curated access to markets
Summary Proposal
Regional and global health actors should explore the benefits and feasibility of a global diagnostics facility (GDxF). The GDxF would allow all countries to source and purchase imaging and diagnostics instruments, tests, and supplies. It would pool demand across platforms, pathologies, and countries to attract multiple suppliers. Additionally, it would provide market access for manufacturers, including smaller enterprises, contribute towards stable supply, fair prices and licenses, and facilitate market entry in countries.
Exploratory work should be done that pressure tests/evaluates and if successful, lays the foundation for a GDxF. There are recent lessons to build on, including documentation of the benefits of organizing[i] and aggregating demand and lessons learned over the last 20 years from pooled procurement facilities[ii], including the Global Drug Facility (GDF), the Global Fund to Fight AIDS, TB, and Malaria, and GAVI. There are also regional efforts to consider leveraging as part of this exercise, such as the Organisation of Eastern Caribbean States (OECS), PAHO pooled vaccine procurement, etc.
Context
Since the emergence of COVID-19, the rhetoric in support of local/regional manufacturing has been in the ascendency. Some global health actors, international development banks and financing institutions, multilateral, and bilateral programs have developed various policies, programs, and platform in support. However, without concerted efforts to ensure market shaping, the efforts to mobilize political, technical, and financial support for local manufacturers could be squandered. This is due to the risk of lack of market access for LMIC manufacturers, and small and medium enterprises (SMEs) in particular, to sell their products.
Benefits for Developers
The function and benefits for public and private diagnostics developers such a GDxF could include:
- Access to biobanks, standards, benchmarking panels and reagents
- Clearing house for clinical trial information
- Tech transfer hub for know-how, including know-how on developing tests that are manufacturer-ready
- Clearing house for open platforms that allow and enable third party test development
- Seeks to link developers with manufacturers for early promising tech
- Technical hub for sequencing data and software downloads
Benefits for Manufacturers
The function and benefits for public and private sector manufacturers, from MNCs to SMEs, of such a GDxF could include:
- Act as a tech transfer hub, both developer to manufacturer and manufacturer to manufacturer
- Sourcing and linkage to raw materials suppliers which has been flagged by manufacturers as a need. An additional benefit could be more affordable materials through aggregating demand.
- Access to external markets by strategic distribution of aggregate demand
- Assistance with applications for WHO Pre-Qualification Project, including financial assistance for quality management and other costly requirements. Subsidies would come from a mix of funding from external sources – such as international finance institutions (IFIs)– as well as sales revenue or surcharges on larger established manufacturers selling through the facility
- Predictability for manufacturers through market intel in the form of projections of future needs, demand and volumes
- (To be explored) Access to CAPEX for manufacturers who otherwise might be too small to receive from IFIs, development financing corporations (DFCs), etc.
Benefits for Buyers/Procurers
The function and benefits of such a facility for public and private sector purchasers could include:
- A “one stop shop” for diagnostics needs to match national diagnostics strategies
- Stability of supply through attracting suppliers using pooled aggregate demand
- Affordable prices and service and maintenance terms due to strengthen pooled negotiations across pathologies (not happening now by Global Fund for Xpert)
- Transparent reference prices to inform with national tendering processes
- Ability to buy on credit
- Assistance with national forecasting and PSCM
- Quick action to avert stockouts through central buffer supplies
- (Preferably) a rejection of extreme tiered pricing among LMICs. Note – this is the policy of the Global Drug Facility (GDF) housed at Stop TB Partnership. Also, GDF requires manufacturers to provide them with the lowest price world-wide.
- Quality and access to performance data
- Encouragement to enroll in WHO CRP to facilitate national registration
Additional, secondary benefits:
- A GDxF by capturing demand versus estimated need could help expose the “diagnostic gap” in LMICs, and in particular the package of diagnostics (and specimen collection) needed at the primary health care level.
- A GDxF could contribute to an alignment of R&D objectives with public health needs in LMICs. The needs of people who manage health systems, administer the tests, or are themselves health care beneficiaries, are not being heard and reflected in the research and development. Rather, the donor-driven and disease-specific, siloed approach to diagnostics development lends itself to commercial developers acting on donor funding or lucrative markets. This has resulted in benchtops full of single-disease instruments and in the best of cases, disease-specific cartridges and reagents for big box proprietary closed machines. One casualty of this siloed development is not listening to the real demand – importance of self-testing (knowledge as protection of households), and multidisease, less invasive, open diagnostics instruments that can fit into national diagnostics ecosystems, rather than the other way around. A GDxF could help developers understand and act according to this demand.
- Countries transitioning from the Global Fund’s pooled procurement to national tendering systems could benefit from the GDxF as a one stop shop given the problems experienced by some countries (the “procurement cliff”) due to lack of registration, lack of power in negotiation for affordable pricing and service and maintenance terms.
- The GDxF through engagement with governments would also encourage countries to adopt good policies and practices such
- Seeking a waiver from VAT for diagnostics in order to contain costs
- Seeking customs fee exemptions for importation of diagnostic raw materials and other means to facilitate timely and affordable importation by developers and manufacturers.
- Seeking a waiver for diagnostics from local tendering process in order to tap this pooled option
- Developing a national diagnostics policy and a national essential drug list
- Fast-tracking regulatory review and approval for priority diagnostics products
- Enrolling in WHO Collaborative Registration Procedure
- Allowing a premium for locally or regionally produced products
Sharonann Lynch <sharonann.lynch@georgetown.edu>
Agrata Sharma <agrata.sharma@georgetown.edu>