A Proposal for a Global Diagnostics Facility

At the 76th World Health Assembly in May 2023, member states passed a resolution on “Strengthening Diagnostics Capacity,” showcasing political commitment to ensure greater access to diagnostics and emphasizing the centrality of diagnostics in ensuring quality health care. We at GHPP welcome this landmark step. Specifically, we applaud the resolution’s focus to “commit resources to invest in research and product development and to promote local production capacity for diagnostics, particularly in developing countries” and promoting “local production in a strategic and collaborative approach”

To achieve this and sustain local manufacturing, we propose establishing a Global Diagnostics Facility (GDxF). Our GDxF model aims to stimulate local production of diagnostics in low and middle-income countries by leveraging demand across platforms, pathologies, and countries. This approach could attract diverse suppliers, facilitate market access for manufacturers (including smaller enterprises), and contribute to a stable supply, fair pricing, and pro-access licensing. A detailed proposal on the structure, functions, and benefits of GDxF is below.

GLOBAL DIAGNOSTICS FACILITY (GDxF)

Proposal for global diagnostics facility for proactive market curation in order to channel demand and diversity and stabilize supply 

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

Unitaid and regional and global health actors should explore the benefits and feasibility of a global diagnostics facility (GDxF) that all countries could avail themselves of in order to source and purchase diagnostics instruments, tests, and supplies, which would have benefits of pooling demand across platforms, pathologies, countries, in order to attract multiple suppliers, provide market access for manufacturers (including smaller enterprises),and 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 and aggregating demand and lessons learned over the last 20 years from pooled procurement facilities, 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

During COVID-19, international development banks, heads of state and other key global health actors voiced strong support for local manufacturing of diagnostics and other countermeasures. This rhetorical support, which affirms the need, hasn’t translated into massive meaningful action, but still could. However, without concerted efforts to ensure market shaping, the efforts to mobilize political and financial support for local manufactures could be squandered given the risk of lack of market access for LMIC manufacturers, and small and medium enterprises (SMEs), in particular, to sell their products. GDxF could help channel demand in order to keep the supply side healthy and robust across multiple suppliers, including SMEs in LMICs.

The rhetorical support to expand local production of diagnostics in LMICs in the face of inequitable availability of Covid-19 tests is on the ascension and laudatory.

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 as:
  • 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