Overcoming Barriers to Scale-Up Point-of-Care Testing: Insights from Key Stakeholders

Study Overview

Thirty participants, including 12 women and 18 men, took part in semi-structured interviews. The group included CEOs, directors, professors, and chief medical officers, with six mid-level participants chosen for their expertise.

The interviews focused on Unitaid’s ‘conditions for scale-up’ and ‘country readiness’. Participants identified barriers and enablers in regulatory frameworks that affect sustainable access and country readiness, emphasizing supportive policies, political engagement, and national advocacy.

Conditions for Scale-Up

Regulatory Approvals

High regulation costs pose a barrier to market access. Participants noted that application fees to the Therapeutic Goods Administration (TGA) are often too high, especially for smaller markets. This leads to financial inhibition for companies seeking approvals. There were calls to base fees on the potential market size of testing products.

One participant commented on the burden of registration costs and the need for assurances about market volume to motivate companies to pursue regulatory approval.

Regulatory Rigor

The degree of regulatory rigor also affects market access. The risk associated with tests should determine the level of scrutiny required for approval. An example cited was the U.S. reclassification of hepatitis C diagnostics, which lowered regulatory barriers, making it more appealing for companies to enter the market.

Establishing Country Readiness for Scale-Up

Funding Models and Pricing

Participants highlighted the need for sustainable funding models to motivate companies to invest in regulatory approval costs. Without proper return on investment, companies may withdraw from pursuing market access. Affordable pricing is crucial to ensure that out-of-pocket expenses do not hinder usage among providers and patients.

One participant stated that the funding model is a key enabler for scale-up.

National Advocacy

National strategies and commitments play a significant role in policy support for scale-up. For instance, WHO guidelines help shape health policies in various countries. Participants acknowledged that Australia’s national strategies for specific diseases facilitate advocacy and create frameworks for implementing point-of-care (POC) testing.

However, discrepancies between policy recommendations and existing regulatory frameworks can hinder effective implementation. POC testing often blurs the lines between primary care and traditional laboratory testing, complicating its acceptance under current guidelines.

Advocacy and Responsibility

Unique challenges exist since no specific body advocates for POC testing market access in Australia. Advocacy efforts often rely on peak bodies, which may lack the necessary resources or influence.

Participants expressed a need for a dedicated group to champion POC testing efforts. Concerns about advocacy fatigue emerged, indicating that sustained interest and engagement are essential for policy change.

COVID-19 POC Testing as a Case Example

The COVID-19 pandemic showcased the effectiveness of POC testing, leading to rapid implementations that can serve as a model for other diagnostic tests. Participants believe that the success of COVID-19 testing can drive advocacy and support for future infectious disease testing initiatives.

This swift action illustrates that government willingness and financial support can overcome barriers and enhance market readiness for new diagnostic technologies.