IDx: An exploration of regulatory, corporate, relational, and technical barriers to uptake of diagnostics in the fight against AMR

Description

Antibiotic resistance is when dangerous bacteria become immune to certain antibiotics that previously used to be able to kill them. The rise in antibiotic resistance leads to increased suffering and death in health care around the world. Up to 50% of antibiotics are believed to be incorrectly prescribed. Not being prescribed the right drug at the first attempt has been found to more than double mortality among infection patients in an intensive care unit. Moreover, all use of antibiotics breeds antibiotic resistance (AMR), including unnecessary use. Bacterial diagnostics are critically important to correctly treat patients as they can identify the right antibiotic. However, despite their importance, such diagnostic technologies are rarely used.

Developing new bacterial diagnostics is far from easy. Although it is hardly emphasized in the research literature, the challenges in developing such diagnostics do not end when the technology itself is in place. On the contrary, the importance of new, advanced bacterial diagnostics is not matched by rapid implementation in hospital laboratories. This slow implementation creates problems for developing companies, for doctors, and ultimately for healthcare and for global efforts to reduce antibiotic resistance.

In the project, we examine challenges for developers of new bacterial diagnostics that arise after the product has passed the development phase. The project takes a broad perspective when examining obstacles to the introduction and correct use of diagnostic technology in healthcare.

Specifically, this project therefore tries to find out why this is the case by exploring regulatory, corporate, relational, and technical barriers to uptake of diagnostics in the fight against AMR. This means investigating barriers arising out of the diagnostic development processes of companies, the diagnostic regulations of health authorities, and the diagnostic use of health practitioners, or form the interactions of two or more of these.

In investigating this, Olof Lindahl and Chantal Morel at Uppsala University have worked with colleagues from the Karolinska Institute, Sweden; the industry association BEAM Alliance, France, Université de Laval, Canada, and the University of Cape Town, South Africa to address these issues. They have also consulted with international experts and policymakers in the field of diagnostics on challenges to implementation.

The obstacles identified in the project’s work concern, for example, government regulation of the development, procurement and use of diagnostics. They also include the private and public funding available for the development and use of diagnostics, how diagnostics are procured, the advantages and disadvantages of different diagnostic technologies, and how different healthcare systems affect the possibilities of using diagnostics.

The project has also explored what the most important commercialization challenges are, when they arise, and how they affect the spread of new bacterial diagnostic technologies. The project also tries, where possible, to identify ways to overcome these barriers to the introduction of diagnostic technologies.

Through this work, the project has generated impact in the form of new knowledge about the obstacles that prevent new diagnostics from being used in hospitals, which is important for both the ability to provide correct care in connection with bacterial infections, and a prerequisite for limiting and monitoring the spread of antibiotic resistance.