New study recommends use of diagnostic tests

UM – 02/2023

Health Action International (HAI), a non-profit organisation that advocates access to and rational use of medicines, published a report in January on the use of diagnostics in the fight against antimicrobial resistance (AMR). It was supported by the PHG Foundation, a think tank on improving healthcare through genomics and related technologies. Its credo: the development of accurate and rapid diagnostics must be a priority to address the challenges posed by antimicrobial resistance.

The "invisible epidemic" – antimicrobial resistance

Every year, an estimated 33,000 people die in the European Union (EU) as a result of AMR. AMR also causes about 1.5 billion Euro in health costs and lost productivity every year. The development of effective medicines is unattractive for the industry because they often have to be held back as an emergency reserve to combat resistant germs, thus preventing their wide use. The World Health Organisation (WHO) has declared AMR to be one of the ten greatest threats to public health.

Bacterial or viral?

Misuse and overuse of antimicrobials are the main drivers for the development of AMR. Approaches to better target the use of antibiotics include the use of diagnostic tests. These are still used with restraint today. The reasons are many, ranging from availability to limitations in the usefulness of a test for different scenarios. According to the HAI, point-of-care (POC) diagnostics based on common biomarkers help to quickly and reliably assess infections in terms of their origin – bacterial or viral, and to prescribe medicines more responsibly.

Redefining cost efficiency

The cost efficiency of test procedures is also essential for future development. Often, only the direct costs of the test are taken into account in the studies. However, their benefits for the population and healthcare systems, as well as short, medium and long-term benefits from reducing antimicrobial resistance through appropriate prescription, must be included. The National Health Service (NHS) in England shows the way. There, two new antimicrobials would be paid for according to their value to the NHS. The number of prescriptions is not important. The HAI suggests extending this approach to the financing of diagnostic tests.

Will diagnostic tests become mandatory?

Combating AMR is one of the political priorities in the upcoming revision of European pharmaceutical legislation. With this in mind, making the use of diagnostics more mandatory prior to treatment with antimicrobials has also been considered. For example, a preliminary version of the draft directive on the so-called "Community Code relating to medicinal products for human use" (2001/83/EC Directive), being discussed in the political circles of Brussels, contains an explicit request to Member States to go beyond the proposals for directives and provide for the mandatory use of diagnostic tests prior to the prescription of antimicrobial medicinal products. The European Commission's official proposal on pharmaceutical legislation is expected to be published at the end of March.