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.