Antimicrobial resistance (AMR) is a major public health challenge, responsible for approximately 35,000 deaths annually in the EU. The European Commission (EC), in an effort to reduce AMR, as it relates to human health specifically, seeks to restrict access to antimicrobials by focusing on several key measures including reclassification of non-prescription antimicrobial medicines, such as antibiotic, antifungal, and antiviral, to prescription-only medicines by amending the Directive 2001/83/EC relating to medicinal products for human use.

In addition, the EC has also set specific targets to reduce the overall consumption of antibiotics by 20% and ensure that at least 65% of antibiotic use in humans is appropriate. These targets are part of a broader effort to reduce the risk of developing resistant strains.

By introducing prescription-only status in these medicines, the EC aims to reduce their consumption, preserve their effectiveness, and slow down the development of resistance. Introducing a prescription-only status for antibiotics to mitigate proven resistance is reasonable, given that antibiotics are often overused, incorrectly prescribed, and frequently involve broad-spectrum antibiotics that contribute to resistance. However, applying the same restriction to antiviral and antifungal non-prescription medicines (NPMs) is the wrong approach, due to reasons outlined below.

1. Health outcomes: Currently, many common infections and conditions are managed effectively with NPMs. Restricting access to these treatments could result in delayed care, leading to more severe health issues and excess incidence in the population.
2. Health systems impact: As people transition from self-care to seeking medical advice from doctors to resolve their conditions, it is also expected that visits to health facilities will be increased. This adds further strain on the health care system and shifts resources to non-critical conditions.
3. Economic impact: Consequently, healthcare-related spendings will increase, as well as indirect costs to individuals such as lost productivity, due to time loss in disability and seeking care.
4. Effectiveness of AMR Reduction: Reclassifying NPMs primarily focuses only on restricting access and shifting care, without addressing the burden of diseases. Therefore, it remains unclear whether such policy change is the most effective approach for reducing consumption of antifungals and antivirals.

In view of this, AESGP has commissioned a study to explore the impact of reverse switching NPM antifungals and antivirals. The study evaluates the potential health outcomes, socioeconomic consequences and the impact to the volume of antifungals and antivirals use as a result of the proposed reclassification. The findings from this study will provide valuable insights to the regulators and policymakers, balancing the need to protect public health while minimizing negative impacts from unintended consequences.