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“Totally Unacceptable” – Industry, Experts React To EU OTC Antimicrobial Reverse-Switch Proposal

Executive Summary

HBW Insight asked European consumer healthcare trade associations and experts for reactions to the news that OTC antifungals, like treatments for athlete’s foot, and OTC antivirals, like cold sore creams, could soon become prescription-only within the European Union.

OTC antifungals, like treatments for athlete’s foot, and OTC antivirals like cold sore creams could soon become prescription-only within the European Union, according to the European Commission.

New “prudent use” rules proposed by the Commission as part of its reforms to EU pharmaceutical legislation include placing OTC antimicrobials under prescription status within the region, revealed the EC's Olga Solomon at the AESGP's Annual Meeting in Paris, France on 23 May.  (Also see "AESGP Annual Meeting: OTC Antifungals, Antivirals Could Become Rx In EU" - HBW Insight, 24 May, 2023.)

In this article, we compile reactions to the news from European OTC trade associations, including Germany, the Netherlands, France, Austria and Switzerland, as well as from global switch expert Natalie Gauld.

Hubertus Cranz, Director General, German Medicines Manufacturers´ Association (BAH)

Hubertus Cranz

Director General, German medicines manufacturers' association, BAH

“Antifungals and antivirals for external use have been for decades an established part of selfcare. They help millions of sufferers, who often look for relief at short notice. To put all these products under prescription is totally unacceptable. The certainly well intended proposal for the revision of the European Union pharmaceutical legislation has to be amended during the legislative procedure in European Council and Parliament. BAH is confident that in light of the scientific profile and the socioeconomic value of these products common sense will prevail at the end.”

Bernard Mauritz

Bernard Mauritz

Executive Director, Dutch OTC medicines manufacturers’ association, Neprofarm

“Prescription status is not an appropriate risk mitigation measure, neither to prevent anti-microbial resistance (AMR), nor to reduce pollution by medicinal products. It will not take away the reason why people take these medicines and will therefore force them to consult a doctor to get a treatment for their symptoms. That will increase the number of doctors’ consultations, while the healthcare system is already overburdened.”

Luc Besancon

Luc Besancon

Executive Director, French self-care industry association, NèreS

“In a time of medical doctor shortages and increased difficulties to have a consultation, such a change would further increase pressure on GPs and prevent prompt responses to minor ailments, while having a significant impact on our industry.”

Christina Nageler, Managing Director, Austrian self-care association, IGEPHA

Christina Nageler

Managing Director, Austrian self-care association, IGEPHA

“While we welcome the Commission's reforms to EU pharmaceutical legislation, it is important to be cautious about the unintended consequences that these reforms may have on the self-care industry. While the reforms are intended to improve patient safety and increase access to medicines, they may also limit consumer choice and restrict access to self-care products. It is important to ensure that any new regulations are carefully crafted to balance the need for patient safety with the need for consumer choice and access to self-care products. IGEPHA believes that it is important to stay informed about these issues and to advocate for policies that support both patient safety and consumer choice in the self-care industry.”

Martin Bangerter, Managing Director, Swiss self-medication industry association, ASSGP

Martin Bangerter

Managing Director, Swiss self-medication industry association, ASSGP

“The Commission's undifferentiated assessment to reclassify antifungal and antiviral drugs from OTC to prescription-only status in order to avoid potential resistances has surprised us. This is mainly because the therapeutic benefits, quick availability, and safe application, aided by pharmacy consultation, significantly outweigh potential AMR risks associated with these drugs available for self-medication. Such a decision would unnecessarily weaken the potential of self-medication and inevitably lead to higher costs in the healthcare system. On the one hand, it would require a doctor's visit for prescription, and on the other hand, there is a concern that corresponding illnesses would tend to be treated only at a later stage.”

Natalie Gauld

Natalie Gauld

Global switch expert, former member of the New Zealand medicines classification committee

“It would be good to have evidence shared that has led to this decision. If there is not evidence supporting this decision across the board, we should not be disadvantaging patients or the health system for something that may have no benefit. If we look at vaginal antifungals, these are medicines that women need fast and often at the weekend, they should not be made to go to the doctor for them unless they have red flags – something pharmacy can work out. A woman with vaginal thrush having to wait days to see a doctor or sit for three or four hours in a clinic waiting will be uncomfortable and hugely inconvenienced only to get what they would normally have got at the pharmacy. It would also add a burden to doctors. Vaginal antifungals have been OTC for at least 30 years in many countries, so it is hard to see that there is suddenly a problem with them now. We need to be evidence-based, patient-centred and transparent with reclassification decisions, and a blanket decision like this does not seem to meet all of these criteria.”

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