PFAS-Free Alternatives Exist for 87% of Human Medicines, Landmark University of Freiburg Report Finds
Key Insights
A University of Freiburg report commissioned by the German Environment Agency (search) found that 87% of PFAS (search)-containing human medicines and 65% of veterinary medicines already have PFAS-free alternatives available for the same indications.
The study examined 111 human and 28 veterinary active pharmaceutical ingredients classified as PFAS (search) under the OECD definition, with alternatives in development for nearly all remaining human medicines.
Over 80% of the PFAS (search) active ingredients examined have the potential to break down into trifluoroacetic acid (search) (TFA), a persistent transformation product considered toxic to reproduction that does not degrade in the environment.
A comprehensive report commissioned by the German Environment Agency (search) (UBA) and produced by researchers at the University of Freiburg has revealed that the vast majority of PFAS (search)-containing active pharmaceutical ingredients used in human medicines could be replaced by environmentally safer alternatives. The study, published in Sustainable Chemistry and Pharmacy, found that for 87% of identified human medicines and 65% of veterinary medicines containing per- and polyfluorinated alkyl compounds (PFAS), PFAS-free active ingredients already exist for the same therapeutic applications.
The research team, led by Prof. Dr Michael Müller at the Institute for Pharmaceutical Sciences, examined 111 active pharmaceutical ingredients for human medicines and 28 for veterinary medicines that meet the PFAS (search) definition established by the Organisation for Economic Co-operation and Development (OECD). Beyond the existing alternatives, the researchers demonstrated that PFAS-free alternatives are already in development for almost all of the remaining human medicines.
"The fact that PFAS (search)-free alternatives already exist for almost all indications is a clear indication that, from a pharmacological point of view, per- or polyfluorination is not strictly necessary," emphasised Prof. Dr Müller.
PFAS (search) Function in Pharmaceuticals and Environmental Consequences
The report provides fundamental insights into the role of PFAS (search) in drug design. For the active pharmaceutical ingredients examined with known mechanisms of action, the PFAS content is not responsible for the intended medical effect. Instead, per- and polyfluorination is employed in pharmacology to improve the stability and distribution of active ingredients within the body.
However, these same properties create significant environmental challenges. Once excreted by patients, these substances are difficult or impossible to break down in nature and place a burden on ecosystems. They may accumulate in living organisms and degrade into problematic, persistent transformation products. According to the expert report, over 80% of the PFAS (search) active ingredients examined have the potential to break down into trifluoroacetic acid (search) (TFA), a compound that does not degrade in the environment, is carried by the water cycle, and is considered toxic to reproduction.
The researchers stressed that there is no immediate risk to patients from medicines containing PFAS (search), as these products undergo thorough testing for potential risks to human health before receiving marketing authorisation.
Clinical and Regulatory Implications
The findings carry immediate practical implications for prescribing practice. Doctors can now use these data to prioritise prescribing PFAS (search)-free medicines, particularly when initiating treatment for new patients, provided this is therapeutically appropriate. To support this transition, the UBA is incorporating the new data into its Environmental Pharmaceutical Index, enabling pharmacists to identify more environmentally friendly medicines.
UBA President Dr Dirk Messner underscored the broader significance: "The study's findings clearly show that environmental protection and healthcare need not be at odds with one another. The pharmaceutical industry already has enormous leverage in this area, right from the drug development process, to significantly reduce the release of persistent chemicals such as PFAS (search) into our waterways and soil in future."
For pharmaceutical companies engaged in research, the publication provides a clear impetus to consider the environmental impacts of per- and polyfluorinated substances at an early stage of drug development.
EU Regulatory Context
The findings arrive at a critical juncture for European chemical regulation. The European Chemicals Agency (search) (ECHA) is currently planning the final scientific assessment of a proposal for an EU-wide restriction on PFAS (search), with completion expected by the end of 2026. Based on this assessment, the European Commission is anticipated to present a corresponding draft legislative proposal in 2027.
Active pharmaceutical ingredients have historically been exempt from the planned PFAS (search) restriction because they are considered essential. The expert report now challenges this assumption, suggesting that more environmentally friendly alternatives are available in many therapeutic areas and that environmental characteristics should receive greater consideration when developing new medicines.