Potential impact of the draft PFAS legislation on patients with asthma and chronic lower respiratory diseases in the European Union

Rationale: The European Chemicals Agency (ECHA) is reviewing proposed legislation for a class ban of per- and polyfluoroalkyl substances (PFAS) molecules from 2026, based on chemical structure, which would encompass currently used propellants in pressurized metered dose inhalers (pMDIs) and HFO1234ze(E); a next generation propellant with near zero global warming potential; which is non-persistent, non-bioaccumulative and non-toxic. To understand the potential impact of the proposed ban, we estimated the prevalent population of respiratory patients in Europe who utilize a pMDI device. Methods: Inhaler sales data, as a surrogate of inhaler use, were obtained from the IQVIA Quarterly MIDAS database (2021). The total patient population living with asthma and/or chronic lower respiratory disease (CLRD, including chronic obstructive pulmonary disease) was calculated using available global, regional, and/or country-specific disease prevalence statistics. Total pMDI utilization was estimated by adjusting the calculated patient population for the pMDI usage factor. Results: The prevalent population of patients living with asthma and CLRD across 27 European countries (EU27) was estimated at 25.4 million and 19.2 million, respectively (Table). After adjusting for the pMDI usage factor, an estimated total of 18.2 million European patients living with asthma and CLRD received a pMDI device as part of their care in 2021; of these patients, an estimated 11.9 million and 9.0 million were living with asthma and CLRD, respectively. In the five largest European Union countries (EU5), there were 13.6 million patients estimated to require a pMDI. Conclusions: These data highlight the potentially high number of patients who could be affected by the draft PFAS legislation being evaluated by ECHA. It is important that any environmental legislation that impacts pMDIs considers the socioeconomic consequences emanating from a restriction of these essential medicines. Funding: AstraZeneca funded this analysis.