Request Copyright Permission

A Global Warning for MDI Propellants: Clinical, Regulatory and Economic Factors Driving the Transition

Pritchard JN.

RDD Asia 2024. Volume 1, 2024: 1-17.

Abstract:

Climate change and global warming continue to be at the forefront of public and political discussions. In response, the European Union (EU) has taken proactive steps to accelerate the reduction in the climate impact of fluorinated gases, which impacts pressurized metered dose inhalers (pMDIs). pMDIs are an essential treatment option for at least 10–20% of asthma and chronic obstructive pulmonary disease (COPD) patients, as well as generally being more affordable, so there are potential onward consequences for patient health. Even although the phase-down under the Kigali Amendment to the Montreal Protocol is not as rapid for developing countries, potential issues with supply of bulk propellant from Western manufacturers, together with competition from other uses, including refrigeration and air conditioning may also lead to issues for pMDI production in these countries as early as 2032.

Alternative low global warming potential (GWP) pharmaceutical grade propellants are now available, and the regulatory requirements for propellant replacement are becoming clearer, to the extent that the first application for market authorization has been submitted in Europe (Breztri, AstraZeneca). Whilst development programs are expensive, commercial returns could be attractive due to potential patent protection for the first entrants, together with the potential removal of corresponding generic products as regulation and propellant cost and/or supply issues become more significant. Of course, transitioning to low GWP propellants also contributes to a company’s environmental and sustainability goals.

Around 70 pMDI companies across the globe are now facing these issues. Companies should monitor what is happening across all uses of F-gases, both current and low-GWP alternatives. Whilst there is more activity in the West, these issues are rapidly becoming global, and it would be prudent for all companies to act now.