Respiratory clinicians in Europe are concerned that an EU push for ‘zero-carbon’ aerosol inhalers could leave patients without access to effective medications.
The EU is consulting on regulation of fluorinated greenhouse gas (‘F-gases’) with a roadmap proposing a steep cut in use of F-gases in medical aerosols from 2027 onwards that would apply to pressured metered dose inhalers (pMDIs).
Updated regulations would also forbid the export of metered dose inhalers to countries outside the EU that have not ratified the Montreal Protocol from 2028.
Some respiratory clinicians have raised concerns that while the need to replace F-gases is clear, the timeline for reduced quotas is too short and could lead to shortages of inhalers.
Speaking with the limbic Professor John Hurst, professor of respiratory medicine at University College London, stressed there was of course a need to address climate change but he had serious concerns about continuity of inhaler supply should the revised regulations be approved.
“This is very likely to impact people with respiratory diseases globally and I’m astonished about the way it’s happening with nobody knowing about it.”
He has sent a consultation response to the proposals on the tapering of F-gases and is urging other respiratory specialists to do the same.
“Most pharmaceutical companies are working on their next generation propellants but they will need to be tested so we know they’re equivalent which will take longer and they won’t be around for a few years after 2027,” he said.
Professor Hurst said estimates suggest transitioning to new green inhalers could take until 2030. In addition, there are concerns that while some, but not all, patients could switch to dry powder alternatives there is not the capacity to ramp up production on the scale needed.
“The goal to replace F-gases is absolutely the right thing to do, it’s the right aim, it’s the timescale that’s the problem.”
In his response to the consultation, he said “the likely result of the current transition timeline is that millions of people will no longer have access to life saving medicines specified on WHO Essential Medicines Lists” and noted that with the EU as a major manufacturer and exporter of inhalers the impact would be seen all over the world.
Pharmaceutical industry feedback to the EU consultation states that companies are developing low global warming potential (GWP) propellants and will transition their pMDI products to near zero carbon from 2025 onwards. However it may take several years to meet the strict EU regulatory requirements for new pharmaceutical products, they warn.
One submission notes that pMDI propellants constitute <0.05% of anthropogenic carbon emissions and calls for an extension of the medical exemption for F-gases to be maintained to 2030, “to allow time for [manufacturers] to complete the development and regulatory approval for low GWP pMDI devices, whilst preserving the right for doctors to tailor care for their respiratory patients.”
In an impact assessment report attached to the consultation, the European Commission said evaluation of current regulations on F-gases found it reduces emissions considerably and that it works relatively well but that it “requires more ambition in light of the reinforced EU’s 2030 climate target and the goal of reaching climate neutrality by 2050”.
In Australia the previous Coalition government’s response to the Montreal Protocol was a program starting in 2018 that avoids a phase out of HFC synthetic greenhouse gases but which aims to ‘phase down’ HFC imports by 85% before 2036.
“The gradual nature of the phase-down will provide users sufficient time to transition to alternatives, and the 15% residual amount of HFC provides a safeguard for uses where alternatives are not available,” the Department of Agriculture Water and Environment said.