After a consultative process which started in 2020, the European Commission published in June 2022 its proposal for a Regulation on Fluorinated Greenhouse Gases. The Regulation is currently being reviewed in the context of the Green Deal for Europe and the EU’s commitment to reduce greenhouse gas emissions from 2030.
Some F-Gases, as they are commonly known, are an important element of liquid inhalers used for asthma and chronic obstructive pulmonary disease (COPD), as they act as a propellant to quickly release the liquid medication into the lungs effortlessly. This legislation is paramount to shape the future inhaler-based treatment for asthma and COPD patients in Europe and beyond.
The proposal to reduce greenhouse gas emissions
The proposal plans to eliminate the F-Gases exemption for medical use (in asthma and COPD medication) to fully align the EU to international climate law.
By eliminating the exemption, inhalers will enter the EU F-Gases quota system (art 16.2) with a set volume of gas available, driving a progressive reduction of F-Gases in medicine, and therefore less greenhouse gases from asthma and COPD medication.
The EC proposal for the F-Gases regulation foresees a sharp curve down of around half per cent of the F-Gases volume used on MDIs in Europe. The EC opts for an optimistic scenario in which many inhalers would presumably be transitioned and available by 2027, with no impact for the patient.
EFA’s response pushes to combine human and planetary health
EFA welcomes the EU’s determination to reduce greenhouse emissions generated in the EU. Climate change negatively affects human health, and more especially the health of vulnerable people such as allergy, asthma and COPD patients. For EFA, having uncompromised environments for patients is part of our mission.
Our recommendations convey clear gaps to the EC proposal for a regulation:
- Monitor the EU and national authorisation procedures and real market access to ensure there are no medication gaps and shortages for patients at any time.
- Conduct research to inform the no impact hypothesis. With new inhalers foreseen to be ready by 2027 by the EC, medications for chronic respiratory disease cannot be changed overnight.
- Collaborate with EMA and HERA to ensure both treatment and preparedness needs are fulfilled during the F-Gas transition period, as F-gas inhalers are now considered as critical medicines during emergencies.
- Investigate the underlying reasons for the current steep increase in the use of F-Gas based inhalers in the EU.
- Scope different cost scenarios for patients access to their basic asthma and COPD both inside and outside the EU.
- Collect and monitor the evolution of asthma and COPD hospitalisations and deaths to measure the impact of this policy revisions from 2022.
- Document and generate evidence around climate-friendlier asthma and COPD treatment plans to prepare healthcare professionals and allowed patients’ informed choices, to structure the transition from a healthcare system perspective and to invest in patient education.
- Connect with the World Health Organisation and the Global Alliance on Respiratory Disease (GARD) to share the EU F-Gases decisions and inform their national care planning.
- Issue a factsheet for patients and healthcare professionals addressing the asthma and COPD inhaler portfolio that is subject to the F-Gases regulation and outlining the next steps.
Opportunity for better lung health
The F-Gases Regulation proposal focuses only on climate change mitigation. As patient representatives, we are strong supporters of a health-in-all-policies approach. We find the greenhouse gas reduction focus short-sighted to the inhaler challenge, as emissions from medication could also be achieved through positive, rather than restrictive, EU action.
The EU Regulation on F-Gases is an opportunity to further address the health requirements to reduce MDI use in Europe, addressing issues such as:
- the application of clinical guidelines for asthma and COPD at international, European and national levels
- patients’ rights, needs and treatment choices
- personalised medicine and alternative medicine development and affordability.
The above are necessary aspects to scale-down the use of MDI to the strictly necessary circumstances.
EFA is informing now Members of the European Parliament on the patient perspective on this important regulation for asthma and COPD in Europe.
Read EFA’s full response to the EU F-Gases regulation proposal.