New EU rules on F-Gases could impact metered dose inhalers (MDIs), crucial for asthma and COPD patients, by treating them like ordinary products. EFA has advocated for adjustments to the legislation to ensure that MDIs are appropriately regulated, protecting patient health and medication adherence.
This month, as part of the green and sustainability agenda, the European Commission adopted new rules on the labelling of products containing fluorinated greenhouse gases (F-Gases), that will apply from 1 January 2025.
The new rules were proposed as a draft for consultation of stakeholders back in June, and EFA responded to the European Commission, highlighting its significance for the EFA community, particularly regarding the labelling of metred dose inhalers (MDIs) used in the treatment for asthma and COPD patients.
The proposal, which comes from the Directorate-General of the European Commission in charge with climate action, focuses on the environmental footprint of products containing F-gases. However, it fails to acknowledge the implications this legislation has specifically on MDIs, which are not an ordinary commodity, but rather life-saving treatment prescribed by healthcare professionals for patients with chronic airway diseases. Despite EFA’s emphasis on the potential health impacts and the importance of clear labelling for medicinal products in our consultation response, the final framework lacks specific considerations for the health implications of using MDIs containing F-Gases.
EFA is concerned with how medicinal products and devices, such as MDIs in this case, are seen as any other product that contain the F-Gases, while they are products that are used by patients who are dependent on their medication. Such rules that contain no clear information on the health impact (or lack of) of making use of an MDI containing F-gases can lead to lower adherence, poor health outcomes and unnecessary concern.
As the European Medicines Agency (EMA) is the agency which will be in charge of authorising the information and providing labelling guidelines for companies, EFA stays committed to work with the EMA and ensure that patients outcomes are not impacted by the new changes in the rules.