Imagine waking up with a tight chest, struggling to breathe and hearing that your inhaler is out of stock at the pharmacy. For millions of people with asthma, severe allergy and other respiratory conditions across Europe, this terrifying scenario is all too familiar. Medicine shortages are a matter of living your life day by day, or sometimes a matter of life or death.
As the EU develops its Critical Medicines Act to address these growing medicine shortages, EFA asked the European Commission to reflect patient needs in the Act’s legislative proposal through its response to the DG SANTE public consultation. Building on EFA’s earlier feedback to the Call for Evidence in February 2025, our response reflects the real experiences of patients and stakeholders from the EFA Community of members featuring national experiences of shortages in Norway, the Netherlands, Spain, Germany, Italy and Bosnia and Herzegovina.
EFA Community’s patient-centred recommendations
1. Focus on patient-centred needs
EFA calls for a broader definition of “medicinal products of common interest” which takes into account seasonal needs, vulnerable populations like children, and risks of medicine overuse. A preventive, patient-centred approach that improves prescription habits and health literacy can reduce shortages and enhance patient safety.
2. Put patient health and safety first to address shortages
The Act must prioritise public health over market interests. EFA tables amendments to key Recitals and Articles to explicitly include patient safety. Emergency procurement rules must not compromise the quality and safety of medicines, as past shortages have sometimes forced patients to use suboptimal or unsafe alternatives.
3. Do not harm patients due to shortages
Medicine shortages should never force patients into unsafe alternatives or interrupted treatment. The Act must guarantee continuity of care, respect clinical guidelines, and uphold patient choice when substitutions are necessary.
4. Shortages as crisis communication
Shortages are a public health crisis. EFA calls on the EU to provide real-time, transparent updates on medicine availability through national and EU-wide portals. In addition, patients affected by shortages also need emotional support, which can be facilitated by connecting them with their local patient organisations.
As the EU Parliament and Council will begin negotiations on the Critical Medicines Act, EFA urges policymakers to adopt a patient-first approach that protects access, safety and continuity of care. We will continue to work with our members and stakeholders to ensure those living with chronic respiratory diseases in Europe no longer have to fear their next medicine shortage.
We thank our EFA community of members for their contributions and commitment to better care and treatment for patients in Europe!
Read our full response to the public consultation here.
Read EFA earlier perspective on the proposal here.