On 27 February, the European Federation of Allergy and Airways Diseases Patients’ Associations (EFA) submitted its input to the European Commission’s call for evidence on the Critical Medicines Act, aligning with the European Patients’ Forum (EPF) response. The Commission published the first proposal for the Act on 11 March, marking an important step in addressing medicine shortages across the EU.
EU’s legislation to regulate availability of critical medicines
Medicines shortages pose a serious public health risk across Europe, affecting access to treatment and patient safety and wellbeing. Due to the complexity and cross-border nature of medicines, a coordinated EU approach is crucial to tackling shortages in a coordinated manner and proportionately across Member States.
The European Commission proposal for a Critical Medicines Act Regulation (CMAR) is an EU priority. It is also a key element of the EU’s broader strategy for an EU #HealthUnion that focus now on securing medicines supply, complementing other initiatives like the revision of the pharmaceutical legislation, the EMA Union Critical Medicines List, and the Health Preparedness and Response Authority (DG HERA) Critical Medicines Alliance (CMA). EFA has been a vocal participating in all these processes and is a member of the CMA.
EFA’s response to the call for evidence on the Critical Medicines Act
For allergy, atopic eczema, asthma, and COPD patients, medicine shortages can be life-threatening and a source of reduced quality of life and economic burden.
EFA welcomes the European Commission efforts to prioritise access in the proposed CMAR but urges legislators to take a broader approach to medicines accessibility that extends beyond supply chain security to fully recognise the patients’ needs and the role of patient organisations addressing medicines shortages.
The following are our key advocacy points:
1. Refine the scope of the act
The CMAR prioritises the medicines listed on the Union Critical Medicines List elaborated by the EMA based on ongoing shortages and risks to health. The latest version of the EMA list includes five respiratory treatments and one for anaphylaxis. However, clarity is needed on which other medicines of common interest could fall within the CMAR’s scope to ensure EU action focuses on the most urgent needs for patients, and also on their preferences and alternative treatments.
2. Expand CMAR beyond industry to fully address public health
The CMAR largely concentrates on strengthening supply chains for medicines considered critical, focusing on the role of industry to ensure supply and the function of national authorities to ensure sustainability through procurement plans and stockpiling. It however fails to consider broader public health concerns, like health system adaptability and the vital role of patients and patient organisations. EFA calls for a broader strategy that includes:
- Use the opportunity of the CMAR to embed patient health literacy on medicine shortages to reduce their impact, through targeted and general awareness campaigns.
- Using patient-reported outcomes to better understand and address the real-world impact of shortages.
3. Ensuring patient involvement in public procurement
Harmonising public procurement rules at the EU level can help strengthen medicine supply chains. However, since shortages impact the delivery of healthcare and the standards of care according to clinical guidelines, EFA calls on the EU to consider long-term impacts on patient outcomes and medicine accessibility. Therefore EFA suggests that patient organisations and healthcare professionals should have a role in procurement and stockpiling discussions at EU and national levels to ensure patient needs are met.
4. Addressing risks in medicine importation
The CMAR promotes collaborative procurement and international partnerships to enhance availability. While this is important, imported medicines must meet EU safety and quality standards, be reimbursed where needed, and be accompanied by clear patient guidance respecting the regulatory requirements for a package leaflet in the local language. Additionally, we emphasise that imports should not create shortages in exporting regions.
Next Steps
EFA’s preliminary analysis of the Critical Medicines Act proposal indicates a strong focus on supply security but insufficient recognition of patient involvement. There are no provisions related to increasing patient health literacy and awareness on shortages.
The Act proposal includes the following chapters:
- Chapter I on general provisions describes the objective, scope and definitions. Next to critical medicines of the Union list, certain chapters also apply to “medicinal products of common interest”. While a definition is given and provides flexibility to Member States to decide when a medicine is insufficiently available and accessible to its patients, it remains too vague and irrespective of the patient need.
- Chapter II on strengthening the Union’s security of supply, which states the strategic objective of the Union and its added value to support Member States.
- Chapter III on enabling conditions for investment introduces the concept of strategic projects on the development of critical medicines, which would enjoy accelerated access to funding and fast-tracked procedures. To be considered a strategic project, it should comply with only 1 out of five criteria described in the Act. It is crucial these projects are accompanied by contractual binding commitments to improve medicine availability. In that sense, impact assessments must be regularly conducted. However, these aspects are not part of the provision.
- Chapter IV on demand side measures obliges Member State authorities to apply other procurement requirements next to price evaluation, and encourages without obligation to look at environmental sustainability and social rights linked to medicines. While this is a step towards harmonizing public procurement in the EU, procurement should also take into account long-term impact on patients, by including patients and healthcare providers in the procurement process. The chapter further obliges Member States to avoid negative impacts of contingency stocks on other Member States as well as allowing for collaborative procurements via different tools.
- Chapter V established the Critical Medicines Coordination Group which facilitates coordination in the implementation of the Regulation. The group, containing Member State experts, the Commission and the Agency as observer, failing to include civil society representatives such as patients organisations.
- Chapter VI on International Cooperation obliges the Commission to explore strategic partnerships to diversify the supply chain of critical medicines. It does not address any of the importation risks related to EU standards, patient impact and solidarity.
- Chapter VII amends the Regulation on Strategic Technologies for Europe Platform (STEP).
- Chapter VIII describes final provisions, including an obligation to evaluate effectiveness and impact five years after its application and every five years thereafter. It does not explicitly state the views of patients and patient organizations should be included.
Moving forward, EFA will continue to monitor the proposal, contribute to public consultations, and advocate for patient-centered policies that ensure medicines remain accessible and safe.
The full EFA response to the call for evidence can be found here.
You can find EPF’s statement on the proposal for the critical medicines act here.