European Federation of Allergy and Airways Diseases Patients' Associations
EFA
The European Federation of Allergy and Airways Diseases Patients’ Associations (EFA) is the voice of the 200 million people living with allergy, asthma, chronic obstructive pulmonary disease (COPD) and atopic eczema in Europe.
ID: 720047092329-73
Lobbying Activity
Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics
6 Oct 2025
The European Federation of Allergy and Airways Diseases Patients Associations (EFA) is the voice of over 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe. We connect European stakeholders to ignite change and bridge the policy gaps on allergy and airways diseases so that patients live uncompromised lives, have the right and access to the best quality care and a safe environment. For the EFA community, ensuring a high level of patient safety through a comprehensive, patient-centred medical device regulation framework is essential. EFA welcomes the Commissions efforts in conducting a targeted evaluation of the Regulations (since 2024) and sees this call for evidence as a real opportunity to hear from the patient community on how to improve the implementation of the Regulations, in a way that preserves public health and safety of patients. EFA agrees with the problems identified in the previous call for evidence on the evaluation, but in this call for evidence, stresses again the importance of maintaining a high level of safety management during any review process. Building on this, we have outlined several considerations that could further ensure all devices on the market remain safe. Our recommendations aim to enhance patient protection while improving regulatory clarity and ensuring accessibility. 1) Medical device regulatory procedure: EFA welcomes efforts to simplify EU medical device regulations but regrets the lack of an impact assessment. The current fragmented system risks patient safety and limits involvement. EFA calls for a centralised EU procedure for high-risk devices, stronger patient representation in regulatory bodies, and specialized notified bodies to ensure consistent, high-quality assessments and equal access across Europe. 2) Access to care: Medical device shortages in Europe severely impact respiratory patients mental health, causing anxiety, depression, and isolation. EFA urges a centralized EU procedure for high-risk devices to ensure safety and equal access. Fragmented national systems delay care and exclude patient voices. Involving patients in regulatory bodies and creating specialized notified bodies can improve safety and reduce psychological distress. 3) Prevention of respiratory diseases: The MDR supports respiratory disease management by ensuring device safety through rigorous evaluation and surveillance. For patients with allergic asthma, reliable devices are vital. EFA stresses that streamlining must not weaken safety standards. A key gap is patient education. Ongoing training is essential but often lacking. A Dutch survey found 66% of chronic respiratory patients never received follow-up device education, despite annual training recommendations. 4) Investing in healthcare systems and innovation: EU-made medical devices are globally valued for their high standards, a key competitive advantage. While streamlining MDR reduces burdens and speeds market access, patient safety must remain paramount. MDR enables innovation, like AI respiratory tools, improving care for asthma and COPD. EFA urges highlighting these benefits and stresses that Member States' actions support, not hinder, EU-wide goals for better device regulation.
Read full responseResponse to EU cardiovascular health plan
16 Sept 2025
The European Federation of Allergy and Airways Diseases Patients Associations (EFA) is the voice of 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe. EFA welcomes a proposal for an EU Cardiovascular Health Plan, as EU-level action is fundamental to address cardiovascular diseases growing cause of death, disability and loss of productivity in the EU, severely impacting patients quality of life and health inequalities. EU legislation can help tackle the impact of cardiovascular diseases on allergy, food allergy, atopic eczema, asthma and COPD patients across Europe. As a patient organisation, EFA calls on the European Commission to consider the role of patients and the organisations representing them and involve them appropriately in the proposed Act. In our consultation response, we advocate for integrating respiratory diseases into the EU Cardiovascular Health Plan, recognizing the frequent overlap between conditions like COPD, pulmonary hypertension, and atrial fibrillation. Environmental factors such as air pollution and heatwaves, along with lifestyle risks like smoking, contribute significantly to both cardiovascular and respiratory diseases, underscoring the need for coordinated prevention strategies. EFA calls for integrated health checks, vaccination programs, and awareness campaigns to reduce the burden of non-communicable diseases (NCDs) and improve public health outcomes. Addressing health inequities is also essential, as social determinantssuch as socioeconomic status, education, gender, and regional disparitiesgreatly influence disease prevalence and mortality. Disadvantaged populations face higher risks, with middle-aged adults in lower socioeconomic groups experiencing up to 150% greater risk of premature death. Gender-specific factors further complicate care, with women facing higher asthma rates and unique challenges related to hormonal changes and healthcare access. EFA urges equity-focused interventions within the EU Cardiovascular Health Plan. To close care gaps, EFA supports increased investment in research and innovation, including AI, digital twins, and personalized medicine. We also call for a dedicated EU Lung Health Plan to address the growing burden of respiratory diseases and build on the success of the cardiovascular blueprint.
Read full responseResponse to European climate resilience and risk management law
4 Sept 2025
The European Federation of Allergy and Airways Diseases Patients' Associations (EFA) welcomes the opportunity to contribute to the call for evidence for a European Climate Resilience and Risk Management, meant to inform an integrated framework for climate adaptation to be adopted in 2026. Climate change poses a tangible threat to vulnerable populations such as patients living with allergy, atopic eczema, asthma and chronic obstructive pulmonary disease (COPD). In the attached document, EFA summarises the multiple risk factors arising from climate change, affirming the need to put health at the heart of future climate resilience plans. In essence, EFA stresses the urgency to ensure that: - Climate mitigation and adaptation should receive equal attention in policymaking, if EU is to enable a comprehensive, climate-proof framework - Vigorous climate-monitoring systems that integrate all climate-driven risks play a key role for an informed public and the prevention of disease - Robust civil protection services, based on emergency alert systems and comprehensive heat-health plans tailored to the needs of the most vulnerable - Increased awareness on the risks of climate change for all relevant actors, including healthcare professionals and patients - Participation of affected communities and citizens in decisions at regional, national and local level
Read full responseResponse to Critical Medicines Act
4 Jul 2025
The European Federation of Allergy and Airways Diseases Patients Associations (EFA) is the voice of 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe. EFA welcomes a proposal for a Critical Medicines Act as a clear effort to mitigate critical medicine shortages in the EU and continue completing the legislative framework of the EU Health Union. The EU is in a great position to address the global issue of availability and access to medicines and help tackle cross-border shortages of medicinal products, increasing EU-wide security of supply, contributing to access to medicines for allergy, food allergy, atopic eczema, asthma and COPD patients across Europe. As a patient organisation, EFA calls on the European Commission to consider patient experiences and the role of patients and the organisations representing them and involve them appropriately in addressing medicines shortages. That is why we encourage the European Commission to task the Union with a Critical Medicines Act that the addresses the dysfunctions in the supply of life saving medicines, but also addresses demand driven variables that modulate the scope and impact of shortages on patients. We have four overarching recommendations: 1. Focus on patient-centred criticality: EFA urges policymakers to broaden the Acts scope beyond the Union list, factoring in seasonal demand, vulnerable groups (e.g. children), and overuse risks. Clear criteria for medicinal products of common interest are needed. A preventive, patient-centred approach, addressing prescription habits and health literacy, can help to reduce shortages, enhance system sustainability, and protect patient safety. 2. Put patient health and safety first to address shortages: EFA urges a stronger public health and patient safety framing in the Act. Current language is market-driven, missing the opportunity to prioritise patient safety. We recommend amending Recitals 7, 12, and 14, and Articles 1.1, 7, 12.5, and 18.1 to explicitly include patient health and safety. Procurement rules must not lower safety standards in emergencies, as seen with adrenaline autoinjector shortages. Strategic projects should serve public health and patient safety, and procurement must ensure usability and patient safety. 3. Do not harm patients due to shortages: The Act should not only address critical shortages without alternatives but also ensure patient safety is not compromised. In Recital 39, EFA urges inclusion of safety, quality, and effectiveness of alternative supplies, considering treatment plans and patient choice. During shortages, clinical guideline adherence drops, risking patient outcomes, increased symptoms, and adverse effects. The Act must safeguard continuity of care and uphold treatment standards for patients. 4. Shortages as crisis communication: This Regulation is a key step for the European Health Union and can boost health literacy through better coordination on shortages. EFA urges the Commission and EMA to invest in people-centered communication, especially as healthcare digitalises. We recommend: (1) using EMA and national portals to provide clear, real-time shortage updates and guidance, and (2) addressing the mental health impact of shortages by linking patients to emotional support resources and patient organisations. EFA applauds the EU-level work on shortages and security of supply and remains engaged to continue working with the Commission on defining systems that guarantee optimal patients access and care. EFA is member of the Critical Medicines Alliance, the HERA Civil Society Forum and the EMA Patients and Consumers Working Party, where we represent allergy and airway diseases patients, providing key insights regarding medicines availability and security of supply of the patient population.
Read full responseResponse to Communication on the EU Stockpiling Strategy
9 May 2025
The European Federation of Allergy and Airways Diseases Patients Associations (EFA) is the voice of 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe. EFA welcomes the European Commissions proposal for an EU Stockpiling Strategy. EFA supports the need to increase the EUs preparedness and resilience and agrees that as with preparedness, stockpiling needs to be based on an all-hazards, whole-of-government and whole-of-society approach. EU legislation can help to strengthen the efficiency of preparedness and responses measures and increase EU-wide security of medicine supply, contributing to access to medicines for allergy, food allergy, atopic eczema, asthma and COPD patients across Europe. EFA has put forward four overarching recommendations: prioritise patient access to medicines in a crisis, ensure safety of medicines being stockpiled, coordinate medicine supply chains across the EU and recognise climate hazards for EU stockpiles. Within these recommendations, there are several considerations suggested: vaccination calendars, medicine delivery, stockpiling generic medicines, access to information, expiry dates, cold-chain requirements, stockpiling non-allergenic vaccines, monitoring stockpiling across the EU, harmonised contingency stocks framework, transparency of stock requirements, procurement practices, vulnerability assessments and climate hazards. Please consider the attachment for further information.
Read full responseResponse to EU Strategy on medical countermeasures
9 May 2025
The European Federation of Allergy and Airways Diseases Patients Associations (EFA) is the voice of 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe. EFA welcomes the proposal for a Strategy to support medical counter measures (MCM) against public health threats. EFA supports the need to reinforce the EUs health security framework, as learned from the COVID-19 pandemic. EU legislation can help to strengthen the efficiency of preparedness and responses measures and increase EU-wide security of medicine supply, contributing to access to medicines for allergy, food allergy, atopic eczema, asthma and COPD patients across Europe. The given Strategy must put the protection of people living with diseases at its core, as they are more vulnerable to public health threats. The current instability of conflict, trade policies, pandemic risks, chemical biological radiological and nuclear threats (CBRN), and environmental and climate change threats, create health threats which are not generated by patients. EFA has put forward five overarching recommendations: ensure access to and safety of crisis-relevant MCMs, prioritise patient safety in research and innovations, strengthen EU stockpiling and supply chains against public health threats, integrate climate hazards into MCMs against public health threats, and work together with civil society. Within these recommendations there are several considerations suggested: vaccination calendars, access to information, digital communication tools, innovation, precision medicine, paediatric populations, gender gap in research and observational/real life studies, equal access and distribution of MCMs, harmonised contingency stocks framework, procurement practices, climate change impacts on heath , climate change impacts on supply chains, Commission collaboration with civil society. Please consider the attachment for further information.
Read full responseResponse to EU Life sciences strategy
17 Apr 2025
The European Federation of Allergy and Airways Diseases Patients Associations (EFA) is the voice of 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe. EFA strongly supports integrating a health-in-all-policies approach in all decisions and especially in research, as health cuts across multiple disciplines and sectors. Medical, social and environmental research combined can untap further understanding around human and planetary health and support the development of novel solutions with the potential to address current unmet medical needs and improve the quality of life of people in Europe. An EU life sciences strategy should aim at facilitating and accelerating the green and digital transitions, improving preparedness, and addressing societal challenges. EFA encourages the European Commission to consider the following considerations: A) Key emerging research areas for allergy and airways patients 1) Continued improvement of technologies and advancements for health such as 1.1) Push precision medicine for better outcomes for patients 1.2) Improve treatments and digital solutions for asthma and COPD self-management 1.3) Promote research for paediatric populations 1.4) Reduce sex inequalities in medical research 1.5) Harness the full potential of a life-course immunization approach 1.6) Bolster observational, real-life studies, as innovative medicinal treatments is only one part of the improvements and solution do disease. 2) Research into healthcare system strengthening such as 2.1) Enhance the understanding of the underlying biological mechanisms of lung diseases and related risk factors 2.2) Propose methodologies for early identification of patients at-risk of COPD among non-smokers since 2.3) Advance multidisciplinary care for inflammatory diseases 2.4) Promote smooth healthcare transitions (HCT) from paediatric to adult healthcare systems. 3) Foster a multidisciplinary research approach to life sciences through 3.1) Dive deep into the concept of nature health as a solution to improve health outcomes 3.2) Promote monitoring systems for environmental health research. 3.3) Harness fully the interaction of indoor air quality on health. 3.4) Support research into identifying, monitoring and characterising emerging environmental risk factors 3.5) Emerging air pollutants such as black carbon (BC) and ultrafine particles (UFPs) 3.6) Accelerate work into the effects of vaping for respiratory and lung health, focusing on the long-term effects. 3.7) Investigate the effect of the consumption of novel foods 3.8 Study association of micro- and nanoplastics (MNPs) with the development and/or worsening of disease. B. Reinforce and establish European research infrastructures by 1) The European Health Data Space (EHDS) should be implemented in a patient-centred way 2) Link the EHDS with other data spaces such as the climate and environmental ones 3) Establish centres of excellence for chronic disease at Member State level 4) Reinforce and sustain clinical trial sites and promote studies that test decentralisation in clinical trials 5) European registries should be reinforced and integrated in disease specific research 6) Strengthen and expand the integrated European biobank network 7) Integrate innovative technologies such as AI tools and High-Performance Computing into life-science research. C. Clarify regulatory complexity in drug-device combination products and apply the climate agenda per pollutant and per sector. D. Promote engagement of patients in life sciences through the co-creation of research agendas in alignment with patient-identified needs; inclusion of patient representatives on ethics and advisory boards; (PROs) and patient experience data that reflect real-world experiences and patient preferences; transparent communication on how patient input has shaped research outcomes; investment in capacity-building and training for both patients and researchers.
Read full responseResponse to EU rules on medical devices and in vitro diagnostics - targeted evaluation
21 Mar 2025
The European Federation of Allergy and Airways Diseases Patients Associations (EFA) is the voice of over 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe. For our community of patients, ensuring a high level of patient safety through a comprehensive, patient-centred medical device regulation framework is essential. EFA has been engaged in the establishment of the Medical Device Regulation (MDR) since 2012, as the therapeutic areas of pulmonology and allergology have a large portfolio of specific medical devices and drug-device combination products. The MDR currently establishes such a framework. While there is always room for improvement, our community emphasizes the importance of maintaining a high level of safety management during any review process. Therefore, we have outlined several considerations below that could further ensure all devices on the market remain safe: 1) Setup mandatory patient education on medical devices 2) Increase medical device usability and safety 3) Increase patient participation in the medical device framework 4) Enhance patient access to post-marketing vigilance and reporting 5) Clarify the regulatory pathways of drug-device combination products 6) Establish an EU centralized procedure for medical devices 7) Allow fast-track innovation for low-risk medical devices 8) Promote commercialization of spare parts. We remain at the disposal of the EU institutions to inform policies and advance innovative medical devices in Europe.
Read full responseResponse to Critical Medicines Act
27 Feb 2025
EFA welcomes a proposal for a Critical Medicines Act, as EU-level action is fundamental to address the global issue of access to medicines. EU legislation can help tackle cross-border shortages of medicinal products and increase EU-wide security of supply, contributing to access to medicines for allergy, food allergy, atopic eczema, asthma and COPD patients across Europe. As a patient organisation, EFA calls on the European Commission to consider the role of patients and the organisations representing them and involve them appropriately in the proposed Act. The Act shouldnt primarily focus on the industry side, which entails a relatively narrow approach to supply and availability of medicines. Given that the aim of the Act is much broader than that, other critical aspects should be considered as well. EFA is a full and founding member of the European Patients Forum (EPF) and has contributed to EPFs response to the Critical Medicines Alliance Strategic Report. EFA therefore fully supports EPFs reply to the call for evidence on the future Critical Medicines Act. In line with their response, we have outlined below several key considerations for the Commission to take into account. Specifically, we encourage the Commission to take closer consideration to the following aspects: (1) A broad medicinal product scope. (2) Recognise the role patient organisations. (3) Focus on access beyond supply chain strengthening. (4) Impact measurement on patients. (5) Step-up public information around critical medicines. (6) Harmonise public procurement rules. (7) Same high standards for imported medicinal products. Please find our full response to this call for evidence in the attachment.
Read full response26 Nov 2024
The European Federation of Allergy and Airways Diseases Patients Associations (EFA) welcomes the opportunity to provide written feedback to the European Commissions Health Technology Assessment Regulation (HTAR) fifth draft implementing Regulation that structures the process for joint scientific consultations (JSC) on medical devices and in vitro diagnostic medical devices. Medical devices and in vitro diagnostic medical devices are essential for the allergy and chronic respiratory diseases patient community, as by using biological samples outside of the human body, they provide modern technologies for testing, monitoring and diagnosing diseases. Innovative and/or digital devices can significantly improve detection and disease management, significantly improve patients lives and therefore their regulation must also take into account the patient perspective. EFA proposes the European Commission and the EMA to consider revisiting the draft implementing act in the following areas: 1) Barriers for individual patient involvement in JSC processes on medical devices 2) Selection of patients organisations in JSC on medical devices and 3) Protection and processing of patient data. Please find attached our consultation reply which fully endorses the submission of the European Patients' Forum to this consultation.
Read full responseResponse to Health technology assessment – Joint scientific consultations on medicinal products for human use
29 Oct 2024
The European Federation of Allergy and Airways Diseases Patients Associations (EFA) welcomes the opportunity to provide written feedback to the HTARs fourth draft Implementing Regulation that covers the joint scientific consultation (JSC) on medicinal products and structures the selection and consultation of stakeholder organisations and patients, clinical experts and other relevant experts (individual experts). EFA is a full and founding member of the European Patients Forum (EPF) and has contributed to EPFs responses to HTA implementing regulations consultations. EFA fully supports EPFs reply to the consultation on the proposal at hand on JSC on medicinal products. With our response we make recommendations to the HTA Secretariat and the HTA Coordination Group on how improve the current proposal for an implementing regulation by 1) reducing barriers for individual patient involvement in EU JSC processes, 2) recognising the role of patients organisations in JSC and 3) clarifying the resulting JSC report and the obligations of Member States. EFA remains committed to contributing to the implementation of the Health Technology Assessment legislative framework in a patient-centred manner that serves the allergy and respiratory patients communities, as part of the HTA Stakeholder Network and further work in the implementation plan of the HTA Regulation. You may find EFAs full position to this consultation on JSC in the attachment.
Read full responseResponse to Health technology assessment – Cooperation with the European Medicines Agency
24 Jul 2024
The European Federation of Allergy and Airways Diseases Patients Associations (EFA) welcomes the adoption of the Health Technology Assessment Regulation (EU) 2021/2282 (HTAR), which contributes to reducing inequalities and improving patients access to the health technologies needed to stay healthy and prevent disease progression or disease, such as medicines, vaccines, and medical devices. We highly welcome the opportunity to provide written feedback on behalf of our patients community to this draft legislation that structures how the HTA Coordination Group and the European Medicines Agency (EMA) are set to cooperate and exchange information in relation to joint clinical assessment (JCA) of medicinal products, to joint scientific consultation (JSC) on medicinal products and medical devices, and around emerging health technologies (EHT). In our response, we highlighted: - The welcomed collaboration between the HTA and the EMA, and the need for integration in the HTA processes of EMAs learnings on patient engagement. - The need for clarification and alignment on the rights and responsibilities of experts in both processes. - The importance of strengthening cooperation on the identification of emerging health technologies (EHT). EFA remains committed to contributing to the implementation of the Health Technology Assessment legislative framework in a patient-centred manner that serves the respiratory patients community, as part of the HTA Stakeholder Network and further work in the implementation plan of the HTA Regulation. You may find EFAs full position to this consultation on the HTA cooperation with the EMA in the attachment.
Read full response26 Jun 2024
The European Federation of Allergy and Airways Diseases Patients Associations (EFA) is the independent and democratic voice of 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe. We bring together 46 national associations from 26 countries and channel their knowledge and demands to the EU institutions. EFA welcomes the adoption of the Health Technology Assessment Regulation (EU) 2021/2282 (HTAR), which contributes to improving patients access to the health technologies they need to stay healthy and prevent disease progression or disease, such as medicines, vaccines, and certain medical devices. We highly welcome the opportunity to provide written feedback on behalf of our patients community to this important consultation that is set to determine how patient participation, and therefore their needs, will be structured for EU joint HTA and beyond. EFA thus proposes that the implementing Regulation for the conflict of interests: - Enables patients organisations participation in the HTA process, and allows for the assessment of risks of conflict of interest among patient organisations in a structured and predictable manner, while looking at ways to manage the potential risk of conflict of interest, rather than applying a zero risk of conflict criteria. - Remains a balanced process that reflects the reality of patients who are part of patient organisations, while ensuring transparency of the process and trust in the EU joint HTA process. - Considers payments for reimbursement of expenses incurred during participation in a conference, seminar, training, or for research purposes not as financial interests that lead to excluding individual patients from taking part in the joint work on health technologies. - Clarifies the criteria on the basis of which the intention to engage in activities with a health technology developer will be determined within the meaning of Article 8(4) of the proposed draft implementing Regulation. EFA remains committed to contributing to the implementation of the Health Technology Assessment legislative framework in a patient-centred manner that serves the respiratory patients community, as part of the HTA Stakeholder Network and further work in the implementation plan of the HTA Regulation.
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