European Respiratory Society

ERS

ERS is the leading professional medical organization in Europe for respiratory health, with members in over 180 countries, focused on alleviating suffering from respiratory disease and promoting lung health.

Lobbying Activity

Response to EU’s next long-term budget (MFF) – EU funding for cross-border education, training and solidarity, youth, media, culture, and creative sectors, values, and civil society

25 Nov 2025

The European Respiratory Society (ERS) and the European Lung Foundation (ELF) urge the European Commission to ensure sustained funding for civil society under the next Multiannual Financial Framework (MFF). As it stands, the proposal does not have standalone elements for health. This inherently risks jeopardising the progress that has been achieved and reversing the efforts to build resilient health systems against current and future threats. Civil society, including patient, youth and health professionals organisations, is essential for achieving EU health security, resilience, preparedness, prevention, and management goals, providing independent evidence, and ensuring that policies reflect the needs of those most affected. This role is protected under Article 11 TEU, which mandates regular and transparent dialogue between EU institutions and civil society. To uphold this obligation, the next MFF must secure long-term, stable funding for civil society and maintain dedicated resources for EU health programmes such as EU4Health and Horizon Europe. 1. EU4Health Under the current MFF proposal, the EU4Health programme is absorbed into the European Competitiveness Fund (ECF) and included as part of a broader cluster on health, biotech, agriculture, and bioeconomy. This shows a de-prioritisation and raises concerns about the EUs ability to sustain its commitment to health. Specifically, the continuity of important health projects is at risk. The EU4Health programme was introduced to strengthen health security, improve health systems, and prepare for future health crises. It is important for the European Commission to ensure these objectives continue to be prioritised through dedicated resources. It has also proven to be an effective policyimplementation feedback mechanism, translating EU ambitions into practice and generating valuable evidence for future policymaking. ERS and ELF actively advocated for the inclusion of lung cancer screening in the EU Councils recommendations on cancer screening. This milestone was followed by a dedicated EU4Health budget line to fund pilot and implementation projects, including the SOLACE project (Strengthening the screening of Lung Cancer in Europe). SOLACE, active in 15 EU countries and 37 sites, provides practical insights that inform EU screening guidelines. This work aligns with the recent inclusion of lung cancer screening in the fifth European Code Against Cancer, published by the International Agency for Research on Cancer (IARC). ERS and ELF also contributed to the development of the respiratory strand within the Healthier Together EU Non-Communicable Diseases Initiative, which led to new EU4Health implementation calls. Two resulting projects, JARED (Member State-led) and LH4L (stakeholder-led, coordinated by ERS and ELF), support actions to prevent and manage chronic respiratory diseases across Europe. Their outcomes will provide important evidence for future EU policy and could lay the foundation for a future EU Respiratory Plan. These examples show how EU4Health successfully links policy, implementation, and evidence generation to strengthen public health in Europe. ERS and ELF urge the Commission to provide the health sector with a standalone window or cluster to guarantee funding for public health and research initiatives to ensure resilience and support the prosperity of public health and healthcare systems. 2. Horizon Europe On Horizon Europe, the ERS and ELF commends the European Commission for increasing the budget allocation but urges further transparency on the division of funds between the four pillars. Closely connecting the ECF and Horizon Europe funding would constitute a significant change compared to the current situation, and joint management might impact Horizons unique characteristics and broad focus. ... The full response is availbale as attachment.
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Meeting with Romana Jerković (Member of the European Parliament, Rapporteur)

25 Nov 2025 · Cardiovascular Health

Respiratory experts demand standalone health funding in EU budget

12 Nov 2025
Message — The ERS requests a separate, dedicated funding category for public health and research. They argue the main research fund must remain independent to support goals beyond economic growth.12
Why — This would secure dedicated resources for respiratory research and specific public health projects.3
Impact — Public health resilience suffers if health goals are sidelined by purely economic objectives.45

Response to Strategy on Intergenerational Fairness

11 Nov 2025

Strategy on Intergenerational Fairness Call for Evidence Response European Respiratory Society (ERS) and European Lung Foundation (ELF) answer the European Commissions Call for Evidence on a Strategy for Intergenerational Fairness The European Respiratory Society (ERS) and the European Lung Foundation (ELF) are strongly committed to a sustainable future where public health remains a priority. Prevention is key to ensure that future generations health is protected. Respiratory diseases are largely preventable but overwhelmingly contribute to Europes health challenges, with 42.7 million people living with asthma, over a quarter of which are children and young people, over 40.4 million with chronic obstructive pulmonary disease (COPD), 10.2 million people (30-69 years old) living with moderate to severe obstructive sleep apnea. Moreover, Europes societal cost of nine major lung conditions amounted to 1.4 trillion euros in 2021 and is increasing annually. Disadvantage during childhood such as prematurity, low socioeconomic status, lack of breastfeeding, early life tobacco or air pollution exposure, or disease in childhood such as asthma, respiratory infections and allergies can increase risk of impaired lung health and development. However, factors such as high levels of physical activity, healthy diet, favourable environments, vaccination, early detection and disease management can have a positive impact on lung development, potentially improving respiratory health over time. Prevention is key to improving respiratory health and should be considered holistically, encompassing primary, secondary, and tertiary levels. Ensuring people live in healthy environments, have access to early detection services, and receive timely interventions is essential. Additionally, for those who do fall ill, proper disease management is crucial to reduce suffering, slow disease progression, and prevent the onset of co-morbidities, for example for COPD which mainly affects the older generation. ERS and ELF recommend considering the following points: Ensure that prevention measures are prioritised: Respiratory diseases are often influenced by epigenetic factors. In particular, chronic lung diseases have been linked to epigenetically sensitive modifications indicating that epigenetic marks may play a pathogenic role in the onset and progression of these conditions. Intergenerational environmental exposures influence the health of future generations. For example, grandparents and parents smoking has been found to impact the onset of asthma in children. Lung development is also an important aspect to consider as it starts in utero and continues into adolescence, reaching its peak in adulthood. Importantly, lung development can be altered by several factors, including genetics and environmental. Prevention of disease is necessary from an early age to ensure everyone can live in healthy environments and in turn to minimize pressure on health systems, reducing health effects and costs. Campaigns like 'Healthy Lungs For Life, which aim to raise awareness on lung health and reduce the burden linked to lung diseases, need to be further promoted and supported at international European and national level. Involving the youth in current decisions is key to making sure all the relevant perspectives are part of the solution making process. Initiatives, such as the ELF Youth Group (focused on identifying and advocating for the needs of young people with lung conditions) should be encouraged while exploring further ideas to involve young generations. This aligns with the EU Youth Strategy and helps embed intergenerational dialogue in policymaking. [to see the full response please see attached pdf]
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European Respiratory Society urges respiratory-focused EU health crisis planning

29 Oct 2025
Message — The ERS requests integrating respiratory health into EU policies and prioritizing patients with chronic lung conditions. They advocate for expanding the ECDC mandate and involving patient organizations.123
Why — This would secure sustained funding and research focus specifically for respiratory medicine and surveillance.45
Impact — Other medical specialties might receive less attention and funding if planning prioritizes respiratory threats.6

Response to New European Bauhaus

17 Oct 2025

The European Respiratory Society and European Lung Foundation response to EU Commissions call for evidence on New European Bauhaus: achievements and future developments The European Respiratory Society and European Lung Foundation commend the European Commission for putting forward the New European Bauhaus. As the only major organ exposed to the outdoor environment, the lungs are affected by the surrounding environment throughout the life course. Therefore, respiratory considerations need to be embedded into any NEB projects. Respiratory health is significantly affected by the built environment. For example: Dampness and mould in indoor environments are associated with adverse respiratory health effects, particularly in children1 Poor housing quality affects indoor air quality, significantly impacting respiratory health2 Radon and asbestos increase the risk of lung cancer 3,4 There is a relationship between energy inefficient housing and winter respiratory disease among the older population5 Renovation of housing using healthy principles results in significant improvements in overall health, asthma, and non-asthma respiratory problems. Additionally, improving insultation existing buildings leads to drier and warmer indoor environments, improved health, decreased sick leave, and decreased visits to healthcare facilities.6 Health criteria, for example ventilation improvements, efficient heating, radon testing and mitigation, moisture management measures, integrated management and restrictions on the use of chemicals need to be integrated into building policies and projects under the NEB. Urban areas need to be healthy environments in accordance with air quality guidelines. Urban areas face a significant burden of both acute (infectious) and chronic respiratory diseases, largely driven by environmental factors such as high air pollution levels and dense populations. A comprehensive, multisectoral approach is essentialone that integrates diverse policy measures and urban innovations to address these challenges. The NEB should prioritise key actions including: Reducing air pollution through initiatives like low-emission zones, Expanding public spaces to promote walking and cycling via low-traffic neighbourhoods, superblocks, 15-minute cities, and car-free zones, Fostering greener cities by planting low-allergy trees. Strengthening EU air quality standards can further accelerate these transformations, ultimately improving the respiratory health of urban residents.7 [for full response please see attached pdf]
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European Respiratory Society urges lung health inclusion in heart plan

15 Sept 2025
Message — The group requests integrating respiratory health into cardiovascular prevention strategies and surveillance. They advocate for stronger vaccination programs and better management of chronic respiratory diseases.123
Why — This would elevate the priority and research funding for respiratory-related medical conditions.45
Impact — Failure to integrate these fields prevents Member States from reaching mortality reduction targets.6

European health groups demand stable funding in EU strategy

5 Sept 2025
Message — The groups demand sustainable, multi-annual funding and inclusion of advocacy in EU frameworks. They argue predictable resources prevent corporate dominance.12
Why — Predictable funding enables these groups to focus on long-term systemic policy impact.3
Impact — Commercial lobbyists lose their relative advantage if independent voices receive adequate funding.4

Response to Critical Medicines Act

6 Jul 2025

European Respiratory Society and European Lung Foundation feedback on European Commissions proposal for a Regulation - 2025/102 (COD) The European Respiratory Society (ERS) and the European Lung Foundation (ELF) support the European Commissions proposal for a Critical Medicines Act. Strengthening the security of supply and availability of critical medicines is crucial to ensure a high level of public health in the EU. The respiratory field comprises a wide range of diseases, including infectious, chronic, and rare conditions, making the issue of critical medicines one of great importance to respiratory patients and health professionals. It is also particularly important to ensure the continuous availability of immunosuppressive therapies for patients who have undergone lung transplantation. To ensure the EU Critical Medicines Act accounts for the needs of patients and health professionals, ERS and ELF highlight the following key aspects of the proposed act: 1. Regarding the definition of critical medicines, the Act refers to the list developed by the Commission, the European Medicines Agency (EMA), and the Heads of Medicines Agencies, based on the seriousness of the disease and the lack of alternatives. While this definition is acceptable as a starting point, it might benefit from greater transparency on how vulnerabilities are identified and prioritised across Member States, primarily to ensure it remains dynamic and responsive to evolving threats, including those driven by AMR or shifting manufacturing dependencies. 2. The Critical Medicines Alliance is not explicitly mentioned as a stakeholder in the implementation or governance structure of the Act. Ensuring the involvement of scientific and clinical societies and patients is important to advise on therapeutic prioritisation. Therefore, there should be a more formal consultative or advisory role in the ongoing work, perhaps through the Critical Medicines Coordination Group or a linked mechanism. 3. It is important to link the Critical Medicines Act with ongoing EU initiatives such as the Pharmaceutical Strategy, the EU4Health Programme, and Europes Beating Cancer Plan, to avoid fragmentation and ensure coherence across policies affecting medicine access and innovation. ERS and ELF support the proposal for the Critical Medicines Act and urge the EU to ensure that medicines are identified and prioritised transparently and in consultation with the Critical Medicines Alliance, including health professionals and patients.
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Respiratory Society demands patient-centered and accountable AI science strategy

5 Jun 2025
Message — The organization requests that AI systems integrate into clinical workflows without adding administrative burdens. They demand that explainability be a baseline requirement and that patients are involved in co-designing tools. Finally, they propose a Research and Innovation Council to prioritize public health and open infrastructure.123
Why — This would reduce clinician stress and improve diagnostic accuracy through better-supported data infrastructure.45
Impact — Underrepresented groups face significant harm if AI tools are developed using biased or unrepresentative data.67

Response to Evaluation of the European Centre for Disease Prevention and Control

12 May 2025

The 2022 Amended Regulation (EC) No 851/2004 establishing a European Centre for disease prevention and control (ECDC) mandates an evaluation of the ECDCs performance in relation to its objectives, mandate, tasks and procedures. Importantly, the 2025 evaluation shall examine the feasibility of extending the ECDC mandate to address the impact of cross border health threats on noncommunicable diseases1 The European Respiratory Society2 and the European Lung Foundation3 strongly advocate for the ECDCs mandate to be extended to noncommunicable diseases (NCDs), as solely focusing on communicable diseases is a missed opportunity to take a holistic approach to health in the EU, overlooks the relationship between communicable and noncommunicable diseases, and especially with NCDs becoming an increasing burden for health. Limiting the ECDC mandate to communicable diseases is a missed opportunity for health Since 2005, the ECDC has made a significant contribution to public health in Europe through its capacity to collect, evaluate, and disseminate scientific and technical data. Moreover, the ECDC provides high-quality expertise and assistance for national bodies to maintain EU-wide disease surveillance and early-warning systems. Supporting data collection of NCDs would increase the sustainability and efficiency of EU-level activities as well as complement the work of national bodies. Expanding the ECDCs mandate would create synergies with EU research programmes and data initiatives, such as the European Health Data Space, fostering innovation in disease prevention and health promotion The 2019 evaluation of the ECDC found that the extension of the Centres mandate in health information, monitoring, determinants, behaviour and promotion would equate to an extension of the mandate into the area of noncommunicable diseases. This is an area in need of strengthening at the EU level and the evaluation found that ECDC is a suitable candidate for increasing/centralising such activities in an existing EU agency.4 Noncommunicable diseases are a major challenge in the EU The majority of lung diseases are preventable, but the lack of effective prevention policies results in an estimated 803.5 billion societal cost of the 9 major lung diseases in the European Union (based on global burden of disease data from 2021)4. Limiting the ECDCs mandate to communicable diseases overlooks the growing and interconnected burden of NCDs, which now represent the leading causes of death and disability in Europe. Not including NCDs in the ECDC mandate will create an incomplete picture of public health and undermines coordinated EU action. The 2019 review identified the ECDC as a suitable candidate to increase activity for noncommunicable diseases in the EU. Specifically, it stated that the extended mandate would address the need for comprehensive evidence-based coverage of population health and burden of disease in an aging European society and provide information on the differences between Member States and the related policy needs for interventions to improve health, quality of life and well-being of EU citizens. It would also address permanent needs for EU-level activities in these areas, demonstrated by successive Joint Actions funded by the Commission under its Health Programme. 5 The current lack of EU-level surveillance and comparable data on chronic diseases must be addressed, as without it, it is difficult to coordinate effective responses and to have a clear vision for future EU health policy. An expanded mandate would also support health equity by enabling comparable indicators across Member States, helping identify and address disparities in NCD burden and health system responses... [For the full response, please refer to the attached pdf.]
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Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

6 May 2025 · Zdrowie płuc

Meeting with Kasia Jurczak (Head of Unit Research and Innovation)

3 Apr 2025 · Intensive care unit (ICU) focused platform trial for EU pandemic preparedness

Meeting with Dan-Ştefan Motreanu (Member of the European Parliament)

19 Feb 2025 · Respiratory health

Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament)

28 Nov 2024 · EU health policy

Meeting with Aldo Patriciello (Member of the European Parliament) and NOVE and Assicurazioni Generali S.p.A

21 Nov 2024 · first general meeting

Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

12 Nov 2024 · respiratory medicine in Europe

Meeting with Pietro Fiocchi (Member of the European Parliament)

15 Oct 2024 · Health

Meeting with Michalis Hadjipantela (Member of the European Parliament)

2 Oct 2024 · Introductory Meeting with European Respiratory Society

Meeting with Nicolás González Casares (Member of the European Parliament)

1 Oct 2024 · Lung diseases

Meeting with Nikos Papandreou (Member of the European Parliament)

24 Sept 2024 · Meeting with ERS

Meeting with Brando Benifei (Member of the European Parliament)

12 Sept 2024 · Policies and initiatives that prioritise lung health, promote preventive measures, and support early detection strategies.

Response to Environmental Implementation Review 2025

5 Jul 2024

Response of the European Respiratory Society, the European Lung Foundation, and Lungs Europe to the Call for Evidence EU environmental law 2025 implementation review The European Respiratory Society, the European Lung Foundation, and Lungs Europe fully support the approach of the European Commission in its 2025 implementation review. This process is key to ensure a high level of health protection is maintained across the Union and it is particularly important that the measures - already put in place - continue to protect vulnerable groups, such as respiratory patients, as much as possible. This review is an opportunity to proactively address the gaps in implementation of not only the environmental laws but also to better join up and link with other legislation aimed at clean air in Europe. 1. Health Protection and Vulnerable Population Clean air and healthy environments can reduce the risk of developing respiratory diseases in the population, particularly in children and the elderly. People with respiratory diseases are among the most vulnerable groups impacted by adverse effects on the environment, such as climate change. Exposure to environmental factors such as air pollution, pollen, and other aeroallergens can affect several respiratory outcomes. There needs to be a focus on mitigating future health, environmental, and economic costs associated with respiratory issues. 2. Impact of Air Pollution on Respiratory Health Air pollution, particularly involving nitrogen dioxide (NO2) and particulate matter (PM2.5), poses a significant threat to respiratory patients (such as in individuals with asthma and lung transplant patients). Impaired respiratory functions (such as in patients with asthma, chronic obstructive pulmonary diseases (COPD), or cystic fibrosis) are strongly affected by changes in weather or extreme weather events, leading to an increased risk of mortality. 3. Recommendations for the Ambient Air Quality Directive Stricter limit values for the concentrations of five main pollutants in the atmosphere should adhere to the WHO air quality recommendations This can help prevent 9.9% of the observed mortality in lung transplant recipients and that up to 11% of all incident childhood asthma cases. 4. Review of the National Emissions reduction Commitments (NEC) Directive The state of implementation of the National Emissions reduction Commitments (NEC) Directive should be considered in this review to help inform the review of the NEC Directive (set to be completed by 2025) A report by the European Environmental Bureau (EEB) states that all Member States except one will not meet their emission reduction commitments by 2030. This report considers that from 2030 onwards, more than half of the Member States will not adhere to their emission reduction commitments. Disparities in emissions among Member States are primarily due to the burning of solid fuels for domestic heating and industrial use The EU has responsibility under the EU Climate Law to address the anthropogenic emissions by sources of greenhouse gases, including methane. As such it is critical for this review to monitor the emission reduction levels and highlight the necessary changes that Member States must bring about. We need to ensure adequate alignment with the NEC Directive as well as the atmospheric concentrations of the pollutants set out in the AAQD. [to read the full consultation please see the attached file]
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Response to Evaluation of the National Emission reduction Commitments Directive

14 Mar 2024

National Emission reduction Commitments (NEC) Directive- Call for Evidence Consultation Introduction The European Respiratory Society (ERS) and the European Lung Foundation (ELF) appreciate the efforts made by the European Commission on the call for feedback on the reduction of national emissions of certain atmospheric pollutants that are known to cause significant harm to human health and to the environment. In the European Union (EU), 253,000 premature deaths are attributable to exposure to fine particular matter air pollution (PM2.5); 52,000 are attributable to exposure to nitrogen dioxide (NO2); and 22,000 are attributable to exposure to ozone (O3).1 Numerous cases of asthma, COPD, acute lower respiratory infections, lung cancer, stroke, myocardial infarction, hypertension, diabetes, dementia and mental health disorders, as well as aggravations of these diseases in already ill persons occur each year and impact families, societies as well as putting a high burden on our already overstretched health care systems. It is well understood now that the threat of air pollution is undeniable and poses a terrible threat to health. Air pollution is also closely related to climate change and its related health effects, as both, air pollution and climate change, have common causes and will amplify each others effects on health. The European legislation needs to address the consequences of airborne emissions for health. As part of the Green Deal, the EU launched the Zero Pollution Action Plan in May 2021, with the The zero pollution vision for 2050: a Healthy Planet for All - Air, water and soil pollution is reduced to levels no longer considered harmful to health and natural ecosystems and that respect the boundaries our planet can cope with, thus creating a toxic-free environment. 2 Achieving the Zero Pollution Action Plan also involves reducing premature deaths caused by air pollution by 55% as well as reduce the area where air pollution poses a threat to biodiversity by 25%.3 The NEC Directive is a great example of legislation that is fundamental for the future of respiratory health in Europe for the correct implementation and functioning of other legislations. To be able to set ambitious standards for air quality across the European Union (EU) and be a leader worldwide for better respiratory health, this Directive remains one of the main instruments the EU can use to reduce the burden of air pollution emitted in the Member States (MS). Air pollution doesnt respect borders, and it is necessary to make commitments in each MS to reduce emissions.4 As such, ERS and ELF are delighted with this opportunity to provide evidence and feedback on the NEC Directive. Effectiveness Reducing Emissions While the NEC Directive had the ambition to set out provisions for the National Emission reduction Commitments (NERCs) for 2020 and 2030, the established targets were low from their implementation in 2016. The 2020 targets were not ambitious enough, and the 2025 targets were not mandatory. The only driver for action remains the 2030 targets, breaches of which will only be recognized in the 2032 report.5 Additionally, a report in 2017 indicated that 22 Member States were already in compliance with at least one of the 2020 NERCs in the year 2012. In some cases, the proposed NERCs would even allow for higher emissions in 2020 than what was permitted under the old NEC Directive for 2010.6 As a consequence of low reduction targets, emissions were not reduced strongly enough to effectively ensure compliance with air pollution limit values in many countries during the past decade, and even more important, not reduced enough to ensure reduction of air pollutant concentrations to science-based recommendations for maximal concentrations across Europe as issued by the WHO in 20057 and 2021.8 [to read the full statement please see attached file]
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European health experts urge phase-out of coal-based heating appliances

14 Dec 2023
Message — The organization recommends phasing out new coal heaters and aligning emission limits with WHO guidelines. They also request that health experts be directly consulted on environmental product policies.123
Why — Stricter standards would reduce the clinical burden of respiratory diseases treated by medical professionals.45
Impact — Manufacturers of coal-based heaters would see their products banned from the European market.6

Respiratory Society calls for stricter health-focused boiler rules

14 Dec 2023
Message — The society requests a phase-out of coal boilers and stricter emission limits. They also demand testing methods that reflect real-life usage and greater health expert involvement.123
Why — Stricter standards would lower medical costs and reduce the prevalence of lung diseases.45
Impact — Manufacturers of coal and biomass boilers face higher costs and potential product bans.67

Meeting with Patrizia Toia (Member of the European Parliament)

2 Mar 2023 · Presentation of the activities of the organization (meeting held by the APA responsible)

Meeting with Michael Bloss (Member of the European Parliament)

27 Feb 2023 · Luftqualität, Gesundheitsfolgen Luftverschmutzung

Meeting with Petros Kokkalis (Member of the European Parliament, Shadow rapporteur)

31 Jan 2023 · Ambient Air Quality directives recast

Meeting with Javi López (Member of the European Parliament, Rapporteur) and European Environmental Bureau and

23 Jan 2023 · Revision of the Ambient Air Quality Directives

Meeting with Gerassimos Thomas (Director-General Taxation and Customs Union) and Philip Morris International Inc. and

18 May 2022 · Videoconference - Stakeholder event to gather views on the upcoming revision of the tobacco taxation directive

Meeting with Sara Cerdas (Member of the European Parliament)

8 Feb 2022 · Improving lung health through the future European Health Data Space

Meeting with Michèle Rivasi (Member of the European Parliament)

10 Sept 2021 · BECA

Meeting with Cyrus Engerer (Member of the European Parliament)

15 Jun 2021 · Lung Cancer Screening

Response to Revision of the EU legislation on medicines for children and rare diseases

6 Jan 2021

The European respiratory Society (ERS) is an international organisation that brings together physicians, healthcare professionals, scientists and other experts working in respiratory medicine. It is one of the leading medical organisations in the respiratory field, with a growing membership representing over 160 countries worldwide. Its mission is to promote lung health in order to alleviate suffering from disease and drive standards for respiratory medicine globally. Europe needs high-quality pharmaceutical innovation to improve health and address the needs of patients. A significant problem is the real deficiency of new innovative medicines in the respiratory field, as less than a dozen new classes of medicines have been developed for patients with respiratory disorders over the past 50 years. This is why we called for the revision of EU laws on medicines for rare diseases and children and for an updating of the incentives frameworks that could improve this situation. Scientific societies, academic research and patients must be central. Any revision proposed should embrace, not hinder, emerging science and technology and digital progress. The roadmap outlines optimistically, that all policy options are expected to have a positive impact on the quality of life of EU rare disease patients and children. The development of new medicines for children and patients suffering from a rare disease needs acceleration. We urge the Commission to therefore propose the most ambitious options in the legislation, given the large market failures and patient expectations for a stronger more effective health union. A broad definition of unmet medical needs must be deployed. There should be strong linkages to the proposed new EU biomedical authority - the health and emergency response authority (HERA). Moreover, it should be emphasised that innovations in this area will only be transformative, if accessibility and availability to medicines across the Union can be improved. Key to advances in drug therapy involves supporting initiatives of public interest. At the European Respiratory Society, we support over twenty clinical research collaborations many of which are exploring the effectiveness of treatments for rare and childhood respiratory diseases. The legislation (in connection with the EU4Health funding programme) should explore all possible incentives to support academic research and scientific societies to find effective treatments for the rare and childhood diseases where the market has failed. Moreover, there is a need to include health care professionals more strongly in clinical trials. We welcome that a robust evidence base will be gathered to inform the review and there are of course multiple factors to consider. For example, one drug developed for cystic fibrosis, focuses on only 8 to 9 possible mutations of the protein involved. However, patients with other mutations will still receive this medicine prescribed off-label by their doctor. As a result, there is no incentive left to research the effectiveness of the drug on other mutations. Another example is in pulmonary arterial hypertension (PAH) where several orphan drugs have been approved targeting the exactly the same mechanism. By incorporating requirements for future research on other applications in the actual approval document, issues such as this could be addressed. The studies announced in the roadmap should assess whether the best incentives are used to stimulate the development of new paediatric medicines. The procedure for obtaining additional market protection could benefit from more coordination and cooperation between developers and researchers. There is also a need for the revision to support registries of children with chronic diseases such as paedriatric asthma to allow rapid assessment of feasibility and recruitment into trials. In conclusion, we strongly support the most ambitious package possible - our patients all across Europe expect it.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

7 Jul 2020

On 11 March 2020, the World Health Organization (WHO) declared the novel SARS-CoV-2 coronavirus and associated respiratory disease COVID-19 to be a global pandemic. That pandemic, and particularly the severe acute respiratory disease causing both premature death and chronic lung conditions, has caused an unprecedented worldwide health crisis. The scale of the crisis demonstrates more than ever the importance of EU actions to foster respiratory health such as the pharmaceutical strategy. Before the pandemic, respiratory diseases represented an enormous and increasing healthcare and economic burden across Europe, with over 600 000 deaths a year and six million hospital admissions with total costs exceeding €380 billion per year [2, 14]. The pandemic has increased this burden and it has shown that the EU must ensure strategic autonomy in active pharmaceutical ingredients and raw materials. Europe needs high-quality pharmaceutical innovation to improve health and address the needs of patients. A significant problem is the real deficiency of new innovative medicines in the respiratory field, as less than a dozen new classes of medicines have been developed for patients with respiratory disorders over the past 50 years. Therefore, we support revising all relevant EU legislation and incentives frameworks that improve on this issue. Scientific societies, academic research and patients must be central to the strategy. Any regulation proposed should embrace, not hinder, emerging science and technology and digital progress such as Artificial Intelligence (AI). Key for respiratory patients is that the strategy is bold and ambitious and looks at meaningful ways together with the Member States to improve the accessibility, availability and affordability of medicines. Shortages of medicines are increasingly becoming an issue for patients and there is a need for a common European response to this problem. Specifically, we call for the strategy to: 1. Incentivise scientific societies and academic research to find effective treatments: we need to mitigate the enormous burden of respiratory diseases. 2. Scale up innovation on new classes of medicines this is particularly needed in the respiratory field. 3. Reduce costs: the strategy should examine ways to reduce the costs of drug development. 4. Foster improvements in the regulatory and incentive framework in respect to drug repurposing. Novel indications of ‘old’ therapies is an important way forward. 5. Boost clinical trials in the EU with a strong focus on academic input and independent clinical trials. 6. Accelerate the Health Technology Assessment proposal in order to improve access, affordability and availability of medicines. 7. Review and revise the legislation and on medicines for children (paediatric regulation.) 8. Examine the rare diseases legislation (orphan regulation) and propose improvements. 9. Expand the mandate and resources of the European Medicines Agency. 10. Embrace not hinder the implementation of new health technologies.
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Meeting with Virginijus Sinkevičius (Commissioner) and

11 May 2020 · To discuss the Green Deal implementation, delivery of zero pollution ambition and exchange of views on latest scientific developments and findings on air pollution

Response to EU rules on industrial emissions - revision

20 Apr 2020

In 2019 Commission President von der Leyen announced the European Green Deal to transform the EU into a fair and prosperous society, with a modern, resource-efficient and competitive economy where there are no net emissions of greenhouse gases in 2050 and where economic growth is decoupled from resource use. The European Respiratory Society welcomed this announcement, in particular the provisions for a climate law to enshrine climate neutrality in legislation as well as a zero-pollution action plan. Representing respiratory health, we are acutely aware of the burden of lung disease in Europe and the expanding body of evidence surrounding the adverse health effects of air pollution. We agree with the Council Conclusions of 5 March that IED revision must be coherent with other efforts to reduce levels of ambient air pollution. To that end, tackling pollution at source is key. In 2017, industry was responsible for over half of all anthropogenic emissions to air of CO2, SOx, NMVOC and the heavy metals Cd, Hg and Pb across the EEA-33. It further contributed to emissions of NOx and PM10, albeit to a lesser degree. Any revision of the Industrial Emissions Directive must be based on the consideration that the ‘’Best Available Technique”’ is the one which prioritises human health through promoting the relevant industrial action with the least negative environmental impact – in particular when it comes to the energy, chemical and ferrous metals sectors. Current events have overtaken this consultation process. The window to respond to this roadmap takes place against an unprecedented health emergency. The knock-on impact of the European wide lockdown poses dramatic challenges to our society, and Europe’s economy will require significant support to rebuild. We maintain that, nonetheless, the policy response must be sustainable and must not result in the short-sighted discarding of environmental protections as seen in other jurisdictions. We count on the European Commission to be resolute and redouble commitments to move away from environmentally damaging practices and to galvanise the momentum witnessed before the COVID-19 pandemic.
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Response to Europe’s Beating Cancer Plan

3 Mar 2020

We welcome the opportunity to give input to this European Commission consultation on a roadmap for Europe’s Beating Cancer Plan and specifically comment on document [Ref. Ares (2020)693786 - 04/02/2020]. In summary, we agree with the suggestion to broaden the scope of cancer screening, we agree with objectives to further reduce prevalence of tobacco use and reduce environmental exposures and lastly we argue the mission on cancer must support a research target to tackle the deadliest of all cancers – lung cancer. ERS is an international not-for-profit organisation that brings together physicians, healthcare professionals, scientists and other experts working in respiratory medicine. We are one of the leading medical organisations in the respiratory field, with a growing membership of 40,000 members representing over 160 countries. Our mission is to promote lung health and alleviate suffering from disease and drive standards for respiratory medicine globally. Possible objectives – intervene early: to reduce the time to diagnosis, […]; to provide evidence-based indications to broaden the scope of cancer screening to other cancers (e.g. lung, prostate and gastric). We agree with the possible objective as outlined above. In the case of lung cancer: “Our job is no longer to assess whether low-dose CT screening for lung cancer works: it does. Our job is to identify the target population in which it will be acceptable and cost-effective.” We submit that there is a sufficient body of evidence to begin lung cancer screening of high-risk target populations in the EU. Two large scale clinical trials: The National Lung Cancer Screening Trial (NLST) and NELSON trial (Dutch/Belgian randomised lung cancer screening trial) showed that lung cancer screening using low-dose CT is feasible and reduces disease associated mortality. This evidence has been strengthened by further national trials across the member states of the EU. Lung cancer can only be successfully treated when diagnosed at an early stage. The European Commission through the Beating Cancer plan is best placed to put in motion common guidelines on lung cancer screening in order to help member states implement screening programmes for high risk individuals. Action at the EU would minimise the risk of unequal access to high-quality lung cancer screening and healthcare in the Member States. The European Beating Cancer Plan should conduct a review of the 2003 recommendations, take into account the latest evidence and put in motion common guidelines. In terms of research, the cancer mission could focus in on early detection and supporting research on target populations for screening of lung cancer. Possible objectives – prevent the preventable: further reduction of smoking prevalence We agree with the possible objective above. Smoking is a preventable cause of many cancers and other NCDs. The plan needs to consider options for further reduction of smoking and tobacco use. Updates of taxation and tobacco product regulation should take into account the harmful health effects of alternative nicotine delivery products and novel tobacco products including heated tobacco. Lastly, the Commission must do more to assist the Member States in fully implementing the Framework Convention on Tobacco Control. Possible objectives – prevent the preventable: tangible reduction in exposure to environmental risks We agree with the possible objective here and hope to see tangible revision of the EU air quality directives with a proposal in 2021 as outlined in the Green New Deal. In 2012, the International Agency for Research on Cancer, classified diesel engine exhaust as carcinogenic to human (Group 1). It is also well established that occupational exposure to asbestos, crystalline silica and hard metals cause lung cancer. As lung cancer is rising in non-smokers, the ambitious Zero Pollution Strategy should complement the Europe’s Beating Cancer Plan. [refs in file attached]
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Meeting with Vytenis Andriukaitis (Commissioner)

20 Nov 2019 · Promotion of lung health

Meeting with Vytenis Andriukaitis (Commissioner) and

22 Nov 2018 · Promotion of lung health

Response to Fitness check of the EU Ambient Air Quality Directives

23 Aug 2017

Air pollution is serious health determinant, currently responsible for the premature death of over 400,000 European citizens a year. In addition to mortality, it has a huge impact on the quality of life of those suffering from chronic respiratory and other chronic diseases. As a professional medical organisation, we consider the issue of ambient air pollution to be first and foremost a health question. This consideration must be key to any revision of the Ambient Air Quality Directives. Our feedback on the fitness check can be found in the file attached.
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