EFA

EFA's Annual General Meeting 2022

On 31^st March 2022, EFA held its Annual General Meeting (AGM) in an online format. The AGM was followed by two membership sessions. EFA is organising an in-person Member Re-Union for 26-27 May 2022 hosted by our two members in Iceland.

General Assembly takes care of business

During the business session, and after detailed presentation of all of the items, the AGM approved EFA’s 2021 Annual Report and accounts, and it adopted the 2022 Workplan and budget as well as a motion from the EFA Board to end coalition membership to EFA. Coalition membership allowed EFA Members from the same country to apply under a unique membership coalition, granting them with a unique vote. The AGM approved to maintain the membership at EUR 500 / year.

EFA welcomes three member organisations from Iceland, Slovakia and Turkey

After a warm welcome from EFA President Carla Jones, three applicant organisations were presented to the Annual General Meeting for consideration. EFA was pleased to welcome the Icelandic Lung Association, COPD Patients’ Society of Turkey and the Slovak Association of Allergic and Asthmatic Patients as full members after formal approval.

Their addition to the network brings EFA membership to 45 national member associations across 26 European countries.

Project and Patient Engagement Officer, Markaya Henderson also congratulated two Members Allergy and Me (Serbia) and Društvo AD (Slovenia), for their growth and accomplishments evidenced by their transition from Trial to Full Members in 2022.

EFA engages Members in a ‘Re-Imagining EFA Membership’ workshop

EFA led several brainstorming sessions to facilitate a re-imagining of what EFA membership brings at European and national levels. To set the stage for the workshop, Markaya Henderson presented preliminary results from the 2022 Membership survey including general demographic information of the network, Member priorities, and current and desired involvement in EFA activities.

Members were divided into three separate groups for the first brainstorming exercise: (1) Capacity Building and Training, (2) Patient Advocacy, and (3) Patient Evidence. Members were asked to evaluate each topic with consideration to current EFA activities, and to share perceived gaps and novel ideas.

For the second brainstorming exercise, Members were reassigned to new groups where each were asked to consider the function and their role in (1) EFA and EU Projects, (2) Events and (3) Working Groups.

EFA was delighted with the high level of attendance and engagement from Members and looks forward to presenting a summary evaluation of the exercises as part of the hybrid Member Re-Union in Iceland.

See you in Iceland for an in-person reunion!

To conclude the day, Events and Programme Officer Alessandra Percuoco presented the preliminary agenda for the upcoming hybrid Member Re-Union in Iceland from 26-27 May 2022.

She was complimented by an overview of pertinent information about Iceland from EFA Board Secretary and hosting Member representative, Fríða Þórðardóttir.

EFA members can register for the Member Re-Union here.

March saw the conclusion of CURE, a four-year long research project funded by the European Union Programme Horizon 2020 which explored new approaches to improve the manageability of asthma. The project focused on the use of bacteriophage (virus) intervention, also known as phage therapy, to address imbalances in the respiratory microbiome contributing to the disease.

Over the last four years, CURE researchers worked to predict with accuracy and repeatability the microbiological, immunological, and clinical effects of adding several types of phages to the respiratory microbiome. They also tried to design an appropriate intervention to the disease. The results of their research can help deliver personalised treatment to asthma patients to better manage their care and eventually lead to a cure for asthma.

Final project conference was a success!

Opening words at the CURE Conference

To showcase the results of the CURE project, EFA organised the CURE Final Conference “Towards a CURE for Asthma: Accelerating Innovation in Personalised Medicine and Phage Therapies” on 15^th March, with the aim of informing the public on the advances in the research, facilitating policy discussion on the regulatory framework for the use of phage therapy in Europe. The conference highlighted the impact that innovation can have on personalised medicine, how this can contribute to an improved patient journey as well as shedding light on the benefit and advantages of phages as “medical” tools.

The full day online conference through a virtual event platform allowed the audience to interact with speakers and other attendees in real-time as well as benefiting from additional content and materials on CURE research and advancement. The conference was moderated by former BBC World News presenter Ms Anya Sitaram and CURE Project Coordinator Prof. Nikolaos Papadopoulos.

The conference was opened by Member of the European Parliament Ms. Tilly Metz (Greens/EFA, Luxembourg) and EFA President, Carla Jones with reflections on the implications of CURE from patient and policy-maker perspective. The conference explored different viewpoints and angles of phage therapy, including how novel technologies and a personalised approach can improve asthma treatment, a brief history of phage therapies, and finally a debate on the current regulatory framework for phage therapy in Europe, identifying its gaps and presenting best practices of how member States are trying to overcome the current limitations.

With final remarks by EFA President, Carla Jones and CURE Project Coordinator Prof. Nikolaos Papadopoulos, the CURE conference was followed by 250+ attendees from all over the world and from a variety of professional background including healthcare professionals, researchers, civil society and EU institutions representative.

Did you miss the Conference? You can find all the sessions on the CURE Website and EFA YouTube Channel.

Speakers

• Tilly Metz, Member of the European Parliament/ Group of the Greens/European Free Alliance
• Carla Jones, President, EFA
• Nikolaos Papadopoulos, Professor of Allergy & Peadiatric Allergy, National Kapodistrian University of Athens
• Barbara Gerratana, Senior Project Adviser, European Innovation Council and SMEs Agency (EISMEA)
• Spyridon (Akis) Megremis, Research Fellow, Division of Evolution, Infection and Genomics, University of Manchester
• Susanne Vijverberg, Assistant Professor Respiratory Medicine, Amsterdam UMC
• Mikaela Odemyr, Vice President, Owner, Swedish Asthma and Allergy Association, Odemyr Counsulting
• Paraskevi Xepapadaki, Pediatrician and Associate Professor, Pediatric Clinic, Allergy Department, University of Athens.
• Nina Chanishvili, Head of the Research and Development Department, G. Eliava Institute of Bacteriophage, Microbiology and Virology
• Martha Clokie, Professor of Microbiology, University of Leicester
• Jean-Paul Pirnay, Director of the Laboratory for Molecular and Cellular Technology, Queen Astrid Military Hospital
• Ryszard Międzybrodzki, Bacteriophage Laboratory, Hirszfeld Institute of Immunology and Experimental Therapy
• Eric Pelfrene, Office of Vaccines and Therapies for Infectious Diseases, Human Medicines Division, European Medicines Agency (EMA)
• Sabrina Green, Director of R&D TAILOR service center, Research Associate, Baylor College of Medicine
• Maia Gotua, Professor, MD., Ph.D., General Director, GA2LEN Network Center of Allergy and Immunology
• Cezmi Akdis, Director Swiss Institute of Allergy and Asthma Research Professor, University Zurich

Apart from terrible costs in human lives and suffering, the Russian war against Ukraine has considerable implications for food availability across Europe and globally. One outstanding example is sunflower oil, of which 80% of global exports are produced by these two countries. Its scarcity will  have an impact on food allergy patients all over Europe.

Widely used in cooking, sunflower oil is a common ingredient in European diets and food markets. The disruptions in the supply chain of sunflower oil has led to shortages in many European countries, forcing food manufacturers to replace it with other ingredients. Some of its substitutes, such as oils from peanut and wheat germ, are made of ingredients that are typified as allergens in the European Union. Others, such rapeseed, coconut and corn oils, are also linked to less common food allergies.

Allergen-based oils: labelling derogations vs health risks

The replacement process has raised concerns over the labelling of the substitute ingredients. Several European countries have granted derogations from the obligation to indicate the ingredients through conventional labelling, as required by the EU Regulation 1169/2011 on the Food Information to Consumers (FIC Regulation).

On April 8, EFA expressed these concerns in a letter addressed to the European Commission Directorate General for Health and Food Safety (DG SANTE). In this letter EFA reminds that food industry and operators need to inform consumers about their new recipes and the allergens present in their products. Allergen labelling is a safety issue for the food allergy patient community. Any label that does not report, information on allergens, or provides it incorrectly or partially, represents a considerable risk to the health of allergic consumers, as an anaphylactic reaction can lead to death.

EFA pinpointed the risks involved in these emergency measures:

• If general temporary derogations to the FIC Regulation are granted, substitute products containing allergens will enter the EU without requirement for labelling changes.
• Adhesive labels and inkjet printing, adopted by many national authorities as temporary solutions, might prevent consumers from readily detecting allergen ingredients, as well as other useful food information.
• Communicating changes only in the physical or online stores may undermine access to information: physical labelling in the store can be easily overlooked; while online information requires a certain level of digital literacy, a device and the availability of internet access.

Given that food allergen labelling constitutes a public health and food safety issue, EFA calls for a response to the situation according to the principles of the EU FIC Regulation 1169/2011:

• Publish a notice addressed to national food safety authorities requiring that any ingredient change implying allergens should be compliant with the EU law, encouraging them to increase their vigilance in case of unclear information and non-declaration of allergenic oils and fats, and alert consumers about these changes.
• Urgently adopt a harmonised EU-wide approach for the use of adhesive stickers (a specific symbol or logo) on the front of the pack, indicating a recipe change relevant to allergens. 
• Monitor the scope and volume of food products that will change composition if replacing sunflower oil to help understand the impact from the consumer and industrial perspectives.

You can find the full EFA letter here.

In 2022, EFA will work alongside the Global Initiative for Asthma (GINA) to further develop  patient guidelines for asthma patients and their carers to increase asthma patients’ empowerment for better self-management and adherence to their care. This project is part of EFA’s mission to make the case for tools and resources to create timely, accessible, and patient-centered care and innovation for allergy, asthma and COPD patients in Europe.

Currently, many asthma patients do not feel in control of their disease management. When EFA conducted its ACCESS report, a 2019 survey of 774 asthma and COPD from Finland, France, Germany, Italy, Poland, Spain and the UK on access to prevention, diagnosis, care and empowerment in Europe, we found that one in three asthma and COPD patients do not feel involved in decisions regarding their therapy and lack information about personalised tools for self-management. At the same time, 20% of asthma patients surveyed stated that they have “never heard about” written self-management plans.

To empower asthma patients in handling their treatment, GINA developed evidence-based strategy documents to guide patients on asthma management. GINA is a global organisation launched in 1993 in collaboration with the National Heart, Lung, and Blood Institute, National Institutes of Health, USA, and the World Health Organization. It works with health care professionals and public health officials around the world to produce resources and intitiatives to reduce asthma prevalence, morbidity, and mortality.

The ‘GINA patient guide: you can control your asthma’ is a patient-friendly guide for asthma management with a lot of potential to grow as a resource. However, there still remains a large gap in knowledge and awareness of what patients living with asthma endure each day in their daily lives, as well as for patients in accessing tailored healthcare to meet their needs. There aslo remain needs for  different audiences such as children and teenager patients, adult patients, and carers to offer the tailored information they need. Patient information also remains to be updated with new developments, information and references and made available for patients in more languages.

In 2022, EFA plans to work alongside  GINA to build on  the current information, assess the GINA patient guide and start developing a patient-friendly report based on GINA annual report, which currently only addresses medical audiences. EFA will seek to work closely with GINA and the European asthma patient community to fulfil this project. The end result will be a tool that offers patients and carers accurate and scientific information to keep them up-to-date about treatment plans and options. It will also serve as a tool for healthcare professionals to support their asthma patients and provide them with guidance.

The project will formulate over the course of 2022 to cumulate in 2023. The range of activities will include:

• A survey with patient representatives to identify information needs and gaps in asthma knowledge and education among patients
• A workshop with EFA membership and open to the GAAPP community seeking partnership with GINA to provide useful data to entail discussions with national scientific societies to advocate for the implementation of the guidelines.
• The development of a GUIDE Asthma hub which will support patients with relevant patient-friendly asthma resources from EFA and partners translated into different languages

The results of the project will be launched on World Asthma Day 2023 alongside a communications toolkit and awareness-raising campaign.

In December 2021, the European Commission’s Directorate General for Energy published its proposal for an updated Energy Performance of Buildings Directive (EPBD). Buildings are crucial for health, particularly for people’s allergy and respiratory disease, as we spend more than 90% of our lives indoors.

While the main goals of the energy performance legislation is to address the buildings’ footprint in the external environment, the way that their conception and renovation will be thought should also take into account the indoor environment of buildings and how it impacts health and quality of life of inhabitants.

For patients living with allergy, asthma and chronic obstructive pulmonary disease (COPD) clean buildings mean, first and foremost, healthy indoor air. From EFA’s perspective, these considerations are not addressed in the European Commission proposal for a Directive and has published a statement highlighting the missed opportunity to tackle indoor air quality in the EPBD.

Indoor air pollution: the dirty elephant in the room

Pollutants of indoor air such as mould, dampness, heating/cooking emissions and tobacco smoke can be found everywhere. At this precise moment where the COVID-19 pandemic has brought the issues of ventilation and air quality to the spotlight, EFA calls on the EU institutions to include indoor air quality criteria in the legislation around buildings.

Indoor air quality is an arguably fragmented policy area, with no unified framework of action at the EU level. While waiting for concise proposals from the Commission, which are expected in 2023 as part of the Zero Pollution Action Plan, the challenge of indoor air pollution is already here and is harming human health in multiple ways: poor indoor air quality accounts for 10% of non-communicable diseases mortality globally; while 2 million disability adjusted life years (DALYs) are lost in the EU every year.

Patients vs indoor air pollution: Need for access to knowledge, prevention mechanisms and protection of health

EFA has responded to the European Commission consultation on the proposed Directive encouraging to take health-oriented approach in its revision of the EPBD that also enables a cleaner building stock in the EU and meets the ambition of the EU Green Deal. We particularly call for attention to:

• Strengthen the performance of buildings contribution to health and wellbeing by explicitly addressing indoor air quality. By integrating health-related considerations into buildings, renovations can also drive the transition towards healthier living indoor environments, reducing disease risk factors and allowing vulnerable groups chronic patients live better lives.

• Define health quality standards for buildings, such as healthiness of built environments and indoor air quality. To this end, we call on the Commission to establish a harmonised indoor air quality monitoring and certification system through the adoption of a mandatory indoor air quality certificate for all new and renovated buildings.

• Match energy criteria with built-in ventilation solutions. While the use of appliances and tools such as air purifiers and CO2 sensors, promoted by several countries during the COVID-19 pandemic, is useful, healthy indoor air should be based on EU level legislative provisions linking ventilation, health and energy performance of new and renovated buildings.

• Include funding tools and mechanisms for building renovations that are linked to health criteria and outcomes. Available EU programme funding must lead by example linking the financing of renovations with health-related criteria. There are several good practices of national examples to draw from including the Irish ‘Warmth and Wellbeing Pilot Scheme’, which facilitates energy upgrades in residential buildings on the basis of health referrals; or the Swedish scheme to support house adjustments through a municipal grant, specifically addressed to those with a disability – including those with severe allergy.

EFA is ready to engage closely with the European Parliament and the Council to ensure that health considerations are reflected in the final text of the revised EPBD.

You can find the full EFA response to the consultation here.

In December 2020, the European Commission launched the revision of the Food Information to Consumers (FIC) regulation 1169/2011, the main EU legislation covering provisions and requirements around food information. Since it entered into force in 2014, the FIC regulation has brought positive change and protection for patients living with food allergies in Europe.

The initiative to review the FIC regulation is part of the EU Farm-to-Fork strategy: the overarching framework of policies aiming to ensure healthy food consumption and a sustainable food production system in Europe. The revision also responds to the EU’s Beating Cancer Plan, whose ambition is to work on the great potential of healthy diets, and particularly nutrition, in the prevention of cancer. Evidence shows that consumer access to information on food and diets has an impact on the occurrence of other chronic diseases too, such as allergy and airways diseases.

As important as these considerations are for human health, unfortunately they have not been adequately reflected in this initial European Commission consultation on FIC. Even more importantly, the current consultation narrows its focus to only review information on nutrition, origin and date, thus leaving allergen labelling considerations out of scope.

At EFA we felt compelled to highlight these gaps by publishing an official statement on allergen labelling, especially regarding Precautionary Allergen Labelling (PAL).

Protecting food allergy patients: the need detail legislation on Precautionary Allergen Labelling

PAL is a voluntary labelling mechanism used by food manufacturers to indicate potential unintended allergen presence in food. In most cases this is due to cross-contact in the production cycle e.g. manufacturing, processing, storage, or transportation. In their actual form, PAL statements are given in various forms such as ‘may contain…’, ‘may contain traces of…, ‘manufactured in a facility that also processes…’.

While the FIC Regulation describes general requirements on voluntary information such as PAL, it stops short of defining the specific aspects of its implementation. Until this happens, food allergy patients are left with a daily uncertainty over the safety of the food bearing a PAL statement.

For EFA and the food allergy patient community we represent, allergen labelling (including PAL) is very much a safety issue. Any label that does not report, or provides incorrect or incomplete, information on allergens represents a severe risk to the health of allergic consumers, as an anaphylactic reaction can lead to death.

As EFA highlighted in its 2019 report ‘FoodDetectives – Quality of Life for People with Food Allergies in Europe: A Menu for Improvement’, the lack of legal provisions and requirements for the use of PAL, and the resulting absence of a harmonised approach across Europe, has led to an inconsistent, but also excessive, use of PAL. In its current use, PAL protects food operators rather than consumers and patients.

Under such circumstances, consumers with food allergies are often forced to interpret themselves the PAL statements that they see, with the obvious health risks that this entails. As EFA has reported, consumers tend to lose trust in the current food labelling system and see their fear and anxiety increase when deciding which foods to consume. 

The revision of FIC should improve current PAL rules

This is why EFA considers the ongoing revision of the FIC Regulation as a missed opportunity to address legislative issues around food information holistically and decisively. We call the European Commission to amend this gap as soon as possible by:

• Harmonising EU-wide rules on Precautionary Allergen Labelling, based on common wording and conditions for use, in line with Article 36 of the FIC Regulation.
• Encouraging and financing scientific research to establish reference doses for the 14 recognised allergens listed in the Annex II of the FIC Regulation, on the basis of a common approach to quantitative risk assessment.

EFA stands ready to convey allergy patients’ needs to the EU institutions and agencies and work closely together to provide the highest food quality information and standards.

You can find here the full EFA response to the consultation on the Food Information to Consumers regulation, and EFA’s Policy Position on Precautionary Allergen Labelling

For more details on PAL and the perspective of food allergy patients, see our 2019 report ‘Quality of Life for People with Food Allergies in Europe: A Menu for Improvement’.

Established at the end of 2021, the Health Emergency Preparedness and Response Authority (HERA) has set up to improve EU coordinated response on the prevention, detection and rapid response to cross-border health crises. Its work will be crucial to ensure the prevention and care of allergy, asthma and COPD in future health crisis via the development and distribution of appropriate medical measures.

While the COVID-19 pandemic has been a crucial trigger for realising the need for better preparedness to address health emergencies, the scope of HERA includes also man-made threats such as chemical, biological, radiological and nuclear (CBRN) threats.

In early 2022, HERA published its first Work Plan, which lays out its annual priorities  with a total budget of 1,3 bn EUR is foreseen tapped from three main sources: the official EU health programme (EU4Health), the Horizon Europe programme, and the Union Civil Protection Mechanism (UCPM).

Throughout 2022, HERA plans to focus specifically on preparedness activities, while establishing a close collaboration with external stakeholders such as civil society, academia, and industry at every step of the way.

HERA 2022 work priorities

According to the Work Plan, HERA will revolve around six main tasks. EFA has identified those expected to have a greatest impact on EFA and its patient community:

• Task 1: Threat assessment and intelligence, including on biological and other health threats. HERA will reinforce threat detection, among others, by joint work with the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA); threat prioritisation, based on the selection of major threats, as well as relevant medical countermeasures (medical responses to the threat, such as mask production in case of a respiratory infection); and threat awareness via dialogue with patients, consumers and healthcare workers.
• Task 2: Promotion of advanced research and development (R&D) of medical countermeasures and related technologies, by funding projects via Horizon Europe, who will support work on next generation immunotherapies for diseases with unmet medical needs; new methods for using real-world data in decision-making; and also projects within the Innovative Health Initiative (IHI).
• Task 3: Addressing market challenges, by developing structures and capacities to identify bottlenecks and market failures that could limit production of medical means during crises.
• Task 4: Provision of medical countermeasures, by working closely with the Union Civil Protection Mechanism which provides recommendations regarding medical and CBRN countermeasures, while identifying potential challenges in their deployment.
• Task 5: Strengthening knowledge and skills, through the organisation of training programmes related to all aspects of access to medical countermeasures.
• Task 6: Building on the international dimension, via close collaboration with global partners to address supply and capacity challenges.

During the European Commission’ consultative process, EFA expressed its hope for a strong and well-equipped HERA which centralises efforts to address cross-border health emergencies. We hoped for an authority to coordinate for quick and accurate responses in times of health emergencies without borders.

We fully agree with the prioritisation of CBRN threats as they are urgent, cross-border, multi-hazardous and directly impacting health. However, in the implementation of its Work Plan, we also wish to see HERA going specific on climate change impacts on health that can become an emergency, such as wildfires and heatwaves, and active volcanos.

Read the EFA response to the HERA consultation and the EFA analysis after the formal establishment of the authority. 

In 2020, the European Commission launched a consultative process to review the current EU Air Quality Directives. As an organisation representing allergy, asthma and chronic obstructive pulmonary disease (COPD) patients, the future of our health and wellbeing hugely depends on the laws that Europe will adopt to reduce air pollution.

While the EU air quality framework has improved the situation as compared to 15-20 years ago, there is clearly still a long way to go to eliminate the health burden of air pollution. For example, the recently updated WHO Air Quality Guidelines have demonstrated the many ways that air pollution damages our health at levels even lower than previously thought.

Air pollution is associated with more than 400.000 premature deaths in the EU each year and it is linked to the development and exacerbation of major non-communicable diseases, including respiratory diseases such as asthma and COPD, cardiovascular diseases, cancer and diabetes.

Towards a new EU air quality framework

In an acknowledgement of our solid knowledge and strong record on air quality issues, European Commission invited EFA to provide the perspective of allergy and airways disease patients to the revision of the EU Air Quality Directives (AQDs). The targeted survey was conducted in February and sought feedback on three main policy areas:

• Closer alignment with the latest recommendations of the WHO
• Improving current framework, including provisions on penalties and public information
• Strengthening of air quality monitoring, modelling and plans

The inputs received will also inform the parallel European Commission exercise to draft an impact assessment of the current EU Air Quality Directives.

EU standards vs WHO recommendations: Can the EU afford not to align?

EFA considers full alignment with WHO recommendations as the only option that truly protects health. We strongly believe that all efforts must be made to make it feasible as soon as possible, and certainly no later than 2030. 

In practice, full EU alignment with WHO recommendations entails that the EU limit values for each pollutant, including fine particulate matter (PM2,5), ground ozone (O3), sulphur dioxide (SO2), nitrogen dioxide (NO2) and carbon monoxide (CO), should become equal to those recommended by WHO. Under the EU legislative framework, these aligned levels would be legally binding and not mere recommendations, so any short or long-term pollutant exceedance would oblige countries to take corrective measures (or face penalties, in case of no or insufficient action).

In addition, EFA urges the European Commission to also address and regulate ‘emerging pollutants’ such as ammonia, black carbon and ultra-fine particulates, all of which have been associated with adverse health effects, including reduced lung function and worsening of respiratory symptoms.

Crucially, EFA calls for strong action on other natural and chemical pollutants with well-documented effects on respiratory health, such as pollen and other aeroallergens, sand and dust storms, and volatile organic compounds (VOCs), detailed below.

Air quality directives should improve information to vulnerable groups

EFA believes that the future EU legislative framework can be reinforced through a combination of targeted interventions to increase its effectiveness and ensure better air quality for all. From EFA’s perspective, information is power and must be the basis for both evidence-based policymaking and an empowered population.

EFA supports the introduction of a mechanism to adjust the EU air quality standards based on new evidence from bodies such as the WHO, the European Environment Agency (EEA), and the Organisation for Economic Cooperation and Development (OECD). This would also entail a regular review of technical and scientific progress, in close collaboration with relevant stakeholders.

Crucially, EFA calls for legally binding information requirements to keep citizens informed of air pollution conditions in real-time, including on pollen, sand/dust storms and volcanic emissions. In fact, In the case of pollen and sand and dust storms, EFA calls for a systematic reinforcement of forecast services and public information, and encourages to set up an EU-wide real-time monitoring system, combined with a formal information threshold arising from the EU Air Quality Directives and messaging targeted to vulnerable groups of the population. To the same end, we call the Commission to harmonise the air quality index bands across all EU countries.

Technology can be an ally for better informed citizens, but conventional as well as the latest communication tools and channels must be free, transparent and user-friendly. The Commission must work to increase awareness of existing tools, such as the EU Air Quality Index and its application, across the society. Information can also be synchronised and channelled via eHealth and mHealth tools that facilitate self-management of diseases, such as the connected inhaler of MyAirCoach.

Sanctions are not the only mechanism to protect the population

In cases where air quality standards are not respected, EFA highlights the need for a clear and precise action plan. Actions must involve all relevant stakeholders, including competent authorities, sectoral representatives, civil society and citizens. An open approach is key to gain a full understanding of specific air pollution events and identify the most effective measures to address them.

Accordingly, in cases of infringements it is important to ensure penalties that make up for the damage done to human health and the environment. Individuals must obtain the right to compensation for damage to health related to air pollution, while access to justice must be open for both groups and individual citizens on these matters.

However, EFA stresses that there can be no full protection of health from air pollution without addressing Indoor Air Quality (IAQ) aspects. Indoor pollutants such as mould, dust, volatile organic compounds, tobacco smoke and emissions from heating and cooking can be extremely damaging to respiratory health. Addressing IAQ means to prioritise health and coordinate actions across sectors and policies, including, but not limited to, the legislation on buildings and renovations, chemicals, product labelling, and smoke-free environments. Taking IAQ considerations into account will help the EU move towards an Air Quality Framework Strategy that is exhaustive and integrated.

Expand air pollution monitoring

EFA reiterates its position that, without a well-functioning air quality monitoring mechanism, we lack the necessary information to support policymaking and individual decisions. Unfortunately, many monitoring stations across the EU today fail to provide data, which points to the need of clear provisions regarding repair and/or replacing of defunct stations.

In addition, EFA calls on the Commission to support citizen science in air quality monitoring, as a complementary tool to official monitoring. This can be achieved through the uptake of low-cost but scientifically proven monitors that are already available today in the market.

Furthermore, we believe that the Commission must expand the scope of EU air quality monitoring to include emerging pollutants such as ammonia, black carbon and ultra-fine particles, but also real-time estimates of natural pollutants such as pollen, sand/dust, and volcanic emissions.

Finally, it is of utmost importance that air quality plans include a health impact assessment at any stage of implementation, in order to ensure transparency and steer corrective action where necessary.

-- --

EFA looks forward to continuing bringing the voice of respiratory patients in the critical discussions to come on the future of air quality in Europe. The upcoming 2^nd stakeholder meeting on the revision of the AQDs (planned in April) will provide a first opportunity to reiterate our asks for a legislative revision that protects health and the environment.

Moreover, we are ready to engage with the institutions and other stakeholders on an ambitious EU air quality framework via our participation in the Zero Pollution Stakeholder Platform.

You can find the full EFA response to the targeted surveys Policy Area 1 and Policy Areas 2 and 3 as well as our response to the air quality directives consulation.

For a third year in a row, EFA Annual General Meeting Business Session will be conducted online, after careful consultation with Members. The uncertainty of the pandemic and the exposure of our network of patient advocates to a COVID infection have been decisive to postpose our physical gathering for some months.

Our Annual General Meeting Business Session and Membership Workshop will take place  on 31 March 2022, you can register here

We will start the AGM business going through the annual report and finances of 2021 and an overview of the 2022 project programme.

We are thrilled that the AGM will decide on accepting new allergy, asthma and chronic obstructive pulmonary disease (COPD) patients’ organisations to our EFA family, growing and strengthening our vibrant patient community. Following the business session, EFA will host networking activities for members and an afternoon Membership Workshop. The Workshop will showcase the 2022 Membership Survey, analysis of early results from Members and a brainstorming activity meant to re-imagine the way we relate, coordinate and move forward as a patient community.

Networking event in person in Iceland

After two years of pandemic, our community is awaiting to meet in person. EFA is organising a hybrid networking event for all members before summer. The event will take place online and in Reykjavik, Iceland, hosted by EFA Member Asthma and Allergy Society of Iceland. Follow EFA’s updates for confirmation of the dates for the 2-day event as well as a detailed programme.

We look forward to coordinating with all members to make sure that we can continue fostering strong working relationships through in-person connection, with the flexibility necessary to ensure everyone’s comfort and safety.

EFA invites you to the CURE conference: “Towards a CURE for Asthma: Accelerating Innovation in Personalised Medicine and Phage Therapies,” which takes place on 15 March 2022, 9:30-12:00 and 13:30-15:20 CET.

EFA participates in several EU-funded projects, to help facilitate patient engagement and dissemination towards patient communities and other stakeholders. The CURE project began in 2017 and will culminate this March with a final scientific conference. 

CURE is an EU Horizon 2020 project designed to explore new approaches to improve the manageability of asthma and the potential of an intervention based on virus (called phage therapy) to address imbalances in the respiratory microbiome contributing to the disease.

As a partner in the research consortium, EFA has led the project communication activities to help inform the public, and in particular people with asthma, about the results of the research conducted within the project. EFA is now organising the final conference and invites you to save the date for a thrilling exploration of project accomplishments and phage adventures in Europe and across the globe.

The event will open with a Member of the European Parliament and a patient representative, speaking on the importance of innovative research and development for allergy and asthma patients.

Project Coordinator Nikolaos Papadopoulos and Horizon Europe Programme Officer, Barbara Gerratana will then present an overview of innovations unique to the CURE project and what we can expect from this novel therapy as the project comes to a close.

Following a short break, there will be two scientific panels exploring phage innovations and best practices from outside the EU, and the legal and regulatory frameworks for future phage applications at the Member State and EU levels.

Mark your calendars and register now.

To know more about this project, visit the CURE website.

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 767015.

Look forward to all the upcoming dates and activities to advocate for patients with allergy, asthma and COPD! To follow the international campaign days throughout the year, EFA has published a calendar to show all the thematic days and key events throughout 2022:

In January 2022, EFA participated in a targeted workshop on the EU General Pharmaceuticals Legislation that the European Commission has opened for revision. EFA participated in one stakeholder consultation to bring the voice of allergy, asthma and chronic obstructive pulmonary disease (COPD) patients and was delighted to be invited to the targeted workshop.

During the workshop, the agency contracted to conduct a study on the evaluation and impact assessment of the general pharmaceutical legislation informed participants about the main trends of the consultation results. In general, stakeholders including patients welcome a revision of the general pharmaceuticals legislation.

The study also sheds light on the market authorisation process ran at the EU level through the European Medicines Agency and compared this to similar regulatory bodies such as the US Food and Drug Agency (FDA) and the Japanese agency. In comparison, the EMA appears as slower and less attractive for companies to get their medicinal products assessed, and a future revision of the legislation could help improve that.

The workshop served as a space to voice issues and concerns on specific topics, and EFA participated in a breakroom on facilitating innovation. We contributed to the discussion on existing legislative gaps in the regulatory chaos for drug-device combinations, the current limbo for medicines addressing the microbiome and the use of phage therapies, and our patient call to maintain hard copy Package Leaflets (PL) on top of the future digitalisation of this information.

On the topic of drug-device combinations, EFA has recently learnt from an analysis conducted by the European Federation of Pharmaceutical Industries Associations (EFPIA) that most of allergy, asthma and COPD medicines fall under this category of products. Their dual nature of being a medical device carrying a medicine such as inhalers or adrenaline auto-injectors make it difficult for a patient to assess the type of product they are using, a situation that also impacts the way these products are being assessed, evaluated, and monitored once in the market.

EFA is currently investigating the current legal framework for these medicines, that are of daily and widespread use among our disease areas. We will inform our members about the outcomes of our research accordingly.

To know more about the EU General Pharmaceutical legislation revision, visit the Commission website.

EFA has responded to the much-awaited European Commission revision of the EU general pharmaceuticals legislation in December 2021 to ensure allergy and airways diseases patients’ unmet needs are part of the discussion.

EFA welcomes this revision, the first in 20 years, which draws on lessons learnt from the COVID-19 pandemic and calls on stakeholders and members of the public to share their views on matters such as unmet medical needs, incentives for innovation, and the affordability of medicines.

Unequal access to medicines

The health inequalities arising from existing differences in access to medicines are caused by a variety of issues including regulation, pricing, access to medicine, and shortages. For example, regulatory issues can mean the gap between marketing authorisation (which is managed centrally for the EU), and the subsequent steps to reach patients. This can lead to patients having to wait years to access necessary medicines in some parts of Europe even after marketing authorisation has taken place.

At the EU level, action can be taken to improve equal and timely access to medicines. EFA calls for the introduction of joint procurement for critical medicines and for small patient populations, and for the EU to use its influence to improve accessibility and affordability in low- and middle-income countries too.

Unmet medical needs

EFA states that to address unmet medical needs, policymakers must work with a range of patient communities to ensure that policies are patient-centred and to create a common understanding of unmet needs and how to address them. In our response, we highlight the need to update and refine the concept of unmet needs to improve policymaking without restricting the definition and lead to creating gaps for various patient groups.

Incentive for innovation

While more incentives are needed to support innovation, they must also support equitable access to affordable medicines for all patients. As unmet need may arise from different causes, e.g. lack of basic research to understand the disease vs. market failure, different unmet needs will require different incentives. Innovation that brings real added value is only possible with patient involvement, so there should be mechanisms instated for patient involvement in clinical trials, regulation, pricing and reimbursement decisions, and safety monitoring at European and national levels.

Future proofing

As the health, medical and pharmaceutical sectors evolve - patient safety must be at the heart of new initiatives and in policy making. Products development, particularly for rare conditions, should be driven by collaborative processes while regulation needs to facilitate rather than hamper future patient-centric scientific and technological advances. These advances can include gene and personalised therapies, smart health applications, and medical technologies including artificial intelligence. Furthermore, with these developments, definitions such as unmet needs will need to be reviewed for regulation to remain relevant.

EFA also calls for EU legislation to take better into consideration the combination of life-saving medication such as the drug-device combination of adrenaline auto-injectors.

Lessons from the pandemic

The pandemic has highlighted the gaps and challenges in the current pharmaceutical regulatory framework and has shown that the EU must strive for strategic autonomy in pharmaceutical ingredients and incentivise production in the European market. Overall, medicines have great social impact for patients with allergy, asthma, and COPD as they can enable maximum health and protection that patients can achieve. It is therefore paramount that any future measure supports this maximum health objective, equally, across the EU through information standards, regulatory frameworks and collaboration in research.

Moving forward with the pharmaceutical legislation

Embedding “patient value” and “patient involvement” in the new EU legislation is an indispensable starting point for a patient-centred, not profit-centred approach legislation that will support innovation that meets patients’ needs.

Want to know more? Read EFA’s full response to the European Commission consultation on the EU General Pharmaceuticals Legislation.

The European Parliament Interest Group on Allergy & Asthma and EFA organised a virtual policy event on ‘Addressing unmet patient needs in allergy and asthma care’ on 13^th January. The event was co-hosted by two of the Vice-Chairs of the Interest Group, MEPs Juozas Olekas (Socialists & Democrats – Lithuania) and Tilly Metz (Greens/EFA – Luxembourg).

Against the backdrop of the new EU Pharmaceutical Strategy and the revision of key legislation, such as the general pharmaceutical law and medicines for rare and paediatric diseases, the event was a timely opportunity to set the scene for allergy and asthma with experts from across sectors.

MEP Tilly Metz opened the event with a speech highlighting the different burdens placed on asthma and allergy patients, including social, emotional and economic, as well as the worryingly number of increasing allergy and asthma cases caused by environmental factors.

EFA President Carla Jones kicked off the discussions by outlining the most pressing unmet needs patients face today, including limited access to treatments and attention to allergy, which leads to low interest in research. Carla was joined by Freja Anckers, Member of the European Allergy & Asthma Youth Parliament, who underlined the unique needs of young people, especially in terms of medicine authorisation, while stressing the importance of digital health and the opportunities that come with it.

In the subsequent panel discussion Prof. Jürgen Schwarze, Secretary General of EAACI, Dr Stanimir Hasardzhiev, Secretary General of Patient Access Partnership (PACT), and Tina Taube, Director of Market Access at EFPIA, participated in a lively exchange on the existing challenges. Some of the policy solutions that were voiced included the alignment of reimbursement policies across Europe to enhance patient access to the right treatment; the improvement of existing guidelines to push for the take up of precision medicine, rather than using the umbrella treatments; and the acceleration of digital health to help patient adherence; and greater patient involvement in co-developing products and technologies.

The panel discussion was followed by a Q&A session with the active participation of the co-host MEPs and the audience. MEP Juozas Olekas closed the event by emphasising the importance of a patient-centred approach to addressing unmet needs in healthcare and outlining potential solutions such as a European Health Union and the integration of digital tools.

Check the full event report here. You can watch the recording of the event here.

In recent months, EFA’s status within the Codex Alimentarius Commission (CAC) has been given a boost with our confirmation as members to several Codex Electronic Working Groups (eWGs). These are thematic groups affiliated to the different CAC committees, with the aim to support them in the various development stages of food guidance and food standards. They bring together stakeholders such as national authorities, NGOs and industry representatives from around the world engaging in discussions and consultations.

Working closely, among others, with the Codex Committee on Food Labelling (CCFL), from now on EFA will be involved in eWGs looking at two key topics from a food allergy perspective:

• Innovative Use of Technology to Provide Food Information
• Internet sales/e-commerce of food, where we have already published a general statement from our community during the last meeting of the CCFL.
• Allergen labelling (re-established)

Ahead of the upcoming annual meeting of the Codex Committee on Food Hygiene (CCFH), but also the broader interesting discussions taking place at Codex, EFA will continue bringing the voice of food allergy patients at the highest political and technical level to ensure the protection of health from food allergens.

Following an annual assessment, the European Medicines Agency (EMA), the EU regulatory agency responsible for the evaluation of medicinal products, has confirmed the continued compliance of EFA with the criteria required to be an “eligible organisation” to EMA.

As an eligible organization, EFA continues to be a recognised and trusted organisation by the EMA, and that we will continue representing allergy, asthma and COPD patients in the EMA Patients' and Consumers' Working Party (PCWP).

EFA has been an EMA eligible organisation since 2013 and is represented by former Vice-President Erna Botjes and Deputy Director Isabel Proaño as her alternate.

Don’t hesitate to take a look at the many other official partnerships that EFA holds with regulatory bodies and institutions.

In October 2021, the WHO Regional Committee for Europe launched the initiative ‘Western Balkans Digital Health Network’, with the aim to accelerate the transformation of regional health systems in the Western Balkans towards digital technology, an interesting activity for allergy and airways diseases patients in Europe.

WHO Europe Regional Director Hans Kluge underlined the importance of digitalisation in fighting the key health challenges of today, as shown during the COVID-19 crisis. Moreover, he pointed to the role of digital health in moving towards a more proactive approach in terms of preparedness and anticipation of emergencies.

The initiative has set 4 overarching goals:

• Support the implementation of digital health priorities identified by the WHO Western Balkans Roadmap for Health 2021–2025.
• Ensure ways to accelerate the digitalisation of national health systems and the development of equitable digital health services in the Western Balkans (with focus on primary health care).
• Promote the sharing of knowledge and identification of best practices.
• Increase subregional collaboration and alignment of actions for digital health.

The Network also published a detailed Roadmap outlining its main priorities and action areas.

EFA has consistently supported digital health and innovation as a key tool to achieve high-quality care, enable research, generate better health outcomes, and improve disease management. In addition, the digitalisation of health can contribute in the reduction of inequalities in the provision of healthcare, which are often in sharp contrast between Eastern and Western Europe.

To know more about EFA’s work, please visit our Digital Health section.

The 3TR project has entered a new phase, and is developing definitions of response and non-response to biological treatments for patients with severe asthma.

3TR is an EU project to understand responses to therapy and disease progression of several different autoimmune, inflammatory and allergic diseases including asthma. The project is the biggest ever funded by the Innovative Medicines Initiative (IMI), a public-private partnership that includes the European Commission.

EFA has worked with the European Lung Foundation (ELF) to recruit patients and coordinate a Patient Working Group (PWG) to support patient engagement with researchers to determine the course of project priorities and outcomes.

In the previous phase of the project, severe asthma patients and carers worked alongside researchers and patient representatives to determine Core Outcome Measure (COM) sets for both adult and paediatric severe asthma patients. COMs are recommendations for other researchers as to what should be measured in all trial settings for specific disease areas, for example lung function and quality of life. By using COMs, it becomes possible to compare data across trial settings for a greater understanding of disease treatment. Importantly, including patients in this process helps to ensure that each study measures aspects that are truly important to patients.

In this new phase of the study, the PWG will work with researchers to develop patient-centred definitions of response and non-response to biological treatments. Currently, there is no definition for whether a biological treatment is working or not for severe asthma. Defining a response will help doctors and patients to decide whether a biological treatment should be continued or if alternative treatments should be used instead.

The EFA network has been integral to our renewed recruitment efforts, welcoming over 10 new severe asthma patients to the PWG, and counting. 

The definition of response study will culminate in March.

Stay tuned for project updates by signing up to the EFA newsletter and checking on the 3TR website.

EFA’s capacity building projects have strengthened the organisational, advocacy, and communication skills of its members since they were first launched in 2014. Each training session is catered to the specific needs of our national patient associations to help them amplify their own work at the national level. The trainings vary on topics and participation depending on the context.

In 2021, EFA offered several capacity building sessions including an advocacy training for the European Allergy and Asthma Youth Parliament, a Meet & Greet with the European Medicines Agency and several personalised trainings to members targeting their direct needs.

These personalised trainings were delivered to Spanish Members, AEPNAA (Spanish Association for People with Food and Latex Allergy) and FENAER, (Spanish Federation of Allergy and Respiratory Diseases’ Patients Associations) in a joint targeted training, and to COPD Support Ireland.

AEPNAA and FENAER convened for two trainings in early January 2022 and explored how to run effective advocacy campaigns in the local, regional and national contexts. The sessions spanned over two evenings and featured expert presenters from UNICEF, Amnesty International, Iberdrola and the public relations agency that conducted them.

In early January, COPD Support Ireland completed a follow-up training with a strategic fundraising firm, specialising in philanthropic impact. Participants took away a plethora of helpful tips and tricks for building a sustainable fundraising strategy.

Reports on the targeted training will be made available in the EFA 2021 Annual Report. Check out last year’s report to learn more about the capacity building project and stay tuned for new capacity building opportunities in 2022.

Interested in developing your patient organisation’s skills but not an EFA Member? Email EFA Projects and Engagement Officer This email address is being protected from spambots. You need JavaScript enabled to view it. and start the process today!

EFA Member the Asthma UK and British Lung Foundation Partnership has started a collaboration with Chest Heart and Stroke Scotland to establish a network for people affected by respiratory conditions. The network will bring together a wide range of patient perspectives to consult the Scottish Government Respiratory Care Action Plan (RCAP).

The RCAP seeks to address the diagnosis, care, treatment, and support of people living with the most prevalent respiratory conditions in Scotland including asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis, Idiopathic Pulmonary Fibrosis (IPF) and obstructive sleep apnoea syndrome.

Learn more about joining the network and have your say!