Hans Jürgen Hoffmann

In-vivo diagnostic test allergens in Europe: A call to action and proposal for recovery plan - An EAACI position paper

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  • L Klimek, Center for Rhinology and Allergology
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  • Hans Jürgen Hoffmann
  • A F Kalpaklioglu, Kirikkale University, Faculty of Medicine, Department of Pulmonary and Allergic Diseases, Kirikkale, Turkey.
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  • P Demoly, Department of Respiratory Medicine, University Hospital of Montpellier, Sorbonne Université, UMR-S 1136, IPLESP, Equipe EPAR, F-75013, Paris, France.
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  • L Agache, Faculty of Medicine, Department of Allergy and Clinical Immunology, Transylvania University Brasov, Brasov, Romania.
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  • T Popov, University Hospital "Sv. Ivan Rilski", 13, Urvich St, 1612, Sofia, Bulgaria.
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  • A Muraro, Past President, European Academy of Allergy & Clinical Immunology (EAACI), Centre for Paediatrics and Child Health, Head Food Allergy Referral Centre Veneto Region, Department of Women and Child Health, Padua General University Hospital, Via Giustiniani, 3 I-35128, Padua, Italy.
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  • P Schmid-Grendelmeier, Allergy Unit, Department for Dermatology, University of Zurich, Gloriastr. 31, CH-8091, Zürich, Switzerland.
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  • S Bonini, Institute of Translational Pharmacology, Italian National Research Council, Rome, Italy.
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  • A Bonertz, Division of Medical Biotechnology, Paul-Ehrlich-Institut, 63225 Langen, Germany.
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  • V Mahler, Division of Medical Biotechnology, Paul-Ehrlich-Institut, 63225 Langen, Germany.
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  • S Vieths, Division of Medical Biotechnology, Paul-Ehrlich-Institut, 63225 Langen, Germany.
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  • O Pfaar, Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany.
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  • T Zuberbier, Department of Dermatology and Allergy, Allergie-Centrum-Charité, Charité - Universitätsmedizin Berlin, Berlin, Germany.
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  • M Jutel, President, European Academy of Allergy & Clinical Immunology (EAACI), Department of Clinical Immunology, Wroclaw Medical University, "ALL-MED" Medical Research Institute, Wroclaw, Poland.
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  • C Schmidt-Weber, Center of Allergy and Environment (ZAUM), Technical University and Helmholtz Center Munich, Biedersteiner Str. 29, D-80802, Munich, Germany.
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  • P Hellings, Belgium and Laboratory of Clinical Immunology, Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.
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  • S Dreborg, Professor emeritus, Child and Adolescent Allergology, Department of Women's and Children's Health, Uppsala University, Academic Hospital, SE-751 86, Uppsala, Sweden.
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  • M Bonini, National Heart and Lung Institute, Imperial College London
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  • H A Brough, Chair for Paediatric Section, European Academy of Allergy & Clinical Immunology (EAACI), Head of Service Children's Allergy Service, Evelina Children's Hospital, Guy's and St. Thomas' Hospital NHS Foundation Trust, Paediatric Allergy Group, Department of Women and Children's Health, King's College London, St. Thomas' Hospital, Paediatric Allergy Group, Peter Gorer Dept of Immunobiology, School of Immunology & Microbial Sciences, King's College London, Guys' Hospital, London, UK.
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  • J Bousquet, MACVIA-France, Contre les Maladies Chroniques pour un VieillissementActifen France, European Innovation Partnership on Active and Healthy Ageing Reference Site, Montpellier, France and INSERM U 1168, VIMA: Ageing and Chronic Diseases Epidemiological and Public Health Approaches, Villejuif, France. Universite Versailles St-Quentin-en-Yvelines, Montigny le Bretonneux, France.
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  • K Hoffmann-Sommergruber, Department of Pathophysiology and Allergy Research, Medical University of Vienna, AKH-EBO 3Q, A-1090, Vienna, Austria.
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  • O Palomares, Department of Biochemistry and Molecular Biology, Complutense University of Madrid, Madrid, Spain.
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  • M Ollert, Department of Infection and Immunity, Luxembourg Institute of Health, Esch-sur-Alzette, Luxembourg and Department of Dermatology and Allergy Center, Odense Research Center for Anaphylaxis, University of Southern Denmark, Odense C, Denmark.
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  • M H Shamji, National Heart and Lung Institute, Imperial College London; Asthma UK Centre in Allergic Mechanisms of Asthma, London, UK.
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  • V Cardona, Allergy Section, Department of Internal Medicine, Hospital Valld'Hebron, 08035, Barcelona, Spain.

Diagnostic allergens are defined as medicinal products in the EU. Marketing authorization by national authorities is necessary, howeverdiagnostic allergensare not homogeneously regulated in different EU member states. Allergen manufacturers argue with increasing costs forcing them to continuously reduce the diagnostic allergen portfolios offeredto allergists. In contrast, EAACI and national European Allergy Societies see the need for the availability of a wide range of high-qualitydiagnostic allergens for in-vivo diagnosis of IgE-mediated allergies not only covering predominant but also less frequent allergen sources. In a recent EAACI task force survey, the current practice of allergy diagnosis was shown to rely on skin tests as first option in almost 2/3 of all types of allergic diseases and in 90 % regarding respiratory allergies. With the need to ensure the availability of high-qualitydiagnostic allergens in the EU, an action plan has been set up by EAACIto analyse the current regulatory demands in EU member states and to define possible solutions stated in this document: 1. Simplification of authorization for diagnostic allergens; 2.Specific regulation of special types of diagnostic allergens; 3. New models beyond the current model of homologous groups; 4. Reduction of pharmacovigilance reporting; 5. Reduction of regulation fees for diagnostic allergens; 6. Reimbursementfor diagnostic allergens. Joining forces of allergists, manufacturers and authorities are of high importance to ensure remaining relevant allergens in the EU markets to facilitatea sustainable and comprehensive service for the diagnosis and treatment of allergic diseases.

Original languageEnglish
JournalAllergy: European Journal of Allergy and Clinical Immunology
Volume75
Issue9
Pages (from-to)2161-2169
Number of pages9
ISSN0105-4538
DOIs
Publication statusPublished - 2020

Bibliographical note

This article is protected by copyright. All rights reserved.

    Research areas

  • European Pharmacopoeia, allergen provocation test, marketing authorization, regulatory framework, skin prick test, skin test allergens

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