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

Ludger Klimek (1) , Hans Hoffmann (2) , Ayse Kalpaklioglu (3) , Pascal Demoly (4, 5) , Ioana Agache (6) , Todor Popov (7) , Antonella Muraro (8) , Peter Schmid‐grendelmeier (9) , Sergio Bonini (10) , Andreas Bonertz (11) , Vera Mahler (11) , Stefan Vieths (11) , Oliver Pfaar (12) , Torsten Zuberbier (13) , Marek Jutel (14) , Carsten Schmidt‐weber (15) , Peter Hellings (16, 17) , Sten Dreborg (18) , Matteo Bonini (19, 20) , Helen Brough (21, 22) , Jean Bousquet (23, 13, 4) , Karin Hoffmann‐sommergruber (24) , Oscar Palomares (25) , Markus Ollert (26, 27) , Mohamed Shamji (20) , Victoria Cardona (28, 29)

1 Center for Rhinology and Allergology = Zentrum für Rhinologie und Allergologie
2 Aarhus University [Aarhus]
3 University of Kirikkale
4 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
5 iPLESP - Institut Pierre Louis d'Epidémiologie et de Santé Publique
6 Transylvania University of Brasov
7 Medical Complex Sveti Ivan Rilski
8 AOUP - Azienda Ospedale Università di Padova = Hospital-University of Padua
9 UZH - Universität Zürich [Zürich] = University of Zurich
10 Italian Research National Council
11 EPI - Paul-Ehrlich-Institute - Federal Institute for Vaccines and Biomedicines
12 Philipps Universität Marburg = Philipps University of Marburg
13 Charité - UniversitätsMedizin = Charité - University Hospital [Berlin]
14 Wrocław Medical University
15 Technical University of Munich and Helmholtz Center Munich
16 EUFOREA - European Forum for Research and Education in Allergy and Airway Diseases
17 KU Leuven - Catholic University of Leuven = Katholieke Universiteit Leuven
18 Uppsala University
19 Unicatt - Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma]
20 Imperial College London
21 Guy's and St Thomas' Hospital [London]
22 King‘s College London
23 MACVIA-LR - Contre les MAladies Chroniques pour un VIeillissement Actif en Languedoc-Roussillon
24 Medizinische Universität Wien = Medical University of Vienna
25 UCM - Universidad Complutense de Madrid = Complutense University of Madrid [Madrid]
26 LIH - Luxembourg Institute of Health
27 SDU - University of Southern Denmark
28 Vall d'Hebron University Hospital [Barcelona]
29 RETIC ARADyAL

Diagnostic allergens are defined as medicinal products in the EU. Marketing authorization by national authorities is necessary; however, diagnostic allergens are not homogeneously regulated in different EU member states. Allergen manufacturers argue with increasing costs forcing them to continuously reduce the diagnostic allergen portfolios offered to allergists. In contrast, EAACI and national European Allergy Societies see the need for the availability of a wide range of high-quality diagnostic 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-quality diagnostic allergens in the EU, an action plan has been set up by EAACI to analyse the current regulatory demands in EU member states and to define possible solutions stated in this document: (a) simplification of authorization for diagnostic allergens; (b) specific regulation of special types of diagnostic allergens; (c) new models beyond the current model of homologous groups; (d) simplification of pharmacovigilance reporting; (e) reduction of regulation fees for diagnostic allergens; (f) reimbursement for diagnostic allergens. Joining forces of allergists, manufacturers and authorities are of high importance to ensure remaining relevant allergens in the EU markets to facilitate a sustainable and comprehensive service for the diagnosis and treatment of allergic diseases.

Mots clés: European Pharmacopoeia; allergen provocation test; marketing authorization; regulatory framework; skin prick test; skin test allergens

Domaines: Sciences du Vivant [q-bio]

Ludger Klimek, Hans Hoffmann, Ayse Kalpaklioglu, Pascal Demoly, Ioana Agache, et al.. In‐vivo diagnostic test allergens in Europe: A call to action and proposal for recovery plan—An EAACI position paper. Allergy, 2020, 75 (9), pp.2161-2169. ⟨10.1111/all.14329⟩. ⟨hal-03530169⟩