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In‐vivo diagnostic test allergens in Europe: A call to action and proposal for recovery plan—An EAACI position paper
Author(s) -
Klimek Ludger,
Hoffmann Hans J.,
Kalpaklioglu Ayse F.,
Demoly Pascal,
Agache Ioana,
Popov Todor A.,
Muraro Antonella,
SchmidGrendelmeier Peter,
Bonini Sergio,
Bonertz Andreas,
Mahler Vera,
Vieths Stefan,
Pfaar Oliver,
Zuberbier Torsten,
Jutel Marek,
SchmidtWeber Carsten,
Hellings Peter W.,
Dreborg Sten,
Bonini Matteo,
Brough Helen A.,
Bousquet Jean,
HoffmannSommergruber Karin,
Palomares Oscar,
Ollert Markus,
Shamji Mohamed H.,
Cardona Victoria
Publication year - 2020
Publication title -
allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.363
H-Index - 173
eISSN - 1398-9995
pISSN - 0105-4538
DOI - 10.1111/all.14329
Subject(s) - medicine , allergy , european union , diagnostic test , allergen , action plan , reimbursement , immunology , business , pediatrics , health care , law , political science , management , economics , economic policy
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.