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