Terms of reference
Initiated: GAM 10.06.2022 Amsterdam
Chair: Prof. Swen Malte John, Osnabrueck, GER
Members:
Luca Stingeni, IT
Radoslaw Spiewak, PL
Ian White, UK
Mark Wilkinson, UK
Vera Mahler, GER
Ana Giménez-Arnau, E
Jeanne Duus Johansen, DK
Heinrich Dickel, GER, National Representative
Cara Symanzik, GER
Mihaly Matura, S
Notes:
- National representatives will be offered to participate (via presidential letter)
ALSO: All national representatives will be asked to describe their national situation and let this task force know in due course. - This group is open to all ESCD members; deadline for signing up: 31 August 2022
- Further: Address all members to ask whether they want to take part in our group?
- No personal consultation of other stakeholders (only as guests for specific topics at a later stage): producers; social partners
- Instead: Asking for written statements by such stake holders
Background:
Cell mediated type IV-reactions as the basis for allergic contact dermatitis: dramatic shortage of available patch test substances which is the prerequisite for identifying an allergic contact dermatitis.
Diagnostic haptens (contact allergens) are defined as medicinal products in the EU. However, this directive (2001/83) is not administered in the same manner across the EU countries. In some countries, availability of commercial patch test substances is dramatically diminishing, while the number of potential contact sensitizers (haptens) is increasing. For that reason, it has become very difficult to obtain a proper allergological diagnosis; many allergies will go undiagnosed currently, with the consequence that the health and well-being of European citizens suffering from contact dermatitis is at risk of being severely jeopardized. Furthermore, with regard to the current EU Strategic Framework on Safety and Health at Work 2021 to 2027, proper allergological work-up and diagnosis are central parts of workers’ health, including prevention and treatment, which will fail without availability of workplace allergens. This is also of high socio-economic importance, considering 5-8 billion € of annual costs due to loss of productivity in industry by occupational contact dermatitis in EU. Training in diagnostic patch testing is a fundamental and mandatory part of the European Training Requirements (ETRs) for dermatology. The EAACI has for the above reasons published a position paper to define possible solutions to ensure the availability of diagnostic allergens in the EU (1).
Objectives:
- to provide input to regulators at the national and at the EU level concerning a uniform interpretation of the current legislation (e.g., license of contact haptens under “well-established-use”)
- that will enable patch testing with commercial patch test trays and allow accurate allergological diagnosis.
- this would help to improve suffering of EU citizens from allergic contact dermatitis including quality of life measures and health economic parameters
- ensure the quality of commercial patch test substances
- options for recognition of new haptens by regulators (e.g. by mixed marketing application)
Format:
The task force may act through:
- formal and informal meetings/contacts especially with European Medicines Agency (EMA) and national regulators and further stakeholders, including the European Commission, the European Parliament
- an ESCD position paper, which highlights the importance of contact allergy diagnosis for the patient and for society and analyzes the situation and defines possible solutions to the current regulatory situation
Time plan:
It is the aim to have the first meeting (digitally) prior to the summer holidays to decide on strategies and a work plan (held on 4 July 2022).
Publications of importance:
- Recommendations on common regulatory approaches for allergen products by the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)
- Concept paper on a Guideline for allergen products development in moderate to low-sized study populations by the EMA
- Bonertz A, Mahler V, Vieths S. New guidance on the regulation of allergen products: key aspects and outcomes. Curr Opin Allergy Clin Immunol. 2020 Dec;20(6):624-630. doi: 10.1097/ACI.0000000000000687.
References:
- Ludger Klimek et al. In-vivo diagnostic test allergens in Europe: A call to action and proposal for recovery plan—An EAACI position paper. Allergy 2020 Sep;75(9):2161-2169. doi: 10.1111/all.1432
HOW TO JOIN THIS TASKFORCE:
E-mail Swen Malte John, Osnabrueck, GER: sjohn@uos.de
DEADLINE: 31 August 2022