Position statement of the Polish Society of Allergology and Polish Dermatological Society regarding the limited accessibility of materials necessary for patch testing. Part I: Technological and legal barriers
Roman J. Nowicki
1
,
Magdalena Czarnecka-Operacz
2
,
Elżbieta Grubska-Suchanek
1
,
Marta Kieć-Świerczyńska
3
,
Cezary Kowalewski
4
,
Beata Kręcisz
5
,
Jerzy Kruszewski
6
,
Maciej Kupczyk
7
,
Cezary Pałczyński
5, 8
,
Jacek Szepietowski
9
,
Magdalena Trzeciak
1
,
Jolanta Walusiak-Skorupa
3
,
Radosław Śpiewak
10
Klinika Dermatologii, Wenerologii i Alergologii, Uniwersyteckie Centrum Kliniczne, Gdański Uniwersytet Medyczny, Gdańsk, Polska
Zakład Alergicznych i Zawodowych Chorób Skóry, Katedra Dermatologii, Uniwersytet Medyczny
im. Karola Marcinkowskiego, Poznań, Polska
Klinika Chorób Zawodowych i Zdrowia Środowiskowego, Instytut Medycyny Pracy im. prof. J. Nofera, Łódź, Polska
Zakład Immunodermatologii, Centrum Diagnostyki Laboratoryjnej, Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji, Warszawa, Polska
Collegium Medicum, Uniwersytet Jana Kochanowskiego, Kielce, Polska
Klinika Chorób Wewnętrznych, Infekcyjnych i Alergologii, Wojskowy Instytut Medyczny – Państwowy Instytut Badawczy, Warszawa, Polska
Klinika Chorób Wewnętrznych, Astmy i Alergii, Uniwersytet Medyczny, Łódź, Polska
Klinika Pneumonologii i Alergologii, Świętokrzyskie Centrum Chorób Płuc, Czerwona Góra, Polska
Katedra i Klinika Dermatologii, Wenerologii i Alergologii, Uniwersytet Medyczny, Wrocław, Polska
Zakład Dermatologii Doświadczalnej i Kosmetologii, Uniwersytet Jagielloński Collegium Medicum, Kraków, Polska
Alergologia Polska – Polish Journal of Allergology 2024; 11, 3: 195–210
Nowicki RJ, Czarnecka-Operacz M, Grubska-Suchanek E, et al. Position statement of the Polish Society of Allergology and Polish Dermatological Society regarding the limited accessibility of materials necessary for patch testing. Part I: Technological and legal barriers. Alergologia Polska - Polish Journal of Allergology. 2024;11(3):195-210. doi:10.5114/pja.2024.142698.
APA
Nowicki, R. J., Czarnecka-Operacz, M., Grubska-Suchanek, E., Kieć-Świerczyńska, M., Kowalewski, C., & Kręcisz, B. et al. (2024). Position statement of the Polish Society of Allergology and Polish Dermatological Society regarding the limited accessibility of materials necessary for patch testing. Part I: Technological and legal barriers. Alergologia Polska - Polish Journal of Allergology, 11(3), 195-210. https://doi.org/10.5114/pja.2024.142698
Chicago
Nowicki, Roman J, Magdalena Czarnecka-Operacz, Elżbieta Grubska-Suchanek, Marta Kieć-Świerczyńska, Cezary Kowalewski, Beata Kręcisz, and Jerzy Kruszewski et al. 2024. "Position statement of the Polish Society of Allergology and Polish Dermatological Society regarding the limited accessibility of materials necessary for patch testing. Part I: Technological and legal barriers". Alergologia Polska - Polish Journal of Allergology 11 (3): 195-210. doi:10.5114/pja.2024.142698.
Harvard
Nowicki, R., Czarnecka-Operacz, M., Grubska-Suchanek, E., Kieć-Świerczyńska, M., Kowalewski, C., Kręcisz, B., Kruszewski, J., Kupczyk, M., Pałczyński, C., Szepietowski, J., Trzeciak, M., Walusiak-Skorupa, J., and Śpiewak, R. (2024). Position statement of the Polish Society of Allergology and Polish Dermatological Society regarding the limited accessibility of materials necessary for patch testing. Part I: Technological and legal barriers. Alergologia Polska - Polish Journal of Allergology, 11(3), pp.195-210. https://doi.org/10.5114/pja.2024.142698
MLA
Nowicki, Roman et al. "Position statement of the Polish Society of Allergology and Polish Dermatological Society regarding the limited accessibility of materials necessary for patch testing. Part I: Technological and legal barriers." Alergologia Polska - Polish Journal of Allergology, vol. 11, no. 3, 2024, pp. 195-210. doi:10.5114/pja.2024.142698.
Vancouver
Nowicki R, Czarnecka-Operacz M, Grubska-Suchanek E, Kieć-Świerczyńska M, Kowalewski C, Kręcisz B et al. Position statement of the Polish Society of Allergology and Polish Dermatological Society regarding the limited accessibility of materials necessary for patch testing. Part I: Technological and legal barriers. Alergologia Polska - Polish Journal of Allergology. 2024;11(3):195-210. doi:10.5114/pja.2024.142698.
One of three Polish residents has contact allergy (Gell and Coombs type IV hypersensitivity reaction). The most frequent clinical manifestation of contact allergy is allergic contact dermatitis (ACD), affecting approximately one of 10 Poles ever in life, while 1 of a 100 has the symptoms at present. Cases of allergic reactions to implanted medical devices are also on the rise, causing failures of endoprostheses, implants, insulin pumps, pacemakers and vascular stents. At present, the only validated method and a gold standard of detecting type IV allergy are patch tests. The number of known haptens that can induce contact allergy amounts to 5200 and is still growing. Therefore, state-of-the art allergy and dermatology diagnosis requires patients’ access to a large number of diagnostic haptens. Contrary to the needs, legal regulations introduced in the EU hamper the accessibility to diagnostic haptens. This overregulation endangers citizens’ rights to state-of-the-art healthcare which may undermine the trust of citizens toward public institution in Poland and the EU. In the present position statement, experts of the Polish Society of Allergology and Polish Dermatological Society emphasize the gravity of the present situation and appeal for a partnership debate between competent authorities in the EU and Poland, allergy and dermatology medical societies, as well as patients’ organizations to find a best way of ensuring citizens’ access to necessary allergy diagnosis. First of all, the experts plea for urgent removal of bureaucratic barriers that limit the availability of diagnostic haptens that are indispensable in the state-of-the-art allergy and dermatology care.
Keywords
patch tests, diagnostic haptens, legal barriers, European law, Polish law, medical devices