Το Ίδρυμα ΦΗΜΟΝΟΗ με επιστολή ζητά από την Επίτροπο Στέλλα Κυριακίδου να πληροφορηθεί αν οι φαρμακευτικές εταιρείες συνεχίζουν να δοκιμάζουν τα φάρμακα μόνο σε άνδρες. Ο λόγος που ζητήθηκε αυτή η πληροφορία είναι διότι φάρμακα που δεν δοκιμάζονται σε γυναίκες πιθανόν να μην έχουν την ίδια επίδραση πάνω τους.

Με επιστολή της προς το Ίδρυμα, η κ Κυριακίδου αναφέρει ότι.  «The European Commission and the European Medicines Agency (EMA) are aware of, and sensitive to, the importance of gender-related differences in disease manifestations, including their relation to medicinal products. For instance, the EMA published a reflection paper on gender differences in cardiovascular diseases (1), highlighting the importance of closely following this issue in the development of new cardiovascular drugs. In addition, and more specifically at the stage of an application for a marketing authorisation of a medicinal product, the EMA receives clinical reports that contain a clear representation of the clinical trial population demographics, including sex distribution. The applicants have to demonstrate that their findings can be extrapolated to the anticipated user population, if that population (e.g. women) is not sufficiently represented in the trials.

 Furthermore, the EMA’s assessment report has a specific “special population” section that includes an analysis of the sex distribution of the studied population, including a critical discussion of any differences emerging from the clinical data and of the (scientific and ethical) criteria for excluding vulnerable groups from the studied population. It is a well established practice and requirement to highlight in the authorised medicinal product information for healthcare professionals and for patients, if there are differences in adverse drug reactions between men and women.»

Στην επιστολή της αναφέρει επίσης ότι

The Commission is attentive to this topic also in the context of clinical trials. The Clinical Trials Regulation – Regulation EU No 536/2014 – outlines, for example, the conditions upon which a clinical trial with pregnant or breastfeeding women can be conducted. In addition, with the technical support of EMA, the Commission has been evaluating the evolution of the clinical research in Europe with a series of metrics based on the data retrieved via the Clinical Trials Information System (CTIS). Recently, a key performance indicator has been included to inform on gender representation in clinical trials: Male – Female – Both gender categories. When looking at clinical trials that have been authorised in CTIS since 31 January 2022, at the end of February 2024, the gender of clinical trials participants was distributed as follows: 131 clinical trials (5%) with only women, 157 clinical trials (6%) with only men and 2203 clinical trials (89%) with both genders.

Εμείς θα συνεχίσουμε να παρακολουθούμε το θέμα και θα συνεχίσουμε να ρωτούμε! Η κ Κυριακίδου καλωσορίζει αυτή τη συνεργασία που αφορά τα θέματα υγείας των ευρωπαίων πολιτών.