Why is there a Patiente Vertriedung form on vaccination side effects?

Since 26 January 2022, a form has been available on the website of the Patients' Association (Patiente Vertriedung asbl), which allows people to report adverse reactions to vaccinations. The MPs Gusty Graas and Carole Hartmann wonder why such a form exists and whether it complies with the legislation.

Il nous revient que la Patiente Vertriedung asbl propose depuis le 26 janvier 2022 un formulaire permettant de signaler tout effet indésirable en relation avec les vaccinations contre la Covid-19. Selon la Patiente Vertriedung asbl, les informations recueillies par le biais de ce formulaire seront communiquées au ministère de la Santé.

Dans ce contexte, nous aimerions poser les questions suivantes à Madame la Ministre de la Santé :

  • Qui est à l’initiative de la mise en ligne de ce formulaire et du transfert de données médicales au ministère de la Santé? Est-ce une initiative individuelle de l’association ou est-ce que le formulaire a été mis en ligne sur demande du ministère de la Santé ?
  • Compte tenu du caractère sensible de ces données, comment Madame la Ministre évalue-t-elle cette démarche par la Patiente Vertriedung asbl ?
  • Est-ce que la démarche proposée par la Patiente Vertriedung asbl se substitue au signalement d’effets indésirables auprès de la Division de la pharmacie et des médicaments ?
  • Le ministère de la Santé a-t-il déjà reçu des données de la part de la Patiente Vertriedung asbl dans ce contexte ? Dans l’affirmative, de combien de questionnaires s’agit-il ?
  • Madame la Ministre estime-t-elle que cette initiative de la Patiente Vertriedung asbl puisse présenter un risque de distorsion des statistiques nationales ?
  • Madame la Ministre reconnaît-elle que le questionnaire mis en circulation par la Patiente Vertriedung asbl peut être source de confusion pour les personnes souhaitant déclarer des effets indésirables ?
  • Le système de pharmacovigilance ne relève-t-il pas de la compétence exclusive de l’État? Dans l’affirmative, quelles suites Madame la Ministre entend-elle réserver à la démarche mise en place par la Patiente Vertriedung asbl ? 

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