Violation of the obligation to provide information in relation to the COVID-19 vaccines
18.2.2022
Question for written answer E-000708/2022
to the Commission
Rule 138
Rosa D'Amato (Verts/ALE)
The Italian Medicines Agency (AIFA) has recently said that the COVID-19 vaccines should be deemed prescription drugs.
The Commission’s implementing decisions granting marketing authorisations for the COVID-19 vaccines state (in Annex II, point B, ‘Conditions and restrictions regarding supply and use’) that medical prescriptions would be required for the legitimate application of the vaccines.
According to AIFA, the vaccines should undergo a thorough assessment and, with the experimental phase ongoing, be administered with caution, subject to a restricted medical prescription. Regulation (EC) No 507/2006 provides that medicines may be granted a conditional marketing authorisation only in the absence of pre-clinical, pharmaceutical and clinical trials.
Prescriptions should be case-specific and issued only once the vaccinating physician has duly informed the patient of the nature, efficacy and safety of the vaccines (Article 8 of Regulation (EC) No 507/2006 and Article 5 of the Oviedo Convention)[1].
According to the International Committee for the Ethics of Biomedicine (ICEB), the provisions for the legitimate use of the COVID-19 vaccines require more thought[2].
Can the Commission say whether it considers there to have been a violation of the obligation to provide information under Article 8 of Regulation (EC) No 507/2006 and Article 5 of the Oviedo Convention?