EMA conduct and pharmacovigilance
26.4.2017
Question for written answer E-002925-17
to the Commission
Rule 130
Piernicola Pedicini (EFDD) , Laura Agea (EFDD) , Rosa D'Amato (EFDD) , Eleonora Evi (EFDD) , Laura Ferrara (EFDD) , Daniela Aiuto (EFDD) , Dario Tamburrano (EFDD) , Ignazio Corrao (EFDD)
The EMA’s 2015 report on the safety of Human Papillomavirus (HPV) vaccines, requested by Denmark, rejected any causal association between the use of the vaccines and certain syndromes arising as adverse reactions.
The Nordic Cochrane Centre (an independent Norwegian research centre) then raised concerns about mismanagement, at first directly with the EMA and then with the European Ombudsman, pointing out a lack of transparency in how the EMA functions.
Specifically, the criticisms concern the secrecy requirements imposed on members of the EMA’s internal committees, the numerous redactions in the official version of the report compared with the confidential version, and the margin of discretion in the selection of studies to be considered. Several researchers have emphasised the need for further research into the toxicity of HPV vaccines and for greater transparency[1], and the need for the EMA to consider independent studies, rather than only those from pharmaceutical companies[2]
Can the Commission:
Explain how the procedures and secrecy requirements imposed by the EMA are meant to protect public health and the patients’ right to complete information?
Describe what measures it intends to take to ensure that the EMA assesses studies from independent research centres along with those commissioned by the pharmaceutical industry?
Make available any reports concerning adverse reactions from pharmacovigilance?