EMA’s procedural handling of safety review was complete and independent

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17/10/2017

EMA’s procedural handling of safety review was complete and independent

European Ombudsman concludes her inquiry into the HPV vaccines referral

The European Medicines Agency (EMA) has welcomed the decision from the European Ombudsman which concludes that there was no maladministration by the Agency in the handling of its safety review of human papillomavirus (HPV) vaccines.

The conclusions of this review were that the available evidence does not support that two specific syndromes, complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women and girls are caused by HPV vaccines. These vaccines are given to prevent infections with the most common types of HPV which can cause cervical cancer, other HPV-related cancers and pre-cancerous conditions.

The procedure was conducted by EMA’s Pharmacovigilance Risk Assessment Committee’s (PRAC) in 2015.

The Ombudsman’s review followed a complaint which expressed concerns about aspects of the PRAC’s handling of the referral procedure.

Following her inquiry into the procedural aspects complained about, the Ombudsman concluded that her inquiry did not identify any procedural issues that could have negatively affected the work and conclusions of the PRAC referral procedure. The examination of scientific evidence was complete and it was independent.

The Ombudsman also considered that EMA’s conflicts of interest policy was fully complied with during the referral procedure on HPV vaccines and that no conflicts of interest were detected.

The Agency welcomes two suggestions made by the Ombudsman to further improve the information on its scientific assessments that it provides to the public and will now explore ways to address these.

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