• February 7, 2019
  • BEUC

Shedding light on EMA interactions with companies before a medicine gets approved

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BEUC, The European Consumer Organisation welcomes the opportunity to comment on the European Ombudsman’s strategic inquiry (OI/7/2017/KR) into pre-submission activities organised by the European Medicines Agency (EMA). 

Interactions between the EMA and medicine developers in the development phase of a medicinal product offer opportunities for medicine developers to obtain procedural advice and guidance for developing their medicine. As such, these pre-submission activities, including in-person meetings, can facilitate the development and availability of high-quality, effective and safe medicines to the benefit of patients and consumers.

Pre-submission activities can moreover be particularly valuable for non-forprofit bodies that have fewer resources and limited experience with the marketing authorisation process. As correctly observed by Ombudsman, such activities may nonetheless pose a risk that the EMA’s eventual decision on granting marketing authorisation is influenced by the presubmission exchanges between the Agency and medicine developers.

This practice may in parallel also contribute to a public perception of bias in the Agency’s assessment of marketing authorisation applications as a result of the relationships developed between EMA staff and medicine developers in the course of these activities.



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