The President of the European Patient’s Forum presented the draft strategy paper on behalf of the EMA. In preparation of this document the EMA was led by two sets of core interests: 1) protecting patients and 2) enabling innovation.
EMA sees its increasing role in connecting stakeholders for the benefit of the patients. New knowledge should transfer to the benefit of the patients.
An interactive exchange of views ensued. Some of the key points discussed included:
- It was agreed that the patients’ contribution to this discussion will help ensuring the regulatory science strategy is patient-centred.
- With regards to ATMPs a large part of the patient community does not receive information, or receives the wrong information on available therapies and, therefore, the EMA considers it imperative to work with patient groups to identify unmet needs.
- It was agreed that the document could benefit from a shorter, more concrete version.
The publication consultation process will close on 30 June 2019. More information is available here