June 2019

EuropaBio Patients Bio-Forum –May 20, 2019 in Brussels

IPOPI was pleased to actively participate in the EuropaBio Patients Bio-Forum which was arranged to discuss the draft of the European Medicines Agency (EMA)’s Regulatory Science Strategy to 2025 with the aim to provide a platform for a genuine exchange of views between regulators, patients, payers and the biopharmaceutical companies of EuropaBio. Jose Drabwell, IPOPI Past President, who has been IPOPI’s representative at the EMA Patients and Consumers Working Party for a number of years, actively participated in the meeting on behalf of IPOPI.

The 5 key goals of the strategy include:

  • catalysing the integration of science and technology in medicine development
  • driving collaborative evidence generation – improving the scientific quality of evaluation
  • advancing patient-centred access to medicines in partnership with healthcare systems;
  • addressing emerging health threats
  • enabling and leveraging research and innovation in regulatory science.

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