Brussels, 1 December 2022 

In recent years, unmet medical needs have been at the core of Europe’s pharmaceutical and public health policies. A major hurdle to overcome is reaching a common understanding of unmet medical needs (hereafter - UMN) as stakeholders have different understandings of the concept based on different perceptions and expectations.

In response to the growing public debate about the definition of UMN, EuropaBio yesterday hosted 2022 Patient BioForum and invited multiple stakeholder groups to discuss and better understand patients’ with UMN experiences and facilitate progress towards a common understanding of the concept.

‘The Patient BioForum is a critical forum for patient-driven discussion and 2022 focussed on patients with unmet medical needs. The concept of UMN is particularly complex; rigid definition risks excluding patients from innovative treatments. Europe needs to put patients and their needs at the centre of the discussion and create a multi-stakeholder system ensuring that their voices are taken into account.’, said Claire Skentelbery, Director General of EuropaBio.

The discussions highlighted the importance of enhancing dialogue and collaboration between industry, patient organisations and policymakers in taking a more streamlined and harmonised approach to identifying UMNs.  This was confirmed by the results of the designated polls session;  69 % of event participants voted for a better dialogue with patients and other stakeholders.

The BioForum speakers and attendees agreed that Europe should caution against legislative intervention that will split the patient population and stifle innovation. Instead, the participants unanimously have asked to proceed with a multistakeholder approach and create a structure allowing stakeholders to exchange their views and identify a set of criteria of UNM.

The outcomes and recommendations from the event will be summarised into the report which will be published and publicly presented in January 2023.

Speakers: Joelle Khraiche, EuropaBio, Patient BioForum co-chair; Anca Toma, EPF, Patient BioForum co-chair; Tobias S. Hagedorn, Secretary of European Society for Phenylketonuria (ESPKU) and Managing Director of DIG PKU Germany; Pedro Franco, Director Europe for Global Regulatory & Scientific Policy at Merck and Chair of EuropaBio’s OMP WG. Moderator: Adrien Samson, Healthcare Biotechnology Manager, EuropaBio