Brussels, 31 January 2023 - Today, EuropaBio publishes the report and recommendations on unmet medical needs (UMN) from its 1 December 2022 invite-only event. In response to the growing public debate about UMN, EuropaBio hosted 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 an important forum for multi-stakeholder discussions between industry and patient groups. Our discussions confirmed that a rigid approach to UMN risks having unintended consequences for patients and innovation. To address the challenges of UMN, the EU needs to create a multi-stakeholder forum to help dialogue and collaboration between policy-makers and stakeholders, with patient voices strongly represented”, said Claire Skentelbery, Director General of EuropaBio.

The report issues the following recommendations to the European Commission, the European Parliament, and the Council of the European Union to enable Europe to address the challenge of UMN:

➢ A multi-stakeholder approach is necessary where patient representatives are involved on an equal footing as other stakeholders and their voices duly considered
➢ Non-legislative approaches to UMN should be privileged to ensure Europe’s approach is scientifically sound, flexible, and future-proof to accommodate the rapid evolution of treatments, science, and disease understanding
➢ A life-cycle approach, from the translation of basic science to innovative therapies as well as care provision and patients is necessary to accommodate for current and future UMN
➢ Significant investments in science and society, by supporting Europe’s life science sector from scientific research to clinical development by positively rewarding innovation and maximising synergies between public and private actors, are necessary to ensure life-changing treatments reach the most patients.

Today, EuropaBio also launches its call for the creation of a multi-stakeholder forum to support reaching a common understanding of UMN and, most importantly, how it may support scientific progress, translational research, and therapeutic development that will improve the lives of millions of patients.

Several organisations, including DIG PKU and ESPKU, have already expressed their support to the initiative and EuropaBio intends to continue to engage with relevant stakeholders.

“Addressing unmet medical needs represent an important challenge for Europe that will require positive tools to stimulate innovation and deliver for patients and society. Addressing unmet medical needs will require us to break the silos and work together toward a common goal, making sure patients’ voices and experiences are heard. We need to adopt a balanced and careful approach and ensure no patients’ needs are unmet”, said MEP Pernille Weiss (EPP, Denmark).