EuropaBio Patient BioForum 2023 Roundtable on Advancing Solutions for Unmet Medical Needs

Hybrid Event | Invitation Only

EuropaBio’s Patient BioForum meets annually to facilitate the exchange of views and expertise on scientific, regulatory, and policy issues between patient organisations and the biopharmaceutical industry.

In recent years, unmet medical needs have been at the core of Europe’s pharmaceutical and public health policies. To address unmet medical needs (UMN), the Commission proposed as part of the revision of the EU General Pharmaceutical Legislation (GPL) to introduce a definition of UMN and a definition of high UMN. Under the Commission’s proposals, all orphan products would qualify as addressing UMN but only a subset of products would meet the HUMN criteria. The Commission’s proposals on UMN and especially HUMN received mixed reactions from patient organisations and negative reactions from the industry.

On 1 December 2022, EuropaBio organised a Patient BioForum which brought together industry and patient organisations to discuss the topic of UMN in view of reaching a common understanding on UMN. Those discussions revealed shared interests and concerns with the possible approach to UMN in the EU Pharmaceutical Legislation. The discussions were followed by a report which outlined recommendations to policymakers to enable Europe to address the challenge of UMN.

With the proposals now presented and being negotiated by the European Parliament and the Council, the 2023 Patient BioForum is an opportunity to build on the 2022 Patient BioForum to foster exchanges between patient groups and industry on UMNs, including expectations from the legislation and beyond. The 2023 Patient BioForum will also be an opportunity to issue multi-stakeholder recommendations to policymakers to ensure the GPL is fit for purpose to address patients need and support innovation.  

Programme

The 2023 Patient BioForum will be held in a roundtable format under Chatham House Rule. A wide range of stakeholders representing patients, regulators, policy-makers, and industry will be invited to take part in the roundtable. All participants will be invited to take an active part in the discussion to bring their unique perspective. The roundtable will be followed by a report to summarise the discussions.

1. Introductions

2. Legislating Unmet Medical Needs: Perspectives from the European Commission and the European Parliament

3. Roundtable topic 1: How Can the EU Pharmaceutical Legislation Help Stimulate Patient-Centric Innovation?

4. Roundtable topic 2: How can Europe Incentivise R&D for UMN and Underserved Areas?

5. Conclusions

If you would like to attend, please contact Adrian Lincoln, a.lincoln@europabio.org