Unmet medical needs definition and incentives: stakeholders perspectives on the reform of the EU pharmaceutical legislation.

ABSTRACT:

Introduction

The 2020 pharmaceutical strategy for Europe stressed that rethinking regulatory policies to foster innovation in disease areas with unmet medical needs (UMN) is one of the European Commission's (EC) priority areas. To understand stakeholders' views regarding appropriate UMN criteria and incentives, the EC developed a survey and launched it for public consultation between September and December 2021. This study aims to assess stakeholders' views on the policy revisions proposed by the EC, particularly those regarding the definition of UMN, its criteria and incentives and evaluate how stakeholders' views are reflected in the proposed reform of the EU pharmaceutical legislation of 2023.

Methods

The public consultation survey comprised 14 questions including multipl

SUBMITTER: Wens I 

PROVIDER: S-EPMC11747691 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature