The vaccines' contribution to unmet medical need in the context of the revision of the EU General Pharmaceutical legislation

On April 26, 2023, the European Commission unveiled its proposal for the revision of the EU General Pharmaceutical Legislation. This ambitious plan seeks to address a multitude of critical objectives, including addressing unmet medical needs (UMN). Part of these efforts include aiming to formalise the definition of ‘Unmet Medical Needs’ and to enhance incentives for innovation in areas of UMN. With 100 vaccine candidates in the industry pipeline aiming to tackle the challenges of today and tomorrow, this concept is critical to ensure sustainable vaccine innovation and address public health needs. 

With this position paper, Vaccines Europe, the Active Citizenship Network, the Federation of European Academies of Medicine, and the Spanish Association Against Meningitis call for a broad, inclusive, and mission oriented UMN concept that:

  • Encompasses innovation needs from prevention to care.
  • Recognises the unique features of vaccines and vaccination programmes.
  • Considers the complexity of vaccine development and sustainably incentivises innovation in vaccine R&D and diverse technology platforms.
  • Considers the impact of infectious diseases on European and global populations, and supports improvements in public health and surveillance infrastructures.
  • Embraces the perspective of target population, both healthy individuals and vulnerable populations, ensuring inclusivity across many different populations and recognising the concept of community immunity.
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