Critical Medicines Act

Background

The Critical Medicines Act is an upcoming EU regulation, currently in the final steps of the legislative process.

Its main objective is increasing the availability and supply of critical medicines in the European Union.

Medicine shortages continue to disrupt patient care in hematology and other medical fields, placing a significant strain on EU healthcare systems.

That is why EHA has closely followed and engaged with this legislative dossier, on behalf of hematologists.

The Critical Medicines Act will introduce measures on both the supply and demand side, including:

  • Funding, priority status, and other support for strategic projects targeting critical medicines or their ingredients
  • Public procurement to improve patient access and health systems’ resilience
  • Collaborative procurement to address access disparaties
  • International partnerships to expand the supply chain

EHA’s position

EHA’s advocacy has been centered around the following priorities:

  • Public funding and other kinds of support must be accompanied by supply obligations, in order to deliver tangible benefits for European patients.
  • The Critical Medicines Act must introduce sufficient safeguards to ensure the affordability of critical medicines and avoid access disparaties in the European Union.
  • Healthcare professionals and patients must be involved in the regulation’s governance structure, and be regularly consulted to ensure that measures around preparedness, prioritization and crisis response are in line with clinical realities.
  • A strong Critical Medicines Act is dependent on EU-wide harmonization and strategic coordination.

In line with the aforementioned priorities, EHA has led the drafting of this comprehensive BioMed Alliance advocacy statement.

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