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EU Council Agreement on Pharma Package reforms of Human Medicines legislation

Date
June 4, 2025
Category

EU Regulations

Description

The European Council finally reached an agreed position on 4 June 2025. See ‘Pharma package’: Council agrees its position on new rules for a fairer and more competitive EU pharmaceutical sector - Consilium

The initial assessment is that the Council position introduces several important improvements:

  • It restores a flat 8-year baseline for Regulatory Data Protection (RDP) with no access conditionalities, which significantly strengthens the innovation framework compared to the Commission and Parliament proposals.
  • Commission proposal on excipients, e.g. TiO2, remains.
  • Council did not support the EP proposal to include environmental and worker safety practices in GMP inspections.
  • There are pragmatic steps forward on shortages, including a risk-based approach to prevention plans, better use of existing data systems and more proportionate notification timelines.
  • The Council supports key forward-looking elements such as EMA governance reform and regulatory sandboxes, both of which can help future-proof the system.

At the same time, some concerns remain.

  • The Council also misses the opportunity to modernise the EU regulatory framework by not supporting shorter assessment timelines or broader use of expedited pathways.
  • Decentralised manufacturing would only be applied in exceptional circumstances for a small number of products.

The so called ‘trialogue’ between the Commission, who issued the original proposals, the European Parliament (EP) and the Council can now begin. Once these three bodies have reached a final agreed text the revised Directive and Regulation will be published in the Official Journal.