In November 2020, the Commission put forward a Pharmaceutical Strategy for Europe which aims to create a future-proof and patient-centred pharmaceutical environment in which the EU industry can innovate, flourish, and continue to be a global leader. As a key part of the EU’s comprehensive response to these challenges, the Commission, in April 2023 proposed an ambitious Revision of the EU General Pharmaceutical Legislation
The five main objectives are
• Make sure all patients across the EU have timely and equitable access to safe, effective, and affordable medicines.
• Enhance security of supply and ensure medicines are always available to patients, regardless of where they live in the EU.
• Offer an attractive, innovation- and competitiveness friendly environment for research, development, and production of medicines in Europe.
• Make medicines more environmentally sustainable.
• Address antimicrobial resistance (AMR) through a One Health approach, encompassing human health, animal health and the environment.
The file was subject to continuous negotiations at EU level for the past 18 months. The Pharma Package reached a very significant milestone in the negotiation of the file on 4th June 2025 when the Council of the European Union agreed their Mandate for negotiations with Parliament.
The Mandate agreed by EU Council is now publicly available at the below links.
data.consilium.europa.eu/doc/document/ST-9286-2025-INIT/en/pdf
data.consilium.europa.eu/doc/document/ST-9285-2025-INIT/en/pdf
Next steps
The Commission, the Parliament and the Council must now aim to agree on a final text for the two proposed pieces of legislation. Following the first trilogue, technical meetings and a second trilogue are expected under the Danish Presidency of the Council, which commenced on 1 July.
