Tuesday morning, the Parliament and Council negotiators reached a provisional deal on new rules seeking to ensure a high level of public health protection for EU citizens by reducing dependency on non-EU countries and boosting the competitiveness of the EU pharmaceutical sector.

The rules will apply to critical medicines, with several provisions also aiming to improve access to medicinal products of common interest (MPCI – medicines that are not sufficiently available to cover patients’ needs in several countries). MEPs ensured that orphan medicinal products (needed to treat rare diseases) can benefit from strategic projects and collaborative procurements opportunities.

The agreed text establishes the criteria for setting up industrial “strategic projects’” located in the EU to create, modernise and increase manufacturing capacity. Companies benefiting from national or EU financial support will have to meet clear obligations, including prioritising supply to the EU market.

Next steps: The provisional agreement needs to be approved by both Parliament and Council before the new rules can enter into force.