EPF’s analysis of the European Parliament reports on the revision of the EU pharmaceutical legislation

On 10 April 2024, the European Parliament adopted the reports on the Directive and the Regulation, thus formalising the Parliament's official position on the revision of the EU pharmaceutical legislation. The reports of the European Parliament amend the proposals for a Directive and a Regulation of the European Commission published in April 2023.

Find below a summary of the main changes proposed by the European Parliament that are relevant to the patient community:

• Inclusion of patient representatives in the ad hoc working groups set up by the Committee for Medicinal Products for Human Use.
• Inclusion of a patient organisation representative in the Coordination Group for Decentralised and Mutual Recognition Procedures.
• Reimbursement of patients’ expenses incurred in performing their duties as members or alternates of EMA’s scientific committees.
• Consultation of patients in drawing up the Union's list of critical shortages and critical medicines.
• Establishment of a system for patients to report shortages at national level.
• Consultation of patients if a Member State decides to implement electronic patient information leaflets only.
• Inclusion of a key information section in the package leaflet reflecting the results of consultations with patient organisations.
• Allowing patient organisations to submit data for new indications for any medicine, beyond those addressing unmet medical needs.

Read the full analysis here.