Greece has applied the same external-reimbursement criteria that already govern ordinary reimbursement entry to medicines supplied through emergency import and early-access routes. The Greek Parliament approved the measure on 15 May, as part of legislaton covering the Innovation Fund and access to new medicines.
The change extends the 5/11 criterion to medicines supplied through the Institute of Pharmaceutical Research and Technology (Ινστιτούτο Φαρμακευτικής Έρευνας και Τεχνολογίας, IFET). IFET is used to import medicines that are not otherwise available through normal domestic supply, including products needed before a standard reimbursement route is complete.
Under the 5/11 criterion, a medicine must already be reimbursed in five of 11 selected European countries before it can proceed through the Greek reimbursement process. Specialist press reported that the new legislation applies that condition to IFET medicines, broadening the reach of a rule based on prior payer decisions in other markets.
The measure comes against a continuing dispute over whether cross-country reimbursement thresholds help control entry into public funding or add an avoidable delay to Greek access. Industry has argued that the 5/11 rule leaves Greece dependent on the speed and sequencing of decisions elsewhere in Europe. That concern is sharper for products with small eligible populations, limited comparator data or uneven launch strategies across member states.
The public consultation run by the Ministry of Health (Υπουργείο Υγείας, MoH) showed similar concern around Article 12 of the draft bill. Stakeholder comments questioned whether a single cross-country reimbursement threshold can be applied fairly across very different product categories, particularly where orphan medicines are concerned.
The legislation may give Greece a more consistent framework for exceptional access, compassionate use, individual patient requests and non-standard indications. Greater consistency, however, also narrows the space for discretion. IFET has functioned as a route for cases falling outside the ordinary reimbursement timetable. Bringing it closer to the same external precondition risks removing this flexibility in the system while making exceptional access more dependent on the pace of reimbursement decisions in other countries.
Source: Euractiv; Ministry of Health
Link: Greece extends drug reimbursement rule, despite delayed medicine access concerns
ΚΕΦΑΛΑΙΟ Β΄ ΡΥΘΜΙΣΕΙΣ ΓΙΑ ΤΟΝ ΕΘΝΙΚΟ ΟΡΓΑΝΙΣΜΟ ΠΑΡΟΧΗΣ ΥΠΗΡΕΣΙΩΝ ΥΓΕΙΑΣ(άρθρα 8-24) (Chapter B: provisions for the National Organisation for Healthcare Services Provision, Articles 8-24)
Date: 20 May 2026; 11 April 2026
