Greece has proposed a closer link between medicine assessment and commercial terms, with therapeutic value feeding directly into price negotiations, reimbursement prioritisation and the exceptional negotiation route used for public-health reasons. The Ministry of Health opened consultation on the draft amendments on 17 September.
Article 61 would add ‘additional therapeutic value’ explicitly to the criteria used by the Medicine Price Negotiation Committee. It would also allow agreements outside the usual criteria based on clawback and rebate exposure where the Evaluation and Reimbursement Committee has classified a medicine according to its therapeutic value against relevant alternatives, where an EU Joint Clinical Assessment applies, or for products referred from the Innovation Fund.
The Negotiation Committee would also have to agree to proposed reimbursement prioritisation among medicines in the same therapeutic class, taking account of comparative clinical assessment alongside budgetary, safety, administration, adherence and eligible-population considerations.
A separate amendment would require the Committee for Evaluation and Reimbursement of Medicines for Human Use to advise the National Organisation for Medicines (EOF) on a medicine’s therapeutic value in relation to unmet medical need before EOF advises the Health Minister on use of the existing ‘negotiation for public-health reasons’ route. The proposal therefore would have EOF retain responsibility for formally advising the Minister, while the assessment committee provides the upstream clinical value assessment.
If enacted, the package would give clinical differentiation a more explicit role in negotiated commercial conditions and in exceptional negotiations intended to preserve access where public-health concerns arise. The consultation closes on 2 October 2026.
Source: Ministry of Health, Greece
Link: Άρθρο 57 Έργο της Επιτροπής Αξιολόγησης και Αποζημίωσης Φαρμάκων Ανθρώπινης Χρήσης - Τροποποίηση άρθρου 247 ν. 4512/2018 (Article 57 Work of the Committee for Evaluation and Reimbursement of Medicines for Human Use – amendment of Article 247 of Law 4512/2018)
Date: 17 September 2026
Source: Ministry of Health, Greece
Link: Άρθρο 61 Κριτήρια διαπραγμάτευσης τιμών φαρμάκου- Τροποποίηση παρ. 2 και 6 άρθρου 254 ν. 4512/2018 (Article 61 Medicine price-negotiation criteria – amendment of paragraphs 2 and 6 of Article 254 of Law 4512/2018)
Date: 17 September 2026
