When a payer cannot be certain a medicine is worth its price, the answer is increasingly not “no” — it is a contract that shares the uncertainty. Greece has just built its most ambitious version of that idea yet.
Managed entry agreements fall into two broad families. Financial-based arrangements — simple discounts, price-volume agreements, budget caps, dose capping — manage the money. Outcomes-based arrangements — coverage with evidence development, payment by results, conditional treatment continuation — tie payment to whether the medicine actually works in practice.
The Greek legal basis
Negotiation in Greece runs through the Negotiation Committee, with the framework set out in Article 254 of Law 4512/2018. Paragraph 9 — introduced in 2019 — sets out an explicit menu: discounts, volume-tiered discounts, outcomes-based agreements, indication-based agreements, risk-sharing agreements and milestone-based agreements. Negotiation is triggered where annual budget impact exceeds €3 million or annual per-patient cost exceeds €12,000.
The Innovation Fund
The most significant recent development is Law 5302/2026, which established a national Innovation Fund (Ταμείο Καινοτομίας). Several features deserve attention:
- It is financed from the state budget — not from clawback — with a ring-fenced credit line tracked separately by EOPYY.
- Scope is narrow: advanced therapy medicinal products and EMA PRIME medicines only.
- It is coverage with evidence development in its purest form. Entry is triggered where the HTA Committee finds high uncertainty and cannot recommend immediate reimbursement. Indicators must span effectiveness, safety and resource use, supported by a national patient registry.
- While a product sits in the Fund, automatic clawback is not imposed on it — a material commercial consideration.
The obligations are unusually hard-edged. Holders must undertake to supply through completion of treatment, and on exit, where negotiation fails, may be required to supply free of charge in defined circumstances. Physicians who fail to complete outcome data face sanctions. This is not a soft pilot.
The transparency question
For unpriced products entering the Fund, EOF assigns a provisional price through a supplementary pricing bulletin that is not published. Greece has, in effect, formally created a confidential price — a notable development in a European debate where external reference pricing depends on list prices that confidential rebates have already rendered fictional.
An honest assessment
Greece has had the legal power to write outcomes-based contracts since 2019, but there is little public evidence about how many exist or whether collected data has ever changed a decision. The Innovation Fund’s registry is the first mechanism designed to answer that systematically.
How PQRA helps
PQRA designs managed entry proposals, builds the evidence and economic case, and negotiates access for high-uncertainty products in Greece.
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