Between a European approval and a Greek reimbursement decision there is typically more than a year. Greece has a defined early access framework to bridge it — but the framework was built around free supply, and it carries publication and promotion restrictions that catch companies by surprise.
The two EU instruments
Article 83 of Regulation (EC) No 726/2004 permits Member States, by way of exemption from Article 6 of Directive 2001/83/EC, to make a medicine available for compassionate use — that is, to a group of patients with a chronically or seriously debilitating or life-threatening disease who cannot be treated satisfactorily by an authorised medicine. The product must either be the subject of a marketing authorisation application or be undergoing clinical trials. CHMP may adopt opinions on conditions of use, distribution and target patients, but those opinions are not binding: Member States “shall take account” of them.
The critical point is competence. EMA’s guideline states that national compassionate use programmes are governed by individual Member State legislation, and that implementation remains the competence of a Member State. Companies cannot request a CHMP opinion — only national authorities can. Only six CHMP compassionate use opinions have ever been issued.
Article 5(1) of Directive 2001/83/EC is the separate named-patient route: a Member State may exclude from the Directive medicines supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised healthcare professional, for use by an individual patient under their direct personal responsibility. EMA does not need to be informed. Compassionate use is a cohort; named-patient supply is an individual.
The Greek framework
Greece regulates early access — παρηγορητική χρήση — under Ministerial Decision Δ.ΥΓ3α/Γ.Π. 85037/10, published in 2011. It creates two EOF-authorised routes:
- A cohort programme. The responsible party is the marketing authorisation applicant or the clinical trial sponsor. Authorisation runs up to one year, renewable, and ceases when the marketing authorisation is granted. The application must include a proposed SmPC and package leaflet in Greek. Product must be labelled as an early access medicine not for sale, and is distributed under the responsibility of the hospital pharmacist. EOF publishes the list of approved programmes.
- An individual authorisation. Here the responsible party is exclusively the treating physician. It is permitted only in exceptional, specifically justified cases — a rare disease requiring an orphan medicine, or extreme urgency where delay would cause death or irreversible serious harm.
Free of charge is not optional
Article 7 of that decision obliges the responsible party to supply the medicine free of charge and without burdening patients, the state budget or the insurance funds, unless specific coverage has been established. Attached to that obligation are conditions companies consistently underestimate:
- Fifteen-year record retention.
- Immediate reporting of serious adverse reactions to EOF.
- No advertising of the medicine concerned.
- The early access process may not be used in the marketing authorisation dossier.
- No publications or conference presentations of early access data before the marketing authorisation is granted.
There is also a compulsion power: where EMA has issued a positive opinion and public health requires it, EOF may require a company to run an early access programme, with refusal permitted only on safety or efficacy grounds.
Where EOPYY funding comes in
Law 4512/2018 establishes the electronic pre-approval system, and Article 265(1) lists the categories it covers. Three are relevant here: medicines not circulating in Greece; medicines not on the positive list and not yet assessed, requested exceptionally for conditions immediately threatening life or capable of causing irreversible harm; and — the express bridge — early access medicines not supplied free of charge by the holder or its local representative, for which a temporary individual authorisation is sought from EOF.
So the sequence is: free supply by the company is the default, and EOPYY funding is the exception where the company does not supply.
Medicines not marketed in Greece
Separately from early access, EOF operates a procedure for individual orders of medicines approved elsewhere but not circulating in Greece, used within their approved indications. There are two routes: a reimbursed route through EOPYY’s electronic pre-approval, and a private pharmacy route where the physician completes a prescribed form, the pharmacy submits it to EOF, and EOF assesses whether the product lawfully circulates elsewhere and whether a similarly composed product exists in Greece.
Supply frequently runs through IFET, the Institute of Pharmaceutical Research and Technology, a company wholly owned by EOF whose pharmaceutical coverage unit imports and distributes unique or irreplaceable products — including new medicines not yet circulating in Greece — on EOF’s instruction, which also sets quantities and price. Hospital-only and infusion products go through the hospital order route via IFET.
This matters for market access planning: EFPIA data indicates that a substantial share of the medicines nominally “available” in Greece are available only on an individual-patient basis, which in practice often means this route rather than the positive list.
How PQRA helps
We design and file early access programmes with EOF, prepare Greek-language product information for programme approval, manage the safety reporting and record obligations that attach, advise on the interaction between free supply and EOPYY pre-approval funding, and plan the transition from early access to a reimbursement dossier without breaching the publication restrictions.
Approved in Europe but not yet reimbursed in Greece? Ask PQRA how to reach patients in the meantime.
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