What are the four checkpoints new medicines must pass?
The draft law establishes four control points that every innovative medicine must clear: the EAAPHA committee, the electronic pre-approval system at IFET, the negotiation committee and the Innovation Fund. A product must receive positive opinions at each stage before it can enter the reimbursed market for two years under the fund and then move to standard pricing and reimbursement rules. The only exception allows the Minister of Health to intervene directly at the negotiation committee and reduce or remove mandatory clawback and rebate obligations when a medicine is at risk of withdrawal for economic reasons, is unique, has no therapeutic equivalent and is considered necessary for public health reasons. This ministerial power applies only when the absence of the medicine would create a public-health problem and no other product maintains the same therapeutic value. The sequence begins with revisions to the EAAPHA assessment process, continues through changes at IFET and the electronic pre-approval system of EOPYY, moves to the negotiation committee and ends at the Innovation Fund that grants the two-year secured funding window. Each checkpoint applies the same core criteria, including clinical benefit, cost-effectiveness, budget impact and transferability of trial results to Greek patients, so that a negative finding at any stage halts further progress.
How will the five-level therapeutic value scale work?
EAAPHA will classify additional therapeutic value as major, substantial, moderate, minor or no improvement compared with existing reimbursed treatments. Products judged to offer insufficient clinical benefit receive a negative recommendation and are excluded from the positive list. The committee will also examine the reliability of clinical data, cost-effectiveness, budget impact and ethical, legal, social and organisational factors. In parallel it assesses whether trial results can be transferred to the Greek population, taking account of differences in epidemiology, demographics, disease severity, patient characteristics and clinical practice conditions. When a biomarker test is required for appropriate use and is not already reimbursed, the test itself undergoes parallel evaluation of its analytical and clinical validity, reproducibility, cost and budget impact. Medicines that receive a positive opinion are re-evaluated every three years. The five-level scale replaces the previous three-category clinical benefit rating and is applied together with the transferability review and the biomarker evaluation where relevant. The assessment further weighs the degree of uncertainty in both clinical and economic data, the medicine’s projected effect on the overall pharmaceutical budget, and a range of non-clinical parameters such as equity of access, data protection compliance, patient and professional acceptance, and the infrastructure, staffing and training changes needed for safe use in Greek hospitals and clinics.
Which population and transferability factors are considered?
Assessors must consider whether trial results can be applied to the Greek population, taking account of differences in epidemiology, demographics, disease severity, patient characteristics and clinical practice conditions. When a biomarker test is required for appropriate use and is not already reimbursed, the test itself undergoes parallel evaluation of its analytical and clinical validity, reproducibility, cost and budget impact. The same transferability review applies to the biomarker evaluation, examining analytical value, sensitivity, specificity, accuracy, quality assurance, reproducibility, quality criteria, clinical validity and clinical utility together with the cost of testing and its effect on the overall cost-effectiveness ratio and budget impact. The indicated population for testing and the budgetary consequences of adopting the test are also examined. These factors are reviewed at every checkpoint to ensure the medicine and any companion test remain appropriate for Greek patients and the national health-service setting. The source leaves unsettled how large a mismatch in patient characteristics or clinical practice would be required to produce a negative transferability finding.
What role does the Innovation Fund play?
Products that meet high unmet medical need criteria, including life-threatening or severely disabling conditions without reimbursed alternatives, may receive temporary unpublished pricing and two years of secured funding. Horizon scanning by EOPYY, together with input from medical societies and centres of expertise, informs selection. After the fund period, standard pricing and reimbursement procedures apply. The fund is fed by the same four checkpoints and receives requests that arrive through the electronic pre-approval system when a new active substance or combination is introduced for the first time, or when a new indication without prior reimbursement is requested. Only requests that demonstrate high unmet medical need for life-threatening or severely disabling conditions without existing reimbursed treatments are forwarded to the fund committee. The temporary price is set by EOF and remains unpublished during the two-year period. Selection also incorporates the five-level therapeutic value rating and the outcome of any parallel biomarker assessment, ensuring that only products meeting the full set of clinical, economic and organisational criteria enter the protected funding window.
How will price negotiation and clawback change?
A forthcoming ministerial decision will set new negotiation criteria that include EU sales volumes and prices, remaining data protection period and the assessed therapeutic value. The minister may intervene to reduce mandatory clawback and rebate amounts for medicines at risk of withdrawal when they are unique and necessary for public health. For centrally authorised medicines still under data protection, reimbursement in at least five of the eleven listed EU countries that operate health technology assessment systems remains a precondition. After exiting the Innovation Fund the medicine receives a published price and follows ordinary reimbursement procedures. The same negotiation framework applies to the temporary price granted while the product is inside the fund. The criteria also cover the time until data protection expires and any lower prices observed in other EU member states. The source does not specify the exact weighting given to each negotiation criterion or the mechanism by which the unpublished temporary price will be converted to a published price at exit.
Frequently asked questions
Which countries must already reimburse a centrally authorised medicine for it to qualify?
Reimbursement in at least five of the eleven listed EU countries that operate health technology assessment systems remains a precondition for products under data protection.
How often will positively assessed medicines be re-evaluated?
Re-evaluation occurs every three years.
Can the health minister override clawback requirements?
Yes, when a medicine faces withdrawal for economic reasons, has no therapeutic equivalent and is considered essential for public health.
Are biomarker tests assessed together with the medicine?
Yes, when the test is not already reimbursed, its analytical performance, clinical utility, cost and budget impact are examined alongside the medicine.
What happens after the two-year Innovation Fund period?
The medicine receives a published price and follows ordinary reimbursement procedures.
