Concern about Greek patients’ access to new, innovative treatments
Only 1 in 5 innovative medicines of the last four years are available in Greece
Press Release
Athens, 26 May 2025.- Fewer new innovative medicines, and indeed with a delay of almost two (2) years from their approval by the European Medicines Agency (EMA), are coming to Greece, as demonstrated by the Hellenic Association of Pharmaceutical Companies (SFEE) in a Press Conference held for the presentation of two (2) studies regarding the access of Greek patients to new, innovative treatments.
- Patients W.A.I.T. Indicator Study (EFPIA-IQVIA) 2024:
This is the most reliable study examining the availability of new medicines across Europe. It has been conducted for 20 years (since 2004) and includes data from 36 countries.
- The study showed that less pharmaceutical innovation reaches Greek patients, as only 75 out of 173 new drugs approved by the EMA came to Greece between 2020 and 2023, compared to 79 out of 167 between 2019 and 2022.
- Of the 173 new medicines, only 25% are fully accessible by Greek patients, 18% are available with restrictions, through the Electronic Preapproval System and IFET, 2% are available only privately, while 55% are not available at all.
- Regarding the time required for the availability of these 75 medicines, it amounts to an average of 654 days from their European approval until they are reimbursed in our country. This time is two and a half (2.5) months more than the European average (578 days the European average) and has worsened by 67 days (more than two months) compared to the previous period (2019-2022), which was 587 days.
- The availability rate of oncology products has the greatest deterioration compared to the other product categories, as it decreased to 59% from 71% in 2023, while the time required for this availability increased to 657 days from 568 in 2023.
- Similarly, for orphan medicines, the availability rate decreased to 36% from 41% in 2023, and the time required for this availability increased to 704 days from 530 days in 2023. The average availability time for orphan products has the greatest deterioration compared to the other product categories: 174 days slower than in the previous period.
The main causes of unavailability and delay of access to innovative treatments for our country primarily concern the amount of mandatory returns, but also the 5/11 rule, i.e. the rule that requires that in order for a new medicine to be submitted for reimbursement in our country, it must already be reimbursed in 5 out of 11 specific European countries.
- Availability of new medicines in Greece:
For the second consecutive year, SFEE commissioned IQVIA to carry out a study on the availability of new medicines in Greece for the period 2021 – 2024, which had the following main findings:
- Of the 178 new innovative medicines approved by EMA in the period 2021-2024, only 36 (20%) are currently (31/03/2025) available on the Greek market (a finding similar to last year), i.e. only 1 in 5 innovative medicines of the last four years are currently available to Greek patients.
- The dire business climate created by the exorbitant mandatory returns means that half (49%) of the 178 new innovative medicines are unlikely to become available to Greek patients in the near future.
The above studies demonstrate the need to address the inequality in Greek patients’ access to new innovative therapies. The State and the pharmaceutical industry together must build common solutions, starting from the significant deficit in public funding for medicines in the country, combined with improving the return on investment through audits and the use of digital tools. We should ensure both equal, universal, and timely access of Greek patients to new, innovative therapies, reducing delays in regulatory and reimbursement procedures, among others, and a sustainable business environment, so that pharma companies can launch new innovative medicines in our country.
As SFEE, we insist that the State should immediately implement its commitments, such as strengthening public pharmaceutical expenditure, substantial rationalization of mandatory returns, strategic evaluation and reimbursement of new medicines, and, of course, structural reforms that will allow the system to operate fairly and effectively. If we want to talk about a sustainable pharmaceutical system and timely universal access for all Greek patients, we need more actions that bring results and meaningful commitment.
Here is the presentation of two (2) studies
