In fact, from 2022 onwards the problem has intensified to such an extent that the unique phenomenon in world history can be observed, where government funding falls short of the mandatory returns of the pharmaceutical industry.
Market experts note that this phenomenon may allow the pharmaceutical treatment of Greek patients to continue uninterrupted, but there are evidences that show that under the existing economic conditions the system simply survives by making large discounts on the treatments that Greek patients enjoy compared to Europeans.
Finally, the EFPIA-IQVIA Patients WAIT Indicator study showed that less pharmaceutical innovation reaches Greek patients, as 79 out of 167 new drugs came to Greece in the period 2019-2022, compared to 90 out of 168 in the period 2018-2021.
In fact, half of them are available with restrictions on access by patients, as they are available through SIP and IFET (Pharmaceutical Research & Technology Institute S.A., which is active in directly meeting the country’s needs in essential drugs and produces unique and irreplaceable medicines). As for the other half, only 5 out of 41 record even one sale in our country in the period 2019-2022. It is easy to understand that availability does not mean access.
Regarding the time required for this availability, for these drugs it takes 587 days on average from the European approval until they are reimbursed in our country. This time is almost two months (56 days) short of the European average.
The causes of these delays were demonstrated by the aforementioned EFPIA study The root causes of unavailability and delay to innovative medicines for 2023 and the study “Availability of innovative medicines in Greece”, carried out by IQVIA for the Association of Pharmaceutical Enterprises of Greece (SFEE) . According to the findings of these two studies, the delays in our country are the result of two factors: the 5/11 criterion and the economic conditions caused by the unrealistic level of mandatory returns burdened by the pharmaceutical industry.
As can be easily seen, the tough business climate that refunds create means that 53% of new innovative drugs will probably not become available for Greek patients in the future, as the study showed.
Four studies
In particular, four studies, concerning the access of Greek patients to new, innovative treatments, the availability of innovative drugs and public funding for the drug, report the following:
1) Patients W.A.I.T. Indicator (EFPIA-IQVIA) 2023.
- The study showed that less pharmaceutical innovation reaches Greek patients, as 79 out of 167 new drugs came to Greece in the period 2019-2022 compared to 90 out of 168 in the period 2018-2021.
- In fact, half of them are available with restrictions on access by patients, as they are available through SIP and IFET.
- Regarding the time required for this availability, for these drugs it takes 587 days on average from European approval until they are reimbursed in our country. This time is almost two months behind the European average but has improved by 74 days compared to the previous period.
2) Root causes of availability and delay to innovative medicines (Main causes of non-availability and delayed access to innovative treatments).
For the first time, a study was presented that, combined with the Patients WAIT Indicator study, focuses on the main causes of non-availability of innovative medicines. In particular, there are significant delays in the release of new medicines in Greece due to the 5/11 criterion, but also the level of mandatory refunds for Greece, but also countries such as Cyprus and Malta.
3) Study IQVIA for the availability of new medicines in Greece in the period 2020-2023.
- 329 new medicines were approved by the EMA from 1/1/2020 to 31/12/2023, of which 221 are new innovative medicines.
- Of the 221 new original drugs, only 43 (19%) are currently available and reimbursed in the Greek market. The remaining 178 (81%) are not compensated.
- Of the 178 medicines that are still not reimbursed in our country, only 35 have received a price, while the remaining 143 have not even received a price.
- Only 5 of the 35 (14%) new innovative medicines that have received a price are certain to be available in the future.
- But 46 of the 143 (32%) new innovative drugs may potentially become available in the future.
- The severe business climate created by exorbitant refunds means that 53% of new innovative drugs will probably not become available for Greek patients in the near future.
4) Update of the study data with data for 2022 on the public financing of pharmaceutical expenditure in our country, compared to other European countries.
- Greece has a deviation of 70 percentage points from the European M.O., while it is the only country that reduced the total (external & in-hospital) financing of the drug in the period 2013-2022.
- Greece is the only country that reduced public hospital funding for the drug, deviating by 116 percentage points compared to the European M.O. the period 2013-2022. Specifically, the European average is +89.6% and Greece has fallen by -26.6%.
- Regarding out-of-hospital public funding, Greece has a deviation of 56 percentage points from the European M.O., as the average of the countries of Europe is +42.5%, while Greece is at -11.09%.
- Comparing the total (hospital and non-hospital) public per capita drug funding for 2022, the study recorded a significant lag of -64% and -70% against Southern European and Western European countries in public per capita hospital drug expenditure and lag, and -13% and -45% in public per capita outpatient pharmaceutical expenditure. In terms of the total public financing of medicine, Greece is behind the countries of Southern and Western Europe.
In conclusion, the above studies clearly demonstrate that it is imperative that the State and the pharmaceutical industry come around the table and build common solutions, starting with the significant shortfall in public funding of medicine in the country, combined with improving the return on investment through controls and use of digital tools. SFEE circles state that equal, universal and timely access of Greek patients to new, innovative treatments and a sustainable business environment should be ensured, so that companies in the sector invest even more in the country.
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