The pharmaceutical industry has highlighted the need for an urgent revision of Greek public hospitals’ pharmaceutical budget. Clawbacks reached an all-time high for the first half of 2023, raising concerns about ongoing patients’ access.
A broad definition of “clawback” refers to “the amount pharmaceutical companies have to return to the state when public spending on drugs exceeds the budget.” It is an added measure to mandatory rebates and other discounts, initially introduced in Greece in 2012 during the financial crisis.
At first, it involved only the public pharmaceutical outpatient expenditure, but 2016 marked the year the policy was introduced to the state pharmaceutical expenditure of the national health system’s hospitals.
Since then, the state pharmaceutical budget has remained more or less stagnant, while expenditures have increased following the growing needs of an ageing population and advances in medicines.
“The major problem remains the underfunding of pharmaceutical expenditure, a consequence of the MoUs imposed during the crisis (2010-2018),” Mihalis Himonas, General Manager of SFEE, the Hellenic Association of Pharmaceutical Companies, told Euractiv.
“Even though we have exited this era, the gap in pharmaceutical funding continues to widen. Currently, we have observed that only 1 in 5 new medicines are available in Greece (IQVIA study 2024 covering the four-year period 2020 – 2023), with our country maintaining the highest pharmaceutical industry returns in the EU,” he added.
Industry in shock
Government notes on the clawback amount the companies must return for the first half of 2023 arrived this October following a 16-month delay. According to those notes, the mandatory returns for the largest portion of the market reached 83% (for products priced above €30), while at one hospital, Papageorgiou in Thessaloniki, they reached 92%.
“The recent release of the hospital clawback notes for the first half of the year 2023 spread great disappointment in the pharmaceutical market”, Himonas commented.
The reaction of the associations representing the pharmaceutical companies was immediate, with press releases, while SFEE sent a letter to the Prime Minister, Kyriakos Mitsotakis, expressing concerns. The Board of Directors asked for an immediate revision of the pharmaceutical budget in hospitals.
“The unprecedented returns for hospital medicines by European and global standards indicate the consistently failed pharma policy and extreme underfunding of the hospital pharmaceutical budget. It is evident that a ‘wrong’ restricted budget, even within public hospitals, can have detrimental effects on both the pharmaceutical companies and the patients relying on these medicines,” the letter said.
Medicines in Greece are priced at the average of the two lowest prices in the Eurozone.
Minimal improvement
The industry outcry was followed by a meeting last week with the Minister of Health, Adonis Georgiadis, and all four associations (SFEE, Pharma Innovation Forum, the Panhellenic Pharmaceutical Industry Association, and SAFEE). Georgiadis was joined by the Deputy Minister to the Prime Minister, Thanasis Kontogeorgis.
“It is unfortunate that in October 2024, there is a significant challenge in adjusting state expenditure for the previous year,” Himonas said to Euractiv.
“This was evident in the recent meeting with the Minister of Health, where we were informed of an additional funding of only €20 million, combined with internal reallocations of clawback and additions to the expenditure from closed budget residues. No one should expect the pharmaceutical sector to be sustainable with returns of approximately 76% (instead of 82.9%)!” he added.
At the meeting, Georgiadis announced some corrective actions, including emergency funding of €20 million from the Ministry of Finance. Also, €33 million is expected to be transferred from unspent funds from closed budgets. With a change of discount rates on clawback, the clawback on products over 30€ will be reduced by €20 million.
Extreme unsustainability
In an announcement following the meeting, SFEE talked about “minimal improvement in funding for hospital medicines”, adding that “the State funds 2.4 medicines out of 10, while the pharmaceutical industry funds the remaining 7.6.”
“We appreciate the efforts of the Ministry of Health to address the issues in hospitals, noting that it is the first channel that has reached a point of extreme unsustainability, and we stand by his commitments that returns for hospital medicines in 2024 will be lower than those in 2022, which were also extremely high (69%) and must be significantly reduced in the coming years. We also value the efforts to reduce spending and increase the return on investment in medicine,” Himonas underscored.
However, he added that the serious problem of underfunded pharmaceutical expenditure, the legacy of the MoUs, remains, while significant barriers to patients’ access to new medicines in Greece persist, as the IQVIA study showed.
“To be fair to the current Minister of Health, he is trying to control prescriptions while increasing the efficiency of pharmaceutical investments. However, this is not enough to close the huge funding gap,” Himonas added.
The notes for the second semester of 2023 are expected before the end of November. They will include changes that have resulted from the aforementioned government interventions.
“ situation calls into question patients’ access to existing as well as new innovative therapies, acknowledging that medicine represents only 15% of the total health expenditure across Europe, which makes it necessary for the State to redefine its priorities,” SFEE’s announcement stated.
