Greece aims to improve patient access to innovative therapies while safeguarding the stability of its healthcare system with the introduction of an Innovation Fund. The move was welcomed by the industry, but with caveats.
The Fund, also referred to as a Transitional Reimbursement Scheme, has an annual budget of €50 million and was announced by Greek Prime Minister Kyriakos Mitsotakis during a speech in Thessaloniki last Saturday, 6 September. The Ministry of Economy and Finance clarified on Tuesday that the Fund will be launched in January 2026.
“The Scheme will allow faster, controlled and more sustainable patient access to potentially clinically innovative and cost-effective therapies,” the Secretary General for Strategic Planning at the Ministry of Health, Aris Angelis, told Euractiv.
Both groups that represent innovative pharmaceutical companies, the Hellenic Association of Pharmaceutical Companies (SfEE) and the Pharma Innovation Forum (PIF), welcomed the announcement. However, concerns were raised about the adequacy of the announced budget to address needs.
Fund designed for critical diseases
The Fund will aim to include innovative medicines offering significant therapeutic advances for critical diseases with limited treatment options, primarily Advanced Therapy Medicinal Products (ATMPs) and medicines under the EMA’s Priority Medicines (PRIME) scheme.
Faster access to the medicines under the Scheme will be achieved in a financially viable way, while offering predictability in terms of costs, “through a well-defined framework that ensures stability for both the state and pharmaceutical companies, with clear entry and exit criteria, as well as a link to evaluation and reimbursement procedures,” Angelis remarked.
Entry will be based on clear criteria, such as prospects of clinical value, cost-effectiveness, unmet need, and the urgency of patient access, with a transparent and time-bound process to avoid delays.
“The process for admitting medicines will be transparent, with explicit deadlines and a structured decision-making flow, to avoid delays and ensure timely and equitable patient access to new treatments,” Angelis explained, adding that exit will follow predefined rules, considering real-world evidence on clinical and economic outcomes, with reimbursement decisions subject to review as new data emerges.
Budget issues
Some preliminary calculations were calling for a twofold or even threefold budget than the one announced for the Scheme to meet the needs in access to new medicines, especially those of higher cost. The €50 million allocation ‘crash-landed’ hopes for a higher budget, at least for now.
“SFEE welcomes the Prime Minister’s announcement for an amount of 50 million euros, which will finance the Innovation Fund/Transitional Reimbursement Scheme for Innovative Medicines,” Mihalis Himonas, the General Manager of the Association, told Euractiv, adding, nevertheless, that sustainable future funding needs to be secured, as the amount set for the Fund is limited.
On the same wavelength, Labrina Barmpetaki, President of PIF, also noted in a press release that “the allocation of €50 million is a positive step; however, it is not sufficient to cover actual needs. “This opportunity for a substantial improvement in access must not be missed, and immediate action is required to ensure that patients genuinely benefit,” she added.
Much-needed intervention
Despite the caveats, the move was highly anticipated by the industry.
“It is a financing model that also exists in other European countries (Italy, for example). At the same time, this commitment by the government is a practical recognition of the value of innovation,” Himonas said, noting the industry’s push towards the formation of the Scheme to finance Greek patients’ access to innovative treatments and “to eliminate inequalities in access, so that Greek patients are at the same level as Europeans.
“We expect this measure to be implemented as soon as possible, and of course to ensure the necessary future financing of the Fund, always with the benefit of Greek patients in mind,” he added.
“Innovation is not a cost, but an investment in health, society and the economy. Timely access to innovative treatments is not a luxury but a necessity,” Barbetaki also argued.
Medicines admitted to the Fund will be under enhanced supervision and will pay reduced clawback and rebate rates. After leaving the Scheme, the final clawback amount will be calculated, with possible refunds for drugs that fail to meet targets. Therapies admitted will be able to remain under the Scheme from two to five years.
Beyond patient benefits, the government is expecting the Fund to boost investment in research and development for innovative therapies in Greece.
(BM)
