The Greek Innovation Fund: a new framework for access to innovative therapies

Executive summary

In May 2026, the Greek government enacted Law 5302/2026, marking a significant evolution in the national healthcare landscape. By establishing an Innovation Fund as a dedicated financing mechanism for innovative therapies, the Greek healthcare system is signaling a strategic shift away from exclusive reliance on horizontal cost-containment measures and toward a more structured framework for managing pharmaceutical innovation.

At its core, the Innovation Fund is designed as a ring-fenced financing mechanism for selected high-value therapies that would otherwise be funded through the general pharmaceutical budget. The framework is primarily targeted at highly innovative medicines, including Advanced Therapy Medicinal Products (ATMPs) and therapies receiving Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), as well as products identified through national horizon scanning processes. A key feature of the model is the introduction of a transitional access pathway, allowing eligible therapies to receive dedicated funding while additional clinical and economic evidence is generated. This structure is intended to improve predictability in market access, support earlier patient access to innovation, and create a more transparent framework for managing uncertainty associated with advanced therapies. The Fund is initially supported by an annual budget of approximately €50 million and governed by a dedicated Innovation Fund Committee operating under the Ministry of Health.

While the Fund represents an important policy milestone, its long-term effectiveness will depend on implementation details, particularly regarding funding adequacy, governance clarity, integration with existing pharmaceutical financing mechanisms, and the operational readiness of data infrastructure required to support real-world evidence generation. From a market access and health economics perspective, the Innovation Fund has the potential to evolve into a meaningful instrument for value-based healthcare. However, without broader structural reforms and careful operational integration, there is a risk that it may function primarily as a supplementary financing layer within an already fragmented pharmaceutical financing system.

Policy rationale and design

For years, the Greek pharmaceutical market has operated within a stringent fiscal environment, characterized by expenditure caps and mandatory payback arrangements, commonly known as clawbacks. Since the introduction of these cost-containment measures, industry clawback liabilities increased from approximately €75 million in 2012 to roughly €1.5 billion by 2021 (Mavridoglou & Polyzos, 2024). While these policies were instrumental in curtailing excess spending during the post-crisis fiscal consolidation, they created a climate of uncertainty for manufacturers, often resulting in delayed launches for new therapies and discouraging R&D investment (Mavridoglou & Polyzos, 2024).

The establishment of the Innovation Fund in May 2026 under Law 5302/2026 represents a strategic shift from viewing pharmaceutical innovation primarily as a cost pressure to recognizing it as an investment in public health and healthcare system performance. This reform acknowledges that scientific excellence must be accompanied by efficient reimbursement pathways that translate regulatory approval into timely patient access.

Rather than relying exclusively on horizontal budget controls, the Greek model seeks to introduce a more structured approach by segmenting funding for innovative medicines from the general pharmaceutical budget. This separation is intended to reduce direct competition between innovation and volume-based expenditure pressures, thereby improving the system’s capacity to absorb high-value therapies in a more predictable manner. This approach aligns with emerging European practices in managed-entry and conditional reimbursement systems, which seek to balance early access with fiscal discipline (OECD, 2023; Ferrario & Kanavos, 2015).

The core policy rationale behind the Fund is therefore threefold: improved patient access to breakthrough therapies, enhanced predictability for stakeholders, and structured management of clinical/financial uncertainty through evidence generation over time. This represents a shift from purely cost-containment-oriented policy toward a value-oriented access framework.

Operational structure and key provisions

The Innovation Fund is governed by a dedicated Innovation Fund Committee operating under the umbrella of the National Organisation for Health Care Services (EOPYY). This committee is responsible for evaluating eligible therapies, overseeing the inclusion process and negotiating agreements with Marketing Authorisation Holders (MAHs).

A key operational feature of the Fund is the use of conditional reimbursement agreements; continued funding is linked to the ongoing demonstration of clinical effectiveness in real-world settings. This introduces a dynamic decision-making model in which reimbursement status may evolve based on accumulated evidence (Ferrario & Kanavos, 2015).

Overall, this operational framework is designed to integrate multiple institutional actors, including HTA, pricing, and reimbursement structures, into a more coordinated decision-making process, while maintaining a clear focus on value generation and outcome monitoring.
Eligibility under the Innovation Fund is generally restricted to medicines that meet defined innovation and regulatory thresholds, including:

• European Medicines Agency (EMA) – approved therapies
• Advanced Therapy Medicinal Products (ATMPs)
• PRIME-designated medicines
• Products identified through national horizon scanning (Angouridi, 2026).

This targeted approach reflects an intent to concentrate resources on therapies with the highest levels of clinical innovation and unmet medical need. It also ensures alignment with broader European regulatory pathways, particularly for therapies where evidence uncertainty at launch remains significant.

Under this framework, selected therapies may receive temporary reimbursement support through the Innovation Fund while additional clinical and economic evidence is generated. According to publicly available information regarding the Fund’s operation, innovative medicines may remain within the Innovation Fund for up to three years, after which their therapeutic effectiveness and accumulated evidence will be evaluated to determine whether they should proceed to standard reimbursement and be incorporated into the permanent list of reimbursed medicines (Efthymiadi, 2026). This approach enables earlier patient access while preserving the ability to reassess therapeutic value and long-term budget impact through real-world evidence generation. The Innovation Fund is initially supported by an annual budget of approximately €50 million (Ministry of Health Greece, 2026). This budget is intended to support a portfolio of high-cost innovative therapies that would otherwise face delays or restricted access under conventional reimbursement pathways.

Strategic value and key considerations

The Innovation Fund represents a meaningful evolution in the structure of pharmaceutical financing in Greece, a step toward a more structured and value-based pharmaceutical access environment. Its primary strategic contribution lies in the creation of a dedicated pathway for innovative medicines that are otherwise difficult to accommodate within traditional budgetary frameworks. The Fund also reflects a broader policy recognition that innovative therapies may require financing approaches that differ from those applied to conventional pharmaceutical expenditure. By creating a separate evaluation and funding pathway, policymakers are seeking to better align reimbursement decisions with therapeutic value while managing uncertainty through evidence generation.

Despite this strategic intent, the success of the Innovation Fund will depend heavily on its integration within the broader healthcare ecosystem. As the European Health Data Space (EHDS) initiative progresses, Greece faces the challenge of harmonizing its existing digital health infrastructure, such as the Electronic Prescription System and Electronic Health Records, to support the data requirements of the new Fund (Mavridoglou & Polyzos, 2024). The ability to leverage real-world evidence will be critical in assessing long-term outcomes and justifying the continued reimbursement of high-cost innovative therapies.

Furthermore, one of the most important considerations is the interaction between the Fund and existing pharmaceutical financing mechanisms, particularly the clawback system. If therapies included within the Fund remain subject to retrospective financial obligations, this may reduce the predictability and attractiveness of the mechanism for manufacturers and limit its impact on launch decisions (Angouridi, 2026).

Governance clarity will also be essential. The definition of the negotiation process, the independence of the evaluation committee, and the transparency of the criteria for entry and withdrawal will determine whether the Fund effectively fosters a sustainable, innovation-led environment. The legislative intent to incentivize investment is clear, but the coming 18–24 months of operational implementation will be the true test of whether these reforms can bridge the gap between regulatory approval and equitable patient access.

Conclusion

The Innovation Fund marks a significant step in the evolution of pharmaceutical policy in Greece. By establishing a dedicated financing mechanism for innovative therapies, it introduces a more structured and differentiated approach to managing high-cost medicines within a constrained fiscal environment. Its design reflects a broader European shift toward value-based and evidence-driven reimbursement models that seek to balance timely patient access with financial sustainability and outcome accountability.

However, the true impact of the Fund will depend on implementation. Funding adequacy, governance clarity, integration with existing pharmaceutical financing mechanisms, and the development of robust data infrastructure will be decisive in determining whether the Fund becomes a transformative policy instrument or remains a supplementary layer within an existing system.

The coming years will therefore be critical in assessing Greece’s ability to transition toward a more predictable, innovation-friendly, and value-based pharmaceutical ecosystem.