Greece steps up clinical trial reforms as industry calls for stronger incentives

Greek government measures designed to boost clinical trial activity are beginning to deliver measurable results, but industry stakeholders warn that stronger incentives and structural changes are still needed to unlock the country’s full potential.

According to the General Secretary of Health Services, Lilian Vildiridi, clinical trials in Greece are gaining renewed momentum. “By the end of 2025, the number of new applications submitted under the new regulatory framework reached 278, up from 217 in 2024, marking a clear upward trend,” she told Euractiv.

“Greece ranked 14th among EU member states, according to ACT EU data for the July–September 2025 period,” she added.

Despite clear progress, policymakers and industry stakeholders agree that further steps are needed to fully unlock the country’s potential as a competitive destination for clinical research.

New ‘modus vivendi’

Vildiridi said clinical trials have become a strategic priority for the Ministry of Health, with Greece now facing what she described as a “window of opportunity” to strengthen its international position.

“Results are encouraging, but they are no cause for complacency. On the contrary, they underscore the need to move faster and with greater focus,” she noted, pointing to a recent joint ministerial decision, which is expected to significantly reduce approval times, allowing different stages of the process to run simultaneously rather than sequentially.

In addition, stricter timelines for each stage of the process have been introduced, alongside standardised contract templates tailored to different types of clinical studies. These measures aim to improve predictability and reduce administrative complexity.

Beyond procedural improvements, the expansion of dedicated clinical trial units within public hospitals marks another important step. “Hospitals across most health regions have either established or are in the process of creating such units, strengthening the country’s operational capacity to host studies,” Vildiridi remarked.

At the same time, the upcoming full deployment of the National Registry of Biomedical Research, funded through the Recovery and Resilience Facility, is expected to enhance transparency and provide real-time data on the lifecycle of clinical trials in Greece.

A system still in transition

“Overall, these interventions form part of a broader set of horizontal reforms in public hospitals, encompassing digital transformation, upgraded infrastructure and medical technology, as well as targeted reinforcement of human resources,” Vildiridi said.

However, further reforms are already under consideration, including changes to the regulatory framework governing clinical trials.

Vildiridi said that among the proposals under examination are expanding eligible trial sites to include day care units and dental schools, the possibility of submitting protocols in English, and the use of digital tools in the informed consent process. There is also a discussion of introducing more flexible models, such as conducting parts of clinical trials at patients’ homes under clearly defined conditions.

Industry calls for stronger incentives

At the same time, the pharmaceutical industry argues that regulatory improvements alone are insufficient to significantly increase investment in clinical trials.

That criticism intensified this week, after the publication of a new government decision outlining the clawback offset scheme for research and development (R&D) and investment plans for 2026–2027.

In a strongly worded response, the Hellenic Association of Pharmaceutical Companies (SFEE) said it was “disappointed” that its longstanding proposals to strengthen incentives for clinical trials had once again been overlooked, despite repeated submissions to the ministries of health, development and finance.

The association warned that the current framework fails to adequately recognise the tangible benefits of clinical research for patients, the healthcare system and the wider economy, raising concerns that Greece risks missing out on future investment and timely access to innovative therapies.

The decision comes just a few weeks after SFEE addressed a letter to key government officials, noting that the current framework for offsetting clawback payments with clinical trial investments has weakened in recent years.

According to SFEE, the amount offset through clinical trials dropped sharply, from €50 million in 2021 to just €5 million in 2024.

While total investments in clinical trials have remained relatively stable at around €100 million annually, the association estimates that Greece’s potential could be at least three times higher.

The industry also underscores the broader value of clinical trials beyond economic metrics. Patients participating in studies gain early access to innovative treatments, often years before they become commercially available, while the cost of these therapies is fully covered by sponsoring companies.

Clinical trials channel resources into public hospitals and support highly specialised medical personnel, contributing to the retention of scientific talent in the country.

Proposals to reshape the clawback framework

SFEE has put forward a series of detailed proposals to redesign the clawback offset mechanism to better support clinical research. Among the key recommendations is extending the incentive scheme beyond current limits, recognising that clinical trials often span three to five years and require long-term planning.

The association also calls for separate budgets for R&D and broader investment activities, arguing that the current combined structure reduces transparency and predictability for investors.

In addition, the industry is advocating for the inclusion of R&D expenses incurred by foreign parent companies, provided that the research is conducted in Greece. This, they argue, would significantly enhance the country’s attractiveness as a destination for multinational clinical trials.

[BM]