Adonis Georgiadis Introduces Opt-In Clinical Trial System Through Health Records

Patients to Opt-In for Clinical Trials via Digital Health Records

The Greek Minister of Health, Adonis Georgiadis, unveiled a new proposal that would allow citizens to declare their willingness to participate in clinical trials directly through their electronic health records.

Under the proposed system, integrated into the national digital health infrastructure (AIF), patients would be able to give pre-consent (opt-in) for participation in clinical studies.

This mechanism would create a centralized pool of potential participants, significantly reducing the time required to recruit patients — one of the main bottlenecks in conducting clinical trials in smaller EU markets.

From Passive Recruitment to Structured Trial Access

Currently, patient recruitment for clinical studies in Greece relies heavily on physicians and hospital-level coordination.

The new model would shift this approach toward a data-driven recruitment system, where eligible participants can be identified faster and more systematically.

According to the plan, this could make Greece a more attractive destination for multinational pharmaceutical companies conducting clinical research.

Boosting Competitiveness in Clinical Research

The initiative is part of a broader strategy to strengthen Greece’s position in the European clinical trials ecosystem managed under the Clinical Trials Information System.

Key government objectives include:

• Increasing the number of clinical trials conducted in Greece
• Attracting higher-value early-phase studies
• Improving overall investment inflows into the health sector

 Focus on Early-Phase Clinical Trials

A central ambition of the policy is to expand Greece’s capacity in Phase I clinical trials, which are typically the most technologically advanced and highest-cost segment of clinical research.

Currently, Greece hosts only a limited number of such studies, with most activity concentrated in Phase II and III trials.

Integration of Hospital Performance Metrics

In parallel with digital reforms, hospital administrators are now being evaluated based on their ability to attract and support clinical trials.

Performance indicators related to clinical research may influence:

• Administrative evaluations
• Contract renewals for hospital leadership

This reflects a broader push to align public hospital management with research and innovation goals.

Rising Investment in Clinical Research

The government reported a significant increase in clinical trial-related investments:

• €60 million (2018)
• €160 million (2020)
• Over €250 million (2025 projection)

Despite this growth, Greece still trails larger Northern European countries in total clinical research spending, largely due to differences in trial phase distribution.

Structural Inequalities in the EU Market

Georgiadis acknowledged that clinical research in Europe is unevenly distributed:

• Wealthier Northern European countries attract higher-value trials
• Smaller Southern economies tend to host more mid- and late-stage studies

This reflects broader structural dynamics in the pharmaceutical research ecosystem, where companies allocate resources based on infrastructure, speed, and cost efficiency.

 Regulatory Frictions and Inter-Ministerial Disputes

The minister also highlighted ongoing tensions with the Ministry of Finance regarding the tax treatment of multinational research expenditures.

A proposal to recognize certain parent-company R&D costs within Greece was rejected due to concerns over auditability and verification.

Despite this, Georgiadis indicated openness to continued technical discussions on improving the investment framework.

Policy Direction

Overall, the reform package combines three core pillars:

• Digital transformation of patient consent and data systems
• Administrative pressure on hospitals to support research activity
• Financial incentives to attract multinational clinical trials

The government expects measurable improvements in Greece’s clinical research footprint starting from 2026.

Source: pagenews.gr