05/21/2026  |  Paulina Mozolewska  |  Euractive

https://www.euractiv.com/news/poland-eyes-fast-track-clinical-trials-reform-to-stay-biotech-competitive/ 

New report says accelerated approval pathway for early-phase clinical trials could save Poland’s health system millions while attracting high-value biomedical investment

Poland could strengthen its position as one of Europe’s leading clinical trial hubs if it introduces a fast-track approval system for early-stage studies, according to a new economic analysis commissioned by major organisations representing the country’s clinical research sector.

The report, “Fast-track for trials: Is it worth it?”, prepared by the Polish Network of Economics (PLSE), argues that shortening registration procedures for phase I and II clinical trials could generate substantial savings for the healthcare system while boosting innovation, employment and scientific capacity.

“Poland has a real opportunity to use its clinical research potential to strengthen its position in the European and global competition for innovation investment,” Michał Byliniak, director general of Infarma, the Polish association of innovative pharmaceutical companies, told Euractiv.

“The greatest leverage lies in shortening trial start-up times and investing in clinical research data and infrastructure,” he added.

Fast-track reform

Poland currently ranks ninth globally and sixth in Europe in terms of participation in the commercial clinical trials market, contributing nearly €2 billion in added economic value in 2024. However, the report warns that Europe’s position in the global market is weakening rapidly amid growing competition from regions such as China.

Over the past decade, the European Economic Area’s share of the global clinical trials market has fallen from 22% to 12%. According to the authors, Poland’s ability to remain competitive will depend largely on introducing a dedicated 14-day fast-track pathway for early-phase clinical trials.

The analysis, based on models implemented in Denmark and Spain, estimates that streamlining registration procedures could attract up to 311 additional commercial trials annually.

Researchers argue that reducing approval timelines to between 14 and 30 days would not merely simplify bureaucracy, but could become a decisive factor in attracting highly advanced R&D projects before products reach the wider market. The report also estimates that faster approvals for early-stage trials could reduce pressure on Poland’s public healthcare budget by around €23 million annually, while enabling patients to access innovative therapies earlier.

“Fast-track pathways for early-phase trials could improve access to breakthrough therapies, ease pressure on public finances and support the creation of highly specialised jobs,” Byliniak said. He stressed that achieving these goals would require coordinated state action and a long-term strategy to strengthen Poland’s clinical research ecosystem.

Economic and scientific gains

The report also highlights the role of clinical trials in offsetting public healthcare costs, particularly in highly specialised therapeutic areas where sponsors cover substantial parts of patient treatment and diagnostic expenses.

Early-phase clinical trials are primarily concentrated in highly specialised fields such as oncology, where sponsors often finance nearly all treatment-related costs. According to the report, this shift could save the state nearly €23 million in public spending each year. The authors describe this as an example of a “Pareto effect” in healthcare, where a relatively small number of highly innovative therapies account for a disproportionately large share of system-wide spending.

The reform could also generate up to 1,300 new jobs, including more than 700 positions for highly specialised medical professionals such as investigators and clinical trial coordinators.

“The fast-track pathway is an opportunity to strengthen Poland’s scientific capacity through high-quality research,” Michał Zabdyr-Jamróz from the Polish Network of Economics, a Warsaw-based economic think tank, said in a statement accompanying the report.

“Professionals experienced in clinical research develop stronger methodological awareness, which directly improves patient safety and quality of care,” he added.

Learning healthcare system

The report further argues that greater exposure to clinical research helps create a “learning healthcare system”, in which knowledge generated during trials is rapidly incorporated into everyday medical practice.

Despite Poland’s relatively strong market position, early-phase studies currently account for only 13% of all clinical trials conducted in the country, compared with nearly 45% in the United States.

“This is a clear signal that Poland urgently needs to increase the share of early-phase trials if the sector is to continue delivering maximum benefits for both the healthcare system and the economy,” Agnieszka Skoczylas, president of the Polish Association of Contract Research Organisations, noted.

According to the report, the total annual added value generated by the reform could exceed €60 million. The implementation of this proposed reform will ensure full synergy with forthcoming EU regulations, such as the European Biotech Act.