Poland needs to loosen up its registration requirements for clinical trials if the strong market growth of recent years is to be maintained, a new report warns.

The Polish market for clinical trials, which includes Phase I-IV studies as well as bioequivalence testing, was worth nearly PLN 630 million (€167 million) in 2007, 10% more than in the previous year, according to the report by research and consulting company PMR.

By 2010 the market could reach PLN 800 million, PMR suggests – but only if the Polish Health Ministry manages to implement less burdensome arrangements for the submission of clinical trial applications. Otherwise, the consultants say, the annual growth rate “will slowly decline to only a few percentage points in 2010”.

Early last year PMR was forecasting growth of 10-12% in the clinical trials market during 2007, thanks mainly to improvements in the quality of co-operation with the Central Register of Clinical Trials (CEBK), the body responsible for clearing trial applications in Poland. As the consultants noted, at the end of 2006 the CEBK published a list of new requirements aimed at streamlining the study registration process.

The new regime waived the need for notarial authentication of certain documents (e.g., Good Manufacturing Practice certificates) every time a company applied for permission to conduct a trial. Moreover, applicants were no longer required to submit copies of their entries in the KRS (National Courts Register) for agreements on clinical trials concluded between parties within Poland.

Despite these encouraging signs, most players in Poland’s clinical trial sector – both pharmaceutical companies and contract research organisations – that were surveyed for the latest PMR report saw the “lengthy and complicated” procedure for registering studies with the CEBK as the key barrier to further business development, pointed out Monika Stefanczyk, senior pharmaceutical analyst and co-author of the report.

No change over next 12 months
Furthermore, most interviewees did not expect conditions in the Polish market to change within the next 12 months. Some were heartened by the fact that the Health Ministry was engaged in legislative work on the Clinical Trials Act as well as the ordinance on templates for applying to launch a drug trial and applying for a bioethics committee opinion on the same. But it was not known when these regulations would come into force, PMR added – most likely not within the coming year.

Another problem was that the market for clinical trials in Poland was now relatively saturated. Nonetheless, PMR noted, more than half of those surveyed for its latest report were optimistic about the current situation in the marketplace. According to Agnieszka Stawarska, pharmaceutical market analyst and the other author of Clinical Trials in Poland 2008, these upbeat assessments were primarily due to the market’s continued development and the large number of trials being organised in Poland.

Respondents also mentioned the still rapid rate of patient recruitment, the availability of highly experienced researchers in Poland and the buoyant level of interest in clinical research among doctors. Compared with PMR’s first market survey, markedly fewer pharmaceutical companies and CROs this year were expecting conditions in the clinical research sector to deteriorate (just 3% in 2008 versus 21% in 2006), the consultants pointed out.