In 2010 the Polish clinical research market might well be worth PLN 800m (€212m), but only if the Health Ministry manages to implement less formalised requirements for submission of clinical trial applications before the end of 2009. Otherwise, the market’s annual growth rate will slowly decline to only a few percentage points in 2010, according to a just released report, “Clinical trials in Poland 2008,” from PMR, a research and consulting company.

CEBK trial registration procedure – the greatest barrier

In 2007 the Polish market of clinical trials, encompassing companies conducting phase I-IV clinical trials and bioequivalence tests, totalled nearly PLN 630m (€167m) following a 10% increase relative to 2006. Yet, it is worth noting that the market is relatively saturated, thus, it is unlikely to experience any spectacular growth in the near future. In addition, market growth might be hampered by legislation detrimental to those engaging in clinical trials. “According to most companies present in the clinical trials sector in Poland (CRO and pharmaceutical firms) surveyed for the report, the lengthy and complicated procedure of trial registration with the CEBK[1] is today the key barrier standing in the way of business development, thus, its removal would help to maintain the clinical research market’s relatively high annualised growth rate.” explained Monika Stefanczyk, PMR’s senior pharmaceutical market analysts and the report’s co-author.

Market assessment – positive nevertheless

Based on research PMR conducted for the report, despite the detrimental legislation and the 22% VAT levied on services related to clinical trials, over half of the persons PMR surveyed were optimistic about the present-day situation on the clinical research market in Poland. Agnieszka Stawarska, PMR’s pharmaceutical market analyst and the report’s other author, explained that the upbeat forecasts are primarily fuelled by the fact that the market continues to develop and that the firms are organising a large number of trials in Poland. Moreover, respondents mentioned the still rapid patient recruitment, highly experienced researchers, and high interest among physicians in taking part in clinical research. Some are also heartened by the fact that currently the Health Ministry is amidst legislative work on the Clinical Trials Act and the Ordinance on Template of Application to Commence a Clinical Trial on Medicinal Product and Application for Opinion of the Bioethics Committee on a Clinical Trial of Medicinal Product.

At the same time, most persons PMR interviewed were of the opinion that the situation on the clinical trials market in Poland will not change within the next twelve months. This point of view is a consequence of the fact that the date the abovementioned regulations will enter into force is not known, but most likely it will not happen within the coming year. In comparison with the findings of PMR’s first survey, decisively fewer pharmaceutical firms and CROs are today expecting the market situation to deteriorate (21% in 2006 versus 3% in 2008).

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