Polish bureaucracy holding back clinical growth

By Phil Taylor

- Last updated on GMT

Related tags: Clinical trials, Clinical trial, Poland

Poland urgently needs to take some of the red tape out of clinical
trial applications if it is to fulfil its potential as a hub for
clinical research, according to new market research.

Last year the value of Poland's clinical trials market - Phase I to IV and bioequivalence studies - was worth around PLN 630m (€167m), 10 per cent up on the previous year, according to research and consulting company PMR. But it is approaching saturation and is facing the possibility that growth rates will fall out to 2010. PMR senior pharmaceutical market analyst Monika Stefanczyk notes that one of the major brakes on growth for pharmaceutical companies and contract research organisations (CROs) carrying out trials is "the lengthy and complicated procedure of trial registration with the CEBK [Central Register of Clinical Trials]​." "Its removal would help to maintain the clinical research market's relatively high annualised growth rate"​ and could allow the market to swell to PLN 800m (€212m) by 2010, said Stefanczyk. She noted that an additional barrier to growth is the 22 per cent value-added tax (VAT) levied on services related to clinical trials. Nevertheless over half of the persons PMR surveyed in the new report, entitled 'Clinical trials in Poland 2008', were optimistic about the current operating climate. Agnieszka Stawarska, PMR's pharmaceutical market analyst and the report's other author, explained that the upbeat forecasts are based on the continuing development of the market, and particularly that firms are still organising a large number of trials in Poland. Patient recruitment - one of the key factors driving companies to look towards emerging markets as bases for clinical testing - is still rapid in Poland, according to the respondents. They also cited good access to highly experienced researchers and commitment among physicians to take part in clinical research as reasons for their optimistic view of the market. Some respondents were also heartened by the fact that Poland's Health Ministry is working on a new legislative framework for clinical trials, under the auspices of its 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. However, most think it unlikely that these will come into force within the coming year. In comparison with the findings of PMR's first survey in 2006, decisively fewer pharmaceutical firms and CROs expect the clinical market in Poland to deteriorate (21 per cent versus 3 per cent). High compliance​ Meanwhile, a recent study of compliance in clinical trial found that Poland was among the best-performing countries in terms of patients adhering to their assigned treatment regimens. Along with Hungary and Russia, more than 90 per cent of patients in Polish clinical trials complied with the treatment protocol. Mexico and Argentina were among the worst performers with compliance rates under 75 per cent, but the most compliant nation was India, with an astonishing compliance level of 97.4 percent. The data were provided by CRF, a company which provides electronic Patient Reported Outcomes (ePRO) technology.

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