'Legislative chaos' hindering Poland's clinical potential

By Kirsty Barnes

- Last updated on GMT

Related tags: Clinical trials, European union, Poland

'Legislative chaos' has been preventing Poland from reaching its
full potential in the increasingly competitive central Eastern
European (CEE) region, although progress is being made.

In the last few years in particular there has been a gradual shift from conducting clinical trials in Western Europe and the US, to emerging markets. This has primarily been to gain access to a fresh pool of willing and suitable trial participants, with the aim of cutting trials times, in addition to costs. Since 2004 the number of clinical trials carried out in the UK, France and Germany has dropped by 30 per cent. With relatively close proximities to the West, along with large treatment-naive populations of a Caucasian gene pool, CEE countries, particularly Russia (141m) and Poland (39m) are in prime position to capture the new business. As part of an analysis published by consulting firm A.T. Kearney earlier this year, Russia came third (behind China and India) on "The country attractiveness index for clinical trials" - a list of the 15 most popular offshore locations. Although Poland also holds potential, its cumbersome process for registering a trial with the Central Register of Clinical Trials (CEBK) - primarily the long time frame for the process - was cited as the greatest deterrent to running clinical trials in the country by respondents (78 per cent) in a survey conducted last year by Polish market research firm PMR. However, since then CEBK has taken steps to streamline and simplify the registration process, waiving the previous requirement for notarial authentication of documents such as GMP certificates, each and every time a firm applied for permission to conduct a trial, said PMR in its report titled: "Clinical trials in Poland 2007". In addition, applicants are no longer required to submit copies of their KRS (the National Court Register) company registration together with agreements concerning clinical trials between entities in Poland. Meanwhile, excessive red tape; bureaucratic chaos and no standardised requirements for trial documentation were other common concerns with the regulatory process cited in the PMR survey. A quarter of the respondents also considered Poland's current legislation (or lack of) a major barrier to market development, labelling it "vague"​ and "inconsistent with EU requirements". ​ Indeed, two relevant EU directives (2001/20/EC and 2005/28/EC) have still not been implemented in full in the country and the lack of a dedicated clinical trials act has been a serious stumbling block for many firms who may have otherwise considered conducting research in the country. In August last year the secretary of state in the Ministry of Health, Boleslaw Piecha, acknowledged the need to remedy this situation and the Ministry pledged to draft a dedicated act for this purpose. It was finally submitted for external consultations on 15 March and was open for comments until 19 May 2007. One particular improvement in the legislation, according to PMR, is the fact that clinical trial applicants will not be obliged to submit copies of contracts confirmed by a notary, which were dubbed by survey participants as an "unnecessary bureaucracy." ​ As a result of the progression thus far, Poland's clinical trials market is tipped to grow 10-12 per cent this year, said PMR.

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