Clinical Trials in Poland – Key Challenges

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The market for clinical tests of drugs in Poland is worth approx. PLN 860 million* and continues to be the largest one in Central and Eastern Europe (including countries belonging to the former Commonwealth of Independent States) with a 12 percent share of all trials conducted in the region – according to a report entitled “Clinical Trials in Poland – Key Challenges” prepared by the consulting company PwC (formerly PricewaterhouseCoopers) under an engagement from the Employers’ Union of Innovative Pharmaceutical Companies INFARMA and the Association for Good Clinical Practice in Poland (GCPpl).

PwC’s experts note that, compared to other countries, the number of clinical trials conducted in Poland continues to be relatively small. The leaders in numbers of clinical trials are the United States and Western Europe. The development of this market in Poland depends primarily on appropriate administrative decisions and regulations – provided that a conducive environment is formed, the volume of clinical trials could increase by 20–30 percent and, as a consequence, revenues to the state budget could increase by PLN 45–65 million per annum. On the other hand, implementing excessively restrictive legal regulations creating bureaucratic barriers could rapidly narrow interest in Poland among the organizations procuring clinical trials.

The key drivers of the clinical trials market in Poland are population size, effective patient recruitment (97 percent of responses) and high quality of trial execution (94 percent of responses). What also makes Poland attractive is the extensive experience of researchers and medical assistants and the integrity of the data collected and processed.

According to as many as 68 percent of the respondents, the primary disadvantages of the Polish market compared to other Central and Eastern European countries are the lengthy and rather unpredictable registration procedures and excessive bureaucracy. Most respondents also admitted that other countries in this region benefit from the fact that some trials (e.g. those in which time is an extremely important factor) are not conducted in Poland due to delays caused by administrative barriers (58 percent of responses).

The authors of the report propose the following changes in order to tap into the market’s potential:

• Implementing a more conducive regulatory context. To this end, the pace/transparency of administrative procedures should be enhanced.
• Improving transparency, especially in terms of a clear split of powers among the various regulatory and approval authorities (e.g. the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and Ethical Committees).
• Enhancing transparency in the cooperation between sponsors (or CRO companies), researchers and medical centers, e.g. by introducing tripartite contracting.
• Improving the quality and transparency of cooperation with medical centers, e.g. by introducing dedicated units responsible for matters related to clinical trials.