Report on Clinical Trials in Poland

This is a report on the current status of clinical trials in Poland, prepared by PwC at the request of and in collaboration with INFARMA – the Employers' Association of Innovative Pharmaceutical Companies, GCPpl – the Association for Good Clinical Practice in Poland, and POLCRO – the Polish Association of Clinical Research Organizations

Clinical trials represent the foundation of modern medicine and are a prerequisite for patients’ access to state-of-the-art therapies while significantly contributing to the advancement of physicians’ professional knowledge. The European Union is currently preparing to implement Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use. The provisions of that regulation are most likely to come into force as of March 2017, and will significantly change the existing rules for securing authorisations to conduct clinical trials. The degree of legislative and administrative preparation for adopting these provisions in national legislation varies from one Member State of the European Union to another. Those differences will affect the distribution of clinical trials across the EU. Hence, it is in Poland’s interest to prepare, both legislatively and administratively, for the coming changes in the best possible way and in a relatively short time.

The analyses presented in the report point to the high growth potential of the clinical trials’ market in Poland. The conduct of clinical trials brings tangible benefits to patients, physicians and the economy as a whole. We believe that this document will pave the way for substantive dialogue on the development of the commercial and non-commercial clinical trials markets in Poland.

The findings of the report were presented for the first time at Health Challenges Congress in Katowice on 18 February 2016.