As part of the implementation of the Clinical Research Development Program prepared by Medical Research Agency (Agencja Badan Medycznych-ABM), a draft act on clinical trials of medicinal products for human use was published on 30 April 2021 for public consultation. The new draft act adjusts Polish law on clinical trials in order to be compliant with Regulation (EU) 536/2014 which is expected to take full effect from 31 January 2022.  As part of complying with Regulation (EU) 536/2014, the draft act introduces national provisions which are projected to be effective before 31 January 2022.  Amongst other things, these provisions include the establishment of a Clinical Trials Participation Protection Fund.

The purpose of the Clinical Trials Participation Protection Fund is to compensate participants for damages resulting from taking part in a clinical trial. The fund is expected to be financed by sponsors' contributions. Before a clinical trial can commence, the sponsor will be obliged to pay a contribution to the Clinical Trials Participation Protection Fund and the amount will depend on the number of participants in the clinical study.  It is anticipated that the fund will help to streamline and speed up the claiming process for damages incurred as a result of participating in clinical trials.

For more details on clinical trials information, visit Axco Clinical Trials.