The law's provisions will take effect on April 14. On that day, a Clinical Trials Compensation Fund will be established at the Patient Ombudsman. This is an innovative solution expected by patients and the clinical research industry. The Ombudsman will also maintain a publicly accessible list of patient organizations.
The law increases the attractiveness of conducting clinical trials in Poland and ensures a high level of care for the rights and interests of participants in these trials. The solutions introduced include:
- Establishment of the Supreme Bioethics Commission,
- A new fee system for conducting scientific and ethical assessments of a research registration application,