On 30 April 2021, the draft bill on clinical trials of medicinal products for human use (the “Draft bill”) was published. It intends to ensure the application of Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials of medicinal products for human use and repealing Directive 2001/20/EC (the “Regulation”). The Regulation will be directly applicable after six months from the date of confirming full functionality of the EU portal and EU database, and from then on the Polish regulations must ensure effective application of the Regulation’s provisions. According to the author, the Draft bill also aims to increase the interest in clinical trials in Poland by creating a transparent legal system free of administrative and legal barriers.
The Draft bill regulates the following:
- the procedure for issuing an authorisation for a clinical trial and an authorisation for a substantial modification of a clinical trial;
- the procedure for the appointment, composition and tasks of the Supreme Bioethics Committee;
- the procedure for authorising bioethics committees to conduct an ethical review of clinical trials;
- the rules and procedure for conducting an ethical review of a clinical trial;
- the responsibilities of the sponsor, principal investigator and the investigator;
- the principles of civil liability of the investigator and sponsor
- the principles of operation of the Clinical Trial Participants Protection Fund;
- the fees and method of payment related to the clinical trial
- the principles for financing healthcare services related to the clinical trial; and
- the principles and procedure for conducting clinical trial inspections.
The Draft bill has been submitted for public consultation until 30 May 2021. Its entry into force will depend on the date of confirming full functionality of the EU portal and EU database by the European Commission.