Work is in progress on a proposal for an act on clinical trials of medicinal products for human use. The main purpose of the act is to transpose Regulation (EU) No. 536/2014 into Polish law and enforce it. The bill was first published for public consultation in April last year, and as of 17 January 2022, following the publication of statements submitted during the consultation process, has been forwarded to the European Union Affairs Committee.

The most significant change in the latest version of the bill is the introduction of the compassionate use procedure into the Polish legal system. Compassionate use of drugs allows patients to access investigational treatments that show promise in clinical trials but have not yet been granted marketing authorization. Specifically, under article 4da of the new bill, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products may grant approval under the individual use programme, for the use of a medicinal product for which a clinical trial is being conducted, a clinical trial has been completed, or an application for marketing authorization has been submitted, for a specific group of patients with a chronic disease or a serious debilitating or life-threatening disease. This applies to patients who cannot effectively be treated with a medicinal product authorized for marketing in Poland, who participated in a clinical trial of that medicinal product, and have received a therapeutic benefit.

Other changes include:

  • the Clinical Trial Participants Protection Fund has been replaced by the Clinical Trial Compensation Fund, and is now at the disposal of the Patient’s Rights Ombudsman (instead of the Medical Research Agency);
  • timelines for conducting ethical reviews of clinical trials have been modified;
  • the scope of statutory obligations of the Sponsor has been reduced in comparison to the original proposal, and currently includes carrying out obligations in accordance with Regulation 536/2014 and obtaining written consent of the principal investigator and the investigator to access the source documents;
  • under the new version of the bill, the chapter on penal liability for violation of the act and the Regulation has been slightly extended

Progress on the legislative work can be monitored at: