New law in clinical trials

On 30th April this year, a bill on clinical trials on medicinal products for human use was published on the Government Legislation Centre’s website.

The basis for the work on the bill is the Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16th April 2014 on clinical trials of medicinal products for human use and repealing Directive 2001/20/EC.

Poland is obliged to adapt its law to these regulations. What is more – the legislator has decided to increase the competitiveness of Poland as a place to run clinical trials.

Therefore, it is planned to implement transparent legal regulations which will enable the application of European standards and the introduction of facilitations and mechanisms encouraging the conduct of clinical trials in our country.

What is provided for in the draft?

  1. Procedure for issuing permits for clinical trials and permits for clinical trial material modification
  2. Rules of the Supreme Bioethics Committee establishing and functioning
  3. Rules of empowering bioethics committees to conduct ethical assessment of clinical trials
  4. Obligations of sponsors, principal investigators and researchers, including rules for civil liability
  5. Rules of the Clinical Trial Participants Protection Fund operation
  6. Amount and method of fee payment related to clinical trial
  7. Principles of financing health care services related to clinical trial
  8. Principles and procedure for conducting clinical trial inspections
  9. Mechanisms for supporting non-commercial clinical trials
  10. Attractiveness of the Polish market for clinical research

One of the assumptions of the bill is increasing the attractiveness of the Polish market for conducting clinical trials.

What is the current situation?

In 2020, approximately 600 clinical trials were conducted in Poland.

Although the Polish market has numerous advantages (large patient population, qualified research staff, strong market of sponsors and CROs and, finally, an attractive level of research costs compared to other European countries), we still conduct fewer trials per capita).

The proposed regulations are expected to significantly increase the number of clinical trials run in our country.

The project is co-financed by the European Regional Development Fund under the Intelligent Development Operational Programme 2014-2022.