Preclinical and Clinical Trial Requirements
All legal aspects surrounding preclinical and clinical trial requirements in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
No, there is no requirement to conduct clinical trials locally to receive marketing approval.
2. How are clinical trials funded?
Clinical trials may be financed from private or public funds. Commercial clinical trials are usually sponsored by the product manufacturer (pharmaceutical company). The Medical Research Agency, established in 2019, is the public authority competent in financing non-commercial clinical trials, i.e. trials conducted by scientific bodies, universities, etc.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
The protocol of a clinical trial regarding medicinal product is prepared by the study sponsor and submitted to the URPL and to the relevant ethics committee. It has to include numerous elements set forth in § 17 Sec. 1 of the Regulation of the Ministry of Health 2 May 2012 on Good Clinical Practice.
The Pharmaceutical Law follows EU law with regard to any changes made to a clinical trial protocol, i.e. it requires notifying the URPL and the ethics committee only about changes that are of a significant nature and have an impact on the safety of the clinical trial participants. There is no definition of “substantial change”/”change of a significant nature” in Polish law, nor is there a list of such changes. On its website, the URPL refers to the European Commission Guidance (CT-1) in this respect.
4. What are the requirements for consent by participants in clinical trials?
Participants in clinical trials of medicinal products must give their informed consent when deciding to take part in the trial. For each trial, specific consent documentation must be prepared and approved by the ethics committee. Informed consent is a written statement of intent, dated and signed, made freely by any person capable of making such statement or, where the person is not capable of making such statement, by his/her legal representative; this statement also contains a note to the effect that it was made after the person had been duly informed of the nature, significance, implications and risks of the clinical trial. If the informed consent cannot be given in writing, consent given orally in the presence of at least two witnesses will be deemed equivalent. A note must be made in the trial documentation if consent is given in this manner. Before obtaining informed consent, the investigator provides the participant of the clinical trial or his/her legal representative, in an understandable manner and without exerting any influence, in oral and written form, with certain information set forth in the Regulation of the Ministry of Health of 2 May 2012 on Good Clinical Practice (information about the aim of the trial, procedures to be used, etc.).
For the clinical trial in regard of medical devices, written informed consent is also required. This consent is given after the investigator or sub-investigator explains to the patient or his/her representative the characteristics of the clinical trial, the risks and inconveniences associated with it, the conditions under which it is to be conducted, and right to withdraw from the clinical trial at any time.
5. May participants in clinical trials be compensated?
Healthy patients of legal age that are able to give informed consent may receive financial incentives or other types of benefits (e.g. renumeration) for participating in the clinical trial of a medicinal product. As a rule, this applies to patients of phase I of a clinical trial, as healthy patients usually participate in this phase. All patients may be compensated for any expenses they incur. The ethics committee must be notified about any financial transactions or compensation.
Healthy patients of legal age may also receive financial incentives or other types of benefits (e.g. renumeration) for participating in the clinical trial of a medical device.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
The Pharmaceutical Law and the Act on Medical Devices require the sponsor and the investigator to provide participants with insurance coverage against any damage caused to them as a result of the experimental activity in a clinical trial. The Regulation of the Ministry of Finance of 30 April 2004 on compulsory civil liability insurance of the investigator and sponsor and the Regulation of the Ministry of Finance of 6 October 2010 on compulsory civil liability insurance of the sponsor and investigator in connection with the conduct of a clinical trial of devices set forth the specific requirements of such insurance, e.g. the date when the insurance obligation arises and the minimum guarantee amount.