Role of Polish bioethical committees in clinical trials – practical comments

Publication date: January 08, 2025

Undertaking clinical trials plays a fundamental role in the development and marketing authorisation of medicinal products. The aim of clinical trials is to test the safety and effectiveness of the products being studied. A trial sponsor is an individual, company, institution or organisation that is responsible for undertaking, managing and organising the financing of a clinical trial.

Bioethics Commission

The composition and functioning of the bioethics commission are specified in Article 29 of the Act of 5 December 1996 on the professions of physician and dentist (consolidated text: Journal of Laws of 26 March 2018, item 617) and in the Regulation of the Minister of Health of 11 May 1999 on the detailed principles of establishing and financing and the mode of operation of the bioethics commission (Journal of Laws No. 47, item 480).

The tasks of the advisory team of the Supreme Bioethics Commission and the advisory team of the bioethics commission include:

• preparing an ethical assessment of the clinical trial covered by the application for authorisation of a clinical trial, taking into account the aspects included in Part I of the assessment report of the application for authorisation of a clinical trial, referred to in Article 6(1)(a), (b) and (e) of Regulation 536/2014, and the aspects included in Part II of the assessment report of the application for authorisation of a clinical trial, referred to in Article 7(1)(a)–(c), (e), (f) and (h) of Regulation 536/2014, together with a detailed substantive justification in the event of a negative assessment;
• preparing an ethical assessment of a significant modification of a clinical trial covered by the application for authorisation of a significant modification of a clinical trial, taking into account the aspects included in Parts I and II of the report on the assessment of the application for authorisation of a clinical trial for the purposes of the application for authorisation of a significant modification of a clinical trial, in the scopes indicated above, together with a detailed substantive justification in the event of a negative assessment;
• cooperation with the Supreme Bioethics Committee and the designated bioethics committee from which the team is selected, in the scope of the ethical evaluation of the clinical trial.

The Committee’s control lasts throughout the entire duration of the trial, because the researcher is obliged to inform the committee of any deviation from the protocol and of any serious adverse events that occurred during the clinical trial, after which the committee responds appropriately and calls on the researcher to provide additional explanations, and may also suspend the trial or decide to discontinue it.

Completion of clinical trials

The sponsor shall notify through the EU portal to each Member State concerned the end of the clinical trial in respect of that Member State, to each Member State concerned the end of the clinical trial in all Member States concerned, as well as in all Member States concerned and all third countries in which the clinical trial was conducted. That notification shall be made within 15 days of the end of the clinical trial in respect of that Member State or, as appropriate, within that period in the last Member State concerned. Regardless of the outcome of the clinical trial, the sponsor shall submit to the EU database a summary of the results of the clinical trial within one year of the end of the clinical trial in all Member States concerned.

In the annexes to the Regulation of the Minister of Health of 9 November 2015 on the requirements of Good Manufacturing Practice (consolidated text: Journal of Laws of 2022, item 1273), one can find regulations according to which the distribution of investigational medicinal products is carried out in accordance with the instructions provided by the sponsor or on its behalf in the distribution order. Moreover, an order for an investigational medicinal product is a document containing the sponsor’s application to produce a given product.

Possibility of further use of the investigated product

Currently, there are no specific regulations in the Polish legal system providing for the possibility of applying the “Compassionate Use” procedure, however, this procedure may be applied based on the binding Article 83 of Regulation 726/2004. The procedure is coordinated and implemented by the Member States, which establish their own rules for its application and financing of such programs. The costs of such therapy are usually covered by both pharmaceutical companies and the health service. This is temporary access to the therapy being conducted, i.e. only until the medicinal product obtains a marketing authorization. If the sponsor has not submitted an application for a marketing authorization for the medicinal product, it is not possible to apply this procedure.

It follows from the above-mentioned legal provisions that the bioethics committee in Poland has no authority to oblige the sponsor of clinical trials to continue supplying the drug being tested after the clinical trial has ended. Furthermore, it is not possible to supply an unregistered medicinal product that cannot be marketed in accordance with applicable legal regulations. It is the sponsor who decides on the orders for medicinal products or on conducting a “follow up study” or “open label study” to enable the continuation of treatment, which is associated with the resumption of the trial.