In brief

On 30 April 2021, the draft of a regulation for completely new clinical trials of medicinal products for human use, which implements Regulation 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repeals Directive 2001/20/EC (“Regulation“), was published for public consultation (“Draft“).

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Contents

1. Supreme Bioethics Committee
2. Ethical review of the clinical trial
3. Sponsor’s obligations
4. Liability for damages arising in connection with the clinical trial
5. Clinical Trials Participants Protection Fund
6. Fees
7. Financing of clinical trial-related healthcare services
8. Clinical trial inspection
9. Penal liability

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The majority of the Draft is intended to come into force simultaneously with the Regulation, whereas the provisions regarding (i) the liability for damages arising in connection with the clinical trial and (ii) the financing of clinical trials-related healthcare services are expected to become valid earlier, three months following the publication of the act.

According to the summary of the Draft (justification), the introduction of new regulations on clinical trials is aimed at increasing the attractiveness of conducting clinical trials in Poland. Stakeholders in the clinical trials market often make the success of dynamic development of clinical trials dependent on the complexity and user-friendliness of legal regulations in the country where the research is carried out. Undoubtedly, one of the stimulants for the development of clinical trials is to ensure a transparent legal system free of administrative and legal barriers. Currently, the ratio of the number of trials conducted in relation to the population is unsatisfactory as compared to other EU countries, such as the Czech Republic or Hungary.

Supreme Bioethics Committee

The Draft envisages the establishment of the Supreme Bioethics Committee (SBC) functioning within the Medical Research Agency (MRA). The SBC will be responsible for conducting ethical reviews of the clinical trials themselves or indicating a bioethics committee from the list. Bioethics committees will be entered onto the list of bioethics committees entitled to prepare an ethical review of the clinical trials maintained by the SBC chair upon request and subject to SBC’s approval.

Ethical review of the clinical trial

As mentioned above, an ethical review of the clinical trial will be conducted by the SBC itself or a selected bioethics committee. While selecting a bioethics committee, the SBC chair will indicate a deadline for the ethical review, along with the clinical trial documentation, of no longer than the following:

• 10 days as of the date a bioethics committee receives an application encompassing aspects addressed in Part I of the assessment report for the authorization of a clinical trial
• 20 days as of the date a bioethics committee receives an application encompassing aspects addressed in Part II of the assessment report for the authorization of a clinical trial
• 10 days as of the date a bioethics committee receives additional information delivered by the sponsor and that was requested within the process of granting authorization of a clinical trial
• 10 days as of the date a bioethics committee receives an application for substantial modification of a clinical trial

If an ethical review is not prepared within the above-mentioned timelines, the SBC will prepare it instead within the timelines envisaged in the Regulation.

Ethical reviews will be carried out by opinion panels consisting of at least five people selected by the SBC chair or the chair of the given bioethics committee. Ethical reviews will be accepted by way of resolution adopted by a three-quarters majority vote in an open ballot.

Sponsor’s obligations

Sponsor will be obliged to do the following:

• Carry out the obligations in accordance with the Regulation.
• Select the principal investigator, the investigator and the site where the clinical trial will be conducted.
• Conduct the clinical trial in accordance with the ICH guidelines within the scope of a detailed set of guidelines for good clinical practice, which is the current internationally accepted standard for planning, conducting, recording and reporting clinical trials consistent with principles derived from the Declaration of Helsinki.
• Obtain written consent from the principal investigator and the investigator to access the source documentation.
• Verify the informed consent of the clinical trial subject to participate in the clinical trial.
• Inform the principal investigator and the investigator that they no longer need to retain clinical trial records.

Liability for damages arising in connection with the clinical trial

The Draft assumes that conducting a clinical trial does not exempt the researcher and sponsor from civil liability arising out of the clinical trial. The sponsor and the researcher are liable for intentional damages of the clinical trial’s participants resulting from their actions.

Analogically to the current regulations, sponsors and investigators will be subject to mandatory liability insurance, except for a low-intervention clinical trial.

Clinical Trials Participants Protection Fund

Prior to commencement of the clinical trial, the sponsor will be obliged to pay a contribution to the Clinical Trials Participants Protection Fund (“Fund“). Each application for clinical trial authorization will be subject to contribution due as of the date of filing the application (returnable subject to certain conditions). The Draft does not contain information on the range or algorithms for calculating the contribution due for a given clinical trial.

In case of bodily injury, health disorder or death, a participant or their relatives will be entitled to file an application to ascertain whether it happened in connection with the clinical trial. Claims for benefits will need to be filed within one year from the date on which the claimant learned of the injury or health disorder of the clinical trial participant or from the date of death, however, this cannot be longer than three years from the date on which an event resulting in bodily injury, health disorder or death of the clinical trial subject occurred.

Claims will be filed with the MRA president, who will appoint a committee to consider the application. Proceedings before the MRA president will not be initiated in relation to the same clinical trial and the same subject if damages or monetary compensation has been finally judged or civil action is pending. The filing of a claim for benefits will interrupt the statute of limitations for claims relating to the effects of the clinical trial envisaged in the Polish Civil Code.

Each application filed with the MRA president will be provided to the sponsor and investigator (and analogically, an insurance company) who will have 30 days to present their position and relevant proof. The Draft envisages a detailed procedure for dealing with the claims that may end up with a maximum compensation of PLN 100,000 (approximately EUR 22,000) for bodily injury or health disorder and PLN 300,000 (approximately EUR 66,000) for a death of a clinical trial participant.

Fees

Applications for clinical trial authorization will be subject to fees ranging from PLN 6,000 (approximately EUR 1,330) for non-commercial clinical trials, to PLN 30,000 (approximately EUR 6,600) for phase I-III commercial clinical trials where Poland is a reporting member state. Fees will be divided into two parts — one paid on the MRA’s account and the other to the account of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (“Office“). Perhaps the idea was that the amount due to the MRA would be simultaneously a sponsor’s contribution to the Fund, but it is not stated or linked anywhere in the Draft.

Financing of clinical trial-related healthcare services

Analogically to current regulations, the sponsor will be obliged to finance healthcare services related to the clinical trial and covered by the protocol, which are not included in the publicly financed healthcare services, as set forth in the relevant provisions of Polish law (guaranteed benefits). In particular, the investigational medicinal products and equipment required for their administration.

In addition, the sponsor also finances, if they are guaranteed benefits, healthcare services that are: (i) necessary to address the consequences of emerging adverse reactions to an investigational medicinal product or adverse events resulting from procedures performed exclusively for the clinical trial; (ii) whose necessity results from the use of the investigational medicinal product; and (iii) performed for the sole purpose of qualifying a patient to participate in a clinical trial.

Clinical trial inspection

The Office’s employees will conduct inspections in accordance with Article 78 of the Regulation, and the relevant secondary legislation thereto. Information about the inspections will be delivered at least 30 days ahead of the planned inspection date, and the inspection plan at least five days ahead. The Office’s inspectors will prepare a report from the inspection within 30 days as of the inspection date and submit it to the Office president. In case of irregularities and/or failures, the Office president will deliver the report to the inspected entity with a request to remove the irregularities within no more than 30 days (in extraordinary cases — up to 90 days).

Penal liability

A person who carries out any of the following, will be subject to a fine, penalty of restriction of liberty or imprisonment for up to three years:

• Contrary to the provisions of Chapter 5 of the Regulation, conducts a clinical trial without obtaining the informed consent of the clinical trial participant or their legal representative.
• Contrary to the provisions of the Draft, uses incentives or financial gratuities in a clinical trial or makes promises to improve health in a clinical trial.
• Contrary to the provisions of the Draft, makes substantial and safety-relevant changes to the clinical trial protocol or documentation submitted in the authorization procedure without obtaining a positive ethical review of the clinical trial and approval of the Office president.
• Initiates or conducts a clinical trial without authorization.
• Fails to comply with the obligations to provide information referred to in Articles 42 (reporting of suspected unexpected serious adverse reactions by the sponsor to the EMA) and 52 (reporting of serious breaches) of the Regulation.