Polish Draft law on clinical trials of medicinal products for human use – what is the aim of the Polish legislator, what changes Polish legislator plans to introduce and what is their justification

The Polish draft law on clinical trials of medicinal products for human use was sent for public consultations on 30 April 2021 and is still waiting for the final wording.

This project aims to bring the current legislation into line with the Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, which aims to ensure the safety of people who take part in clinical trials, to simplify and speed up the authorisation procedures for such trials, which are a key part of the process of developing new medicines and improving treatment with existing medicines.

An additional objective of the Polish legislator is to increase the competitiveness of the Republic of Poland as a location for clinical research through the implementation of legal regulations allowing for the application of European standards and the introduction of additional facilitations encouraging clinical research, which will positively distinguish Poland from other countries. However, the Regulation is not exhaustive and requires Member States to introduce legal regulations which cannot be adopted at the Community level.

According to Article 1. of the bill, it is to regulate the following issues: the procedure for issuing an authorisation for a clinical trial of a medicinal product for human use and an authorisation for a substantial modification of a clinical trial; the tasks of the Supreme Bioethics Committee for Clinical Trials and the procedure for its appointment; the rules and procedure for entry into and removal from the list of bioethics committees authorised to conduct ethical assessment of clinical trials rules and procedure for ethical assessment of a clinical trial; obligations of the sponsor, principal investigator and researcher; rules for civil liability of the investigator and sponsor; rules for operation of the Clinical Trial Participants Protection Fund; amount and manner of payment of fees related to a clinical trial; rules for financing health care services related to a clinical trial; rules and procedure for clinical trial inspections.

The guidelines to Regulation 536/2014 (recital 31) require the introduction of appropriate statutory safeguards for informed consent to participate in a clinical trial including taking into account circumstances that could influence a potential participant’s decision to participate in a clinical trial, in particular whether the potential participant belongs to an economically or socially disadvantaged group or is in a situation of institutional or hierarchical dependence that could inappropriately influence their decision to participate in a clinical trial. Taking this into account, the proposed Article 3 (1) of the Act provides, as a general rule, that in clinical trials, no incentives, financial gratifications or promises to improve health may be used, with the exception of compensation for increased costs.

In the preamble to the Regulation, indent 81 indicates that Member States should take measures to support non-commercial clinical trials. Therefore, regulations have been introduced to the draft with a view to increasing the number of non-commercial clinical trials conducted in Poland and facilitating the obtaining of permits to conduct such trials.

The draft also addresses personal data protection issues. The proposed Article 7 of the Act provides for restrictions on the application of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC, with regard to the right to request erasure of personal data and restrictions on the right to request access to data during the duration or period of participation in a clinical trial.

Chapter II of the Regulation 536/2014 regulates the procedure for issuing an authorisation for a clinical trial and an authorisation for a substantial modification of a clinical trial, leaving it to the national level to regulate the authority competent to consider the application and to introduce mechanisms to ensure timely consideration of the authorisations. Article 9(1) of the draft Act sets out the types of proceedings introduced by the Regulation conducted in connection with a clinical trial. According to the preamble to the Regulation, it should be left for the Member State concerned to determine the relevant authority or authorities involved in assessing applications for authorisation to conduct a clinical trial. In the proposed Article 9(2) it is indicated that the competent authority for conducting the proceedings referred to in paragraph 1 is the President of the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Article 80 of the Regulation states that the European Medicines Agency, in collaboration with Member States and the European Commission, shall establish and maintain a portal at European Union level, which shall constitute a single point of entry for data and information on clinical trials. The proposed Article 15 of the Act indicates that the administrator of the EU portal will be the President of the Office, who will grant access to the EU portal to the Chairman of the Supreme Bioethics Committee for Clinical Trials of Medicinal Products.

Chapter 3 of the bill contains regulations concerning the Supreme Bioethics Commission. In the act it is proposed that the Supreme Bioethics Committee will operate at the President of the Medical Research Agency, however independently from the President himself. Such organisational positioning of the Supreme Bioethics Committee is justified by the statutory objective and area of activity of the Medical Research Agency, which is to support innovative activity in health care, with particular emphasis on the development of non-commercial clinical trials.

According to Article 9 of the Regulation, Member States shall ensure that the persons validating and assessing the application do not have a conflict of interest, are independent of the sponsor, the clinical trial site and of the investigators participating in the trial and of the persons funding the clinical trial in question, and are not subject to any other undue influence. Therefore, the draft law introduces provisions to guarantee the absence of conflicts of interest at the level of members of the Supreme Bioethics Committee.

The proposed Chapter 5 of the Act sets out the responsibilities of the sponsor, principal investigator and researcher. The proposed Article 32 defines who may act as the principal investigator. Within the meaning of the Regulation, the principal investigator in a clinical trial of a medicinal product conducted in the territory of Poland may be a physician, dentist, nurse or midwife who has the right to practice in the territory of Poland and holds a university degree in nursing or midwifery. In the case where the principal investigator will be a nurse or a midwife, an additional requirement was introduced that one of the investigators in the research team should be a physician or a dentist.

The act also regulates the problem of financing healthcare services in clinical trials by the National Health Fund. As the legislator points out, in the current legal state all ambiguities lead to a situation where the burden of financing health care services guaranteed by public funds is shifted from the public payer to the sponsor.