POLAND Law and Practice Contributed by: Barbara Kiełtyka, Jakub Gładkowski and Małgorzata Kiełtyka, Kieltyka Gladkowski KG Legal
low-risk AI systems, while supporting solutions will be considered high-risk AI systems. 8.5 Drug Discovery and Development It is important to focus on the most crucial aspect of the drug discovery process, namely its final phase: clinical trials. Polish regulations directly address the analysis of drug testing results in humans based on a positive decision to conduct a clinical trial. This con - cerns the functionality of the AI algorithm for analysing data from the first patients of the drug being tested, ie, clinical trial participants. When using AI/machine learning-based AI as a subset of AI technology in the context of drug evaluation, development or monitoring, as recommended by the European Medicines Agency (EMA), prior regulatory support must be obtained, for example, through scien - tific advice or qualification of the innovative develop - ment method. These recommendations are present - ed, among others, in ‘Review of AI/ML applications in medicines lifecycle’, 9 July 2025 (EMA/571739/2024). In Poland, the Act on Clinical Trials of Medicinal Prod - ucts for Human Use is in force, implementing Regu - lation (EU) 536/2014. Although it does not directly address AI, its provisions apply to AI-based tools used in clinical trials. According to the regulations, the ethi - cal review of the trial is performed by the Supreme Bioethics Committee (Chapter 5). Furthermore, the use of Good Clinical Practice is rec - ommended. In Poland, these principles are recom - mended not only for clinical trials of drugs but also for other medical experiments, particularly those involv - ing human participants. These standards expand upon the provisions of the Medical Profession Act regarding medical experiments. According to the European Parliament guidelines, any use of AI in clinical trials requires appropriate ethical oversight. All medicinal products are subject to Good Manufac - turing Practice in accordance with the Polish Phar - maceutical Law. According to Polish Pharmaceutical Act, an application for a marketing authorisation for a medicinal product must include a description of the
manufacturing of the medicinal product and a descrip - tion of the control methods used in the manufacturing process, and for this purpose the regulatory authority will examine issues such as, among others: • machine learning and molecular dynamics; • pharmacokinetic modelling; • molecular docking; and • identification of lead compounds, and the method of applying AI in these processes. In the EU, regulation of AI in drug discovery and devel - opment is based on co-operation between national regulatory authorities, the EMA and the European Commission. According to Recital 25 of the AI Act, AI systems used solely for scientific research and development purposes are exempt from the regula - tion (Article 2 (6) of the AI Act), which aims to protect scientific freedom and foster innovation. Article 2 (8) of the AI Act exempts pre-market AI research and devel - opment from regulation, except for tests in real-world conditions. 9. Future Trends and Regulatory Developments in Healthcare AI 9.1 Pending Legislation and Regulation Legislative work is currently under way in Poland on the draft Act on Artificial Intelligence Systems, devel - oped by the Polish Ministry of Digital Affairs. This pro - ject aims to implement the provisions of the AI Act, particularly a coherent national system for oversight of AI systems. The proposal would establish a new institution to oversee and support the AI sector: the Commission for the Development and Security of Artificial Intel - ligence. In June 2025, the European Commission received the final version of the General-Purpose AI Code of Practice, which is designed to help industry comply with the AI Act’s rules on general-purpose AI, includ - ing healthcare AI systems.
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