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LEGAL ASPECTS OF THE USE OF ML AND AI IN PHARMACEUTICAL PRODUCTION – POLISH AND EU REGULATIONS

Publication date: January 16, 2026

Pharmaceutical production is one of the most regulated activities in Poland, Europe, and globally. The reason seems obvious: creating drugs can cause numerous complications, health problems, and in extreme cases, even death, depending on the individual patient’s health contraindications. Due to the above-mentioned reasons, the process of creating a new drug is often very expensive and lengthy, and involves a large number of professionals and scientists specializing in this field. In an era of dynamic digitalization, the need to develop specific operational rules for drug production and principles for using AI (Artificial Intelligence) and ML (Machine Learning) models is increasingly emphasized. Manufacturers are often considering implementing AI systems to support pharmaceutical production processes.

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LifeScience Kraków Cluster meeting

Publication date: January 16, 2026

On January 15, 2026, our colleague, Zofia Kubic, had the opportunity to participate in the LifeScience Kraków Cluster meeting, representing the KG Legal Kiełtyka Gładkowski law firm, a member of the cluster. The meeting was held as a Cluster Breakfast and was concise and strategic in nature, focusing primarily on the organization’s development plans for the coming year and beyond. Additionally, 2026 was considered a special year in the Cluster’s history, marking its 20th anniversary.

During the meeting, it was emphasized at the outset that the Cluster would continue its activities in its existing key areas. These included: bioeconomy, healthcare technology, innovative therapies and medical devices, diagnostics, and preventive healthcare. Emphasizing these areas was intended to confirm the continuity of the Cluster’s strategy and further direct its activities, including through the development of roadmaps and the development of cooperation between partners operating in these sectors.

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THE END OF THE INSTITUTION OF INCAPACITATATION IN POLAND, THE DRAFT ACT ON INSTRUMENTS FOR SUPPORTED DECISION-MAKING

Publication date: January 16, 2026

Prepared by Konrad Byrski, KIELTYKA GLADKOWSKI KG LEGAL

One of our lawyers, Konrad Byrski, had recently the opportunity to participate in the Legal and Psychological Congress, which aimed to exchange views, discuss and present interesting issues regarding the participation of expert psychologists and psychiatrists in various types of proceedings provided for in the Polish legal system and basic institutions that include an emphasis on psychological sciences.

The topic of his presentation was the institution of incapacitation, periods of momentary consciousness of a mentally ill person (the so-called “lucidum intervallum”) and their impact on the performance of legal acts, as well as the institution of total and partial incapacitation with a strong emphasis on the draft act on instruments of supported decision-making, which put the existence of these two institutions in uncertainty in the near future.

This article will explore the draft of this bill. It will discuss the reasons for these likely changes, the new regulations it provides, and its implications for individuals already subject to various forms of incapacitation.

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Poland blocks the national implementation of the EU Act on the provision of electronic services

Publication date: January 15, 2026

The draft act amending the Act on the Provision of Electronic Services and certain other acts represents a significant step in adapting Polish legal regulations to the rapidly evolving digital landscape. The growing number of entities operating online, new methods of electronic communication, and the vast scale of data processing mean that the current regulations are increasingly imprecise or inadequate for the current times. In response to these challenges, the legislator proposed changes aimed at both increasing the protection of network users and clarifying the obligations of entities providing electronic services.

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Analysis of the new rules of the Warsaw Stock Exchange for issuers listed in the NewConnect alternative trading system and methods of delisting a company from NewConnect

Publication date: January 13, 2026

The NewConnect exchange operates as an alternative trading system operated by the Warsaw Stock Exchange. It was established to create a space for small and medium-sized companies with high potential, which can be tapped thanks to the capital injection NewConnect seeks to offer. In November 2025, the WSE announced changes to the regulations of this exchange, as well as the Catalyst exchange. However, it is widely known that the change will primarily affect NewConnect. It is intended to increase the transparency of companies listed there and ensure the attractiveness of the exchange. This is one of the first steps towards the “revitalization of NewConnect.” Nevertheless, companies continue to withdraw from NewConnect or seek to migrate to the regulated market.

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