Publication date: March 05, 2025

The AI Act is a regulation adopted by the European Union regulating the use of artificial intelligence in various sectors of the economy, including health, finance and public administration. It is a groundbreaking legal act in this matter. The AI Act has a particular impact on the life science sector, as companies related to the medical industry are increasingly using artificial intelligence in biomedical research, diagnostics and the development of new therapies. The regulation introduces new regulations that entities related to the life science sector are required to implement by August 2026.

The regulation must be complied with by both EU and non-EU entities if they introduce or use AI systems on the EU market (Article 2 (c) AI Act ). Importantly, AI systems used solely for research, innovation, non-professional activities, national security, defence and military purposes are not subject to AI ACT regulations.

Regulatory context

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Publication date: February 19, 2025

Introduction: The ambivalence of the issue and the regulatory context

The issue of informing the patient about the drug is of key importance in the treatment process, because the proper provision of information can affect the effectiveness of the therapy, patient safety and minimizing the risk of adverse effects. From a regulatory perspective, the rules regarding drug leaflets are precisely defined in both national and EU legal acts, but in practice we encounter differences in the formulation of this information by manufacturers, even in relation to products intended for the treatment of the same condition.

A comparative analysis based on the example of the comparative leaflets of two sample drugs, Maxitrol and Floxal – two preparations used in the treatment of blepharitis, although differing in composition and mechanism of action – reveals a certain editorial freedom of the manufacturers in shaping the content of the leaflets.

On the one hand, the law regulates in detail the requirements for the content of leaflets, on the other hand, there is flexibility in their formulation, especially in stylistic and organizational matters. The aim of this report is to provide an in-depth analysis of the legal provisions regulating this issue, as well as to present a comparison of two leaflets, taking into account both their substantive content and form.

Report objectives:

• Understand the laws that govern prescription drug information leaflets.
• Analysis of the details of the presentation of active substances, dosage, contraindications, etc.
• An assessment of the extent to which the drug manufacturer has freedom to edit such information and what the legal consequences of these choices are.

Legal Basis for Prescription Drug Disclosure Obligations

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Publication date: February 05, 2025

The ongoing digitalization of the healthcare sector in Poland brings new opportunities, but also challenges related to personal data protection and improving process efficiency. One of the latest achievements in this area is the introduction of the Health ID application, which aims to simplify and secure the process of confirming patients’ identity during the implementation of e-prescriptions. The new application, developed as part of the Potential Project, is an innovative solution that changes the approach to patient identification, while responding to the needs of modern data security standards [1].

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Publication date: January 28, 2025

What does the Regulation concern?

From 13.12.2024 there came into force in Poland, the provisions of Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and of the Council and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC (OJ EU. L. of 2023, No. 135, p. 1), hereinafter referred to as the “GPSR Regulation”. The abbreviation comes from the words General Product Safety Regulation. This legal act replaced the General Product Safety Directive (GPSD) from 2001, which, due to the enormous technological progress and the increased share of online sales on the market, has become outdated in the opinion of the EU legislator. The focus was on the unification of legal provisions, because the provisions were included in a regulation, which is binding in its entirety and directly applicable in all Member States, and therefore does not require implementation, e.g. by means of a separate statute.

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Publication date: January 14, 2025

Introduction

Super generics, often referred to as hybrid medicines in the European Union (EU) and complex generics in the United States (US), represent an important and growing category of pharmaceutical products. These medicines generally share a similar active substance with an already authorized product but differ significantly in their formulation, strength, route of administration, or indications. Such differences introduce additional value, enhancing therapeutic outcomes or addressing patient needs that existing generics may not fully meet.

In the EU, hybrid medicines are regulated through the European Medicines Agency (EMA). The hybrid application pathway is used for products that demonstrate therapeutic improvements over the reference medicine. This could include differences in dosage forms or additional indications, but the active substance remains the same. Hybrid medicines must meet the standard regulatory requirements for generics while demonstrating clinical efficacy and safety improvements related to the innovation. The EMA’s scientific assessment is central to determining whether the added value is sufficient to justify market approval.

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