Publication date: January 09, 2026
Much of the EU’s pharmaceutical legislation was adopted over 20 years ago. It is clear that much progress has been made in this area since then. Furthermore, due to the nature of European Union legislation, these regulations are fragmented into numerous smaller regulations and directives. To address both of the aforementioned issues, in 2023, the European Commission presented a draft of new legislation in this area. This draft was called the Pharmaceutical Package. After publishing the draft regulation and directive, the European Parliament adopted the draft with amendments at first reading in 2024. Since then, negotiations have been ongoing with the Council of the EU on the final shape of the regulations. However, on December 16, 2025, the Council published the outcome of the negotiations, announcing that both legislative bodies had reached a preliminary agreement on the final shape of the regulations.[1] Now, the draft will be put to a vote by the EU Council, where, probably after introducing the agreed amendments, it will be sent back to the Parliament, which will have to accept the amendments.
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Publication date: January 09, 2026
Disclosure obligations under MAR
Regulation (EU) No 596/2014 of the European Parliament and of the Council of 2014 (the so-called MAR Regulation) imposes a number of key information and disclosure obligations on issuers of financial instruments and persons discharging managerial responsibilities.
The main disclosure obligations contained in the aforementioned regulation include, among others, the disclosure of confidential information, as set forth in Article 17. Under this provision, the issuer of securities must publicly disclose all confidential information that directly concerns it as soon as possible after the issue. All such information should be provided in a manner that ensures prompt access and allows for full public review. However, a delay in disclosure is possible. This situation occurs when immediate disclosure could harm the issuer’s interests, but the delay does not mislead the public, and the issuer is able to ensure the confidentiality of the information. The Polish Financial Supervision Authority must be notified of any delay immediately after the information is published.
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Publication date: January 07, 2026
The Listing Act is a legislative package proposed by the European Commission and adopted by the European Parliament and the Council. Its goal is to increase the attractiveness of public securities markets for companies, primarily by facilitating access for small and medium-sized enterprises (hereinafter referred to as SMEs). The changes introduced are intended to simplify procedures and reduce documentation, as well as reduce burdens and costs for companies.
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Publication date: January 07, 2026
The European Union has launched a comprehensive regulatory framework for biotechnology and support for businesses in this field. It is estimated that approximately 80 percent of active pharmaceutical ingredients are imported, particularly from countries such as China and India. The European economy cannot afford this current state of affairs if it is to remain competitive, stable, and attractive to investors. For this reason, the so-called Biotech Act, which is intended to regulate the field and industry of biotechnology, as well as research conducted on it, in such a way as to solve the current problems occurring therein.
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Publication date: January 07, 2026
Intellectual property law plays a key role in protecting creativity and innovation, regulating the use, management, and transfer of rights to works, inventions, and trademarks. In the Polish legal system, these issues are grounded in specific provisions, such as the Copyright and Related Rights Act and the Industrial Property Law, as well as in the general provisions of the Civil Code. The transfer of intellectual property rights, including their transferability, succession, and the form of contracts, raises many practical questions. Can intellectual property rights be transferred under the Civil Code? What are the rules governing their transfer? This article will examine these key issues, including the relationship between the general provisions of the Civil Code and the provisions of specific laws.
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