The sale of a new drug or medical device and clinical trials is a process between two opposing interest groups. On the one hand, it is about patient protection and the safety of the pharmaceutical market. On the other hand, it is about creating a legal environment that will accelerate the creation of new drugs.
Both goals are important. It is important to create the right legal balance. The balance between patient protection and facilitation of modern medicines and medical devices makes Europe attractive for locating new innovations in technology and creating new medicines and medical devices.
Placing legal priorities in creating law is a political compromise between the speed of producing a new drug and blocking innovation justified by patient safety.
The attractiveness of Europe for the pharmaceutical business compared to other global markets depends on the proper placement of priorities.
Due to extremely positive reviews of our Clients – for which our team is utterly grateful, three of our departments have been ranked among best firms in the Legal500 EMEA for Poland.
KIELTYKA GLADKOWSKI is honoured to present a piece of artwork which is a watercolour by the Polish artist colorQ, who is supported by our law firm KIELTYKA GLADKOWSKI as a part of one of the iSTART1® programs of our law firm. We have donated many of his works.
The artist focuses the work on motifs referring to the financial bull markets. This is watercolour technique on 100% cotton paper. The technique involves watercolour with professional SMITH and Schmincke paints, including dry pastels from Manufaktura Wełna and Rembrandt, and gilding with 23 carat Russian yellow gold and 22 carat gold (moon gold or champagne gold with an admixture of copper). The technique involves gold gilding with gold leaves.
New obligations of issuers of asset-linked tokens and e-money-linked tokens and crypto-asset service providers
Assumptions and purpose of the draft act on crypto assets
The draft act on crypto-assets is intended to implement into national regulations Regulation (EU) 2023/1114 of the European Parliament and of the Council of 31 May 2023 on crypto-assets markets and amending Regulations (EU) No. 1093/2010 and (EU) No. 1095/2010 and Directives 2013/36/EU and (EU) 2019/1937 (Journal of Laws EU. L. of 2023, No. 150, p. 40, as amended) (hereinafter: MiCA) specifying the principles of emission regulation and supervision, trading and providing services related to cryptocurrencies. The regulation has been in force since June 29, 2023, but will become fully applicable only in December 2024. The draft act provides for the introduction of new solutions in the area of the crypto-assets market sector, aimed at implementing the tasks arising from the MiCA regulation, in particular in the field of effective supervision and investor protection. According to the legislator, taking actions aimed at implementing the above-mentioned objectives will ensure long-term market development and security by extending supervisory competences. The Undersecretary of State of the Ministry of Finance is responsible for the draft act.
In the face of changing regulations and court practices, the issue of liability of management board members for the tax liabilities of limited liability companies, even after their formal dismissal, constitutes a significant challenge for legal practice. The latest case law, including the final judgment of the Polish Supreme Administrative Court, sheds new light on the interpretation of the provisions regarding the scope and conditions of this liability. Analysis of these judgments, in the context of Art. 116 paragraph 1 and 2 of the Polish Tax Ordinance and the Commercial Companies Code, reveals that dismissal from the management board is not in itself a sufficient basis for exemption from liability if actual actions prove the continuation of performing the function. In the context of company management, it is crucial to monitor changes in case law and legal regulations that may affect the interpretation of the duties and responsibilities of management board members. New court decisions may bring changes in the understanding of company management regulations, emphasizing the importance of appropriate documentation and procedures. For managers and legal advisors, continuous monitoring and adaptation to current legal requirements becomes an essential element of effective risk management and avoiding potential legal consequences.
