The Ministry of Health in Poland has proposed a number of draft laws aimed at combating the sale of electronic cigarettes and heated tobacco products. The new regulations will concern the amendment of the Act of 9 November 1995 on the protection of health against the effects of using tobacco and tobacco products (consolidated text: Journal of Laws of 2024, item 1162), hereinafter referred to as the “Tobacco Act”. The Government Legislation Centre website currently presents draft laws prohibiting the sale of nicotine-free electronic cigarettes to persons under 18 years of age and introducing the definition of a heated tobacco product into the Tobacco Act. The Ministry of Health has also announced a draft law on a complete ban on the sale of disposable cigarettes.
Ban on the sale of electronic cigarettes to persons under 18 years of age and other restrictions
The document “Principles of Corporate Governance for Supervised Institutions” developed by the Polish Financial Supervision Authority (KNF) is a key set of principles regulating the functioning of supervised institutions, such as banks, pension funds, insurers and other financial market entities. Adopted by the KNF resolution of 22 July 2014, it has been in force since 1 January 2015 and serves as a guide in ensuring transparency, stability and ethics of the operations of entities on the financial market.
According to Food and Drug Administration (FDA), a ‘generic drug’ is the same as a brand name drug in many aspects such as dosage, safety, strength, how it is taken, quality, performance, and intended use. On the other hand, the term supergeneric is applied to the development process for small molecule drugs which represent new therapeutic entities which demonstrate an improvement in either product delivery, design or through the application of a more efficient manufacturing process.
The importance of artificial intelligence in creating new drugs
Artificial intelligence is increasingly used in research on the search for new drugs. Pharmaceutical companies are investing in AI programs that will allow for the production and introduction of new drugs to the market more efficiently. Studies show that the market for artificial intelligence in the process of discovering new drugs will increase fivefold in 5 years [1]. The efficiency of this technology should also be addressed. Boston Consulting Group has prepared a report on the issue of the number of active molecules discovered by AI [2]. The authors of the review confirmed that thanks to artificial intelligence, a doubling of the overall productivity of pharmaceutical research and development can be expected. It should be remembered, however, that the molecules discovered by AI are still in the testing phase, but the results are satisfactory so far. Due to the growing popularity of using AI in this way, legislators must regulate these issues in generally applicable laws. Lawmakers in the United States and the European Union are introducing new regulations regarding the regulation of AI systems. This may have a significant impact on the production of medical devices and their admission to trade.
The IP Box (Innovation Box) relief is one of the tools introduced to the Polish tax system to support research, development and innovation activities. Since 2019, Polish entrepreneurs, including individuals conducting business activities, can benefit from a preferential tax rate of 5% for income obtained from qualified intellectual property rights. This solution is of particular importance for the dynamically developing IT industry, in which the work of programmers often generates qualified income, for example from copyrights to software.
However, the IP Box relief raises many interpretation controversies, especially in relation to the definition of qualified intellectual property rights and documentation obligations. In practice, taxpayers often encounter difficulties in separating income covered by the relief and meeting the requirements for maintaining detailed records. An additional challenge is the application of the relief in the context of international cooperation, especially in the case of Polish programmers implementing contracts with foreign companies.
