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.
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.
The use of AI and machine learning solutions in drug manufacturing technologies with the use of machine learning and quantitative, high-throughput in vivo experiments; the EU regulations for advanced therapy medicinal products (ATMP) and the procedures for placing the most modern drugs on the world market by the European Medicines Agency.
The intensive development of medicine affects the medical regulatory law in the European Union, which should cover more and more new legal problems related to the increasingly common application of advanced solutions of artificial intelligence, machine learning, telemedicine solutions and cyber solutions to the technology of manufacturing medicinal products.
One of the characteristics of diseases and conditions is that different illnesses often affect people to completely different degrees and with completely different frequencies. With the advancement of modern medicine, organizations have begun to take a more serious look at the problem of rare diseases. However, the diagnosis and treatment of such diseases are still highly problematic. One of the problems associated with this is the low revenue from such drugs. Due to the fact that some diseases are very rare, the cost of the process of developing and introducing them to the market is disproportionate to the expected sales of such drugs. This happens because of a very narrow group of people affected by such diseases. Drugs for these rare diseases are called orphan drugs or orphan medicinal products (Orphan medicinal products).
The Polish Act on the Protection of Health against the Consequences of Using Tobacco and Tobacco Products (Journal of Laws 1996, No. 10, item 55, as amended) has undergone several significant changes in recent years.
On March 31, 2025, a law introducing a ban on the sale of heated tobacco products with a characteristic aroma was signed. It is worth mentioning that Commission Delegated Directive (EU) 2022/2100 of 29 June 2022 amending Directive 2014/40/EU of the European Parliament and of the Council as regards the abolition of certain exemptions for heated tobacco products (OJ L 283, 2022, p. 4), which required EU Member States to introduce such a ban, waited almost 3 years for implementation.
At the time of the act’s signing, work was underway on two further draft bills. The first of these had already been submitted and adopted as the Act of 21 May 2025 amending the Act on the Protection of Health against the Effects of Using Tobacco and Tobacco Products (Journal of Laws of 2025, item 799).
