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).
Algorithms can be used in machine learning. A medical algorithm can help and guide the user on how to treat their patient and predict what condition they might potentially suffer from. This allows the system to provide health analysis based on the data provided. It is crucial to notice that algorithms can bring in more accuracy into medical diagnosis. This data can help a doctor to make recommendations on future steps in their patients’ treatment.
Machine learning that uses algorithms can be classified as medical devices. Those medical devices can be used for:
In-Vitro diagnosis
Assessment of public health
Prediction of the possibility of diseases
Detection of health conditions such as brain diseases, cancer etc.
