The need for doctors to use a medicinal product not approved for marketing in Poland raises the question of whether the lack of registration of the drug in Poland is equivalent to a ban on its use.
The solution to this problem can be found in Article 45 paragraph 3 of the Act of 5 December 1996 on the professions of physician and dentist (Journal of Laws of 2024, item 1287), which indicates that in justified cases, a physician may prescribe medicines admitted to trading in other countries, with a detailed justification in the medical documentation.
The Polish Ministry of Health will promote free applications that allow monitoring of the health of patients. Applications will be able to receive the title of “MZ Certified Application” (Software certified by the Ministry of Health) for a period of 24 months. According to the regulations for awarding applications the title of Ministry of Health Certified Application, the aim of the competition is not only to find applications that will provide information on health, but will also store data safely and their software will be a medical device.
There were attempts to introduce into the Polish legal system the compassionate use procedure, when implementing the amendments to the Polish Clinical Trial Act and Pharmaceutical Law. The changes were to enter into force in 2022, however, ultimately, the Act did not include any mention of the so-called compassionate use procedure. This procedure, also known as the use of medicines in exceptional situations, allows patients to access therapies that have not yet been registered on the market. This is particularly important in the context of rare and serious diseases, where available treatments are insufficient or ineffective. In many European countries, including in EU law, compassionate use is regulated and is an important tool in protecting public health. Unfortunately, in Poland, the implementation of this procedure encounters numerous obstacles, which is a serious problem for patients and doctors.
The concept of a named patient concerns the access to the supply of a medicinal product that is excluded by a Member State from the provisions of Directive 2001/83/EC, in accordance with the applicable provisions and in order to meet special needs [based on Article 5(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ EU L 311, 2001, No. 311, p. 67, as amended)].
On Thursday, October 10, KIELTYKA GLADKOWSKI KG LEGAL will take part in the meeting at the Life Science Cluster with SELVITA, on “Deciphering the Code of Drug Discovery: Application of Machine Learning in Designing Compound Libraries”. The meeting will be hosted by the leading Polish biotechnology company Selvita, including a Senior Machine Learning Specialist, responsible fordevelopment of the proprietary TADAM model (Target- Aware Drug Activity Model). This is a deep machine learning model that allows for efficient high-throughput virtual screening. This model has a significant advantage over other existing solutions on the market – it is much faster and more accurate in the analyses performed, and also achieves state-of-the-art results, enabling the creation of combinatorial library subsets targeted to a specific biological target. Studies of such sets significantly increase the probability of identifying the right active compounds, which is crucial for drug development. Additionally, a separate model has been developed to predict the optimal conditions for the amidation and Suzuki reactions. This facilitates the synthesis of the targeted libraries described above using appropriately arranged catalysts, reagents and solvents for optimal performance based on substrates.
