With the current medical standards, the birth of a new medicinal product (drug) can only become a fact as part of a long and expensive research and development process. Such a process is burdened with a high risk of failure. Usually, the research and development process lasts many years and is low in efficiency. However, such research is undoubtedly needed.
How to obtain permission for a clinical trial of a medicinal product?
In order to obtain permission to conduct such a trial in the territory of the Republic of Poland, an application for permission must first be submitted. Such an application may be submitted only by the sponsor – which stands for a natural person, company, institution or organization responsible for initiating, managing and arranging the financing of a clinical trial (Article 2, paragraph 2, point 14 of the Regulation of the European Parliament and of the Council (EU) No 536/2014 of 16 April 2014, OJ EU.L.2014.158.1). The sponsor is obliged to submit such an application via CTIS (i.e. the new European system, Clinical Trials Information System) to each interested Member State concerned by a given clinical trial. In the case of the Republic of Poland, the body that issues permits for clinical trials is the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
The risks associated with artificial intelligence in healthcare are extremely diverse and complex. These may include not only potential harm to patients, but also impact on medical practice, physician effectiveness, and medical ethics. For example, artificial intelligence algorithms can influence the clinical decisions of physicians by suggesting diagnoses or therapies based on the analysis of patients’ medical data. However, if these algorithms are not sufficiently accurate or are not properly tested, they can lead to misdiagnoses or therapeutic recommendations, which in turn can negatively affect patients and treatment outcomes.
Therefore, it is necessary to properly classify and identify the risks associated with each artificial intelligence tool in health care. Some algorithms can represent low risk when used in simple tasks, such as analysing laboratory test results. However, if they are used in more complex situations, for example in the diagnosis of diseases, the risk can be much greater.
Parallel import of medicinal products is an institution that has its source in the EU law, resulting from the free movement of goods (Articles 34-36 TFEU), consisting in importing medicinal products from the European Union countries or a Member State of the European Free Trade Agreement. According to Article 21a of the Pharmaceutical Law, the medicinal products subject to parallel import must have “the same active substance or the same combination of active substances, at least the same indications up to level 3 of the ATC/ ATCvet code […], the same strength, the same route of administration and the same form as a medicinal product authorized for marketing in the territory of the Republic of Poland or a similar form that does not cause therapeutic differences in relation to a medicinal product authorized for marketing in the territory of the Republic of Poland.”[1]
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.
