Each hospital is obligated to provide health services in accordance with the current medical knowledge. This means that therapeutic decisions should be made based on the clinical condition of the individual patient and the latest scientific data on therapy in the particular clinical condition. Despite this, in practice, many hospitals do not fulfill this obligation due to organizational, legal or economic problems. In recent years, these issues have become particularly important in the context of therapy with state-of-the-art medicinal products such as biological and non-biological complex drugs (NBCD). These products, due to their extremely complex structure and sensitivity to any change in the manufacturing process, differ significantly from simple chemical drugs. In general, it is assumed that it is not possible to ensure that product molecules, which in theory constitute the same substance but originate from different manufacturing sites, are identical copies. For this reason, there are no unequivocal scientific positions as to the possibility of switching during therapy a biological drug or NBCD from one manufacturer into biological drugs or NBCD produced by another company. There is no doubt, however, that any substitution should be a physician's decision dictated by medical premises. At the same time, in the realities of the Polish health service, purchases of medicinal products are made by hospitals as a part of public tenders, in which the subject of the order is described by the name of the active substance and only the price decides about the choice of the offer. In this case, the selection of a drug to continue the therapy for patients is not made by a physician, but is the result of the price criterion used in the tender. It can therefore result in the automatic switch of a biological medicinal product or NBCD of one manufacturer for a medicinal product from another manufacturer without medical reasons for such a switch. This may lead to a breach of the obligation to treat in accordance with the current medical knowledge and the rights of the patient.
In our assessment, an Innovative Hospital is a hospital that has developed appropriate organizational and legal solutions to ensure that its medical staff will be able to provide health services in accordance with the current medical knowledge. Without thusly interpreted innovative hospital it will not be possible to fully realize the patient's rights to receive appropriate and innovative treatment adapted to the clinical condition of a particular patient. Our Law Office has experience in developing such solutions and is prepared to present them to you. The key to providing patients with drug therapy in line with current medical knowledge is primarily medical competences of hospital staff. However, for these competences to be fully utilized, a favorable organizational and legal environment is necessary. We would like to help you create such an environment with our presentation.
The Law Firm Dobrzański Bzymek-Waśniewska Sroka-Maleta
Attorney-at-Law. A graduate of the Faculty of Law and Administration of Jagiellonian University. He completed attorney-at-law apprenticeship in the District Chamber of Attorneys-at-Law in Kraków. During his studies, Andrzej was a member of the Student Legal Clinic in the section of Medical Law. Andrzej gained his professional experience in the legal department of one of the biggest clinical hospitals in Poland. He specializes in issues in the field of medical and pharmaceutical law. He is also the author of academic publications in these fields of law. He has many years of experience in consulting in the field of reimbursement, registration and marketing of medicinal products.
During his studies, he was active in the Medical Law Section of the Student Legal Clinic. He gained professional experience in the legal department of one of the largest Polish clinical hospitals.
He specializes in issues in the field of medical and pharmaceutical law. He is also the author of scientific publications in these areas of law. Has many years of experience in consulting in the field of reimbursement, registration and marketing of medicinal products.