Аналітично-порівняльне правознавство (May 2024)
Criteria for granting access by an EU member state to a severely ill patient to an unauthorized medicine
Abstract
The article focuses attention on the fact that a structural element of everyone's subjective legal right to medical care is the right to access to a medicinal product. It is emphasized that the Covid-19 pandemic, the increase in the spectrum of incurable diseases and the number of patients suffering from them, Russia's aggression against Ukraine, the consequences of which are an increase in the number of military personnel and civilians who need the use of medicinal products created using the latest technologies, but which (medicines) are still not allowed in the state, the integration of Ukraine with the EU became the factors that actualized the discussion of scientists and practitioners on the issue of the conditions that must be observed by the EU member state in order to apply the provisions of Article 1. 5 of Directive 2001/83/EC of the European Parliament and of the Council on the Community Code regarding medicinal products intended for human use, the exception is to provide an EU member state with access to a patient to a medicinal product not authorized by the competent authorities of such a member state and thereby fulfill its obligation to provide everyone's constitutional right to medical care. The conditions that must be observed by the EU member state in order to apply the provisions of Article 1. 5 of the Exclusion Directives - for an EU member state to provide a patient with access to a medicinal product that is not authorized by the competent authorities of such a member state: 1) the presence of a norm of national law that allows the supply of a medicinal product for which a permit was not granted; 2) the goal is to meet the special needs of a specific seriously ill patient (private interest) and ensure the protection of public health (public interest); 3) be due to the absence on the national market of any authorized medicinal product - the equivalent of an unauthorized medicinal product; 4) delivery is made in response to a bona fide order on one's own initiative; 5) supply is carried out according to the prescription in accordance with the specifications of the authorized medical worker; 6) an unauthorized medicinal product is prescribed for use by a specific patient under his direct personal responsibility. The signs of the patient's special needs are highlighted: 1) the specific situation of the patient's state of health and the course of his illness; 2) medical reasoning, which is justified; 3) the patient's need for a certain medicinal product. The grounds for an unregistered medicinal product to be prescribed by a doctor are: the doctor's therapeutic considerations; results of research, analyzes of the patient. In a situation where there are authorized medicinal products on the market of an EU member state - analogues of prohibited medicinal products - the import of unauthorized medicinal products can be qualified as an act of non-fulfillment by the EU member state of its obligations, provided for in Article 1. 6 Directives.
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