The Legal Regulation of Manufacturing and Access to Blood Products and Protection of Intellectual Property Rights in the Pharmaceutical Sector under the Conditions of War

Анотація

The article is devoted to the study of legal aspects of the production and access to blood products, taking into account the needs of Ukrainian healthcare system under the conditions of war. At present time, Ukraine, being in unprecedented conditions for the modern world, is waging a defensive war against the unprovoked Russia’s full-scale military aggression, and hence, one of the urgent tasks for the national healthcare system is to ensure public interests in access to medical treatment and to remove the existing obstacles using appropriate legal mechanisms. The stability of the blood system with a regular supply of donor blood, blood components, and availability of access to necessary blood products is critically important for saving human lives. Therefore, the state, which is implementing the state policy in the field of healthcare, should apply a comprehensive approach in maintaining the stability of the blood system and the access to blood products, and inter alia, eliminating the barriers created by the protection of intellectual property rights in the field of medicine and pharmacy. And since donor blood cannot be currently replaced by any other substance, donated blood and manufactured blood products are a national asset of critical importance of the healthcare system. Under the condition of emergency, which is the war in Ukraine at present, it is expedient and in the field of health care, it is also necessary and fair to apply legal mechanisms to ensure the access to medicinal products. This mechanism is proposed by Art. 73 of the TRIPS Agreement, which enshrines provisions on security exceptions, according to which the Member States may depart from their commitments to protect intellectual property rights, and, inter alia, to protect their essential security interests and taken in time of war or other emergency situations in international relations.

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