Concept and Legal Regime of Innovative Pharmaceuticals and their Impact on the Pharmaceutical Market

Innovations, including innovative pharmaceuticals, are key factors in the development of modern economy, contributing to the availability of high-quality and effective medical care. However, legislation is lacking a legal definition of an “innovative medicinal product.” Moreover, the current legal doctrine lacks a unified view on the essence of this concept and the advisability of its enshrining in law. The author reviews the main approaches to defining an innovative medicinal product (remedy) using doctrinal sources and the achievements of professional communities with the purpose of disclosing the content of the legal regime for innovative medicinal products. This includes an examination of the essential elements of such a legal regime, a study of the concepts of “pharmaceutical market” and “pharmaceutical market participants,” and the impact of the legal regime for innovative medicinal products on the pharmaceutical market. The author analyzes various definitions of an innovative medicinal product formulated by representatives of the doctrine and professional communities, e.g., the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union. Existing approaches to the legal regime for innovative medicinal products are analyzed. The study relies on formal-logical, dogmatic, comparative, and axiological methods. Approaches to defining the concept of an innovative drug are analyzed, including its scope and content, as well as its main elements. Relationships between the concepts of an innovative drug, an original drug, and other concepts contained in legislation are examined. The need of enshrining the concept of an innovative drug in legislation is argued, along with the scope and possible areas of its practical application. The content of the legal regime for innovative drugs is considered, including its main elements and constituting components. Approaches to the concept of pharmaceutical market and the composition of its entities, considered both in a broad and narrow sense, are formulated; the influence of the legal regime for innovative drugs on the activities of pharmaceutical market agents is identified. The results obtained underscore the relevance of introducing the concept of “innovative drug” into official documents for ensuring the transparency of funding, creating incentives for scientific research and innovation in pharmaceuticals, and extending the availability of modern drugs. The legal regime for innovative drugs consists of three levels: general, special, and specific. The specific component of the legal regime is aimed at stimulating research, protecting intellectual property rights, ensuring accessibility and competition, influencing the activities of a wide range of pharmaceutical market participants.

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