Legal Aspects of Drug Provision for Citizens Suffering from Rare (Orphan) Diseases

The main purpose of this study is to suggest possible ways to improve the scope of drug provision for patients suffering from orphan diseases in the Russian Federation. The objectives of this study: to analyze ethical and legal considerations in the field of drug provision for orphan patients; to identify the main economic and legal ways to encourage pharmaceutical organizations to research, develop and produce orphan medicines; to highlight the features of advanced states, tracing the specifics of approaches and the evolution of legislation in the field of legal regulation of drug provision for patients with orphan diseases; compare legislation and national policies for patients with orphan diseases in countries such as the United States of America (hereinafter referred to as the United States), the European Union (hereinafter referred to as the EU), South Korea, Taiwan, Singapore, the Philippines (hereinafter referred to as the Asian region) and the Russian Federation. Laws and policies abroad are somewhat similar, but not identical. It is important to understand the main differences between all approaches and legal systems in order to improve cross-national cooperation in this area.