The article presents the results of a comparison of the Orphan Drugs Register approved for use in the United States and the 2020 Vital and Essential Drugs List approved on October 12, 2019 by Order of the Government of the Russian Federation No. 2406-r. The comparison identified 305 international non-proprietary names relating to the main and/or auxiliary therapy for rare diseases. The analysis of the market of drugs included in the Vital and Essential Drugs List, which can be used to treat rare (orphan) diseases in Russia was conducted.

No abstract

Prospects for the development of a transdermal dosage form (DF) based on microneedles were considered. Methods for obtaining such systems, the application areas, and data from the pharmaceutical market were examined. A wide sample of INNs that are used to reduce pain in osteoarthritis patients was formed based on clinical guidelines. The market capacity, sales by Anatomical Therapeutic Chemical (ATC-2) groups, and sales depending on the DF were discussed. Criteria for the choice of active ingredients with market potential were defined. An analysis of a short list revealed that meloxicam has sufficient market potential to create a microneedle DF. A forecast of meloxicam consumption based on time series models indicated stable sales-growth dynamics and a potential market size of 4.6 billion Russian rubles by 2030. Results of the study indicated good market prospects and justification of pharmaceutical development of a new transdermal DF including meloxicam microneedles as the active ingredient.

Objective: analysis of state regulation of prices and costs for the purchase of medicines (drugs) in the United Kingdom (UK), and proposal development to improve the processes of state regulation of manufacturers’ marginal registered prices of medicines included in the list of vital and essential drugs approved in the Russian Federation.Material and methods. Analysis of the structure of state regulation of prices and costs for the procurement of drugs was carried out based on information contained in the regulatory legal documents of the UK Government, health services and technical regulation, and data provided in systematic reviews and articles.Results. A key feature of regulation in the UK is maximizing the efficiency of health care costs based on the principles of digitization, long-term planning and health technology assessment in pricing. Government regulation of costs is focused on the patent-protected drug segment. Providers of such medicines fall under the Voluntary or Statutory Scheme and are required to make payments in the form of a fixed percentage of sales to the Department of Health and Social Care. Certain drug segments are exempt from payments to stimulate innovative development of the pharmaceutical industry and accelerate market access for new therapies. As practice shows, the Voluntary Scheme is more profitable for most companies. Regulation in the segment of reproduced drugs is carried out by free-market mechanisms and the antimonopoly service.Conclusion. The analysis revealed the mechanisms and key features of the methods of state regulation of prices and costs of the health care system for the procurement of drugs, identified best practices that are promising for adaptation to improve the state regulation of prices in the Russian Federation.