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Внедрение новых технологий синтеза фармацевтических субстанций – интенсивного проточного микрореакторного синтеза АФС и асимметрического синтеза интермедиатов и активных фармацевтических субстанций (АФС) с использованием ферментов, созданных методами генетической инженерии – имеет важное значение для локализации производства АФС в России. Показаны возможности использования имеющихся в России научных заделов для быстрого внедрения в отечественное производство нового портфолио АФС с наименьшими операционными затратами, максимальной экономической эффективностью и конкурентоспособностью.

Objectives: The German healthcare system introduced an early benefit assessment for new active ingredients and successive price negotiations with payers in 2011. This paper analyzes how the assessment is in accordance with Porter's concept of value-based healthcare and which specific value-based starting points pharmaceutical companies possess during drug development and benefit assessment. It is further investigated which importance patient benefits possess for pharmaceutical companies and how the benefit assessment led to changes in strategies and structures. Future tendencies for development are discussed. MethOds: A literature review established the linkages between the value-based healthcare concept (Michael Porter) and the German market-access process. Seven in-depth, qualitative interviews were conducted with German executives from the research-driven pharmaceutical industry in May 2016 according to a semi-structured interview guideline. The data was coded and analyzed. Results: The market-access process and the value-based healthcare concept mainly match in aspects of clinical outcome measures, pricing approaches and cost-benefit-assessments. All pharmaceutical companies interviewed act patient-oriented. This influences study design by increasingly gathering quality of life data. Several companies are open to new healthcare models as well as new pricing models (f.i. outcome-based pricing; capitation). However, major challenges exist both internally and externally: discrepancies with payers about payback period (short-term financial planning of statutory health insurances), inconsistencies in the study design, marketing authorization and HTA requirements between different countries, and implicit as well as explicit organizational change on different hierarchy levels and departments. Market-access/HEOR departments are gaining importance while marketing/sales departments remain important (with changes in certain task areas). cOnclusiOns: The results reveal an increasing shift towards value-based elements in healthcare for pharmaceutical companies, payers and public authorities. However, major obstacles and methodological challenges still exist. More appreciation and respect for each other need to be developed in order to establish successful initiatives jointly which are focusing stronger on treatment outcomes of patients.

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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.