2021. RFLSP.Russian.Finnish.Life.Science.Industry.EN

1.2.2 Problems and barriers of the Russian pharmaceutical market
The past decade has revealed a number of issues that are characteristic not only of the
development of the local pharmaceutical industry, but stemming from general trends in the
development of social systems and high-tech industries. This range of problems is outlined in
the draft Pharma-2030 Strategy:
1. The pharmaceutical market as a part of the global healthcare market depends on the
trends characteristic of the development of the entire system.
2. The main systemic problem is the lack of funding for social programs and, in particular,
healthcare, both in developed and developing countries.
3. Due to the lack of funding, all markets are trying to reduce or at least keep the healthcare
spending through various methods – price control, implementation of evidence-based
medicine mechanisms, replacement of original drugs with generic ones, strengthening of
regulatory barriers in registration or quality control of production and circulation of
medicines.
4. Many technological competencies are becoming more accessible in local markets, which
weakens the position of global pharmaceutical companies in the markets of developing
countries (in the light of expiration of patent protection for most of the expensive drugs in
recent years, this trend seems to be especially significant).
5. The development of medical science and personalized medicine makes it impossible to use
traditional systems of financing healthcare budgets, challenges the existing medical
standards and treatment regimens, proposes new models of informing the medical
community about diagnostic and therapeutic opportunities through the introduction of
telemedicine systems and systems to support medical decision-making.
6. Entering local markets with finished pharmaceutical forms becomes extremely difficult
due to the extremely high cost and regulatory risks when registering and inspecting the
quality of pharmaceutical production in the target market. Therefore, having competencies
in the matter of a full production cycle as well as singularity of products become even more
important to ensure the possibilities of export to foreign markets.
The main barriers for the Russian pharmaceutical industry include the following:
§ dependence of the local market on imported products;
§ pressure from the regulatory systems of countries producing pharmaceutical products
for export;
§ regulatory barriers in the registration of medicines and quality control of medicines
circulation;
§ lack of local technological competencies: the dependence of both the segment of
finished pharmaceutical forms production and the segment of pharmaceutical
substances synthesis of chemical and biotechnological production on the
manufacturers of laboratory, pilot and industrial equipment; strengthening of the
sanctions’ the role in the global system of access to innovative technology platforms;
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