1. SID & GP
MINPROMTORG OF RUSSIA
Corporate
Communication
Center
IV ALL-RUSSIA GMP CONFERENCE
ASPECTS OF PPP ACCORDING TO THE PROGRAM OF MODERNIZATION FOR REGIONAL BLOOD TRANSFUSION STATIONS UNDER SPIC

2. SPIC
At present, domestic plasma preparations are not produced in an amount sufficient to meet the needs of Russian patients. There is no Russian production of certain types of plasma preparations. At the same time, recombinant preparations cannot completely replace plasma products.
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СПИК
In order to develop Russian manufacturing competencies, on September 25, 2018, a special investment contract No. 25 was signed between the Russian Federation, Octapharma-Pharmimex LLC, a joint venture of the Swiss Octapharma and Pharmimex JSC, Scopinfarm LLC and Pharmimex JSC itself.
Production of the following 10 plasma preparations will be mastered under the SPIC:
coagulation factors VIII and IX, VIII + von Willebrand factor
coagulation factors II, VII, IX and X in combination [Prothrombin complex]
human immunoglobulin anti-Rhesus Rho [D])
human immunoglobulin normal for subcutaneous (extravascular administration)
human immunoglobulin normal 5% and 10%
human albumin
General partner: Strategic partners: Official partners: Regional partners:

3. MODERNIZATION OF BLOOD TRANSFUSION STATIONS
The main problems of domestic production of high-quality and competitive (including on the world market) plasma drugs: the lack of modern technologies and the necessary legislative framework for the preparation of plasma for fractionation (substance), as well as limited access to a sufficient amount of plasma produced in full compliance with GMP.
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ГЧП
Within the framework of the concluded SPIK, Pharmimex JSC has to create 10 plasma centers by 2025, including using public-private partnership mechanisms with the constituent entities of the Russian Federation and the Federal State Budget Health Institution Blood Center of the FMBA of Russia.
PHARMIMEX Group
Carries out the creation and furnishing of a plasma center
Carries out technical operation
Transfers production technology
Carries out quality audits
Provides for consumables
Acquires plasma for fractionation
Constituent entity
Accepts a plasma center and hands over its stations for operation
Fulfills other obligations under PPP
Blood transfusion station
Carries out procurement of human plasma for fractionation in accordance with GMP
Transmits plasma for Pharmimex fractionation
General partner: Strategic partners: Official partners: Regional partners:

4. BENEFITS FOR PARTICIPANTS
PHARMIMEX Group
Constituent entity
Obtaining high-quality substance for the functioning of the pharmaceutical production of domestic drugs from human blood plasma
Stable long-term relations with the manufacturer (SEC) with the participation of a Constituent entity of the Russian Federation
Investments in the construction of a regional plasma center
Furnishing the SEC with modern equipment;
Savings of the budget funds of the constituent entity for the re-equipment and maintenance of the stations at the expense of a private investor
Creation of new jobs at the SEC
Payment of taxes to the local budget
Modern technology transfer as per GMP standards
Development of a new improved donor program in the region, optimization of the use of donor resources
Acquisition of new competencies by SEC employees
Stable long-term investor relations.
General partner: Strategic partners: Official partners: Regional partners:

5. FURTHER MARKET DEVELOPMENT
This direction development will allow to:
Fully meet the needs of Russian patients in plasma preparations;
Organize the supply of high-quality and competitive plasma preparations for export;
In the future - master the production of new drugs from blood plasma.
However, further development of the legislative framework is necessary, including for the following purposes:
Involvement of private investors in the process of procuring blood and its components for industrial use (creating private plasma centers) while maintaining state control over the circulation of this raw material within the Russian Federation;
Harmonization of legislation on blood donation and its components with legislation on the circulation of drugs in terms of the procurement of raw materials as a pharmaceutical substance, eliminating gaps and contradictions;
Involvement of private investors in the development of donor programs.
General partner: Strategic partners: Official partners: Regional partners:

6. THANK YOU FOR YOUR ATTENTION!
General partner: Strategic partners: Official partners: Regional partners: