1. КОМПЛЕКСНЫЙ ПОДХОД К СОЗДАНИЮ ЭФФЕКТИВНОЙ СИСТЕМЫ ЗАГОТОВКИ ПЛАЗМЫ ЧЕЛОВЕКА ДЛЯ ФРАКЦИОНИРОВАНИЯ

2. World Health Organization
1975 year
To promote the development of national blood service on voluntary non-remunerated donation of blood
2010 year
To reach self-sufficiency with plasma-derived medicinal products

3. Symposium EDQM 2019 «Plasma Supply Management»
Trends and obstacles problems in manufacturing and using of plasma-derived medicinal products
Symposium EDQM 2019 «Plasma Supply Management»
Increasing of demand for medicinal products
High price
Constraint with Immunoglobulin
Dependency of Europe from the source plasma supply from the US
Decreasing of recovered plasma collection
Increasing of demand for apheresis plasma
Decreasing number of donors in Europe
Compensation effect on donors and plasma safety

4. Non-remunerated donations
The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine
WHO - encouraging of non-remunerated donations

5. Portion of apheresis plasma collection in European countries
Self-sufficiency with plasma-derived medicinal products
Portion of apheresis plasma collection in European countries
Czech Republic
88%
Germany
65,3%
Netherlands
52,9%
Belgium
37,8%
Italy
26,8%
France
25,2%
Sweden
19,5%
Slovakia 0%
Symposium Summary:
To increase using of recovered plasma
To Increase apheresis plasma collection for plasma-derived medicinal products manufacturing
To involve the Blood Establishments in collection of plasma for fractionation

6. Development of plasma-derived medicinal products manufacturing in Russia
Russian Federation Presidential Decree № 598 «Improvement national policy in Healthcare Service» № “List of Vital and essential medicines” includes blood and plasma-derived medicinal products
human blood coagulation factors
human albumin
human immunoglobulin normal and specific
Russian Federation Presidential Dicretion № 598, enacted to achieve in 2018 year level of manufacturing of plasma-derived medicinal products in Russia up to 90% of demand
Road Map directed to promoting manufacturing of plasma-derived medicinal products

7. Involving of Blood Establishments in supplies of plasma for manufacturing of medicinal products
Federal Law № 61 «On drug circulation”, artical 45:
- manufacturing drug license and confirmation of compliance with GMP

8. Updating of directive and regulatory documents
Introduction of amendments to “Medical assessment of the donor”
Introduction of amendments to Monograph «Human plasma for fractionation»

9. Thank you for your
attention !