There is a variety of blood-based drugs and they are all irreplaceable and vital for patients. These are, for example, blood clotting factors, proteins taken by patients with hemophilia, and immunoglobulins.
Before, due to unresolved issues with the use of donated blood and its components within the country for the production of essential medicines, Russian pharmaceutical companies used imported raw materials, among other things, but sanctions have brought about their own corrections.
In 2022, significant changes were made to the Federal Law "On Blood Donation and its Components". It is provided that blood plasma can be transferred for the production of medicines not only to medical organizations, but also to manufacturers of medicines that are not related to medical organizations. In addition, the law creates conditions for attracting private investment in the development of the state blood donation system. The concept of increasing the procurement of blood plasma for the production of medicines for the period up to 2030 has been approved by the Russian Government.
The first stage is designed for 2023-2024. During this period, it will be necessary to modernize plasma centers and blood service facilities.
How the legislative regulation of blood plasma procurement for the production of medicines is currently being implemented was discussed on 28 June 2023 in the State Duma at a meeting of the Expert Council on Improving the Blood Service of the Russian Federation.
The event was attended by representatives of the legislative and executive authorities, businesses, blood services and the patient community. According to the participants, it is necessary to develop effective logistics, the so-called roadmap, which should answer the questions: Where to send plasma? Who will be transporting? Who concentrates and who produces?
Leonid A. Ogul, Deputy Chairman of the State Duma Committee on Health Protection, noted that the country's Blood Service is reaching a new level of development.
"There are strategic tasks for the implementation of the set goals. At the same time, the Blood Service needs state support in the development of the material and technical base, in the unified information system of donation and in the development of gratuitous donation. The relevance of the issue has become important in connection with the imposed sanctions, when restrictions affected the supply of a number of foreign-made medicines. But in order for the Blood Service to be able to fulfill its assigned role, it is necessary to eliminate the problems it faces," Leonid Anatolyevich noted.
Within the framework of the meeting, the Department of Emergency Medical Care and Health Risk Management presented statistics. Thus, the number of donors in Russia in 2022 was 1 million 380 thousand, of which 117 thousand were plasma donors. With the help of 400 thousand donations, 900 thousand liters of plasma were harvested. On average, a donor makes three donations. According to the legal regulation, 21 donations per year are allowed. Even with the available donor potential, it is possible to increase the harvest to 1.5 million liters per year. At the same time, the annual plasma demand for clinical use is about 350 thousand liters. Based on the data on the total volume of plasma harvesting, up to 500 thousand liters can already be sent to production.
As of today, according to the results of the audit, 8 constituent entities have been identified that have sufficient potential for harvesting blood plasma in the medium term. These are the Republics of Bashkortostan and Mordovia, Voronezh, Moscow, Nizhny Novgorod, Orenburg, Penza and Samara regions. Then, the main regional freelance transfusiologists spoke about to what extent these regions are ready to implement the law.
The chief physician of the Mordovian Republican Blood Transfusion Station, Olga Gennadyevna Makedonskaya noted that the Volga Federal District includes 14 subjects of the Russian Federation with a high population density. About 20% of all donors in Russia live in the Volga Federal District. The donor activity and donor potential in the region is huge.
"We are limited by the clinical need of our region. More than 11 million people could become donors. And this significant growth may close the needs of drug manufacturers in blood plasma. Today, the district provides its own production of blood products. These are the Nizhny Novgorod Blood Center, the Samara Regional Transfusion Station, as well as 37.5 tons of liters of donor plasma that are sent to production facilities that operate in the Russian Federation. The total contribution of the district to the production of drugs is 77 thousand liters. We are ready to go further," Olga Gennadievna said.
The chief physician of the Penza Regional Clinical Blood Center, Tatiana Vsevolodovna Krylova, said that in 2010 the Blood Service was reorganized in the region. Today, the only institution engaged in the procurement, processing and storage, as well as the provision of all institutions, including federal, with blood components is the Regional Clinical Blood Center.
"Within the framework of the federal program, the module "medical blood center" has been introduced, which meets modern requirements. Thus, the shortage of production areas has been eliminated. The center is ready to enter into a program to increase plasma production," Tatyana Vsevolodovna said.
Part of the plasma that is undergoing quarantine and is not in demand in medical institutions is sent to the pharmaceutical enterprise. However, in order to not surpass the planned tasks, in the Penza region, as in many other regions, blood plasma donors are artificially restricted.
The chief physician of the Moscow Regional Blood Center, Maria Viktorovna Appalup, stated that the Moscow region provides an opportunity for the implementation of many tasks that Russia and the region itself face. The developed transport network creates unique logistical conditions for donors and the creation of a network of plasma centers.
"Transfusion care has increased significantly over the past five years, both in terms of the number of patients who need help and the volume of transfused components. The consumption of red blood cells has increased by more than 50%, then platelets – by 181%. This indicates the development of medical care. At the same time, plasma consumption has increased by only 1% in five years. The plasma that remains in excess does not meet the GMP parameters for use in production. And the standard of laboratory examination, which is necessary for the clinic with the entire immunohematological line, makes the cost higher than if it were with targeted plasma harvesting," stated Maria Viktorovna.
According to the concept of increasing the procurement of blood plasma for the production of medicines, a public-private partnership is provided. In order to increase the volume of plasma harvesting, pharmaceutical enterprises will take on the tasks of re-equipping regional Blood Service facilities. The algorithm of interaction and the procedure for the tripartite conclusion of agreements on the joint development of the infrastructure of the subject of the circulation of donated blood and its components was also announced at the meeting.
In turn, representatives of the Blood Service, in order to avoid a situation where the head of an institution is left to deal with a complex legal problem alone, not described in the legislation, it was suggested that: All issues arising from new economic relations between public institutions and private investors will promptly be submitted for discussion for a collegial decision.
Dmitry Sergeyevich Galkin, Director of the Department for the Development of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of the Russian Federation, noted that the new law makes it possible to correctly formulate the terminology and regulate the pricing of plasma for fractionation, which is a raw material for drugs. The direct purchase price will be fixed by the marginal ceiling, taking into account costs and controlled by the FAS. Agreements on the infrastructural creation of plasma centers and the modernization of blood transfusion stations will also be taken into account.
First Deputy Director General of the NMRC for Hematology, Chief Freelance Transfusiologist of the Ministry of Health of Russia, Tatyana Vladimirovna Gaponova, speaking about the cost, noted that the resolution provides for negotiations and elaboration of all of these issues.
"The simplest mechanism for reducing the cost of plasma, so that the price is acceptable and interesting for the manufacturer and blood transfusion stations, is, of course, the provision of consumables and laboratory tests, because more than 70% are direct costs. It is possible to reduce plasma to a minimum cost," said Tatiana Vladimirovna.
By 2030, three new plasma processing and drug production enterprises should start operating in Russia.
